OSBI Criminalistics Services Division quality manual 12-31-10 |
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OSBI Criminalistics Services Division Quality Manual Revision #3 Effective Date: 12-31-10 Page 2 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director Table of Contents OSBI Mission and Vision Foreword Quality Policy Section Subject 1 Scope 2 References 3 Glossary 4 Management 4.1 Organization (QP 1) 4.2 Management system 4.3 Document control (QP 2) 4.3.1 General 4.3.2 Approval and Issue 4.3.3 Document changes (QP 3) 4.4 Review of requests, tenders, and contracts (QP 4) 4.5 Subcontracting tests 4.6 Purchasing Services and Supplies (QP 8, QP 9) 4.7 Service to the customer (QP 10, QP 11) 4.8 Complaints (QP 12) 4.9 Control of nonconforming testing (QP 13) 4.10 Improvement Page 3 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director Table of Contents Section Subject 4.11 Corrective action (QP 14) 4.11.1 General 4.11.2 Cause analysis 4.11.3 Selection and implementation of corrective actions 4.11.4 Monitoring of corrective actions 4.11.5 Additional audits 4.12 Preventive action (QP 15) 4.13 Control of records (QP 16.1, QP 16.2) 4.14 Internal audits (QP 17) 4.15 Management reviews (QP 18) 5 Technical requirements 5.1 General 5.2 Personnel (QP 19) 5.3 Accommodation and environmental conditions (QP 20) 5.4 Test and calibration methods and method validation 5.4.1 General (QP 21) 5.4.2 Selection of methods 5.4.3 Laboratory-developed methods 5.4.4 Non-standard methods 5.4.5 Validation of methods Page 4 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director Table of Contents Section Subject 5.4.6 Estimation of uncertainty of measurement (QP 22) 5.4.7 Control of data 5.5 Equipment (QP 24) 5.6 Traceability (QP 23, QP 24, QP 25, QP 26) 5.6.1 General 5.6.2 Specific requirements 5.6.3 Reference standards and reference materials 5.7 Sampling 5.8 Handling of test and calibration items (QP 5, QP 6, QP 7) 5.9 Assuring the quality of test results (QP 30, QP 31, QP 32) 5.10 Reporting the results (QP 28, QP 33) 5.10.1 General 5.10.2 Test reports and calibration certificates 5.10.3 Additional Requirements 5.10.4 Calibration certificates 5.10.5 Opinions and interpretations 5.10.6 Testing and calibration results obtained from subcontractors 5.10.7 Electronic transmission of results 5.10.8 Format of reports and certificates 5.10.9 Amendments to test reports Page 5 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director Attachments OSBI CSD QMA 1.1, Rev. 0 Notice to Customers OSBI CSD QMA 2, Rev. 1 Evidence Acceptance Requirements OSBI CSD QMA 3, Rev. 2 Evidence Sealing Guidelines OSBI CSD QMA 4, Rev. 1 Facilities and Available Services OSBI CSD QMA 5, Rev. 2 Alternate Service Providers OSBI Mission The mission of every OSBI member is to insure the safety and security of the citizens of Oklahoma. OSBI Vision The OSBI will continue to be the professional law enforcement agency for the State of Oklahoma. We provide specialized apprehension and crime detection services through teamwork, training, research, and implementation of innovative technologies. We recruit and retain the expertise required to meet changing responsibilities. We increase public awareness through proactive publicity and education. Foreword The Oklahoma State Bureau of Investigation (OSBI) and the Criminalistics Services Division (CSD) are dedicated to provide quality service and results. The OSBI CSD has adopted the standards set forth by the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB) Legacy and International accreditation programs. In order to facilitate accreditation by the International program, this manual has been organized using the same outline structure as the International Organization for Standardization and the International Electrotechnical Commission (ISO/IEC) 17025 standards. Much of the language in this manual is new. However, some language was extracted from the previous CSD Quality Manual. Quality Policy The OSBI CSD management is committed to providing quality and professional service to our customers. It is the objective of the OSBI CSD to provide service that meets or exceeds the customer's needs and to ensure that quality and analytical practices meet or exceed the standards required for accreditation. The management system documents are provided to CSD employees to communicate the procedures which must be followed to provide this level of quality and service. As indicated in Section 1 below, all CSD personnel are responsible for knowing and implementing these policies. This manual and the laboratory practices will be reviewed regularly in order to attain compliance with ISO/IEC 17025 standards and to continually improve the effectiveness of the management system. Page 6 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 1. Scope 1.1 This manual sets forth the policies and procedures which govern the work performed by members of the OSBI CSD. 1.2 All members of the CSD are responsible for knowing and abiding by all management system policies and procedures. 2. References The following standards guide the requirements set forth in this policy manual. If the reference listed does not include a date, the most recent revision of the referenced document applies. ISO/IEC 17025:2005 ASCLD/LAB-International Supplemental Requirements – Testing (Effective 04/01/2011) Quality Assurance Standards for Forensic DNA Testing Laboratories (Effective 07/01/2009) Quality Assurance Standards for DNA Databasing Laboratories (Effective 07/01/2009) The FBI Quality Assurance Standards Audit for DNA Databasing Laboratories (Effective 07/01/2009) The FBI Quality Assurance Standards Audit for Forensic DNA Testing Laboratories (Effective 07/01/2009) ASCLD/LAB Proficiency Review Program ASCLD/LAB Guiding Principles located at http://www.ascld-lab.org/about_us/guidingprinciples.html Page 7 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 3. Glossary In addition to the terms and definitions listed below, any definition provided in one of the documents listed in Section 2 also applies. ADMINISTRATIVE STAFF: The Criminalistics Administrators, CSD Director and Executive Secretary. ADMINISTRATIVE SUPERVISION: The authority to monitor the day-to-day activities and perform traditional managerial duties of assigned units or laboratories. CASE FILE: The file folder containing hard copy documentation relevant to a particular case or the electronic file contained within the BEAST that contains documentation relevant to a particular case. CASE RECORD: The cumulative records which document the quality, technical, and analytical information relevant to a particular case. COMPLAINT: The expressed dissatisfaction by a customer with the quality or timeliness of work products or services. CONVENIENCE PACKAGE: Evidence which is properly sealed and marked for identification may be placed in unsealed containers such as boxes or bags for the purpose of grouping items of evidence or for the convenience of carrying the evidence without that container having to meet the “proper seal requirements,” as long as evidence security requirements are otherwise met. These containers should be marked as a “convenience package.” CORRECTIVE ACTION: An action or actions implemented to correct circumstances which led to non-conforming work. Successful corrective actions should prevent a reoccurrence of the same type of non-conforming work. This is also referred to as “preventive measures taken” by QAS Standard 14.1.b.5. CORRECTIVE ACTION PLAN: A plan to resolve a discrepancy identified in casework, database activities, or proficiency testing work which will correct the problem and prevent a future occurrence. (QAS based definition – Std. 14) CRIMINALISTICS ADMINISTRATOR (CA): Individual who reports directly to the CSD Director and is responsible for supervising Criminalist Supervisors. CRIMINALIST SUPERVISOR: Individual who reports to a Criminalistics Administrator and supervises criminalists. CRITICAL REAGENT: A reagent that requires testing on established samples before use on evidentiary samples in order to prevent unnecessary loss of sample. Page 8 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director CUSTOMER (CLIENT): A recipient of the OSBI Criminalistics Services Division reports and/or services. A customer can also be within the Criminalistics or Investigative Services Division. DERIVATIVE EVIDENCE: Any tangible material removed or derived from an evidence item already having an assigned item number. Examples are cuttings, debris collections, latent lifts, and retained stain samples. Derivative evidence or containers will be marked with appropriate case number, item or sub-item numbers, analyst's initials and date, and listed in the case file. EVIDENCE: For the purposes of this directive, evidence shall mean all materials submitted for scientific analysis during the course of an official criminal investigation. EVIDENCE DESTRUCTION FORM: A form used to document permission for the destruction of evidence. EVIDENCE RELEASE FORM: A form used to document the return or release of evidence to the courts, OSBI employees, or submitting agencies. EVIDENCE TAPE: Tamper proof tape used in sealing evidence containers. FUNCTION VERIFICATION: A check to determine if a piece of equipment or instrumentation is working correctly within specified parameters. MAJOR DEVIATION: A planned and approved modification to current policy or protocol which will apply for a set period of time or to a defined grouping of cases or samples. MINOR DEVIATION: A planned and approved modification which will be applied to a single case, sample, or single batch of samples/cases. NO ANALYSIS CASE: Evidence in cases submitted to the laboratory where charges have been dismissed or for some other reason no analysis is required can be returned to the submitting agency. NON-CONFORMING WORK: Work that does not meet the standards set forth in policy, procedure, protocol, or does not meet the needs of the customer. This may occur due to protocol drift or due to a quality or technical problem with a reagent, supply, or instrument. ORIGINAL REQUESTING AGENCY: The agency having jurisdiction in the case that made the request for services. Evidence will be returned after analysis to the original requesting agency unless specified otherwise in this policy. PERFORMANCE CHECK: Actions taken to ensure analysis methods still perform as intended. Performance checks are similar to validations, but more limited in scope. Page 9 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director PHYSICAL EVIDENCE TECHNICIAN: Individual responsible for the reception, storage, documentation, and handling of the physical evidence submitted to an Oklahoma State Bureau of Investigation Laboratory. PREVENTIVE ACTION: Actions taken to improve circumstances which could lead to non-conforming work. (ISO/IEC 17025:2005 based definition) PROTOCOL DRIFT: Unintentional and/or unauthorized deviations from current protocol. PROPER SEAL: An evidence container is “properly sealed” only if its contents cannot readily escape and only if opening the container would result in obvious damage/alteration to the container or its seal. Staples alone cannot provide a sealed condition on evidence packaging. It is acknowledged that not all evidence can be sealed inside a container. A proper seal would constitute tape sealing, heat-sealing, or lock sealing and initialing the seal. A date on the seal is also recommended. Evidence such as weapons which will require only test firing or serial number restoration may be tagged with an identification tag and do not require a container. QUALITY: Adhering to generally recognized standards of good laboratory practice. QUALITY ASSURANCE (QA): Those processes necessary to provide confidence that the results from OSBI Criminalistics Services Division analysis and testing will satisfy given requirements for quality. QUALITY ASSURANCE AUDIT: A systematic examination and review to determine whether quality processes and related results comply with the protocols, policies, and procedures, and whether these practices are suitable and effective in achieving the quality objectives. QUALITY ASSURANCE PROGRAM: OSBI Criminalistics Services Division guidelines describing recognized quality assurance requirements for forensic laboratory analysis and reporting. QUALITY CONTROL (QC): The day-to-day operational techniques and activities used by the laboratory to consistently provide accurate analytical results that fulfill the requirements for quality. QUALITY IMPROVEMENT COMMITTEE (QIC): The Quality Improvement Committee is an ongoing committee for the purposes of reviewing and implementing ways to improve the quality of laboratory services. This committee, which meets at least quarterly, is composed of all Regional and Unit Supervisors, discipline Technical Managers and Administrative Staff. Page 10 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director QUALITY MANAGER (QM): The Criminalistics Administrator assigned the responsibility of overseeing quality operations including proficiency testing, auditing, reviewing non-conforming work, etc. QUALITY RECORDS: Records generated from quality assurance procedures. This includes, but is not limited to, proficiency tests, corrective and preventive actions, audits, training documentation, continuing education, and testimony review. REFERENCE MATERIAL: A material for which values are certified by a technically valid procedure and accompanied by or traceable to a certificate or other documentation, which is issued by a certifying body. Examples include known drug standards and NIST Standard Reference Materials (SRM’s) which can include known values for a variety of substances, including DNA profiles. REFERENCE STANDARD: A traceable standard, generally having the highest metrological quality available, from which measurements are derived. An example would be NIST traceable weights. REMEDIATION: Steps taken to correct non-conforming work, such as issuing an amended report, re-testing, etc. This is also referred to as “corrective actions taken” by QAS Standard 14.1.b.4. REQUESTING OFFICER: The individual, authorized by statute, requesting examination of the submitted evidence. Criminalists will not be listed as a requesting officer. RFLE: Request For Laboratory Examination form. SAMPLING: The practice of testing a portion of a substance and reporting a conclusion for the whole substance using a statistically based or reasonable assumption of homogeneity of the whole. SAMPLE SELECTION: The practice of selecting one or more samples from an item for testing based on training and experience. Following analysis, results are reported clearly and unambiguously to indicate that the results reported apply to the sample, not the whole item. SUBMITTING OFFICER: The person delivering evidence to an OSBI laboratory. Criminalists will be listed as the submitting officer when involved with the collection of evidence. TECHNICAL MANAGER (TM): The individual assigned the responsibility and authority for the technical operations in a particular discipline. TECHNICAL PROTOCOLS (PROCEDURES): Technical procedures are a key element in establishing and maintaining quality control within the laboratory. Written procedures will be prepared for those routine tests performed in the OSBI Laboratory. The procedures used may be Page 11 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director those developed and adequately validated by an outside agency or laboratory or those developed and validated in-house. TECHNICAL RECORDS: Documentation generated in the analysis of casework or database samples. This includes reports, examination documentation, quality control results, etc. TEMPORARY EVIDENCE CLOSURE OR SEAL: Temporary evidence closure consists of a piece of tape across a box, a paper clip on a folded evidence envelope, or some other closure that would not normally constitute a proper seal on evidence. A temporary closure is acceptable when the analyst will be away from the work area for a short period of time or overnight as long as the evidence is secured in a locking drawer or controlled access evidence area. TESTING: Testing refers to analysis conducted at the request of OSBI CSD customers. This may include casework analysis, database sample analysis, or other work mandated for the OSBI CSD. This does not apply to training, research, etc. TRACEABILITY: The property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons. VALID COMPLAINT: A complaint that has been verified and that warrants action. VERIFICATION: Determining whether or not a stated complaint is well founded, and indisputable. Page 12 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4. Management Requirements 4.1 Organization 4.1.1 Legal Responsibility The OSBI CSD is a division of the Oklahoma State Bureau of Investigation, which has been granted legal authority by state statute. Refer to O.S. Title 74, Section 150.2. The CSD Director is appointed by the Director of the OSBI and has the responsibility and authority for all laboratory functions and personnel. 4.1.2 Operating Guidelines The OSBI CSD will provide forensic science service which meets or exceeds the needs of customers. OSBI CSD service will also meet or exceed the applicable standards set forth by ASCLD/LAB. 4.1.3 Management System Scope The policies and procedures set forth in the management system apply to work performed by CSD personnel in any temporary, mobile, or permanent facility. 4.1.4 Interrelation of the OSBI CSD In addition to serving customers outside the OSBI, the CSD also provides services to the Investigative Division of the OSBI. An agency organizational chart is located on the OSBI Intranet at http://128.1.2.243:7001/hr_master/faces/orgchart.jspx?_adf.ctrl-state= 1475ubhsll_14. The responsibilities of the agency director, deputy director, and investigative personnel are located in OSBI Policy 103. 4.1.4.1 The responsibilities and authority of the CSD Director are defined in Quality Procedure (QP) 1. 4.1.4.1.1 The OSBI CSD Director shall have sufficient authority to make and enforce decisions. 4.1.5 Management Requirements The OSBI CSD ensures the effectiveness of the management system through the following steps. Page 13 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director a) Personnel are provided sufficient authority and resources to complete their duties, including implementing the management system and identifying, correcting, and minimizing deviations from policies, procedures, and protocols. b) Personnel are protected from influences which could adversely affect the quality of work performed. See OSBI Policy 105 and O.S. 257-20-1-9. c) Confidential case information, including electronically stored and distributed reports and documentation, is protected. Refer to Oklahoma Statute Title 74, Section 150.5. d) Activities which would bring question to the competence or integrity of the agency and its employees are prohibited. Refer to the OSBI Code of Ethics and OSBI Policy 105. e) Organizational structure, including relationships between management, technical, and support personnel is defined. Refer to the agency organizational chart on the OSBI Intranet. f) The authority, responsibilities, and interrelations for any position which impacts the quality of work performed are specified. Refer to the agency organizational chart and QP 1. Current job descriptions are located at http://www.ok.gov/opm/jfd/jfd_g-page.htm. 1. No employee is accountable to more than one supervisor per function. g) Testing staff, including trainees, will be supervised by individuals who are familiar with the methods and procedures used. This may be accomplished through the Supervisor’s own experience in the methods and procedures used by staff or through the Supervisor’s coordination with Technical Managers and/or Criminalistics Administrators familiar with the methods used. Refer to QP 19 for additional information on training. h) Each discipline has a technical manager who has the authority, responsibility, and resources required to ensure the appropriate quality of work. Refer to QP 1 for additional information regarding responsibilities and authority. i) The CA responsible for managing the forensic biology discipline has been appointed as the QM for the CSD. Refer to the agency organizational chart and QP 1. Current job descriptions are located at http://www.ok.gov/opm/jfd/jfd_g-page. htm. j) Key managerial personnel (as defined in section 4.1.8 below)are responsible for naming a designee and notifying employees during planned absences. If a designee is not named, or there is an unplanned absence, the individual’s Page 14 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director supervisor will be responsible for appointing a designee and notifying employees. Deputies for key managerial personnel are responsible at a minimum, for the critical duties of the position which cannot be delayed until the individual returns. k) Through routine unit and discipline meetings, all employees are informed of the importance of their activities and how those activities help ensure that the CSD meets the objectives of the management system. 4.1.6 Effectiveness of the Management System Administrative staff meets regularly and during meetings discusses the effectiveness of the management system and reviews the communication processes used in the laboratory to ensure they are appropriate. 4.1.7 Safety Coordinator The CA responsible for the administration of the controlled substances discipline has been appointed as the CSD Safety Coordinator and has the responsibility and authority for implementing, updating, and ensuring compliance with the health and safety program. 4.1.8 Key and Top Management Key management personnel includes the following positions: • CSD Director • Quality Manager • Safety Coordinator • LIMS Administrator • FSC Building Manager • Technical Managers • All Supervisors and Administrators Top management is the CSD Director. 4.2 Management System 4.2.1 Management System Documents The OSBI CSD management system documents the policies and procedures to be followed in order to ensure the quality of laboratory services provided. The OSBI CSD management system consists of the quality policy manual, the quality procedure manual, and discipline quality and protocol manuals. The documents of the Page 15 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director management system are available to all CSD employees on the OSBI Intranet, http://osbinet/main/. Refer to QP 2 for distribution procedures. 4.2.2 Quality Manual This document in its entirety is the quality manual for the OSBI CSD. The Quality Policy Statement is located following the Foreword. 4.2.2.1 The ASCLD/LAB Guiding Principles of Professional Responsibility for Crime Laboratories and Forensic Scientists have been included as a reference to this manual (See Section 2 – References). 4.2.2.2 The CSD Director ensures that these Guiding Principles are reviewed by all CSD personnel annually and maintains a record of that review, in accordance with QP 18. 4.2.3 Management Commitment Management is committed to developing, implementing, and continually improving the effectiveness of the management system. This is evident through management's involvement in quality procedures including audits, proficiency testing, management system review, etc. 4.2.4 Management Communication Management communicates the importance of meeting customer, statutory, and regulatory requirements during regular meetings of the Quality Improvement Committee (QIC). 4.2.5 Supporting Procedures Quality policies are included in the quality manual, which follows the same outline as the ISO/IEC 17025 standards. Procedures governing the implementation of these policies which apply to multiple disciplines are included in the Quality Procedures. Quality policies and technical procedures which apply to a single discipline are included in the discipline quality and protocol manuals. Discipline specific manuals should not contradict the CSD Quality Manual or Quality Procedures. 4.2.6 Roles and Responsibilities The roles and responsibilities of technical management and the quality manager are provided in section 4.1.5 above and the referenced attachments. Page 16 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.2.7 Management System Integrity CSD Management will preserve the integrity of the management system anytime changes to the system are planned and implemented. 4.3 Document Control 4.3.1 General The OSBI CSD controls all documents included in the management system to ensure the documents are appropriate to the work conducted. The management system consists of internally and externally generated documents. Documents as referenced in this policy include policies, procedures, regulations, standards, software, manuals, etc. Refer to QP 2 for document control procedures. 4.3.2 Approval and Issue 4.3.2.1 Any technical protocol or discipline quality manual documents will be reviewed by the technical manager or his/her designee. Technical protocols and discipline quality manuals will be approved by the technical manager and the Criminalistics Division Director or designee, in his/her absence. Management system documents including quality policies and quality procedures will be reviewed by the Quality Manager and will be approved by the Quality Manager and the Criminalistics Division Director or designee, in his/her absence. 4.3.2.2 QP 2 describes the steps taken to ensure that: a) The current authorized version of management system documents is available at all OSBI CSD facilities. b) Management system documents are periodically reviewed and revised as appropriate. c) Documents which are no longer valid are removed from use promptly. d) Retired documents that are retained for legal or knowledge preservation purposes are marked appropriately to prevent unintended use. 4.3.2.3 Each internally issued document will be identified with the information specified in QP 2. Page 17 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.3.3 Document Changes 4.3.3.1 Changes to documents can be made in two ways. Documents are revised following QP 2. In addition, changes to documents can be documented using a major deviation, as described in QP 3. Both methods follow the same review and approval method. 4.3.3.2 Each internally issued document will include an attached document history page or section. Insertions or alterations made to the document with each revision will be noted in this section, whenever practical. 4.3.3.3 Documents will only be amended as indicated under section 4.3.3.1 above. Amendments may not be made by hand writing on documents. 4.3.3.4 QP 2 details how changes are made and controlled for documents issued through the OSBI Intranet. 4.4 Review of Requests, Tenders, and Contracts 4.4.1 General QP 4 establishes the procedures that will be followed for the review of requests, tenders, and contracts. This procedure ensures that: a) The customer's requirements, which include the type of analysis or methods to be used, are well defined, documented, and understood. b) The OSBI CSD is capable of meeting the customer's needs. c) The appropriate test method is selected. Any differences between the request, tender, or contract will be resolved before work commences. Each contract should be satisfactory to both the OSBI CSD and the customer. 4.4.2 Records An electronic or hard copy of the RFLE will be maintained with the case file as a record of the request, review, and contract. In addition, any significant changes will be recorded in a conversation log, e-mail, or equivalent document. All records of changes to the contract will also be maintained with the case file (either electronic or hard copy). Page 18 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.4.3 Subcontracted Work This review process shall apply to work performed by any OSBI laboratory, regardless of which laboratory received the evidence and performed the review. It shall also apply to analysis that is subcontracted to a non-OSBI laboratory. 4.4.4 Deviations The customer will be informed of deviations from the contract. If an analyst determines that requested analysis is not appropriate or recommends alternate or additional analysis, the customer will be contacted prior to modifying the contract. 4.4.5 Amendments Any amendment or modification to the contract after analysis begins will be reviewed in the same manner listed under QP 4. The person making the amendment will notify the affected personnel. 4.5 Subcontracting of Tests In order to provide the best service possible, OSBI laboratories may choose to transfer work to another OSBI laboratory or subcontract to an outside vendor. 4.5.1 Qualification of Subcontract Laboratory All OSBI laboratories and any laboratory performing work for the OSBI must be accredited through the ASCLD/LAB Legacy or ASCLD/LAB International program. 4.5.2 Customer Notification The OSBI CSD shall notify customers in writing when subcontracting work to an outside vendor. When appropriate, the OSBI CSD will also obtain approval from the customer, preferably in writing. 4.5.3 Review of Subcontracted Work The OSBI CSD maintains responsibility for subcontracted work, unless the customer or a regulatory authority specifies which subcontractor will be used. 4.5.4 Records of Subcontractors The QM will receive and maintain a copy of the accreditation certificate for any laboratory which performs analysis on behalf of the OSBI. Page 19 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.6 Purchasing Services and Supplies 4.6.1 General Selection and purchasing of services and supplies will be made according to OSBI Policy 208. The purchase, receipt, and storage of reagents and consumable materials used for analysis will be conducted according to QP 8. 4.6.2 Verification of Reagents, Supplies, and Consumable Materials Any supply, reagent, or consumable item that will affect the quality of analysis will not be used until inspected and/or verified according to QP 8. 