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Corrective and/or Preventive Action Procedure

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Make-it-simple, Oct 2, 2015.

  1. Make-it-simple

    Make-it-simple New Member

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    Hello fellow QA Professionals; I am putting together a new procedure for CAPA and want to implement some of Duke Okes problem solving and corrective action themes. I feel that creating the templates and forms would be easy. That being said, does anyone have a good example of a procedure which would discuss newer methods used today for corrective action, root cause analysis, and problem solving?

    Thanks!
     
  2. MCW8888

    MCW8888 Well-Known Member

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    In the resource tab of this website there is a presentation on problem solving based on the PDCA method. This, I think, might be then newer method of cottective action that is basef on root cause, Hope this helps. Have a nice weekend
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Do you work in a regulated industry where the concept of CAPA is a common expectation? If not, one procedure for Corrective Action and Preventive Action is, in my experience totally inappropriate. There is woefully bad understanding of both - particularly when it comes to taking actions which seem preventive in nature, but in response to a problem which has occurred, so to have pushed the 2 into one document causes this confusion to be reinforced, in my mind. I'd strongly suggest separating them out before looking into specific techniques. Actually, when you do, you'll see that they demand different approaches which cannot be commonized in one procedure. If you ARE in a regulated industry - good luck!
     
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  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I agree with Andy.

    We can, especially from here on out, rightfully call Corrective Action problem solving (well, we always could...) and Preventive Action risk management (again, we could have always called it that). The methods and tools have been in place for a long time. In the old days we called them the Seven Management Tools but since we've added to the list. The only one true criteria for selecting a tool is What Is Effective For Your Organization.
     
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  5. RoxaneB

    RoxaneB Moderator Staff Member

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    To me, the CAPA procedure(s) scope was to capture the flow of the CAPA activities (from initiator to resolver to analyzer and so on). The idea of using it to detail the methods of corrective or preventing something seems non-value-added to me. The form(s) can identify the sections where suitable methods are to be applied. Training can detail the methods applicable to the appropriate situation(s). The procedure was, in my opinion, used to address responsibilities and flow of information.
     
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  6. Nikki

    Nikki Well-Known Member

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    We have our procedures separated as well.
     

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