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Quality Manual

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0% found this document useful (0 votes)
72 views108 pages

Quality Manual

Uploaded by

my lea
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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QUALITY

MANUAL

Division of Forensic Services


Forensic Sciences Command
QUALITY MANUAL
TABLE OF CONTENTS
Last Date Reviewed: December 31,
2022 QM Rev. 84 (02/05/2023)
# of Pages
Preface Preamble to the Quality Manual 2
Preface Glossary of Terms 4
QM-1 Quality System Goals and Objectives 2
QM-2 Organizational Structure 1
QM-3 Quality System 5
QM-4 Document Control 3
QM-5 Technical Review and Evaluation of Testimony 2
Appendix 5.1.1 – Testimony Evaluation Form 2
Appendix 5.2.1 – Witness Critique Survey Questions 2
QM-6 Competency and Proficiency Tests 10
QM-7 Quality Assurance Measures 11
Appendix 7.1 – Indexing Case File Review Checklist 1
Appendix 7.2 – On Site Visit Report Form 2
Appendix 7.3 – Analyst Response Form 2
Appendix 7.4 – Quality Review Coordinator Response Form 2
Appendix 7.5 – Preventative Action Tracking Form 2
QM-8 Corrective Action for Quality Concerns - Quality Issue Report (QIR) 2
Appendix 8.1 – Quality Issue Report and Corrective Action Plan 3
Appendix 8.2 – Quality Issue Notification Form 1
Appendix 8.3 – Quality Issues or Situations that Require a QIR 1
Appendix 8.4 – Effectiveness of Corrective Actions and Management System Review 1
QM-9 Internal Audits and External Assessments 7
Appendix 9.1 – Internal Audit Checklist 4
Appendix 9.2 – Command Audit Nonconformity Sum 1
Appendix 9.3 – Command Audit Appeal Form 1

QM-10 Requirements for Laboratory Facilities 1


Equipment Use, Repair, Maintenance, Disposal and Calibration
QM-11 Use, Repairs and Maintenance, Disposal, Calibration/Performance Checks 4
QM-12 Maintenance and Control of Case Information 4
QM-13 REMOVED 0
QM-14 Reference Materials, Reference Collections, and Reagents 8
Appendix 14.1 – Quick Reference Guide for Stock Chemicals and Reagents 1
QM-15 Personnel Records 1
QM-16 Customer Satisfaction 3
Appendix 16.1 – Quality Assessment Survey Questions 3
QM-17 Laboratory Quality Flags 3
Appendix 17.1 – Laboratory Quality Flag Form 1
Appendix 17.2 – Approved Quality Flag List 1
QM-18 Measurement Uncertainty 1
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Preamble to the Quality Manual


Page 1 of 2
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

The Illinois State Police (ISP), Division of Forensic Services (DFS), Forensic Sciences Command (FSC) is
mandated to provide forensic science services for Illinois law enforcement agencies in criminal investigations
under the authority of Illinois State Statute 20 ILCS 2605-40. The FSC is committed to provide world-class
forensic service to our customers by ensuring that accurate, complete, and timely analyses are conducted by
highly trained employees who take pride in producing a quality product. Quality services begin with the
initial agency contact, continue through the analysis, and end with providing testimony in court.

To meet customer requirements and provide world-class forensic analysis, established a quality
management system consisting of the necessary policies and procedures that ensure quality services are
provided. This quality management system complies with the requirements of the ISO 17025:2017 standards
and the ANAB accreditation requirements for quality as well as those required by the Federal Bureau of
Investigation (FBI) DNA Quality Assurance Standards.

Employees of the FSC are committed to complying with the guidelines and measures of the quality
management system in all areas - from the administrative aspects through the analytical procedures, to the
report issued and the testimony given in support of the findings – so a quality product is achieved. This
commitment to quality is spearheaded by FSC’s executive management. We will strive for continuous
improvement of the quality management system to ensure that the ideals established by the FSC are met.

The FSC Quality Manual serves to inform all FSC employees of the guidelines and measures associated with
a quality product - not only in the work itself, but in all areas, from the administrative aspects through the
analytical procedures, to the reports issued and testimony given in support of the findings. These directives,
issued under the authority of the Director of Quality Assurance, outline the necessary actions to assure that
quality services are provided. Emphasis is placed on the improvement of quality and on prevention of and
correction of concerns. Since the FSC holds the individual producing the results accountable for the accuracy
of the report, progressive and corrective disciplinary action may occur when there is inaccurate analysis. The
Forensic Sciences Command closely monitors all situations which could result in inaccurate, incomplete, or
untimely analysis.

All properly submitted evidence relinquished to the FSC will be handled with extreme care to ensure
evidential integrity and that a proper chain of custody is maintained. During the process of evaluating and
analyzing evidence, the FSC will employ due diligence and reasonable procedures to preserve the evidence;
however, certain analytical techniques may require consumption and/or alterations such that the evidence can
no longer be utilized for its intended purpose. The FSC will select and utilize appropriate, validated scientific
techniques of our choice to include outsourcing of analytical services to provide our user/client agencies with
accurate, complete, and timely forensic science services. By submitting evidence to the FSC, the user/client
agency agrees to the conditions and terms expressed in this “Pledge to Provide Quality Services” notification.

The FSC will initiate various checks to monitor the quality of services. Input from agencies and other sources
will be solicited to improve the quality of service. Forensic scientists are encouraged to share their
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Preamble to the Quality Manual


Page 2 of 2
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

experiences, both positive and negative, to assist in improving quality. The quality of casework is directly
related to the care taken in both choosing an appropriate analytical scheme and in performing the analysis.
These actions involve following the established standards and controls and incorporating good scientific
practices. While a self-checking process is a fundamental aspect of quality assurance, external checks and
reviews are necessary to monitor the overall quality of work performed. These checks and reviews involve at
least yearly audits of laboratories by FSC personnel or independent third-party assessors. Periodic
reevaluation of the FSC’s standards and controls considering advances in technology, results of proficiency
testing, and review of a representative sampling of casework is also mandated. An ongoing review of the
Quality Assurance Program will be conducted by the Director of Quality Assurance.

In the event of a work stoppage, the lab(s) will be considered officially closed and routine quality checks will
be suspended.

Angelo Bommarito - Director of Quality Assurance


Forensic Sciences Command
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/1997 Policy: Glossary of Terms

Page 1 of 4
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

• Administrative Documentation
1. Records such as case related conversations, evidence receipts, description of evidence packaging
and seals, and other pertinent information.
2. These include all administrative case information that is not considered part of the examination
documents but are relevant to the laboratory case number and the evidence received and having
no other pre-determined storage location. Examples include evidence receipts, laboratory
reports, subpoenas duces tecum and responses, phone conversation records, custody and
location history records, investigative reports, and xerographic copies of evidence.

• Annual Term
Yearly events (calibrations, audits, etc.) which must occur within 30 calendar days from the date
they were conducted in the previous year. Examples: 1) Calibration of an instrument occurs
on June 4.The next calibration must be conducted by July 4 of the next year. 2) An audit was
conducted on March 31. The annual audit must be conducted by April 30 of the next year to
be in compliance.

• Blind Proficiency
Cases made up by the Quality Review Coordinator, and with the assistance of the submitting
agencies, are sent through as an actual case by the agency for the receiving analyst to work.

• Case File Reviews


Reviews of cases for analytical procedures and adherence to standards and controls, such as
reportwording, utilized by the analyst/examiner.

• Case Reanalysis
Cases that are randomly selected, if possible, and reworked by the Quality Review Coordinator.

• Examination Documentation (See also the term Notes)


1. Includes reference to procedures followed, tests conducted, standards and controls used,
diagrams,printouts, audio radiograms, photographs, observations and results of examinations.
2. These include all analytical notes and documentation generated in the laboratory and used by
the analyst to draw and support his/her conclusions. Examples include but are not limited to:
work notes,spectra, charts, references to routine and non-routine procedures, photographs, and
any other documentation required by the Procedures Manual.
• External Proficiency Test
Tests made by an outside testing agency which are submitted to, and worked by, Forensic
SciencesCommand analysts/examiners/technicians; results are graded by the testing agency to
ascertain theproficiency in area of analysis.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/1997 Policy: Glossary of Terms

Page 2 of 4
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

• ANAB (ANSI-ASQ NAB)


American National Standards Institute-American Society for Quality National Accreditation
Board

• Internal Proficiency Test


Specific tests made by the Quality Review Coordinator and worked by the analyst/
examiner/technician to test his/her proficiency in area of analysis.

• ISO/IEC
International Organization for Standardization/International Electrotechnical Commission

• Issues Affecting Case


Issues that would deter or have an effect on the adjudication process.

• Major Error
An error in a proficiency test or casework which not only is in opposition to what has been
determined as a correct answer, but has been worked in such a manner as to cast doubt about
an analyst’s/section’s abilities to perform casework in the particular area or discipline.

• Master File
The original file folder created at the time the case is first signed in at the originating laboratory.
It isstored in the laboratory’s file storage room numerically, and contains all examination and
administrative documentation required for that uniquely identified case, including completed
Working Files. Cannot include any physical evidence.

• Measurement Uncertainty
The doubt that exists about the result of any measurement; parameter, associated with the result
of a measurement, that characterizes the dispersion of the values that could reasonably be
attributed to themeasurand (item being measured).

• Minor Issues
Issues found during case review/reanalysis which do not deter nor have an effect on the
adjudicationprocess.

• Monthly
Events that occur once a month and not less than 24 days from the date the event was conducted
in the previous month.
• Notes (See also the term Examination Documentation)
Documentation of procedures, standards, controls and instruments used, observations made,
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/1997 Policy: Glossary of Terms

Page 3 of 4
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

results oftests performed, charts, graphs, photos, and other documents generated which are used
to support the examiner’s conclusions.

• On-Site Visit (non-DNA section)


A visit made by the Quality Review Coordinator to the analyst’s/examiner’s laboratory to observe
the analyst/examiner working cases in their home laboratory environment.

• Qualified Analyst
A qualified analyst is an analyst who has successfully completed training in a specific area, passed
an appropriate test, and has been approved to perform independent casework. An individual
released from a training program will be considered qualified as of the date listed on the
memorandum notifying him/her of the release from training.

• Quality
Accurate, complete and timely analysis of casework; the totality of features and characteristics
of aproduct or service that bear on its ability to satisfy stated or implied needs; conformance
to requirements.

• Quality Assurance
The measures which determine that the quality system is performing properly and also provide
a course of action to improve analysis and the resulting information provided to the criminal
justicesystem.

• Quality Committee
Committee composed of the Director of Quality Assurance, Quality Review Coordinators, and
Laboratory Quality Managers. Meets at least annually to discuss the quality program.

• Quality Control
The action of following standards and controls and following valid methods and procedures.
Properquality control mandates that the individual Forensic Scientist uses and documents the
proper functioning of all tests performed. A well-defined set of standards and controls for the
Forensic Scientist to use as a basis for producing quality work is a cornerstone of quality.
• Quality Documents
All documents utilized by the Command to provide quality forensic services such as manuals,
forms,and procedures. These are maintained in the Command Directives, Command Quality
Manual, Procedures Manuals, Training Manuals, Command Safety Manual and the Facility
Operations Manuals.

• Quality Improvement
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/1997 Policy: Glossary of Terms

Page 4 of 4
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

Actions taken throughout the organization to increase the effectiveness and efficiency of
activitiesand processes in order to provide added benefits to both the organization and its user
agencies.

• Quality Issue
Potential nonconforming work or a departure from the policies and procedures in the quality
systemor technical operations; after investigation it will be determined whether the issue is
substantiated

• Quality Manager
The individual responsible for ensuring that the quality system is implemented and followed
at all times for the laboratory or the Forensic Sciences Command. The command quality
manager is designated as the Director of Quality Assurance. The Laboratory Quality Manager
oversees the quality system for the respective laboratory.

• Quality Measures
To assure that results are of the highest quality and that the system is performing as it is
designed,information will be obtained through both direct and indirect means.
a. Direct Means consist of routine checks, both periodic and random, which are initiated
within thecommand.
b. Indirect Means consist of input from individual analysts/examiners, administrators,
qualityreview or training coordinators or others as designated.

• Quality Review Coordinator


A bench analyst, selected from one of the analytical sections, who reviews case files, performs
reanalysis of cases, creates and grades proficiency tests for the other members of that analytical
section, and performs other assigned quality assurance duties.

• Working File
Minimally contains documents pertaining to a particular analyst’s work such as examination
documentation, analytical reports and pertinent administrative documentation (e.g., copies of
evidence receipts, CALMS property inventory sheets, documentation of agency requests).
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-1 Quality System Goals and
Objectives
Page 1 of 2
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

I. GOALS

A. The Forensic Sciences Command (FSC) is committed to providing quality scientific analysisof
evidence to the law enforcement community. Quality services begin with the initial agency
contact, continue through the analysis, and end with providing testimony in court. To this end,
Command is committed to good professional practice and the quality of its forensic testing
activities in servicing its customers via these objectives:

II. OBJECTIVES

A. |Conducting forensic analyses that are accurate, relevant, complete, timely, impartial
and satisfy customer requirements,

B. Interpretation of analytical results without bias and free of internal and external influence,

C. The presentation of the results of analyses and examinations in reports and testimonies
that are clear, objective, balanced and easily understood by its customers,

D. The ongoing development of the skills and expertise of its personnel,

E. Establishing an integrated quality management system, as set forth in in the FSC/CSSC


Directives, Procedures Manuals, Quality Manual, and Command Training Manuals.

F. The conformance of laboratory policies and procedures with the accreditation


requirements of the Division’s accrediting body under ISO 17025 guidelines, National
DNA Index System (NDIS) Operational Procedures Manual, FBI Quality Assurance
Standards for Forensic DNA Testing Laboratories, and the FBI Quality Assurance
Standards for DNA Databasing Laboratories,

G. |Continuous improvement of the effectiveness of the management system and quality of


forensic science provided to customers, using this quality policy, audit results, analysis of
data, corrective and preventive actions, and management review. ensuring that when
changes are made, they do not impact the integrity of the management system.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-1 Quality System Goals and
Objectives
Page 2 of 2
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

H. To develop principles and performance standards that validate and advance the strategies
and techniques associated with forensic analysis,

I. To heighten the awareness of all Forensic Sciences Command personnel regarding the
importance of quality assurance and encourage suggestions for improvement of analysis
and service,

J. Identifying risks to impartiality on an ongoing basis, including risks that arise from its
laboratory activities, relationships of personnel or other risks such as commercial and
financial. The risk shall be investigated and documented as required in QM-8.

K. Adherence to the Code of Ethics as described in Command Directives – ADM 01.


Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-2 Organizational Structure

Page 1 of 1
Date of Revised Issue: 08/30/19 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 19-01

I. COMMAND ORGANIZATIONAL STRUCTURE

The Division of Forensic Services, Forensic Sciences Command, contains the forensic laboratory
function of the Illinois State Police. Authority for the establishment of the forensic laboratories is set
forth in the Illinois State Statute 20 ILCS 2605-40. The Director of the Illinois State Police, appointed
by the Governor of the state of Illinois, appoints the Colonel of the Division of Forensic Services. The
Colonel has responsibility and authority for oversight of the Forensic Sciences Command. The
Colonel, through the Lieutenant Colonel, directs the Command executive management through the
Commander of the Forensic Sciences Command.

The Forensic Sciences Command organizational structure can be found in the Command Directives
(ORG 1).

A. The Commander is responsible for the overall administration of the Forensic Sciences
Command.

B. The Bureau Chiefs administer the laboratories and training units. The various laboratories
and/or specialties will be divided among the Bureau Chiefs and periodic rotation of one or
more functions may occur. A designated Bureau Chief will perform the duties of the
Commander in his/her absence.

C. ▌The Director of Quality Assurance is responsible for the daily operations of the quality
assurance program. Through delegated authority, the Assistant Director of Quality Assurance
will perform various activities for which the Director of Quality Assurance is responsible. In
the absence of the Director of Quality Assurance, the Assistant Director of Quality Assurance
will assume the duties for administering the quality assurance program.

D. Laboratory Directors are responsible for the daily operation of the laboratories, with Assistant
Laboratory Directors or Deputy Laboratory Directors in place who are authorized to assume
their duties in their absence.

E. Key personnel outside of the Forensic Sciences Command that have influence on the
operation of the Command include the Director of the Illinois State Police, who is influential
in the budget process and strategic planning, and the First Deputy Director who assists the
Director in managing the Illinois State Police.

II. INDIVIDUAL LABORATORY ORGANIZATIONAL CHARTS

▐ The organizational charts for individual Forensic Sciences Command laboratories can be found on the
Command intranet site.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-3 Quality System

Page 1 of 5
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

The Forensic Sciences Command will provide and maintain quality forensic services by utilizing a quality
assurance program/quality management system in accordance with ISO 17025:2017 Option A. All items in
ISO17025:2017 (and supplemental accrediting body requirements) designated with the words agreed, appoint,
authorize, define, instructions, method, plan, procedure, program, record, schedule, or specify shall be
addressed in one of the Command controlled documents (Command Directives, Quality Manual, Section
Procedures Manual, Laboratory Facility Operations Manual, Safety Manual, Training Manual).