4.6.3 Descriptions of Items Affecting Quality Items that affect the quality of analysis will be identified on the Internal Purchase Request (IPR) with a description specific enough to ensure the appropriate quality of item is purchased. This description may be a product number, catalog number, a reference to a particular grade or purity, or other technical description. The description provided will be reviewed and approved with the IPR. 4.6.4 Evaluation of Suppliers The technical manager of each discipline will determine which reagents, consumables, supplies, and services are critical and affect the quality of testing. The technical managers will also oversee the evaluation of suppliers and maintain a list of approved suppliers, as described in QP 9. 4.7 Service to the Customer 4.7.1 Assisting the Customer The OSBI CSD will cooperate with OSBI customers to ensure that service provided meets customers' needs. This includes clarifying requests for analysis and monitoring the laboratory's work performance. However, the OSBI CSD will ensure that cooperation with one customer does not compromise confidentiality of other customers. Refer to QP 10 for procedures on customer assistance. 4.7.2 Soliciting Feedback from Customers The OSBI CSD will seek feedback from customers, primarily through the use of surveys. Feedback will be utilized to improve the management system, analytical procedures, and customer service. QP 11 details the procedure for soliciting general Page 20 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director customer feedback. QP 32 details the procedure for soliciting feedback specific to testimony provided. 4.8 Complaints Complaints will be resolved and documented according to QP 12. 4.8.1 Quality Complaints QP 12 will also be used to resolve and document complaints submitted by employees regarding quality aspects of the management system. 4.9 Control of Nonconforming Work 4.9.1 Policy Any work that does not conform to the requirements set forth in this manual, the Quality Procedures, or in OSBI technical protocols shall be addressed according to QP 13. By following the procedure detailed in QP 13, OSBI CSD shall ensure that: a) Responsibilities and authorities for managing nonconforming work are specified and appropriate actions are defined and taken when nonconforming work is identified. b) The nonconforming work is evaluated to determine the significance. c) A decision regarding the acceptability of nonconforming work is made and correction is done immediately. d) The customer is notified and work is recalled when necessary. e) The responsibility for authorizing work to resume is defined. 4.9.2 Implementation of Corrective Action If the evaluation of the nonconforming work indicates a significant possibility that the problem could recur, or there is an indication that lab operations do not comply with OSBI policy and procedures, then corrective action procedures outlined in QP 14 will be followed. Page 21 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.10 Improvement The management system will be continually improved using information gained during audits, analysis of statistical data, corrective and preventive actions taken, management review, etc. 4.11 Corrective Action 4.11.1 General When nonconforming work is identified, it will be addressed according to QP 13. This procedure details the appropriate authorities for implementing corrective actions. 4.11.2 Cause Analysis As indicated in QP 14, the first step of corrective action will be to investigate the root cause of nonconforming work. 4.11.3 Selection of Corrective Action After the completion of the root cause analysis, potential corrective actions will be evaluated. The goal of the corrective action is to correct the problem and prevent the problem from recurring. The corrective action plan will also be appropriate to the magnitude and risk of the problem. The corrective action plan most likely to succeed in these areas will be selected and implemented. Any changes necessary as a result of the corrective action investigation will be implemented and documented. 4.11.4 Monitoring Corrective Actions For each corrective action plan, the results of the corrective action will be monitored to determine effectiveness. 4.11.5 Additional Audits When the nonconforming work indicates that there is a failure to comply with ISO/IEC 17025 standards or CSD policies and procedures, an audit of the areas of activity in question will be conducted as soon as possible. In addition, an audit may be used following the implementation of a corrective action plan in order to assess the effectiveness of the corrective action. Page 22 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.12 Preventive Action 4.12.1 General Needed improvements or potential sources of nonconformity will be identified and routed as indicated in QP 15. Preventive action plans will be developed, implemented, and monitored for effectiveness in order to ensure that opportunities for improvement are exploited and nonconforming work is prevented. 4.12.2 Procedure QP 15 details how to initiate preventive actions and how to utilize controls or other measures to ensure the preventive action is effective. 4.13 Control of Records 4.13.1 General 4.13.1.1 QP 16.1 describes the procedure for maintaining quality and technical records. Quality records and technical records are defined in the glossary. 4.13.1.2 Records will be legible and stored in a manner that they are readily retrievable and protected from damage and loss. Retention times for records are also reflected in QP 16.1. 4.13.1.3 Records will be kept in secure locations and are confidential. 4.13.1.4 Procedures for records stored electronically are detailed in QP 16.1. 4.13.2 Technical Records 4.13.2.1 The OSBI CSD will retain records of examination documentation and supporting documentation, such as quality assurance/quality control documentation, and copies of reports for the period of time defined in QP 16.1. Each case record will contain enough information to identify factors affecting uncertainty of measurement, if possible and applicable, and to enable re-analysis to be conducted under conditions as close to the original as possible. The identity of the individuals who sampled evidence, conducted testing, and/or verified results will be reflected in the case record. 4.13.2.2 Observations, data, and calculations must be recorded at the time they are made and must be identifiable to the specific case involved. Page 23 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.13.2.2.1 Examination documentation must include at a minimum, the start and end dates of examination. 4.13.2.3 Mistakes in examination documentation will be crossed out with a single line, initialed, and the correct value added alongside. Erasing, obliterating, or otherwise making the original data illegible is not permitted. Similar measures must be taken with records stored electronically to avoid losing or altering original data. 4.13.2.3.1 Any change made to existing hard copy examination documentation will also be initialed by the person making the addition. 4.13.2.3.2 Examination documentation is considered complete when it is submitted for administrative and/or technical review. Any change made to completed examination documentation shall be tracked. 4.13.2.4 Documents maintained as part of the case record are identified in QP 16.2. 4.13.2.5 Examination and supporting documentation must be sufficient for another examiner to determine what was done and to independently interpret the data. 4.13.2.5.1 Latent print documentation shall meet all requirements listed in Appendix C of the ASCLD/LAB Supplemental Requirements. 4.13.2.5.2 Operating parameters used during instrumental analysis shall be recorded in the examination documentation, protocol, or another suitable and appropriate location. 4.13.2.6 Each page of examination documentation will bear the case number and examiner's handwritten initials (or secure electronic equivalent of initials or signature). 4.13.2.7 If a technician or other individual prepares examination documentation which another analyst interprets, reports, or testifies to, the person who prepares the examination documentation must initial the page(s) he/she prepares. 4.13.2.8 All administrative documentation, received or generated by the OSBI CSD, must be labeled with the laboratory case number. 4.13.2.9 When multiple cases are analyzed simultaneously, the case number of each case must be appropriately recorded on the printout if the data is recorded on a single printout. Page 24 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.13.2.10 Examination documentation should be one-sided. Each side of any two-sided examination documentation will be treated as a separate page (initialed and case numbered). 4.13.2.11 Examination documentation will be permanent in nature. 4.13.2.12 Verifications of analytical findings, such as latent print or firearms identifications, will be conducted by qualified examiners. Verifications will be documented to include what was verified, whether the second examiner agreed, and when the verification was conducted. 4.13.2.13 The meaning of any abbreviations or symbols specific to the OSBI CSD will be documented either in the case record or in discipline quality manuals or protocols. 4.14 Internal Audits 4.14.1 The OSBI CSD shall conduct internal audits as described in QP 17. 4.14.1.1 Internal audits will be conducted annually. 4.14.1.2 Documentation of internal audits will be retained as quality records according to QP 16.1. 4.14.2 If audit findings identify nonconforming work or indicate that the effectiveness of operations or validity of test results may be questionable, then procedures outlined in QP 13, if applicable, and QP 14 will be promptly followed. 4.14.3 An audit report will be completed according to QP 17. 4.14.4 Implementation and effectiveness of any corrective actions generated as a result of an internal audit will be verified and recorded according to QP 14. Page 25 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.14.5 Each OSBI laboratory will submit an Annual Accreditation Audit Report to ASCLD/LAB according to the deadline in QP 17. 4.15 Management Reviews 4.15.1 OSBI CSD management will conduct a review of the management system and casework activities, at least annually, to ensure their continued effectiveness and to introduce changes or improvements as needed. The procedure for management system reviews is detailed in QP 18. Records of management system reviews will be retained as a quality record according to QP 16.1. Management system reviews will include the following topics: a) suitability of policies and procedures b) reports from managerial and supervisory personnel c) outcome of recent internal audits d) corrective and preventive actions e) external audits f) proficiency test results g) changes in volume and type of analysis h) customer feedback i) complaints j) recommendations for improvement k) any other relevant factors 4.15.2 Findings from management reviews and the actions taken will be recorded according to QP 18. CSD management will ensure that actions are carried out according to an appropriate timetable. 5. Technical Requirements 5.1 General 5.1.1 Several factors impact the reliability of analysis conducted by the OSBI CSD. These may include the following: Page 26 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director • human factors (5.2) • environmental conditions (5.3) • protocols and method validation (5.4) • equipment/instrumentation (5.5) • measurement traceability (5.6) • sampling (5.7) • evidence handling (5.8) 5.1.2 The OSBI CSD shall take account of the factors listed above when developing and validating procedures, training and qualifying personnel, and in the selection and calibration of instrumentation. 5.1.3 The reliability of reagents will be verified according to QP 8. 5.1.3.1 Reagents prepared in-house will be labeled with the identity of the reagent and the lot number or date of preparation at a minimum. Records identifying who prepared the reagent and documenting the function verification will be maintained. 5.2 Personnel 5.2.1 OSBI CSD Management shall ensure the competence of any individual who performs analysis, operates instrumentation, evaluates results, or signs reports. Work conducted by trainees shall be properly supervised. The education, training, experience, and/or demonstrated skill of an employee shall be used to qualify the individual. 5.2.1.1 Each OSBI CSD discipline shall have a documented training program which will be used to train employees in the knowledge, skills, and abilities necessary to perform analysis. Requirements for discipline training manuals are outlined in QP 19. 5.2.1.2 Where applicable, training programs shall also address courtroom testimony. 5.2.2 OSBI CSD Management has established the goals for education, training, and skills of employees. These goals and the procedure for identifying training and conducting Page 27 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director training are outlined in each discipline training manual. QP 19 details how the effectiveness of the training program will be evaluated. 5.2.3 OSBI CSD shall use personnel employed by or under contract to the OSBI. If contract or additional support personnel are used, OSBI CSD will ensure that these personnel are also appropriately supervised and competent for the work they perform. Their work shall also be in accordance with the OSBI CSD Management System. 5.2.4 Current job descriptions for managerial, technical, and key support personnel involved in analysis are located at http://www.ok.gov/opm/jfd/jfd_g-page.htm. More specific job descriptions may also be located in each discipline's quality manual. 5.2.5 OSBI CSD Management shall indicate which procedures and work each employee is authorized to perform by providing a written memo detailing the task(s) and the date the individual is authorized to perform the work. Records of these authorizations shall be maintained in an electronic or hard-copy training notebook for each individual. 5.2.6 OSBI CSD personnel shall meet the education and competency requirements detailed in the ASCLD/LAB Supplemental Requirements. Technicians will meet the educational requirements established in the applicable written job description. If there is not an applicable job description available through the Office of Personnel Management, the Supervisor will be responsible for developing a written job description for the technician position(s) in his/her unit. 5.2.7 The OSBI CSD provides access to current literature sources by ordering journals and by providing internet access and on-line subscriptions to employees. 5.3 Facilities 5.3.1 OSBI CSD shall provide laboratory facilities with proper energy sources, lighting, temperature, and other environmental conditions to ensure correct performance of Page 28 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director tests and procedures. Employees should exercise caution when conducting sampling or analysis in a location other than a permanent facility, such as a crime scene, to ensure that environmental conditions do not negatively impact the integrity of evidence or results. Accommodations and environmental conditions which would impact results shall be documented in the technical protocols. 5.3.2 When specific environmental conditions are required by the technical procedure or could impact the quality of results, the OSBI CSD shall monitor, control, and record the appropriate environmental conditions. Testing shall be stopped if the environmental conditions would negatively impact test results. 5.3.3 Incompatible testing activities shall be separated by time or space in order to prevent cross-contamination. 5.3.4 Access to laboratories and evidence rooms will be limited to employees assigned to the laboratory unit, evidence technicians assigned to the physical facility, Criminalistics Administrative personnel, and other personnel as authorized by the Criminalistics Services Division Director on a limited or permanent basis. 5.3.4.1 Laboratory security procedures are located in QP 20. 5.3.5 Good housekeeping shall be maintained in OSBI CSD facilities. If necessary, technical protocols will be prepared for cleaning/sterilization procedures. 5.3.6 OSBI CSD follows the health and safety program detailed in OSBI Policies 121.0 through 121.5. 5.4 Test Methods and Validation 5.4.1 General OSBI CSD uses appropriate methods for all testing and evidence handling. Evidence handling procedures are included in QP 6 and QP 7. Technical procedures, Page 29 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director estimations for uncertainty of measurement, and any statistical techniques for analysis of testing data are included or referenced in discipline specific quality manuals and/or protocols. Instructions on the operation of instrumentation, sample handling and preparation will also be included or referenced in the discipline specific quality manuals and/or protocols, if written instructions are necessary to ensure the quality of test results. Any deviations to these procedures occur only as outlined in QP 3. 5.4.1.1 All analytical protocols shall be documented and issued according to QP 2. 5.4.1.2 Appropriate controls and standards shall be specified in the analytical records and the results of controls and standards tested shall be documented in the case record. 5.4.2 Selection of Methods The OSBI CSD shall use analysis methods which meet the needs of the customer and which are appropriate for the testing conducted. 5.4.2.1 The reliability of any new method will be internally validated and the results of the validation study documented prior to implementing the procedure for use in casework. The procedure for suggesting, conducting, documenting, and maintaining records of a validation study are outlined in QP 21. 5.4.3 Laboratory-developed Methods Validation of new methods developed by the OSBI CSD shall be planned and conducted by qualified personnel who have the necessary resources. Effective communication shall be maintained and the validation plan shall be updated as the method development proceeds. 5.4.4 Non-standard Methods Only approved technical procedures will be used in the analysis of casework. If a non-standard method is necessary, the method shall be subject to the agreement of the customer. The agreement with the customer shall include a clear specification of the customer's requirements. The method must be validated prior to use on evidence samples. 5.4.5 Validation of Methods 5.4.5.1 Validation of a method shall provide objective evidence that the method meets the particular requirements for a specific intended use. Page 30 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.4.5.2 All methods used by the OSBI CSD shall be validated to ensure that the methods are fit for the intended use. Documentation of validation studies shall record the results obtained, the procedure used, and a conclusion indicating whether the method is fit for the intended use. 5.4.5.3 In order for a method to be determined fit for an intended use, the range and accuracy of the values obtained from the method must be relevant to the customer's needs. 5.4.5.4 Before implementing a validated method new to the OSBI CSD, the reliability of the method will be demonstrated against any documented performance characteristics (such as sensitivity or specificity) of the method. Records of the performance check shall be retained. 5.4.6 Estimation of Uncertainty of Measurement The procedure for estimating the uncertainty of measurement is located in QP 22. 5.4.7 Control of Data 5.4.7.1 Calculations and data transfers shall be subject to appropriate checks in a systematic manner, such as the administrative and technical review process. If an additional check is required, it should be included in the appropriate discipline protocol(s). 5.4.7.2 When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage, or retrieval of test data, OSBI CSD Management shall ensure that: a) Computer software is documented in sufficient detail and suitably validated. b) Procedures are used to protect the data; such procedures shall include, but are not limited to, integrity and confidentiality of data entry or collection, data storage, data transmission, and data processing. c) Computers and equipment are maintained to ensure proper functioning and are provided with environmental and operating conditions necessary to maintain the integrity of the data. Page 31 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.5 Equipment 5.5.1 OSBI CSD Management shall furnish each laboratory and/or unit with the equipment necessary to ensure the correct performance of analytical tests conducted. If equipment outside of the immediate control of the OSBI CSD is used for analysis of evidence samples, OSBI CSD Management shall ensure that the equipment meets the standards outlined in ISO/IEC 17025. 5.5.2 Equipment and software used to perform analysis, calibration, or sampling will comply with specifications relevant to the test and shall be adequate to achieve the required accuracy. Calibration programs/procedures will be established as outlined in QP 24. 5.5.3 Instruments will be operated by authorized CSD personnel. Authorization for unsupervised use of instruments will be documented in the authorization to work memo addressed in section 5.2.5. OSBI CSD trainees and technicians, practicum students, and interns are authorized to use equipment/instruments in the unit(s) they are assigned to under the supervision of authorized CSD personnel. Current instructions for use and maintenance will be included in discipline protocols so that they are readily available for use by the appropriate CSD personnel. Alternately, manufacturers’ manuals or use and maintenance instructions may be referenced in the protocol and placed in a designated location for easy access by authorized personnel. 5.5.4 Whenever possible, each instrument used for testing and its software significant to the test result will be uniquely identified. At a minimum, unique asset numbers will be assigned in accordance with OSBI Policy 209. 5.5.5 For each instrument and its software significant to the analysis performed, the following records will be maintained according to QP 24: a) the identity of the instrument and software b) the manufacturer's name, model number, and serial number and/or asset number Page 32 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director c) documentation of function verification d) the current location, if appropriate e) the instruction manual, if available, or a reference to the location of the manual f) copies of all calibration and adjustment reports/certificates, including the date, result of calibration/adjustment, acceptance criteria, and the due date for the next calibration g) the maintenance plan, if appropriate, and records of maintenance performed to date h) description of any damage, malfunction, modification, or repair 5.5.6 Procedures for safe handling, transport, storage, use, and maintenance of measuring equipment are located in QP 24. 5.5.7 Instruments and equipment which have been mishandled or have been shown to be outside acceptable limits will be taken out of service. Out of service instruments and equipment will be clearly labeled as out of service until repairs are made and the instrument/equipment is placed back in service following a successful function verification/calibration. The impact of the defect or departure from acceptable limits will be evaluated and procedures outlined in QP 13 will be initiated. 5.5.8 Whenever possible, equipment which requires calibration will be labeled to show the status of the calibration, including the date of the last calibration and when recalibration is due. 5.5.9 When equipment goes outside of the laboratory, whether for repair or another purpose, the function and calibration status will be checked and shown to be satisfactory before the equipment is returned to service. Page 33 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.5.10 If intermediate calibration checks are needed to maintain confidence in the calibration status of equipment, the checks will be done according to a written protocol approved by the appropriate Technical Manager. 5.5.11 Where calibrations result in correction factors that must be used, the discipline shall implement a procedure to ensure that any copies (e.g. in computer software) are correctly updated. 5.5.12 Applicable controls, defined in protocol, will be used to safeguard test and calibration equipment including hardware and software from adjustments which would invalidate the test and/or calibration results. 5.6 Measurement Traceability 5.6.1 General Any equipment used for testing or calibration which has a significant impact on the accuracy or validity of the test, calibration, or sampling shall be calibrated before being placed in service. This includes any equipment used for subsidiary measurements such as environmental conditions, if it would have a significant impact on the validity or accuracy of results. The procedures for calibration of equipment are outlined in QP 24. 5.6.1.1 As specified in QP 24, the procedures for checking the calibration of equipment are established based on the specific requirements of the tests being conducted. Under normal circumstances, a check of calibration will be conducted after any shut down and following service or other substantial maintenance. Calibration check intervals will not be less stringent than the manufacturer's recommendations. 5.6.2 Specific Requirements 5.6.2.1 Calibration The OSBI does not provide calibration services as defined by ISO/IEC 17025. Page 34 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.6.2.2 Testing 5.6.2.2.1 As indicated in QP 23 and QP 24, the calibration program for equipment is designed to ensure that calibrations and measurements are traceable to the International System of Units (SI), if possible. This is not required if the associated contribution of the calibration to the total uncertainty of the test results is negligible. In this situation, the OSBI CSD shall ensure that the equipment used provides the uncertainty of measurement needed. 5.6.2.2.2 Where traceability of measurements to SI is not possible and/or relevant, the OSBI CSD shall provide confidence in measurements by establishing traceability to appropriate standards such as certified reference materials, specified methods, and/or consensus standards. 5.6.3 Reference Standards and Materials 5.6.3.1 Reference Standards QP 25 outlines the procedures for the calibration of reference standards. Reference standards will be calibrated by an organization capable of providing traceability to SI units as described in ISO/IEC 17025 standard 5.6.2.1. Reference standards will only be used for calibration unless it can be demonstrated that other use will not invalidate their performance as a reference standard. Reference standards will be calibrated before and after adjustments. 5.6.3.2 Reference Materials As specified in QP 26, reference materials will be traceable to SI units of measurement, or to certified reference materials, whenever possible. Accuracy of internal reference materials will be checked as far as is technically and economically practical. 5.6.3.2.1 Reference collections of data or items encountered in casework that are maintained for identification, comparison, or interpretation purposes shall be fully documented, uniquely identified, and properly controlled. 5.6.3.3 Intermediate Checks When checks are needed to ensure confidence in the calibration status of reference, primary, transfer or working standards and reference materials, these checks will be carried out according to defined procedures and schedules. 5.6.3.4 Transport and Storage QP 26 establishes the procedures for safe handling, transport, storage, and use of reference standards. These procedures prevent contamination and deterioration of the standards and protect their integrity. Page 35 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.7 Sampling The OSBI CSD will not report results based on a statistical sampling method (see glossary). The OSBI CSD may report results for a whole based on testing a portion in limited circumstances which include toxicology analysis and the identification and quantitation of controlled substances. Discipline quality manuals and protocols will specify the necessary steps to ensure homogeneity of toxicology and drug quantitation samples and the amount of sample to be used for analysis. State statute establishes a legal basis for homogeneity for the identification of controlled substances and the amount of sample to be tested will be based on the analyst’s training and experience. 5.8 Evidence Handling 5.8.1 The procedures for transportation, receipt, handling, protection, storage, retention and/or disposal of evidence items are included in QP 5 through QP 7. These procedures include all provisions necessary to protect the integrity of evidence and the interests of the OSBI CSD and our customers. 5.8.1.1 Through compliance with the evidence handling procedures outlined in QP 5 through QP 7, the OSBI CSD documents the chain of custody for evidence received and analyzed by the laboratory. The minimum components of a chain of custody record include the person (by signature or electronic equivalent) or location receiving evidence, the date of receipt or transfer, and a description or unique identifier of the evidence. In order to ensure a complete and accurate chain of custody, all employees will document evidence transactions in the LIMS at the time evidence is physically moved from one location to another, unless exceptions are provided for in evidence handling procedures. In addition, employees shall not share LIMS passwords with anyone. Failure to comply with this policy will result in progressive discipline. Failure to comply with evidence handling procedures may also result in progressive discipline. 5.8.1.1.1 As detailed in QP 6, when evidence is subdivided in the laboratory, the OSBI CSD requires the same chain of custody documentation for any sub-items created. 