Quality Events
What was wrong, what was done about it, and whether it worked.
13 steps · 10 questions · 6 screens on this shelf
The screens on this shelf
Records
Nonconformances
Something is wrong with identified material. Containment before analysis: what is affected, where it is, and whether any of it has already gone to a customer.
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Records
Corrective & Preventive Actions
The investigation, and — the part that is always skipped — the check that it worked. A CAPA closed without a verification date is closed on hope.
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Records
CAPA Actions
What each CAPA actually asked somebody to do, and whether they did it.
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Records
Audits
Internal, supplier, customer and certification audits, with the finding counts that say whether it was a good audit or a quiet one.
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Records
Audit Findings
Every finding that is not an observation has to become an action. The CAPA link is what proves it did.
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Records
Customer Complaints
The regulated half of a complaint, which a service case cannot carry: the reportability decision, its clock, and whether the product actually failed.
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