OSBI Criminalistics Services Division quality manual

              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
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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
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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
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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.
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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
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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.
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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.
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OSBI CSD Quality Manual
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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.
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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
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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.
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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.
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OSBI CSD Quality Manual
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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
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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
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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.
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OSBI CSD Quality Manual
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Distribution: All CSD Personnel
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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.
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OSBI CSD Quality Manual
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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).
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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:
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• 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
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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
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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,
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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
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OSBI CSD Quality Manual
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“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