Accreditation of Forensic Science Service Providers

Transcription

1 Accreditation of Forensic Science Service Providers Laurel J Farrell Senior Accreditation Manager ANSI-ASQ National Accreditation Board Quality Matters

2 Topics Accreditation what it is and what it is not History of ANAB and ASCLD/LAB accreditation of forensic service providers Current statistics of ANAB accredited forensic service providers ISO/IEC General requirements for the competence of testing and calibration laboratories ANAB ISO/IEC 17025:2005 Forensic Science Testing Laboratories Accreditation Requirements Other possible accreditation requirements that may be evaluated in an ANAB forensic assessment activity (e.g., FBI QAS, ABFT) Building a nimble organization with a culture of quality 2

3 Accreditation Definition Third-party attestation related to a forensic service provider conveying formal demonstration of its competence to carry out specific tasks. (adapted from ISO/IEC 17000:2004) What it is Evaluation of: Conformance - With requirements Competence - Of personnel Effectiveness - Of the organization 3

4 Accreditation Definition Third-party attestation related to a forensic service provider conveying formal demonstration of its competence to carry out specific tasks. (adapted from ISO/IEC 17000:2004) What it is not An assessment of every record produced by a forensic service provider Assessment activities employ sampling Personal certification Individual test result certification 4

5 History ASCLD/LAB The American Society of Crime Laboratory Directors Laboratory Accreditation Board Initial connection with ASCLD st crime laboratory accredited Legacy Program Community voice International Program ISO/IEC Testing and Calibration 5

6 History - ANAB ANSI-ASQ National Accreditation Board 1989 ANSI-ASQ National Accreditation Board Management Systems Laboratory + Forensics Acquired Forensic Quality Services in 2011 FQS 1st ISO/IEC based forensic accreditation in 1999 ANSI-ASQ National Accreditation Board Merged with ASCLD/LAB 2016 Management Systems Laboratory Forensics 6

7 ANAB Forensic Accreditation Programs ASCLD/LAB Calibration Laboratories - Reference Material Producer (2007) ASCLD/LAB Calibration Laboratories - Breath Alcohol Measuring Instruments (2016) ANAB Forensic Science Calibration Laboratories (2017) ASCLD/LAB Forensic Science Testing Laboratories (2011) ANAB Legacy Forensic Testing Laboratories (2016) ANAB Forensic Science Testing Laboratories (2017) ANAB International (non-usa) Forensic Science Testing Laboratories (2017) ANAB Forensic Inspection Bodies (2017) ANAB International (non-usa) Forensic Inspection Bodies (2017) 7

8 ANAB Forensic Accreditation Programs ASCLD/LAB Calibration Laboratories - Reference Material Producer (2007) Transitioning to ISO 17034: 2016 General requirements for the competence of reference material producers ASCLD/LAB Calibration Laboratories - Breath Alcohol Measuring Instruments (2016) Will sunset December 31, 2018 ANAB Forensic Science Calibration Laboratories (2017) 8

9 ANAB Forensic Accreditation Programs ASCLD/LAB Forensic Science Testing Laboratories (2011) Will sunset December 31, 2018 ANAB Legacy Forensic Testing Laboratories (2016) Will sunset December 31, 2018 ANAB Forensic Science Testing Laboratories (2017) ANAB International (non-usa) Forensic Science Testing Laboratories 9

10 ANAB Forensic Accreditation Programs ANAB Forensic Inspection Bodies ANAB International (non-usa) Forensic Inspection Bodies 10

11 Current Accreditation Statistics ANAB Internat'l Inspection 2% ANAB Internat'l Testing 2% ANAB Forensic Testing 1% ANAB Forensic Inspection 5% ASCLD/LAB RMP 0% ASCLD/LAB Calibration - Breath Alc Measuring Instruments 8% ANAB Forensic Calibration 0% ANAB Legacy Forensic Testing 11% ASCLD/LAB Testing 71% ANAB Accreditation Statistics Forensic Service Provider Locations n= 627 Organizations =

12 Current Accreditation Statistics Private Corp 9% Govn't- International 8% Govnt-Fed 10% Govnt-Local 33% Govnt- State 40% TYPE OF ACCREDITED LOCATION 12

13 Cake of Requirements Top layer Forensic service provider s management system As applicable, state/local laws May include OSAC Standards FBI Quality Assurance Standards American Board of Forensic Toxicology National Association of Medical Examiners Sector specific ANAB Forensic Requirements Foundation ISO/IEC 17025:

14 ISO History and Mission Founded in 1947, based in Switzerland 1946 delegates from 25 countries national standards bodies Created an international organization to facilitate the international coordination and unification of industrial standards Mission: to promote the development of standardization and related activities in the world with a view to facilitating international exchange of goods and services and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity 14

15 What is a standard?.a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. A standard also helps to define the quality or characteristics of a product and/or a service. 15

16 ISO/IEC General requirements for the competence of testing and calibration laboratories History Previously ISO/IEC Guide 25:1990 First issued as a standard in 1999 Revised in 2005 Reviewed in No revision was initiated Revision initiated in 2015 Publication anticipated in December