5.8.1.1.2 As described in QP 5, evidence accepted and stored by the OSBI CSD will be properly sealed. Page 36 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.8.2 The OSBI CSD utilizes the “BEAST” Laboratory Information Management System (LIMS) to identify evidence items while they are in OSBI CSD custody. This system, in conjunction with the evidence handling procedures, ensures that evidence cannot be confused physically or when referred to in the case record or other documentation. The system allows for sub-dividing groups of evidence items, transfer of evidence within the laboratory, and receipt and return of evidence. 5.8.3 When evidence is received, any abnormalities regarding the packaging or condition of evidence will be recorded. If there is doubt whether the item is suitable for testing or if the item does not match the description provided, the customer will be consulted for clarification and the conversation recorded using the “Narrative” button on the “Case Info” tab in the LIMS before proceeding. 5.8.4 QP 6 details the procedures for preventing loss, deterioration, or damage to evidence items during storage and handling. This includes ensuring the security and proper environmental conditions of evidence storage locations. 5.8.4.1 All evidence will be stored in a secured, limited access storage area when not in the process of examination. 5.8.4.2 QP 6 details how to secure unattended evidence in the process of examination. 5.8.4.2.1 QP 6 also clearly defines when evidence is considered to be in the process of examination. 5.8.4.3 Each item of evidence shall be marked with the case number and item number. If it is not possible to mark the evidence or if marking the evidence with the item number could affect the integrity of the evidence, then the proximal container or tag shall be labeled. 5.8.4.4 When evidence, such as latent prints or impressions, can only be recorded or collected by photography and the image itself is not recoverable, the photograph or negative of the image shall be treated as evidence. 5.8.4.5 OSBI CSD personnel collecting evidence at a crime scene will ensure that the evidence is protected from loss, cross-transfer, contamination, and deleterious change, whether in a sealed or unsealed container, during transport to the Page 37 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director laboratory. Crime scene evidence shall be appropriately identified, packaged, and entered into the LIMS as soon as practical. 5.8.4.6 The OSBI CSD maintains individual characteristic databases in the Latent Evidence Unit, CODIS Unit, and Firearms Unit. Procedures for the operation of individual characteristic databases are located in the appropriate discipline/unit quality manuals and/or protocols. These procedures include a designation of how database samples will be treated (as evidence, reference sample, etc.), how samples will be identified, how samples will be protected from loss, cross-transfer, contamination, and deleterious change, and how access to the databases will be restricted. 5.9 Assuring Quality of Test Results 5.9.1 The OSBI CSD procedures for monitoring the validity of tests are located in technical protocols as appropriate. In addition, procedures for proficiency tests, re-examination, and reviews are referenced below. Quality control data will be recorded in a way to allow trends to be detected and whenever practical, statistical techniques will be used to review the data. OSBI CSD quality control monitoring is planned and reviewed according to the procedures referenced. Monitoring includes the following: a) use of appropriate controls and standards, which are specified in protocols and recorded in case records b) regular use of certified or secondary reference materials, as appropriate c) internal and external proficiency testing d) re-analysis of casework 5.9.2 Quality control data will be analyzed and planned action will be taken to correct the problem if the quality control data is outside the predefined window for acceptability. 5.9.3 The OSBI CSD proficiency testing program is located in QP 30. Page 38 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.9.4 Technical review of casework will be conducted according to QP 31 in order to routinely verify that conclusions reported are accurate and supported by the examination documentation. QP 31 further defines the scope of a technical review, how technical reviews will be documented, and what actions will take place if a discrepancy is noted. 5.9.5 Administrative review of casework will be conducted according to QP 31 to ensure that reports and case records are accurate and complete. All OSBI CSD reports, with the exception of no analysis reports, will be administratively reviewed prior to release. 5.9.6 Testimony provided by OSBI CSD analysts will be monitored according to QP 32. 5.10 Reporting Results 5.10.1 General The results of all analyses and examinations conducted by OSBI CSD personnel will be reported accurately, clearly, unambiguously, and objectively in a Criminalistics Examination Report. 5.10.1.1 In the event that a request for analysis is cancelled, no-analysis or partial analytical reports will be issued according to QP 28. 5.10.2 Test Reports Analytical reports will be prepared and issued according to QP 28. 5.10.3 Test Reports – Additional Requirements 5.10.3.1 OSBI CSD reports and/or case records will include the following information: a) Deviations from, additions to, or exclusions from the protocol and specific test conditions as necessary for interpretation of the test results shall be recorded in the case record. Page 39 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director b) When relevant, a statement of compliance with requirements or specifications should be included in the case record. c) Where applicable, a statement on the estimated uncertainty of measurement should be included in the test report. Under most circumstances, records for uncertainty of measurement will be maintained by the laboratory and available on request. A statement should be included in the report when it is relevant to the validity of the test result, the customer requests the statement, or if the uncertainty affects compliance to a specification limit. d) Opinions and interpretations shall be included in the report when necessary. For example, expert opinions regarding comparison of latent prints or interpretations of DNA profiles. e) Additional information shall be included in the report and/or case record as required by the method or by the customer. 5.10.3.2 If a sampling plan is used to analyze evidence, the following information shall be included in the case record: a) the date of sampling b) identification of the item sampled c) location of sampling d) reference to the plan and procedures used e) details of any environmental conditions during sampling that may affect the test results f) any standard or other specification for the sampling method and any deviations, additions to, or exclusions from the specification 5.10.3.3 QP 33 describes the procedure used for releasing case information. 5.10.3.4 Any OSBI CSD analyst who issues a report or testifies based on the examination documentation generated by another individual shall complete and document a review of all relevant pages of documentation in the case record. 5.10.3.5 When associations are made, the significance of the association shall be communicated clearly and qualified in the report. Page 40 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.10.3.6 If comparisons are performed and result in an elimination, the elimination shall be clearly communicated in the report. 5.10.3.7 If results are inconclusive, the reason why no definitive conclusion could be reached shall be documented in the report. 5.10.4 Calibration Certificates The OSBI CSD does not issue calibration certificates. 5.10.5 Opinions and Interpretations The OSBI CSD issues reports including opinions and interpretations only for forensic disciplines which have been appropriately validated and documents the training of each analyst issuing reports with opinions and interpretations. Opinions and interpretations shall be clearly identified in OSBI CSD reports. 5.10.6 Testing Results from Subcontractors When analysis is subcontracted, the subcontractor shall provide a case record and report which meet the same requirements as OSBI reports and case records. The OSBI shall maintain a copy of the case record, and after reviewing the case record and report, the subcontractor's report will be sent to the customer. 5.10.7 Electronic Transmission of Results Reports issued electronically must meet the same requirements stated above. 5.10.8 Format of Reports OSBI CSD reports shall be formatted in a manner to accommodate the types of tests conducted and to minimize the possibility for misunderstanding or misuse. 5.10.9 Amendments to Reports Modifications to OSBI CSD reports shall be handled according to QP 28. Analysis conducted subsequent to the issuance of a report will be included in a separate, uniquely identified report. Corrections to an issued report will be made by issuing a corrected report and indicating which report it replaces. Page 41 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director History Revision # Effective/Review Date History 0 3-23-09 Original issue. Replaces QA 1, rev. 7; QA 2, rev. 9; QA 3, rev. 9; QA 4, rev. 8; QA 8.1, rev. 5. 1 10-9-09 Removed QMA 1. Org chart located on OSBI Intranet. Updated QMA 3 to include instructions for packaging/sealing of liquids and/or glass containers. Update QMA 5 to include agencies for crime scene cleanup. Updated references to reflect new Quality Assurance Standards and Audits. Revised glossary. Made grammatical and typographical changes to clarify sections 4.1.5.d, g, h, and j; 4.1.7; 4.2.5; 4.7.2; 4.9.1; 4.13.1.1; 4.13.2.1; 4.14.1.2; 5.4.1.1; 5.4.7.1; 5.5.3; 5.5.4; 5.5.6; 5.5.10; 5.5.12; 5.6.2.2.1; 5.6.3.2; 5.8.3; 5.9.4; 5.9.5; 5.10.1; 5.10.9. 2 5-14-10 Added bookmarks/hyperlinks to table of contents. Minor grammatical changes to Foreword and sections 1.2, 4.5, 4.14.4, 4.14.5, and 5.7. Incorporated deviation to section 4.1.5.j. Added language regarding chain of custody to section 5.8.1.1. 3 12-31-10 Added Notice to Customers (QMA 1.1 Rev 0). Updated all attachments – changed QMA 2 to evidence acceptance requirements; deleted redundant sentence from QMA 3; changed QMA 4 to a list of facilities and available services; added animal disease and diagnostic lab to QMA 5. Updated reference to 2011 Supplemental Requirements. Incorporated deviation to update corrective action terms in glossary (corrective action, corrective action plan, preventive action, remediation). Changed definition of quality records. Changed process for designating deputies for key managerial personnel (4.1.5.j). Added list of key/top management (4.1.8). Added sections 4.2.2.1, 4.2.2.2, 4.4.3, 4.13.2.3.2, 4.13.2.5.2, last 2 sentences of 5.2.6, sentences 2-3 of 5.5.3, 5.8.1.1.2, and 5.10.1.1. Added reference to glossary in 4.13.1.1. Corrected QP reference in 4.13.2.1. Changed 4.14.5 to reference QP 17. Changed language to be more consistent with 2011 Supplemental Requirements in 4.13.2.2.1, 4.13.2.3.1, 4.15.1, sub-sections of 5.8.4, and 5.9.1.a. Changed 5.5.2 to reference QP 24. Changed Page 42 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director “instruments” to “measuring equipment” in 5.5.6. Revised section 5.5.7. Added Quality Procedures to References. OSBI CSD QMA 1.1, Rev. 0 Page 1 of 2 ***Notice to Customers*** ASCLD/LAB‐International accreditation requirements state that laboratories must notify customers (investigators, prosecuting attorneys, etc.) in certain circumstances listed below. ASCLD/LAB has established that labs may conduct these notifications on a case by case basis or through a general notification made available to all customers. This notice will serve as a general notification to customers for these areas. Submitting evidence to the OSBI Criminalistics Services Division (OSBI CSD) indicates consent with these terms. Review of Requests for Analysis (ISO/IEC 17025:2005 Std. 4.4.1): Each request for forensic analysis is reviewed by OSBI CSD personnel. The OSBI CSD will use the review process to ensure: 1. that the customer’s needs are understood (ex: which items need to be processed by the Latent Evidence Unit, etc.), and 2. that the OSBI CSD can meet those needs. However, the OSBI CSD will determine the most appropriate method(s) of analysis (ex: which chemical processing would best develop latent prints on an item submitted for latent processing) based on the information provided by the customer. Once the OSBI CSD accepts a request for analysis, the accepted request is considered a contract between the requestor and the OSBI. Changes to Contracts (ISO/IEC 17025:2005 Std. 4.4.4): In addition, the OSBI CSD may select the item(s) most appropriate for analysis and/or elect to not analyze all items submitted based on the needs and circumstances of the case. The OSBI does not consider this a change to the “contract,” and this may be done without additional notice to the customer. The OSBI CSD does strive to provide the highest quality and most valuable forensic analysis possible. For that reason, if analysts conducting testing identify alternate and/or additional testing that may prove beneficial to our customers, the OSBI CSD may notify the customer on a case by case basis. This notification will always be done if the proposed analysis will require consumption of the evidence and/or limit future examinations. OSBI CSD QMA 1.1, Rev. 0 Page 2 of 2 Subcontracting Analysis (ISO/IEC 17025:2005 Std. 4.5.2): The OSBI CSD will transfer evidence between OSBI CSD laboratories in order to accommodate efficient analysis. In limited circumstances, the OSBI CSD may subcontract analysis, if the OSBI CSD cannot provide the service necessary. This includes sending out samples for mitochondrial DNA (mtDNA) analysis and for the DNA identification of human remains and/or associated reference samples. Any unidentified human remains and/or any reference samples associated with missing persons or unidentified remains that are subcontracted will be sent to the University of North Texas Missing Persons/Unidentified Remains program. Any other evidence requiring mtDNA analysis will be sent to the Federal Bureau of Investigation (FBI) or one of their regional mtDNA labs. Deviations from Analytical Procedures (ISO/IEC 17025:2005 Std. 5.4.1): The OSBI CSD utilizes analytical methods that are generally accepted in the forensic science community and that have been validated by OSBI CSD personnel and documented in written protocols. In addition, the OSBI CSD maintains a policy to allow for suggesting, evaluating, approving, and documenting deviations to policy and procedure when necessary. These deviations are not communicated on a case by case basis, but are documented according to policy and can be discussed with customers upon request. Selection of Methods (ISO/IEC 17025:2005 Std. 5.4.2): OSBI CSD analytical methods are documented in written protocols and in some circumstances the analytical method used is also referenced in the case file and/or case record. In some circumstances, the analytical methods used may be listed in the examination report, as required by accreditation and quality standards. In any case in which a report does not list the analytical methods used, the OSBI CSD will provide this information upon request. In addition, a list of current services and/or analytical methods currently in use by the OSBI CSD is located in OSBI CSD QMA 4. OSBI CSD QMA 2, Rev. 1 Page 1 of 2 Oklahoma State Bureau of Investigation - Criminalistics Services Division (OSBI CSD) Evidence Acceptance Requirements The following requirements must be met for the OSBI CSD to accept evidence for analysis: 1. The evidence must be submitted by an individual or agency authorized to request services from the OSBI CSD. The agencies and individuals authorized to request services are listed in Title 74, Sections 150.2 and 150.5. The OSBI CSD cannot accept evidence from private citizens or other individuals/agencies not listed in statute. 2. The evidence must be relevant to an investigation which is expected to result in criminal charges being filed. Evidence relevant to civil investigations or non-criminal product cases such as food or drugs suspected of being old, faulty, etc., will not be accepted for analysis. 3. The evidence must not include any explosive devices, explosive samples, or post-blast samples. 4. The evidence must not include syringes, which under normal circumstances will not be accepted for analysis. Exceptions to this will be evaluated on a case by case basis and exceptions must be approved by a Criminalist Supervisor, Criminalistics Administrator, or designee. 5. Evidence must be submitted in person or through a delivery service such as the United States Postal Service (USPS), United Parcel Service (UPS), or Federal Express (FedEx). Evidence in digital form (images of latent prints, etc.) will not be accepted by e-mail. 6. Evidence must be collected and packaged in a manner that preserves the integrity of the evidence. Evidence which is packaged in a manner that would invalidate the results of testing will be refused. Refer to the OSBI Evidence Collection Manual for information regarding appropriate collection and packaging of evidence. 7. Evidence must be properly collected, packaged, and sealed. Refer to QMA 3 for evidence sealing guidelines. 8. The evidence must have a legitimate associated service request. A listing of available services is detailed in QMA 4. Evidence will not be accepted for the purpose of long-term storage or if the OSBI CSD cannot meet the needs of the customer. OSBI CSD QMA 2, Rev. 1 Page 2 of 2 9. Evidence samples submitted for the purpose of comparison (paints, fibers, projectiles, DNA, etc.) must be accompanied by the appropriate reference samples. In most cases, comparison samples will not be accepted unless both the questioned and reference samples are provided. However, this does not apply to samples submitted for comparison to a database. For example, DNA cases with no suspect identified may be submitted with the evidence sample(s) and victim reference sample. OSBI CSD QMA 3, Rev. 2 Page 1 of 2 Oklahoma State Bureau of Investigation - Criminalistics Services Division (OSBI CSD) Evidence Packaging and Sealing Guidelines Evidence submitted to the OSBI CSD must be stored in an appropriate container under proper seal. The seal must be sufficient to prevent item(s) contained from being lost, removed, or contaminated by outside sources. A container is considered “appropriate” and “properly sealed” only if its contents cannot readily escape and only if entering the container results in obvious damage/alteration to the container or its seal. 1. All evidence must be packaged in a suitable container that protects the evidence from loss, cross-transfer, or contamination. a) Some evidence, such as weapons submitted for serial number restoration or test fire, can be tagged and would not require a container. b) Other evidence, such as liquids may require multiple containers. For example, containers of liquid samples must be stored in a plastic bag, bucket, or other container that will contain the liquid if the immediate container leaks. c) Glass containers should be placed inside a container that will also protect the glass from breaking. d) Containers used to protect the immediate evidence package from leaks or breakage may be treated as convenience packages. However, only one item should be in each “convenience package” to prevent contamination in the event of a leak. 2. All evidence must bear a proper seal. A proper seal includes the initials or other identification of the person sealing the evidence and an acceptable evidence container seal. The following should be used as a guide for acceptable evidence container seals: a) Boxes: A box container seal includes the long seam at both the top and bottom of the box. Boxes should be sealed with two-inch tape, 3M 3750 or equal. Evidence tape may also be acceptable. b) Sacks, bags: All sack-like containers should be sealed by folding down the flap of the sack across the top and placing a continuous piece of 2 inch tape, 3M 3750 or equal, across the fold and around the sack edges. Evidence tape may also acceptable. OSBI CSD QMA 3, Rev. 2 Page 2 of 2 c) Envelopes: The top (unsealed) flap of the envelope should be sealed along or across the seam using two inch tape, 3M 3750 or equal, or using evidence tape. d) Cans: One continuous piece of evidence tape across the top and down the sides of the container (including buckets with lids) or two separate pieces of evidence tape across from each other are to be used to seal all can-like containers. The seal must be marked or initialed. No clear adhesive tape is to be used on cans if it can be peeled off without evidence of removal. e) Kits: Sexual assault kits, GSR kits, and other purchased kits are acceptable with the seal provided by the kit manufacturer. f) Bulky Evidence: Some items of evidence do not lend themselves to a container. In those cases, the area of interest for analysis should be isolated, protected and marked or initialed. Examples are doors or car bumpers. 3. Evidence which is properly sealed and marked for identification may then be placed in unsealed containers such as boxes or bags for the purpose of grouping items of evidence or for the convenience of carrying the evidence without that container having to meet the requirements of identification and sealing, as long as evidence security requirements are otherwise met. These containers should be marked as a “convenience package” or “convenience container.” 4. Heat sealing a container of an item of evidence is also acceptable. Identifying marks or initials of the person sealing the evidence must be present across the heat seal. 5. The submitting officer will be expected to correct improperly sealed evidence prior to the evidence being accepted by the lab. If evidence received by the laboratory has an acceptable evidence seal but is not initialed or marked and that individual is not available to remedy the problem, the receiving personnel will place a piece of evidence tape across the evidence seal at an approximate 90 degree angle and initial across the tape or place the entire evidence container in a heat sealed container and initial across the heat seal. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 1 of 6 FACILITIES: The OSBI CSD provides services at the following 5 facilities: OSBI Forensic Science Center (FSC) OSBI Eastern Regional Laboratory 800 East Second Street 701 West Carl Albert Edmond, OK 73034 McAlester, OK 74501 (405) 330-6724 (918) 423-6672 OSBI Northwest Regional Laboratory OSBI Northeast Regional Laboratory 1305 E. Garriott 1995 Airport Parkway Enid, OK 73701 Tahlequah, OK 74464 (580) 242-2600 (918) 456-0653 OSBI Southwest Regional Laboratory 5 Northeast 22nd Street Lawton, OK 73507 (580) 355-6144 For the convenience of OSBI CSD customers, evidence may be submitted at any CSD facility. OSBI CSD personnel will transport evidence between facilities when necessary to provide the appropriate or most timely analysis. SERVICES: The following services/analytical methods are available. However, the OSBI reserves the right to select the most appropriate method and to select the item(s) most appropriate for analysis (see “Notice to Customers” – OSBI CSD QMA 1.1). If a particular test method or service is desired for a specific item, please contact a Criminalist from the discipline in question for assistance with the review of the request. Biology (FSC, SWRL, and NERL): 1. Screening Evidence can be screened for biological material including blood, semen, and hair. 2. Confirmatory Testing Tests are available to confirm the presence of blood and semen. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 2 of 6 3. Hair Evaluation Hair samples can be evaluated to determine whether the hair is animal or human and, if human, whether adequate sample is present for nuclear or mitochondrial DNA testing. 4. DNA Analysis The OSBI CSD can perform two types of Short Tandem Repeat (STR) DNA analysis – autosomal and/or Y-STR analysis. Y-STR analysis generates a DNA profile based on locations on the Y-chromosome only, which means in order to generate a profile, the sample must contain male DNA. Y-STR analysis is only available at the FSC and NERL facilities. The OSBI CSD can forward evidence to an FBI Regional Mitochondrial DNA Laboratory for analysis. 5. Database Entry/Search All eligible DNA profiles obtained during the analysis of casework can be entered into the state CODIS (Combined DNA Index System) database and national database (NDIS). Controlled Substances (FSC, ERL, NERL, NWRL, SWRL): 1. Controlled Substance Identification Identification of controlled and some non-controlled substances. 2. Controlled Substance Quantitation (FSC Only) Some evidence items can be analyzed to determine the concentration of the controlled substance. 3. Clandestine Laboratory Analysis Analysis can be conducted on clandestine laboratory samples to detect controlled substances, precursors, and chemicals related to the illegal manufacture of controlled substances. 4. Poison Identification Some poisons such as Strychnine can be identified by the drug lab. Other compounds such as Ethylene Glycol (antifreeze) that can be used as poisons can also be identified. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 3 of 6 Firearms/Toolmarks (FSC): 1. Function Test Guns submitted for analysis can be tested to determine if the weapon is functional. 2. Trigger Pull Analysis Analysis can be performed to determine the amount of trigger pull required to fire a gun. 3. Fired Bullet and Casing Analysis Fired projectiles and/or fired casings can be compared to other fired evidence (bullets/casings) or to a suspect gun. In addition, fired projectiles and fired casings can also be examined and may sometimes provide information regarding potential makes and models of guns that could have fired the evidence. This is dependent on the amount and type of characteristics present on the fired evidence. 4. Serial Number Restoration When requested, analysis can be performed to attempt to restore the serial number of a gun. 5. Distance Determination In some cases, evidence can be examined to determine an approximate distance between an object and the point/location from which a gun was fired. 6. Database Entry/Searching Test fires from suspect weapons or fired evidence can be evaluated to determine suitability for entry into the Integrated Ballistic Identification System (IBIS). Items entered into IBIS will be automatically searched against the region (Oklahoma and Texas). The OSBI can request searches through other regional databases as well. 7. Toolmark Analysis Analysis can be conducted to determine, if possible, whether or not a particular tool was used to generate impressions or striations on the item submitted (padlock, window frame, etc.). In addition, analysis can be done to determine if the toolmarks on multiple evidence items were made by the same tool. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 4 of 6 Latent Evidence (FSC): 1. Footwear Analysis Photos or casts of questioned footwear impressions can be compared to known shoe samples. The OSBI CSD cannot examine questioned footwear impressions without known shoes for comparison purposes. 2. Tire Impression Analysis Photos or casts of questioned tire impressions can be compared to casts or photos of known tire impressions. Tires will not be accepted for comparison purposes. The OSBI CSD cannot examine questioned tire impressions without known tire impressions for comparison purposes. 3. Latent Print Analysis Processing: Items suitable for latent print development which have been properly collected and packaged can be processed to detect and lift/capture latent prints for comparison or AFIS entry. 4. Latent Print Comparison Questioned latent prints submitted or recovered from items submitted for processing can be compared to known inked impressions submitted or to known impressions from retained records when the subject’s information (name, race, sex, date of birth, and SID number) is provided. 5. Database Entry/Searching All latent prints (including palm prints) of appropriate quality that are not identified to a known can be evaluated for entry into the Oklahoma Automated Fingerprint Identification System (AFIS). The OSBI CSD can also request a search be conducted using the Integrated Automated Fingerprint Identification System (IAFIS), which searches records from the FBI files. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 5 of 6 Toxiology (FSC): 1. DUI Cases Blood or urine collected from individuals suspected of driving under the influence can be analyzed for the presence of alcohol or drugs. 2. Drug Facilitated Sexual Assault Blood and/or urine collected from an individual reporting a drug facilitated sexual assault can be analyzed for the presence of impairing substances. 3. Alcoholic Content Liquids suspected of containing alcohol can be analyzed to determine the presence and quantity of alcohol. (Ex: suspected moonshine) 4. Poisons Samples suspected of containing poison can be tested for select poisons, such as the active ingredient in Visine. 5. Toxic Vapors Blood may also be analyzed for other substances which cause impairment such as toxic vapors inhaled by a suspect (i.e. huffing). Trace Evidence (FSC): 1. Ignitable Liquids Residue Analysis Properly packaged samples of fire debris can be analyzed for the presence of ignitable liquids such as gasoline, paint thinner, or diesel, etc. 2. Primer Gunshot Residue Analysis (GSR) Evidence submitted using an OSBI GSR Evidence Collection Kit can be analyzed for the presence of elements that are characteristic of gunshot residue (lead, antimony, and barium). 