I. QUALITY MANAGER

The Quality Manager for the Illinois State Police, Forensic Sciences Command is the Director of
Quality Assurance. The Director of Quality Assurance will manage the daily operations of the Quality
Assurance Program. Through delegated authority, the Assistant Director of Quality Assurance will
perform various activities for which the Director of Quality Assurance is responsible. The Director of
Quality Assurance is responsible for, but not limited to:

A. Coordinating and implementing each section’s quality assurance program and monitoring
subsequent activities;

B. Supervising the distribution and monitoring the results of the Command’s proficiency testing
program;

C. Supervising the reporting of external proficiency tests;

D. Administration of the Command’s Quality Review Coordinator program, which includes case
reanalysis program;

E. Maintaining and reviewing the Command Quality Manual;

F. Ensuring compliance with ISO/IEC 17025:2017, supplemental accreditation provider


requirements, and the FBI DNA Quality Assurance Standards;

G. Administration of the Command’s Safety Program;

H. Conducting laboratory audits and quality system reviews, and arranging for external
audits/reviews;

I. Overseeing the corrective action process for quality issues;

J. Serving as administrative aide to the Commander and Bureau Chiefs as appropriate;

K. Serving as the evidence custodian for the Command; and


Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-3 Quality System

Page 2 of 5
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

L. |Ensuring FSC fulfills the objective of testimony review per QM-5.

II. LABORATORY QUALITY MANAGER

Each laboratory will designate an individual as the Laboratory Quality Manager. This individual, in
conjunction with the Laboratory Director, will be responsible for facilitating the quality program at the
laboratory. This individual will be responsible for working directly with the Director of Quality
Assurance on all quality matters involving his/her laboratory. Specific duties for the Laboratory
Quality Manager include, but are not limited to:

A. Coordinating, implementing, and monitoring the laboratory’s quality assurance activities;

B. Monitoring laboratory practices to verify continual compliance with ISO/IEC 17025:2017,


supplemental accreditation provider requirements, and the FBI DNA Quality Assurance
Standards;

C. Coordinating and monitoring proficiency tests participation for the laboratory;

D. Coordinating and monitoring reanalysis and case file review activities in the laboratory;

E. Participating in an annual internal (in-house) laboratory audit and assessing requirements


according to appropriate accrediting body's and Command criteria;

F. Participating in Command audits of the quality management system;

G. Monitoring and participating in resolving any quality issues within the laboratory;

H. Proposing corrections and improvements in the quality system of the laboratory and the
Command;

I. Conducting an annual review of the laboratory’s quality system and submitting


documentation of the review through the chain-of-command to the Director of Quality
Assurance;

J. |Documenting that each testifying employee in the laboratory has had his/her testimony
monitored, and verifying that analyst without feedback did not testify in the calendar year in
accordance with QM-5;

K. Recommending training to improve the quality of laboratory staff.


Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-3 Quality System

Page 3 of 5
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

III. |DNA TECHNICAL LEADER

This individual will be responsible for working directly with the Director of Quality Assurance on all
quality matters (all documents on reviews, proficiency tests, continuous improvement projects,
reanalysis, etc.) involving DNA. They will provide input on corrective action, recommend changes as
necessary for continuous improvement of DNA quality assurance, and have access to all documents
relating to quality assurance measures in DNA.

IV. PROGRAM MANAGERS

These individuals will be responsible for working directly with the Director of Quality Assurance on
quality matters assigned to them (e.g. revisions to quality documents, continuous improvement
projects, preventive action, etc.) that involve their program areas. They will recommend corrective
action to address identified quality issues including the remediation of any ISO assessment
nonconformity as applicable. They will request input from the Director of Quality Assurance to
ensure laboratories continue complying with policies, procedures, and accreditation standards within
the assigned areas. The Program Managers will provide input to the Director of Quality Assurance on
improving quality assurance measures.

V. QUALITY DOCUMENTS

In addition to those contained in the Quality Manual, other quality documents are contained in the
Command Directives, the Safety Manual, Procedures Manuals, Training Manuals and Facility
Operations Manuals. Specific quality-related topics such as type and extent of laboratory
examinations, disclosure of information and facilities (location and contact information) are listed in
the Command Directives; all safety items are discussed in the Command Safety Manual and Facility
Operations Manuals; Facility Operations Manuals discuss the specific operations for a particular
laboratory; while Procedures and Training Manuals content is discussed elsewhere in this manual.

VI. |MINIMUM STANDARDS AND CONTROLS

Minimum standards and controls have been established to ensure the integrity of analysis and to
provide consistency of analysis among laboratories. The standards and controls have been designated
to cover the majority of analyses performed within the Forensic Sciences Command. However, it is
not possible to establish controls for every eventuality that might arise during the examination of a
case by a Forensic Scientist. The absence of standards and controls does not negate the responsibility
of the Forensic Scientist to perform examinations in accordance with sound scientific principles and
according to good laboratory practice. Nor will the adherence to the standards and controls always
ensure that additional examinations are not necessary. If the nature of the evidence warrants further
examination, preservation, etc. than is indicated by the standards and controls, the forensic scientist is
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-3 Quality System

Page 4 of 5
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

expected to take that action and document the extent of the actions in the case notes.

VII. QUALITY ASSURANCE ACTIVITIES

The activities defined below serve as a resource to Command administration by allowing forensic
analysts to act in an advisory capacity to review emerging analytical technology/instrumentation,
training needs, casework trends and to improve or revise standards and controls for analytical
casework.

A. Quality Review Coordinators - Quality Review Coordinators will be selected from each
forensic science discipline.

1. Qualifications

An individual serving as a Quality Review Coordinator must have extensive


experience in the specific discipline and produce quality casework. Additionally, the
individual will have a thorough awareness of the interrelationship of forensic
disciplines. They will demonstrate an interest in improving the work product of those
individuals working in their forensic discipline; and can objectively evaluate
situations, identify problems and recommend solutions.

2. Selection Process

Interested employees will send a request for consideration as a Quality Review


Coordinator to their Laboratory Director through the appropriate chain of command.
The Laboratory Director will provide input to the Director of Quality Assurance
about the employee’s capabilities. The selection of the Quality Review Coordinator
is made by the Commander and the Director of Quality Assurance.

3. Term

Term of the Quality Review Coordinator is three years in the forensic biology,
microscopy, trace chemistry, footwear/tiretrack, DNA, Y-STR DNA, Indexing, and
toxicology sections, and is considered a part-time assignment, with casework
production still a duty.

Term for the Quality Review Coordinator in drug chemistry, latent prints, and
firearms/toolmarks is two years. These positions are considered as full-time, with
limited casework done as time permits. The DQA may extend terms when necessary.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-3 Quality System

Page 5 of 5
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

4. Responsibilities - Responsibilities include, but are not limited to, the following
duties:

a. Provide technical assistance to each section member;

b. Conduct quality assurance visits as requested by the Laboratory Director or


the Director of Quality Assurance including an evaluative report provided to
the Laboratory Director and Director of Quality Assurance;

c. Address the analytical capabilities of each section member by conducting


case reanalysis, technical review and internal proficiency testing (as needed).
Notifications of these activities will be issued to the Director of Quality
Assurance and respective Laboratory Quality Manager, with all matters to be
handled in a confidential manner;

d. Review the section’s procedures and standards and controls as needed, and
forward any potential procedural concerns and providing recommendations
for change to the DQA Director of Quality Assurance;

e. Review of all external proficiency tests for analysts which fall under their
discipline in accordance with QM-6;

f. Select Technical Review and Reanalysis cases for each analyst, notifying the
respective quality managers in a timely fashion to transfer cases as needed;

g. Provides the Director of Quality Assurance with a year-end report of section


quality assurance activities, to include a review of the section’s adherence to
policies and procedures, as well as detailing areas of improvement identified;

h. Participates in Command QA Committee Meetings; and

i. Maintains a high level of quality work and serves as an example to others.

B. Quality Assurance Committee - A Quality Assurance Committee composed of all Quality


Review Coordinators, the Director of Quality Assurance, the Assistant Director of Quality
Assurance, and Laboratory Quality Managers will meet twice each year to assess the quality
assurance activities in the Command.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-4 Document Control

Page 1 of 3
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

POLICY

Quality documents used in the Forensic Sciences Command Quality Management System are controlled to
ensure that only current, up-to-date documents are being utilized.

I. DEFINITION

Quality Documents - All documents utilized by the Command to provide quality forensic services
such as manuals, forms and procedures. These are maintained in the Command Directives, Command
Quality Manual, Procedures Manuals, Training Manuals, Command Safety Manual and the
laboratories’ Facility Operations Manuals (FOM).

Worksheets - The templates used in formatting the analytical data printed from LIMS. Worksheets
are created for technical review, courtroom testimony, and/or dissemination of records for discovery
and/or Freedom of Information Requests.

Forms – The document templates used to record specific analytical information in LIMS in addition to
the notes. These are Quality Documentsand are controlled. Forms are found in all the manuals listed
above for Quality Documents, and include documents such as: balance function check logbook
sheets, and equipment maintenance logbook sheets.

II. CONTROL

A. Only approved quality documents may be utilized.

B. Approved documents may not be customized or altered.

C. Control of manuals and dissemination is discussed in ADM 18, Electronic Manuals, of the
Command Directives.

D. Authorization/approval for the manuals is as follows:

1. Command Directives - Commander

2. Quality Manual - Director of Quality Assurance

3. Procedures Manual - Appropriate Bureau Chief or Program Manager

4. Training Manuals - Director of Training


Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-4 Document Control

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Revision Transmittal Number: QA 22-01

5. Command Safety Manual - Director of Quality Assurance

6. Laboratory FOMs - Laboratory Director

F. Reviews

1. The Command Directives, Quality Manual, Safety Manual and Laboratory FOMs are
reviewed annually, at a minimum, and all new policies are reviewed prior to
implementation.

a. Reviews for adequacy are overseen by the person designated as having


authorization/ approval for the manual.

b. Reviews can be conducted by committees of individuals picked by the


review overseer, with any necessary additions or changes noted for
implementation.

c. Review dates and version number will be noted in each manual.

d. Changes to the Command Directives Safety Manual, Quality Manual, and


FOM’s will be communicated to staff via email, using a solid bar next to any
changes.

2. Section Procedures Manuals review policy is covered in Command Directives –


ADM 11.

III. LIST OF QUALITY DOCUMENTS

A. The Director of Quality Assurance controls a legal edition of ISO/IEC 17025:2017.

B. In lieu of a list of approved documents distributed to Command personnel, an equivalent


process is implemented in which each manual will contain:

1. Table of contents, which lists the document or policies within;

2. Revision/acceptance date of documents to demonstrate the most current version;

3. Date of last review, or for Procedures/Training Manuals, date of next review;


Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-4 Document Control

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Revision Transmittal Number: QA 22-01

4. Authorizations for transmittal and use of the documents by the person identified in
II.E of this directive.

C. A version of the Quality Assurance Standards for Forensic DNA Testing and Databasing
laboratories can be obtained from the Federal Bureau of Investigation website (refer to QM-
9 for the exact location of the documents).

D. When a section’s procedures manual states Forensic Sciences Command analysts must rely on
an equipment operating manual for a procedure (e.g. conducting analysis or performing
maintenance), then the manual is defined as a “controlled document.” The relevant
edition/version of the operating manual must be listed in the approved procedure manual.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-5 Technical Review and


Evaluation of Testimony
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Revision Transmittal Number: QA 22-01

POLICY

It is the responsibility of the Forensic Sciences Command to ensure that testimony in each forensic discipline is
technically reviewed annually to ensure that the expression of any result, interpretation and/or opinion is
accurate and supported by the technical record from which it is derived.

It is also the responsibility of the laboratory management to ensure each individual analyst’s testimony is
evaluated annually. This may be accomplished by a technical review, a non-technical evaluation of testimony,
submitting court cards to attorneys and judges, or by conversation with the attorneys and judges involved for
feedback.

I. PROCEDURE

a. Technical review of testimony

i. A testimony reviewer (TR) must be selected that is:


1. Competency tested in the discipline for which the testimony is being given,
and
2. Trained in the techniques which were utilized to form the foundation of the
scientific opinion.

ii. It is preferred that the TR:


1. Be currently participating in proficiency testing in the relevant discipline,
2. Not have been the original technical reviewer of the case, and
3. Not work in the same laboratory as the analyst which will testify.
4. Be a manager or quality review coordinator (QRC) as available.

iii. |Prior to the testimony, the TR will familiarize themselves with the case file and
discuss any questions if needed with the testifying analyst. The TR will perform a
Post Review within LIMS to document the review.

iv. The TR will record all observations in Appendix 5.1.1 –Testimony Evaluation Form.

v. |Upon completion, Appendix 5.1.1 will be provided to the Quality Manager from the
analyst’s laboratory. The Laboratory Quality Manager will review the form, and
document the technical reviewer in the activity log for the court testimony. If the
review is free of issues, Appendix 5.1.1 will be forwarded to appropriate Command
personnel for attachment to the activity log entry in LIMS. The analyst and
supervisor review the feedback and document appropriately in LIMS. In addition,
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Forensic Sciences Command

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Revision Transmittal Number: QA 22-01

the respective Bureau Chief will be provided a copy for review. Any unexpected
results and/or issues will be communicated to the Director of Quality Assurance ,
Technical Leader (if applicable) and respective Bureau Chief by the Lab Quality
Manager to determine if any corrective actions are needed per QM-8.

vi. In lieu of witnessing a live testimony, transcripts of a testimony can be reviewed by


the TR and evaluated using Appendix 5.1.1.

b. Evaluation of testimony (Non-Technical)

i. Evaluation of testimony that is not intended to meet the requirements in (I.a.) above
need not be performed by a previously competency tested employee.

ii. Appendix 5.1.1 will be utilized; however, it is not required to fill out the “Technical
Review” section.

iii. |Upon completion, Appendix 5.1.1 will be provided to the Quality Manager from the
analyst’s laboratory. The Lab Quality Manager will review the document. If the
review is free of issues, Appendix 5.1.1 will be forwarded to appropriate Command
personnel for attachment to the activity log entry in LIMS. The analyst and
supervisor will review the feedback and document appropriately in LIMS. The
reviewer should be consulted as needed. Any unexpected results and/or issues will
be communicated to the Director of Quality Assurance, Technical Leader (if
applicable) and respective Bureau Chief by the Lab Quality Manager to determine if
any corrective actions are needed per QM-8.

c. External Court Testimony Feedback

i. |All personnel will ensure that a witness critique survey (Appendix 5.2.1) is made
available to both the prosecuting and the defending attorneys for cases in which
they appear for the purpose of testifying. In addition, whenever possible, a card
should be given to the judge hearing the case. Alternative means outlined in the
LIMS user guide (email, etc.) to provide a link to the survey are also acceptable.

ii. |All court testimony will be documented using the activity log in LIMS.

iii. |Testimony feedback received from an external source will be attached to the
Illinois State Police Division of Forensic Services

Forensic Sciences Command

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Revision Transmittal Number: QA 22-01

particular activity log entry in LIMS and reviewed by both the analyst and their
supervisor.

iv. If the feedback is negative in nature the laboratory will notify the Director of Quality
Assurance, and corrective action will be taken as needed in accordance with QM-8.

v. If a review is not conducted on an analyst, this must be documented in the activity


log, and an explanation given as to why there was no review (e.g. the analyst did not
testify during the calendar year).
ILLINOIS STATE POLICE
DIVISION OF FORENSIC SERVICES
FORENSIC SCIENCES COMMAND

QUALITY MANUAL – APPENDIX 5.1.1 ‐ TESTIMONY EVALUATION FORM

General Information
Analyst Name
Date
Testimony Reviewer (TR)
Case Number
Venue

Pre – Testimony (only required for Technical Review) YES NO N/A


Were the notes subpoenaed prior to the testimony?
Was a pre‐trial conference held with the State’s Attorney?
Were any issues identified by the ASA prior to testimony?
Was a pretrial conference held with the Defense Attorney?
Were any issues identified by the Defense prior to testimony?
Did the TR review the case file? (if so, document as a post review)
Did the TR understand and agree with the scientific basis for which any result,
opinion and/or interpretation was made?
Were qualifying questions given to ASA?

Personal Impressions/Demeanor SATISFACTORY UNSATISFACTORY


Voice (adequate volume, tone, fluency)
Eye contact
Posture
Facial Expressions
Gestures
Dress
Etiquette
Confidence

Testimony YES NO N/A


Clear and Concise?
Responsive to questions?
Understandable?
Limited to area of expertise?
Asks for clarification when needed?
Referred to notes when necessary?
Was the evidence handled properly?
Were visual aids clear and used effectively?
Were the qualifying questions utilized by the relevant attorney in an appropriate
manner?

