FIS 480 - FORENSIC QUALITY ASSURANCE QUESTIONS
AND ANSWERS A+ GRADED
After march 2009
all forensic labs must seek accreditation through the ISO program
ANSI-ASQ National Accreditation Board (ANAB)
(American National Standards Institute - American Society for Quality
ASCLD/LAB
American Society of Crime Lab Directors- Laboratory Accreditation Board
ANAB acquired ASCL/LAB; 1 accrediting body
ISO
International Organization for Standardization
promote the development of standardization and related activities to facilitate the
international goods and services.
Reason for accrediation: Reliability of tests
Critics will try to find any perceived errors in cases and use them to support their stance
of reliability.
ex.) OJ Simpson case
-Contamination
-Careless collection
-Mishandling of Evidence
-Tampering
ex.) Ramsey case
-Not sealing off crime scene
-Allowing people in/out of the house right after crime
Other reasons to become accredited:
-Sometimes law requires it.
-Your lab will have an increased confidence in personnel and their work.
-increase public confidence; recognizing mark of approval
-Improved control of operations.
-Increased credibility with clients/customers.
-Savings of time and money because of increased efficiency and effectiveness.
,-reducing uncertainties in data used to establish baselines for key analyses and
decisions
What exactly is Accreditation?
accreditation. is a process by which a laboratory is formally recognized, by
an independent third party, to be scientifically and technically competent, according to
some national or international standard, to do certain tests
Quality System:
Laboratory activities aimed at producing accurate work and a high-quality work product.
Quality Control:
Planned activities designed to provide a quality product.
-checking a reagent before using it
-running a control on your instrument before you run it
-technical review of reports
-something you are actively doing
Quality Assurance:
Planned activities designed to ensure that the quality control activities are being
properly implemented.
includes quality control manual which consists of all your quality control activities
Policy:
Statement of the overall direction of the organization with regard to the subject of
activity.
A generalized philosophy.
Procedure:
Document that specifies a way to perform an activity, the purpose and scope of the
activity, and describe who, what, where, and how it shall be done.
ex.) procedure for extracting DNA
Document (Noun):
This is a policy, procedure, forms, manuals,etc.
Document (Verb):
Creation of a record, ("if it isn't documented, it did not happen.")
Record:
Evidence of compliance with quality system, for example, your documentation.
Quality System
Quality System Documents
Quality Manager
Quality Assurance Board
Quality System Documents
Quality Manual
,written document that identifies the policies, organizational objectives, functional
activities, and specific quality activities designed to achieve the quality goals desired for
the operation of the system.
needs to be flexible and adaptable to changes in methods, techniques, and personnel.
ILAC - International Laboratory Accreditation Cooperation
A group comprising representatives from about 50 countries interested in ways to obtain
accreditation.
Quality Manual: QA policy
Describes the objectives of the program, management's commitment to the program,
and managing of the QA program.
Description of the Manual
Describes how the manual will be amended, supplemented, and distributed, and
describes the laboratory work the manual will cover.
Quality Manual: Laboratory Organization
The responsibilities of management and operating personnel.
Equipment
Describes procedures for inventorying and
maintaining equipment.
Environment
Control Specifications and monitoring procedures.
temp. logs
Analytical Methods
Criteria for the selection of methods and procedures for method validation.
Sample handling
Disbursement, storage, disposal, and special security procedures, including record
keeping.
chain of custody
Analytical Results
Requirements for reporting, verifying, and validating analytical results.
Records
Maintenance of records and requirements for confidentiality.
QS DOC: All of a laboratory's documentation.
Audit procedures
Evaluating the effectiveness of the QA program, proficiency testing requirements, and
taking corrective actions.
Contract Work
Procedures for verifying the correctness of data received from external contract
facilities.
Work Instructions
For example: A short procedure on how to make a particular reagent
OR
, How to run a small piece of equipment.
Quality Assurance Committee
Usually made up of supervisory staff or trained auditors in the lab to assist the quality
Assurance Manager in implementing quality policies and procedures. They review with
the QAM all necessary additions/revisions to the quality assurance program.
Quality Manager Duties
-Monitoring quality assurance activities to determine conformance with policy and
procedures.
-Making recommendations for corrections and improvements to the program.
-Conduct audits.
audit vs assessment
audit happens in you lab every year, internal audit team--> see if you're meeting the
standards with your team of all sections within your laboratory
lab is seeking accreditation--> assessment is done by ANAB
Management system
strong QA program with implementation of standards--> accuracy of test reports
Legal responsibility
4.1.1
Documentation on file to show that your lab is an identifiable legal entity.
Could be a statute that brings your lab into existence.
4.1.2
Objectives Section
some overarching statement of what the main goal of the laboratory is.
Permanent, temporary and mobile lab facilities....
4.1.3
For example, a satellite lab for breath test equipment or if an employee works from a
home office.
The manual needs to explain how these employees are subject to supervision, security,
etc.
Conflict of Interest....
4.1.4
Include policy statement that says "The laboratory results are free from bias and outside
influence."
Conflict of Interest Document
Individuals who affect the quality of the test result....
4.1.5(a)
"Individual with authority"\
The Laboratory Director has the ultimate authority to identify problems in the lab and
find a solution for correction. Is dependent on Unit Supervisors/Technical Managers and
staff for support in identifying departures from the quality system and reporting them.
