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

phil.mistretta@transcat.com