QUALITY MANUAL – APPENDIX 5.1.1 – Testimony Evaluation Form Rev 10/31/2022 Page 1 of 2
Technical Review Yes No N/A
Were the results, interpretations, and/or opinions conveyed consistent with the
analytical results and report issued to the agency?
Were visual aids consistent with the findings conveyed on the report?
Was the evidence sealed as described on the notes, apart from any explainable
differences?

Comments (required for any unexpected result or issue indicated above)

Corrective Action (to be completed by Quality Manager) YES NO


Is corrective action necessary?
If yes, please list the QIR #

QUALITY MANUAL – APPENDIX 5.1.1 – Testimony Evaluation Form Rev 10/31/2022 Page 2 of 2
Appendix 5.2.1 - Witness Critique Survey Questions

The Illinois State Police (ISP) value the comments of officials of the court to ensure our forensic services
staff provide effective courtroom testimony. Your open communication and cooperation with us will
help us to achieve service excellence.

Please provide the following case information


1. Prosecuting County/Jurisdiction
2. Date of Testimony
3. ISP Case Number
4. Submitting Agency
5. ISP Employee

The witness was prepared for trial


1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree

The witness was responsive to subpoena requests and/or appropriate pretrial communications
1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree

The witness was objective


1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree

The witness was responsive


1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree

The witness was professional


1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree

Revised 02/05/2023 Page 1 of 2


The testimony was clear
1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree

The technical content of the testimony was understandable


1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree

Rank your overall level of satisfaction with the testimony of the witness
1. Strongly Unsatisfied
2. Somewhat Unsatisfied
3. Neutral
4. Somewhat satisfied
5. Strongly Satisfied

Comments on testimony / Suggestions for improvement


Comments

Would you like someone to contact you regarding this witness testimony?
1. Yes
2. No

Thank you for your assistance. Please contact us if you have any questions or concerns.

Email: [email protected]

Contact information for person completing survey


1. Name and Title
2. Phone Number
3. Email Address

Case Involvement
1. Judge
2. States’ Attorney
3. Defense
4. Other(please specify)

Revised 02/05/2023 Page 2 of 2


4. Other(please specify)

Revised 09/10/19
Illinois State Police Division of Forensic Services

Forensic Sciences Command

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Revision Transmittal Number: QA 22-01

POLICY

The Forensic Sciences Command has four types of performance tests that may be used as quality assurance
measures. These are the competency tests, internal proficiency tests, external proficiency tests and blind
proficiency tests. Proficiency testing will be used either as an assessment of the analyst’s ability to obtain
accurate results and interpret them properly or as a measure and comparison of reproducibility between
laboratories, as in quantitative analysis. Since proficiency testing is considered a training evaluation
mechanism, no disciplinary action will be taken against an employee for incorrect analysis, results or
conclusions.

I. COMPETENCY TESTS

A. Frequency and Purpose

1. The purpose of the competency test is to establish that an analyst has demonstrated
the achievement of technical skills and knowledge necessary to perform specific
forensic analyses. It is also used to ensure that new techniques are instituted in the
Command in a uniform manner. A competency test may consist of a written test
and/or sample analysis.

A competency test must be given to an analyst, including but not necessarily limited
to the following situations, unless otherwise directed by the DQA, DNA technical
leader, BC or Commander:

a. |During initial training, prior to performing supervised casework.

b. |When an analyst is assigned to a different laboratory and has not operated


the type of instrumentation found at the destination laboratory, or there are
sufficient differences in testing between the two laboratories ( i.e. an
analyst transferring from a laboratory that does not perform toxicology
blood drug quantitation to one that does).

c. When new techniques are instituted in the Command.

2. A competency test (or a proficiency test in substitution) must be given to an analyst


who has not performed analyses for a significant period or has been on leave that
takes them out of the proficiency test cycle. The laboratory director may request
retraining of an analyst based upon the length of the leave, which will be approved
by the Commander. If the request for retraining is for a DNA analyst, the technical
Illinois State Police Division of Forensic Services

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leader must assess the extent and approve the retraining plan which must include
competency testing.

3. For all other situations, the decision to give a competency test rests with the
Laboratory Director or Laboratory Quality Manager.

B. Administering the Test

1. The Training Coordinator is responsible for directing the creation, administration


and evaluation of the competency test. However, it is the responsibility of the
Laboratory Director to request the test and ensure that the examiner has taken and
passed the test before performing specific forensic analyses.

2. If the test involves sample analysis, samples will consist of a set of unknowns which
the analyst is to analyze utilizing the designated technique.

3. The time allotted to complete the test is to be established by each Quality Manager
and the analyst involved; however, it will not exceed four (4) weeks.

4. All samples will be kept until notification of successful completion of the tests is
received.

C. Evaluating the Results

1. The analyst must submit the test in LIMS. The completed test will include a report
along with the supporting notes to the training coordinator or designated reviewer
for technical review.

2. The analyst must report all findings in concordance with the responses anticipated
in preparation of the test. Inconclusive answers are acceptable if anticipated by test
design or if acceptable as a part of sections protocols.

3. When the test involved sample analysis and the analyst did not pass the first test,
laboratory management will notify Statewide Training or the Director of Quality
Assurance immediately depending on the purpose of the test. The results of the test
will be communicated to the analyst, and the individual shall be retested. The
analyst may not be responsible for an error since the test samples may have been
mislabeled, the person being tested may not have understood the instructions, or the
sample being submitted may have deteriorated. To accommodate these possibilities,
the analyst will receive a second sample, different from the first, but on the same
Illinois State Police Division of Forensic Services

Forensic Sciences Command

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subject matter. This second sample is to be analyzed upon arrival with results due
within two (2) weeks. If there is an error in the results of the second test, the
Director of Quality Assurance or Statewide Training will inform Command
Administration and the appropriate DNA Technical Leader (for DNA issues).
Laboratory management, Command Administration, the Director of Quality
Assurance, and the appropriate DNA Technical Leader (for DNA issues) will
discuss the appropriate actions to be taken. A review of the test by another analyst
may also be warranted.

4. When the test did not involve samples analysis (i.e. written tests) and the analyst
did not pass the first test, laboratory management will notify Statewide Training or
the Director of Quality Assurance immediately depending on the purpose of the test.
Laboratory management, Command Administration, the Director of Quality
Assurance, and the appropriate DNA Technical Leader (for DNA issues) will
discuss the appropriate actions to be taken.

5. Upon satisfactory completion, the designated tester will send a report to the
appropriate Laboratory Quality Manager and the Director of Quality Assurance.
The Laboratory Quality Manager will communicate successful completion of the
test to the analyst.

D. Maintaining Test Records

Test records will be maintained in each analyst’s laboratory training file as specified by the
Command Directives.

II. EXTERNAL PROFICIENCY TESTS (EPT)

A. Frequency and Purpose

1. All laboratory personnel assigned to do casework in a specific laboratory activity


will be required to pass an external proficiency test every year in their specific
discipline(s) for which a test has been developed This includes all DNA analysts
that participate in casework, as designated by the technical leader(s). External
proficiency tests are required to be passed annually for the testing activities listed
below unless otherwise indicated:

a. |Body Fluid Identification -1 test per year may be combined with a DNA test
b. |Casework & Indexing DNA – 2 tests per year, per the FBI QAS requirements
c. Toxicology:
Illinois State Police Division of Forensic Services

Forensic Sciences Command

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i. Blood alcohol/volatile analysis


ii. Blood Drug analysis
iii. Urine Drug Analysis
d. Firearms/Toolmarks
i. Firearms Comparison
ii. Serial Number Restoration
iii. Toolmarks Examination
iv. Distance Determination
e. Drug Chemistry
i. Cannabis Identification
ii. Drug Identification
f. |Latent Print
i. Latent Print Comparison
g. Footwear/Tiretrack
i. Footwear/Tiretrack comparison (alternate years)
h. Micro/Trace
i. Arson
ii. Primer Gun Shot Residue
iii. Paint
iv. Fiber Comparison
v. Physical Match

2. A Laboratory Director may, with the approval of the appropriate Bureau Chief,
request an additional proficiency test for any individual at any time.

3. Proficiency testing may be used either as an assessment of the analyst’s ability to


obtain accurate results and interpret them properly, following all ISP policies and
procedures, or as a measure and comparison of reproducibility between
laboratories, as in quantitative analysis.

4. |Proficiency tests shall be purchased from providers accredited to the ISO 17043
standard. If no test exists, an approved alternative test will be used as approved by
the current laboratory accrediting body. Prior to the purchase of the external
proficiency test, it will be approved by the casework and indexing technical leaders.

5. For the DNA and Indexing tests, the received date of the proficiency test will be
considered as the performance date of the test, with the next test to be performed
not less than four months nor greater than eight months after this date.

B. Administering the Test


Illinois State Police Division of Forensic Services

Forensic Sciences Command

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1. |A test will be administered every year to certify the analyst for the following period,
i.e., completion in 2019 will certify casework in 2020. Analysts who recently
completed training will participate in the next external proficiency test that is
available after the completion of training (no more than 8 months from the release
of training for DNA analysts). For example, in all sections but DNA, if training is
completed in March 2020, and the external proficiency test was administered in
January 2020, the first proficiency test the analyst will participate in will be for
January 2021.

2. All analysts working cases must be proficiency tested for those casework areas for
which a test is available. This includes casework areas done by Evidence
Technician IIs, but which the analyst may have performed in the absence of the ET.

3. Evidence Technician IIs will be tested based on their training qualifications


and to the degree they participate in casework. Evidence Technician IIs
will participate in the external proficiency test for the section as they do in
casework if they do not receive a separate external proficiency test. This
will be documented in LIMS.

4. Analysts will treat the proficiency test as normal casework, except as


otherwise noted in II.B. Testing will be performed with adherence to the
relevant minimum standards and controls using LIMS to record all notes
and to generate a report.

5. If an answer sheet requires an answer that is not normally reported in


casework (for instance, an answer sheet that includes a scale of similarity)
the most appropriate answer will be chosen on the answer sheet, while the
mock “report” generated in LIMS will reflect how the analyst would report
the results of testing if it were an actual case.

6. The quality manager will assign analysts the external tests using LIMS.
Proficiency tests take precedence over casework. DNA test are required to
be completed in 6 weeks, and all other tests are required to be completed in
one month, unless approved by the laboratory.

7. EPTs will be worked independently and will not be subject to peer review
or verification prior to submission to the Quality Review Coordinator
(QRC). If required in the LIMS matrix, a supervisor will initial the
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verification field to allow submission of the test but will not perform
verification.

8. When complete, the analyst will submit the test first to the test provider,
then subsequently to the QRC for review (with provider answer sheet
attached in the image vault) in LIMS.

9. For DNA proficiency tests:

a. |For DNA casework proficiency tests, the autosomal typing test kit will
be used for each semi-annual test in the calendar year. Additionally,
analysts qualified in a YSTR typing kit will need to conduct this
analysis in one of the semi-annual tests in the respective calendar year.
For DNA Indexing proficiency tests, analysts that are qualified in both
autosomal and YSTR typing kits will need to use each of these typing
kits on one of the semi-annual tests in the calendar year. However, it
will only be necessary to use the autosomal typing kit for each semi-
annual test in the calendar year if the analyst is only qualified in the
autosomal typing test.

b. |For DNA casework and Indexing proficiency tests, each analyst will
perform at least one method in each methodology for which they are
qualified at least once per year. For the definitions of method and
methodology refer to the FBI Quality Assurance Standards for Forensic
DNA Testing Laboratories and Databasing Laboratories.

c. |For DNA casework proficiency tests, the LIMS notes packet shall
contain documentation of the number of contributors for each unknown
sample and all mixture samples will need to be differentiated as
appropriate following ISP Interpretation procedures.

d. |If a quality issue occurs with the analytical processes for DNA
casework proficiency tests, the DNA technical leader must be notified
that the issue being documented with the Incident Report contains
proficiency test samples. This notification must occur prior to the
submission of the results to the test provider.

e. |The statewide CODIS administrator must also be notified in the event


of non-administrative discrepancies that affect the typing results and/or
conclusions.
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10. For Toxicology proficiency tests:

a. All samples must undergo full volatile and/or drug analysis as warranted by
sample type/request of the proficiency test vendor, and no analysis will be
deferred. For example, a urine drug proficiency test would require EMIT and
confirmatory testing for all positives, and a general drug screen. Analysts will
only be responsible for drugs listed in the toxicology drug panel (See Toxicology
PM).

C. Evaluating the results

1. Upon receipt of the results from the test provider, the QRC will review the test using
the Proficiency Test Checklist in LIMS. Once complete, the analyst, laboratory
quality manager, DNA technical leader (for DNA and Indexing proficiency tests)
and Director of quality assurance will be notified in LIMS of the results. If the
answer is concordant with the proficiency test provider’s results and follow ISP
procedures, the test will be considered satisfactory.

2. Non-Concordant Results
a. Administrative Issues
i. If the QRC can determine that the non-concordant answer is due to
an administrative (typographical) error, the laboratory will
document this issue using a quality flag (QM-17). It must be clear
from the supporting data that the analyst would have arrived at the
correct response but filled out the answer sheet incorrectly.
b. Reporting Limitations
i. A non-concordance can arise when a section’s policies and
procedures preclude the analyst from submitting a concordant
answer. In this case, when reviewing the test, the QRC will
determine if the conclusions submitted to the proficiency test
provider adhered to Illinois State procedures. If true, the laboratory
will document this issue using a quality flag (QM-17). If this is not
the case, proceed to (c).
c. Technical Issue
i. Issues that arise that are technical in nature will be documented
using the Quality Issue Report (QM-8) and root cause analysis will
be performed. The QRC must notify the Laboratory Quality
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Manager, Director of Quality Assurance, and appropriate discipline


technical leader upon this determination. The course of action and
all corrective actions will be approved by the discipline technical
leader.
ii. In addition to any other corrective actions that result, the analyst
will be required to pass a second test for the same testing activity.
An additional external proficiency test may be procured, or the
QRC will prepare an internal test for the analyst, in consultation
with the DQA and subject to section III of this policy.
iii. Should the results of the second test be non-concordant, the analyst
will be suspended from casework until competency in the testing
activity can be re-established.

3. For quantitative toxicology samples:

i. A result will be deemed concordant if the value reported is less than


or equal to 2 Standard Deviations (SD) of the reported Grand Mean
(GM).
ii. If the value reported is greater than 2 and less than 3 SD of the GM,
then the Toxicology technical leader must review the test. If the
results are acceptable, this review will be documented in a quality
flag. If the result is due to a technical issue, follow II C.2.c. above.
Should the value be greater than 3 SD of the GM, the test will be
treated as a non-concordant answer, and follow II.C.2.c above.

4. If the Director of Quality Assurance or the Laboratory Quality Manager becomes


aware of any discrepancies or inappropriate results, he/she will immediately brief
the appropriate Laboratory Director, Bureau Chief and Commander. If necessary,
corrective action will be initiated and documented per QM-8.

5. If an error appears to be systemic, the Director of Quality Assurance will notify the
Commander and take any additional necessary actions, which may include
recommending the appropriate Program Manager or Bureau Chief to determine the
appropriate course of action which may include remedial training and/or method
modification.

6. If a major error is identified, the Commander or DNA technical leader as


appropriate may require that casework in a particular area be suspended in a
laboratory or the Command until appropriate remedial actions are taken.
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ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

D. Maintaining Record and Samples

1. All proficiency tests will be given a DFS case number and all data, notes and
reports will be maintained in LIMS. All samples may be discarded once the
analyst has successfully completed the proficiency test as indicated by the test
provider, or through the quality assurance mechanisms listed in II C. above.
Whenever possible, the Laboratory Quality Manager will contact the Director of
Training prior to disposal of the tests to determine if there is a training need for
the samples, and forward tests as appropriate.
2. The DNA database laboratory does not utilize LIMS to perform casework at this
time, therefore these tests will will not be assigned a LIMS case number, nor
stored in LIMS. The tests will be stored in a secure, limited access location on the
network

III. INTERNAL PROFICIENCY TESTS (IPT)

A. Internal proficiency tests will be prepared by the Quality Review Coordinator as needed in
consultation with the DQA. Internal test will be used only as a supplement to external
testing, or for testing activities that do not have a suitable external test. All applicable
requirements listed in section II for external tests will apply for internal tests.

1. Additional requirements of internal proficiency tests

a. Tests prepared by the Quality Review Coordinator will be analyzed by the


Training Coordinator or a past Quality Review Coordinator prior to
distribution to verify the sample. If there is no Training Coordinator or past
Quality Review Coordinator available, a designee will be assigned by the
Director of Quality Assurance to perform this duty. Any exceptions to
verifying the test will be approved by the Director of Quality Assurance.
b. Samples will be marked appropriately to allow identification and are to be
varied, where practical, to ensure that all analysts at the same laboratory do
not receive the same samples.
c. Exceptions to this might include samples which are for quantitation, for
evaluation of techniques, or as indicated in the section’s quality assurance
protocol.
d. An answer key for samples will be sent to the Director of Quality Assurance
prior to issuing the test to the analyst.

