The Critical Reagents Program s Quality Initiatives. Critical Reagents Program (CRP)

Transcription

1 Our Vision is to protect the Warfighter by maintaining uncontested global supremacy in CBRN medical countermeasure development and delivery. DRAFT The Critical Reagents Program s Quality Initiatives February 3, 2010 Presented to: 2010 OnSite Analysis for Homeland Security, Forensics, and Environmental Restoration Amanda A. Gordon, PMP Technical Quality Manager, Critical Reagents Program URS Corporation amanda.a.gordon@us.army.mil; agordon@egginc.com Critical Reagents Program (CRP) Chemical Biological Medical Systems (CBMS)

2 The Critical Reagents Program The Critical Reagents Program (CRP) under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) manufactures and distributes products such as, Electrochemiluminescence (ECL) Immunoassays, Polymerase Chain Reaction (PCR) assays, Hand Held Assays (HHAs), antibodies, select agent antigens, nucleic acid panels, and Biological Sampling Kits that are crucial to the mission of all current and future Department of Defense (DoD) Biological Warfare (BW) agent detection and medical diagnostic systems. As a supporting program of both Biological Defense detection and medical diagnostic systems and a provider of stand-alone detection products, the Critical Reagents Program supports the warfighter and the nation. 2

3 CRP Reagents and Assays Reagents: Ingredients or raw materials used for testing and assay development Assays: Tests that can be used alone or in conjunction with specific detection equipment All CRP products come from a common repository of reference cells Unified Culture Collection Antigens and Genomic products are extracted from the reference cell culture Antigens The Antigens, weakened forms of the cells, are used to make the Antibodies Genomics Genomic materials from the reference cell cultures are used to make PCR assays Antibodies PCR Assays The Antibodies are then packaged into ECL assays and LFI assays ECL Assays LFI Assays 3

4 CRP s Mission and Vision Serve Serve as as the the principal principal resource resource of of of high of high high high quality, quality, quality, quality, validated, validated, validated, validated, and and standardized standardized standardized biological standardized biological detection detection biological biological assays assays detection detection and and reagents reagents assays assays that that and meet and meet reagents reagents the the requirements requirements that that meet meet of the of the of the of the the the requirements warfighter requirements warfighter and and of Joint of Joint the the warfighter biological warfighter biological defense and defense and Joint Joint systems systems biological biological systems systems and and defense defense support and support and support support systems systems the the biological biological the the and and biological support defense biological support defense the community the community defense biological defense biological by community by community defense defense facilitating facilitating community community by the by the the facilitating the facilitating transition transition by by facilitating facilitating the of the of new of transition new of transition new new technologies the technologies the transition of transition of new new and and of of new and new and technologies coordinating technologies coordinating their and their and coordinating advanced coordinating advanced development, development, their their advanced advanced efficient efficient efficient development, efficient development, production production production production efficient efficient and and timely timely and and timely production distribution production distribution timely distribution distribution and and timely timely distribution distribution To To be be recognized recognized as as the the provider provider of of choice choice for for a a comprehensive comprehensive portfolio portfolio of of world-class world-class biological biological detection detection assays assays and and reagents reagents to to safeguard safeguard the the warfighter warfighter and and the the homeland homeland 4

5 Selection of Management Systems to Support CRP s Mission Management system refers to what the organization does to manage its processes, or activities, so that its products or services meet the objectives it has set itself, such as: satisfying the customer's quality requirements, complying with regulations, or meeting environmental objectives. Management system standards provide a model to follow in setting up and operating a management system. 5

6 CRP Quality Initiatives CRP QA (Internal Oversight) American Association of Laboratory Accreditation (External Oversight) JPEO QA (External Oversight) ISO Guide 34 (FY10) ISO 9001 (FY08) CRP Program Office MOA Reagent Production Labs ISO (FY10) Conformance Test Labs Oversight for ISO Guide 34 and ISO Compliance A2LA Accreditation Body Oversight for products and activities related to laboratories/programs as stated in the QA Program Plan JPEO QA Program Commercial Contracts Contract Specified QA Commercial Businesses 6

7 Selection of Management Systems to Support CRP s Mission Production Laboratories: ISO Guide 34 is an international standard that gives General Requirements for the Competence of Reference Material Producers (RMPs) in combination with ISO/IEC ISO Guide 34 requires compliance with: ISO Guide 30 (Terms and Definitions Used in Connection with Reference Materials), ISO Guide 31 (Contents of Certificates of Reference Materials), and ISO Guide 35 (Certification of Reference Materials General and Statistical Principles). Testing Laboratories: ISO/IEC is an international standard that gives General Requirements for the Competence of Testing and Calibration Laboratories. Requirements are outlined in two main sections: (Section 4) Organization and management requirements (ISO 9001 elements) (Section 5) Technical requirements 7

8 Original Implementation Plan Conduct Gap Analyses Completed at 6 labs March June 2007 Complete reports August 2007 Apply for Accreditation August September 2008 Fill Gaps March-December 2007 Conduct External Audits (A2LA) November 2008 January 2009 Begin Implementation January 2008 Correct Deficiencies November 2008 February 2009 Conduct Internal Audits May-August 2008 Receive Accreditation January 2009 April

9 ISO Guide 34/ISO Implementation Plan: 2008 and Beyond Estimated timeline is contingent upon labs receiving funds and having onsite support as requested by February 2008 Draft Documents March 2008 December 2008 Apply for Accreditation June 2009 July 2009 Fill Gaps March 2008 December 2008 Conduct External Audits (A2LA) September 2009 December 2009 Begin Implementation January 2009 Correct Deficiencies September 2009 January 2010 Conduct Internal Audits March 2009 June 2009 Receive Accreditation November 2009 March

10 Accreditation Benefits Applicants Provides a credential Regular, objective check-ups Increased productivity International recognition and acceptance (adopted as the basis for accrediting laboratories globally) Staying on cutting edge Improved performance Users Confidence in accuracy of data/materials/products Customers gain efficiency by deferring to assessments by accreditation body Reduced overhead with reliance on accredited third-party labs 10

11 Accreditation Benefits International Recognition Use of these standards has encouraged laboratories and reference material producers to adopt internationally accepted testing and measurement practices This in turn allows countries to establish agreements among themselves, based on mutual evaluation and acceptance of each other s accreditation systems Such international agreements, called mutual recognition arrangements (MRAs), are crucial in enabling test data and materials to be accepted between countries As such, each MRA partner recognizes the other partner s accredited entities as if they themselves had undertaken the accreditation of the other partner s organization Currently, 54 laboratory accreditation bodies are signatories of the multi-lateral ILAC Arrangement - greatly enhancing the acceptance of data across national borders 11

12 Strategic Overview Path Forward to Technical Quality Initiatives Timeline FY07 FY08 Identify and Fill Gaps ISO Guide 34 & ISO Develop and Revise Documentation FY08 - FY10 Implementation Stability Studies Homogeneity Tests Full System Internal Audits Apply for Accreditation Full System External Audits FY10 and Beyond Accreditation and Continuous Process Improvement A2LA Accredited Labs Standardized Processes Increased Confidence in Products Increased Customer Satisfaction 12

13 Conclusion: DoD s Most Reliable Network Implementation of quality and standards starting from research and development through validation to actual use of biosensors, assays, and methods to protect us at home and abroad during any biological attack. 13