CBA Practice Questions - ASQ Certified Biomedical Auditor Exam

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During a supplier audit, an auditor observes that the supplier's employees are following undocumented procedures that differ from the written SOPs. How should the auditor classify this finding?

Observation only, since no regulatory requirement is cited Nonconformance, because actual practice does not conform to documented procedures Opportunity for improvement, because the undocumented practices may be more efficient Minor nonconformance only if the difference creates a product risk

Correct Answer:

Nonconformance, because actual practice does not conform to documented procedures

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