2. Test Preparation
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-6 Competency and Proficiency


Tests
Page 10 of 11
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

a. If the test is prepared for use as a second test as indicated in section II.C.1.c
above, the QRC will prepare samples to assess the same testing activity.
b. If the test is prepared for a testing activity where no suitable external test
exists, the test should mimic casework samples as closely as possible.
c. If the internal test is to be taken after a non-concordant test as indicated in
II.C.1.c above, the analyst will have two (2) weeks to complete the analysis.
Any extension must be submitted through chain and be approved by the
DQA. Extension requests must be made no later than three (3) working
days before the due date.

3. Testing activities that require an internal test:

a. Firearms and Toolmarks


i. Make/Model Determination, Determination of Functionality, and
Barrel Length Measurement – Internal Proficiency Test
ii. Individual Characteristic Database – Case Review
b. Latent Prints (Friction Ridge)
i. Enhancement – Case Review
ii. Individual Characteristic Database – Case Review
c. Footwear
i. Enhancement – Case Review

IV. BLIND PROFICIENCY TESTS

A. Frequency and Purpose

The Command may periodically submit blind proficiency testing samples to its employees.
This serves as an assessment of the analyst’s ability to obtain accurate results.

B. Administering the Test

1. Command administration and the Director of Quality Assurance, sometimes


utilizing other units within the command, will prepare samples for distribution.

2. The samples will be prepared in duplicate and will resemble actual case material.
One set of samples will be maintained by the Director of Quality Assurance for
comparison purposes. Careful notes will be taken as the tests are prepared.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-6 Competency and Proficiency


Tests
Page 11 of 11
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

3. Blind proficiency testing will require the cooperation of user agencies. The
user agency will submit the test, which shall be carefully disguised as an actual case
submitted by that agency. Officers will be aware that the purpose of the test is to
ensure that quality laboratory service is being rendered to their agency. The LD
will be the designated contact for the involved agency. The agency will be
instructed to return test materials to the DQA after analysis by the laboratory.

C. Evaluating the Results

1. Upon satisfactory completion, the Laboratory Quality Manager will send a


memorandum of successful completion to the Director of Quality Assurance. The
memorandum will be maintained by the Director of Quality Assurance as
documentation of the blind proficiency testing.

2. If there is an error in the results, a Quality Issue Report will be issued. It will be the
responsibility of the appropriate Bureau Chief to notify the Laboratory Director and
analyst.

a. The submitting agency will not be advised of any errors.

b. A thorough review of the “case” with the analyst and Laboratory Quality
Manager will be conducted so that all the notes can be reviewed for possible
sources of error.

i. If the integrity of the sample tested is in question, the reference


sample will be examined by the preparer in the presence of the
examiner to determine if the original sample is valid.
ii. If valid, every effort will be made to determine the source of the
analyst’s error.

D. Maintaining Test Records

All test materials (photos, notes, spectra, etc.) will be retained as quality records per the
Command Directives.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 1 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

I. MEASURING SERVICE TO ASSURE QUALITY

A. Quality Service

The Forensic Sciences Command is committed to providing high quality services to the
law enforcement community. These directives outline the necessary actions to ensure that
quality services are provided.

B. Monitoring Our Service

The Command will initiate various checks to monitor the quality of services.

1 Input from agencies and other sources will be solicited to improve the
quality of service.

2. Forensic Scientists are encouraged to share their experiences, both positive


and negative, with the Director of Quality Assurance to assist in improving quality.

3. The quality of casework is directly related to the care taken in both choosing an
appropriate analytical scheme and in performing the analysis. This will involve:

a. Following the established standards and controls

b. Incorporating good scientific practices

4. While a self-checking process is a fundamental aspect of quality assurance,


external checks and reviews are necessary to monitor the overall quality of work
performed.

a. These checks and reviews involve at least yearly audits of laboratories by


audit teams authorized by Command administration.

b. Periodic reevaluation of the Command’s standards and controls in light of


advances in technology, results of proficiency testing and review of a
representative sampling of casework is also mandated.

5. An ongoing review of the Quality Assurance Program will be conducted by the


Director of Quality Assurance.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 2 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

II. QUALITY MEASURES

A. The Laboratory will monitor the validity of testing using quality control procedures.
Each discipline’s procedure manual will outline the quality control procedures for
that specific discipline. The following are examples of quality control procedures:

• Use of reference collections;


• Use of certified reference materials;
• Use of positive and negative controls;
• Participation in proficiency testing programs;
• Performance Checks on instruments and equipment;
• Review of reported results and verifications.

Each discipline’s procedure manuals will specify the controls and standards utilized in
each method or procedure. All controls and standards utilized in casework will be
documented in the examination documentation. The laboratory will perform technical
review on 100% of scientific examination documentation and test reports prior to
release. Verifications are performed as specified in each discipline’s Procedure
Manuals. The technical review process ensures the conclusions are reasonable within
the constraints of the validated technical knowledge and supported by the examination
documentation. Technical reviews are documented in LIMS.

B. Quality Assurance Reviews

The quality service of both the laboratory as a whole and the individual analysts will be
monitored continually through administrative reviews. Various checks will be conducted
at both the laboratory and Command level. Minimum requirements for this review will be
utilization of court cards, file and testimony reviews, the use of agency questionnaires,
reanalysis of selected cases as appropriate, and other reviews as described in the Command
Directives. The adherence to quality assurance measures will be noted in an analyst’s
annual performance evaluation.

C. Case Reanalysis

1. Frequency and Purpose

a. The Commander, Bureau Chiefs, the Director of Quality Assurance,


Laboratory Directors or their designees may select a case for re-
examination.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 3 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

b. In each discipline, a minimum of two cases per analyst per calendar year
will be reanalyzed, except for drug chemistry, which will have three cases
reanalyzed, and Indexing, where hit verifications will serve as reanalysis
in place of having samples reanalyzed.

c. Casework DNA will not routinely use reanalysis as a quality control


measure due to the nature of the samples and the potential for
consumption.

d. In some instances, the number of cases worked by a given analyst does not
warrant or permit this amount of reanalysis. The Director of Quality
Assurance will determine the appropriate number of cases to be reanalyzed
in those situations.

2. Coordinating the Analysis

a. The case will be re-examined by the Quality Review Coordinator, however


there may be certain situations where a Training Coordinator, DNA or
Toxicology Technical Leader or a Forensic Scientist III may also perform
this analysis.

b For Indexing, hit verifications will serve as reanalysis in place of having


samples reanalyzed. The procedures for hit verifications are in the
Indexing Procedures Manual, and those procedures will be followed.

3. Evaluating the Results

a. If there is no disagreement with the results of the original analysis, a


reanalysis report will be issued to the submitting agency.

b. If non-conforming work is identified, the Director of Quality Assurance


will be immediately notified. The course of action to be followed will be
determined in conjunction with the appropriate Bureau Chief and
Commander (See QM-8 and QM-17). However, a course of action
involving a technical DNA issue will be followed upon the approval of the
DNA technical leader. All issues will remain confidential. A reanalysis
report will be issued to the submitting agency upon resolution of the
discrepancy.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 4 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

4. Maintenance of Reanalysis Records

a. All documentation from the reanalysis will be maintained in LIMS.

D. Case File Reviews

1. Author Review

Prior to the administrative and technical review, the author of the report is
responsible for reviewing the case file and accompanying report for editorial
correctness, technical accuracy, and completeness. At the completion of the
Author review, the analyst will submit the case for technical review, which will
apply the analyst’s signature to the report. This signature serves as authorization
of the results.

2. Technical and Administrative Review

a. Prior to releasing the laboratory report, LIMS requires that technical and
administrative reviews of case files and their accompanying laboratory
reports are completed by an individual who did not conduct the laboratory
activity. The reviewer is usually a currently qualified analyst in the
discipline of testing but may be any individual previously qualified in the
area the reviews are encompassing. The reviewer is responsible for
confirming technical accuracy of the conclusions from supporting data
within the case notes, that appropriate policies and scientific procedures
are followed and for editorial correctness.
b. The reviewer will utilize the technical review checklist in LIMS to
document the review. If calculations are made that are subject to human
error, this task will be added to the technical review checklist, and the
calculations will be reviewed. Upon successful completion, the reviewer
will mark the case as “REVIEW COMPLETE” in LIMS. If corrections
are needed, the case will be sent back to the analyst, and the reasons
documented in the comments section. The analyst will make any
necessary corrections and re-submit the case for technical review.

c. For non-routine or novel procedures, the reviewer will make every effort
to verify the original work of an analyst. This will include checking
sources of information i.e., literature references and analytical accuracy.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 5 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

d. Technical/Administrative reviews and verifications of identifications will


not be performed by individuals who have a real or apparent conflict of
interest due to a known relationship (including but not limited to
household, family, or financial) with the forensic scientist who performed
the analysis.

e. Should there be a disagreement with the verification of an identification


or the technical/administrative review of a report, information will be
presented to Laboratory management who will then take appropriate
action by contacting the Director of Quality Assurance for input in
resolving the disagreement. The appropriate DNA Technical Leader will
be contacted for all DNA issues in dispute.

f. Any forensic scientist who observes quality concerns with the work of
another laboratory employee has the ethical obligation to inform the
Laboratory Director through the appropriate chain of command. It is the
Laboratory Director’s responsibility to investigate and document the
situation.

g. The minimum number of reports that requires administrative/technical


review is as follows:
1) Personnel in training regardless of position titles - 100%
2) Forensic Scientists, regardless of position titles - 100%

3. Supervisory Review (Management Review)

a. Each Laboratory Director will ensure that laboratory management reviews


three cases per month for each case working analyst in all sections. If a
case working analyst did not complete three cases during the month, then
laboratory management will review all the cases that are available (e.g.
The laboratory manager reviews the single case that is completed in April
and then reviews three of the five cases completed in May).

b. The cases reviewed will be documented using the management review


checklist in LIMS. Any discrepancies will be addressed through the
appropriate process and documented.

4. Quality Review Coordinator Case File Reviews


Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 6 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

a. The Quality Review Coordinator will review a portion of the case files
generated by each analyst for completeness and accuracy. Efforts will be
made to ensure a representative sample of the analyst’s work is selected
for review in each calendar year that the analyst worked. If the coordinator
or management feels that further review is needed based on laboratory
circumstances, additional case files may be reviewed. The review will be
documented in the same fashion as technical review indicated above,
except for Indexing, which will utilize Appendix 7.1.

b. The type and amount of DNA cases selected for annual review will be
determined by the DNA technical leader.

c. The number of cases selected for QRC technical review varies per
discipline, and is as follows:

Discipline Amount/Analyst
Biology 5
DNA: autosomal 5
DNA: Y-STR 3
Drug Chemistry 7
Firearms/Toolmarks 5
Latent Prints 5
Toxicology 5
Footwear/Tiretracks 2
Micro/Trace 5
Indexing 5

i. If a particular analyst did not work a sufficient number of cases


in a given year (i.e. extended leave, change in assignment) these numbers
can be modified with the approval of the DQA.
ii. If an analyst works within multiple disciplines (for instance
trace, physical match, and firearms), a total of 5 cases per analyst only
need be reviewed incorporating an appropriate sampling of cases from
each discipline.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 7 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

d. The types of cases selected for QRC technical review varies per discipline,
and is as follows:

Discipline Case Types to be Reviewed


Biology Any
DNA Autosomal STR cases selected will have unknown evidentiary sample(s)
which have been profiled. Cases in which there are only sample(s) that have
been stopped at quantification or cases that only have reference standards
profiled shall not be reviewed. At least three of the cases shall have sample(s)
in which a mixture was differentiated.

Y-STR cases selected will have at least one unknown evidentiary sample
which has been profiled along with a reference standard for comparison.
Drug Chemistry Any
Firearms/Toolmarks Bullet/Cartridge case comparisons, Distance Determination, Toolmarks
Latent Prints Mix of lifts, porous, and non-porous, 2 cases should have prints that have been
compared but not identified (exclusions and/or inconclusives), and two cases
should have ABIS/NGI searches that did not result in hits
Toxicology At least one quantitative result, one blood alcohol, one drug analysis, and one
Criminal Sexual Assault Analysis, if possible.
Footwear/Tiretracks May supplant file reviews in Latent Prints and/or Firearms.
Micro/Trace GSR, Fiber, Paint, Materials, Arson
Indexing Indexing Analytical files

E. Laboratory Visits

1. Frequency and Purpose

The purpose of the visit is to give the Quality Review Coordinator the opportunity
to observe the analyst at work in his/her home laboratory and to discuss various
aspects of casework. The visits will be at the direction of the Director of Quality
Assurance and when the need arises as demonstrated by issues with case
reanalysis, proficiency tests, file reviews or from findings made during internal or
external audits.

2. Conducting the Visit

a. The Quality Review Coordinator will:


Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 8 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

1) Meet with the Laboratory Director or designee initially to


discuss the visit;
2) Meet with each analyst, if possible;
3) Review and summarize the visit with the Laboratory Director
and the analysts in a close-out session to discuss strong points
and concerns and make recommendations;
4) Provide a document (memo or form) after the close-out session
summarizing the results of the visit.

b. Extent of the Visit

As time and circumstances permit each Quality Review Coordinator will


observe the following areas, along with items described in each section’s
quality assurance protocol:

1) Safety procedures
2) Evidence receiving, handling, and storage procedures
3) casework, including the case approach followed and procedures
used
4) Supplemental activities, such as preventive maintenance, reagent
preparation, etc.
5) Interaction of the section with laboratory management and other
sections
6) Court testimony observations, if possible
7) Standard reference files, if applicable
8) Instrument maintenance and calibration records

c. Close-Out Session
During the close-out session, an attempt will be made to resolve any
questions that may have arisen during the visit, defining which items are
concerns for correction and which are suggestions. Recommendations for
corrective action will be presented for any deficiencies.

d. Report of Laboratory Visit


The results of the laboratory visit, including the close-out session, will be
summarized in either a memorandum or on the Report of On-Site Visit
form (Appendix 7.2). The original report will be sent to the Director of
Quality Assurance; copies will be sent to the analysts, Laboratory
Director, and Laboratory Quality Manager. This will include the
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 9 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

recommended follow-up action plan to ensure that any deficiencies are


corrected.

e. Analyst Response
Each analyst must complete the Analyst’s Response Form (Appendix 7.4)
and return it to the Quality Review Coordinator within one (1) week after
receiving the Quality Review Coordinator’s report; copies will also be sent
to their Laboratory Quality Manager, Laboratory Director, and the
Director of Quality Assurance. If the analyst agrees with the
recommendations, this will be so indicated. If the analyst disagrees with
the Quality Review Coordinator’s recommendations, a request for a peer
review may be made. Specific areas of contention will be included with
the request.

f. Quality Assurance Response


After the Quality Review Coordinator completes the exit interview with
the Laboratory Director and the analysts, the coordinator will complete the
Quality Review Coordinator Response Form (Appendix 7.4) and forward
it to the Director of Quality Assurance. The Director of Quality Assurance
will evaluate the comments and advise Command administration when
appropriate.

III. PREVENTIVE ACTION

A. Preventive action is a proactive process to identify opportunities for needed improvements


and potential sources of nonconformities, either technical or concerning the quality system.
If, during casework analysis or the performance of any quality assurance measure, a
Forensic Sciences Command employee identifies a need for improvement in procedures or
a potential source of non-compliance, the individual will inform the immediate supervisor,
the Command Advisory Board Chairperson, or the Director of Quality Assurance.

B. Preventive Action Processes

When preventive action is required, the Forensic Sciences Command will utilize various
methods for developing and implementing action plans to take advantage of the
opportunity for improvement. These methods include, but are not limited to, the following:

1. Recommendations from the Command Advisory Boards are reviewed and


approved per policies documented in Command Directives ADM 11.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 10 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

2. Research projects are coordinated by the Research and Development Laboratory


per policies documented in Command Directives ORG 4

3. Preventive Action Tracking (PAT)


a. The Preventive Action Tracking (PAT) form (Appendix 7.5) may be
utilized to document and follow the progress of an action plan.

b. Once a need for improvement in procedures or a potential source of non-


compliance is confirmed, an action plan will be created and implemented
to remedy the situation.

c. After implementation of the action plan, the results of the action plan will
be reviewed for effectiveness, and may be repeated as necessary.

d. Upon receiving the final information regarding completed actions, the


Director of Quality Assurance or designee will note the date received. The
appropriate DNA Technical Leader will approve the completed actions for
DNA-related issues. The Director of Quality Assurance will approve the
action plan is complete and appropriate. The PAT will then be forwarded
to the appropriate Bureau Chief and the Commander for review and
signature.

C. Monitoring Results of Preventive Action

1. Command Advisory Board


The Command Advisory Board is responsible for reviewing and
communicating issues of section concern to Command Administration. This
includes reviewing any revisions to procedures resulting from preventive actions.
Command Advisory Board discussions occur at least once a year.