17 ISO/IEC 17025:2005 & ANAB Forensic Accreditation Requirements Document Structure Section 1 - Scope Section 2 - Normative references Section 3 - Terms and definitions Section 4 - Management requirements Section 5 - Technical requirements 17

18 ISO/IEC 17025:2005 Section 4 Management Requirements 4.1 Organization Scope of work Impartiality Confidentiality of information Resources 4.2 Management System ANAB Guiding Principles of Professional Responsibility for Forensic Service Providers and Forensic Personnel, or equivalent document 4.3 Document Control Current instructions to perform work 18

19 ISO/IEC 17025:2005 Section 4 Management Requirements 4.4 Review of requests, tenders, contracts 4.5 Subcontracting of tests and calibrations 4.6 Purchasing services and supplies Agreement to perform work Allowed to a competent subcontractor Input impacts output 4.7 Service to the customer 19

20 ISO/IEC 17025:2005 Section 4 Management Requirement 4.8 Complaints 4.9 Control of nonconforming testing and/or calibration work Reactive 4.11 Corrective action 20

21 ISO/IEC 17025:2005 Section 4 Management Requirements 4.10 Improvement 4.12 Preventive action 4.13 Control of records 4.14 Internal Audit 4.15 Management Review Proactive continuous improvement Maintenance Sufficiency Internal evaluation of conformance Internal evaluation of organization effectiveness 21

22 ISO/IEC 17025:2005 Section 5 Technical Requirements 5.1 General ANAB - Reagents 5.2 Personnel Acknowledgement that all sections that follow impact the quality of test/calibration results Ensure competence Training goals Authorization to perform work ANAB - Education requirements for those who issue a report that includes test/calibration results ANAB A training program with required elements ANAB Competency testing 22

23 ISO/IEC 17025:2005 Section 5 Technical Requirements 5.3 Accommodation & environmental conditions ANAB Security and access 5.4 Test and calibration methods & method validation ANAB No new topic but added requirements Acceptable facility Appropriate Validation Uncertainty of measurement Control of data 23

24 ISO/IEC 17025:2005 Section 5 Technical Requirements 5.5 Equipment 5.6 Measurement Traceability Appropriate Authorized users Instructions for use Maintenance Tie to the International System of Units 5.7 Sampling Testing a sample and making an inference to the whole 24

25 ISO/IEC 17025:2005 Section 5 Technical Requirements 5.8 Handling of test and calibration items ANAB Chain of Custody 5.9 Assuring the quality of test & calibration results ANAB Verification ANAB - Proficiency Testing ANAB Technical Review Receipt, handling, storage, retention, disposal System for identification Quality control procedures 25

26 ISO/IEC 17025:2005 Section 5 Technical Requirements 5.10 Reporting the results ANAB Significance of associations ANAB Database search results ANAB Requirements when measurement uncertainty is reported ANAB Use of the accreditation symbol accurately, clearly, unambiguously & objectively Included information Opinions & interpretations Amended reports 26

27 Structure Comparison ISO/IEC 17025: Scope 2. Normative References 3. Terms and Definitions 4. Management Requirements 5. Technical Requirements Annex A 9001 Cross References Annex B Guidelines for Applications Bibliography ISO/IEC FDIS 17025: Scope 2. Normative References 3. Terms and Definitions 4. General Requirements 5. Structural Requirements 6. Resource Requirements 7. Process Requirements 8. Management System Requirements Annex A Metrological Traceability Annex B Management System Bibliography

28 Provides greater flexibility emphasis on the results of a process instead of the detailed description of its tasks and steps. Process Approach from ISO/IEC FDIS the resulting approach is combined with the organization taking into account the risk of not having the detailed description of each task or step in each process.

29 Focus on Information Technologies the standard now recognizes and incorporates the use of computer systems, electronic records and the production of electronic results and reports. Modern-day laboratories work increasingly with information and communication technologies and the working group felt it was necessary to develop a chapter on this topic

30 Risk Based Thinking ISO/IEC 17025:2017 page V enabled some reduction in prescriptive requirements and their replacement by performance-based requirements. Identify Assess & determine which to address Plan and implement actions to address risks and opportunities Control and monitor Rationale: establishes a basis for increasing effectiveness of the management system, achieving improved results and preventing negative effects. Risk Assessment Risk Management Risk Communication

31 Culture of Quality The degree of excellence defining the characteristic features of and associated with the forensic service provider s work product 31

32 What is Organizational Culture? It. is an expression of the employee s behavior and the meanings attached to their actions. defines the characteristic features associated with the quality of the work product. is how an organization is viewed or perceived both internally and externally. 32

33 Organizational Culture Affects how employees interact with each other with leadership/management with customers and stakeholders Reflective of mission, vision and values Fostered by management 33

34 The Value of a Culture of Quality Clear understanding of mission, vision, goals and objectives Management and leadership structure and support System and process approach Commitment on all levels through involvement of people Customer focus Continuous improvement mindset

35 Accreditation Provides a foundation for an effective organization with a culture of quality An organization continuously improving: Making data-based decisions Acting proactively to improve Reacting when necessary Accreditation is a proven tool to improve the quality of a forensic service provider s work product. 35

36 Thank you Laurel Farrell ANAB Forensics Senior Accreditation Manager (desk) (cell) ANSI-ASQ National Accreditation Board