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9001 Risk Based Thinking

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Somashekar, Oct 15, 2015.

  1. Somashekar

    Somashekar Moderator Staff Member

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    SUB : 9001: Risk Based Thinking

    Hi all. Newbie.
    We are a smallish (60 people) engineering company certified to 9001:2008.
    With the recent release of the new 9001:2015 standard, do our current manufacturing procedures and work instructions cover the RBT?
    Thank you for any comments.


    {Post in my inbox from New member Inspector 2s}
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Difficult to tell without seeing them. Procedures and work instructions are, in pure terms, about process control. If there is inherent risk that the authors of such documents are aware of, risk treatment may have been included in them. Otherwise, it's best to perform an evaluation of risks and see if the document talk about that.
     
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  3. yodon

    yodon Active Member

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    If it's strictly manufacturing procedures, chances are there will be some RBT embedded (maybe some in-process tests) but the expectations, I believe, are for the company to take a more holistic view of risk.

    Just some things that come to mind...
    * When you take on a new job, is it introducing new risk (skills, equipment, production rate, etc.)?
    * What if parts shipments are late? Or short?
    * Are all the specifications complete? Are you having to make assumptions?

    This would, I believe, also include any business continuity considerations.

    So take a step back and think broadly. Presumably you're doing process-based internal auditing so consider risks associated with each of those processes (risks to the business, risk to the customer, risks to operators, and so on).

    The challenge will be meeting auditors' expectations! Who knows what will be considered enough (in the eyes of the auditors).
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    One example, I'm fairly familiar with is when suppliers are sourced/changed. If you are mature about RBT, your procedures will consider what's important to control from that new supplier - is it a proprietary part for example? Or is it made to print and you have a problem trying to check the material which, if let into your process may not become apparent until the customer gets and uses your product. What do your procedures say about planning for supplier initial checks/certifications of materials/inspection results etc?
     
    Last edited: Oct 15, 2015
  5. Eric Twiname

    Eric Twiname Well-Known Member

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    Ewww...there's a term and mindset I hope doesn't catch on...
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Probably isn't what I meant, as I was on the phone when I wrote it... Duly edited.
     
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  7. Eric Twiname

    Eric Twiname Well-Known Member

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    I figured not...but couldn't/didn't resist... :rolleyes:
     
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