2. Quality Assurance Measures


For preventive actions affecting case analysis, quality assurance measures
(e.g. administrative/technical reviews, cases reanalysis, proficiency tests, etc.)
ensure the procedures implemented for preventative actions are effective.

3. Laboratory management
As applicable, laboratory management will review and document the
effectiveness of any preventive action when conducting the laboratory’s annual
management review.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-7 Quality Assurance Measures

Page 11 of 11
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA20-02

V. ANNUAL PERFORMANCE EVALUATION

Laboratory management will comment on the employee’s adherence and performance in regard to
quality assurance guidelines, tests, and standards and controls during the reporting period. This is
to be done in the narrative portion of the employee performance evaluation.
DNA INDEXING ANALYTICAL FILE REVIEW CHECKLIST

Analyst Extraction Plate Name:


1°/2° Reviewer Amplification Plate Name:
Evaluator Date
Type of Analysis Type of Review
Correct Software/Analysis Parameters/Panels

Controls Result

Negative Control - Primer Peaks Present/Documented


Positive amplification control passes interpretation guidelines and documented
Orientation Control - Correct position, Min 6 loci verified and indicated in project
Ladders verified and documented in project

Comments

Samples: Result

Review of Samples indicated in project


Interpretation thresholds followed
Correct Sample Calls
Tri-alleles and previously unseen variants verified before upload to CODIS
Exceptions approved by Technical Leader
Project saved to designated location
Utility tables saved to designated location
Yield Gel Worksheet for manual extractions in folder
Total number of pages for maual review on first page of review table
Pages numbered correctly

Comments

Add Page Remove Page

Appendix 7.1 - Page 1 of 1


Revised Date: December 9, 2020
REPORT OF ON-SITE VISIT

SECTION: ____________________________ PURPOSE OF VISIT: ______________________________

LABORATORY: _______________________ DATES OF VISIT: ________________________________

ANALYST: ___________________________ DATE OF REPORT: _______________________________

___________________________________________________________________________________________

SUMMARY OF GENERAL REVIEW (Include both strong & weak points.):

___________________________________________________________________________________________

SUMMARY OF _______FILES REVIEWED: ________(Include both strong & weak points.):

___________________________________________________________________________________________

SUGGESTED ACTION(S) TO BE TAKEN:


CORRECTIVE:

FOLLOW-UP:

___________________________________________________________________________________________

Evaluator _____________________________________________ Date________________________________

Appendix 7.2 - Page 1 of 1


Last Revised: December 9, 2020
ANALYST’S RESPONSE

DO YOU WISH THIS REPORT REVIEWED BY A QUALITY ASSURANCE REVIEW BOARD? Y N

IF YES, WHICH RECOMMENDATIONS DO YOU WISH REVIEWED?

OTHER COMMENTS:

Analyst’s Signature:______________________________________________Date:________________________

Appendix 7.3 - Page 1 of 1


Last Revised: December 9, 2020
ILLINOIS STATE POLICE
DIVISION OF FORENSIC SERVICES
FORENSIC SCIENCES COMMAND

Quality Review Coordinator Response Form

1. Was the laboratory director courteous and patient?

2. Did the laboratory director allow enough time for the exit interview (cancel interruptions; i.e., phone
calls, other business)?

3. Did the laboratory director properly address recommendations and issues concerning the Quality
Assurance visit?

4. Did the laboratory director utilize the Quality Assurance review as a management tool?

5. Was the assistant laboratory director in attendance?

6. Other comments?

Quality Review Coordinator signature____________________________ Date___________________

Appendix 7.4 - Page 1 of 1


Last Revised: December 9, 2020
ILLINOIS STATE POLICE
DIVISION OF FORENSIC SERVICES
FORENSIC SCIENCES COMMAND

PREVENTIVE ACTION TRACKING

PAT

Part I: Issue Statement


Reported By: Date:
Laboratory/Program:

Description of Issue: ___________________________________________________________________


____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________

Part II: Action Plan Assignment/Development

Preventive Action Plan to be developed by __________________________________________________


(Attach completed plan)

Targeted completion date of action plan ____________________________________________________

Reviewed by ________________________________________________ ______________________


Signature Date

Appendix 7.5 - Page 1 of 2


Last Revised: December 9, 2020
Part III: Results of Action Plan

Brief description of what occurred as a result of implementation of the action plan:


____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________

Part IV: Review

Results Received: Date: ______________________


QA Review: Signature___________________________________ Date:___________________
Bureau Chief: Signature___________________________________ Date:___________________
Commander: Signature___________________________________ Date:___________________

Comments:___________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________

Appendix 7.5 - Page 2 of 2


Last Revised: December 9, 2020
Illinois State Police
Division of Forensic Services
Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-8 Corrective Action for Quality
Concerns - Quality Issue Report (QIR)
Page 1 of 2
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

I. POLICY

To monitor potential and/or confirmed quality issues requiring corrective action, the Quality Issue
Report Form (Appendix 8.1) is used. The Effectiveness of Corrective Actions and Management
System Review form (Appendix 8.4) is used to evaluate the effectiveness of any actions taken. The
Quality Issue Report (QIR) Form is utilized to follow the progress of corrective action taken to
resolve a quality issue and serves as a record of the actions taken. Quality issues or situations
requiring corrective action include, but are not limited to, the list in Appendix 8.3. As necessary,
the Bureau Chief (BC), Command Quality Assurance (Director of Quality Assurance and/or
designee), or Commander may direct the laboratory manager to initiate corrective action for any
quality issue.

II. PROCEDURE

A. |Within two working days after discovery by laboratory management, the Laboratory
Quality Manager (LQM) will notify the BC, DQA and their Laboratory Director of a
potential quality issue. In addition, the DNA and Toxicology technical leaders must be
included in the notification regarding a technical quality issues within those respective
sections. If the DNA quality issue affects the DNA records entered into CODIS, the State
CODIS administrator will be notified. Command Quality Assurance (QA) will assign a
QIR number and indicate that the case(s) is involved with a QIR in LIMS. QA maintains a
log of all QIRs assigned and tracks their progress accordingly.

B. Within 10 working days of being notified of the issue, the LQM or designee will complete
Part I of Appendix 8.1 and forward it to QA. The details of the issue and all corrections
taken shall be reviewed for accuracy with the staff that is involved in the issue prior to
submission.

C. |Within 7 working days of receipt, QA will review Appendix 8.1 and contact the LQM to
assist in completing Part II of the form. The LQM and QA will meet with relevant
personnel, technical leader(s) and/or laboratory management to perform cause analysis and
determine appropriate corrective actions. If the quality issue in DNA or Toxicology is
technical, the appropriate technical leader must approve all corrective actions prior to
implementation. The notification will be documented on Appendix 8.1.

D. The individual(s) assigned to oversee the containment/corrective actions will have no longer
than 60 days to complete the action and report the results to the LQM and QA, unless
authorized by the DQA. Any impediments to completing actions within this time frame, as
well as the steps taken to mitigate the impediments must be documented by the assigned
individual in Part II of the form.
Illinois State Police
Division of Forensic Services
Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-8 Corrective Action for Quality
Concerns - Quality Issue Report (QIR)
Page 2 of 2
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

E. If additional issues/concerns arise while executing corrective actions in step C, it may be


necessary to perform additional cause analysis and develop additional corrective actions as
outlined in step C. Any additional corrective actions will be added to Appendix 8.1 and be
approved by the Technical Leader, as appropriate.

F. Upon completion of all corrective actions in Part II (or earlier, if applicable), the LQM and
QA will meet to discuss Part III to evaluate any additional risks/opportunities identified
during the issue and any actions taken based upon these factors.

G. Once all parts of Appendix 8.1 are completed, it will be routed to applicable management
as listed on the form for review and approval. Once all required approvals are obtained, QA
will then store the form and related attachments in a secure server location.

H. Using Appendix 8.4, the LQM and QA must also determine the plan for reviewing the
effectiveness of corrective actions listed in Appendix 8.1 and any management system
changes that are necessary in order to establish the time frame for follow up and to determine
if the actions were effective. The Bureau Chief and appropriate Technical Leader will be
notified if the review indicates that the actions were not effective. Additional
containment/corrective action steps may be implemented as necessary and documented via
a QIR.
a. |Once all reviews are completed, Appendix 8.4 will be attached to the QIR.
b. |A summary of all Appendix 8.4 reviews will be provided to top management via the
annual management review.

III. Notifications and Review of Documentation

A. |The BC and QA must evaluate the initial notification from the laboratory to triage the
severity of the issue. If the issue represents a potential significant risk to the laboratory, the
Commander, and DNA Technical Leader and CODIS Administrator, as appropriate, must
be immediately notified to determine whether work must be suspended promptly until the
emergent issue can be resolved.

B. The DQA will provide status updates and gather feedback at regularly scheduled meetings
with top Command management.

C. |The following personnel will be notified of the completed document and provided access
to the final version.
a. Personnel involved in the quality issue
b. Laboratory Director and Quality Manager
c. Program Manager and/or Command Coordinator
d. Technical Leaders
Illinois State Police QIR #
Division of Forensic Services
Appendix 8.1 – Quality Issue Report and Corrective Action Plan

Part I:

Issue Information

Type: Type of Issue Date Discovered: Date

Location: Laboratory Date Command Notified: Date

Section: Section Date of Issue: Date

Discovered By: Date of Amended Report: Date

Part I Completed By: Date Part I Rec’d by QA: Date

Personnel Involved: Date Personnel Notified: Date

Tech Reviewer (TR): Date TR Notified: Date

Agency: Date Agency Notified: Date

Case(s)/Items(s):

Offense:

Describe the Quality Issue


What is the issue:

How the issue was discovered:

Why it is an issue:

What data was used to deem the situation an issue:

Immediate Corrections Taken


Action Date Completed
Date

Case Review/Reanalysis

Page 1
Revised 10/31/2022
Quality Issue Report

Are Reviews Warranted/Possible?

Type of Review:

Date Sent for Review:

Part II:

Case Review/Reanalysis Results


Date Completed:
Case Number Date Original Analysis Results of Review
Completed
Date

Consequences/Effect of the Discrepancy


Impact to the case(s):

Impact to other cases in the laboratory:

Impact to the customer:

Cause Analysis (Staff Interviews, 5 Whys analysis, Failure Modes Effects Analysis, fishbone
diagrams, as appropriate)

Containment/Corrective Action Plan:

Action 1

Page 2
Revised 10/31/2022
Quality Issue Report

Individual overseeing action:


Technical Leader Approval (if required):
Date Corrective Actions Due:
Date Completed:
Results:

Timeframe
Estimated Completion Date of Corrective Action Plan:

Identify any impediments to completion in this time frame:

Plan to mitigate impediments:

Part III:

Additional Risks and Opportunities Analysis


Additional risks identified/actions taken:

Opportunities identified/actions taken:

Final Review
Title Signature Date
Director of Quality Assurance: Date

Bureau Chief: Date

Commander: Date

Page 3
Revised 10/31/2022
[This form will be printed on colored paper so it can be differentiated
from the other administrative documents]

Quality Issue Report / Laboratory


Quality Flag Notification

A Quality Issue Report Laboratory Quality Flag


is associated with this case:

See QIR or
Flag number

Appendix 8.2
January 30, 2015
APPENDIX 8.3

Quality Issues or Situations that Require a QIR

1. If analysis requested of the laboratory can no longer be performed or results cannot be reported
due to quality issue (e.g. no latent prints analysis possible because glass item has shattered or
DNA contamination prohibits reporting the results)

2. External and internal audit non-conformities

3. Concerning technical competence (e.g. DNA mixture interpretation, suitability of latent


impression, AFIS tracing)

4. ▌Proficiency test results are different from expected answer (including “inconclusive” results or
administrative errors, except as provided for in QM-17, Appendix 17.2)

5. Requiring QRC reanalysis or additional cases need to be reanalyzed

6. Involving or affecting entire section, laboratory, or statewide operations

7. Defense expert report conflicts with laboratory report

8. Upon individual’s third, similar quality issue (unless otherwise directed by a Bureau Chief)

9. If situation or quality issue results in a known, significant impact to the case (e.g. the SAO
communicated that the case was dropped because of the quality issue)

10. If a new or revised Command policy/procedure must be developed to address the quality issue

11. Missing evidence

12. Missing case file that was needed for court, supplemental case analysis, CODIS, etc.

13. DNA contamination and the following criteria are met:

a. The blank is consumed, the sample is consumed, or it is not possible to re-swab parent
exhibit (essentially exhibit is rendered unusable and another parent exhibit will need to be
analyzed for results)

b. DNA for the exhibit is unsuitable, the result is Inconclusive/cannot be reported because
the contamination affects the interpretation, or the interpretable profile is not eligible for
NDIS entry due to contamination associated to the exhibit

c. Upon multiple documented incidents (Incident Reports) of contaminations for an


individual

Appendix 8.3
November 16, 2015
Illinois State Police QIR #
Division of Forensic Services
Appendix 8.4 – Effectiveness of Corrective Actions and
Management System Review

Plan
Action(s) to be taken to review the effectiveness of the corrective action plan:

Frequency of the review:


Duration of the review:

Results
Has the issue re-occurred(Y/N)?
Date of Reviews and Results

Were the corrective actions effective (explain if necessary)?

Management System Review

Actions taken to improve management system, if necessary:

Action Date Completed

Page 1 of 1
Revised 10/31/2022
Illinois State Police
Division of Forensic Services
Forensic Sciences Command

Policy: QM-9 Internal Audits and External


Assessments

Date of Original Issue: 03/01/97 Page 1 of 6


Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 20-02

1. Purpose

a. The Forensic Sciences Command conducts internal audits and participates in external
assessments to ensure the laboratory system is executing operations in accordance with the
stated goals and objectives outlined in QM-1.

2. Internal Audits

a. The Forensic Sciences Command is responsible for conducting at least one internal
management system and operational audit per year at each laboratory. A successful internal
audit involves a critical evaluation of each of the standards by knowledgeable personnel to
ensure conformance to each relevant standard.

b. The Internal Audit will ensure compliance with the following standards, as applicable:

i. Forensic Science Command Audit Checklist (Appendix 9.1)


ii. FBI DNA QAS Guidelines
1. Casework
a. https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=15744
2. Indexing
a. https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=15741
iii. ISO/IEC 17025:2017 - General requirements for the competence of testing and
calibration laboratories
1. Official Copy maintained by DQA, Audit Spreadsheet available on ISP
Portal
iv. ANAB - AR 3125, ISO/IEC 17025:2017 Forensic Testing and Calibration
Laboratories Accreditation Requirements
1. https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=12371

v. A report with the findings of the internal (in-house) audit is then sent to the
appropriate Bureau Chief and the Director of Quality Assurance within 60 days
from the beginning of the audit unless an extension is granted by the Director of
Quality Assurance. The Director of Quality Assurance will retain records of each
laboratory’s audit report.
vi. The laboratory will document the direct observation of any new procedures
Illinois State Police
Division of Forensic Services
Forensic Sciences Command

Policy: QM-9 Internal Audits and External


Assessments

Date of Original Issue: 03/01/97 Page 2 of 6


Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 20-02

implemented since the date of the last internal audit and include this information
with the internal audit report. In addition, the laboratory management will observe
a sampling of the accredited services from each discipline in the laboratory.
vii. Corrective actions for the internal (in-house) audit will be documented using the
Quality Issue Report (QIR) form. Command Administration and the appropriate
DNA Technical Leader will review the audit documents and, wherever applicable,
approve the corrective action(s).

3. Command Audit

a. The Director of Quality Assurance is responsible for conducting an annual Command Audit
of each laboratory, using trained auditors where practical. This annual audit may be
superseded byan external audit of the Command laboratories.

b. The Command Audit is conducted using the guidelines in 2.b. above (as applicable).
Whenever necessary (e.g. travel restrictions, operational needs, etc.), the Director of
Quality Assurance is responsible for appropriately modifying the scope of the Command
Audits. Any modifications will be discussed with the laboratory’s chain of command and
documented in the Command Audit Nonconformity Summary form (Appendix 9.2).

c. Findings from the Command Audit will be documented using the Command Audit
Nonconformity Summary form (Appendix 9.2). The Director of Quality Assurance or
designee (lead assessor) will provide this document to laboratory management and
appropriate personnel in Command Administration.

d. Laboratories may appeal the nonconformities observed in the Command Audit.

e. To begin the appeal process, the laboratory must complete the Command Audit Appeal
Form (Appendix 9.3) and send it to the Director of Quality Assurance within 10 business
days after receiving the laboratory’s Command Audit Nonconformity Summary document.

f. The Commander and an independent committee composed of scientific management


personnel from Command Administration will then evaluate the laboratory’s Command
Audit Nonconformity Summary document and appeal. The committee’s decision will be
documented on the Command Audit Appeal Form. The Commander will determine which
Command Administration personnel is appointed to the committee.

g. The Command Audit Nonconformity Summary document will be appropriately updated,


Illinois State Police
Division of Forensic Services
Forensic Sciences Command

Policy: QM-9 Internal Audits and External


Assessments

Date of Original Issue: 03/01/97 Page 3 of 6


Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 20-02

if necessary, after the committee’s decision. The Director of Quality Assurance or designee
(lead assessor) will provide laboratory management with the completed Command Audit
Appeal Form and updated Command Audit Nonconformity Summary document (if
applicable).

h. Corrective actions for the Command Audits will be documented using the Quality Issue
Report (QIR) form.

