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This book provides descriptions of current laboratory accreditation schemes and explains why these schemes fall short of assuring data purchasers that the data produced from accredited laboratories are always quality products. The book then presents a system for laboratory accreditation in conjunction with data certification that assures data purchasers their data are useful for the purposes for which they are intended. Simple quality assurance and quality control techniques, in addition to concepts of total quality management, are described and then applied to the environmental laboratory industry. This "System For Success" was developed from real problems and real solutions within the industry and represents an integration of proven techniques that offer a better way to ensure quality laboratory data is obtained. Laboratory Accreditation: A Workable Solution is a must for government officials, environmental professionals, independent environmental laboratories, hazardous waste disposal industries, chemical manufacturers, QA professionals, and testing laboratories.
Table of Contents
LABORATORY ACCREDITATION AND CERTIFICATION-HISTORICAL PERSPECTIVE AND DEFINITION OF NEED. Definition of Need. The Goals of Laboratory Accreditation/Certification. Process Inspection Versus Product Inspection. Evolution and Description of the Current Programs. The Role of the Government in Accreditation and Evaluation. The Role of Professional and Trade Organizations. The Role of the Laboratory Industry. The Role of Private Certification Companies. Statement of the Problem: Current Programs Do Not Effectively Meet the Goals. The Solution-An Introduction. CERTIFICATION, ACCREDITATION, REGISTRATION AND LISTING. Definition of Terms. Use of the Terms Accreditation and Certification. Current Use of Related Terms. Public Perception and Confidence of Programs and Terms. PRINCIPLES OF LABORATORY ACCREDITATION. Description. Strengths and Weaknesses. Public Perception and Confidence and Scientific Validity. Cost and Benefits. Effectiveness and Integrity. PRINCIPLES OF PRODUCT CERTIFICATION-AS RELATED TO LABORATORY ACCREDITATION. Description. Third-Party Product Certification Programs. Listing Programs. Strengths and Weaknesses. Public Perception and Confidence and Scientific Validity. Cost and Benefits. Effectiveness and Integrity. Description of Current "Certification" Programs. Description of Current "Listing" Programs. Critique-Do the Current Programs Meet Product Certification Requirements? Product Certification and Data Inspection-The Critical Link. THE ENVIRONMENTAL PROTECTION AGENCY CONTRACT LABORATORY PROGRAM-A DE FACTO CERTIFICATION PROGRAM THAT INCLUDES PRINCIPLES OF EACH SYSTEM. Introduction. Pre-Award Elements. Post-Award Elements. CLP Strengths and Weaknesses. Successful Application of the CLP. Public Perception and Confidence and Scientific Validity. Cost and Benefits. Effectiveness and Integrity. THE TOTAL QUALITY MANAGEMENT APPROACH. Description. Understanding Total Quality Management-Deming's Fourteen Points. Total Quality Management and its Relation to Accreditation and Certification Systems. The Purpose of Certification and Accreditation in Relation to Vendors and Purchasers. Vendor Accreditation and Purchaser Certification - Are These Systems Needed? Improvement of the Current Programs Through Application of Total Quality Management Principles. THE SOLUTION-A SYSTEM FOR INDEPENDENT THIRD-PARTY CERTIFICATION OF ANALYTICAL DATA. Description. Appraisal of Process Capability. Appraisal of the Ability of the Laboratory to Perform. Specifications and Requirements of the System. The Role of Accreditation and Certification Bodies and the Role of Data Purchasers. Third-Party Certification Authorities. Oversight of Third-Party Organizations. IMPLEMENTATION CONSIDERATIONS. Introduction. Roadblocks to Implementation of a National Program. Reluctance of the Federal Government. Reluctance of Laboratories to Accept a National Program. The General Approach-A Schematic Design. Accreditation and Certification Criteria. Tiered Approach to Defining Requirements. The Future System-Quality Assurance or Chaos? "New" Requirements. Old Requirements-Redesigned. Responsibility for Development of Quality Specifications and Requirements. Responsibility for System Logistics. Distribution of Accreditation and Certification Information. Appeals, Arbitrations, and Liability. The Importance of Education. Cost and Benefits. Additional Hurdles to Implementation. PERFORMANCE EVALUATION MATERIALS-A VITAL ELEMENT OF THE SYSTEM. Introduction. Definition of Terms. Current Use of Blind Samples in Laboratory Evaluation Programs. Real Matrix Samples Versus Synthetic Samples-Are Both Types Valid? Internal Versus External QC Samples. The Use of Performance Evaluation Materials by Industry. The Optimal Solution-Use of Performance Evaluation Materials by Both Accreditation Programs and Data Purchasers. Use of Performance Evaluation Materials Versus Split Samples. Use of Performance Evaluation Materials to Assist in Data Review and Assessment. Performance Evaluation Materials Suppliers. Cost of Performance Evaluation Samples. Use of Performance Evaluation Materials in the Proposed Accreditation and Certification Program. APPLICATION OF THIS SYSTEM TO NON-ENVIRONMENTAL LABORATORIES. Comparison of the Mission of Non-Environmental Testing Laboratories to Environmental Testing Laboratories. Key Elements of the System that Apply to All Laboratory Types. Applicability of the Concept. THE IMPACT OF NATIONAL LABORATORY ACCREDITATION ON INTERNAL QUALITY ASSURANCE AND CONTROL. Internal Laboratory Quality Assurance-Research and Development QA Versus "Contract Chemistry" QA. Elements of a Formal Internal Quality Assurance Program. Internal Quality Assurance-Why It is Needed. Internal QA-More Critical Than Ever Before. THE ROLE OF INDUSTRY IN LABORATORY ACCREDITATION AND DATA CERTIFICATION. Introduction. Industry's Role. Criteria for Data Purchase. Cost of Poor Data to Industry. Industry's Responsibility. Tools to Assist Industry in Meeting Their Responsibility. Future Responsibilities for Industry. SUMMARY OF THE PROBLEM AND THE SOLUTION. Restatement of the Problem. The Problem-Stated in a Slightly Different Way. Synopsis of the Solution. Potential Future Application of the Solution. Limited Recommendations. THE FUTURE IN THE 90's. Introduction. The CLP-Is it a Good Model-Or a Failure? Projections for the Future for Environmental Data. Final Hope for the Future. Index.
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