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8.3 Design and development

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by DennisK, Sep 28, 2018.

  1. DennisK

    DennisK Member

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    Dear all,

    Our company received a major nonconformity during an ISO 9001:2015 audit on chapter 8.3
    The NC was described as follows:

    'The process Product Planning misses the decision points and the appointment of persons who have the authority to bring a project to the next phase'

    In our process we have described that we go from model phase to release model to proto phase to release prototype and finally move to 0-series production. We have briefly described that during the project team meeting is discussed whether or not move to the next phase of the project. The project team consists of employees that have been appointed by the project leader.

    Between release prototype and 0-series production there is verification and validation of the machine by an 'independant' department of our company. Results are kept as documented information.

    In my humble opinion the standard does not have a strong view on appointing employees/functions that have the right to make decisions on whether or not move to the next phase.

    What are your thought on this matter?

    Kind regards,
    Dennis
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I believe you are correct, DennisK. Especially, since the standard is written for even "Two Freds in a Shed" type businesses. What value does it bring to write down who approves the design?

    I'd add this isn't a "major" for a start, even if someone believes it IS a non-conformity, it surely ISN'T a breakdown of the QMS etc.

    Appeal it. Contact your CB Operations management and tell them you don't accept it, to remove it and not send THAT particular auditor back (refer them to ISO 19011 Auditor attributes)
     
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  3. DennisK

    DennisK Member

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    Thanks for your reaction, my thoughts exactly...

    This auditor is strongly focused on in- and output of processes including decision moments and he wants us to rewrite our processes and make use of flowcharts where we show who and when decisions (diamond shape) are made in the process.
    With this in mind, I think that this is the reason of why he reports it as a major nc.
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    A good candidate for some electric shock therapy...
     
  5. Serious Man

    Serious Man Active Member

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    Beware of people who say "appeal" easily.
     
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why? Every time the CB auditor performs an opening or closing meeting, they point out there's an appeals process. Nothing easier than that! An appeals process is a requirement of ISO/IEC 17021, the Conformity Assessment Body Accreditation criteria.

    Because people DON'T appeal such findings, countless hours are spent attempting to close ridiculous valueless findings and, worse, the auditor feels vindicated and goes on to create more and more such useless work.

    No, rather than beware, be empowered...
     
    Last edited: Sep 28, 2018
  7. Serious Man

    Serious Man Active Member

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    If I've chosen path of objection every time I've heard "You are wrong!" I wouldn't know, what I know now.
    Beginnings were hard.

    I was not with Dennis, I have not seen what auditor has seen, so how can I say he was right or wrong.
    Dennis remarks looks like there is something - "briefly description", "auditor's focus on in- out-".
    It looks like their system process documentation might be not so strong, but I was not there.

    I've met poor auditors, who were able to ask at least one question which made me think.
    I profit from that.

    After all, it is Dennis decision and I am not his auditor.
     
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  8. John C. Abnet

    John C. Abnet Well-Known Member

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    "...and he wants us..."

    And herein lies the problem. "He" is not the standard and not only should "he" not be consulting, "he" is prohibited to do so.

    I would also be curious to know what specific clause ("shall") the auditor is claiming the nonconformance. against. Can you please share that with us?
     
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This not an effective way to learn! I guarantee, if you look at the cost effectiveness your boss will question your logic! If you pay (US rates) #1300/day for a poor auditor, and you only learn 1 "good" thing, I'd want to know why a) you are engaging a poor auditor and b) how much MORE should have been learned from employing a "good" auditor.

    We need to get beyond our personal preferences and consider this in the true light - the value of doing work to enhance our business performance. Nothing Dennis's auditor has reported does that...
     
  10. Artem

    Artem Member

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    Hi Dennis,
    Do you think it is possible to show us the process as it was before the audit? Or at least a simulation of a part of it? I think we will be able to give a better response if we see the flow chart.
    What bothers me in the nature of NC and the way you address it is a Dismond form :) I have seen very very often that diamond shape condists text „product ok?“ or something like this. This is exactly where there is no authority described on WHO makes the decision.
     
