Quality Manual
Quality Manual
MANUAL
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
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.
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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 Reanalysis
Cases that are randomly selected, if possible, and reworked by the Quality Review Coordinator.
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• ISO/IEC
International Organization for Standardization/International Electrotechnical Commission
• 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
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results oftests performed, charts, graphs, photos, and other documents generated which are used
to support the examiner’s conclusions.
• 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
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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.
• 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
Date of Original Issue: 03/01/97 Policy: QM-1 Quality System Goals and
Objectives
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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,
Date of Original Issue: 03/01/97 Policy: QM-1 Quality System Goals and
Objectives
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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.
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Date of Revised Issue: 08/30/19 Compliant with ISO 17025 standards and the
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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.
▐ The organizational charts for individual Forensic Sciences Command laboratories can be found on the
Command intranet site.
Illinois State Police Division of Forensic Services
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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;
D. Administration of the Command’s Quality Review Coordinator program, which includes case
reanalysis program;
H. Conducting laboratory audits and quality system reviews, and arranging for external
audits/reviews;
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Revision Transmittal Number: QA 23-01
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:
D. Coordinating and monitoring reanalysis and case file review activities in the laboratory;
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;
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;
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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.
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.
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
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expected to take that action and document the extent of the actions in the case notes.
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
2. Selection Process
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
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4. Responsibilities - Responsibilities include, but are not limited to, the following
duties:
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;
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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
C. Control of manuals and dissemination is discussed in ADM 18, Electronic Manuals, of the
Command Directives.
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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.
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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
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
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,
Illinois State Police Division of Forensic Services
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.
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.
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
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.
General Information
Analyst Name
Date
Testimony Reviewer (TR)
Case Number
Venue
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?
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.
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
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
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]
Case Involvement
1. Judge
2. States’ Attorney
3. Defense
4. Other(please specify)
Revised 09/10/19
Illinois State Police Division of Forensic Services
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
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:
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.
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.
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
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.
Test records will be maintained in each analyst’s laboratory training file as specified by the
Command Directives.
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
2. A Laboratory Director may, with the approval of the appropriate Bureau Chief,
request an additional proficiency test for any individual at any time.
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.
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.
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
Illinois State Police Division of Forensic Services
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.
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.
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).
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
Illinois State Police Division of Forensic Services
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.
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
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.
2. Test Preparation
Illinois State Police Division of Forensic Services
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.
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.
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
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.
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.
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.
All test materials (photos, notes, spectra, etc.) will be retained as quality records per the
Command Directives.
Illinois State Police Division of Forensic Services
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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.
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.
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:
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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:
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.
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
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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.
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.
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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.
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
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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.
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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
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d. The types of cases selected for QRC technical review varies per discipline,
and is as follows:
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
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.
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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.
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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.
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:
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c. After implementation of the action plan, the results of the action plan will
be reviewed for effectiveness, and may be repeated as necessary.
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
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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
Controls Result
Comments
Samples: Result
Comments
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
FOLLOW-UP:
___________________________________________________________________________________________
OTHER COMMENTS:
Analyst’s Signature:______________________________________________Date:________________________
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?
6. Other comments?
PAT
Comments:___________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
Date of Original Issue: 03/01/97 Policy: QM-8 Corrective Action for Quality
Concerns - Quality Issue Report (QIR)
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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)
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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.
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
Case(s)/Items(s):
Offense:
Why it is an issue:
Case Review/Reanalysis
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Quality Issue Report
Type of Review:
Part II:
Cause Analysis (Staff Interviews, 5 Whys analysis, Failure Modes Effects Analysis, fishbone
diagrams, as appropriate)
Action 1
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Quality Issue Report
Timeframe
Estimated Completion Date of Corrective Action Plan:
Part III:
Final Review
Title Signature Date
Director of Quality Assurance: Date
Commander: Date
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[This form will be printed on colored paper so it can be differentiated
from the other administrative documents]
See QIR or
Flag number
Appendix 8.2
January 30, 2015
APPENDIX 8.3
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)
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)
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
12. Missing case file that was needed for court, supplemental case analysis, CODIS, etc.
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
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:
Results
Has the issue re-occurred(Y/N)?
Date of Reviews and Results
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Illinois State Police
Division of Forensic Services
Forensic Sciences Command
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:
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
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.
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.
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
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.
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.
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.
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.
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.
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
ii. At least 2% of the cases/exhibits (as defined by the laboratory’s Facility Operations
Manual) in the laboratory must be inspected.
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.
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
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 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?
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?
List any new procedures implemented and observed since the last internal audit.
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?
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:
Committee decision
Date of response:
Appendix 9.3
Revised December 9, 2020
Illinois State Police Division of Forensic Services
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
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
A. Equipment will not be used at facilities outside of the laboratory’s permanent control.
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.
II. DISPOSAL
A. All disposable equipment and/or items used when performing analyses shall be disposed
of appropriately.
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).
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
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.
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
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
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.
(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.
A. Current policies and requirements are delineated in the Command Directives Manual
(EVH 31).
1. Current policies and requirements are delineated in the Command Directives Manual
(EVH 31).
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.
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
A. Current policies and requirements are delineated in the Command Directives Manual (EVH
20).
A. Current policy and requirements are delineated in the Command Directives Manual (EVH 17).
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.
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.
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
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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.
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.
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
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3. Chemicals that are reference materials will be purchased from reputable distributors,
with supplier and lot number information maintained.
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."
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):
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.
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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.
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.
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IV. Reagents (see also Appendix 14.1 for quick reference guide)
A. Definitions
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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:
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.
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.
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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
3. Critical Reagents
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.
1. Stock chemicals and manufactured reagents must be labeled with the following
information when received into the laboratory:
b. Date of receipt
Illinois State Police Division of Forensic Services
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Revision Transmittal Number: QA 23-01
a. Name
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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.
▌ 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
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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.
4. The laboratory director or designee will ensure that no individuals cited in the
complaint are responsible for the evaluation.
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Revision Transmittal Number: QA 23-01
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.
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
Revised 9/9/19
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
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
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
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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.
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:
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
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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.
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.
|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.
1. |Laboratory management will give access to the completed Laboratory Quality Flag
Illinois State Police Division of Forensic Services
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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.
Date Reported:
Laboratory:
Section:
Quality Flag:
Date of Occurrence:
Employee(s) Associated:
Case(s) Associated:
Actions Taken:
Date Completed:
Appendix 17.1
February 1, 2013
APPENDIX 17.2 – Approved Quality Flag List:
9. Equipment failure
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.
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
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)
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.
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I. POLICY
Measurement uncertainty determinations will be calculated (and periodically reviewed) for the
following laboratory activities: