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Process approach documentation for ISO9001

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Marty K, Dec 21, 2015.

  1. Marty K

    Marty K New Member

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    4.1 a) requires the organization to "Determine the processes needed for the quality management system...". In a recent third party audit I was faced with an auditor who insisted that 4.1 a) meant that my quality policy manual must have a process flow chart similar to the one in the introduction (Section 0.2). Without such a flowchart with my processes identified and cross-referenced to ISO clauses, there was no evidence that we had identified processes. We ended up having a minor non-conformance for this, and she considered if it should be a major non-conformance.

    Explanations that the quality policy manual listed the processes that are the basis for the QMS fell on deaf ears. My organization has had ISO9001 registration for 20 years, and has never been asked for such a chart. Has anyone else had a similar experience?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You can bet someone somewhere has... Simply contact your CB management, ask them for clarification - and subsequent removal of this bogus finding and banning of their auditor from you account. If your CB supports their auditor in this matter, it costs nothing to transfer...
     
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  3. Sidney Vianna

    Sidney Vianna Well-Known Member

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    It never ceases to amaze me how idiotic some auditors can be. A flowchart would be used as a way of identifying sequence and interaction of the processes. But, even still, a flowchart is not a mandatory requirement. Please review step 5.1.4 of the Guidance on the Concept and Use of the Process Approach for management systems document which reads
    I am in agreement that this is a bogus NC as long as you can demonstrate how you comply with 4.1. b) of ISO 9001:2008.

    I can almost guarantee this auditor is very early in her maturity journey of this profession. Worthless NC. Push back to the CB is a must.
     
  4. Golfman25

    Golfman25 Well-Known Member

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    Good luck. I am dealing with a similar NC. We even have separate documents for each process linking them to the clauses, people, metrics, procedures, etc. We can lay them out on a table to create a "virtual process map." That was no good. Appealed to the CB and got absolutely nowhere. Bottom line, while they will deny it, in their eyes you need a "process map" (they even ask for it pre audit) which includes the process as they define them, not us. Suffice it to say this is my last audit with that CB.
     
  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Auditor training on what to expect in process mapping has been terrible for the 2008 version, but there was more for the 2015 version. It is still interesting to hear of an auditor asking for a diagram to be based on what's in the standard, which is not a process map at all and is not among the requirements, which start in Section 1. I would dispute an NC about a process map if it is written against an imagined requirement to make it look like the image in .02. Auditors who get this wrong should not be allowed to continue - you would be doing the CB a service in pointing out this training opportunity.

    Looking forward to 2015:

    Training for process mapping was improved, but perhaps not 100% accurate. the technical committee published a guidance document ISO/TC 176/SC2/N1286 that advises:
    "...Although ISO 9001:2015 does not specifically requires any of them, examples of documents
    that can add value to a QMS may include:
    − Organization charts
    − Process maps, process flow charts and/or process descriptions..." (emphasis mine)

    And in the Introduction section (again, these explanatory clauses are not part of the requirements, which begin in Section 1) 0.3.2 of ISO 9001:2015 shows a map that people will be tempted to copy and some well-meaning, though incorrect auditors will probably try to hold people to. The language "...a) determine the inputs required and the outputs expected from these processes; b) determine the sequence and interaction of these processes;..." is still there, but I do not find the words "process" and "map" next to each other anywhere in the standard.

    Several dozen CB auditors I know had it drilled into us to not accept flow charts by themselves, and to look for this or that type of diagram. This is where my viewpoint differs. If flow charts include the little circles that indicate connection to other processes/flow charts, that clearly indicates interaction. I have a client that has written descriptions in a table, which includes inputs and outputs columns and the affected processes. It was very informative, arguably more useful for new mangers to review so they can understand - and isn't that the point? We need to be open to more imagination when auditing.

    If I were in charge of auditor training I would have cleared this up, but I regret to say I think we can expect some more trouble.
     
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I have heard - second hand - that one CB isn't accepting "swimlane" diagrams for process documentation
     
  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    For 2008 or 2015 versions? But that is a moot point really, as the 2008 standard wants us a "description" of the interactin between the processes and of the quality management system" but it does not say "process map" either. That fact is very poorly understood, in my view.

    If for 2015, I can't think why. Is it the CB or one of its auditors? We are notoriously hard to calibrate. Since a process map is not specifically required, I would be interested to see swimlane diagrams to describe processes. It seems reasonable to imagine they could also show the outputs and inputs to which other process - the handoffs - which would identify the internal customers. It is my understanding that identifying internal customers (stakeholders) and understanding our place in the QMS is the point of having a process map. Without something, it can be easy for support processes to be left out. I think of that as a "street light effect" in that bright focus is centered on production processes, while others get the idea they aren't really part of it. I have seen that with IT and facilities maintenance. The oversight was unfortunate, and potentially costly.
     
  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I can envision myself getting called out on some of these points by my documentation reviewers. I am ready for battle. :mad:
     
  9. Sidney Vianna

    Sidney Vianna Well-Known Member

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    It is UNBELIEVABLE that we seem cursed to have discussions about process approach and what is required/admissible for the rest of eternity. Sometimes I feel like screaming so we STOP THE INSANITY of PAOCD (Process Approach Obsessive Compulsive Disorder).

