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. 1.Process Tolerance – Design – Measurement Requirements – Process Tolerance – Risk Classification / Determination 2.Suitability Determination – Instrument Evaluation – Instrument Selection Documentation Measurement Quality Assurance Program

7. 3. Producing Valid Results

8. Key Components for Producing Valid Results 1.Equipment 2.Process 3.People

9. Equipment 1.Manufacture’s Manual

10. Equipment 1.Manufacture’s Manual 2.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 1.Cables, Connectors, Fittings, Terminals, Switches 2.Environment 3.Handling and Storage 4.Movement and Control

12. People 1.Training – Initial – Periodic 2.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