4. External Audit

a. The Director of Quality Assurance is responsible for coordinating external audits with
independent, third-party assessors.

b. The third-party assessor will document findings from an external audit in a report.

c. The third-party assessor will prescribe the format for documenting the laboratories’
responses to the findings; however, corrective actions for an external audit will also be
documented using the Quality Issue Report (QIR) form. Appropriate Command
Administration will review the audit documents and related QIRs.

5. Annual Reviews

a. The Director of Quality Assurance is responsible for completing an annual quality


assurance report for the Command. This annual report will describe all quality assurance
activities and issues during the previous year and include a summary of laboratory activities
based on the annual laboratory management reviews.

i. Each Quality Manager is responsible for conducting an annual management review


of the quality system in place at the laboratory. This review is important for
ensuring the continued suitability and effectiveness of the system and for ensuring
all measures are being taken to provide the highest quality service. The review
should include information obtained from various internal and external audits and
how the audits were used to continue/improve quality. The following should be
provided/considered:

1. New programs/procedure/objectives initiated to improve quality, and their


Illinois State Police
Division of Forensic Services
Forensic Sciences Command

Policy: QM-9 Internal Audits and External


Assessments

Date of Original Issue: 03/01/97 Page 4 of 6


Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 20-02

effect;
2. The suitability of policies and procedures;
3. Status of actions from previous management reviews;
4. Reports from managerial and supervisory personnel;
5. Review of the effectiveness of corrective/preventive actions taken in
accordance with QM-8;
6. Results of inter-laboratory comparisons or proficiency tests;
7. Changes in the volume or type of work;
8. Changes in internal and external issues that are relevant to the laboratory
9. Customer feedback;
10. Recommendations for improvement;
11. Complaints;
12. Adequacy of resources;
13. Internal audit and DNA TL onsite visit schedule for the following year;
14. A review of any risks and/or opportunities associated with laboratory
activities, including how to integrate and implement the results of this
review, ensuring the effectiveness of these actions, and that they are
proportional to the potential impact on the validity of the laboratory
results;
15. Outcomes of the assurance of the validity of results;
16. Any other relevant factors, such as quality control activities, resources and
staff training.

b. These reviews are due to the Director of Quality Assurance by January 31st of the following
year.

c. Top laboratory management will determine the appropriate actions to be taken in response
to concerns noted in the management review. Actions arising from the management
reviews shall be recorded or a plan with completion timeframes. Top management
(Forensic Sciences Command) will select opportunities from the laboratory management
reviews, and implement any actions deemed necessary statewide.

d. Corrective actions for quality issues noted in the management review will be documented
using the Quality Issue Report (QIR) form. Appropriate Command Administration will
review the audit documents and related QIRs.

6. Evidence Vault Audits


Illinois State Police
Division of Forensic Services
Forensic Sciences Command

Policy: QM-9 Internal Audits and External


Assessments

Date of Original Issue: 03/01/97 Page 5 of 6


Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 20-02

a. The method and frequency of evidence vault audits is described in the following
paragraphs. Audits may also be necessary for specific instances as noted elsewhere in the
Illinois State Police Operations Directives.

b. The following routine audits will be conducted:

c. Semi-Annual Audits

i. Each Laboratory Director will arrange to have semi-annual audits of all evidence,
handling records, disposition records and evidence storage facilities maintained at
their laboratory. Upon completion, a report of the audit is to be forwarded within
two weeks to the Laboratory Director.

ii. At least 10% of the cases/exhibits (as defined by the laboratory’s Facility
Operations Manual) in the laboratory must be inspected.

iii. Semi-annual audits will be recorded by the laboratory Quality Manager..

d. Reports of the audit will be generated describing who conducted the audit, the date(s) of
the audit, the amount of evidence reviewed (number and percentage) and any discrepancies
noted.

e. Semi-annual audits may supplant a monthly audit. Appropriate documentation must be


maintained by the laboratory Quality Manager.

f. Annual 100% Audit

i. At least once every year, each Laboratory Director (or designee) will conduct a
complete (100%) audit of laboratory evidence, and issue a report as described in
III.A.4.

ii. The annual 100% audit will be documented by the laboratory Quality Manager.

iii. The 100% audit may supplant a monthly audit.

g. Monthly Audits

i. At least once each month, each Laboratory Director (or designee) will conduct an
Illinois State Police
Division of Forensic Services
Forensic Sciences Command

Policy: QM-9 Internal Audits and External


Assessments

Date of Original Issue: 03/01/97 Page 6 of 6


Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 20-02

unannounced audit of laboratory evidence.

ii. At least 2% of the cases/exhibits (as defined by the laboratory’s Facility Operations
Manual) in the laboratory must be inspected.

iii. Monthly audits will be recorded by the laboratory Quality Manager.

iv. The monthly audits required by this directive can be supplanted by the semi-annual audits
or annual 100% audit. Appropriate notation must be made by the laboratory Quality
Manager.

h. Unannounced audits by others

i. In the instance external assessors conduct a vault audit, this audit can supplant the
semi-annual or monthly audits if the percentage of evidence inspected meets the
minimum requirements described above. Appropriate notation must be recorded
by the laboratory Quality Manager.
Appendix 9.1 - INTERNAL AUDIT CHECKLIST

Scope: This checklist is to be utilized in conjunction with the ISO17

• ISO17025:2017 Checklist (on ISP portal)


• The FBI Casework and/or Indexing QAS Checklists (see QM-9 2.b for links)
• Safety Manual Appendix 1.1 – Safety Audit Checklist

Please enter S (Satisfactory), U(unsatisfactory) or N/A for each criteria listed below. All unsatisfactory
marks must be described in the comments section at the end of the document.

ADMINISTRATIVE

Criteria S U N/A
Is a procedure developed that assures all memos/directives are communicated to all
affected employees?
Are the following licenses/permits posted:
DEA DRUG LICENSE
STATE DRUG LICENSE
FEDERAL ALCOHOL PERMIT
STATE ALCOHOL PERMIT
IEMA X-RAY/LASER REGISTRATION
Does each section or analyst maintain court qualifying questions?
Are timekeeping records maintained appropriately?
Are management and employee job descriptions maintained and available to staff?
Does the laboratory maintain a current Curriculum Vitae of each professional
employee?
Does the laboratory document training courses and seminars attended by staff?
Does the laboratory perform required audits of archive master files on site?
Are all sections following the appropriate case management strategies (i.e. deferral
policies, etc...)
Does the laboratory have a method for tracking priority cases in each section?

AUDITS

Criteria Secured (Y/N) S U N/A


Drug Standards
Alcohol
Key/Access Card
Vendor Evaluation
Firearms Reference Collection
Evidence (in accordance with QM-9)

Revised 02/05/2023 Page 1 of 4


EVIDENCE CONTROL/STORAGE

Criteria S U N/A
Is written authorization obtained from the submitting agency prior destroying
evidence?
Is all analyzed evidence returned in a timely fashion?
Are evidence lockers properly utilized?
Is evidence received in the mail secured upon receipt?
Does each refrigerator/freezer housing evidence have its own thermometer which is
properly maintained for temperature variances, if applicable?
Is evidence properly stored at analyst workstations?
Does effective separation exist between areas of the lab with incompatible activities?

EVIDENCE HANDLING:

Inspect 10 items of evidence in each of the applicable sections’ vaults for Proper labeling, marking, and
seals. For one item in each section, is the packaging accurately reflected in LIMS?

Section/Location Labels (S/U) Initials (S/U) Seals (S/U) LIMS (S/U)


Drug Chemistry
Toxicology
Trace/Microscopy
Forensic Biology
Firearms/Toolmarks
Latent Prints

REPORTS

Criteria S U N/A
Do all technical employees in a trainee position have their reports approved by their
training coordinator?
Are all amended reports reviewed by management?
Has the laboratory obtained permission for all intra-agency cc’s on reports?

DIRECT OBSERVATION OF NEW PROCEDURES:

List any new procedures implemented and observed since the last internal audit.

Procedure Date Implemented Date Observed

DIRECT OBSERVATION OF EXISTING PROCEDURES:

Auditors must observe at least one procedure per section.

Revised 02/05/2023 Page 2 of 4


Procedure Date Observed

OVERALL CONDITION OF SECTION:

Section/Location Condition
Drug Chemistry
Toxicology
Trace/Microscopy
Forensic Biology
Firearms/Toolmarks
Latent Prints
Clerical/Evidence Receiving
Chemical Storage
Other

CHEMICAL STORAGE

Criteria S U N/A
Is a master list maintained of all chemicals in the laboratory?
Is the chemical storage area continuously vented?
Are all chemicals and reagents properly labeled and dated?
Are all chemicals in storage reviewed periodically so unstable or unused chemicals are
disposed of?
Is the light bulb in an explosive proof fixture and switched outside the storage room?

SECURITY

Criteria S U N/A
Is the laboratory security system periodically checked for functionality?
Does the laboratory record access to analytical areas by non-laboratory personnel?
Do all employees have proper identification and laboratory access?
Are all confidential documents shredded when appropriate?

Revised 02/05/2023 Page 3 of 4


COMMENTS:

Revised 02/05/2023 Page 4 of 4


Command Audit Nonconformity Summary

Laboratory:
Assessment Dates:
Lead Assessor:
Scope of Assessment:

NC / OFI / Repeat
NC/OFI # Quality Standard and Clause #
Comment Finding? Description of Finding
Y N
Y N
Y N
Y N
Y N
Y N

Appendix 9.2
Revised December 9, 2020
Command Audit Appeal Form

Appellant
Laboratory:
Date of appeal:
Nonconformity
Nonconformity being appealed (#):
Quality Standard and Clause #:
Description of nonconformity:

Description of appeal (attach any relevant information)

Committee decision

Date of response:

Appendix 9.3
Revised December 9, 2020
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-10 Requirements for Laboratory


Facilities

Page 1 of 1
Date of Revised Issue: 09/10/19 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 19-01

POLICY

It is the policy of the Forensic Sciences Command to establish the minimum facility and environmental
requirements for laboratories where testing activities occur.

REQUIREMENTS

I. Laboratory facilities will be appropriate to facilitate performance of all aspects of testing


and provide for storage of records, supplies, space for equipment and instruments and
shall not adversely affect the validity of results.

II. Normal laboratory environmental conditions shall be controlled and monitored by the
laboratory. All testing activities require normal laboratory environmental conditions
unless noted in a procedure. Examinations will be stopped when the environmental
conditions could jeopardize the results. If environmental conditions could affect the
quality of an examination, the conditions will be recorded in the appropriate case records.

III. The laboratory will ensure that effective separation exists between incompatible laboratory
activities (e.g. drug chemistry and toxicology sample prep in different rooms). This will be
monitored and reviewed during the laboratory internal audit. Any changes to the laboratory
layout shall ensure that effective separation still exists.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-11 - Equipment Use, Repair,


Maintenance, Disposal and Calibration
Page 1 of 4
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

I. USE, REPAIRS AND MAINTENANCE

A. Equipment will not be used at facilities outside of the laboratory’s permanent control.

B. Monitoring of equipment maintenance and any associated problems is the responsibility of


each Laboratory Director. Current procedures are found in the Command Directives
Manual.

C. General service equipment not directly used for making measurements (e.g., hot plates,
stirrers, non-volumetric glassware, cameras, refrigerators) will be maintained by visual
examination, safety checks, and cleaning as necessary.

D. High quality flasks and cylinders are used for measuring volumes and reagent preparation;
volumetric equipment is maintained by visual examination, cleaning, and performance
checks.

E. |Instruments/equipment that is repaired/serviced (not including calibration) will have


performance checks made before the instrument/equipment is returned to service, when
applicable. Repairs/service will be recorded in LAM. The procedures for the
Biology/DNA/Indexing critical instruments/equipment are located in the
Biology/DNA/Indexing Procedures Manuals.

F. Equipment will be handled, transported, and stored in accordance with manufacturer’s


specifications in order to prevent contamination and/or deterioration. If the equipment is
moved to a new location, or stored for an extended period of time, a
calibration/performance check will be performed as provided in III below.

II. DISPOSAL

A. All disposable equipment and/or items used when performing analyses shall be disposed
of appropriately.

III. CALIBRATION/PERFORMANCE CHECKS

A. Instruments identified by the laboratory which require calibration or performance checks


will use labels which signify the status of the instrument - green for “In-Service for
Analytical Use” - red for “Not-In-Service, Do Not Use.”

B. Instruments will be protected from unintentional changes to the operating status by


following the standards and controls for operating the instruments found in the Procedures
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-11 - Equipment Use, Repair,


Maintenance, Disposal and Calibration
Page 2 of 4
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

Manual for that discipline.

C. Calibration and performance check records are maintained in log books for each
instrument.

D. |Performance checks will be conducted on any instrument/equipment that goes outside the
direct control of the laboratory for calibration before the instrument/equipment is returned
to service. This excludes equipment sent to an ISO 17025 accredited calibration service
provider.

E. Only ISO 17025 accredited calibration vendors, or an equivalent approved by the Director
of Quality Assurance, will be used. An equivalent supplier will only be approved after the
competence, capability, and traceability for the supplier are confirmed, using objective
evidence. This information will be kept in the instrument log book. Laboratories will
review the validity of the vendor’s accreditation, whenever applicable, prior to use.
Accrediting bodies that will be accepted include those that are members (or signatories) of
the International Laboratory Accreditation Cooperation (ILAC), the European Cooperation
for Accreditation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC),
or the Inter-American Accreditation Cooperation (IAAC).

F. A listing of approved vendors providing critical consumables, calibration services, or


maintenance services will be maintained by each laboratory, to include a documented
periodic review.

G. If required to establish traceability in a method the following items must be calibrated by


an ISO 17025 accredited calibration vendor prior to utilization and adhere to the following
schedule for successive calibrations/verifications (if a calibration certificate is provided,
the date of calibration on this certificate will serve as the initial calibration date in LIMS
and the laboratory must ensure that these items are scheduled for calibration at the next
service date as indicated on the certificate):
a. Drug Chemistry, Toxicology and Trace Balances – every 6 months
b. Pipettors – annually
c. Gage Blocks – every five years
d. NIST Rulers/Tape Measures – every five years
e. Temperature verification units - annually
f. Microscope stage micrometers – every ten years
g. Weight sets – every six years
h. Volumetric Glassware – every ten years

H. The balance acceptability checks below are the recommended course of action for analytical
work; however, it is recognized that the prescribed masses may not fit with a section’s normal
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-11 - Equipment Use, Repair,


Maintenance, Disposal and Calibration
Page 3 of 4
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
FQS supplemental requirements.
Revision Transmittal Number: QA 22-01

practices. In those instances, refer to the Minimum Standards and Controls of each analytical
section’s Procedures Manual for the appropriate masses, acceptability ranges, and exact
procedures to use.

1. Specific manufacturer recommendations for a specific balance performance check


will be followed. If none exist, follow the criteria in H.2.
2. Balance Check Acceptability
a. One (0.1g), Two (0.01 g), Three (0.001 g) and Four Decimal (0.0001 g)
Place Balances: Balances will be checked at the frequency prescribed by
the section’s Procedures Manual, when each balance is in use, with a
minimum of three masses across the range of the balance which must include
100 mg, 1 g, and 10 g. The numerical balance reading will be recorded in
the log book. For each mass used, the balance must read within ±2
readability units. Higher additional masses may be used with a balance
reading within ±5 readability units. The readability unit of a balance is the
smallest numerical readout increment (in grams) on a digital display. If the
mass is out of range, a second mass set will be used to verify all balance
readings. If the mass is still out of range, adjustments (such as cleaning
and/or rebalancing) will be performed. If the mass is still out of range, the
balance may need servicing by an outside vendor. The laboratory will not
perform any type of calibration (either manual or auto) in an attempt to return
the balance to service unless the NIST traceability of the internal standard
weight has been established by the calibration service provider.
b. High Capacity Balances: Balances will be checked at the frequency
prescribed by the section’s Procedures Manual, when each balance is in use,
with a minimum of three masses which must include 5kg and 0.5kg. The
numerical balance reading will be recorded in the log book. For the three
masses used, the balance must read ±0.01 kg. If the mass is out of range, a
second mass set will be used to verify all balance readings, if possible. . If
the mass is still out of range, adjustments (such as cleaning and/or
rebalancing) will be performed. If the mass is still out of range, the balance
may need servicing by an outside vendor. The laboratory will not perform
any type of calibration (either manual or auto) in an attempt to return the
balance to service unless the NIST traceability of the internal standard
weight has been established by the calibration service provider.

