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FSC330 > Lesson 2 - QA and Standards > Flashcards

Lesson 2 - QA and Standards Flashcards

1
Q

What are QA and standards?

A

Often documents that specify the quality requirements for a product/service

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2
Q

True are false: QA and standards are usually mandatory.

A

False, they are often voluntary

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3
Q

How are QA and standards developed? What is the benefit of this?

A

Developed by consensus, makes them more robust and defensible.

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4
Q

List the two important areas that help establish appropriate standards in forensic science.

A

The organization of scientific area committees
Accreditation

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5
Q

What group is OSAC administered by?

A

The national institute of standards and technology (NIST)

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6
Q

What is the aim of OSAC?

A

To strengthen the use of forensic science by facilitating the development of technically sound forensic science standards and promoting their adoption.

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7
Q

What does OSAC produce?

A

Documents that define minimum requirements, best practices, standard protocols, and other guidance to help ensure that the results of forensic analysis are reliable and reproducible.

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8
Q

Outline the multi-level organizational structure of OSAC.

A

A forensic science standards board
Seven scientific area committees
22 discipline-specific subcommittees
FSSB resource task groups

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9
Q

What are the seven SACs in OSAC?

A

Digital/multimedia
Biology
Chemistry: seized drugs and toxicology
Chemistry: trace evidence
Physics/pattern interpretation
Scene examination
Medicine

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10
Q

What is the role of the forensic science standards board (FSSB) in OSAC?

A

Promulgation of standards,
address standard development issues,
coordinate scientific area committee work

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11
Q

What is the role of OSAC’s scientific area committees?

A

provide direction and oversee work performed by discipline specific subcommittees

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12
Q

What is the role of OSAC’s subcommittees?

A

do the work and draft the documents

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13
Q

True or false: OSAC has the authority to approve and enforce standards.

A

False. OSAC approves the standards but does not have the authority to make them standards.

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14
Q

What are standards development organizations (SDO)

A

organizations that are accredited to develop and approve standards.

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15
Q

Give examples of SDOs.

A

AAFS standards board
ASTM international
American dental association
International organization for standardization
National fire protection association

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16
Q

How many standards are on the OSAC registry?

A

200

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17
Q

What is accreditation?

A

Formal recognition by an independent body that an organization is operating according to defined standards through an assessment of laboratory and staff competence

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18
Q

Why might a lab want to become accredited?

A

Increases confidence in laboratory services
Helps to ensure laboratory is performing according as expected/defined by standards
Mandatory in some jurisdictions or required to obtain grants or private work

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19
Q

Explain how standards might be amplified.

A

accreditation standards set out requirements.
Standard may be applicable to many industries
Standards may be amplified with a supplemental document that is specific to the industry in question

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20
Q

Give an example of a supplemental document

A

ANAB 3125 supplements ISO/IEC 17025

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21
Q

What is ISO/IEC 17025

A

General requirements for the competence of testing and calibration laboratories

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22
Q

What is ANAB 3125?

A

Accreditation requirements for forensic testing and calibration

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23
Q

What are accrediting bodies?

A

The groups that assess laboratories/agencies against the standards

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24
Q

Give examples of accrediting bodies

A

ANAB
SCC
CALA
A2LA
UKAS
IAS

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25
Q

Who accredits the accrediting bodies?

A

ISO 17011

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26
Q

What is validation?

A

Process of taking a method and evaluating the ability to provide accurate and reproducible results.

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27
Q

Outline ISO 17025 s. 7.2.2

A

The lab shall validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application.

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28
Q

Outline ANAB 3125, s. 7.2.2.1.1

A

Method validation shall:
a) Be conducted according to a validation plan
b) Include the associated data analysis and interpretation
c) Establish the data and acceptance criteria required to report a result, opinion, interpretation, or statement of conformity; and
d) identify limitations of the method

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29
Q

What is ISO/IEC 17025?

A

General requirements for competence testing and calibration laboratories

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30
Q

What areas does the ISO/IEC 17025 standard cover?

A

Reporting
Management
Measurement uncertainty
Proficiency
Method validation
Personnel
Lab structure
Equipment
Reagents
Non-conforming work
Control of records
etc.

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31
Q

Outline ISO/IEC 17020.

A

Requirements for the operation of various types of bodies performing inspection.

32
Q

Give examples of forensic inspection body disciplines under ISO/IEC 17020.

A

Anthropology
Digital and video/imaging analysis
Firearms/toolmarks
Impressions
Medicolegal death investigations
Scene investigations

33
Q

What is ISO/IEC 17020 used for?

A

For forensic practitioners that do not conduct analytical scientific testing using instrumentation and equipment found in a traditional science lab.

34
Q

What factors does the ISO/IEC 17020 standard focus on?

A

Impartiality
Independence
Confidentiality
Item selection
Item handling

35
Q

True or false: Firearms/toolmarks can be accredited under either ISO/IEC 17020 OR 17025?

A

True

36
Q

Outline the six steps of the accreditation process.

A

Develop quality management system
Application
Pre-assessment
Assessment
Response
Surveillance

37
Q

Who has the ultimate authority over QMS?

A

Quality manager but quality is everyone’s responsibility

38
Q

Describe the pre-assessment stage of the accreditation process.

A

External group assesses how you’re expected to do and then addresses issues

39
Q

Outline the assessment stage of the accreditation process.

