1 What’s the best quality program for your lab? Grant Maxie, DVM, PhD, DACVP Director, Animal Health Laboratory; Co-Executive Director Nadine Ryan, BSc Quality Manager, Laboratory Services Division, University of Guelph CAHLN-RCTLSA annual meeting, Calgary, AB June 8, 2010
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Whats the best quality program for your lab? Grant Maxie, DVM, PhD, DACVP Director, Animal Health Laboratory; Co-Executive Director Nadine Ryan, BSc Quality.
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What’s the best quality program for your lab?
Grant Maxie, DVM, PhD, DACVPDirector, Animal Health Laboratory; Co-Executive Director
Nadine Ryan, BScQuality Manager, Laboratory Services Division, University of Guelph
CAHLN-RCTLSA annual meeting, Calgary, AB June 8, 2010
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• Why have a quality program?
• Alternatives
• Comparisons
• Components of a quality system
• Test validation
• Discussion/Questions
What’s the best quality program for your lab?
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Why have a quality program?
meet the expectations of clients especially if a requirement of contracts
ensure credibility of results – locally, nationally, and internationally
deal with complaints and solve problemsroot cause analysis
minimize re-work employee recruitment and retention business sustainability and continuity continuous improvement!!
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Stakeholders/partners of the AHL:
Livestock producers
& animal owners
Practitioners
AHL
CFIA
WOAH (OIE) Public
healthUniversity
Provincial agriculture ministry
Industry
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AHL function and structure
Client service
Laboratory testing
Quality program
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What client services do AHL’s provide?
timely, accurate diagnostic testing credible consultative services support for teaching and research activities strongly client-focused data for risk management - wellness, on-farm food safety, quality assurance animal health surveillance data - public health link (CAHSN – CNPHI)
Periodic strategic planning Management and staff involvement and
commitment
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Overarching quality principles
say what you do do what you say prove it improve upon it
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Accreditation routes
1. ISO 9001:2008 Quality Management Systems registration, customer-focused
2. ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories test-specific scope accreditation
3. AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory, v 4.3 incorporates ISO/IEC 17025/OIE standards
4. OECD Good Laboratory Practice (GLP)
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1. ISO 9001:2008 registration
focuses on customer satisfaction and managing the organization’s interconnected processes to meet the customer’s and regulatory requirements
includes management responsibility, resource management, product (service) realization, and measurement, analysis and improvement
the requirements of ISO 9001 are generic and apply to all organizations
involves annual surveillance audits and a registration audit every 3 years
general in scope, and does not involve assessment of competence to perform individual tests
Cost = ~$5,000 + expenses / year
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Why ISO 9001 for a lab?
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Continuous improvement cycle – plan, do, check, actFor a laboratory – substitute “service” for “product”
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2. ISO/IEC 17025 accreditation
expands upon the ISO 9001 generic requirements, rewriting to specific laboratory requirements and adding technical requirements relevant to the laboratory’s competence to produce accurate and reliable results
federal labs (CFIA, USDA) typically operate under an ISO/IEC 17025 standard, and work subcontracted from them must meet this standard
biennial external audits are required, questionnaire in intervening years
accreditation is scope-specific (limited to audited tests) and posted on the website of the national accrediting body, e.g., Standards Council of Canada (SCC)
Cost = ~ $6,000 - $29,000 + expenses / year depending on # of tests
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Why ISO/IEC 17025 for vet dx lab? Internationally recognized Global acceptance of laboratory
data Canada’s accreditation bodies
(SCC & CALA) are members of the International Laboratory Accreditation Cooperation (ILAC) and evaluated by other members
The ILAC network consists of 135 bodies representing 88 different economies
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3. AAVLD accreditation
publically supported veterinary diagnostic labs only has evolved from a peer-help process now based on the OIE Quality Standard and Guidelines
for Veterinary Laboratories: Infectious Diseases, 2008, which is consistent with the ISO/IEC 17025 standard
external audits vary, with a maximum of 5 years between audits
42 accredited labs in North America – BC and ON in Canada
annual fee of $500, audit year = $1,000 + $500/branch lab + local expenses
ISO/IEC 17025 flexible scope (tentative) include multiple test/test types within a broader
scope, e.g., “veterinary microbiology” USA - A2LA (American Association for
Laboratory Accreditation) http://www.a2la.org/ Veterinary Laboratory Accreditation Program
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Components of a quality program
ISO section 4 – Management requirements4.1 organization and management – authorities4.2 quality system – quality policy and objectives
documented in a quality manual
4.3 document control4.4 review of requests, tenders, contracts4.5 subcontracting of test services4.6 purchasing of services and supplies4.7 complaints4.8 control of nonconforming testing and test results4.9 corrective and preventive actions4.10 records management4.11 internal audits4.12 periodic management reviews
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Components of a quality program
ISO section 5 – Technical requirements5.1 general5.2 personnel (competence, training)5.3 accommodation and environmental conditions5.4 test methods and method validation
SOPs, documented proficiency
5.5 equipment – maintenance, calibration5.6 measurement traceability – reference materials5.7 specimens - sampling5.8 handling of specimens5.9 ensuring the quality of test results - QC5.10 reporting of test results
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Challenges in maintaining any Q program
staying current – annual/biennial review/ updating of all materials
internal auditing – how frequent, followup on CAPAs
trend analysis – QC on tests, trends in nonconformances
Volume 45, Special Issue: Validation and application of diagnostic tests used in veterinary
epidemiologic studies AAVLD Workshop on Test Validation AAVLD Epidemiology Committee
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Summary
The bottom line of an effective and auditable laboratory quality program is client satisfaction through rigorous monitoring of valid tests and continuous improvement of processes.