3. Manufactured Fibers: Questioned fibers can be analyzed and compared to reference or known samples submitted to determine if the questioned and known sample may have originated from the same source. This comparison applies to man-made fibers only. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 6 of 6 Analysis of questioned fibers can also be conducted to determine the composition of the fiber(s). However, this analysis is limited to the material (e.g. nylon, acetate, etc.) and color. The OSBI CSD does not have the capability to indicate what item(s) may have been a source of the questioned fiber(s). The OSBI CSD does not perform hair comparisons. 4. Paint Evidence: Questioned paint samples can be analyzed and compared to known samples, when available, to determine if the questioned and known samples may have originated from the same source. If known paint samples are unavailable, then unknown samples may be submitted for possible Make and Model determination utilizing the Paint Data Query (PDQ) database. 5. Elemental/Chemical Analysis: Evidence can be analyzed to determine its elemental composition. The most common application of this analysis is to identify the presence of poisonous materials such as lead, arsenic, and mercury. Elemental analysis can also be conducted to identify elements used in clandestine drug manufacturing, such as phosphorus and iodine. 6. Fracture Matches: Miscellaneous types of evidence that are torn or broken can be compared to a sample suspected to be the source of the evidentiary sample. For example, duct tape removed from a victim can be compared to a roll of duct tape found in a suspect’s possession. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Alternate Service Providers OSBI CSD QMA 5, Rev. 2 Page 1 of 4 In the event that the OSBI CSD cannot provide a particular service requested by a customer, OSBI CSD personnel may assist the customer in locating an appropriate agency or organization that can provide the service. The list below summarizes some of the agencies or organizations that may be able to provide service to customers. This list is intended to be used as a tool to provide assistance to customers and is not intended to serve as a guarantee of service or endorsement of the agencies and organizations listed. Alcohol, Tobacco, Firearms: Bureau of Alcohol, Tobacco, and Firearms (ATF): Firearms, Explosives, Arson—1-800-283-4867 Arson Hotline—1-888-283-3473 (24 Hours) Explosives Hotline—1-888-283-2662 (24 Hours) Firearms Hotline—1-888-283-4867 (24 Hours) Animal/Agricultural: Animal Disease and Diagnostic Lab Livestock Diseases 405-744-6623 Department of Agriculture: Herbicides and Insecticide Poisoning, Animal Food Poisoning 405-521-3864 OSU School of Veterinary Medicine: Animal Deaths 405-262-5291 Aviation: Federal Aviation Administration: Investigations and evidence involved in airplane accidents 405-954-3011 Bomb Squads: Agency Jurisdiction Phone OCPD All incorporated areas of OKC except for State property 405-297-3477 405-297-1000 OCSO All unincorporated areas of OKC except for State property 405-713-1044 MWCPD All incorporated areas of Midwest City 405-739-1388 Edmond PD All incorporated areas of Edmond 405-354-4420 Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Alternate Service Providers OSBI CSD QMA 5, Rev. 2 Page 2 of 4 Norman PD All incorporated areas of Norman 405-321-1444 Tulsa PD All incorporated areas of Tulsa 918-596-9222 OHP All areas of the State that do not have a bomb squad in their jurisdiction. 405-425-2435 405-682-4343 405-202-3763 US Army Fort Sill Fort Sill EOD will assist any PD or FD 24/7 580-442-8885 580-442-2313 Crime Scene Cleanup: Heartland BioClean AEGIS Biosystems (Edmond) 405-802-6246 405-341-4667 Environmental Management, Inc. (Guthrie) Traumatix Solutions (Glen Poole) 405-282-8510 918-605-2556 Environmental Cleanup, Inc. (Oklahoma City) Ferguson Environmental Resources, Inc. 405-677-0565 405-495-6336 Crime Scene Cleanup (Reimbursement and Referral): District Attorney’s Council (DAC) Victim Services 405-264-5006 Emergency Management: Oklahoma Department of Civil Emergency Management 1-800-800-2481 or 405-521-2481 Entomology (Analysis of Insects): Oklahoma State University Zoology Department Stillwater, OK 405-744-5527 Environmental Concerns: Department of Environmental Quality State Lab: Poisoning of ground water/public or private water supply/soils 405-752-1000 US EPA-ERT Environmental Response Center 2890 Woodbridge Avenue, building #18 (MS 101) Edison, NJ 08837-3679 1-732-321-4398 http://www.ert.org Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Alternate Service Providers OSBI CSD QMA 5, Rev. 2 Page 3 of 4 Food/Drug: Food and Drug Administration: Retail Food/Medication (for Human Consumption) Tampering 405-231-4544 (Oklahoma City) 214-253-5200 (Dallas, 24 Hours) Health Departments: Non-criminal tampering/contamination of food or over the counter medications 405-271-5243 Oklahoma State Department of Health 405-425-4348 Oklahoma County Health Department 918-595-4301 Tulsa County Health Department Oklahoma State Department of Health Biological contamination of foods (e.g. bacterial or viral contaminants) 405-271-5070 Forensics (Fee for Service): The BODE Technology Group Reliagene Springfield, Virginia New Orleans, LA 703-646-9740 800-256-4106 LabCorp Serological Research Institute 1912 Alexander Drive 3053 Research Drive Research Triangle Park, NC 27709 Richmond, CA 94806 800-533-0567 (510) 223-7374 Sorenson Forensics, LLC Tarrant County M.E.’s Office 2495 S. West Temple 200 Feliks Gwozdz Pl. Salt Lake City, UT 84115 Fort Worth, TX 76104 800-824-3457 or 888-488-1122 807-920-5700 www.sorensonforensics.com Hazardous Materials: OHP HAZMAT 405-425-2017 Level A hazmat Poisoning Deaths: Office of the Chief Medical Examiner 405-239-7141 Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Alternate Service Providers OSBI CSD QMA 5, Rev. 2 Page 4 of 4 Soil Analysis: FBI Trace Analysis Unit Attn: Bob Fram 2501 Investigation Parkway Quantico, VA 22135 703-632-8449 Toxicology: Bexar County Medical Examiner’s Office Northwest Toxicology (Lab One) Bexar County Forensic Science Center Salt Lake City, Utah 7337 Louis Pasteur 1-800-322-3361 or 1-801-268-2431 San Antonio, TX 78229-4565 210-335-4000 El Sohly Laboratories University Toxicology Lab Oxford, Mississippi 405-271-3840 1-662-236-2609 National Medical Services (Can analyze hair samples for drugs) 3701 Welsh Road Willow Grove, PA 19090 (800) 522-6671 www.nmslab.com Weapons of Mass Destruction/Terrorism: 63rd Weapons of Mass Destruction Civil Support Team 63rd WMD CST 405-228-5880 Note: normally dispatched via Oklahoma Dept of Civil Emergency Management for response. FBI Counter Terrorism Unit 405-290-7770 or 405-290-3615 Explosives, radiation State Department of Health (Biological Weapons (e.g. Anthrax)) Public Health Laboratory Services P.O. Box 24106 Oklahoma City, OK 73214 Phone: 405-271-5070 Fax: 405-271-4850 405-271-4060 Epidemiologist on call 24 hours 405-271-4341 Security, alternate 24 hr number QP 1 ‐ Responsibilities and Authority Page 1 of 6 Distribution: All CSD Personnel Revision: 3 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures I. Scope This procedure explains the responsibilities and authority of key CSD personnel. II. Procedure A. Responsibilities of CSD Personnel 1. CSD Director The CSD Director will promote and direct the quality system and ensure that the policies and objectives are documented, as well as communicated to, understood by, and implemented by CSD personnel. The CSD Director serves as the laboratory director for the Forensic Science Center (FSC) and is an ex officio member of all CSD committees. 2. Criminalistics Administrators Each Criminalistics Administrator (CA) will be assigned the administrative supervision of specific laboratories and/or laboratory units. Each CA will also be assigned additional responsibilities as indicated below. a) The CA responsible for the administrative supervision of the Forensic Science Center (FSC) Toxicology Unit, Firearms/Toolmarks Unit, Latent Evidence Unit, and the FSC Physical Evidence Technician Unit is responsible for the statewide coordination of these forensic disciplines. This position will also be responsible for coordinating CSD activities in the areas of laboratory planning, laboratory construction and renovation, grants management, purchasing, laboratory surveys, complaints, and control drug reversal distribution. All activities will comply with quality standards set forth by the OSBI CSD. b) The CA assigned the administrative supervision of the FSC Drug Unit, FSC Trace Unit, the Northwest Regional Laboratory at Enid, and the Eastern Regional Laboratory at McAlester is responsible for the statewide coordination of forensic drug identification. This position will also be responsible for coordinating CSD activities in the area of LIMS Administration, safety management, serving as the OSBI safety officer, and oversight of assigned regional laboratory facilities. All activities will comply with quality standards set forth by the OSBI CSD. QP 1 ‐ Responsibilities and Authority Page 2 of 6 Distribution: All CSD Personnel Revision: 3 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures c) The CA responsible for the administrative supervision of the FSC Forensic Biology Unit, CODIS Unit, Southwest Regional Laboratory at Lawton, and the Northeast Regional Laboratory at Tahlequah is responsible for the statewide coordination of forensic biology. This position will also serve as the Division Quality Manager and will be responsible for coordinating CSD activities in the area of quality control/quality assurance. This includes proficiency testing, laboratory accreditation, testimony monitoring, and audits. 3. Administrative Programs Officer – Evidence Discipline The administrative programs officer over the evidence unit at FSC shall: a) Oversee the storage, maintenance, archival, and destruction of technical records. b) Oversee the destruction of evidence samples and prescription drug samples. c) Oversee and coordinate statewide activities of the physical evidence technicians/units. d) Assist with Laboratory Information Management System (LIMS) administration and generation of statistical reports. 4. Technical Managers Each Criminalist Supervisor at the FSC, with the exception of the FBU and CODIS Supervisors, also serve as the Technical Manager for his/her discipline. The Biology Technical Manager will be identified on a Biology specific organizational chart. Each OSBI CSD Technical Manager shall: a) Assist with management reviews as described in QP 18. b) Review and approve all technical procedures within the discipline. c) Implement and review quality documentation within the discipline. d) Stay abreast of recommendations made by Scientific Working Groups for the discipline and incorporate appropriate recommendations. e) Educate all discipline members in the implementation of the quality assurance program and confirm that all members of the discipline understand the importance of the program. f) Participate in audits and inspections when requested. QP 1 ‐ Responsibilities and Authority Page 3 of 6 Distribution: All CSD Personnel Revision: 3 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures 5. Criminalist Supervisors Each OSBI CSD Criminalist Supervisor shall: a) Assist with management reviews as described in QP 18 and disseminate information regularly to members of their unit. b) Ensure that members of the unit understand and follow all quality assurance procedures. c) Know and follow the CSD Quality Assurance Program. d) Make recommendations to improve quality within the discipline and division. e) Educate all unit members in the implementation of the quality assurance and safety programs and confirm that all members of the discipline understand the importance of the program. f) Serve as laboratory director, if assigned to a regional laboratory. g) Criminalist Supervisors are responsible for monitoring administrative review for their lab or functional unit. Supervisors are to be knowledgeable regarding the quality of casework produced by their staff. 6. Criminalists Each Criminalist shall: a) Know, understand and apply quality procedures that pertain to their specific discipline. b) Ensure completeness of laboratory reports, notes and essential documentation and make recommendations and suggestions for improvements of procedures used for the examination of forensic evidence. c) Advise Technical Manager and/or Supervisor of any technical problems or questionable results and make recommendations for improvements. 7. Physical Evidence Technicians Each physical evidence technician shall: QP 1 ‐ Responsibilities and Authority Page 4 of 6 Distribution: All CSD Personnel Revision: 3 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures a) Know, understand and apply all quality procedures that apply to proper evidence handling including evidence submission, transfer, return or destruction. b) Notify the Technical Manager and/or Supervisor of any concerns relating to the quality assurance program of the Division. 8. Laboratory Technicians Each laboratory technician or part time employee shall: a) Know, understand and apply quality procedures that apply to their specific discipline or job task. b) Notify the Technical Manager and/or Supervisor of any concerns relating to the quality assurance program of the Division. B. Authority of CSD Personnel 1. CSD Director The CSD Director has the authority to make and enforce decisions impacting any and all work produced by the division. 2. Criminalistics Administrators Under the administrative direction of the CSD Director, the Criminalistics Administrators have the following authority: a) The Quality Manager will have the express authority to immediately halt any laboratory activity that fails to exhibit the required levels of accuracy, specificity, reliability or validity with respect to the CSD Quality Assurance program. b) Technical decisions made by each Criminalistics Administrator responsible for the coordination of a forensic discipline will apply to all personnel engaged in any capacity within the affected forensic discipline. These decisions will be made after consultation with the Technical Manager for the discipline. c) The Safety Program Coordinator has the express authority to immediately halt any laboratory activity which is determined to fall outside established safety policies and procedures and applicable laws. QP 1 ‐ Responsibilities and Authority Page 5 of 6 Distribution: All CSD Personnel Revision: 3 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures d) Authority of each Criminalistics Administrator shall include but not be limited to the assignment of specific duties or responsibilities to specific personnel and the review of the activity of those personnel engaged in these duties including all quality practices adopted by the OSBI CSD. 3. Technical Managers The technical manager of each discipline has the following authority: a) Technical managers will assign and approve forensic procedures. All procedures will address and include practices consistent with the quality standards. b) Technical managers have the authority to suspend any work which does not comply with the OSBI CSD Quality System or any applicable quality standards. 4. Criminalist Supervisors Criminalist supervisors have the authority to suspend any work which does not comply with the OSBI CSD Quality System or any other applicable quality standards. III. Attachments None IV. History Revision # Effective/Review Date History 0 3-23-09 Original issue. Replaces QA 2, rev. 9. 1 9-4-09 Added language addressing responsibilities of APO over evidence unit, Criminalist Supervisor in regional lab, and authority of Technical Managers and Criminalist Supervisors to suspend work. 2 4-23-10 Removed references to CSD Assistant Director. Updated responsibilities of Criminalistics Administrators. 3 12-31-10 Added language to II.A.1 and II.A.4 to identify the FSC Lab Director and Technical Managers. Updated Division Director name. QP 2 – Document Control Page 1 of 4 Distribution: All CSD Personnel Revision: 1 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures I. Scope All management system documents will be approved, issued, modified, and controlled according to this procedure. Management system documents include policies/procedures developed internally, externally prepared documents or standards which are referenced or used (user’s manuals, applicable standards, etc.), and software (internally or externally developed) used for testing purposes. II. Procedure A. Control 1. All approved, internally generated CSD management system documents (policies, procedures, protocols, forms, etc.) will be placed on the OSBI Intranet. Any hard copy or other electronic copy is considered an uncontrolled document. 2. Uncontrolled copies may be made, if necessary, to reference at a work area that doesn’t have easy access to the OSBI Intranet. However, CSD employees creating or using uncontrolled copies must verify the uncontrolled copy is still current before each use and immediately dispose of any uncontrolled copy that is not current. 3. Uncontrolled copies may also be made for the purpose of responding to discovery requests/orders. 4. External documents, software, and any other management system documents which are not distributed through the OSBI Intranet will be referenced in the CSD or appropriate discipline quality manual, protocol, or an attachment to the appropriate document. The reference must identify the current revision/version approved for use and the distribution or location of the document. 5. The individual responsible for the initial approval of internally generated documents (Quality Manager (QM) or appropriate Technical Manager) should maintain a copy of the current version that can be edited when the document requires revision. B. Approval 1. Technical protocols/procedures, discipline quality manuals, and related attachments and references will be approved by the appropriate Technical Manager and the CSD Director or designee. 2. The CSD Quality Manual, Quality Procedures, and related attachments and references will be approved by the QM and the CSD Director or designee. 3. CSD documents distributed through the OSBI Intranet will include the signature of the individuals who have approved the document.. QP 2 – Document Control Page 2 of 4 Distribution: All CSD Personnel Revision: 1 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures C. Issue Once approved, the document(s) shall be distributed to the designated point(s) of issue. When a document is replaced or rescinded, it shall be removed from the point(s) of issue at the time it is replaced or no longer effective. 1. Approved CSD documents distributed through the OSBI Intranet, with the exception of forms, will be scanned or otherwise converted to pdf format prior to placing the documents on the Intranet. 2. Documents may be added to and removed from the OSBI Intranet by the Quality Manager, appropriate Technical Manager, FSC Executive Secretary or designee. 3. Documents referenced by the CSD or discipline quality manuals will be added to or removed from the designated point(s) of issue by the QM, appropriate Technical Manager, or designee. 4. Externally generated management documents will be available at each location where related work is conducted. For example, any externally generated management documents referenced by analysts conducting drug analysis will be located at each regional laboratory providing drug analysis. D. Notification For internally generated management documents, an e-mail will be sent to the appropriate individuals indicating that the document has been issued, revised, or rescinded. The e-mail will be sent by the Quality Manager, appropriate Technical Manager, FSC Executive Secretary, or designee. E. Archiving Obsolete versions of management system documents should be retained indefinitely. All retained, obsolete documents must be moved to a specified archive location and/or marked as obsolete or out of date. Whenever possible, archived documents will be maintained electronically in a secure OSBI network folder. Any hardcopy archived management system documents which are retained should be maintained, at a minimum, in the FSC administration area. F. Identification Internally generated CSD management system documents will be uniquely identified and include the following: 1. document number or designation 2. title QP 2 – Document Control Page 3 of 4 Distribution: All CSD Personnel Revision: 1 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures 3. date of issue and/or revision number 4. page numbering 5. total number of pages or mark indicating the end of the document 6. issuing authority Forms or other attachments to management system documents will be identified in the following manner: 1. unique form number or designation 2. date of issue and/or revision number 3. page number and total number of pages (e.g. page X of Y) or the designator “ΑΩ” may be used to indicate a one page form Revision numbers for forms and attachments may be tracked independent of the document revision number. The current attachment revision number (if applicable), changes made to attachments, and approval of attachments will be included in the attachment, history, and approval section of the document it is attached to. G. Review and Revision 1. Management system documents will be reviewed annually. 2. Internally generated CSD documents will include a history section or attachment which will be used to document the completion of revisions and, when possible, identify modifications made during revision. Management system documents which are reviewed and found not to need revision may be documented in the history section/attachment and/or in the management system review memo submitted according to QP 18. 3. Temporary deviations or modifications implemented between annual review/revision will be documented and issued according to QP 3. III. Attachments None QP 3 – Deviations Page 1 of 4 Distribution: All CSD Personnel Revision: 2 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures I. Scope This procedure explains the process to follow when a CSD employee believes that a deviation from a current CSD-authored, controlled document is necessary. This procedure does not apply to any policies or procedures issued from outside the CSD. Any deviations from CSD policy, procedure, or protocol which do not comply with this procedure are considered protocol drift and must be evaluated as potential non-conforming work according to QP 13. II. Procedure A. Requirements and recommendations In order to ensure the quality of analysis conducted and services provided, written policies, procedures, and protocols have been established and issued to all appropriate CSD personnel. However, due to the variability of evidence and circumstances encountered, many protocols, procedures, and policies are worded to include recommendations (indicated by “should”) instead of requirements (indicated by “shall”, “will”, or “must”). All CSD personnel are expected to follow both requirements and recommendations set forth in CSD policies, procedures, and protocols, with the following exceptions: 1. Planned deviations from requirements can be requested and conducted following approval of a minor or major deviation as indicated below. 2. CSD employees may deviate from recommendations stated in protocol, procedure, or policy, provided the employee can articulate a legitimate reason which warrants the deviation. 3. CSD employees should make a notation explaining the deviation from recommended procedure. 4. If an employee is not certain whether circumstances warrant a deviation from recommended procedure, he/she should consult the Supervisor for assistance. B. Minor deviations CSD employees will complete the following steps to request, approve, and document authorization to deviate from current policy, procedure, or protocol for an individual sample, case, or batch of samples/cases. 1. The employee will describe the proposed deviation to his or her immediate Supervisor or designee and obtain approval before implementing the deviation. 2. The Supervisor or designee will evaluate the benefits and risks of the proposed deviation to determine if the circumstances warrant the deviation. The Supervisor or designee will consult with the discipline Technical Manager (TM) or CSD QP 3 – Deviations Page 2 of 4 Distribution: All CSD Personnel Revision: 2 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures Quality Manager (QM), if necessary, to thoroughly evaluate the benefits and risks of the deviation. 3. If approved, the deviation will be documented in the case notes when applicable to case work and documented in a relevant location for non-case work activities. 4. The approval will be documented by initialing a short description of the deviation in the case notes or applicable materials in non-case work activities. 5. Alternately, a description of the requested minor deviation may be documented electronically by the analyst in the narrative section of the electronic case file. A Supervisor or designee may document his/her approval electronically by logging into the case and entering a narrative indicating his/her approval. C. Major deviations CSD employees will complete the following steps to request, approve, and document authorization to deviate from current policy, procedure, or protocol for a defined period of time or grouping of cases or samples. These steps will also be used to initiate, approve, and document permanent changes to policies, procedures, and protocols in between annual review and revision of controlled documents. 1. The requesting individual will complete Section I of the Deviation Request Form (CSD QPA 3.1) and specify on the form: a) the applicable protocol, procedure, or policy b) a description of the requested deviation c) the specific instance(s) for which the deviation is requested d) the reason for the deviation 2. The requesting individual will then forward the form for approval as indicated below. 3. Prior to implementation, all major deviations must be approved by the same authorities responsible for approving the document being modified. a) Section II must be completed by the appropriate Technical Manager for any deviation impacting a discipline quality manual or protocol approved by the TM. b) Section III must be completed by the Quality Manager for any deviation impacting the CSD Quality Manual, any Quality Procedure, attachment, or any other management system document initially approved by the QM. c) Section IV must be completed by the CSD Director or designee for all major deviation requests. d) Any deviation request for a document which was also originally approved by another individual must be routed to that individual for evaluation and approval. QP 3 – Deviations Page 3 of 4 Distribution: All CSD Personnel Revision: 2 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures This additional evaluation and approval should be documented on an attached memo or e-mail. 4. Individuals responsible for reviewing a deviation request will evaluate the request in the same fashion as the document being modified. This review includes an evaluation of the merit and risk of the deviation and whether the proposed modification complies with any and all applicable standards. 5. Major deviations which are approved will be issued in the same fashion as the controlled documents affected by the deviation. The FSC administrative office will retain a copy of approved deviation requests. 6. Deviation requests which are not approved will not be disseminated or retained. The individual denying the deviation request should notify the requestor of the decision. 7. Approved deviations may be effective once signed by the CSD Director or designee. When necessary to delay the implementation of a deviation until employees have had an opportunity to be notified of the deviation, the CSD Director, QM, or TM may indicate an effective date on the bottom of the form. If the effective date is left blank, the deviation is effective on the date it was signed by the CSD Director. 8. Major deviations should be routed and approved/disapproved by the appropriate persons within two weeks of the date of request. III. Attachments OSBI CSD QPA 3.1, Rev 1 Deviation Request Form IV. History Revision # Effective/Review Date History 0 3-23-09 Original issue. Replaces QA 16, Rev. 6. 1 9-17-10 Updated Division Director. Add time frame for approval/disapproval of major deviations. 2 12-31-10 Updated Division Director’s name. Added effective date to form (QPA 3.1 Rev 1) and incorporated language to II.C.7. OSBI Criminalistics Services Division Deviation Request Form OSBI CSD QPA 3.1, rev. 1 ΑΩ I. Explanation of Request Name: Date: Applies to (Policy/Procedure): Describe Requested Deviation: Specify the Instance/Circumstance for which the Deviation is Requested: Reason for Deviation: II. Technical Review and Authorization Merits: Risks/Impact: Duration of Authorization: Restrictions/Limitations: Authorized/Rejected (signature) Date: III. Quality Assurance Manager Authorization Acceptability Within General Quality Assurance Principles? YES/NO Significant Negative Impact to Division-Wide Quality Standards? YES/NO Restrictions/Limitations: Authorized/Rejected (signature) Date: IV. Criminalistics Division Director Authorization Authorized/Rejected (signature) Date: Effective Date: QP 4 – Review of Requests, Tenders, and Contracts Page 1 of 3 Distribution: All CSD Personnel Revision: 1 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures I. Scope This procedure will be used to evaluate all requests for laboratory examination and provide response to the customer requesting analysis. Wh
Object Description
Description
Title | OSBI Criminalistics Services Division quality manual 12-31-10 |
Notes | Revision #3 |
OkDocs Class# | I2100.5 C929q 12/2010 |
Digital Format | PDF, Adobe Reader required |
ODL electronic copy | Downloaded from agency website: http://www.ok.gov/osbi/documents/QM%20and%20all%20QPs%2012-31-10.pdf |