A

~ 1 week
Each section’s standards are evaluated
Then identify findings

40
Q

How long does accreditation certification last?

A

4 years

41
Q

Describe the surveillance stage of the accreditation process/

A

Individual assessments made annually

42
Q

What information is provided to assessors? (6)

A

General policies
Analytical methods
Validation records
Info about staff qualifications
Court monitoring
Complaint process

43
Q

Outline the accreditation assessment. (7)

A

On-site assessment
Observe testing in progress
Resolution of any non-conformities
Review training records
Staff interviews
Accreditation decision
Conformance monitoring and reassessment

44
Q

What are the downsides to accreditation?

A

cost
complicated documentation
Not a panacea that prevents every problem

45
Q

Why are proficiency tests often used in court?

A

To help establish expertise and reliability of examiner

46
Q

What two main questions does proficiency testing aim to investigate?

A

Is the testing method reliable?
How often does a particular analyst make an error?

47
Q

Where do you get proficiency testing from?

A

Internal
External

48
Q

Do external proficiency test providers have to be accredited?

A

Yes

49
Q

What is blind proficiency testing?

A

Submitted as an authentic case
Test recipients don’t know it’s a test

50
Q

What are the benefits of blind proficiency testing?

A

Treated like a regular case
Evaluates lab as a whole

51
Q

What is non-conforming work?

A

When policy/procedure is not followed

52
Q

What needs to be done if non-conforming work indicates a systemic problem?

A

Further action needs to be taken by the laboratory quality assurance manager

53
Q

What is preventive action?

A

A process that occurs when a potential non-conformity or general area of improvement is noticed.

54
Q

Give examples of when preventive action could arise.

A

Data monitoring over time
Review of technical procedures
New available techniques
Following published guidelines

55
Q

How would actual issues be identified? (5)

A

Proficiency testing
Case file reviews
Laboratory staff
Internal auditing
Client complaints

56
Q

What are Forensic Science Oversight Bodies in the US typically involved in? (4)

A

Ensuring that standards are implemented, especially accreditation
Coordinating state or grant funding
Preventing or mitigating problems by serving as investigator of misconduct or professional negligence
Licensing/certification, complaint review

57
Q

How is forensic science governed in canada? ON?

A

Forensic laboratories - provincial legislation
Ontario- forensic laboratories act, 2018

58
Q

Outline the accreditation requirements in s. 2 of the forensic laboratories act in ON.

A

No person shall, in laboratory, conduct a test to which this section applies, unless,
a) the lab is accredited, by an accrediting body prescribed by the regulations, to a prescribed general standard; and
b) if the test is a prescribed test, the laboratory is accredited, by an accrediting body prescribed by the regulations, to a prescribed standard for that test.

59
Q

What disciplines does s. 2 of the forensic laboratories act apply to?

A

Biology and toxicology

60
Q

Are there similar requirements as s. 2 of the forensic laboratories act anywhere other than ON?

A

No

61
Q

What is root cause analysis?

A

Tool designed to help identify not only what happened, how it happened, but also why it happened.

62
Q

Who can use root cause analysis?

A

May be used in many different areas

63
Q

What did the National commission on forensic science say about root cause analysis?

A

It is recommended that appropriate root cause analysis protocols for all forensic science service providers or forensic science medical providers be adopted.

64
Q

What is the important thing to remember about root cause analysis?

A

Purpose is learning, not punishment

65
Q

What are the 5 classifications of an error during root cause analysis?

A

Catastrophic
Major
Moderate I
Moderate II
Minor

66
Q

Describe the ‘catastrophic’ classification of root cause analysis.

A

Systemic errors in procedure(s) that affect several outcomes or reported results;
intentional misconduct by personnel

67
Q

Describe the ‘Major’ classification of root cause analysis.

A

Casework error that affects outcome or reported result.
Could include potential problems that may affect the reliability or accuracy of a test procedure or serious negligence by personnel.

68
Q

Describe the ‘Moderate I’ classification of root cause analysis.

A

Clerical error - Does affect result but corrected during the review process prior to release of report

69
Q

Describe the ‘moderate II’ classification of root cause analysis.

A

Clerical error nonconformity that does not affect outcome of reported result.

70
Q

Describe the ‘minor’ classification of root cause analysis.

A

Clerical error - does not affect outcome or reported result.

71
Q

What was the root and cultural cause analysis of report and testimony errors by FBI MHCA examiners?

A

Review by FBI started in 2012 of microscopic hair comparison after cases were highlighted where errors had occurred.

72
Q

What was the main finding of the root and cultural cause analysis of report and testimony errors by FBI MHCA examiners?

A

The most important cause of report and testimony errors was that the MHCA examiners did not have sufficiently specific guidance

73
Q

Outline the root cause model. (6)

A

Identify event
Define the issue
Collect and analyze data
Identify contributing factors
Implement corrective action
Monitor the quality system

74
Q

Why is the goal of root cause analysis to ask follow up questions five times/

A

Not all problems have a single root cause
To uncover multiple root causes, the method must be repeated asking a different sequence of questions each time

75
Q

What is the difference between quality control and quality assurance?

A

QC - Day-to-day things done to ensure quality of results
QA - ensuring entire product is fit for purpose

FSC330 (10 decks)

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