2. Balance acceptability checks are performed using reference materials.

I. Should the parameters for calibration/performance checks not be met, the instrument/
equipment will be taken out of service until it meets those parameters by adjustments or
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-11 - Equipment Use, Repair,


Maintenance, Disposal and Calibration
Page 4 of 4
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
FQS supplemental requirements.
Revision Transmittal Number: QA 22-01

repairs. If it is determined that the instrument/equipment was used on casework while not
meeting these parameters, corrective action will be initiated to document the issue and
ensure the validity of reported results.

J. If the calibration interval has been exceeded (due to administrative issues, such as
procurement or vendor issues), but the instrument/reference materials is free from defects
and in working order, the laboratory may continue to use the item, provided that:
1. The laboratory implements an acceptable interim strategy that has been approved
by the appropriate technical leader/command coordinator if applicable.
2. The period of the interim strategy does not exceed the calibration interval in III
G
above.
3. The issue and interim strategy is documented using a quality flag, per QM-17.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-12 Maintenance and Control of


Case Information
Page 1 of 4
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

I. CASE DOCUMENTS

A. All worksheets, case notes, analytical records/reports (client test reports) and
administrative records (evidence receipts, conversation records, etc.) must be of a
permanent nature and be maintained in a case file or in the Laboratory Information
Management System (LIMS).

B. Handwritten notes regarding casework must be in ink, never in pencil. For all cases worked
after January 1, 2018 (including applicable CALMS cases) the item will be scanned into
the image vault for the case in LIMS.

C. |Observations, data, and calculations will be recorded at the time they are made and be
identifiable to the tests run. LIMS will include the start date, end date, and the identity of
the individual performing each laboratory activity including checking data and results.
Observations will include sufficient information to facilitate, if possible, identification of
factors affecting the measurement result and its associated measurement uncertainty. The
notes will enable the repetition of the laboratory activity under conditions as close as
possible to the original. In addition, data will be recorded such that, another reviewer
possessing the relevant knowledge, skills and abilities could evaluate what was done and
interpret the data.

D. |Manual calculations and data transfers will be checked by a second analyst during
technical review.

E. The laboratory case number and examiner’s initials must be on each page of the
examination documentation in the case record. Every page of all other documents in the
case file must bear the laboratory case number.

F. If an analyst performs testing for another analyst, the date of testing and the identity of the
analyst performing the testing will be documented in LIMS.

G. Handwritten/Printed Records: All corrections to handwritten/printed notes, worksheets


and other case documents must be made by making a single line out, dating, and initialing
(see example).

Example: Human blooood ab 4/1/14 blood indicated.

Handwritten/printed notes, worksheets and other case documents will be considered


“permanent” at the point they are submitted for Administrative/Technical Review. After
worksheets and/or other case documents are considered “permanent,” interlineations
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-12 Maintenance and Control of


Case Information
Page 2 of 4
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

(inserted text) will be initialed and dated by the examiner making them.

H. Electronic Records: Notes, worksheets and other case documents in LIMS will be
considered “permanent” at the point they are submitted for technical review. After that
point, all changes will be recorded in LIMS. A new notes packet will be generated with the
alterations, and the date of the change and person responsible for the change will be stored
in the audit log.

I. In general, case documents will not be removed from case files or LIMS for the purpose of
disposing those documents. Documents may be removed from LIMS if they are duplicates,
and of poor image quality/readability, provided a suitable replacement/original is uploaded.
If any other documentation is removed, a description and reason for removal will be
documented on the worksheet in LIMS for that case.

J. If/when a test result or observation is rejected, the reason(s), date, and individual taking
the action shall be recorded.

K. Instrument Tracking

Items of equipment that are used for testing will be identified in the case notes if they are
significant to the result or used to provide a measurement of some quantity critical to the
result. This would include instruments such as GC/MS, IR, CEs, Thermocyclers, etc. In
addition, balances and pipettors must be identified to allow for tracking of work and
reproducibility of results.

If necessary, general service equipment (e.g., hot plates, stirrers, non-volumetric glassware,
cameras, refrigerators) will be identified in the case notes in accordance with the
requirements outlined in the section’s Procedures Manual.

L. Any technical abbreviations used in the matrix will be defined in the section specific
procedures manual.

II. LABORATORY CASE REPORTS

A. Current policies and requirements are delineated in the Command Directives Manual
(EVH 31).

B. Reporting Measurement Uncertainty

1. For every procedure where measurement uncertainty is applicable, it will be


Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-12 Maintenance and Control of


Case Information
Page 3 of 4
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

documented in the respective discipline’s Procedures Manual.

2. A statement on the estimated uncertainty of measurement will be included in the


laboratory case reports in accordance with the procedures outlined in the section’s
Procedures Manual.

C. Amended Laboratory Case Reports

1. Current policies and requirements are delineated in the Command Directives Manual
(EVH 31).

III. REPORTS FROM LABORATORIES EXTERNAL TO THE COMMAND

Whenever a Command laboratory must send evidence to any other laboratory (i.e. the FBI
Laboratory) for analysis, a cover letter will be sent with the evidence which will include a request
that any report generated be sent to the original agency which submitted the evidence to the
Forensic Sciences Command. A copy of the report is to be sent to the submitting laboratory. If the
agency refuses to send the laboratory a copy, documentation of the refusal will be placed in the
case file.

IV. CASE INFORMATION

Local agencies need not go further than their local Illinois State Police laboratory to obtain
assistance on any type of laboratory examination.

A. A local agency may call a laboratory to obtain information concerning any type of
examination.

B. The laboratory will check the appropriate source and get back to the agency.

C. The agency may submit any type of evidence according to evidence submission guidelines
currently in effect and the receiving laboratory will forward the evidence to a laboratory
that can perform the requested examination if the receiving laboratory cannot comply with
the request.

D. The submitting agency will be able to call their regional laboratory and check on the status
of any case submitted to that laboratory.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-12 Maintenance and Control of


Case Information
Page 4 of 4
Date of Revised Issue: 10/31/2022 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

V. DOCUMENTATION OF PHONE CALLS OR CONVERSATIONS

A. Current policies and requirements are delineated in the Command Directives Manual (EVH
20).

VI. SIGNATURE REQUIREMENTS

A. Current policy and requirements are delineated in the Command Directives Manual (EVH 17).

VII. PAGINATION OF EXAMINATION DOCUMENTATION

A. Laboratory generated examination documentation will be paginated by numbering the


individual pages upon creation of a notes packet in LIMS.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-13 Procedures Manuals/


Training Manuals
Page 1 of 1
Date of Revised Issue: 09/10/19 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 19-01

I. POLICY

▌ It is the policy of the Forensic Sciences Command to create and maintain procedures and training
manuals for each analytical section. The electronic version of the procedures and training manuals
located on-line. These manuals are the sole source of the Forensic Sciences Command’s latest valid
version of methods, procedures, and supporting documentation relevant to laboratory activities. If
the method or procedure is inappropriate or not possible to use, the Command will take corrective
action in accordance with QM-8.

II. PROCEDURES MANUALS

Procedures manuals, which contain the standards and controls for performing the procedures, are
produced for each section. A detailed description of the manuals and their make-up, mechanism for
changes, pilot projects, validation studies, and use of non-routine procedures is found in the
Command Directives Manual.

III. TRAINING MANUALS

Training manuals are produced for each section by Statewide Training. A detailed description of the
manuals and their function is found in the Command Directives Manual.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-14 Reference Materials,


Reference Collections, and Reagents

Page 1 of 8
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

I. POLICY

The Forensic Science Command's commitment to providing high quality services is based upon
several factors. One of these is having a number of checks to monitor the quality of service. A part
of quality monitoring is to ensure that appropriate reference materials and reagents are adequate for
the procedures used and are traceable to primary sources.

II. Reference Materials

A. Definition - Material, sufficiently homogeneous and stable with respect to one or more
specified properties, which has been established to be fit for its intended use in measurement
or in examination of nominal properties (ISO Guide 30:1992(E) Amendment 1:2008, JCGC
200:2008).

1. "Reference material" is a generic term that is applicable to all materials that meet the
definition. Subcategories of reference materials include, but are not limited to,
"reference standards" or "internal reference materials." See section II.A.3 in this
policy.

2. Reference materials in the Forensic Sciences Command will be used for


identification, quality control, performance checks of instruments, or quantitation.

3. Examples of reference materials include the following: analytical "drug standards;"


NIST traceable weight sets; NIST traceable gage blocks, toxicology quantitation
standards and controls used for calibration curves; polystyrene, PFTBA, or holmium
oxide.

B. Reference materials shall, where possible, be traceable to accredited reference material


producers (e.g. Cerilliant, Cayman Chemical or other ISO 17034 certified provider) or the
International System of Units (SI) certified by nationally/internationally recognized
metrology institutes (e.g. NIST, BCE, or NME).

1. Each section will follow the steps outlined in its Procedures Manual for meeting
traceability criteria.

2. Where no such traceability exists, alternative reference materials are used which are
fully documented as to their origin, accuracy, stability, and/or uncertainty factors.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-14 Reference Materials,


Reference Collections, and Reagents

Page 2 of 8
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

3. Chemicals that are reference materials will be purchased from reputable distributors,
with supplier and lot number information maintained.

C. Additional subcategories of reference materials include "reference standards" or "internal


reference materials."

1. Reference standards are reference materials that shall be used for calibration as
defined by the ISO 17025 quality standard (e.g. calibration of balances or pipettes)
and for no other purpose. Forensic Sciences Command does not perform such
calibrations.

2. Internal reference materials are typically acquired from case samples or made in the
laboratory. Examples of internal reference materials include semen positive control
or secondary "drug standards."

a. Internal reference materials shall be checked against traceable reference


materials unless they are obviously from a known source (e.g. blood sample
collected from personnel for forensic biology analysis).

b. Each section will follow the steps outlined in its Procedures Manual for
meeting traceability criteria for internal reference materials.

D. The following policies pertain to reference materials that are used for chemical or biological
instrumental analysis (e.g. toxicology "calibrators," toxicology "controls," PFTBA, or
polystyrene):

1. When the laboratory receives or opens a new reference material, it will be


authenticated prior to, or concurrent with, casework examination.

2. For quantitative analysis, expiration dates for reference materials will be supplied by
the manufacturer or assigned in the laboratory. These reference materials will not be
used in casework after their expiration dates until they have been re-authenticated.

a. An expired reference material will be re-authenticated prior to, or


concurrent with, casework examination. When re-authenticating, the results
must meet the originally defined criteria or it may be compared with data
obtained from the first authentication. After re-authenticating, the reference
material will be given a new expiration date.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-14 Reference Materials,


Reference Collections, and Reagents

Page 3 of 8
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

b. If the reference material is considered a stable substance, the newly


assigned expiration date will not exceed five years from the date it was re-
authenticated.

c. Reference materials known to be unstable must be re-authenticated with


higher frequency. This testing frequency is dependent on the nature of the
instability and storage conditions. Therefore, the newly assigned expiration
date for these reference materials will be less than five years from the date
they were re-authenticated.

d. Each section will follow any other steps outlined in its Procedures Manual
for assigning expiration dates and the frequency a reference material will be
re-authenticated to verify its integrity.

3. It is unlikely that the identity of a reference material that is an element or chemical


compound will change. Therefore, for qualitative analysis, expiration dates for
reference materials will not be used unless outlined in the section's Procedures
Manual.

4. Reference materials that are analyzed daily during the course of casework will not
need to be assigned expiration dates. Each section must list these reference
materials in its Procedures Manual.

E. Unless indicated in II. D, each section will follow the steps outlined in its Procedures Manual
regarding expiration dates and the frequency a reference material will be re-authenticated to
verify its integrity.

F. Upon becoming aware that an expired reference material was used for casework, the
laboratory management will refer to sections QM-8 and QM-17 of the Command Quality
Manual to determine the appropriate course of action.

III. Reference Collections

A. Definition - Groups of data, items, or materials encountered in casework which are


maintained for identification, comparison, or interpretation purposes.

1. Typically, reference collections are used to assist in determining the class


characteristics of evidence.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-14 Reference Materials,


Reference Collections, and Reagents

Page 4 of 8
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

2. Examples of reference collections include firearms, ammunition, flammable liquids,


in-house mass spectral libraries, purchased mass spectral libraries, wood fragments,
fibers, or hairs.

B. Reference collections shall be fully documented, uniquely identified, and properly


controlled.

1. Fully documented - Description of pertinent characteristics such as make/model;


source (e.g. cocaine reference material with date or alphanumeric code); or
specifications shall be documented on the item itself, packaging, or as part of a
database record.

2. Uniquely identified - Individual data, items, or materials may be identified with a


unique name (e.g. Mass Spectral and GC data of Drugs, Poisons, Pesticides,
Pollutants, and their Metabolites by Pfleger, Maurer, and Weber; GCMS
S1/Fentanyl/480DC5094-1; Amoco E-85 gasoline; or gray squirrel hair) or a
laboratory generated alphanumeric code.

3. Properly controlled - Access to the reference collection will be limited to section


members and laboratory management. Expiration dates are not applicable because
visual examinations can verify the integrity of the item and/or the stability of the
item is known.

IV. Reagents (see also Appendix 14.1 for quick reference guide)

A. Definitions

1. Reagent - A chemical substance that is being actively used in casework for


any of the following purposes:

a. A chemical substance used because of its chemical or biological


activity (e.g. EMIT Reagents 1 and 2)

b. A chemical substance used in chemical analysis (e.g. bicarbonate


buffer), chemical reactions (e.g. cobalt thiocyanate color test),
physical testing, or physical examination (e.g. Fry's Reagent or
dyes such as the KPIC #1 and Rhodamine 6G solutions)
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-14 Reference Materials,


Reference Collections, and Reagents

Page 5 of 8
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

2. Stock chemical - An element, chemical compound, or a mixture of chemical


compounds purchased from a vendor and which is stable over time. It is
usually used as a solvent or as an ingredient for in-house reagents. This
term is not synonymous with "stock solution" or "stock standard" which are
defined in each section's Procedures Manual if applicable.

Examples of stock chemicals include methanol, sodium acetate, acetic acid,


Rhodamine 6G (solid), or cobalt thiocyanate (solid).

3. In-house reagents - A chemical solution, chemical mixture, or dilution that


laboratory personnel prepared by combining two or more chemical
compounds.

Examples of in-house reagents include combining the stock chemicals


glacial acetic acid, sodium acetate, and deionized water for AP Buffer or
40% formaldehyde and concentrated sulfuric acid for Marquis color test

4. Manufactured reagents - A chemical solution, chemical mixture, or dilution


that a manufacturer created by combining two or more chemical compounds
and which is purchased by the laboratory.

Examples of manufactured reagents include 10X Genetic Analyzer Buffer


with EDTA or EMIT Reagent 1.

5. Critical reagents - In-house or manufactured reagents determined by


empirical studies or routine practice to require testing on established
samples before use on evidentiary or casework reference samples.

6. DNA "Commercial reagents" - A term only used in the Quality Assurance


Standards for Forensic DNA Testing and Databasing Laboratories and not
in this Quality Manual. It pertains to the substances Forensic Sciences
Command categorized as stock chemicals and manufactured reagents (see
definitions listed above).
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-14 Reference Materials,


Reference Collections, and Reagents

Page 6 of 8
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

B. Expiration Dates for Stock Chemicals and Reagents

1. EXPIRED STOCK CHEMICALS OR REAGENTS WILL NOT BE USED IN


CASEWORK.

2. For stock chemicals and reagents, the expiration dates provided by the chemical
suppliers must be followed.

3. If the chemical suppliers do not provide expiration dates, the following policies must
be followed:

a. For stock chemicals, there are no expiration dates.

b. For in-house reagents, the expiration date will be one year from the
preparation date or earlier (e.g. one of the components in the chemical
solution expires sooner than one year).

c. For manufactured reagents, each section will follow the steps outlined in its
Procedures Manual for assigning expiration dates.

d. Frozen in-house or manufactured reagents will have an expiration date of


one year from the date they are thawed and put into use, which will be
noted on the reagent container.

e. When the expiration date was originally assigned by the laboratory, in-
house or manufactured reagents will not be used in casework after their
expiration dates until they have been re-authenticated.

i. Expired in-house or manufactured reagents must be re-


authenticated prior to, or concurrent with, casework examination.
When re-authenticating, the results must meet the originally
defined criteria or it may be compared with data obtained from the
first authentication. After re-authenticating, the in-house or
manufactured reagents will be given a new expiration date that is
one year from the re-authentication date.

ii. Thawed in-house or manufactured reagents will not be re-


authenticated.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-14 Reference Materials,


Reference Collections, and Reagents

Page 7 of 8
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

C. Testing In-house and Critical Reagents

1. In-house reagents will be tested to ensure their reliability and quality for casework
analysis. For DNA analysis, only the critical reagents are tested. The testing will be
conducted using one of the methods described below and recorded either in the case
notes or a logbook.

a. Tested when made (e.g. against controls) and prior to use in casework

b. Tested (e.g. against control s) when an analyst refills his/her bench bottle

c. Analyzed concurrently in casework with control(s)

2. If the in-house reagent is made up on a case-by-case basis, then positives controls


are documented in the case notes.