Rights and Permissions | This Oklahoma state government publication is provided for educational purposes under U.S. copyright law. Other usage requires permission of copyright holders. |
Language | English |
Full text | OSBI Criminalistics Services Division Quality Manual Revision #3 Effective Date: 12-31-10 Page 2 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director Table of Contents OSBI Mission and Vision Foreword Quality Policy Section Subject 1 Scope 2 References 3 Glossary 4 Management 4.1 Organization (QP 1) 4.2 Management system 4.3 Document control (QP 2) 4.3.1 General 4.3.2 Approval and Issue 4.3.3 Document changes (QP 3) 4.4 Review of requests, tenders, and contracts (QP 4) 4.5 Subcontracting tests 4.6 Purchasing Services and Supplies (QP 8, QP 9) 4.7 Service to the customer (QP 10, QP 11) 4.8 Complaints (QP 12) 4.9 Control of nonconforming testing (QP 13) 4.10 Improvement Page 3 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director Table of Contents Section Subject 4.11 Corrective action (QP 14) 4.11.1 General 4.11.2 Cause analysis 4.11.3 Selection and implementation of corrective actions 4.11.4 Monitoring of corrective actions 4.11.5 Additional audits 4.12 Preventive action (QP 15) 4.13 Control of records (QP 16.1, QP 16.2) 4.14 Internal audits (QP 17) 4.15 Management reviews (QP 18) 5 Technical requirements 5.1 General 5.2 Personnel (QP 19) 5.3 Accommodation and environmental conditions (QP 20) 5.4 Test and calibration methods and method validation 5.4.1 General (QP 21) 5.4.2 Selection of methods 5.4.3 Laboratory-developed methods 5.4.4 Non-standard methods 5.4.5 Validation of methods Page 4 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director Table of Contents Section Subject 5.4.6 Estimation of uncertainty of measurement (QP 22) 5.4.7 Control of data 5.5 Equipment (QP 24) 5.6 Traceability (QP 23, QP 24, QP 25, QP 26) 5.6.1 General 5.6.2 Specific requirements 5.6.3 Reference standards and reference materials 5.7 Sampling 5.8 Handling of test and calibration items (QP 5, QP 6, QP 7) 5.9 Assuring the quality of test results (QP 30, QP 31, QP 32) 5.10 Reporting the results (QP 28, QP 33) 5.10.1 General 5.10.2 Test reports and calibration certificates 5.10.3 Additional Requirements 5.10.4 Calibration certificates 5.10.5 Opinions and interpretations 5.10.6 Testing and calibration results obtained from subcontractors 5.10.7 Electronic transmission of results 5.10.8 Format of reports and certificates 5.10.9 Amendments to test reports Page 5 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director Attachments OSBI CSD QMA 1.1, Rev. 0 Notice to Customers OSBI CSD QMA 2, Rev. 1 Evidence Acceptance Requirements OSBI CSD QMA 3, Rev. 2 Evidence Sealing Guidelines OSBI CSD QMA 4, Rev. 1 Facilities and Available Services OSBI CSD QMA 5, Rev. 2 Alternate Service Providers OSBI Mission The mission of every OSBI member is to insure the safety and security of the citizens of Oklahoma. OSBI Vision The OSBI will continue to be the professional law enforcement agency for the State of Oklahoma. We provide specialized apprehension and crime detection services through teamwork, training, research, and implementation of innovative technologies. We recruit and retain the expertise required to meet changing responsibilities. We increase public awareness through proactive publicity and education. Foreword The Oklahoma State Bureau of Investigation (OSBI) and the Criminalistics Services Division (CSD) are dedicated to provide quality service and results. The OSBI CSD has adopted the standards set forth by the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB) Legacy and International accreditation programs. In order to facilitate accreditation by the International program, this manual has been organized using the same outline structure as the International Organization for Standardization and the International Electrotechnical Commission (ISO/IEC) 17025 standards. Much of the language in this manual is new. However, some language was extracted from the previous CSD Quality Manual. Quality Policy The OSBI CSD management is committed to providing quality and professional service to our customers. It is the objective of the OSBI CSD to provide service that meets or exceeds the customer's needs and to ensure that quality and analytical practices meet or exceed the standards required for accreditation. The management system documents are provided to CSD employees to communicate the procedures which must be followed to provide this level of quality and service. As indicated in Section 1 below, all CSD personnel are responsible for knowing and implementing these policies. This manual and the laboratory practices will be reviewed regularly in order to attain compliance with ISO/IEC 17025 standards and to continually improve the effectiveness of the management system. Page 6 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 1. Scope 1.1 This manual sets forth the policies and procedures which govern the work performed by members of the OSBI CSD. 1.2 All members of the CSD are responsible for knowing and abiding by all management system policies and procedures. 2. References The following standards guide the requirements set forth in this policy manual. If the reference listed does not include a date, the most recent revision of the referenced document applies. ISO/IEC 17025:2005 ASCLD/LAB-International Supplemental Requirements – Testing (Effective 04/01/2011) Quality Assurance Standards for Forensic DNA Testing Laboratories (Effective 07/01/2009) Quality Assurance Standards for DNA Databasing Laboratories (Effective 07/01/2009) The FBI Quality Assurance Standards Audit for DNA Databasing Laboratories (Effective 07/01/2009) The FBI Quality Assurance Standards Audit for Forensic DNA Testing Laboratories (Effective 07/01/2009) ASCLD/LAB Proficiency Review Program ASCLD/LAB Guiding Principles located at http://www.ascld-lab.org/about_us/guidingprinciples.html Page 7 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 3. Glossary In addition to the terms and definitions listed below, any definition provided in one of the documents listed in Section 2 also applies. ADMINISTRATIVE STAFF: The Criminalistics Administrators, CSD Director and Executive Secretary. ADMINISTRATIVE SUPERVISION: The authority to monitor the day-to-day activities and perform traditional managerial duties of assigned units or laboratories. CASE FILE: The file folder containing hard copy documentation relevant to a particular case or the electronic file contained within the BEAST that contains documentation relevant to a particular case. CASE RECORD: The cumulative records which document the quality, technical, and analytical information relevant to a particular case. COMPLAINT: The expressed dissatisfaction by a customer with the quality or timeliness of work products or services. CONVENIENCE PACKAGE: Evidence which is properly sealed and marked for identification may be placed in unsealed containers such as boxes or bags for the purpose of grouping items of evidence or for the convenience of carrying the evidence without that container having to meet the “proper seal requirements,” as long as evidence security requirements are otherwise met. These containers should be marked as a “convenience package.” CORRECTIVE ACTION: An action or actions implemented to correct circumstances which led to non-conforming work. Successful corrective actions should prevent a reoccurrence of the same type of non-conforming work. This is also referred to as “preventive measures taken” by QAS Standard 14.1.b.5. CORRECTIVE ACTION PLAN: A plan to resolve a discrepancy identified in casework, database activities, or proficiency testing work which will correct the problem and prevent a future occurrence. (QAS based definition – Std. 14) CRIMINALISTICS ADMINISTRATOR (CA): Individual who reports directly to the CSD Director and is responsible for supervising Criminalist Supervisors. CRIMINALIST SUPERVISOR: Individual who reports to a Criminalistics Administrator and supervises criminalists. CRITICAL REAGENT: A reagent that requires testing on established samples before use on evidentiary samples in order to prevent unnecessary loss of sample. Page 8 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director CUSTOMER (CLIENT): A recipient of the OSBI Criminalistics Services Division reports and/or services. A customer can also be within the Criminalistics or Investigative Services Division. DERIVATIVE EVIDENCE: Any tangible material removed or derived from an evidence item already having an assigned item number. Examples are cuttings, debris collections, latent lifts, and retained stain samples. Derivative evidence or containers will be marked with appropriate case number, item or sub-item numbers, analyst's initials and date, and listed in the case file. EVIDENCE: For the purposes of this directive, evidence shall mean all materials submitted for scientific analysis during the course of an official criminal investigation. EVIDENCE DESTRUCTION FORM: A form used to document permission for the destruction of evidence. EVIDENCE RELEASE FORM: A form used to document the return or release of evidence to the courts, OSBI employees, or submitting agencies. EVIDENCE TAPE: Tamper proof tape used in sealing evidence containers. FUNCTION VERIFICATION: A check to determine if a piece of equipment or instrumentation is working correctly within specified parameters. MAJOR DEVIATION: A planned and approved modification to current policy or protocol which will apply for a set period of time or to a defined grouping of cases or samples. MINOR DEVIATION: A planned and approved modification which will be applied to a single case, sample, or single batch of samples/cases. NO ANALYSIS CASE: Evidence in cases submitted to the laboratory where charges have been dismissed or for some other reason no analysis is required can be returned to the submitting agency. NON-CONFORMING WORK: Work that does not meet the standards set forth in policy, procedure, protocol, or does not meet the needs of the customer. This may occur due to protocol drift or due to a quality or technical problem with a reagent, supply, or instrument. ORIGINAL REQUESTING AGENCY: The agency having jurisdiction in the case that made the request for services. Evidence will be returned after analysis to the original requesting agency unless specified otherwise in this policy. PERFORMANCE CHECK: Actions taken to ensure analysis methods still perform as intended. Performance checks are similar to validations, but more limited in scope. Page 9 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director PHYSICAL EVIDENCE TECHNICIAN: Individual responsible for the reception, storage, documentation, and handling of the physical evidence submitted to an Oklahoma State Bureau of Investigation Laboratory. PREVENTIVE ACTION: Actions taken to improve circumstances which could lead to non-conforming work. (ISO/IEC 17025:2005 based definition) PROTOCOL DRIFT: Unintentional and/or unauthorized deviations from current protocol. PROPER SEAL: An evidence container is “properly sealed” only if its contents cannot readily escape and only if opening the container would result in obvious damage/alteration to the container or its seal. Staples alone cannot provide a sealed condition on evidence packaging. It is acknowledged that not all evidence can be sealed inside a container. A proper seal would constitute tape sealing, heat-sealing, or lock sealing and initialing the seal. A date on the seal is also recommended. Evidence such as weapons which will require only test firing or serial number restoration may be tagged with an identification tag and do not require a container. QUALITY: Adhering to generally recognized standards of good laboratory practice. QUALITY ASSURANCE (QA): Those processes necessary to provide confidence that the results from OSBI Criminalistics Services Division analysis and testing will satisfy given requirements for quality. QUALITY ASSURANCE AUDIT: A systematic examination and review to determine whether quality processes and related results comply with the protocols, policies, and procedures, and whether these practices are suitable and effective in achieving the quality objectives. QUALITY ASSURANCE PROGRAM: OSBI Criminalistics Services Division guidelines describing recognized quality assurance requirements for forensic laboratory analysis and reporting. QUALITY CONTROL (QC): The day-to-day operational techniques and activities used by the laboratory to consistently provide accurate analytical results that fulfill the requirements for quality. QUALITY IMPROVEMENT COMMITTEE (QIC): The Quality Improvement Committee is an ongoing committee for the purposes of reviewing and implementing ways to improve the quality of laboratory services. This committee, which meets at least quarterly, is composed of all Regional and Unit Supervisors, discipline Technical Managers and Administrative Staff. Page 10 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director QUALITY MANAGER (QM): The Criminalistics Administrator assigned the responsibility of overseeing quality operations including proficiency testing, auditing, reviewing non-conforming work, etc. QUALITY RECORDS: Records generated from quality assurance procedures. This includes, but is not limited to, proficiency tests, corrective and preventive actions, audits, training documentation, continuing education, and testimony review. REFERENCE MATERIAL: A material for which values are certified by a technically valid procedure and accompanied by or traceable to a certificate or other documentation, which is issued by a certifying body. Examples include known drug standards and NIST Standard Reference Materials (SRM’s) which can include known values for a variety of substances, including DNA profiles. REFERENCE STANDARD: A traceable standard, generally having the highest metrological quality available, from which measurements are derived. An example would be NIST traceable weights. REMEDIATION: Steps taken to correct non-conforming work, such as issuing an amended report, re-testing, etc. This is also referred to as “corrective actions taken” by QAS Standard 14.1.b.4. REQUESTING OFFICER: The individual, authorized by statute, requesting examination of the submitted evidence. Criminalists will not be listed as a requesting officer. RFLE: Request For Laboratory Examination form. SAMPLING: The practice of testing a portion of a substance and reporting a conclusion for the whole substance using a statistically based or reasonable assumption of homogeneity of the whole. SAMPLE SELECTION: The practice of selecting one or more samples from an item for testing based on training and experience. Following analysis, results are reported clearly and unambiguously to indicate that the results reported apply to the sample, not the whole item. SUBMITTING OFFICER: The person delivering evidence to an OSBI laboratory. Criminalists will be listed as the submitting officer when involved with the collection of evidence. TECHNICAL MANAGER (TM): The individual assigned the responsibility and authority for the technical operations in a particular discipline. TECHNICAL PROTOCOLS (PROCEDURES): Technical procedures are a key element in establishing and maintaining quality control within the laboratory. Written procedures will be prepared for those routine tests performed in the OSBI Laboratory. The procedures used may be Page 11 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director those developed and adequately validated by an outside agency or laboratory or those developed and validated in-house. TECHNICAL RECORDS: Documentation generated in the analysis of casework or database samples. This includes reports, examination documentation, quality control results, etc. TEMPORARY EVIDENCE CLOSURE OR SEAL: Temporary evidence closure consists of a piece of tape across a box, a paper clip on a folded evidence envelope, or some other closure that would not normally constitute a proper seal on evidence. A temporary closure is acceptable when the analyst will be away from the work area for a short period of time or overnight as long as the evidence is secured in a locking drawer or controlled access evidence area. TESTING: Testing refers to analysis conducted at the request of OSBI CSD customers. This may include casework analysis, database sample analysis, or other work mandated for the OSBI CSD. This does not apply to training, research, etc. TRACEABILITY: The property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons. VALID COMPLAINT: A complaint that has been verified and that warrants action. VERIFICATION: Determining whether or not a stated complaint is well founded, and indisputable. Page 12 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4. Management Requirements 4.1 Organization 4.1.1 Legal Responsibility The OSBI CSD is a division of the Oklahoma State Bureau of Investigation, which has been granted legal authority by state statute. Refer to O.S. Title 74, Section 150.2. The CSD Director is appointed by the Director of the OSBI and has the responsibility and authority for all laboratory functions and personnel. 4.1.2 Operating Guidelines The OSBI CSD will provide forensic science service which meets or exceeds the needs of customers. OSBI CSD service will also meet or exceed the applicable standards set forth by ASCLD/LAB. 4.1.3 Management System Scope The policies and procedures set forth in the management system apply to work performed by CSD personnel in any temporary, mobile, or permanent facility. 4.1.4 Interrelation of the OSBI CSD In addition to serving customers outside the OSBI, the CSD also provides services to the Investigative Division of the OSBI. An agency organizational chart is located on the OSBI Intranet at http://128.1.2.243:7001/hr_master/faces/orgchart.jspx?_adf.ctrl-state= 1475ubhsll_14. The responsibilities of the agency director, deputy director, and investigative personnel are located in OSBI Policy 103. 4.1.4.1 The responsibilities and authority of the CSD Director are defined in Quality Procedure (QP) 1. 4.1.4.1.1 The OSBI CSD Director shall have sufficient authority to make and enforce decisions. 4.1.5 Management Requirements The OSBI CSD ensures the effectiveness of the management system through the following steps. Page 13 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director a) Personnel are provided sufficient authority and resources to complete their duties, including implementing the management system and identifying, correcting, and minimizing deviations from policies, procedures, and protocols. b) Personnel are protected from influences which could adversely affect the quality of work performed. See OSBI Policy 105 and O.S. 257-20-1-9. c) Confidential case information, including electronically stored and distributed reports and documentation, is protected. Refer to Oklahoma Statute Title 74, Section 150.5. d) Activities which would bring question to the competence or integrity of the agency and its employees are prohibited. Refer to the OSBI Code of Ethics and OSBI Policy 105. e) Organizational structure, including relationships between management, technical, and support personnel is defined. Refer to the agency organizational chart on the OSBI Intranet. f) The authority, responsibilities, and interrelations for any position which impacts the quality of work performed are specified. Refer to the agency organizational chart and QP 1. Current job descriptions are located at http://www.ok.gov/opm/jfd/jfd_g-page.htm. 1. No employee is accountable to more than one supervisor per function. g) Testing staff, including trainees, will be supervised by individuals who are familiar with the methods and procedures used. This may be accomplished through the Supervisor’s own experience in the methods and procedures used by staff or through the Supervisor’s coordination with Technical Managers and/or Criminalistics Administrators familiar with the methods used. Refer to QP 19 for additional information on training. h) Each discipline has a technical manager who has the authority, responsibility, and resources required to ensure the appropriate quality of work. Refer to QP 1 for additional information regarding responsibilities and authority. i) The CA responsible for managing the forensic biology discipline has been appointed as the QM for the CSD. Refer to the agency organizational chart and QP 1. Current job descriptions are located at http://www.ok.gov/opm/jfd/jfd_g-page. htm. j) Key managerial personnel (as defined in section 4.1.8 below)are responsible for naming a designee and notifying employees during planned absences. If a designee is not named, or there is an unplanned absence, the individual’s Page 14 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director supervisor will be responsible for appointing a designee and notifying employees. Deputies for key managerial personnel are responsible at a minimum, for the critical duties of the position which cannot be delayed until the individual returns. k) Through routine unit and discipline meetings, all employees are informed of the importance of their activities and how those activities help ensure that the CSD meets the objectives of the management system. 4.1.6 Effectiveness of the Management System Administrative staff meets regularly and during meetings discusses the effectiveness of the management system and reviews the communication processes used in the laboratory to ensure they are appropriate. 4.1.7 Safety Coordinator The CA responsible for the administration of the controlled substances discipline has been appointed as the CSD Safety Coordinator and has the responsibility and authority for implementing, updating, and ensuring compliance with the health and safety program. 4.1.8 Key and Top Management Key management personnel includes the following positions: • CSD Director • Quality Manager • Safety Coordinator • LIMS Administrator • FSC Building Manager • Technical Managers • All Supervisors and Administrators Top management is the CSD Director. 4.2 Management System 4.2.1 Management System Documents The OSBI CSD management system documents the policies and procedures to be followed in order to ensure the quality of laboratory services provided. The OSBI CSD management system consists of the quality policy manual, the quality procedure manual, and discipline quality and protocol manuals. The documents of the Page 15 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director management system are available to all CSD employees on the OSBI Intranet, http://osbinet/main/. Refer to QP 2 for distribution procedures. 4.2.2 Quality Manual This document in its entirety is the quality manual for the OSBI CSD. The Quality Policy Statement is located following the Foreword. 4.2.2.1 The ASCLD/LAB Guiding Principles of Professional Responsibility for Crime Laboratories and Forensic Scientists have been included as a reference to this manual (See Section 2 – References). 4.2.2.2 The CSD Director ensures that these Guiding Principles are reviewed by all CSD personnel annually and maintains a record of that review, in accordance with QP 18. 4.2.3 Management Commitment Management is committed to developing, implementing, and continually improving the effectiveness of the management system. This is evident through management's involvement in quality procedures including audits, proficiency testing, management system review, etc. 4.2.4 Management Communication Management communicates the importance of meeting customer, statutory, and regulatory requirements during regular meetings of the Quality Improvement Committee (QIC). 4.2.5 Supporting Procedures Quality policies are included in the quality manual, which follows the same outline as the ISO/IEC 17025 standards. Procedures governing the implementation of these policies which apply to multiple disciplines are included in the Quality Procedures. Quality policies and technical procedures which apply to a single discipline are included in the discipline quality and protocol manuals. Discipline specific manuals should not contradict the CSD Quality Manual or Quality Procedures. 4.2.6 Roles and Responsibilities The roles and responsibilities of technical management and the quality manager are provided in section 4.1.5 above and the referenced attachments. Page 16 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.2.7 Management System Integrity CSD Management will preserve the integrity of the management system anytime changes to the system are planned and implemented. 4.3 Document Control 4.3.1 General The OSBI CSD controls all documents included in the management system to ensure the documents are appropriate to the work conducted. The management system consists of internally and externally generated documents. Documents as referenced in this policy include policies, procedures, regulations, standards, software, manuals, etc. Refer to QP 2 for document control procedures. 4.3.2 Approval and Issue 4.3.2.1 Any technical protocol or discipline quality manual documents will be reviewed by the technical manager or his/her designee. Technical protocols and discipline quality manuals will be approved by the technical manager and the Criminalistics Division Director or designee, in his/her absence. Management system documents including quality policies and quality procedures will be reviewed by the Quality Manager and will be approved by the Quality Manager and the Criminalistics Division Director or designee, in his/her absence. 4.3.2.2 QP 2 describes the steps taken to ensure that: a) The current authorized version of management system documents is available at all OSBI CSD facilities. b) Management system documents are periodically reviewed and revised as appropriate. c) Documents which are no longer valid are removed from use promptly. d) Retired documents that are retained for legal or knowledge preservation purposes are marked appropriately to prevent unintended use. 4.3.2.3 Each internally issued document will be identified with the information specified in QP 2. Page 17 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.3.3 Document Changes 4.3.3.1 Changes to documents can be made in two ways. Documents are revised following QP 2. In addition, changes to documents can be documented using a major deviation, as described in QP 3. Both methods follow the same review and approval method. 4.3.3.2 Each internally issued document will include an attached document history page or section. Insertions or alterations made to the document with each revision will be noted in this section, whenever practical. 4.3.3.3 Documents will only be amended as indicated under section 4.3.3.1 above. Amendments may not be made by hand writing on documents. 4.3.3.4 QP 2 details how changes are made and controlled for documents issued through the OSBI Intranet. 4.4 Review of Requests, Tenders, and Contracts 4.4.1 General QP 4 establishes the procedures that will be followed for the review of requests, tenders, and contracts. This procedure ensures that: a) The customer's requirements, which include the type of analysis or methods to be used, are well defined, documented, and understood. b) The OSBI CSD is capable of meeting the customer's needs. c) The appropriate test method is selected. Any differences between the request, tender, or contract will be resolved before work commences. Each contract should be satisfactory to both the OSBI CSD and the customer. 4.4.2 Records An electronic or hard copy of the RFLE will be maintained with the case file as a record of the request, review, and contract. In addition, any significant changes will be recorded in a conversation log, e-mail, or equivalent document. All records of changes to the contract will also be maintained with the case file (either electronic or hard copy). Page 18 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.4.3 Subcontracted Work This review process shall apply to work performed by any OSBI laboratory, regardless of which laboratory received the evidence and performed the review. It shall also apply to analysis that is subcontracted to a non-OSBI laboratory. 4.4.4 Deviations The customer will be informed of deviations from the contract. If an analyst determines that requested analysis is not appropriate or recommends alternate or additional analysis, the customer will be contacted prior to modifying the contract. 4.4.5 Amendments Any amendment or modification to the contract after analysis begins will be reviewed in the same manner listed under QP 4. The person making the amendment will notify the affected personnel. 4.5 Subcontracting of Tests In order to provide the best service possible, OSBI laboratories may choose to transfer work to another OSBI laboratory or subcontract to an outside vendor. 4.5.1 Qualification of Subcontract Laboratory All OSBI laboratories and any laboratory performing work for the OSBI must be accredited through the ASCLD/LAB Legacy or ASCLD/LAB International program. 4.5.2 Customer Notification The OSBI CSD shall notify customers in writing when subcontracting work to an outside vendor. When appropriate, the OSBI CSD will also obtain approval from the customer, preferably in writing. 4.5.3 Review of Subcontracted Work The OSBI CSD maintains responsibility for subcontracted work, unless the customer or a regulatory authority specifies which subcontractor will be used. 4.5.4 Records of Subcontractors The QM will receive and maintain a copy of the accreditation certificate for any laboratory which performs analysis on behalf of the OSBI. Page 19 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.6 Purchasing Services and Supplies 4.6.1 General Selection and purchasing of services and supplies will be made according to OSBI Policy 208. The purchase, receipt, and storage of reagents and consumable materials used for analysis will be conducted according to QP 8. 4.6.2 Verification of Reagents, Supplies, and Consumable Materials Any supply, reagent, or consumable item that will affect the quality of analysis will not be used until inspected and/or verified according to QP 8. 