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7.1.6 Organizational Knowledge

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, Sep 26, 2016.

  1. tony s

    tony s Well-Known Member

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    I'd like to post two questions on this topic to further my understanding:
    1. If you would assess an organization against the requirements of ISO 9001:2015 clause 7.1.6 - Organizational knowledge, what evidences would you expect to see?
    2. Should an organization fail to provide your expected evidences, would you write an NC against this clause?
     
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  2. Chris Glover

    Chris Glover Active Member

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    This is a big one for us right now...since April we have lost about 180 years of experience...
     
  3. RoxaneB

    RoxaneB Moderator Staff Member

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    1. I'd look to see what processes the organization has established and assess the evidence generated as outputs from those processes.
    2. If the organization fails to provide evidence supporting their own process(es), then yes.

    IF, however, you're asking for my own personal take on what evidence/process I would like to see, now we're getting into consulting and I shouldn't be doing that as an external auditor. From an internal auditor perspective, I'd have no qualms about identifying opportunities such as:

    • Cross-training
    • Links to competency assessments (i.e., job observations, nonconformance rates, etc.)
    • Databases for improvement events/projects
     
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  4. tony s

    tony s Well-Known Member

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    Sorry Chris. I didn't get what you mean. Can you clarify?
     
  5. tony s

    tony s Well-Known Member

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    I posted this question since I believe there are various ways to satisfy the requirements on Organizational Knowledge such as documenting the procedures/best practices/improvements, retaining training materials, determination of necessary intervention for capability enhancement, project debriefing, stand-down meetings, things-gone wrong analysis, corrective actions done on processes that have a potential for incurring the same problem, subscription on regulatory websites, membership on QFO and Elsmar :rolleyes:, and so on.

    Due to these, I find that most, if not all, organizations will not encounter any problems in demonstrating fulfillment of clause 7.1.6. Just like with the requirements in clause 7.4.

    If others can give other examples, I'd really appreciate your generosity.
     
  6. Chris Glover

    Chris Glover Active Member

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    Since April we have had 20 people resign..those 20 people represent almost 180 years of experience..and lost knowledge.
     
  7. Dr Vipul Patel

    Dr Vipul Patel New Member

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    Training Record as evidence.
     
  8. MCW8888

    MCW8888 Well-Known Member

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    Not that easy. I will have to look at other stuff first such as employee turn over, process performance and I will ask for some questions around succession planning programs. If I consider 7.1.6 the underlying root cause for them not achieving their performance objective, then maybe I will write a minor. However, I have to be very clear on the objective evidence because they will have to respond with corrective actions based on root cause. This is just my own opinion and may not even reflect what others are doing. Our company has a succession planning program so it might be a challenge for an auditor to give us a non-conformance on this clause.
     
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm not sure "training" is the same thing as knowledge and I'm not sure, as management, I'd accept training as "evidence". I have certificates of training but little practical knowledge of certain topics.

    Knowledge comes from a number of sources, including experience. Training often results in not much knowledge - take young car drivers for example, who have never driven in snow, on ice, in the wet, on dirt, motorways/interstates, a manual transmission, in the dark and so on... Yet, they can obtain a license! What knowledge did they get from their driver training? Very little in reality.
     
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  10. askartsolutions

    askartsolutions Member

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    The attachment to this post addresses question 1 posed by Tony S.
    For question 2, whether an auditor writes up an n/c would depend on a number of factors such as:
    1. The identification of risks related to organizational knowledge (OK) for the company being audited.
    2. Clear evidence that one or more of these risks have materialized
    3. The extent and effectiveness of implementation of the OK process requirements listed in the attachment that could have prevented or mitigated such occurrence.
    4. The auditor must examine the PDCA controls and data provided by the company being audited; discuss with personnel responsible for the OK process; and reach an informed decision on whether or not there is an n/c.
    5. In my experience, I almost always get the auditee to agree with me if there is indeed an n/c.
    Cheers.
     

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  11. Mdoremus

    Mdoremus New Member

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    Hi, I'm working on my checklist for transitioning to 2015, I appreciate all the advise, comments and discussions.
    For 7.1.6 OK, what would you expect to see for evidence of determining the knowledge necessary for the operation?
    Would job descriptions, job postings and an org chart fulfill this requirement?
     
  12. tony s

    tony s Well-Known Member

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    I don't think so. JDs and Org Charts are intended to define the peoples' roles and responsibilities. If I'm a new operator for a manufacturing company, having some orientation from older employees, reading and implementing the operation's work instructions - will help me to perform my task better than just knowing the Org Chart. OK are knowledge needed to effectively operate the organization's processes. Notes 1 and 2 have provided some useful guidance for understanding OK.
     
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  13. Mdoremus

    Mdoremus New Member

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    We're an engineering company, building only prototype drive trains. The engineers are hired with specific qualifications and experience required. We have some mentoring and on the job training for the prototype assembly and machine shop, but the core of the business is engineering.
     
  14. MCW8888

    MCW8888 Well-Known Member

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    From my perspective, I will look for evidence such as succession planning, matrix to show back-up responsibility, employee personal profile showing SME, mentoring and coaching, etc.. If I see any of these being used, I will not write a NC on this clause.
     
  15. Andrej

    Andrej Member

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    ISO/TS 9002:2016 document has been developed to assist users to apply the quality management system requirements of ISO 9001:2015

    In the clause 7.1.6 Organizational knowledge there is (among others) the following guide:

    In determining, maintaining and making available organizational knowledge, the organization can consider:
    a) learning from failures, near miss situations and successes;
    b) gathering knowledge from customers, external providers and partners;
    c) capturing knowledge that exists within the organization, e.g. through mentoring, succession planning;
    d) benchmarking;
    e) an intranet, libraries, awareness sessions, newsletters, etc.
     
  16. Lonewalker

    Lonewalker Member

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    Has anyone written a procedure on Organizational Knowledge or retaining documented information on this requirement? I know that the standard does not require it, but is it sufficient to just to have a couple of lines in the manual? It would be very easy to make this a huge area for maintaining and keeping up to date.

    I would be interested in how CB's are looking at this section and any information would be appreciated. Thanks.
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I would hope no-one is writing procedures, unless they thought it through and decided it was part of the "context of the organization" and that it also addressed "external and internal issues" to do with "interested parties". Simply put, writing a procedure WITHOUT considering these things is WRONG.

    So, let me ask you a question. If you had to satisfy a customer's repeat requirement (a re-order) and weren't able to recall, from memory, how that requirement was met previously, what information/records would you assemble and review?

    If you obtain and new process/machine/technology and it's different from what you had previously used, how do you get control of that outputs from that?

    Therein lies (most) of the answer you're looking for...
     
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  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Andy is right.

    No, you don't need a procedure. But if controls for hiring, identifying and completing intake steps appeals to you, how about checklists?
     
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  19. Pancho

    Pancho Active Member

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    I agree with Andy and Jennifer. A procedure for organizational knowledge is impractical. However, a policy might be useful. The policy would direct process owners to make sure their processes transform tacit into explicit knowledge, capture new knowledge as it comes in, and makes all available to users.

    Then, specific procedures in the qms may address the items Andrej highlited above. For example, the continuous improvement process captures knowledge through its lessons learned procedure and its corrective actions procedure, or the marketing process captures knowledge through its customer satisfaction survey procedure, &c.
     
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  20. Lonewalker

    Lonewalker Member

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    Thank-you for the responses. I think they echo my initial thoughts, but break it down in a simpler way for me to understand, as I feel that I have been over thinking it. I think that I am going to add an agenda item into Management Review as well, as there may be new knowledge such as a new product technologies for incorporation into a product that we need to find out more about or get a designer trained in for example.
     
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