3. Critical Reagents

a. As applicable, a list of critical reagents must be maintained in the section's


Procedures Manual.

b. Each section will follow the steps outlined in its Procedures Manual for
testing critical reagents. Critical reagents must be routinely tested on
established samples before using on evidentiary or casework samples.

c. Lot numbers of critical reagents must be recorded.

D. Labeling Stock Chemicals and Reagents

1. Stock chemicals and manufactured reagents must be labeled with the following
information when received into the laboratory:

a. Initials of personnel receiving the chemical

b. Date of receipt
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-14 Reference Materials,


Reference Collections, and Reagents

Page 8 of 8
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

c. Expiration date or a clear notation that there is no expiration date

2. In-house reagents must be labeled with:

a. Name

b. Concentration, where appropriate

c. Preparation and expiration date

d. The identity of the preparer

e. Storage conditions, if relevant

f. A hazard warning, where necessary


Appendix 14.1. Quick Reference Guide for Stock Chemicals and Reagents

Testing Required? Expiration Policies Must Be Labeled With


Stock chemical No • Follow expiration date provided • Initial of personnel receiving
• If no date provided, will not • Date of receipt
expire • Expiration date or clearly noted
there is no expiration date
Reagents:
In-house reagent • Yes, for non-DNA sections • Expire in one year • Name of reagent
• Testing occurs before or • Frozen in-house reagent expire • Identity of preparer
concurrently with casework one year after thawing • Expiration date
• If a critical reagent, then also • May confirm the quality of the • If needed or relevant:
see critical reagent category reagent and give new expiration o Concentration
date o Storage conditions
o Hazard label
Manufactured reagent • No, unless a critical reagent; • Follow expiration date provided • Initial of personnel receiving
then, see critical reagent • If no date provided, follow • Date of receipt
category Procedures Manual • Expiration date or clearly noted
• If laboratory assigned the date, there is no expiration date
may confirm the quality of the
reagent and give new expiration
date
Critical reagent Yes, before using in casework • Follow applicable in-house • Follow applicable in-house
reagent policies reagent policies
• Follow applicable manufactured • Follow applicable manufactured
reagent policies reagent policies

Revised May 11, 2015


Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 03/01/97 Policy: QM-15 Personnel Records

Page 1 of 1
Date of Revised Issue: 12/13/10 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 10-01

I. JOB DESCRIPTIONS

Job descriptions are a general explanation of the distinguishing features of work, illustrative examples
of work and desirable requirements for all job classifications. Job descriptions for specific individuals
are maintained by the laboratory to which the individual is assigned and are based on the scope of the
work performed.

Position descriptions are defined on the Illinois State Form, CMS-104, for all personnel positions in the
Command. These list the various positions and a description of the duties and responsibilities of the
position.

More detailed performance standards and objectives for each employee are documented in an annual
performance review to include information for the next reporting period.

II. TRAINING RECORDS

▌ Initial training records are kept by Statewide Training. Subsequent training records for all employees
(such as schools, seminars, workshops, etc.) are maintained by the individual laboratories. A
curriculum vitae for each professional employee shall be maintained by the individual laboratories.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date Original Issue of: 03/01/97 Policy: QM-16 Customer Satisfaction

Page 1 of 3
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

I. OBTAINING USER AGENCY FEEDBACK

A. The Quality Assurance Survey

The Quality Assessment Survey (Appendix 16.1) is designed to elicit continuous feedback
about the user agency’s satisfaction with the provided services and the quality of the
services. Since the actions and attitudes of personnel affect the opinion of user agencies, a
careful evaluation of user agency observations will assist in identifying strong points and
areas where improvements are needed. A survey link will be included with every DFS
Report email notification issued in order to obtain general feedback from user agencies.

The Director of Quality Assurance will be responsible for reviewing and distributing surveys
to the relevant laboratory director, bureau chief, program manager and/or technical leader as
appropriate. If corrective action is required, the process will be documented in accordance
with QM-8.

B. Complaints

1. All DFS report notifications issued will include a link to contact the Director of
Quality Assurance should they have any concerns or questions.

2. All complaints will be evaluated and the results will be documented in accordance
with QM-8 and/or QM-17.

3. Upon completion of cause analysis and corrective actions (as appropriate), or at


regular intervals prior to the completion of the investigation if necessary, the
laboratory director (or designee) will contact the complainant to discuss the results
and notify them of the formal end of the complaint review. This will be documented
in the quality issue report.

4. The laboratory director or designee will ensure that no individuals cited in the
complaint are responsible for the evaluation.

5. The complaint may also be investigated by the Department of Internal Investigation


should the conditions of the complaint warrant it as determined by the Commander.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date Original Issue of: 03/01/97 Policy: QM-16 Customer Satisfaction

Page 2 of 3
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

6. Defense expert reports that address specific analytical conclusions of a Forensic


Sciences Command Employee shall be treated as a complaint and evaluated by
Quality Assurance with the assistance of subject matter experts (Technical
Leader, Quality Review Coordinator, and/or Training Coordinator as appropriate)
to determine if corrective action is necessary. This review will be documented in
accordance with QM-8 if the issue is deemed legitimate and impacts the reported
findings in any way, or in accordance with QM-17 if there is no technical issue or
change in reported findings.

C. Direct Interaction with Agencies

1. Law Enforcement Organization Membership

Law enforcement organization meetings will be utilized to provide feedback on


laboratory performance and possible areas of improvement. Laboratory Directors
should maintain membership in associations for law enforcement officials and/or
police chief associations within their service area.

a. Memberships will be maintained in good standing. Regular attendance is


expected. Regular attendance will be defined through agreement between
each Laboratory Director and their respective Bureau Chief.

b. Agency feedback will be communicated to the laboratory’s Bureau Chief.


Attendance and feedback will also be summarized in the annual
management review of the laboratory’s quality system.

c. If there are no appropriate organizations within the service area of a


laboratory and the Laboratory Director is unable to identify an organization
nearby, the Laboratory Director will develop a meeting opportunity for the
agencies. The meeting will be defined through agreement between each
Laboratory Director and the respective Bureau Chief.

2. Agency contacts made by laboratory personnel either at the laboratory when


agencies are present or during professional association meetings may be utilized to
provide feedback. Feedback received must be forwarded through laboratory
management to Command administration.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date Original Issue of: 03/01/97 Policy: QM-16 Customer Satisfaction

Page 3 of 3
Date of Revised Issue: 02/05/2023 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 23-01

II. UTILIZING USER AGENCY FEEDBACK

Feedback obtained from questionnaires or other means will be reviewed by Command


Administration. Any changes or improvements which are derived from this review will be
implemented and communicated.
Appendix 16.1
Illinois State Police Forensics Services Quality Assessment Survey Questions

The Illinois State Police (ISP) Division of Forensic Services is requesting your assistance in improving the
high level of service we strive to provide. Please take the time to complete this survey. This will be used
solely to assess the quality of services provided to your agency.

Please provide the following contact information


1. Agency
2. Name
3. County
4. Email Address
5. Phone Number

Are you providing feedback on Crime Scene for Forensic Laboratory Services?
1. Crime Scene Services
2. Forensic Laboratory Services

Please select the Illinois State Police Laboratory this survey is directed towards.
1. Forensic Science Center at Chicago
2. Joliet Forensic Science Laboratory
3. Metro East Forensic Science Laboratory
4. Morton Forensic Science Laboratory
5. Rockford Forensic Science Laboratory
6. Springfield Forensic Science Laboratory
7. Overall ISP Forensic Laboratory Services

Services rendered meet investigative and/or trial requirements


1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree
Comments

Our Agency is satisfied with the timeliness of results


1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree
Comments

ISP staff maintained professionalism in all interactions with our agency


1. Strongly Disagree
2. Somewhat Disagree

Revised 9/9/19
3. Neutral
4. Somewhat Agree
5. Strongly Agree
Comments

Communication with ISP Forensic Services staff is effective and timely


1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree
Comments

Reports generated by ISP Forensic Services are clear and comprehensive


1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree
Comments

Our agency is satisfied with the quality of service provided by ISP Forensic Services
1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree
Comments

ISP Forensics Services accommodates rush requests in a timely manner


1. Strongly Disagree
2. Somewhat Disagree
3. Neutral
4. Somewhat Agree
5. Strongly Agree
Comments

What is one improvement ISP Forensic Services could make to better service your agency, other law
enforcement agencies, or the citizens of Illinois.
Comments

Please provide comments regarding situations of when your agency was particularly satisfied with
services rendered.
Comments

Please provide comments regarding situations of when your agency was dissatisfied with services
rendered.
Comments

Revised 9/9/19
Does your agency have a need for services that ISP Forensics Services does not offer?
Comments

Do you have any additional comments regarding The Illinois State Police Division of Forensics Services?
Comments

If you would like to have a representative from the Illinois State Police Division of Forensic Services
contact you for additional follow‐up regarding any concerns or suggestions made, please provide your
contact information in the following fields.
1. Name
2. Phone Number
3. Email Address

Thank you for your assistance.

If you have questions or concerns and would prefer to contact us, please email your message to
[email protected]

Revised 9/9/19
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 02/08/13 Policy: QM-17 Laboratory Quality Flags

Page 1 of 3
Date of Revised Issue: N/A Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

I. POLICY

The Laboratory Quality Flag form (Appendix 17.1) is used for documenting the actions laboratory
management take to remediate quality issues that do not warrant corrective action. In these instances,
there is no justification for root cause analysis or developing a corrective action plan. Unless
otherwise specified by the Bureau Chief, Director of Quality Assurance, or Commander, Appendix
17.2 lists the quality issues for which laboratory managers will remediate and then document with the
Laboratory Quality Flag. Laboratory management will also maintain a centralized database of issued
Laboratory Quality Flags, which may be used to investigate a recurring issue.

II. LABORATORY QUALITY FLAG FORM

A. Assigning the Laboratory Quality Flag Identification Number

1. The Laboratory Quality Manager will maintain a centralized log of all issued
Laboratory Quality Flag forms by number and will track their progress accordingly.

2. Once notified of a quality issue requiring a Laboratory Quality Flag, the Laboratory
Quality Manager will assign an identifying number to the issue.

3. Flag numbers are generated sequentially, beginning with “1" and progressing until
the end of the calendar year. Flag numbers are identified to a particular laboratory
and year by the prefix preceding the sequential number. Laboratory designators are
as follows:

FSCC– Forensic Science Center-Chicago


|CMD – Forensic Science Command
JOL– Joliet Forensic Science Laboratory
MET– Metro-East Forensic Science Laboratory
MOR– Morton Forensic Science Laboratory
RD– Research and Development Laboratory
ROC– Rockford Forensic Science Laboratory
SPR– Springfield Forensic Science Laboratory
|DEC – Decatur Forensic Science Laboratory

Therefore, an example of the first flag number issued at the Joliet Forensic Science
Laboratory in 2013 is JOL-13-01.
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 02/08/13 Policy: QM-17 Laboratory Quality Flags

Page 2 of 3
Date of Revised Issue: N/A Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

B. Instructions for the Laboratory Quality Flag Form:

1. Upon discovery of a quality issue, the Laboratory Quality Manager will be notified.
The Laboratory Quality Manager will review Appendix 8.3 to determine whether a
Quality Issue Report (QIR) must be initiated. If a QIR is not required and the quality
issue is listed in Appendix 17.2, then the Laboratory Quality Manager assigns a
Laboratory Quality Flag identification number.

Laboratory management should contact the appropriate Bureau Chief should there be
special circumstances that warrant a QIR when a Laboratory Quality Flag would
normally be initiated. Quality issues or situations that are not clearly listed in
Appendix 8.3 or Appendix 17.2 will be discussed with the appropriate Bureau Chief
to determine whether a QIR or Laboratory Quality Flag is required.

2. Appropriate laboratory management will investigate and take action(s) to remediate


the quality issue.

3. |Appropriate laboratory management will complete the Laboratory Quality Flag form
fields and inform his/her Laboratory Quality Manager. While the form must be
completed in a timely fashion, a thorough, accurate communication of facts in the
form is expected.

4. The Laboratory Quality Manager will approve the Laboratory Quality Flag form once
determining all the actions taken are appropriate and complete. This signed
document is a completed Laboratory Quality Flag.

5. |The Laboratory Quality Manager will maintain the original, completed Laboratory
Quality Flag indefinitely in approved secure server locations.

C. Monitoring the Actions Taken

|Command management will review the appropriateness of the actions taken and the
completion of the Laboratory Quality Flags periodically and when conducting the laboratory’s
annual management review.

D. Communicating Laboratory Quality Flags

1. |Laboratory management will give access to the completed Laboratory Quality Flag
Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 02/08/13 Policy: QM-17 Laboratory Quality Flags

Page 3 of 3
Date of Revised Issue: N/A Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 22-01

to all Command employees directly involved in the quality issue.

3. |After a Laboratory Quality Flag identification number for a quality issue has been
assigned, all cases affected will be flagged in LIMS. For any cases with physical
paper files, the Quality Issue Report / Laboratory Quality Flag Notification form
(Appendix 8.2) will be placed within the administrative documentation of each case
involved in the quality issue. This is only applicable for Laboratory Quality Flags
that involve cases.

4. Refer to Command Directives EVH 22 for responding to prosecution or defense


requests of a Laboratory Quality Flag.
ILLINOIS STATE POLICE
DIVISION OF FORENSIC SERVICES
FORENSIC SCIENCES COMMAND

LABORATORY QUALITY FLAG FORM

Flag Number: Reported By:

Date Reported:

Laboratory:

Section:

Quality Flag:

Date of Occurrence:

Employee(s) Associated:

Case(s) Associated:

Actions Taken:

Laboratory Quality Manager Approval:

Date Completed:

Appendix 17.1
February 1, 2013
APPENDIX 17.2 – Approved Quality Flag List:

1. Consumed evidence without obtaining permission – if permission granted afterwards

2. Contamination or compromised evidence due to missed agency request

3. Delayed analysis of evidence

4. DNA CODIS - Improper CODIS search resulting in hit

5. DNA CODIS - Improperly including sample into CODIS database

6. DNA extraction issue

7. DNA sample switch

8. |DNA One locus mis-match

9. Equipment failure

10. Evidence returned to incorrect agency

11. Evidence with incorrect barcode label so incorrect laboratory report mailed

12. Expired reagent, standard, or control used in casework and it is demonstrated that there is no change
in the reaction of the chemical.

13. Failed performance check that was not noticed and it is demonstrated that the instrument is
operating correctly.

14. Improperly disposed evidence or broken evidence

15. Incomplete analysis (missed examining an item)

16. Incorrect reporting due to non-technical (e.g. typographical or administrative) error

17. Missed performance check/calibration, and it is demonstrated that the instrument is operating
correctly.

18. Missing case file unless impacting court proceeding or further case analysis

19. Original evidence packaging mis-handled

20. Unidentified or unsecured evidence

21. Unsubstantiated agency "complaint" of analysis results

22. Non-Concordant proficiency test results arising from administrative issues and/or reporting
limitations imposed by the test provider (see QM-6 II C. 2)

Revised 02/05/2023 Page 1 of 2


APPENDIX 17.2 – Approved Quality Flag List:

23. |Reanalysis results in a change in findings when the original analysis was conducted appropriately
and following all ISP policies and procedures. (i.e. originally reporting an inconclusive result for
a latent print when a subsequent analysis indicates a more definite conclusion, a low
concentration seized drug item that is reanalyzed and results in an identification). The quality
flag must document that the QRC and/or discipline technical leader has reviewed the finding and
deemed it to be within the acceptable range of conclusions.

24. Review of a “defense expert” report by the Director of Quality Assurance with the assistance of
subject matter experts (Technical Leader, Quality Review Coordinator, and/or Training
Coordinator) that addresses specific analytical conclusions by a Forensic Sciences Command
analyst but does not result in the need for corrective action.

Revised 02/05/2023 Page 2 of 2


Illinois State Police Division of Forensic Services

Forensic Sciences Command

Date of Original Issue: 12/09/2020 Policy: QM-18 Measurement Uncertainty

Page 1 of 1
Date of Revised Issue: 12/09/2020 Compliant with ISO 17025 standards and the
ANAB accreditation requirements.
Revision Transmittal Number: QA 20-02

I. POLICY

Measurement uncertainty determinations will be calculated (and periodically reviewed) for the
following laboratory activities:

Discipline-Component/Parameter Frequency of Review


Firearms – Length Measurement Every 5 Years
Seized Drugs – Weights Every 2 Years
Seized Drugs – Quantitative Determination Every 2 Years
Toxicology – Quantitative Determination Continually Reviewed using Control Charts

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