4.6.3 Descriptions of Items Affecting Quality Items that affect the quality of analysis will be identified on the Internal Purchase Request (IPR) with a description specific enough to ensure the appropriate quality of item is purchased. This description may be a product number, catalog number, a reference to a particular grade or purity, or other technical description. The description provided will be reviewed and approved with the IPR. 4.6.4 Evaluation of Suppliers The technical manager of each discipline will determine which reagents, consumables, supplies, and services are critical and affect the quality of testing. The technical managers will also oversee the evaluation of suppliers and maintain a list of approved suppliers, as described in QP 9. 4.7 Service to the Customer 4.7.1 Assisting the Customer The OSBI CSD will cooperate with OSBI customers to ensure that service provided meets customers' needs. This includes clarifying requests for analysis and monitoring the laboratory's work performance. However, the OSBI CSD will ensure that cooperation with one customer does not compromise confidentiality of other customers. Refer to QP 10 for procedures on customer assistance. 4.7.2 Soliciting Feedback from Customers The OSBI CSD will seek feedback from customers, primarily through the use of surveys. Feedback will be utilized to improve the management system, analytical procedures, and customer service. QP 11 details the procedure for soliciting general Page 20 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director customer feedback. QP 32 details the procedure for soliciting feedback specific to testimony provided. 4.8 Complaints Complaints will be resolved and documented according to QP 12. 4.8.1 Quality Complaints QP 12 will also be used to resolve and document complaints submitted by employees regarding quality aspects of the management system. 4.9 Control of Nonconforming Work 4.9.1 Policy Any work that does not conform to the requirements set forth in this manual, the Quality Procedures, or in OSBI technical protocols shall be addressed according to QP 13. By following the procedure detailed in QP 13, OSBI CSD shall ensure that: a) Responsibilities and authorities for managing nonconforming work are specified and appropriate actions are defined and taken when nonconforming work is identified. b) The nonconforming work is evaluated to determine the significance. c) A decision regarding the acceptability of nonconforming work is made and correction is done immediately. d) The customer is notified and work is recalled when necessary. e) The responsibility for authorizing work to resume is defined. 4.9.2 Implementation of Corrective Action If the evaluation of the nonconforming work indicates a significant possibility that the problem could recur, or there is an indication that lab operations do not comply with OSBI policy and procedures, then corrective action procedures outlined in QP 14 will be followed. Page 21 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.10 Improvement The management system will be continually improved using information gained during audits, analysis of statistical data, corrective and preventive actions taken, management review, etc. 4.11 Corrective Action 4.11.1 General When nonconforming work is identified, it will be addressed according to QP 13. This procedure details the appropriate authorities for implementing corrective actions. 4.11.2 Cause Analysis As indicated in QP 14, the first step of corrective action will be to investigate the root cause of nonconforming work. 4.11.3 Selection of Corrective Action After the completion of the root cause analysis, potential corrective actions will be evaluated. The goal of the corrective action is to correct the problem and prevent the problem from recurring. The corrective action plan will also be appropriate to the magnitude and risk of the problem. The corrective action plan most likely to succeed in these areas will be selected and implemented. Any changes necessary as a result of the corrective action investigation will be implemented and documented. 4.11.4 Monitoring Corrective Actions For each corrective action plan, the results of the corrective action will be monitored to determine effectiveness. 4.11.5 Additional Audits When the nonconforming work indicates that there is a failure to comply with ISO/IEC 17025 standards or CSD policies and procedures, an audit of the areas of activity in question will be conducted as soon as possible. In addition, an audit may be used following the implementation of a corrective action plan in order to assess the effectiveness of the corrective action. Page 22 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.12 Preventive Action 4.12.1 General Needed improvements or potential sources of nonconformity will be identified and routed as indicated in QP 15. Preventive action plans will be developed, implemented, and monitored for effectiveness in order to ensure that opportunities for improvement are exploited and nonconforming work is prevented. 4.12.2 Procedure QP 15 details how to initiate preventive actions and how to utilize controls or other measures to ensure the preventive action is effective. 4.13 Control of Records 4.13.1 General 4.13.1.1 QP 16.1 describes the procedure for maintaining quality and technical records. Quality records and technical records are defined in the glossary. 4.13.1.2 Records will be legible and stored in a manner that they are readily retrievable and protected from damage and loss. Retention times for records are also reflected in QP 16.1. 4.13.1.3 Records will be kept in secure locations and are confidential. 4.13.1.4 Procedures for records stored electronically are detailed in QP 16.1. 4.13.2 Technical Records 4.13.2.1 The OSBI CSD will retain records of examination documentation and supporting documentation, such as quality assurance/quality control documentation, and copies of reports for the period of time defined in QP 16.1. Each case record will contain enough information to identify factors affecting uncertainty of measurement, if possible and applicable, and to enable re-analysis to be conducted under conditions as close to the original as possible. The identity of the individuals who sampled evidence, conducted testing, and/or verified results will be reflected in the case record. 4.13.2.2 Observations, data, and calculations must be recorded at the time they are made and must be identifiable to the specific case involved. Page 23 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.13.2.2.1 Examination documentation must include at a minimum, the start and end dates of examination. 4.13.2.3 Mistakes in examination documentation will be crossed out with a single line, initialed, and the correct value added alongside. Erasing, obliterating, or otherwise making the original data illegible is not permitted. Similar measures must be taken with records stored electronically to avoid losing or altering original data. 4.13.2.3.1 Any change made to existing hard copy examination documentation will also be initialed by the person making the addition. 4.13.2.3.2 Examination documentation is considered complete when it is submitted for administrative and/or technical review. Any change made to completed examination documentation shall be tracked. 4.13.2.4 Documents maintained as part of the case record are identified in QP 16.2. 4.13.2.5 Examination and supporting documentation must be sufficient for another examiner to determine what was done and to independently interpret the data. 4.13.2.5.1 Latent print documentation shall meet all requirements listed in Appendix C of the ASCLD/LAB Supplemental Requirements. 4.13.2.5.2 Operating parameters used during instrumental analysis shall be recorded in the examination documentation, protocol, or another suitable and appropriate location. 4.13.2.6 Each page of examination documentation will bear the case number and examiner's handwritten initials (or secure electronic equivalent of initials or signature). 4.13.2.7 If a technician or other individual prepares examination documentation which another analyst interprets, reports, or testifies to, the person who prepares the examination documentation must initial the page(s) he/she prepares. 4.13.2.8 All administrative documentation, received or generated by the OSBI CSD, must be labeled with the laboratory case number. 4.13.2.9 When multiple cases are analyzed simultaneously, the case number of each case must be appropriately recorded on the printout if the data is recorded on a single printout. Page 24 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.13.2.10 Examination documentation should be one-sided. Each side of any two-sided examination documentation will be treated as a separate page (initialed and case numbered). 4.13.2.11 Examination documentation will be permanent in nature. 4.13.2.12 Verifications of analytical findings, such as latent print or firearms identifications, will be conducted by qualified examiners. Verifications will be documented to include what was verified, whether the second examiner agreed, and when the verification was conducted. 4.13.2.13 The meaning of any abbreviations or symbols specific to the OSBI CSD will be documented either in the case record or in discipline quality manuals or protocols. 4.14 Internal Audits 4.14.1 The OSBI CSD shall conduct internal audits as described in QP 17. 4.14.1.1 Internal audits will be conducted annually. 4.14.1.2 Documentation of internal audits will be retained as quality records according to QP 16.1. 4.14.2 If audit findings identify nonconforming work or indicate that the effectiveness of operations or validity of test results may be questionable, then procedures outlined in QP 13, if applicable, and QP 14 will be promptly followed. 4.14.3 An audit report will be completed according to QP 17. 4.14.4 Implementation and effectiveness of any corrective actions generated as a result of an internal audit will be verified and recorded according to QP 14. Page 25 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 4.14.5 Each OSBI laboratory will submit an Annual Accreditation Audit Report to ASCLD/LAB according to the deadline in QP 17. 4.15 Management Reviews 4.15.1 OSBI CSD management will conduct a review of the management system and casework activities, at least annually, to ensure their continued effectiveness and to introduce changes or improvements as needed. The procedure for management system reviews is detailed in QP 18. Records of management system reviews will be retained as a quality record according to QP 16.1. Management system reviews will include the following topics: a) suitability of policies and procedures b) reports from managerial and supervisory personnel c) outcome of recent internal audits d) corrective and preventive actions e) external audits f) proficiency test results g) changes in volume and type of analysis h) customer feedback i) complaints j) recommendations for improvement k) any other relevant factors 4.15.2 Findings from management reviews and the actions taken will be recorded according to QP 18. CSD management will ensure that actions are carried out according to an appropriate timetable. 5. Technical Requirements 5.1 General 5.1.1 Several factors impact the reliability of analysis conducted by the OSBI CSD. These may include the following: Page 26 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director • human factors (5.2) • environmental conditions (5.3) • protocols and method validation (5.4) • equipment/instrumentation (5.5) • measurement traceability (5.6) • sampling (5.7) • evidence handling (5.8) 5.1.2 The OSBI CSD shall take account of the factors listed above when developing and validating procedures, training and qualifying personnel, and in the selection and calibration of instrumentation. 5.1.3 The reliability of reagents will be verified according to QP 8. 5.1.3.1 Reagents prepared in-house will be labeled with the identity of the reagent and the lot number or date of preparation at a minimum. Records identifying who prepared the reagent and documenting the function verification will be maintained. 5.2 Personnel 5.2.1 OSBI CSD Management shall ensure the competence of any individual who performs analysis, operates instrumentation, evaluates results, or signs reports. Work conducted by trainees shall be properly supervised. The education, training, experience, and/or demonstrated skill of an employee shall be used to qualify the individual. 5.2.1.1 Each OSBI CSD discipline shall have a documented training program which will be used to train employees in the knowledge, skills, and abilities necessary to perform analysis. Requirements for discipline training manuals are outlined in QP 19. 5.2.1.2 Where applicable, training programs shall also address courtroom testimony. 5.2.2 OSBI CSD Management has established the goals for education, training, and skills of employees. These goals and the procedure for identifying training and conducting Page 27 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director training are outlined in each discipline training manual. QP 19 details how the effectiveness of the training program will be evaluated. 5.2.3 OSBI CSD shall use personnel employed by or under contract to the OSBI. If contract or additional support personnel are used, OSBI CSD will ensure that these personnel are also appropriately supervised and competent for the work they perform. Their work shall also be in accordance with the OSBI CSD Management System. 5.2.4 Current job descriptions for managerial, technical, and key support personnel involved in analysis are located at http://www.ok.gov/opm/jfd/jfd_g-page.htm. More specific job descriptions may also be located in each discipline's quality manual. 5.2.5 OSBI CSD Management shall indicate which procedures and work each employee is authorized to perform by providing a written memo detailing the task(s) and the date the individual is authorized to perform the work. Records of these authorizations shall be maintained in an electronic or hard-copy training notebook for each individual. 5.2.6 OSBI CSD personnel shall meet the education and competency requirements detailed in the ASCLD/LAB Supplemental Requirements. Technicians will meet the educational requirements established in the applicable written job description. If there is not an applicable job description available through the Office of Personnel Management, the Supervisor will be responsible for developing a written job description for the technician position(s) in his/her unit. 5.2.7 The OSBI CSD provides access to current literature sources by ordering journals and by providing internet access and on-line subscriptions to employees. 5.3 Facilities 5.3.1 OSBI CSD shall provide laboratory facilities with proper energy sources, lighting, temperature, and other environmental conditions to ensure correct performance of Page 28 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director tests and procedures. Employees should exercise caution when conducting sampling or analysis in a location other than a permanent facility, such as a crime scene, to ensure that environmental conditions do not negatively impact the integrity of evidence or results. Accommodations and environmental conditions which would impact results shall be documented in the technical protocols. 5.3.2 When specific environmental conditions are required by the technical procedure or could impact the quality of results, the OSBI CSD shall monitor, control, and record the appropriate environmental conditions. Testing shall be stopped if the environmental conditions would negatively impact test results. 5.3.3 Incompatible testing activities shall be separated by time or space in order to prevent cross-contamination. 5.3.4 Access to laboratories and evidence rooms will be limited to employees assigned to the laboratory unit, evidence technicians assigned to the physical facility, Criminalistics Administrative personnel, and other personnel as authorized by the Criminalistics Services Division Director on a limited or permanent basis. 5.3.4.1 Laboratory security procedures are located in QP 20. 5.3.5 Good housekeeping shall be maintained in OSBI CSD facilities. If necessary, technical protocols will be prepared for cleaning/sterilization procedures. 5.3.6 OSBI CSD follows the health and safety program detailed in OSBI Policies 121.0 through 121.5. 5.4 Test Methods and Validation 5.4.1 General OSBI CSD uses appropriate methods for all testing and evidence handling. Evidence handling procedures are included in QP 6 and QP 7. Technical procedures, Page 29 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director estimations for uncertainty of measurement, and any statistical techniques for analysis of testing data are included or referenced in discipline specific quality manuals and/or protocols. Instructions on the operation of instrumentation, sample handling and preparation will also be included or referenced in the discipline specific quality manuals and/or protocols, if written instructions are necessary to ensure the quality of test results. Any deviations to these procedures occur only as outlined in QP 3. 5.4.1.1 All analytical protocols shall be documented and issued according to QP 2. 5.4.1.2 Appropriate controls and standards shall be specified in the analytical records and the results of controls and standards tested shall be documented in the case record. 5.4.2 Selection of Methods The OSBI CSD shall use analysis methods which meet the needs of the customer and which are appropriate for the testing conducted. 5.4.2.1 The reliability of any new method will be internally validated and the results of the validation study documented prior to implementing the procedure for use in casework. The procedure for suggesting, conducting, documenting, and maintaining records of a validation study are outlined in QP 21. 5.4.3 Laboratory-developed Methods Validation of new methods developed by the OSBI CSD shall be planned and conducted by qualified personnel who have the necessary resources. Effective communication shall be maintained and the validation plan shall be updated as the method development proceeds. 5.4.4 Non-standard Methods Only approved technical procedures will be used in the analysis of casework. If a non-standard method is necessary, the method shall be subject to the agreement of the customer. The agreement with the customer shall include a clear specification of the customer's requirements. The method must be validated prior to use on evidence samples. 5.4.5 Validation of Methods 5.4.5.1 Validation of a method shall provide objective evidence that the method meets the particular requirements for a specific intended use. Page 30 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.4.5.2 All methods used by the OSBI CSD shall be validated to ensure that the methods are fit for the intended use. Documentation of validation studies shall record the results obtained, the procedure used, and a conclusion indicating whether the method is fit for the intended use. 5.4.5.3 In order for a method to be determined fit for an intended use, the range and accuracy of the values obtained from the method must be relevant to the customer's needs. 5.4.5.4 Before implementing a validated method new to the OSBI CSD, the reliability of the method will be demonstrated against any documented performance characteristics (such as sensitivity or specificity) of the method. Records of the performance check shall be retained. 5.4.6 Estimation of Uncertainty of Measurement The procedure for estimating the uncertainty of measurement is located in QP 22. 5.4.7 Control of Data 5.4.7.1 Calculations and data transfers shall be subject to appropriate checks in a systematic manner, such as the administrative and technical review process. If an additional check is required, it should be included in the appropriate discipline protocol(s). 5.4.7.2 When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage, or retrieval of test data, OSBI CSD Management shall ensure that: a) Computer software is documented in sufficient detail and suitably validated. b) Procedures are used to protect the data; such procedures shall include, but are not limited to, integrity and confidentiality of data entry or collection, data storage, data transmission, and data processing. c) Computers and equipment are maintained to ensure proper functioning and are provided with environmental and operating conditions necessary to maintain the integrity of the data. Page 31 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.5 Equipment 5.5.1 OSBI CSD Management shall furnish each laboratory and/or unit with the equipment necessary to ensure the correct performance of analytical tests conducted. If equipment outside of the immediate control of the OSBI CSD is used for analysis of evidence samples, OSBI CSD Management shall ensure that the equipment meets the standards outlined in ISO/IEC 17025. 5.5.2 Equipment and software used to perform analysis, calibration, or sampling will comply with specifications relevant to the test and shall be adequate to achieve the required accuracy. Calibration programs/procedures will be established as outlined in QP 24. 5.5.3 Instruments will be operated by authorized CSD personnel. Authorization for unsupervised use of instruments will be documented in the authorization to work memo addressed in section 5.2.5. OSBI CSD trainees and technicians, practicum students, and interns are authorized to use equipment/instruments in the unit(s) they are assigned to under the supervision of authorized CSD personnel. Current instructions for use and maintenance will be included in discipline protocols so that they are readily available for use by the appropriate CSD personnel. Alternately, manufacturers’ manuals or use and maintenance instructions may be referenced in the protocol and placed in a designated location for easy access by authorized personnel. 5.5.4 Whenever possible, each instrument used for testing and its software significant to the test result will be uniquely identified. At a minimum, unique asset numbers will be assigned in accordance with OSBI Policy 209. 5.5.5 For each instrument and its software significant to the analysis performed, the following records will be maintained according to QP 24: a) the identity of the instrument and software b) the manufacturer's name, model number, and serial number and/or asset number Page 32 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director c) documentation of function verification d) the current location, if appropriate e) the instruction manual, if available, or a reference to the location of the manual f) copies of all calibration and adjustment reports/certificates, including the date, result of calibration/adjustment, acceptance criteria, and the due date for the next calibration g) the maintenance plan, if appropriate, and records of maintenance performed to date h) description of any damage, malfunction, modification, or repair 5.5.6 Procedures for safe handling, transport, storage, use, and maintenance of measuring equipment are located in QP 24. 5.5.7 Instruments and equipment which have been mishandled or have been shown to be outside acceptable limits will be taken out of service. Out of service instruments and equipment will be clearly labeled as out of service until repairs are made and the instrument/equipment is placed back in service following a successful function verification/calibration. The impact of the defect or departure from acceptable limits will be evaluated and procedures outlined in QP 13 will be initiated. 5.5.8 Whenever possible, equipment which requires calibration will be labeled to show the status of the calibration, including the date of the last calibration and when recalibration is due. 5.5.9 When equipment goes outside of the laboratory, whether for repair or another purpose, the function and calibration status will be checked and shown to be satisfactory before the equipment is returned to service. Page 33 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.5.10 If intermediate calibration checks are needed to maintain confidence in the calibration status of equipment, the checks will be done according to a written protocol approved by the appropriate Technical Manager. 5.5.11 Where calibrations result in correction factors that must be used, the discipline shall implement a procedure to ensure that any copies (e.g. in computer software) are correctly updated. 5.5.12 Applicable controls, defined in protocol, will be used to safeguard test and calibration equipment including hardware and software from adjustments which would invalidate the test and/or calibration results. 5.6 Measurement Traceability 5.6.1 General Any equipment used for testing or calibration which has a significant impact on the accuracy or validity of the test, calibration, or sampling shall be calibrated before being placed in service. This includes any equipment used for subsidiary measurements such as environmental conditions, if it would have a significant impact on the validity or accuracy of results. The procedures for calibration of equipment are outlined in QP 24. 5.6.1.1 As specified in QP 24, the procedures for checking the calibration of equipment are established based on the specific requirements of the tests being conducted. Under normal circumstances, a check of calibration will be conducted after any shut down and following service or other substantial maintenance. Calibration check intervals will not be less stringent than the manufacturer's recommendations. 5.6.2 Specific Requirements 5.6.2.1 Calibration The OSBI does not provide calibration services as defined by ISO/IEC 17025. Page 34 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.6.2.2 Testing 5.6.2.2.1 As indicated in QP 23 and QP 24, the calibration program for equipment is designed to ensure that calibrations and measurements are traceable to the International System of Units (SI), if possible. This is not required if the associated contribution of the calibration to the total uncertainty of the test results is negligible. In this situation, the OSBI CSD shall ensure that the equipment used provides the uncertainty of measurement needed. 5.6.2.2.2 Where traceability of measurements to SI is not possible and/or relevant, the OSBI CSD shall provide confidence in measurements by establishing traceability to appropriate standards such as certified reference materials, specified methods, and/or consensus standards. 5.6.3 Reference Standards and Materials 5.6.3.1 Reference Standards QP 25 outlines the procedures for the calibration of reference standards. Reference standards will be calibrated by an organization capable of providing traceability to SI units as described in ISO/IEC 17025 standard 5.6.2.1. Reference standards will only be used for calibration unless it can be demonstrated that other use will not invalidate their performance as a reference standard. Reference standards will be calibrated before and after adjustments. 5.6.3.2 Reference Materials As specified in QP 26, reference materials will be traceable to SI units of measurement, or to certified reference materials, whenever possible. Accuracy of internal reference materials will be checked as far as is technically and economically practical. 5.6.3.2.1 Reference collections of data or items encountered in casework that are maintained for identification, comparison, or interpretation purposes shall be fully documented, uniquely identified, and properly controlled. 5.6.3.3 Intermediate Checks When checks are needed to ensure confidence in the calibration status of reference, primary, transfer or working standards and reference materials, these checks will be carried out according to defined procedures and schedules. 5.6.3.4 Transport and Storage QP 26 establishes the procedures for safe handling, transport, storage, and use of reference standards. These procedures prevent contamination and deterioration of the standards and protect their integrity. Page 35 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.7 Sampling The OSBI CSD will not report results based on a statistical sampling method (see glossary). The OSBI CSD may report results for a whole based on testing a portion in limited circumstances which include toxicology analysis and the identification and quantitation of controlled substances. Discipline quality manuals and protocols will specify the necessary steps to ensure homogeneity of toxicology and drug quantitation samples and the amount of sample to be used for analysis. State statute establishes a legal basis for homogeneity for the identification of controlled substances and the amount of sample to be tested will be based on the analyst’s training and experience. 5.8 Evidence Handling 5.8.1 The procedures for transportation, receipt, handling, protection, storage, retention and/or disposal of evidence items are included in QP 5 through QP 7. These procedures include all provisions necessary to protect the integrity of evidence and the interests of the OSBI CSD and our customers. 5.8.1.1 Through compliance with the evidence handling procedures outlined in QP 5 through QP 7, the OSBI CSD documents the chain of custody for evidence received and analyzed by the laboratory. The minimum components of a chain of custody record include the person (by signature or electronic equivalent) or location receiving evidence, the date of receipt or transfer, and a description or unique identifier of the evidence. In order to ensure a complete and accurate chain of custody, all employees will document evidence transactions in the LIMS at the time evidence is physically moved from one location to another, unless exceptions are provided for in evidence handling procedures. In addition, employees shall not share LIMS passwords with anyone. Failure to comply with this policy will result in progressive discipline. Failure to comply with evidence handling procedures may also result in progressive discipline. 5.8.1.1.1 As detailed in QP 6, when evidence is subdivided in the laboratory, the OSBI CSD requires the same chain of custody documentation for any sub-items created. 