Forensic Laboratory Quality Assurance and ISO/IEC 17025

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1
What is quality assurance in a forensic laboratory?
The planned and systematic activities intended to provide confidence that laboratory processes and results meet established quality requirements.
2
What is quality control in forensic laboratory work?
Operational checks and procedures used to monitor whether specific analytical processes are performing as intended.
3
What is the distinction between quality assurance and quality control?
Quality assurance addresses the overall system for achieving quality, while quality control focuses on monitoring particular processes and results.
4
What is ISO/IEC 17025?
An international standard specifying general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories.
5
Does ISO/IEC 17025 accreditation guarantee that every laboratory result is correct?
No. Accreditation evaluates conformity with requirements but does not eliminate human error, analytical limitations, or uncertainty.
6
What is laboratory accreditation?
Formal recognition by an authorized accreditation body that a laboratory meets specified requirements for defined activities.
7
What is a laboratory's scope of accreditation?
The specific testing or calibration activities for which the laboratory has been assessed and accredited.
8
What is method validation?
The process of establishing through objective evidence that an analytical method is fit for its intended purpose.
9
What is method verification?
Confirmation that a laboratory can properly perform an established method under its own operating conditions.
10
What is analytical accuracy?
The closeness of a measured result to an accepted reference or true value.
11
What is analytical precision?
The closeness of agreement among repeated measurements made under specified conditions.
12
What is repeatability?
Measurement precision under conditions involving the same method, operator, equipment, location, and a short time interval.
13
What is reproducibility?
Measurement precision assessed under changed conditions, often including different laboratories, operators, or equipment.
14
What is analytical sensitivity?
A method's ability to detect or respond to small amounts or changes in the target substance, depending on the defined analytical context.
15
What is analytical specificity?
A method's ability to distinguish the target analyte from potentially interfering substances.
16
What is a limit of detection or LOD?
The lowest analyte amount or concentration that can be reliably distinguished from an appropriate blank under specified conditions.
17
What is a limit of quantitation or LOQ?
The lowest analyte amount or concentration that can be measured quantitatively with acceptable performance under specified conditions.
18
What is measurement uncertainty?
A parameter expressing the dispersion of values reasonably attributable to a measured quantity.
19
Why should measurement uncertainty be considered in forensic quantitative results?
It helps communicate the limits of precision and supports appropriate interpretation of measurements near relevant decision thresholds.
20
What is a calibration standard?
A reference material or device with an established value used to calibrate an instrument or measurement system.
21
What is metrological traceability?
The property of a measurement result whereby it can be related to a reference through a documented, unbroken chain of calibrations with stated uncertainties.
22
What is a certified reference material?
A reference material accompanied by documentation providing certified property values, uncertainties, and metrological traceability where applicable.
23
What is a reagent blank?
A control containing reagents without the intended sample analyte, used to evaluate possible contamination or background response.
24
What is a positive control?
A sample expected to produce a specified positive response, used to check whether an analytical procedure is functioning.
25
What is a negative control?
A sample expected not to produce the target response, used to detect contamination or nonspecific reactions.
26
What is a substrate control in forensic evidence examination?
A sample of background material collected to assess whether the underlying surface contributes substances or effects relevant to the evidence.
27
What is carryover contamination?
Unintended transfer of material from one sample or analytical run into a subsequent sample or run.
28
What is cross-contamination?
Unintended transfer of material between samples, evidence items, environments, or processing equipment.
29
Why is physical separation of pre-PCR and post-PCR areas important in DNA laboratories?
It reduces the risk that amplified DNA products will contaminate low-template samples or preparation areas.
30
What is a proficiency test?
An assessment of an analyst's or laboratory's performance using test materials with results evaluated against specified criteria.
31
What is a blind proficiency test?
A proficiency test in which the examiner does not know that the submitted material is part of a performance assessment.
32
What is an interlaboratory comparison?
Evaluation of measurements or test results produced by two or more laboratories on the same or similar materials.
33
What is a laboratory audit?
A systematic and documented examination of activities and records to determine conformity with specified requirements.
34
What is a nonconformity in a laboratory quality system?
A failure to meet an applicable requirement, procedure, or standard.
35
What is corrective action?
Action taken to eliminate the cause of an identified nonconformity and reduce the likelihood of recurrence.
36
What is root cause analysis?
A structured investigation to identify underlying factors responsible for a problem or nonconformity.
37
What is technical review of a forensic report?
An evaluation of analytical records, methods, data, interpretations, and conclusions by a qualified reviewer.
38
What is administrative review of a forensic report?
A check for completeness, consistency, required documentation, and compliance with applicable reporting procedures.
39
What is an analytical case record?
The collection of notes, observations, instrument data, calculations, and other documentation supporting a forensic examination.
40
Why must changes to electronic forensic laboratory records be traceable?
An audit trail helps establish who made changes, when they occurred, and whether the original information remains recoverable.
41
What is cognitive bias in forensic interpretation?
A systematic influence on judgment arising from expectations, contextual information, or other cognitive processes.
42
What is confirmation bias?
The tendency to seek, interpret, or emphasize information that supports an existing belief or hypothesis.
43
What is contextual bias in forensic examination?
Influence on an examiner's judgment from case information that is not necessary for the scientific task.
44
What is linear sequential unmasking?
A bias-management approach in which potentially influential information is disclosed in a controlled sequence after relevant initial observations are documented.
45
What is a false-positive error in forensic classification?
An incorrect conclusion that a specified characteristic, condition, or association is present when it is absent.
46
What is a false-negative error in forensic classification?
An incorrect conclusion that a specified characteristic, condition, or association is absent when it is present.
47
Why must forensic error rates be interpreted in relation to the testing conditions?
Observed error rates depend on the method, sample difficulty, study design, decision criteria, and population of tested cases.
48
What is the ethical duty of a forensic expert when findings do not support the requesting party's theory?
To report the scientifically supported findings impartially, including results that contradict the requesting party's expectations.
49
Scenario: A toxicology instrument produces a positive result in a reagent blank. What should the analyst do?
Investigate possible contamination or analytical problems and avoid relying on affected results until the issue is appropriately resolved.
50
Scenario: A forensic examiner realizes that a signed report contains a material analytical error. What is the appropriate response?
Promptly follow laboratory correction procedures, preserve the original record, issue a documented correction, and notify affected parties as required.
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