Laboratory Accreditation and Data Certification

I. 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 -- II. 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 -- III. Principles of Laboratory Accreditation -- Description -- Strengths and Weaknesses -- Public Perception and Confidence and Scientific Validity -- Cost and Benefits -- Effectiveness and Integrity -- IV. 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 -- V. 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 -- VI. 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 Vendor Certification - Are These Systems Needed? -- Improvement of the Current Programs through Application of Total Quality Management Principles -- VII. 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 -- VIII. 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 -- IX. 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 Samples 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 ProposedAccreditation and Certification Program -- X. 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 -- XI. 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 -- XII. 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 -- XIII. 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 -- XIV. 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.