5.8.1.1.2 As described in QP 5, evidence accepted and stored by the OSBI CSD will be properly sealed. Page 36 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.8.2 The OSBI CSD utilizes the “BEAST” Laboratory Information Management System (LIMS) to identify evidence items while they are in OSBI CSD custody. This system, in conjunction with the evidence handling procedures, ensures that evidence cannot be confused physically or when referred to in the case record or other documentation. The system allows for sub-dividing groups of evidence items, transfer of evidence within the laboratory, and receipt and return of evidence. 5.8.3 When evidence is received, any abnormalities regarding the packaging or condition of evidence will be recorded. If there is doubt whether the item is suitable for testing or if the item does not match the description provided, the customer will be consulted for clarification and the conversation recorded using the “Narrative” button on the “Case Info” tab in the LIMS before proceeding. 5.8.4 QP 6 details the procedures for preventing loss, deterioration, or damage to evidence items during storage and handling. This includes ensuring the security and proper environmental conditions of evidence storage locations. 5.8.4.1 All evidence will be stored in a secured, limited access storage area when not in the process of examination. 5.8.4.2 QP 6 details how to secure unattended evidence in the process of examination. 5.8.4.2.1 QP 6 also clearly defines when evidence is considered to be in the process of examination. 5.8.4.3 Each item of evidence shall be marked with the case number and item number. If it is not possible to mark the evidence or if marking the evidence with the item number could affect the integrity of the evidence, then the proximal container or tag shall be labeled. 5.8.4.4 When evidence, such as latent prints or impressions, can only be recorded or collected by photography and the image itself is not recoverable, the photograph or negative of the image shall be treated as evidence. 5.8.4.5 OSBI CSD personnel collecting evidence at a crime scene will ensure that the evidence is protected from loss, cross-transfer, contamination, and deleterious change, whether in a sealed or unsealed container, during transport to the Page 37 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director laboratory. Crime scene evidence shall be appropriately identified, packaged, and entered into the LIMS as soon as practical. 5.8.4.6 The OSBI CSD maintains individual characteristic databases in the Latent Evidence Unit, CODIS Unit, and Firearms Unit. Procedures for the operation of individual characteristic databases are located in the appropriate discipline/unit quality manuals and/or protocols. These procedures include a designation of how database samples will be treated (as evidence, reference sample, etc.), how samples will be identified, how samples will be protected from loss, cross-transfer, contamination, and deleterious change, and how access to the databases will be restricted. 5.9 Assuring Quality of Test Results 5.9.1 The OSBI CSD procedures for monitoring the validity of tests are located in technical protocols as appropriate. In addition, procedures for proficiency tests, re-examination, and reviews are referenced below. Quality control data will be recorded in a way to allow trends to be detected and whenever practical, statistical techniques will be used to review the data. OSBI CSD quality control monitoring is planned and reviewed according to the procedures referenced. Monitoring includes the following: a) use of appropriate controls and standards, which are specified in protocols and recorded in case records b) regular use of certified or secondary reference materials, as appropriate c) internal and external proficiency testing d) re-analysis of casework 5.9.2 Quality control data will be analyzed and planned action will be taken to correct the problem if the quality control data is outside the predefined window for acceptability. 5.9.3 The OSBI CSD proficiency testing program is located in QP 30. Page 38 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.9.4 Technical review of casework will be conducted according to QP 31 in order to routinely verify that conclusions reported are accurate and supported by the examination documentation. QP 31 further defines the scope of a technical review, how technical reviews will be documented, and what actions will take place if a discrepancy is noted. 5.9.5 Administrative review of casework will be conducted according to QP 31 to ensure that reports and case records are accurate and complete. All OSBI CSD reports, with the exception of no analysis reports, will be administratively reviewed prior to release. 5.9.6 Testimony provided by OSBI CSD analysts will be monitored according to QP 32. 5.10 Reporting Results 5.10.1 General The results of all analyses and examinations conducted by OSBI CSD personnel will be reported accurately, clearly, unambiguously, and objectively in a Criminalistics Examination Report. 5.10.1.1 In the event that a request for analysis is cancelled, no-analysis or partial analytical reports will be issued according to QP 28. 5.10.2 Test Reports Analytical reports will be prepared and issued according to QP 28. 5.10.3 Test Reports – Additional Requirements 5.10.3.1 OSBI CSD reports and/or case records will include the following information: a) Deviations from, additions to, or exclusions from the protocol and specific test conditions as necessary for interpretation of the test results shall be recorded in the case record. Page 39 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director b) When relevant, a statement of compliance with requirements or specifications should be included in the case record. c) Where applicable, a statement on the estimated uncertainty of measurement should be included in the test report. Under most circumstances, records for uncertainty of measurement will be maintained by the laboratory and available on request. A statement should be included in the report when it is relevant to the validity of the test result, the customer requests the statement, or if the uncertainty affects compliance to a specification limit. d) Opinions and interpretations shall be included in the report when necessary. For example, expert opinions regarding comparison of latent prints or interpretations of DNA profiles. e) Additional information shall be included in the report and/or case record as required by the method or by the customer. 5.10.3.2 If a sampling plan is used to analyze evidence, the following information shall be included in the case record: a) the date of sampling b) identification of the item sampled c) location of sampling d) reference to the plan and procedures used e) details of any environmental conditions during sampling that may affect the test results f) any standard or other specification for the sampling method and any deviations, additions to, or exclusions from the specification 5.10.3.3 QP 33 describes the procedure used for releasing case information. 5.10.3.4 Any OSBI CSD analyst who issues a report or testifies based on the examination documentation generated by another individual shall complete and document a review of all relevant pages of documentation in the case record. 5.10.3.5 When associations are made, the significance of the association shall be communicated clearly and qualified in the report. Page 40 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director 5.10.3.6 If comparisons are performed and result in an elimination, the elimination shall be clearly communicated in the report. 5.10.3.7 If results are inconclusive, the reason why no definitive conclusion could be reached shall be documented in the report. 5.10.4 Calibration Certificates The OSBI CSD does not issue calibration certificates. 5.10.5 Opinions and Interpretations The OSBI CSD issues reports including opinions and interpretations only for forensic disciplines which have been appropriately validated and documents the training of each analyst issuing reports with opinions and interpretations. Opinions and interpretations shall be clearly identified in OSBI CSD reports. 5.10.6 Testing Results from Subcontractors When analysis is subcontracted, the subcontractor shall provide a case record and report which meet the same requirements as OSBI reports and case records. The OSBI shall maintain a copy of the case record, and after reviewing the case record and report, the subcontractor's report will be sent to the customer. 5.10.7 Electronic Transmission of Results Reports issued electronically must meet the same requirements stated above. 5.10.8 Format of Reports OSBI CSD reports shall be formatted in a manner to accommodate the types of tests conducted and to minimize the possibility for misunderstanding or misuse. 5.10.9 Amendments to Reports Modifications to OSBI CSD reports shall be handled according to QP 28. Analysis conducted subsequent to the issuance of a report will be included in a separate, uniquely identified report. Corrections to an issued report will be made by issuing a corrected report and indicating which report it replaces. Page 41 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director History Revision # Effective/Review Date History 0 3-23-09 Original issue. Replaces QA 1, rev. 7; QA 2, rev. 9; QA 3, rev. 9; QA 4, rev. 8; QA 8.1, rev. 5. 1 10-9-09 Removed QMA 1. Org chart located on OSBI Intranet. Updated QMA 3 to include instructions for packaging/sealing of liquids and/or glass containers. Update QMA 5 to include agencies for crime scene cleanup. Updated references to reflect new Quality Assurance Standards and Audits. Revised glossary. Made grammatical and typographical changes to clarify sections 4.1.5.d, g, h, and j; 4.1.7; 4.2.5; 4.7.2; 4.9.1; 4.13.1.1; 4.13.2.1; 4.14.1.2; 5.4.1.1; 5.4.7.1; 5.5.3; 5.5.4; 5.5.6; 5.5.10; 5.5.12; 5.6.2.2.1; 5.6.3.2; 5.8.3; 5.9.4; 5.9.5; 5.10.1; 5.10.9. 2 5-14-10 Added bookmarks/hyperlinks to table of contents. Minor grammatical changes to Foreword and sections 1.2, 4.5, 4.14.4, 4.14.5, and 5.7. Incorporated deviation to section 4.1.5.j. Added language regarding chain of custody to section 5.8.1.1. 3 12-31-10 Added Notice to Customers (QMA 1.1 Rev 0). Updated all attachments – changed QMA 2 to evidence acceptance requirements; deleted redundant sentence from QMA 3; changed QMA 4 to a list of facilities and available services; added animal disease and diagnostic lab to QMA 5. Updated reference to 2011 Supplemental Requirements. Incorporated deviation to update corrective action terms in glossary (corrective action, corrective action plan, preventive action, remediation). Changed definition of quality records. Changed process for designating deputies for key managerial personnel (4.1.5.j). Added list of key/top management (4.1.8). Added sections 4.2.2.1, 4.2.2.2, 4.4.3, 4.13.2.3.2, 4.13.2.5.2, last 2 sentences of 5.2.6, sentences 2-3 of 5.5.3, 5.8.1.1.2, and 5.10.1.1. Added reference to glossary in 4.13.1.1. Corrected QP reference in 4.13.2.1. Changed 4.14.5 to reference QP 17. Changed language to be more consistent with 2011 Supplemental Requirements in 4.13.2.2.1, 4.13.2.3.1, 4.15.1, sub-sections of 5.8.4, and 5.9.1.a. Changed 5.5.2 to reference QP 24. Changed Page 42 of 42 OSBI CSD Quality Manual Revision #3 Effective Date: 12-31-10 Distribution: All CSD Personnel Approved By: Andrea Swiech, Division Director “instruments” to “measuring equipment” in 5.5.6. Revised section 5.5.7. Added Quality Procedures to References. OSBI CSD QMA 1.1, Rev. 0 Page 1 of 2 ***Notice to Customers*** ASCLD/LAB‐International accreditation requirements state that laboratories must notify customers (investigators, prosecuting attorneys, etc.) in certain circumstances listed below. ASCLD/LAB has established that labs may conduct these notifications on a case by case basis or through a general notification made available to all customers. This notice will serve as a general notification to customers for these areas. Submitting evidence to the OSBI Criminalistics Services Division (OSBI CSD) indicates consent with these terms. Review of Requests for Analysis (ISO/IEC 17025:2005 Std. 4.4.1): Each request for forensic analysis is reviewed by OSBI CSD personnel. The OSBI CSD will use the review process to ensure: 1. that the customer’s needs are understood (ex: which items need to be processed by the Latent Evidence Unit, etc.), and 2. that the OSBI CSD can meet those needs. However, the OSBI CSD will determine the most appropriate method(s) of analysis (ex: which chemical processing would best develop latent prints on an item submitted for latent processing) based on the information provided by the customer. Once the OSBI CSD accepts a request for analysis, the accepted request is considered a contract between the requestor and the OSBI. Changes to Contracts (ISO/IEC 17025:2005 Std. 4.4.4): In addition, the OSBI CSD may select the item(s) most appropriate for analysis and/or elect to not analyze all items submitted based on the needs and circumstances of the case. The OSBI does not consider this a change to the “contract,” and this may be done without additional notice to the customer. The OSBI CSD does strive to provide the highest quality and most valuable forensic analysis possible. For that reason, if analysts conducting testing identify alternate and/or additional testing that may prove beneficial to our customers, the OSBI CSD may notify the customer on a case by case basis. This notification will always be done if the proposed analysis will require consumption of the evidence and/or limit future examinations. OSBI CSD QMA 1.1, Rev. 0 Page 2 of 2 Subcontracting Analysis (ISO/IEC 17025:2005 Std. 4.5.2): The OSBI CSD will transfer evidence between OSBI CSD laboratories in order to accommodate efficient analysis. In limited circumstances, the OSBI CSD may subcontract analysis, if the OSBI CSD cannot provide the service necessary. This includes sending out samples for mitochondrial DNA (mtDNA) analysis and for the DNA identification of human remains and/or associated reference samples. Any unidentified human remains and/or any reference samples associated with missing persons or unidentified remains that are subcontracted will be sent to the University of North Texas Missing Persons/Unidentified Remains program. Any other evidence requiring mtDNA analysis will be sent to the Federal Bureau of Investigation (FBI) or one of their regional mtDNA labs. Deviations from Analytical Procedures (ISO/IEC 17025:2005 Std. 5.4.1): The OSBI CSD utilizes analytical methods that are generally accepted in the forensic science community and that have been validated by OSBI CSD personnel and documented in written protocols. In addition, the OSBI CSD maintains a policy to allow for suggesting, evaluating, approving, and documenting deviations to policy and procedure when necessary. These deviations are not communicated on a case by case basis, but are documented according to policy and can be discussed with customers upon request. Selection of Methods (ISO/IEC 17025:2005 Std. 5.4.2): OSBI CSD analytical methods are documented in written protocols and in some circumstances the analytical method used is also referenced in the case file and/or case record. In some circumstances, the analytical methods used may be listed in the examination report, as required by accreditation and quality standards. In any case in which a report does not list the analytical methods used, the OSBI CSD will provide this information upon request. In addition, a list of current services and/or analytical methods currently in use by the OSBI CSD is located in OSBI CSD QMA 4. OSBI CSD QMA 2, Rev. 1 Page 1 of 2 Oklahoma State Bureau of Investigation - Criminalistics Services Division (OSBI CSD) Evidence Acceptance Requirements The following requirements must be met for the OSBI CSD to accept evidence for analysis: 1. The evidence must be submitted by an individual or agency authorized to request services from the OSBI CSD. The agencies and individuals authorized to request services are listed in Title 74, Sections 150.2 and 150.5. The OSBI CSD cannot accept evidence from private citizens or other individuals/agencies not listed in statute. 2. The evidence must be relevant to an investigation which is expected to result in criminal charges being filed. Evidence relevant to civil investigations or non-criminal product cases such as food or drugs suspected of being old, faulty, etc., will not be accepted for analysis. 3. The evidence must not include any explosive devices, explosive samples, or post-blast samples. 4. The evidence must not include syringes, which under normal circumstances will not be accepted for analysis. Exceptions to this will be evaluated on a case by case basis and exceptions must be approved by a Criminalist Supervisor, Criminalistics Administrator, or designee. 5. Evidence must be submitted in person or through a delivery service such as the United States Postal Service (USPS), United Parcel Service (UPS), or Federal Express (FedEx). Evidence in digital form (images of latent prints, etc.) will not be accepted by e-mail. 6. Evidence must be collected and packaged in a manner that preserves the integrity of the evidence. Evidence which is packaged in a manner that would invalidate the results of testing will be refused. Refer to the OSBI Evidence Collection Manual for information regarding appropriate collection and packaging of evidence. 7. Evidence must be properly collected, packaged, and sealed. Refer to QMA 3 for evidence sealing guidelines. 8. The evidence must have a legitimate associated service request. A listing of available services is detailed in QMA 4. Evidence will not be accepted for the purpose of long-term storage or if the OSBI CSD cannot meet the needs of the customer. OSBI CSD QMA 2, Rev. 1 Page 2 of 2 9. Evidence samples submitted for the purpose of comparison (paints, fibers, projectiles, DNA, etc.) must be accompanied by the appropriate reference samples. In most cases, comparison samples will not be accepted unless both the questioned and reference samples are provided. However, this does not apply to samples submitted for comparison to a database. For example, DNA cases with no suspect identified may be submitted with the evidence sample(s) and victim reference sample. OSBI CSD QMA 3, Rev. 2 Page 1 of 2 Oklahoma State Bureau of Investigation - Criminalistics Services Division (OSBI CSD) Evidence Packaging and Sealing Guidelines Evidence submitted to the OSBI CSD must be stored in an appropriate container under proper seal. The seal must be sufficient to prevent item(s) contained from being lost, removed, or contaminated by outside sources. A container is considered “appropriate” and “properly sealed” only if its contents cannot readily escape and only if entering the container results in obvious damage/alteration to the container or its seal. 1. All evidence must be packaged in a suitable container that protects the evidence from loss, cross-transfer, or contamination. a) Some evidence, such as weapons submitted for serial number restoration or test fire, can be tagged and would not require a container. b) Other evidence, such as liquids may require multiple containers. For example, containers of liquid samples must be stored in a plastic bag, bucket, or other container that will contain the liquid if the immediate container leaks. c) Glass containers should be placed inside a container that will also protect the glass from breaking. d) Containers used to protect the immediate evidence package from leaks or breakage may be treated as convenience packages. However, only one item should be in each “convenience package” to prevent contamination in the event of a leak. 2. All evidence must bear a proper seal. A proper seal includes the initials or other identification of the person sealing the evidence and an acceptable evidence container seal. The following should be used as a guide for acceptable evidence container seals: a) Boxes: A box container seal includes the long seam at both the top and bottom of the box. Boxes should be sealed with two-inch tape, 3M 3750 or equal. Evidence tape may also be acceptable. b) Sacks, bags: All sack-like containers should be sealed by folding down the flap of the sack across the top and placing a continuous piece of 2 inch tape, 3M 3750 or equal, across the fold and around the sack edges. Evidence tape may also acceptable. OSBI CSD QMA 3, Rev. 2 Page 2 of 2 c) Envelopes: The top (unsealed) flap of the envelope should be sealed along or across the seam using two inch tape, 3M 3750 or equal, or using evidence tape. d) Cans: One continuous piece of evidence tape across the top and down the sides of the container (including buckets with lids) or two separate pieces of evidence tape across from each other are to be used to seal all can-like containers. The seal must be marked or initialed. No clear adhesive tape is to be used on cans if it can be peeled off without evidence of removal. e) Kits: Sexual assault kits, GSR kits, and other purchased kits are acceptable with the seal provided by the kit manufacturer. f) Bulky Evidence: Some items of evidence do not lend themselves to a container. In those cases, the area of interest for analysis should be isolated, protected and marked or initialed. Examples are doors or car bumpers. 3. Evidence which is properly sealed and marked for identification may then be placed in unsealed containers such as boxes or bags for the purpose of grouping items of evidence or for the convenience of carrying the evidence without that container having to meet the requirements of identification and sealing, as long as evidence security requirements are otherwise met. These containers should be marked as a “convenience package” or “convenience container.” 4. Heat sealing a container of an item of evidence is also acceptable. Identifying marks or initials of the person sealing the evidence must be present across the heat seal. 5. The submitting officer will be expected to correct improperly sealed evidence prior to the evidence being accepted by the lab. If evidence received by the laboratory has an acceptable evidence seal but is not initialed or marked and that individual is not available to remedy the problem, the receiving personnel will place a piece of evidence tape across the evidence seal at an approximate 90 degree angle and initial across the tape or place the entire evidence container in a heat sealed container and initial across the heat seal. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 1 of 6 FACILITIES: The OSBI CSD provides services at the following 5 facilities: OSBI Forensic Science Center (FSC) OSBI Eastern Regional Laboratory 800 East Second Street 701 West Carl Albert Edmond, OK 73034 McAlester, OK 74501 (405) 330-6724 (918) 423-6672 OSBI Northwest Regional Laboratory OSBI Northeast Regional Laboratory 1305 E. Garriott 1995 Airport Parkway Enid, OK 73701 Tahlequah, OK 74464 (580) 242-2600 (918) 456-0653 OSBI Southwest Regional Laboratory 5 Northeast 22nd Street Lawton, OK 73507 (580) 355-6144 For the convenience of OSBI CSD customers, evidence may be submitted at any CSD facility. OSBI CSD personnel will transport evidence between facilities when necessary to provide the appropriate or most timely analysis. SERVICES: The following services/analytical methods are available. However, the OSBI reserves the right to select the most appropriate method and to select the item(s) most appropriate for analysis (see “Notice to Customers” – OSBI CSD QMA 1.1). If a particular test method or service is desired for a specific item, please contact a Criminalist from the discipline in question for assistance with the review of the request. Biology (FSC, SWRL, and NERL): 1. Screening Evidence can be screened for biological material including blood, semen, and hair. 2. Confirmatory Testing Tests are available to confirm the presence of blood and semen. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 2 of 6 3. Hair Evaluation Hair samples can be evaluated to determine whether the hair is animal or human and, if human, whether adequate sample is present for nuclear or mitochondrial DNA testing. 4. DNA Analysis The OSBI CSD can perform two types of Short Tandem Repeat (STR) DNA analysis – autosomal and/or Y-STR analysis. Y-STR analysis generates a DNA profile based on locations on the Y-chromosome only, which means in order to generate a profile, the sample must contain male DNA. Y-STR analysis is only available at the FSC and NERL facilities. The OSBI CSD can forward evidence to an FBI Regional Mitochondrial DNA Laboratory for analysis. 5. Database Entry/Search All eligible DNA profiles obtained during the analysis of casework can be entered into the state CODIS (Combined DNA Index System) database and national database (NDIS). Controlled Substances (FSC, ERL, NERL, NWRL, SWRL): 1. Controlled Substance Identification Identification of controlled and some non-controlled substances. 2. Controlled Substance Quantitation (FSC Only) Some evidence items can be analyzed to determine the concentration of the controlled substance. 3. Clandestine Laboratory Analysis Analysis can be conducted on clandestine laboratory samples to detect controlled substances, precursors, and chemicals related to the illegal manufacture of controlled substances. 4. Poison Identification Some poisons such as Strychnine can be identified by the drug lab. Other compounds such as Ethylene Glycol (antifreeze) that can be used as poisons can also be identified. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 3 of 6 Firearms/Toolmarks (FSC): 1. Function Test Guns submitted for analysis can be tested to determine if the weapon is functional. 2. Trigger Pull Analysis Analysis can be performed to determine the amount of trigger pull required to fire a gun. 3. Fired Bullet and Casing Analysis Fired projectiles and/or fired casings can be compared to other fired evidence (bullets/casings) or to a suspect gun. In addition, fired projectiles and fired casings can also be examined and may sometimes provide information regarding potential makes and models of guns that could have fired the evidence. This is dependent on the amount and type of characteristics present on the fired evidence. 4. Serial Number Restoration When requested, analysis can be performed to attempt to restore the serial number of a gun. 5. Distance Determination In some cases, evidence can be examined to determine an approximate distance between an object and the point/location from which a gun was fired. 6. Database Entry/Searching Test fires from suspect weapons or fired evidence can be evaluated to determine suitability for entry into the Integrated Ballistic Identification System (IBIS). Items entered into IBIS will be automatically searched against the region (Oklahoma and Texas). The OSBI can request searches through other regional databases as well. 7. Toolmark Analysis Analysis can be conducted to determine, if possible, whether or not a particular tool was used to generate impressions or striations on the item submitted (padlock, window frame, etc.). In addition, analysis can be done to determine if the toolmarks on multiple evidence items were made by the same tool. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 4 of 6 Latent Evidence (FSC): 1. Footwear Analysis Photos or casts of questioned footwear impressions can be compared to known shoe samples. The OSBI CSD cannot examine questioned footwear impressions without known shoes for comparison purposes. 2. Tire Impression Analysis Photos or casts of questioned tire impressions can be compared to casts or photos of known tire impressions. Tires will not be accepted for comparison purposes. The OSBI CSD cannot examine questioned tire impressions without known tire impressions for comparison purposes. 3. Latent Print Analysis Processing: Items suitable for latent print development which have been properly collected and packaged can be processed to detect and lift/capture latent prints for comparison or AFIS entry. 4. Latent Print Comparison Questioned latent prints submitted or recovered from items submitted for processing can be compared to known inked impressions submitted or to known impressions from retained records when the subject’s information (name, race, sex, date of birth, and SID number) is provided. 5. Database Entry/Searching All latent prints (including palm prints) of appropriate quality that are not identified to a known can be evaluated for entry into the Oklahoma Automated Fingerprint Identification System (AFIS). The OSBI CSD can also request a search be conducted using the Integrated Automated Fingerprint Identification System (IAFIS), which searches records from the FBI files. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 5 of 6 Toxiology (FSC): 1. DUI Cases Blood or urine collected from individuals suspected of driving under the influence can be analyzed for the presence of alcohol or drugs. 2. Drug Facilitated Sexual Assault Blood and/or urine collected from an individual reporting a drug facilitated sexual assault can be analyzed for the presence of impairing substances. 3. Alcoholic Content Liquids suspected of containing alcohol can be analyzed to determine the presence and quantity of alcohol. (Ex: suspected moonshine) 4. Poisons Samples suspected of containing poison can be tested for select poisons, such as the active ingredient in Visine. 5. Toxic Vapors Blood may also be analyzed for other substances which cause impairment such as toxic vapors inhaled by a suspect (i.e. huffing). Trace Evidence (FSC): 1. Ignitable Liquids Residue Analysis Properly packaged samples of fire debris can be analyzed for the presence of ignitable liquids such as gasoline, paint thinner, or diesel, etc. 2. Primer Gunshot Residue Analysis (GSR) Evidence submitted using an OSBI GSR Evidence Collection Kit can be analyzed for the presence of elements that are characteristic of gunshot residue (lead, antimony, and barium). 