Validation

­­The term VALIDATION as stated by FDA is “Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.” [CFR 21 Part 820.3(z)]

• Our interpretation: High degree of confidence looking forward.

On the other hand, Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. [CFR 21 Part 820.3(aa)]

• Our interpretation: High degree of confidence looking back.

In reality VALIDATION is part/process specific since it is very difficult to balance the generic needs of all equipment users and the unique circumstances of each equipment implementation and dimensional inspection.

Although we are following the most effective IQ, OQ, and PQ approach, but at the same time bringing about a paradigm shift in the OQ and subsequent PQ processes that is meaningful, realistic and effective:

• A structured approach to installation and acceptance through IQ, Installation Qualification
• Executing OQ, Operational Qualification for the CMM measurement process with an in-depth analysis of risk management and measurement uncertainty instead of operational verification of the measurement system using the widely used but non-value added checklist format
• Developing and Deploying PQ, Process Qualification as a plan in place that insures the long term sustainability of the OQ results

As a part of this IQ, OQ, and PQ service, the customer will receive:

1. Documents titled IQ protocol, OQ protocol, and PQ protocol describing the processes
2. Completed IQ, OQ, and PQ forms using the process described in the protocols.
3. A detailed Process Validation Protocol explaining the measurement system process validation including but not limited to dimensional inspection methodology and associated GD&T.
4. Additional documentation pertaining to the validation of the CMM measurement system

Validation Success Produces Quantifiable Benefits:

• Effective risk management by reducing product liability exposure
• Improved accept/reject decisions for product
• Improved ability to determine process capability
• Meeting compliance and business requirements

This is our effort on applying critical thinking and risk management to produce value-added evidence!

Please contact us for more information on CMM measurement, surface finish measurement and dimensional inspection. Or Request a Quote today!