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How many People work for your company

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Jamie Lill, Mar 17, 2016.

  1. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    ISO does not deal with failures, it says we must deal with them. I agree that corrective action does not always work the first time. When it does not work, we have not found the true cause(s) or implemented appropriate solutions.

    I had a student with Dyslexia who was aided (it was not a cure, but by some magic it helped) with colored paper. It doesn't work for all Dyslexic people, and when they are diagnosed they may find different colors work for different people. My student was aided by light blue, light gray and light tan. There are even colored Mylar overlays for computer screens, or times when colored paper is not available. I once had a colleague who, upon being diagnosed as an adult, was sent to a special school where she learned to read write backward. It worked - she turned out to be a good NDT inspector. My Samsung tablet even has a screen setting for Kindle books where I can select the background color... Dyslexia is pretty common and often can be addressed in order to improve performance. We did not have colored Mylar sheets for Dyslexic people in those days.

    It may be possible to set the person's computer screen to a different background color, if it helps.

    People make mistakes for any number of reasons. As in dealing with safety hazards, we should try an engineering solution first (error proofing, which the 2015 version of the standard calls for) then an administrative solution (shorter task time, rotating duties, maybe even reassignment) and lastly personal solutions like training.
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    ISO is not supposed to be this hard. A risk chart is not required. Nor is a risk register, or even a process map.

    What is required is for the organization to identify risks and address them through (management's prerogative, so long as customer requirements are met) accept, reduce, or eliminate. This requires some thought, but would it take less time than dealing with errors? Would it cost less than rework or wasted time/materials?

    There are other ways to demonstrate RBT. I have listed some sources for methods in the Risk Based Planner I put in the Resources Forum. If you put in place controls and checks as appropriate, and check to see if they are working, feel free to point out to whomever that you did so in order to control risk of xyz. A procedure might even have some introductory statement, and list who is the internal/external customer for the process and what the outputs are - this can help you "demonstrate" that you have identified process interactions.

    The technical committees who produced ISO documents 9001, 14001 and (going through update 45001, safety) purposely avoided listing specifics on how risk is addressed so as to give smaller organizations like yours the freedom to establish and maintain a system that is not a paperwork burden.
     
  3. Eric Twiname

    Eric Twiname Well-Known Member

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    LOL...I think we are agreeing violently again...

    There is a "theoretical official" and a "practical official".
    ..and I am following my nature and staying on the practical side...

    Can I make a case, and push things up the chain...sure. But cost/benefit rarely warrants that in my experience. for practical purposes, the CB auditor (if they're worth anything) can be the end of the chain. In all cases I've seen so far, it is faster and cheaper to comply with the auditor than to argue a point with his/her superiors.
    Does that mean we do things that might not really be necessary? Sure. But doing the unnecessary things can be the easier path than standing up for a point.

    At the end of the day, the goal is to get back to work and make money. If this is cheaper by arguing up the chain, then do it. If it is cheaper to do something stupid for an auditor, then I'll do something stupid for an auditor.

    To the OP...saying that "The CA is to accept that this happens and I choose not to address this...cost/benefit analysis attached" is how I would handle it...assuming of course that the Cost/Benefit actually shows that it isn't worth addressing.

    Who knows...maybe I've just had decent CB auditors and have a very skewed viewpoint...it certainly is possible.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Eric, no product designer or manufacturer asks for the final say on how to do their work from the QC people...
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I cannot believe what I just read... Now I can't un-read it!o_O:cool:
     
  6. Eric Twiname

    Eric Twiname Well-Known Member

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    Reminds me of another thread here where we discussed whether it is a company's responsibility to hold an auditor accountable or to fight a stupid ruling.
    We disagreed there...and this is the same topic methinks. Let's not derail this thread any more than we (probably me) already has.
    Business is business.
     
  7. hogheavenfarm

    hogheavenfarm Well-Known Member

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    I agree with Eric, sometimes is it 'beneficial' for a company to accommodate a foolish auditor, it is all about risk after all. The QM doesnt make those decisions, it comes from higher up. The company may decide not to fight an NC and simply accept it to maintain certification, to minimize expenditure, or simply not to make waves. That may not be my call. I can advise Management on the facts, but I cannot choose to fight anything without Top M backing.
     
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  8. tony s

    tony s Well-Known Member

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    Just to assist those who would like to contribute to this thread, here's the ISO 9000:2015 definition:
    Corrective action - action to eliminate the cause of a nonconformity and to prevent recurrence.
    Note 1. There can be more than one cause for a nonconformity.
    Note 2. Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.​
     
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