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Quality of Process or Quality Process?

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by xrat86, Mar 31, 2017.

  1. xrat86

    xrat86 Member

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    New here and to the world of ISO.

    Regarding an ISO audit, is the auditor empowered to render judgement WRT to the quality (i.e. robustness) of the processes or are they limited to affirmation that the quality processes exist?
     
  2. normzone

    normzone Well-Known Member

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    The processes must exist, and they must be effective.

    Common real world examples of what an auditor finds include:

    Process, but not effective
    Effective process but wholly undocumented, no evidence available to prove it
    No process at all to meet the requirement
    Process was developed and exists on paper, but nobody uses it
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Which "auditor" are you thinking of here?
     
  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It is not enough for a process to exist; it is expected to be effective.

    Auditors at all levels: 1st party (Internal auditors), 2nd party (customer or other interested party auditors), and 3rd party (certification body auditors) are all likely and are arguably chartered to to audit a process's effectiveness (we might use the synonym robustness). There may be a certain amount of judgement applied to decide if a process is effective. That can be done based on a sample. The allowable error in a sample is determined by the party the auditor represents.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Surely not? If there's an objective for a process, there is measurement and monitoring and, therefore, results to be observed, where's the judgment? In the context of (some) third party audits I've witnessed very recently, there's far too much "judgment", without objective evidence of ineffectiveness. Telling a client they have ineffective processes when all that's recorded are "admin" issues, such as sign offs or 1 training record missing is totally bogus.
     
  6. xrat86

    xrat86 Member

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    Thanks for your replies.
    Andy,
    My initial question is related to what Jennifer refers to as 3rd party auditors. We already have 2nd party auditors "telling us what to do" WRT to our business and it chaps my hide.

    WRT to ISO, our plan is to have what i'd call a feedback loop to determine the effectiveness of a process. IMHO that cuts both ways, we can either improve the process OR eliminate it all together if it proves ineffective.
     
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  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It takes more than one missing training record to determine a process is not effective. The determination is made when considering documentation, what people say, and what is observed. What the client thinks is effective may or may not be the case, and clients don't always have monitoring and measurement to recognize it/report it to management for action.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Totally agreed, but this was what was reported - and by an ISO/TS qualified auditor (acting as a consultant)...
     
  9. Bev D

    Bev D Moderator Staff Member

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    I think there are 2 questions that must be answered first:
    1. What do you mean when you say 'process'? what kind of process?
    2. What do you mean when you say 'effective'?

    It always bothered me when people talk about the effectiveness of the QMS: do they mean compliance to the QMS process(es) or do they mean that the QMS helps the company make better products at a reasonable cost?

    Lets take training as an example. the objective of a 'training process' is to provide the target employees with the right knowledge and skill to perform their tasks correctly. The sub-process of creating and maintaining training records with all of the 'right' information on the forms had no ability to ensure that people are actually effectively trained to perform their tasks correctly. So if training records are missing or not filled out completely/correctly what is ineffective? certainly the training record process is not effective from a compliance to the 'required' information, but what else does that effect? we would have to assess the employees level of knowledge and skill to assess if the training itself was effective...so now we are stuck with a 'so what' question: so what if the sub-process of training records is not effective in creating complete records of training? what negative impact does that have to the organization? are auditors focusing on the trivial yet easy to audit things like records used for 'objective' evidence? or should they focus on the effectiveness of processes that do affect the organization and the product quality?
     
  10. MCW8888

    MCW8888 Well-Known Member

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    MHO: As an internal auditor I would summarize the process audit by going back to the objective:
    Positive statements about the process being audited
    Process working well (effective?)- is it getting the anticipated results as required by the input requirements? I will probably bring in the clause of the standards
    Summarize the nonconformities.
    Process not working well - might bring in the 5Y (or less) to explain why results are not achieve as planned. I would probably bring the IATF clauses and operational procedure,
    Lastly I would offer positive statement to encourage process owners to improve.
     
  11. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    As I was not present and the ISO/TS auditor is not here to defend himself/herself, I am not able to comment further except to say there is a potential for specific types of training records to be critical. What was the training record in question for? Nor do I see how the ISO/TS auditor acted as a consultant. Can you give details?
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    True, but in this case the operator was simply loading/unloading an nc machine.
    As you know, many auditors also function as consultants, when not doing CB type TS audits. This, IMHO makes things really wrong on so many levels...
     
    Last edited: Apr 6, 2017
  13. tony s

    tony s Well-Known Member

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    CB auditors should evaluate objectively. They should refrain from comparing the auditee's approach/interpretation against their own interpretation. It would be like a case of two Christians debating on a topic in the bible. If their intention is to audit "effectiveness", then they should stick with the definition of effectiveness (i.e. extent to which planned activities are realized and planned results are achieved). A process can only be deemed effective if evidence/s are available to demonstrate that its planned results are achieved through the realization of its planned activities.
     
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  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Excellent points, Tony! In many cases it's the evaluation of the effect on results which is missing (completely). So, we have an nc "dressed up" to include a pre-printed statement on the CB's nc form which reads "...could not be demonstrated as fully effective..." but without any record of what that means. The supporting "evidence" is a simple compliance to a requirement.
     
  15. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    What is an nc machine, Andy? What was being loaded and unloaded? It is difficult for me to understand inherent risk since I was not present. I can offer that IATF is rather strict and leaves less room for an auditor to judge - automotive customers have been pressuring for more strenuous application as a form of advocating for their, and their end users' interests. CB audit documentation has been changing to facilitate things like that.

    Of course auditors consult. We are so often contracted instead of paid benefits, that it is often important for us to diversify our work. Perceptions of right or wrong aside, we are forbidden by registrars to consult for the same clients we audit - my exposure is a 2 year time frame. ABs thus recognize the current structure and allows for it as long as we can remain objective and impartial by no auditing our own clients.

    If we consult during an audit, that is another thing. It is forbidden by ARs. Some auditors are better than others at not crossing the line. Again, not having been present I am not able to comment on behavior of the auditor you are describing.
     
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    As with many numerical control machines, (aka cnc), all that's necessary is for a person to load and unload parts into a work holding device, then press "go"... Recording an audit nc for a lack of training and then calling that an ineffective process is totally bizarre...
     
  17. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Is that person a machinist?

    Were the parts for automotive components?

    Why was the record for this person's training missing?

    Had a training/competency process been determined for CNC (thank you for clarifying, I understand now) operators? If so, do they include anything beyond "Load machine" and "Unload machine"?
     
  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I have worked with CNC operators who would take offense at the characterization of their job as "load and unload parts into a work holding device, then press "go".
     
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed. Some are responsible for post-machining such as deburring and gauging. Others also program. These operators did none of that - which, of course the auditor should have determined and, therefore, understood that the lack of a training record wasn't anything to do with product quality. In fact, this job is one of those where if they could afford to put a robot on it, they would...
     
  20. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Along with my previous 3 questions, do I correctly understand this CB audit's documentation included the template formatted language you described earlier: "...could not be demonstrated as fully effective..."?

    Maybe they would have put in a robot to do it, intention for which is described as reducing process variation, but they did not. They put a human in there, a process that turns raw stock into machined parts. If you think the client should dispute the action request, by all means pursue it but standards require documented evidence of determining competency in processes affecting the customer.
     

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