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First time in 4 years helping a company pass an audit

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by claudiogut, Aug 12, 2019.

  1. claudiogut

    claudiogut Member

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    I'm an engineering consultant at an industrial distributor company and they recently asked me to help them navigate a third party audit. It's been what feels like forever since I helped a company do this and the third party is being very finicky about it. The company is already ISO 9001:2008 but don't have a quality resource on staff.

    Their main areas that they need to improve are:

    • We couldn’t see evidence of engineering resources dedicated to review drawings with customers and suppliers in order to make sure the parts comply.
    • We couldn’t see evidence a robust process for the following Quality Systems: 1) Receiving Inspection , 2) Corrective Actions 3) Calibration System. Evidence of Well Define KPI's is required.
    • We couldn't see evidence of a Robust Supplier Selection and Vendor Management Process. Also there wasn’t resources involved looking Supplier Quality & KPI Monitoring.
    • We Couldn’t see a Robust Process for Customer Complains and How Complains are Track and Taking Care.
    • We Couldn't see Evidence of a Robust Process for receiving inspection process in order to avoid any future issues with Critical Parts. Also, We couldn't see a Robust Corrective Action System able to track and resolve issues.
    Seems to me that these are minor issues that can easily be solved by hiring a quality control person, generating and implementing some good internal documentation and tracking communications, and emphasizing different types of inspections. Seems almost too easy. Am I missing something here?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome!

    Can we clarify a couple of things. ISO 9001:2008 and ISO 9001:2015 are somewhat different beasts. The certification has expired since September 2018.

    Is this what the CB auditor wrote as audit non-conformities? At the stage 1 or stage 2 audit? They read like opinion,s since much of this would have been in a QMS under ISO 9001:2008, so I'm wondering what's going on. Can you explain and help us?
     
  3. Golfman25

    Golfman25 Well-Known Member

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    Yeah, I don't like the "robust process" language if that's what the auditor wrote. And you don't need "well defined" kpis of receiving inspection, corrective action, and calibration. None of your issues seem insurmountable, but I would keep it simple.

    1) Engineering resources -- I am sure they have some type of review. Find out what they do and fill in any gaps. Could be as easy as initials on the print or a checklist.
    2) Is receiving inspection even required in your situation? I am sure they forward the paperwork to the office. Do they verify anything beforehand? If so, place it on the paperwork and proceed.
    3) Corrective actions -- sounds like a more formal process is needed, logs and such.
    4) Calibration -- same thing. How are they keeping their gages straight now?
    5) What is a "Robust" supplier selection process? Figure out your criteria and match your suppliers to it. Have purchasing track their delivery and quality issues.
    6) Customer complaints -- keep it simple, incorporate it into your corrective action system.

    You don't necessarily need an extra quality control person. Figure out a way to make it seamless -- just part of the daily activity. Good luck.
     
  4. claudiogut

    claudiogut Member

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    Well, they're the auditor's summaries. He had a list of action items and opportunities for improvement. This is stage 2 and he will be coming back at the end of the month. His complete comments are in the attached file.
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

  5. claudiogut

    claudiogut Member

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    Thanks, Golfman25. I agree that this is not insurmountable but they're just being extra picky for some reason. And as for an additional quality resource... the thing is that they currently don't have anybody officially as the quality guy. So I think they're just going to be name me as their quality resource since I'm engaged in a long-term consulting job for them and I'm DNV-certified. And as for receiving inspection... I think they refer to simply receiving shipments of material or machinery that they integrate with existing products. This is more of a warehouse/distributor that happens to dabble in engineered solutions.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Is this an IAF member, accredited Certification Body? This auditor isn't auditing to ISO 9001:2015, not are they being objective. You should REJECT this report back to the Certification Body and withhold payment until they do a professional job of auditing.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    No, this auditor is rubbish.
    What does this mean?
    There's nothing to fix, until you have a professional audit done and reported.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This looks and reads like a Supplier Quality Audit report. Are you saying it's a Certification Audit done by a Third Party?
     