AND ANSWERS A+ GRADED
After march 2009
all forensic labs must seek accreditation through the ISO program
ANSI-ASQ National Accreditation Board (ANAB)
(American National Standards Institute - American Society for Quality
ASCLD/LAB
American Society of Crime Lab Directors- Laboratory Accreditation Board
ANAB acquired ASCL/LAB; 1 accrediting body
ISO
International Organization for Standardization
promote the development of standardization and related activities to facilitate the
international goods and services.
Reason for accrediation: Reliability of tests
Critics will try to find any perceived errors in cases and use them to support their stance
of reliability.
ex.) OJ Simpson case
-Contamination
-Careless collection
-Mishandling of Evidence
-Tampering
ex.) Ramsey case
-Not sealing off crime scene
-Allowing people in/out of the house right after crime
Other reasons to become accredited:
-Sometimes law requires it.
-Your lab will have an increased confidence in personnel and their work.
-increase public confidence; recognizing mark of approval
-Improved control of operations.
-Increased credibility with clients/customers.
-Savings of time and money because of increased efficiency and effectiveness.
,-reducing uncertainties in data used to establish baselines for key analyses and
decisions
What exactly is Accreditation?
accreditation. is a process by which a laboratory is formally recognized, by
an independent third party, to be scientifically and technically competent, according to
some national or international standard, to do certain tests
Quality System:
Laboratory activities aimed at producing accurate work and a high-quality work product.
Quality Control:
Planned activities designed to provide a quality product.
-checking a reagent before using it
-running a control on your instrument before you run it
-technical review of reports
-something you are actively doing
Quality Assurance:
Planned activities designed to ensure that the quality control activities are being
properly implemented.
includes quality control manual which consists of all your quality control activities
Policy:
Statement of the overall direction of the organization with regard to the subject of
activity.
A generalized philosophy.
Procedure:
Document that specifies a way to perform an activity, the purpose and scope of the
activity, and describe who, what, where, and how it shall be done.
ex.) procedure for extracting DNA
Document (Noun):
This is a policy, procedure, forms, manuals,etc.
Document (Verb):
Creation of a record, ("if it isn't documented, it did not happen.")
Record:
Evidence of compliance with quality system, for example, your documentation.
Quality System
Quality System Documents
Quality Manager
Quality Assurance Board
Quality System Documents
Quality Manual
,written document that identifies the policies, organizational objectives, functional
activities, and specific quality activities designed to achieve the quality goals desired for
the operation of the system.
needs to be flexible and adaptable to changes in methods, techniques, and personnel.
ILAC - International Laboratory Accreditation Cooperation
A group comprising representatives from about 50 countries interested in ways to obtain
accreditation.
Quality Manual: QA policy
Describes the objectives of the program, management's commitment to the program,
and managing of the QA program.
Description of the Manual
Describes how the manual will be amended, supplemented, and distributed, and
describes the laboratory work the manual will cover.
Quality Manual: Laboratory Organization
The responsibilities of management and operating personnel.
Equipment
Describes procedures for inventorying and
maintaining equipment.
Environment
Control Specifications and monitoring procedures.
temp. logs
Analytical Methods
Criteria for the selection of methods and procedures for method validation.
Sample handling
Disbursement, storage, disposal, and special security procedures, including record
keeping.
chain of custody
Analytical Results
Requirements for reporting, verifying, and validating analytical results.
Records
Maintenance of records and requirements for confidentiality.
QS DOC: All of a laboratory's documentation.
Audit procedures
Evaluating the effectiveness of the QA program, proficiency testing requirements, and
taking corrective actions.
Contract Work
Procedures for verifying the correctness of data received from external contract
facilities.
Work Instructions
For example: A short procedure on how to make a particular reagent
OR
, How to run a small piece of equipment.
Quality Assurance Committee
Usually made up of supervisory staff or trained auditors in the lab to assist the quality
Assurance Manager in implementing quality policies and procedures. They review with
the QAM all necessary additions/revisions to the quality assurance program.
Quality Manager Duties
-Monitoring quality assurance activities to determine conformance with policy and
procedures.
-Making recommendations for corrections and improvements to the program.
-Conduct audits.
audit vs assessment
audit happens in you lab every year, internal audit team--> see if you're meeting the
standards with your team of all sections within your laboratory
lab is seeking accreditation--> assessment is done by ANAB
Management system
strong QA program with implementation of standards--> accuracy of test reports
Legal responsibility
4.1.1
Documentation on file to show that your lab is an identifiable legal entity.
Could be a statute that brings your lab into existence.
4.1.2
Objectives Section
some overarching statement of what the main goal of the laboratory is.
Permanent, temporary and mobile lab facilities....
4.1.3
For example, a satellite lab for breath test equipment or if an employee works from a
home office.
The manual needs to explain how these employees are subject to supervision, security,
etc.
Conflict of Interest....
4.1.4
Include policy statement that says "The laboratory results are free from bias and outside
influence."
Conflict of Interest Document
Individuals who affect the quality of the test result....
4.1.5(a)
"Individual with authority"\
The Laboratory Director has the ultimate authority to identify problems in the lab and
find a solution for correction. Is dependent on Unit Supervisors/Technical Managers and
staff for support in identifying departures from the quality system and reporting them.
