Quality Progress

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  • 1.  Back to Basics September 2020 QP

    Posted 09/10/20 09:01 AM

    A nice article, but the author should know the difference between corrective and preventive actions. What is described is the final step in the corrective action process, not preventive action, a common mistake. ISO 9000:2015 describes corrective action as" action to eliminate the cause of a nonconformity (3.6.9) and to prevent recurrence" (Bolding is mine). Preventive action, according to ISO 9000:2015 is "action to eliminate the cause of a potential nonconformity (3.6.9) or other potential undesirable situation". 

     




  • 2.  RE: Back to Basics September 2020 QP

    Posted 09/10/20 10:33 AM
    Actually both are correct.  Preventive action might be taken in response to a risk assessment or seeing a performance trend, both of which are not related to corrective action (e.g., there is no problem, but might be if no action is taken).  Preventive action is also taken towards the end of the corrective action process by implementing the solutions not only where the problem occurred, but in other areas (products, processes, facilities, ...) where there is the potential for it to occur.  This is one reason for the term CAPA used in the medical device industry.