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CAPA programs

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  • #36746

    Pritesh
    Participant

    Hello,
    I need some help.  I have been tasked to develop a Preventive Action (PA) methodology for the company that I work at.  We currently have a CAPA program, but the PA side of it needs serious work. 
    As I think more to it, most companies say that if you open a CAPA, you should have both; the CA to correct the issue on hand, and the PA to prevent it from happening again. Is this the right philosophy to take. 
    Do you think that the CA should be seperated from the PA? 
    Is the DMAIC methodology a good process to use when trying to do a PA?
    Any help in this matter is greatly appreciated.
     
    -Pritesh.

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    #106760

    Scott C.
    Member

    Pritesh,
    I will attempt to answer your questions…..
    Do you think that the CA should be seperated from the PA? 
    It depends.  If the company you work for is regulated by the FDA, then you have to have both.  Even if you are not regulated by the FDA, it just makes good business sense to keep the two concepts together because if you don’t, how will you ever know that your preventive actions were effective or not? If you didn’t do both, then if you had something that happened requiring CA, then how would you know whether or not this is a reoccurrence?  That is where the PA comes in.  It helps to establish the link between doing preventive measures and monitoring if there are any reoccurrences.
    Is the DMAIC methodology a good process to use when trying to do a PA?
    Yes, it could be used.  I have not personally used the DMAIC process for the CAPA process.  I have witnessed the PDCA cycle used for the CAPA process and heard there was a great deal of success.  Since I have no experience in doing a DMAIC project on the CAPA process, I will leave that to some of the other posters.
    Hope I have helped,
    Scott

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    #106772

    jediblackbelt
    Participant

    I have pretty much used PFMEA for the PA side of the coin.  What are the potential causes and then go after them.  We also do a lot of PA work with Kaizen suggestions for improvements.  Don’t get too wrapped up in the “well if they have already seen it then is it CA?”  Bottomline is to solve the problems at hand and as long as you are consistent in your techniques you can always argue for one side or the other.
    DMAIC is always a good process, but again don’t get hung up on if you Define a problem then isn’t it CA instead of PA?  Basic premise of all the tools out there is to find a problem, fix it, and then repeat the process.

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    #106803

    Nitin Sahni
    Participant

    Pritesh –
    You might initiatie a PA program based on following tools:
    1. FMEA – You identify and priritize potential causes and then take countermeasures so as to reduce RPN’s
    2. Control Charts – Early warning signs based upon various out of control situations
    Regards
    Nitin Sahni
     

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    #106808

    GDS
    Participant

    CAPA
    CA – CA’s find you. The event/failure happened.
    PA – PA’s are found by you before they occur.
    We are always looking for PAs when we process map, perform a process / policy audit, we encourge our employees to be on the look out for PAs, our monthly safety walks.
    When we have a CA in one process, we look at all processes for PAs of the same nature.

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