Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Collecting Objective Evidence for Corrective Actions

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by The PPAP Assassin, Dec 13, 2017.

  1. The PPAP Assassin

    The PPAP Assassin Active Member

    Joined:
    Mar 20, 2017
    Messages:
    67
    Likes Received:
    29
    Trophy Points:
    17
    Location:
    Kent, OH
    Real quick...

    In order to officially close a corrective action, there needs to be a certain amount of objective evidence collected that proves the corrective action has worked..

    What about in situations where nothing can be done aside from waiting to see that the non conformance has not reoccurred? I've closed out a few handful of them where I have stated that there has been no further occurrences in the past 2 or 3 months..

    My question is, is that legal from an ISO auditors standpoint? Or, does there need to be actual evidence in the form of a procedure change, or something similar?

    Thanks!
     
  2. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    724
    Likes Received:
    356
    Trophy Points:
    62
    We use that one a lot, especially for active routine processes. But you usually do something - a procedure change, awareness training, etc. You then verify if it took hold.
     
  3. normzone

    normzone Well-Known Member

    Joined:
    Aug 3, 2015
    Messages:
    137
    Likes Received:
    76
    Trophy Points:
    27
    My take on it - we are required to have "an effective corrective action system".

    It would be unreal to expect any system to be 100% flawless - I would expect that periodically you'd be compelled to close a corrective action with at best partial effectiveness. I kept one open for a couple of years once, because in order to demonstrate it's effectiveness somebody would have to purchase a multi-thousand dollar component in order to recreate the challenges of the original that began the CAR.

    I finally closed it noting that it appeared to have been resolved in the field but I could not replicate it in house for financial reasons. As always, your auditor experience may vary, mine said " well enough " and moved on.
     
  4. RoxaneB

    RoxaneB Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    868
    Likes Received:
    994
    Trophy Points:
    92
    Location:
    Ontario, Canada
    Would not the lack of recurrence imply that the corrective action worked?

    That said, I realize that sometimes we simply cannot reproduce the events which lead up to the need for correction action. I, too, have used the 3-month time frame in these situations, as long as I also have evidence of training, process changes, etc.
     
  5. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    724
    Likes Received:
    356
    Trophy Points:
    62
    What if what you're correcting is only a rare occurrence to begin with? We can go years between some things occurring.
     
  6. RoxaneB

    RoxaneB Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    868
    Likes Received:
    994
    Trophy Points:
    92
    Location:
    Ontario, Canada
    That would be one of the scenarios to which I was referring.
     

Share This Page