3. Manufactured Fibers: Questioned fibers can be analyzed and compared to reference or known samples submitted to determine if the questioned and known sample may have originated from the same source. This comparison applies to man-made fibers only. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Facilities and Available Services OSBI CSD QMA 4, Rev. 1 Page 6 of 6 Analysis of questioned fibers can also be conducted to determine the composition of the fiber(s). However, this analysis is limited to the material (e.g. nylon, acetate, etc.) and color. The OSBI CSD does not have the capability to indicate what item(s) may have been a source of the questioned fiber(s). The OSBI CSD does not perform hair comparisons. 4. Paint Evidence: Questioned paint samples can be analyzed and compared to known samples, when available, to determine if the questioned and known samples may have originated from the same source. If known paint samples are unavailable, then unknown samples may be submitted for possible Make and Model determination utilizing the Paint Data Query (PDQ) database. 5. Elemental/Chemical Analysis: Evidence can be analyzed to determine its elemental composition. The most common application of this analysis is to identify the presence of poisonous materials such as lead, arsenic, and mercury. Elemental analysis can also be conducted to identify elements used in clandestine drug manufacturing, such as phosphorus and iodine. 6. Fracture Matches: Miscellaneous types of evidence that are torn or broken can be compared to a sample suspected to be the source of the evidentiary sample. For example, duct tape removed from a victim can be compared to a roll of duct tape found in a suspect’s possession. Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Alternate Service Providers OSBI CSD QMA 5, Rev. 2 Page 1 of 4 In the event that the OSBI CSD cannot provide a particular service requested by a customer, OSBI CSD personnel may assist the customer in locating an appropriate agency or organization that can provide the service. The list below summarizes some of the agencies or organizations that may be able to provide service to customers. This list is intended to be used as a tool to provide assistance to customers and is not intended to serve as a guarantee of service or endorsement of the agencies and organizations listed. Alcohol, Tobacco, Firearms: Bureau of Alcohol, Tobacco, and Firearms (ATF): Firearms, Explosives, Arson—1-800-283-4867 Arson Hotline—1-888-283-3473 (24 Hours) Explosives Hotline—1-888-283-2662 (24 Hours) Firearms Hotline—1-888-283-4867 (24 Hours) Animal/Agricultural: Animal Disease and Diagnostic Lab Livestock Diseases 405-744-6623 Department of Agriculture: Herbicides and Insecticide Poisoning, Animal Food Poisoning 405-521-3864 OSU School of Veterinary Medicine: Animal Deaths 405-262-5291 Aviation: Federal Aviation Administration: Investigations and evidence involved in airplane accidents 405-954-3011 Bomb Squads: Agency Jurisdiction Phone OCPD All incorporated areas of OKC except for State property 405-297-3477 405-297-1000 OCSO All unincorporated areas of OKC except for State property 405-713-1044 MWCPD All incorporated areas of Midwest City 405-739-1388 Edmond PD All incorporated areas of Edmond 405-354-4420 Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Alternate Service Providers OSBI CSD QMA 5, Rev. 2 Page 2 of 4 Norman PD All incorporated areas of Norman 405-321-1444 Tulsa PD All incorporated areas of Tulsa 918-596-9222 OHP All areas of the State that do not have a bomb squad in their jurisdiction. 405-425-2435 405-682-4343 405-202-3763 US Army Fort Sill Fort Sill EOD will assist any PD or FD 24/7 580-442-8885 580-442-2313 Crime Scene Cleanup: Heartland BioClean AEGIS Biosystems (Edmond) 405-802-6246 405-341-4667 Environmental Management, Inc. (Guthrie) Traumatix Solutions (Glen Poole) 405-282-8510 918-605-2556 Environmental Cleanup, Inc. (Oklahoma City) Ferguson Environmental Resources, Inc. 405-677-0565 405-495-6336 Crime Scene Cleanup (Reimbursement and Referral): District Attorney’s Council (DAC) Victim Services 405-264-5006 Emergency Management: Oklahoma Department of Civil Emergency Management 1-800-800-2481 or 405-521-2481 Entomology (Analysis of Insects): Oklahoma State University Zoology Department Stillwater, OK 405-744-5527 Environmental Concerns: Department of Environmental Quality State Lab: Poisoning of ground water/public or private water supply/soils 405-752-1000 US EPA-ERT Environmental Response Center 2890 Woodbridge Avenue, building #18 (MS 101) Edison, NJ 08837-3679 1-732-321-4398 http://www.ert.org Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Alternate Service Providers OSBI CSD QMA 5, Rev. 2 Page 3 of 4 Food/Drug: Food and Drug Administration: Retail Food/Medication (for Human Consumption) Tampering 405-231-4544 (Oklahoma City) 214-253-5200 (Dallas, 24 Hours) Health Departments: Non-criminal tampering/contamination of food or over the counter medications 405-271-5243 Oklahoma State Department of Health 405-425-4348 Oklahoma County Health Department 918-595-4301 Tulsa County Health Department Oklahoma State Department of Health Biological contamination of foods (e.g. bacterial or viral contaminants) 405-271-5070 Forensics (Fee for Service): The BODE Technology Group Reliagene Springfield, Virginia New Orleans, LA 703-646-9740 800-256-4106 LabCorp Serological Research Institute 1912 Alexander Drive 3053 Research Drive Research Triangle Park, NC 27709 Richmond, CA 94806 800-533-0567 (510) 223-7374 Sorenson Forensics, LLC Tarrant County M.E.’s Office 2495 S. West Temple 200 Feliks Gwozdz Pl. Salt Lake City, UT 84115 Fort Worth, TX 76104 800-824-3457 or 888-488-1122 807-920-5700 www.sorensonforensics.com Hazardous Materials: OHP HAZMAT 405-425-2017 Level A hazmat Poisoning Deaths: Office of the Chief Medical Examiner 405-239-7141 Oklahoma State Bureau of Investigation – Criminalistics Services Division (OSBI CSD) Alternate Service Providers OSBI CSD QMA 5, Rev. 2 Page 4 of 4 Soil Analysis: FBI Trace Analysis Unit Attn: Bob Fram 2501 Investigation Parkway Quantico, VA 22135 703-632-8449 Toxicology: Bexar County Medical Examiner’s Office Northwest Toxicology (Lab One) Bexar County Forensic Science Center Salt Lake City, Utah 7337 Louis Pasteur 1-800-322-3361 or 1-801-268-2431 San Antonio, TX 78229-4565 210-335-4000 El Sohly Laboratories University Toxicology Lab Oxford, Mississippi 405-271-3840 1-662-236-2609 National Medical Services (Can analyze hair samples for drugs) 3701 Welsh Road Willow Grove, PA 19090 (800) 522-6671 www.nmslab.com Weapons of Mass Destruction/Terrorism: 63rd Weapons of Mass Destruction Civil Support Team 63rd WMD CST 405-228-5880 Note: normally dispatched via Oklahoma Dept of Civil Emergency Management for response. FBI Counter Terrorism Unit 405-290-7770 or 405-290-3615 Explosives, radiation State Department of Health (Biological Weapons (e.g. Anthrax)) Public Health Laboratory Services P.O. Box 24106 Oklahoma City, OK 73214 Phone: 405-271-5070 Fax: 405-271-4850 405-271-4060 Epidemiologist on call 24 hours 405-271-4341 Security, alternate 24 hr number QP 1 ‐ Responsibilities and Authority Page 1 of 6 Distribution: All CSD Personnel Revision: 3 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures I. Scope This procedure explains the responsibilities and authority of key CSD personnel. II. Procedure A. Responsibilities of CSD Personnel 1. CSD Director The CSD Director will promote and direct the quality system and ensure that the policies and objectives are documented, as well as communicated to, understood by, and implemented by CSD personnel. The CSD Director serves as the laboratory director for the Forensic Science Center (FSC) and is an ex officio member of all CSD committees. 2. Criminalistics Administrators Each Criminalistics Administrator (CA) will be assigned the administrative supervision of specific laboratories and/or laboratory units. Each CA will also be assigned additional responsibilities as indicated below. a) The CA responsible for the administrative supervision of the Forensic Science Center (FSC) Toxicology Unit, Firearms/Toolmarks Unit, Latent Evidence Unit, and the FSC Physical Evidence Technician Unit is responsible for the statewide coordination of these forensic disciplines. This position will also be responsible for coordinating CSD activities in the areas of laboratory planning, laboratory construction and renovation, grants management, purchasing, laboratory surveys, complaints, and control drug reversal distribution. All activities will comply with quality standards set forth by the OSBI CSD. b) The CA assigned the administrative supervision of the FSC Drug Unit, FSC Trace Unit, the Northwest Regional Laboratory at Enid, and the Eastern Regional Laboratory at McAlester is responsible for the statewide coordination of forensic drug identification. This position will also be responsible for coordinating CSD activities in the area of LIMS Administration, safety management, serving as the OSBI safety officer, and oversight of assigned regional laboratory facilities. All activities will comply with quality standards set forth by the OSBI CSD. QP 1 ‐ Responsibilities and Authority Page 2 of 6 Distribution: All CSD Personnel Revision: 3 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures c) The CA responsible for the administrative supervision of the FSC Forensic Biology Unit, CODIS Unit, Southwest Regional Laboratory at Lawton, and the Northeast Regional Laboratory at Tahlequah is responsible for the statewide coordination of forensic biology. This position will also serve as the Division Quality Manager and will be responsible for coordinating CSD activities in the area of quality control/quality assurance. This includes proficiency testing, laboratory accreditation, testimony monitoring, and audits. 3. Administrative Programs Officer – Evidence Discipline The administrative programs officer over the evidence unit at FSC shall: a) Oversee the storage, maintenance, archival, and destruction of technical records. b) Oversee the destruction of evidence samples and prescription drug samples. c) Oversee and coordinate statewide activities of the physical evidence technicians/units. d) Assist with Laboratory Information Management System (LIMS) administration and generation of statistical reports. 4. Technical Managers Each Criminalist Supervisor at the FSC, with the exception of the FBU and CODIS Supervisors, also serve as the Technical Manager for his/her discipline. The Biology Technical Manager will be identified on a Biology specific organizational chart. Each OSBI CSD Technical Manager shall: a) Assist with management reviews as described in QP 18. b) Review and approve all technical procedures within the discipline. c) Implement and review quality documentation within the discipline. d) Stay abreast of recommendations made by Scientific Working Groups for the discipline and incorporate appropriate recommendations. e) Educate all discipline members in the implementation of the quality assurance program and confirm that all members of the discipline understand the importance of the program. f) Participate in audits and inspections when requested. QP 1 ‐ Responsibilities and Authority Page 3 of 6 Distribution: All CSD Personnel Revision: 3 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures 5. Criminalist Supervisors Each OSBI CSD Criminalist Supervisor shall: a) Assist with management reviews as described in QP 18 and disseminate information regularly to members of their unit. b) Ensure that members of the unit understand and follow all quality assurance procedures. c) Know and follow the CSD Quality Assurance Program. d) Make recommendations to improve quality within the discipline and division. e) Educate all unit members in the implementation of the quality assurance and safety programs and confirm that all members of the discipline understand the importance of the program. f) Serve as laboratory director, if assigned to a regional laboratory. g) Criminalist Supervisors are responsible for monitoring administrative review for their lab or functional unit. Supervisors are to be knowledgeable regarding the quality of casework produced by their staff. 6. Criminalists Each Criminalist shall: a) Know, understand and apply quality procedures that pertain to their specific discipline. b) Ensure completeness of laboratory reports, notes and essential documentation and make recommendations and suggestions for improvements of procedures used for the examination of forensic evidence. c) Advise Technical Manager and/or Supervisor of any technical problems or questionable results and make recommendations for improvements. 7. Physical Evidence Technicians Each physical evidence technician shall: QP 1 ‐ Responsibilities and Authority Page 4 of 6 Distribution: All CSD Personnel Revision: 3 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures a) Know, understand and apply all quality procedures that apply to proper evidence handling including evidence submission, transfer, return or destruction. b) Notify the Technical Manager and/or Supervisor of any concerns relating to the quality assurance program of the Division. 8. Laboratory Technicians Each laboratory technician or part time employee shall: a) Know, understand and apply quality procedures that apply to their specific discipline or job task. b) Notify the Technical Manager and/or Supervisor of any concerns relating to the quality assurance program of the Division. B. Authority of CSD Personnel 1. CSD Director The CSD Director has the authority to make and enforce decisions impacting any and all work produced by the division. 2. Criminalistics Administrators Under the administrative direction of the CSD Director, the Criminalistics Administrators have the following authority: a) The Quality Manager will have the express authority to immediately halt any laboratory activity that fails to exhibit the required levels of accuracy, specificity, reliability or validity with respect to the CSD Quality Assurance program. b) Technical decisions made by each Criminalistics Administrator responsible for the coordination of a forensic discipline will apply to all personnel engaged in any capacity within the affected forensic discipline. These decisions will be made after consultation with the Technical Manager for the discipline. c) The Safety Program Coordinator has the express authority to immediately halt any laboratory activity which is determined to fall outside established safety policies and procedures and applicable laws. QP 1 ‐ Responsibilities and Authority Page 5 of 6 Distribution: All CSD Personnel Revision: 3 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures d) Authority of each Criminalistics Administrator shall include but not be limited to the assignment of specific duties or responsibilities to specific personnel and the review of the activity of those personnel engaged in these duties including all quality practices adopted by the OSBI CSD. 3. Technical Managers The technical manager of each discipline has the following authority: a) Technical managers will assign and approve forensic procedures. All procedures will address and include practices consistent with the quality standards. b) Technical managers have the authority to suspend any work which does not comply with the OSBI CSD Quality System or any applicable quality standards. 4. Criminalist Supervisors Criminalist supervisors have the authority to suspend any work which does not comply with the OSBI CSD Quality System or any other applicable quality standards. III. Attachments None IV. History Revision # Effective/Review Date History 0 3-23-09 Original issue. Replaces QA 2, rev. 9. 1 9-4-09 Added language addressing responsibilities of APO over evidence unit, Criminalist Supervisor in regional lab, and authority of Technical Managers and Criminalist Supervisors to suspend work. 2 4-23-10 Removed references to CSD Assistant Director. Updated responsibilities of Criminalistics Administrators. 3 12-31-10 Added language to II.A.1 and II.A.4 to identify the FSC Lab Director and Technical Managers. Updated Division Director name. QP 2 – Document Control Page 1 of 4 Distribution: All CSD Personnel Revision: 1 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures I. Scope All management system documents will be approved, issued, modified, and controlled according to this procedure. Management system documents include policies/procedures developed internally, externally prepared documents or standards which are referenced or used (user’s manuals, applicable standards, etc.), and software (internally or externally developed) used for testing purposes. II. Procedure A. Control 1. All approved, internally generated CSD management system documents (policies, procedures, protocols, forms, etc.) will be placed on the OSBI Intranet. Any hard copy or other electronic copy is considered an uncontrolled document. 2. Uncontrolled copies may be made, if necessary, to reference at a work area that doesn’t have easy access to the OSBI Intranet. However, CSD employees creating or using uncontrolled copies must verify the uncontrolled copy is still current before each use and immediately dispose of any uncontrolled copy that is not current. 3. Uncontrolled copies may also be made for the purpose of responding to discovery requests/orders. 4. External documents, software, and any other management system documents which are not distributed through the OSBI Intranet will be referenced in the CSD or appropriate discipline quality manual, protocol, or an attachment to the appropriate document. The reference must identify the current revision/version approved for use and the distribution or location of the document. 5. The individual responsible for the initial approval of internally generated documents (Quality Manager (QM) or appropriate Technical Manager) should maintain a copy of the current version that can be edited when the document requires revision. B. Approval 1. Technical protocols/procedures, discipline quality manuals, and related attachments and references will be approved by the appropriate Technical Manager and the CSD Director or designee. 2. The CSD Quality Manual, Quality Procedures, and related attachments and references will be approved by the QM and the CSD Director or designee. 3. CSD documents distributed through the OSBI Intranet will include the signature of the individuals who have approved the document.. QP 2 – Document Control Page 2 of 4 Distribution: All CSD Personnel Revision: 1 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures C. Issue Once approved, the document(s) shall be distributed to the designated point(s) of issue. When a document is replaced or rescinded, it shall be removed from the point(s) of issue at the time it is replaced or no longer effective. 1. Approved CSD documents distributed through the OSBI Intranet, with the exception of forms, will be scanned or otherwise converted to pdf format prior to placing the documents on the Intranet. 2. Documents may be added to and removed from the OSBI Intranet by the Quality Manager, appropriate Technical Manager, FSC Executive Secretary or designee. 3. Documents referenced by the CSD or discipline quality manuals will be added to or removed from the designated point(s) of issue by the QM, appropriate Technical Manager, or designee. 4. Externally generated management documents will be available at each location where related work is conducted. For example, any externally generated management documents referenced by analysts conducting drug analysis will be located at each regional laboratory providing drug analysis. D. Notification For internally generated management documents, an e-mail will be sent to the appropriate individuals indicating that the document has been issued, revised, or rescinded. The e-mail will be sent by the Quality Manager, appropriate Technical Manager, FSC Executive Secretary, or designee. E. Archiving Obsolete versions of management system documents should be retained indefinitely. All retained, obsolete documents must be moved to a specified archive location and/or marked as obsolete or out of date. Whenever possible, archived documents will be maintained electronically in a secure OSBI network folder. Any hardcopy archived management system documents which are retained should be maintained, at a minimum, in the FSC administration area. F. Identification Internally generated CSD management system documents will be uniquely identified and include the following: 1. document number or designation 2. title QP 2 – Document Control Page 3 of 4 Distribution: All CSD Personnel Revision: 1 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures 3. date of issue and/or revision number 4. page numbering 5. total number of pages or mark indicating the end of the document 6. issuing authority Forms or other attachments to management system documents will be identified in the following manner: 1. unique form number or designation 2. date of issue and/or revision number 3. page number and total number of pages (e.g. page X of Y) or the designator “ΑΩ” may be used to indicate a one page form Revision numbers for forms and attachments may be tracked independent of the document revision number. The current attachment revision number (if applicable), changes made to attachments, and approval of attachments will be included in the attachment, history, and approval section of the document it is attached to. G. Review and Revision 1. Management system documents will be reviewed annually. 2. Internally generated CSD documents will include a history section or attachment which will be used to document the completion of revisions and, when possible, identify modifications made during revision. Management system documents which are reviewed and found not to need revision may be documented in the history section/attachment and/or in the management system review memo submitted according to QP 18. 3. Temporary deviations or modifications implemented between annual review/revision will be documented and issued according to QP 3. III. Attachments None QP 3 – Deviations Page 1 of 4 Distribution: All CSD Personnel Revision: 2 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures I. Scope This procedure explains the process to follow when a CSD employee believes that a deviation from a current CSD-authored, controlled document is necessary. This procedure does not apply to any policies or procedures issued from outside the CSD. Any deviations from CSD policy, procedure, or protocol which do not comply with this procedure are considered protocol drift and must be evaluated as potential non-conforming work according to QP 13. II. Procedure A. Requirements and recommendations In order to ensure the quality of analysis conducted and services provided, written policies, procedures, and protocols have been established and issued to all appropriate CSD personnel. However, due to the variability of evidence and circumstances encountered, many protocols, procedures, and policies are worded to include recommendations (indicated by “should”) instead of requirements (indicated by “shall”, “will”, or “must”). All CSD personnel are expected to follow both requirements and recommendations set forth in CSD policies, procedures, and protocols, with the following exceptions: 1. Planned deviations from requirements can be requested and conducted following approval of a minor or major deviation as indicated below. 2. CSD employees may deviate from recommendations stated in protocol, procedure, or policy, provided the employee can articulate a legitimate reason which warrants the deviation. 3. CSD employees should make a notation explaining the deviation from recommended procedure. 4. If an employee is not certain whether circumstances warrant a deviation from recommended procedure, he/she should consult the Supervisor for assistance. B. Minor deviations CSD employees will complete the following steps to request, approve, and document authorization to deviate from current policy, procedure, or protocol for an individual sample, case, or batch of samples/cases. 1. The employee will describe the proposed deviation to his or her immediate Supervisor or designee and obtain approval before implementing the deviation. 2. The Supervisor or designee will evaluate the benefits and risks of the proposed deviation to determine if the circumstances warrant the deviation. The Supervisor or designee will consult with the discipline Technical Manager (TM) or CSD QP 3 – Deviations Page 2 of 4 Distribution: All CSD Personnel Revision: 2 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures Quality Manager (QM), if necessary, to thoroughly evaluate the benefits and risks of the deviation. 3. If approved, the deviation will be documented in the case notes when applicable to case work and documented in a relevant location for non-case work activities. 4. The approval will be documented by initialing a short description of the deviation in the case notes or applicable materials in non-case work activities. 5. Alternately, a description of the requested minor deviation may be documented electronically by the analyst in the narrative section of the electronic case file. A Supervisor or designee may document his/her approval electronically by logging into the case and entering a narrative indicating his/her approval. C. Major deviations CSD employees will complete the following steps to request, approve, and document authorization to deviate from current policy, procedure, or protocol for a defined period of time or grouping of cases or samples. These steps will also be used to initiate, approve, and document permanent changes to policies, procedures, and protocols in between annual review and revision of controlled documents. 1. The requesting individual will complete Section I of the Deviation Request Form (CSD QPA 3.1) and specify on the form: a) the applicable protocol, procedure, or policy b) a description of the requested deviation c) the specific instance(s) for which the deviation is requested d) the reason for the deviation 2. The requesting individual will then forward the form for approval as indicated below. 3. Prior to implementation, all major deviations must be approved by the same authorities responsible for approving the document being modified. a) Section II must be completed by the appropriate Technical Manager for any deviation impacting a discipline quality manual or protocol approved by the TM. b) Section III must be completed by the Quality Manager for any deviation impacting the CSD Quality Manual, any Quality Procedure, attachment, or any other management system document initially approved by the QM. c) Section IV must be completed by the CSD Director or designee for all major deviation requests. d) Any deviation request for a document which was also originally approved by another individual must be routed to that individual for evaluation and approval. QP 3 – Deviations Page 3 of 4 Distribution: All CSD Personnel Revision: 2 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures This additional evaluation and approval should be documented on an attached memo or e-mail. 4. Individuals responsible for reviewing a deviation request will evaluate the request in the same fashion as the document being modified. This review includes an evaluation of the merit and risk of the deviation and whether the proposed modification complies with any and all applicable standards. 5. Major deviations which are approved will be issued in the same fashion as the controlled documents affected by the deviation. The FSC administrative office will retain a copy of approved deviation requests. 6. Deviation requests which are not approved will not be disseminated or retained. The individual denying the deviation request should notify the requestor of the decision. 7. Approved deviations may be effective once signed by the CSD Director or designee. When necessary to delay the implementation of a deviation until employees have had an opportunity to be notified of the deviation, the CSD Director, QM, or TM may indicate an effective date on the bottom of the form. If the effective date is left blank, the deviation is effective on the date it was signed by the CSD Director. 8. Major deviations should be routed and approved/disapproved by the appropriate persons within two weeks of the date of request. III. Attachments OSBI CSD QPA 3.1, Rev 1 Deviation Request Form IV. History Revision # Effective/Review Date History 0 3-23-09 Original issue. Replaces QA 16, Rev. 6. 1 9-17-10 Updated Division Director. Add time frame for approval/disapproval of major deviations. 2 12-31-10 Updated Division Director’s name. Added effective date to form (QPA 3.1 Rev 1) and incorporated language to II.C.7. OSBI Criminalistics Services Division Deviation Request Form OSBI CSD QPA 3.1, rev. 1 ΑΩ I. Explanation of Request Name: Date: Applies to (Policy/Procedure): Describe Requested Deviation: Specify the Instance/Circumstance for which the Deviation is Requested: Reason for Deviation: II. Technical Review and Authorization Merits: Risks/Impact: Duration of Authorization: Restrictions/Limitations: Authorized/Rejected (signature) Date: III. Quality Assurance Manager Authorization Acceptability Within General Quality Assurance Principles? YES/NO Significant Negative Impact to Division-Wide Quality Standards? YES/NO Restrictions/Limitations: Authorized/Rejected (signature) Date: IV. Criminalistics Division Director Authorization Authorized/Rejected (signature) Date: Effective Date: QP 4 – Review of Requests, Tenders, and Contracts Page 1 of 3 Distribution: All CSD Personnel Revision: 1 Approved By: Andrea Swiech, CSD Director Effective Date: 12‐31‐10 Manual: OSBI CSD Quality Procedures I. Scope This procedure will be used to evaluate all requests for laboratory examination and provide response to the customer requesting analysis. Wh |
Date created | 2011-08-30 |
Date modified | 2011-10-28 |
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