  11. DennisK

    DennisK Member

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    Thank you for the replies. I will come back to this next Monday when I'm back at the office, currently I'm enjoying weekend :)
     
  12. BufferMess

    BufferMess Member

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    In my opinion your design process lacks precise boundries at each approval stage because only one team decides the project phases. If you had different task groups at each project phase, he wouldn't object. But you have a project leader, right? Is the project leader not the one signing papers?

    Still, this is not a major NC.

    'persons who have the authority to bring a project to the next phase' - something to do with the organizational structure, roles, responsibilites etc.

    Somebody must be accountable for the project milestones.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The problem with opinions is, everyone has one... Auditors can't use opinions.
     
  14. DennisK

    DennisK Member

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    @John, he does not claim a specific clause, just 8.3.

    Our organization has detailed function descriptions which clearly defines the roles, responsibilities and authorities for R&D Manager, Project Manager and the R&D Engineers. Although in none of the function descriptions is specifically mentioned that one has the authority to close a certain phase in a project and move to the next one. But it is also not mentioned in the standard that you have to assign this authority. During team meetings results are discussed and in the end it is the project leader that is responsible for the project.

    Currently our process descriptions do not have such diamonds, but that is what the auditor wants to see and he wants us to introduce diamonds in process descriptions so that it is clear when and who is responsible for taking decision to move to the next phase. But again, in my opinion this is not required by the standard.

    Next Monday I will see if I can post (a part of) the process description...
     
  15. pkfraser

    pkfraser Active Member

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    This seems to be based on one person's opinion of what a process description / flowchart / process map should look like.

    Showing a "diamond" does not imply that someone is identified as being "Responsible" - you need some sort of RACI convention for that.

    "Visio-style" / "words in boxes" presentations do not often meet requirements, since i) they can be difficult to follow for a complex process, with multiple "go this way / go that way" branches, ii) it can be difficult to get sufficient detail into a graphical flowchart, and iii) an apparently simple task can actually involve a major decision (eg "select a project manager"). "Diamonds are for never" - or at least not for ever...
     
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  16. Golfman25

    Golfman25 Well-Known Member

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    I would definitely appeal. By definition your project leader would have the final decision, no. That you build consensus with other team members is great. Have you had any issues with advancing / not advancing projects? If you can't point to any, them what is the problem.

    As for diamonds as decision points in flow charts, I'd tell the guy where he could put his diamonds. I frequently take diamonds out of procedures to simplify the procedure and reduce the pages. I can explain the decision in a note. Not every decision needs a diamond.
     
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  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    And therein lies your reason to reject the NC and tell the CB to never send them back...
     
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  18. judegu

    judegu Well-Known Member

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    Firstly, I don`t agree on the Major NC thing. However, in my organization, during the development of the product, every major phase does have a "Diamond" where the decision responsibilities is clearly assigned.
     
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If you want to get truly into the meaning of life and flow charts, "diamonds" - or any other flow chart symbol - are ineffective. Flow charts are used to define the logic of something not the process - as practiced. Logic isn't what a QMS is about. Something can look totally logical, but when you actually SEE what happens (think LEAN spaghetti chart) there's zero logic...
     
  20. tony s

    tony s Well-Known Member

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    Missing decision points is definitely not an NC. NC is defined as "non-fulfillment of a requirement". Ask the auditor what requirement was violated? If there was no mention of the appointment of persons in the documented procedure but there is actual assignment of people at each design and development stage, then there is also no NC.

    If this is about Clause 8.3.2d, you have to read the entire statement - which should be like" "In determining the stages and controls for design and development, the organization shall consider... the responsibilities and authorities involved in the design and development process". Therefore, it is not mandatory. In the concept of ISO standards, the word "consider" means it is necessary to think about the topic but it can be excluded, whereas "take into account" means it is necessary to think about the topic but it cannot be excluded (see A.3 Clarification of Concepts in ISO 14001:2015).
     

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