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• Confidence• Risk Mitigation• Regulation
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)
Quality Measurements
• Measurement Quality Assurance Program– Collection of activities– Planned– Interrelated– Cohesive
1. Process Tolerance– Design– Measurement Requirements– Process Tolerance– Risk Classification / Determination
2. Suitability Determination– Instrument Evaluation– Instrument Selection
• Documentation
Measurement Quality Assurance Program
3. Producing Valid Results
Key Components forProducing Valid Results
1. Equipment2. Process3. People
Equipment
1. Manufacture’s Manual
Equipment
1. Manufacture’s Manual2. 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
Process
1. Cables, Connectors, Fittings, Terminals, Switches
2. Environment3. Handling and Storage4. Movement and Control
People
1. Training– Initial– Periodic
2. Repeatability & Reproducibility– Initial– Periodic
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*
Questions?Thank You
Philip Mistretta, Metrology ManagerTranscat, Inc., 35 Vantage Point Drive,
Rochester, NY, 14624Phone: (800) 828-1470