ESSENTIAL EVALUATION

[...]it's time to determine the effectiveness of the corrective or preventive actions. [...]in the CAPA cycle, the QMS requires evidence that the implemented corrective or preventive action was effective, and the intended objective was indeed accomplished. [...]to determine whether a corrective...

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Bibliographic Details
Published in:Quality progress 2021-06, Vol.54 (6), p.40-45
Main Authors: Rodríguez-Pérez, José, Peña-Rodríguez, Manuel E
Format: Magazinearticle
Language:English
Subjects:
Performance evaluation
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Summary:[...]it's time to determine the effectiveness of the corrective or preventive actions. [...]in the CAPA cycle, the QMS requires evidence that the implemented corrective or preventive action was effective, and the intended objective was indeed accomplished. [...]to determine whether a corrective action was effective, analyze the process that root cause acted upon. Common pitfall: lack of effectiveness evaluation of action taken A corrective action is considered effective if it can avoid the recurrence of the cause. [...]the evaluation of the effectiveness cannot be tied to the presence or absence of the symptom because: * The same symptom can be produced by different root causes. * The same root cause can create different symptoms. An example of an adequate verification of effectiveness is: "During the next two months, a performance evaluation of 15 associates (five from each shift, randomly selected) will be performed to verify compliance with the procedure related to the use of personal protective equipment.
ISSN:0033-524X