    Many operational processes might affect product conformity and customer satisfaction. Identify those and the activities within those processes that might lead to non conforming products and customer complaints. Make sure these processes are properly managed from THIS perspective and, voila', you have understood the process approach.

    Why ISO fails to develop actionable and pragmatic guidance document on this is beyond me....:mad:
     
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That's why I was cautious about the 'second hand" bit! As we all know, CB makes a policy and it's sometimes mishandled later...
     
  11. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It may not be clear if it's a CB policy or what. Years ago, I attended the AIAG Lead Auditor class for TS 16949. The class was told we must enforce the clients' use of the core manuals although the standard doesn't require them (it is customers that usually require their use). I couldn't get anyone on this side of the Atlantic or the other to tell me where that "requirement" comes from. They just wanted it. I am sure it's a phantom requirement because our own CB (when I was an internal auditor) insisted we must use them. But when I pushed back and asked "Where does it say that?" he did not write the NC.
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Along similar lines, I had to do battle with a CB who INSISTED that all 3 types of study - linearity, bias and stability be conducted for ALL types of measurement (equipment) uncertainty. Odd, when you consider all 3 don't apply in all cases...
     
  13. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Was it a TS 16949 with customer requirement to conform to the core manuals? In any case, no I do not recall that all three are required in the core manual, or ever were. But a well-designed study can capture all if "Parts selected for use in the MSA should span the full tolerance range" as Raytheon asked of its suppliers. They helpfully provided a template spreadsheet.

    But we digress.
     
  14. Golfman25

    Golfman25 Well-Known Member

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    I am dealing with this one as well. My CB told me that the IATF had a finding against them and thus linearity, bias and stability studies are required.
     
  15. V S Ramesh Rao

    V S Ramesh Rao Member

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    I understand the agony & having been on both sides of the table, understand the problem too well. I have been a QMS auditor with a major CB who took pains to "calibrate" their auditors to ensure consistent interpretation of the clause requirements & didn't get into avoidable arguments with clients. In order to determine the process for developing a Quality Management System, all of the following is considered acceptable
    1. Swim-lane diagram that give a visual depiction of the process steps and interaction - This is by far the most complete way where interaction between functions is brought out very well. We can also show what documents are needed & what records are produced at what stage in the process, who needs them & for what. The greatest advantage of a swimlane diagram (also known as functional deployment mapping) is that improvement opportunities become visible. a very useful tool to satisfy the clause requirement on continual improvement!

    2. Block diagrams

    3. Step by step process description - too much text and process is not "visible"

    4. A process interaction matrix: This lesser known of all tools & also the least used. Nevertheless, the matrix can show how processes interact but needs a lot of text to explain the process

    Now on the NC...
    1. If there is no description of the process, it is an NC against a clause requirement.
    2. If description of the process exists, & if the auditor has a view different from that of the client auditee, it can only be an observation. NC can be raised only against a clause requirement and never against good practices.

    Hope this helps
     
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  16. Golfman25

    Golfman25 Well-Known Member

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    In my experience, the IATF has "secretly" changed the TS 16949 standard and process maps are now in fact required. It is part of the expectation to provide said process map as part of pre-audit planning. They actually use the term "process map" as a required submission in in the answer to question 31 on page 13.

    http://www.iatfglobaloversight.org/docs/Rules 4th Edition_FAQ_June_2015.pdf

    I'm not saying, I'm just saying.
     
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  17. Glenn0004

    Glenn0004 Member

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    Looking back at the original post, this looks typical of the issues around evidencing that you have met the requirements of the standard within your implementation and the size and nature of your organisation against satisfying the expectations of the auditor. I have come across an auditor requesting to see how the QMS management processes are implemented and form the management system (i.e the process life cycle within section 0.2), this is something we had; as we maintain a suite of policies that implement the requirements of 9001 and 14001 across the business and thee interation of these policies is documented as a life cycle. However if for the planning of product realisation, process mapping at level 0,1,2 and 3 to either a locally defined standard or recognised standard is not accepted then it's time to rethink your CB or the value of 9001 accreditation.
     
  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    My heart is with you. While taking AIAG's Lead Auditor training I was told clients must use the core manuals, though the standard contained no such requirement and some customers do not specify such a requirement.
     
  19. Golfman25

    Golfman25 Well-Known Member

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    And who sells the core manuals ? Funny how that works.
     
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  20. tony s

    tony s Well-Known Member

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    IMHO clauses 4.1a of ISO 9001:2008 doesn't mean anything but to require organizations to determine the processes employed within its QMS while 4.1b is asking to determine their sequence and interaction. The requirement to include a description of the interaction between the processes of the QMS is on clause 4.2.2c. So, the requirement is about "describing the interaction" and not "describing the processes". Note1 of clause 4.1 mentions at least 4 groups of processes where we can describe the interaction. ISO/TS 16949 mentions at least two groups of processes in clause 5.1.1 (i.e. product realization and support). Other interpretations, which I subscribe to, suggest at least three groups such as core, support and management processes. My approach in satisfying clause 4.2.2c is to depict a high-level process map to describe the interactions.
    upload_2016-4-22_10-30-38.png
     

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