What are types of observations and how they are classified?

Question

Accepted Answer

Observations can be classified as critical, major, or minor based on their impact on quality and compliance.

Critical observations have a significant impact on product quality and regulatory compliance.
Major observations have a moderate impact on product quality and regulatory compliance.
Minor observations have a minimal impact on product quality and regulatory compliance.
Observations can be related to equipment, processes, documentation, or personnel.
Examples of critical observations include contamination, failure to follow procedures, or inadequate validation.
Examples of major observations include deviations from specifications or inadequate training.
Examples of minor observations include minor documentation errors or minor deviations from procedures.

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