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New Quality Manager looking for advice and support!

Discussion in 'New Member Introductions' started by Colin Pitman, Sep 10, 2017.

  1. Colin Pitman

    Colin Pitman Member

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    Hi all,

    I've recently been made Quality Manager at my work - and I've got virtually no quality experience! I got the job because the last QM retired, and his assistant became QM, only for the assistant to then leave in quick succession because he found work nearer to his home (1.5 hour commute - I couldn't blame him). The hunt was on and it was highly desirable for us to recruit internally. I was asked because I have lots of product knowledge and systems/process knowledge, and after some negotiating I accepted the offer.

    We are a sub-contract EMS (Electronics Manufacturing Service) based in Crawley in the UK, and our customer base is medical, oil/gas, transport, and cyber-security. Our main output is populated PCB (Printed Circuit Boards) assemblies, however we also have a wiring shop where we can build these PCBs into finished equipment should this be the customer requirement.

    I am currently attending several BSI training courses on 9001 and 13485, and have a transitional audit coming up in October. We are already compliant to 2008, but will be the first time we'll be audited to the 2015 standard.

    I just wanted to say hi before I post a couple of specific questions I have in hopefully the right section.

    Thanks,

    Colin.
     
  2. Qualmx

    Qualmx Well-Known Member

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    Is very short time for you to understand the system, and pass the audit in the appropiate manner.
    I, ll suggest, to hire a consultant for this job.
    Maybe you could do it alone, But need full time and Will have some risks.
    Dont take it so easy, talk yo you boss and take the best option.
    hope this helps
     
  3. Colin Pitman

    Colin Pitman Member

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    Thanks for the advice. I've assisted on previous audits, so I kind of know what's involved. We're well set up having been compliant for a number of years, and the QM who's just left has said that we should be compliant to 2015 as-is and I've no reason to distrust him. If we have a series of NCs then my boss is prepared for that and we'll just work out what to do next.
     
  4. indicator

    indicator Member

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    The good thing is that you did not approach for the role, you were approached so that is a good sign.
    Congragualtion @Colin Pitman on your new role. You will fine be just trusted your ability and believe in yourself. Follow the guidelines and post as many questions you like on the forum and knowledgeable members will assist you with the solutions.
     
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Erm, unless you did some rock 'n' roll stuff with your ISO 9001:2008 system (over and above the actual requirements) you WON'T be compliant with 2015 (Context of the Organization comes to mind as significantly different), so you should do a full comparison of what your QMS is, compared to the 2015 requirements, frankly. As a person exiting the organization, you might question his comment...
     
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  6. Colin Pitman

    Colin Pitman Member

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    Agree! In my view the company did not have a good contingency plan in place for the eventuality of the QM leaving right before an audit. As 2015 is all about risk and top management being responsible - the company falls flat on its face right there!

    I don't know how 'over and above' we are, but we've got a well established QMS and have been compliant for years. 2015 comes along, and yes, there are a few changes. But what's the worst that can realistically happen? Non-conformities that I then have to work my butt off to put right? Or worse? :eek:

    Feeling woefully inadequate... :oops:
     
  7. RoxaneB

    RoxaneB Moderator Staff Member

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    All the more reason to do that comparison to the new standard and its requirements as suggested by Andy. Best case scenario - the former QM was right and everything is fine...and you have the added bonus of being more familiar with the subtleties of the standard and your organization's system (and skeletons). Worst case scenario - You identify some gaps and your organization develop action plans to address them so that when the 3rd party shows up, your organization butt may be covered somewhat.

    But to blindly accept the former QM's words as gospel, is potentially opening your organization up to...as you put it...risk. Best to do what you can to minimize it.
     
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  8. Colin Pitman

    Colin Pitman Member

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    Exactly... why do you think I'm here? ;) :)

    I've resolved to get top management together next week and tell them what I fear and what I feel the gaps are and that we need to start something rolling even if we don't make it in time for the audit next month. As you say, at least that way we can show we're trying.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This is called "Management Review" in the standard and should be done anyway. Hold one, record it and at least claim credit for THAT, because I'm guessing the previous QM didn't know to do that. If you have a month, you can easily address the section 4 "Context" stuff very easily before the audit (and that's a significance difference which would attract low hanging ncs). Having a (strategic/business) plan to address the issues determined in section 4, should also demonstrate "risk based thinking" and go a long way to meeting section 6, which is also quite different to 2008.
     
