3.1. Process Changes / Facility Changes
Modifications made to manufacturing processes or production facilities to improve efficiency, adapt to new regulations, or address quality issues.
Evaluation of the impact of any changes to the manufacturing process on product quality and compliance.
Verification that the modified manufacturing processes consistently produce a product that meets the pre-determined specifications and requirements.
Oversight and control of suppliers to ensure the continued quality and compliance of purchased materials and components.
First Article Inspections to evaluate the conformance of the initial production unit after a process or facility change.
Assessment of the impact on product quality and compliance when transferring production to a new or modified facility.
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Independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose.
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Ensuring that the testing methods used to evaluate product quality and compliance are reliable and suitable.