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Closing Actions

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Garry Chidgey, Dec 13, 2019.

  1. tony s

    tony s Well-Known Member

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    Well that's a problem when the CB dictates what is needed by the organization. Maybe that's why there's a supporting standard to provide clarification for seemingly absolute statements in the standard like "shall establish quality objectives at relevant functions, levels and processes". I hope CBs are also guided by ISO/TS 9002 in formulating their position since this standard clarified that "Quality objectives should be established at relevant functions, levels and processes, as appropriate...".

    I just wonder if CBs practice what they preach and are able to demonstrate conformance with ISO/IEC 17021 clause 10.2.1 which specifies "The certification body's top management shall establish and document policies and objectives for its activities". I would love to know what are the objectives set by a CB on its document control and management review activities - not processes but activities. :rolleyes:
     
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If I understand correctly, you no longer work for a CB? In that case - and I've heard of no other North American CB who mandates such ridiculous requirement - do you still hold personally that this is necessary? (I posted before you made that comment, incidently)
     
  3. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I do work for the same CB on a very limited basis.

    I was a "hard sell" until I went to a site with 8 of its QC Lab people overdue in their recurring quals. Additionally, they had 99 overdue (some were ancient) Management of Change projects. Note they used the MOC system for multiple systems.

    The overdue QC Lab quals had been called out as a nonconformance in the previous audit. Now, a year later they were still not done. The training person had repeatedly told the QC Lab Supervisor "Persons x, y, z etc. are overdue for ___" but the quals were never completed. So I come along and, per our rules must issue a major based on repeat.

    The overdue MOCs all into the category of corrective actions. It can be a real issue to let them sit there.

    In both these cases, top management was not aware because there were no targets or goals to report the overdue actions. At that point I understood what Craig Cochran meant when he said "Anyone who is irrelevant, raise your hand." And when I described the issue to top management in closing meeting, they said they in fact did not know of these overdue things.

    Lastly, I used to be a document control administrator and remember the urgency of ensuring current document versions were available at point of use. Some had to be printed, so this needed care and the organization determined tracking performance was a good idea. While auditing I saw the sorry effects of out-of-revision documents in use, and maintained the viewpoint that it is important and worth watching. I understand many people view document control as something that people just do, but where I come from it's more than that.
     
  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I have internally audited the CB and can vouch that they have extensive metrics and are being watched for document control.

    It's all well and good to refer to CBs and quote 17021 and 9002, but we were originally talking about the OP's question and 9001, which contains pretty straightforward language on the subject. Those of us who don't agree are doing that by selective interpretation and choice.
     
  5. tony s

    tony s Well-Known Member

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    Those of us with the opportunity to acquire additional information from other references should share it to others for their benefit. CBs don't have the monopoly of understanding the standards.
    The OP here is not asking about setting quality objectives. ISO 9001 is silent, of course, about completion dates. However, section 9.2.2 of ISO 9002 clarified that "Typically, the organization establishes a time to respond to and correct nonconformities and to take corrective actions, to ensure they are effectively implemented in a timely manner". Not a requirement, but a sound guidance for ensuring "appropriate correction and corrective actions without undue delay".

    The discussion about quality objectives started when you posted this:
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I believe it's the same CB who stated to its clients that "swim lane" diagrams are NOT acceptable as depicting of processes? I'd laugh if it weren't so serious...
     
  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I don't know and I don't think it's relevant to this discussion.
     
  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Fair enough.

    While it's true that the standard does not dictate closure time frames for corrective action, in 9.2.1e, 9001 says [The organization shall] "take appropriate correction and corrective actions without undue delay" and the OP described actions as having been open for a long time. Despite that, I expected trouble when suggesting there be a metric to pay attention to closure times, and I got it.

    Yes, it's a worthy discussion but by now I have to question whether it continues to provide value to the readers.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's relevant in that CBs shouldn't be dictating, through their auditors - and thereby to this forum - requirements which are NOT in ISO 9001! Explaining for our (less experienced) readers that some individuals post comments based on (generally) unknown "directives" is very useful. As with much mythology, there is a kernel of "truth" to the myth and when we all understand that kernel, the myth becomes apparent. It's important - since myths are created almost daily from many sources - to ensure a balanced viewpoint. ISO 9001 already has much baggage due to these kinds of myths. It started with "say What You do etc and has morphed now to all kinds of shenanigans...
    In 40 years of implementing ISO 9001 and similar quality systems, setting objectives for an arcane activity such as document or records control has never been an issue - except in a business where that was their scope. I won't make it an issue with management. Any auditor who does risks bringing further disrepute on ISO and certification - or worse - forcing clients into doing non-value added (costly) activities to keep an auditor "happy".
     
  10. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    The wording in 6.2.1 looks pretty clear to me. So does 9.2.1e.

    I think I have done a poor job of communicating that when I refer to XYZ requirement sent down through the CB, I am trying to respond to the message that auditors are making these things up. There is still a lot of confusion about certain things; the Technical Committee is not issuing guidance documents for everything and accrediting bodies are continually telling CBs to do things differently (or with more rigor). So no it is not necessarily about keeping the auditor "happy." And yes, having seen the repercussions of getting document control wrong I do think it's worth tracking getting it right. It is very fortunate that after 40 years you have not encountered such a thing.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Well, yes, of course. It's a requirement to have an effective document control system. But that isn't the same as having objectives and measurements for design, manufacturing product etc. And, as an order of priority, the things which make/waste money (risk) are usually the things management lose sleep about. I understand your POV, as a document controller in a previous life. However, as a practical set of implementation focus actions, for management to tackle when implementing a QMS, I'm not going to put setting objectives to documentation controls any time soon...
     
  12. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Does this mean you feel the document control process isn't relevant? How can that be explained if its important to the organization's success to get it right?
     
  13. tony s

    tony s Well-Known Member

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    When we raise audit findings against 6.2.1, we cannot just stop at "objectives at relevant functions, levels and processes". As a value-adding auditor, we also need to figure out how such findings will affect the process if they have to satisfy all the other statements under this clause (e.g. sub-clauses a) to g) and the supporting clause 6.2.2). I've been a document controller myself and I was able to ensure the right people have the right versions of the right document even without establishing quality objectives as per 6.2.
     
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  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    This is absolutely true. Metrics should never be just statements. They should support the QMS goals and honestly reflect the process performance as a contribution to those goals.

    No I didn't need a metric to control document versions either. But the metric was a way to signal to top management that it was working.