    Last edited: Aug 13, 2019
  9. claudiogut

    claudiogut Member

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    Andy Nichols, my apologies, this is indeed a supplier quality audit and I'm not entirely familiar with the auditor's qualifications. I have yet to meet him and I will have a couple of weeks to better prepare for his follow-up. In the meantime, I want to thank you very much for your feedback and opinions. This auditor represents a big customer of the company and I don't think he can just be told to go home and not come back. I am, however, interested in learning some of the points on which you say the report should be rejected. What the spreadsheet that uploaded had on it were mostly his personal observations.

    By the way, I should've expanded on my DNV-certified comment. DNV is Det Norske Veritas, a quality classification society that's pretty big here in Houston and in the oil and gas industry in particular. I am a certified internal auditor and have helped other small companies in the past with their QMS audits.
     
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  10. Golfman25

    Golfman25 Well-Known Member

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    Since this is a customer audit, then all bets are off. They are auditing to their needs, wants and desires, not the ISO standard. Your best bet is to work with them on satisfactory resolutions. Good luck.
     
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  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Sadly, to confirm Golfman's comments, all bets are off. The auditor isn't competent. You'll have to do as best you can to convince them that the company does have a QMS - I'm still interested to know the status, because ISO 9001:2008 has officially become obsolete. What is the auditor auditing you against? ISO 9001:2015? Or do they have their own supplier QA requirements?

    A distributor doesn't need "engineering" to know how to review a customer order.

    A robust process and KPIs are not a requirement of ISO 9001:2015

    Once again, these aren't requirements of ISO 9001:2015. Supplier EVALUATION is. Supplier Quality isn't mentioned in ISO 9001

    Customer feedback is a requirement, not (sic) "complains" (I'm guessing English is their second language)

    Once again, these are not required, since the word "robust" isn't used, neither is "critical parts" (whatever they are). Receiving inspections isn't required, per se.. Corrective actions should have been part of ISO 9001:2008, so what was he shown?

    How familiar are you with the ISO 9001 requirements?
     
  12. Golfman25

    Golfman25 Well-Known Member

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    I am not sure ISO clauses are entirely relevant. If you look at some of the audit wording they frequently use "our" as in our requirements/needs. So for example, it sounds like they want some receiving inspection checking their critical characteristics. They don't really care about their other customers.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's why I am asking for clarification about whether it's ISO 9001 or a client SQA requirement (which looks loosely based on ISO as many are)...
     
  14. tony s

    tony s Well-Known Member

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    First question that you should ask, What, exactly, do you mean by "robust?"
     
  15. claudiogut

    claudiogut Member

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    Thanks, tony s. I will definitely try to get this nailed down before anything else.
     
  16. claudiogut

    claudiogut Member

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    It's probably what you said, that it's an internal SQA requirement based on ISO... I'll ask soon. Thank you very much for all your valuable feedback, Andy Nichols. It's invaluable and it's putting me in the right mindset to approach this process!
     
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  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Please come back with more questions. We're all here to help each other.
     
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  18. claudiogut

    claudiogut Member

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    So, I'm meeting this auditor guy today. I'll of course ask him what he means by "robust", as per tony s' recommendation, but what are some other good, unoffensive questions I can ask him to see how many hoops he wants my company to jump through? It seems to be that he's auditing a distribution center by the same yardstick that he would a manufacturing center.
     
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  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'd simply ask him to describe what he wants to see for the processes that he cited in his write-ups. If he's building in cost, then you can explain how much you'll have to charge them to meet his personal requirements. You could ask him for his professional qualifications to audit... (he might not take kindly to that)

    I'd show him what you currently do and ask him to identify where it's ineffective or lacks "robustness"...
     
  20. Golfman25

    Golfman25 Well-Known Member

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    Since he is a customer, he can "consult." So ask him what he would suggest. Good luck.
     

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