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Preventive Action removed from ISO 9001:2015?

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Venkatesh, Aug 12, 2016.

  1. Venkatesh

    Venkatesh Member

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    In 2015 there no preventive action
    Should we remove from the process /CAPA? Only corrective action need to be taken?
     
  2. normzone

    normzone Well-Known Member

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    Preventive action seems to be an appropriate tool to use as part of risk management.
     
  3. Venkatesh

    Venkatesh Member

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    What about CAPA shall we remove preventive action?
     
  4. Bev D

    Bev D Moderator Staff Member

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    The removal of the specific section on Preventive Action separate from Corrective Action was due in part to the absolute confusion regarding the nature of Preventive Action and Corrective Action to prevent recurrence.

    Preventive Action was intended to be taken to prevent Problems - or non-conformances - that had not yet occurred.
    Corrective Action was intended to be taken on Problems - or non-conformances - that had occurred. And where appropriate that action was to prevent recurrence.

    You must still have a system to take Corrective Action to prevent the recurrence of Problems that have occurred.

    You also need to have some risk based thinking which prevents occurrence of problems that have not yet occurred...
     
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  5. tony s

    tony s Well-Known Member

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    In 2015, the framers of the standard decided to go two (2) steps backward in determining preventive actions. First step backward: determine potential undesirable effects when planning for the QMS. Second step backward: adopt the risk-based thinking concept. Thus, any organization with a mindset for managing risks will no longer have the need for requirements on determining and implementing preventive actions.
     
  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Bev D and Tony S: well said! :D
     
    Last edited: Aug 14, 2016
  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Agree 100% with Tony and Bev.

    8.5.3 has been my biggest source of discomfort with ISO 9001:2008. It suggests we get up in the morning and say "Let's go do a preventive action today!" So many times I would review this process with clients and they would produce one or two, just so they could show conformance to the standard and avoid a nonconformance. It was a non-value-added activity. Realistically, organizations behave differently. We "front load" these considerations in the planning stage. The 2015 version recognizes that and so, has done away with the confusing 8.5.3.
     
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  8. Chris Glover

    Chris Glover Active Member

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    I always disagreed with the concept of linking CA with PA...
    CA happens AFTER a problem occurs..you have containment, root cause...etc
    PA is supposed to address issue BEFORE they happen..no containment, no root cause...

    I think they were linked because someone liked the acronym "CAPA" ;)
     
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  9. Costas Chantzis

    Costas Chantzis New Member

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    I concur with Tony S. and Bev D.
    In my view, the FDA correctly wants the industry to make each of its Quality System related disposition decisions based on user risk, NOT profit risk. Risk must be reduced As Far As Possible (AFAP) within current state-of-the-art. In the past, a change in labeling info or a few more warnings on the packaging or improved training of medical practitioners were considered proper fix but not anymore. This direction is consistent with FDA's emphasis on Quality-by-Design (QbD), design quality into the product, NOT test 100% of it at final inspection. We might argue about a number of not so clearcut FDA regulations but I believe this one is in the right direction.
     
  10. BradM

    BradM Moderator Staff Member

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    I am kind of torn on this one.
    On the one hand, I totally agree with the previously mentioned points. You have a deviation.... instant CAPA. So some poor soul gets stuck with this 8 page document to complete on his/her own; and then ends up in a ping-pong match with QA regarding whether the wording is sufficient or not; whats correction/CA/PA; if there is a PA; is it needed; etc. Preventive Actions, to me, should be part of the process improvement program like Lean/SS.

    On the other hand, if it (PA) isn't required somewhere, I'm not sure anyone will do it if it's not required. Who is going to do it, and what will motivate them?

    Take for example, a situation where two parts are glued together temporarily until it can be passed on to the final assembly. Procurement, being the good folks that they are, finds an adhesive a lot less expensive and recommends using it. Shortly after, problems start arising, as the two parts are shifting before they can be permanently attached.

    Correction: Use the adhesive that had been used previously.
    Corrective Action: Write in the procedure what type of adhesive is to be used (ironically, there was no mention in the procedure before...).

    Well... technically we're done.

    But will there ever be any preventive action put in place on writing procedures? Will anyone at the company take the time to critically look and recommend a checklist/flow diagram/ etc. for writing procedures?
    Who will ever take any proactive measures to mistake proof the system, if it's not tied to something?

    I think in the end it's a good idea to separate them. Primarily, because I see so few CAPA'S done correctly and as a team. But it is nice to see requirements in place to at least have the organization address Preventive Action.
     
  11. Ganesh Sundaresan

    Ganesh Sundaresan Active Member

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    That's sort of Procedure for Procedure, isn't it. I would rather screw the guy who reviewed the procedure.

    On the larger point, 10.2.1 has a room for this, I guess;
    "e) update risks and opportunities determined during planning, if necessary;
    f) make changes to the quality management system, if necessary."
     
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  12. tony s

    tony s Well-Known Member

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    Clause 6.1 of the 2015 version can provide guidance for organizations to address preventive actions which is defined as "actions to eliminate causes of potential problems or other potential undesirable situation". If risks are determined during planning for the QMS and/or its processes, it will help organizations to "prevent, or reduce, undesired effects" (see 6.1.1c). In 6.1.2, there's a requirement to plan the actions to address risks and how these actions are to be integrated/implemented into the QMS processes. The actions are also required to be evaluated for effectiveness and must be proportionate to the potential impact on product/service conformity. Reading through these requirements gives us the impression that Clause 8.5.3 of the 2008 version is still very well covered by the 2015 version.
     
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