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Producing Valid Results (Risk Mitigation and Measurement Assurance)

Producing Valid Results (Risk Mitigation and Measurement Assurance). Learning Objectives. Measurements as Systems Identify 3 Key Components of a Measurement Quality Assurance Program Identify 3 Key Areas Impacting Valid Measurement Results. Why do we measure?. Information, knowledge

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Producing Valid Results (Risk Mitigation and Measurement Assurance)

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  1. Producing Valid Results (Risk Mitigation and Measurement Assurance)

  2. Learning Objectives Measurements as Systems Identify 3 Key Components of a Measurement Quality Assurance Program Identify 3 Key Areas Impacting Valid Measurement Results

  3. Why do we measure? Information, knowledge Confidence Risk Mitigation Regulation

  4. The Unites States Code of Federal regulations, Title 21- Food and Drugs states, “Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results.”(21 CFR 820.72)

  5. Quality Measurements • Measurement Quality Assurance Program • Collection of activities • Planned • Interrelated • Cohesive

  6. Measurement Quality Assurance Program • Process Tolerance • Design • Measurement Requirements • Process Tolerance • Risk Classification / Determination • Suitability Determination • Instrument Evaluation • Instrument Selection • Documentation

  7. 3. Producing Valid Results

  8. Key Components forProducing Valid Results Equipment Process People

  9. Equipment Manufacture’s Manual

  10. Equipment • Manufacture’s Manual • Preventative Maintenance • Operator Level • Self-Calibrations, Standardizations using pH & conductivity solutions, Exercising, Zeroing, fan filters • Organizational Level • Ancillary equipment • Vacuum pumps, oil levels, air driers, filters, bath fluids, dry well holes and inserts…. • Software & Drivers • Calibration

  11. Process Cables, Connectors, Fittings, Terminals, Switches Environment Handling and Storage Movement and Control

  12. People • Training • Initial • Periodic • Repeatability & Reproducibility • Initial • Periodic

  13. Learning Objectives • Measurements as Systems • Identify Key Components of a Measurement Quality Assurance Program • Process Tolerance Determination • Instrument Suitability • Producing Valid Results • Identify Key Areas Impacting Valid Measurement Results • Equipment • Process • People*

  14. Questions? Thank You Philip Mistretta, Metrology Manager Transcat, Inc., 35 Vantage Point Drive, Rochester, NY, 14624 Phone: (800) 828-1470 phil.mistretta@transcat.com

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