GLOSSARYGlobal

Effectiveness Check

Objective evidence gathered after a corrective or preventive action is implemented, to show that the cause was removed and the nonconformity has not recurred. In a recall the term means something different: verifying that consignees received the recall notice and acted on it.

Where it is written: ISO 13485:2016 clauses 8.5.2(f) and 8.5.3(e); 21 CFR 7.42(b)(3) for the recall meaning; no standard defines the phrase for corrective and preventive action
Also called: effectiveness review

Avoid This Mistake

In recall rules, the term means something else: verifying that consignees received the notice and acted on it (21 CFR 7.42(b)(3)).

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Effectiveness Check

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