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  10. Colin Pitman

    Colin Pitman Member

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    Good tips, thanks. There was a management review last year which hasn't been seen by the auditor yet, but yes, there's definitely case for another one in light of all of these changes...
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's another area for you to improve upon. One review a year is worthless, even if the CB auditor bought into the idea...
     
  12. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It might be a good time to note that CB auditors, having no "shall" for management review frequency, cannot "buy into" an idea of an annual management review or any other frequency. We accept annual reviews because we have little choice unless there is something missing.

    In years past, management review has been considered by many to be an exercise to be carried out in order to supply needed records for certification audits. An annual review was scheduled and carried out, and duly trotted out for the CB auditor. But I have found many more meetings take place, in which organizational performance is discussed, and updates and needs shared. These lower level meetings do not get called Management Review because they do not include all of the required Inputs.

    Andy is right to suggest pieces be addressed by management as the year progresses. Nothing requires all of the inputs to be included in the same meeting. An organization can provide these meetings as part of management review, and use other venues to cover the rest of the required inputs. If a CB auditor issues a nonconformity stating all inputs must be covered in any given meeting, it is a good time for a dispute. The auditor is incorrect.

    The ISO standards have been meant to be business documents for many years. Our own tendency to over-interpret the documents tends to limits our ability to use them constructively. It may be true that the system already addresses the requirements of the 2015 version. Your job, for the sake of certification, will be to take the auditor through it.

    You may find the audit to be difficult unless you can show internal audits have been done to the new requirements, and at least one management review has been done that include results of the audits (and their resulting internal actions).
     
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  13. Colin Pitman

    Colin Pitman Member

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    I spoke to Chris the MD (my new boss) today after a "train crash" (his words) of a customer audit yesterday. He reassured me it wasn't my fault - he knows I have little experience (that, but also the lady who carried out the audit used to work for us, and so had a serious axe to grind...), but it was a wake up call for him that we're really not in a good place for a BSI audit. So we hired a consultant today called David, and I sent our current policies and procedures off earlier for "a quick look". David's reply?


    Colin,

    The Quality Manual and Procedures you sent me are very much ISO9001:2008. Only reference to ISO9001:2015 is one line in the Management Review. So not done by any means.

    My response: AAAAAAAAAAAAAAAAAAARRRRRRRRRRRRRRRGGGGGGGGGGGGGGGHHHHHHHHHHHHHHHHHHHHH!

    There is now a forehead-shaped imprint in my desk. I now think that the 1.5 hour commute was probably not the only reason for the previous QM leaving. My office is now at DEFCON 2 and I have some serious overhaulage on the QMS to do.

    Am I up for the challenge? You bet!
     
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  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Please purchase the book ISO 9001:2015 In Plain English by Craig Cochran, right now, even if you must use your own money. Call it a tax writeoff if it helps. I have the book and found it excellent. A client of mine directly used some of its examples to reshape their QMS. The author's more recent Internal Auditing in Plain English also looks good.
     
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  15. Colin Pitman

    Colin Pitman Member

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    Good call Jennifer! I've just put in a purchase req!
     
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Colin, please bear in mind that Craig is a "Southern Gentleman" (I don't mean Sussex, either) and his "plain English" is different from your and mine! (He's a friend of mine btw)
     
  17. Colin Pitman

    Colin Pitman Member

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    I need all the help I can get right now - so even if he wrote the book in double dutch I'd still be better off understanding it than the standard itself, which, apparently, is written in English! :D
     
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  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I thought Craig did a good job of describing his subjects, but I should also admit I am on this side of the pond too... I do believe his books are valuable resources. They are straightforward and "real life" - that is, they do advocate a lot of "bells and whistles."

    Andy's point about language barrier is valid. The most maddening part about the new standards is the obscure terminology, which the ISO technical Committees have a mixed success record in clarifying via their ISO 9000"2015 standard, as well as the guidance documents within the guidance documents viewable in the New Guidance Material released by the ISO TC 176 to support ISO 9001:2015 implementation thread and the ISO 9001 Auditing Practices Group website. This is why I recommend Craig's book. I think he has done a better job at "decoding" the standard than anyone else.
     
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You didn't read my book? ;)
     
  20. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I did, and found them to be quite different in their approach. Yours is more appropriate for a more mature organization.
     

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