
Human Error; Human Error Prevention;
Human Error Reduction; Error; Human Performance; Human Performance Improvement;
Root Cause Analysis; Corrective Action;
Process Improvement
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Implementing a QMS in the Laboratory – NELAC Accreditation Paul Mills |
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Audience |
Laboratory managers, supervisors and analysts. Laboratory auditors. Users of laboratory services. |
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Learning Outcomes |
Upon completion of this seminar, one will be able to: · Understand and apply laboratory quality terminology; · Understand the requirements of laboratory quality standards and their underlying principles; · Design and implement a laboratory quality management system; · Given knowledge of auditing, assess the effectiveness of a laboratory quality management system; · Apply for or maintain NELAC accreditation. |
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Outline |
Summary of the NELAC Standards · PBMS · ISO 17025, ISO 9001, ISO 9002 · Proficiency Testing Program · On-Site Assessment · Accreditation Process · Laboratory Quality System Scope of Accreditation · Field · Matrix · Technology/Method · Analyte/Analyte Group · Supplemental General Laboratory Requirements · Organization and Management · Quality System · Establishment · Essential Quality Controls · Data verification · Audits, · Personnel · Physical Facilities · Accommodation · Environment · Equipment and Reference Materials · Measurement Traceability and Calibration · Test Methods and Standard Operating Procedures · Sample Handling, Sample Acceptance Policy and Sample Receipt · Records · Laboratory Report Format and Contents · Subcontracting Analytical Samples · Outside Support Services and Supplies · Complaints Chemistry Requirements · Quality Systems: Positive and Negative Controls · Analytical Variability/Reproducibility · Method Evaluation · Detection Limits · Data Reduction · Quality of Standards and Reagents · Selectivity · Constant and Consistent Test Conditions Documentation for Accreditation · The Laboratory's Accreditation Application · Previous Assessment Reports · Proficiency Test Sample Results · Official Laboratory Communications With the Accrediting Authority and Associated Records · Laboratory Organization Charts · Signature Log · Personnel Qualifications, Experience and Training · Laboratory Quality Manual · SOPs, Including Those for the Test Methods for Which Accreditation Is Sought · Instrumentation and Equipment · Standard and Reagent Origin, Receipt, Preparation, and Use · Initial Method Validation Studies · Demonstrations of Capability for Each Analyst · Test Method Measure of Precision, Central Tendency and Accuracy · Sample Receipt and Handling · Internal Audits · Software Documentation and Verification, Software and Hardware Audits, Records of Changes to Automated Data Entries · Annual Management Review · Document Control Records · Corrective Action Reports · Complaints · Subcontractor Registry · Measurement Uncertainty Calculations · A Sample Client Report Ethics in the Laboratory · Ethical Conduct in Business · Standards of Behavior · Professional Codes · Understanding Goals — How and Why the Analyst Contributes to Goals · Independent Judgment · Lab Fraud · Definitions · Consequences · Examples · Data Integrity · Data Integrity Plan · Management Responsibilities · Training · Control and Documentation · Information Processing and Reviews · Flowcharts · Responsibilities · Physical and Electronic Data Security · Data Access · Data Use · Data Storage · Confidential Business Information — Client Protections · Plagiarism · Definitions · Examples · Licensing and Copyright Protection · Definitions · Examples · Ombudsman · Access · Confidentiality · Corrective Action |
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Handouts |
• Copy of the visual aids • Typical laboratory QMS procedures • Supplemental
reading materials |
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