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8.1 - Operational planning and control

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Mia Langford, Jan 21, 2021.

  1. Mia Langford

    Mia Langford New Member

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    HI All

    I’ve just joined up with the forum.

    I am new to working with ISO 9001, I’ve just completed my Quality internal audit course.

    Recently we had an external audit and gained a major NC on 8.1 the audit report simply says -

    (The organization must plan, document, implement and control processes needed to meet the requirements of the service provision)

    I’m stuck I don’t understand what I need to provide as evidence or what I have to create.

    Please can you help
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hello Mia and you are very welcome here!

    Is this the actual wording of the auditor's non-conformity? Also, can you tell us the scope of your ISO 9001 certification? It sounds a little bogus to me (as an ex-CB auditor) and also, if the auditor left and you, their client are confused, that could indicate the auditor is wrong. In such a case, you can and should reject the finding.

    But let us know a little more, first...
     
  3. tony s

    tony s Well-Known Member

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    Is your organization a service provider?
     
  4. Mia Langford

    Mia Langford New Member

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    Hi Andy and thank you for making me welcome :)

    That is exactly straight from the audit report.

    We are currently moving away from a non accredited audit company, this finding was during a audit by a UKAS accredited company. We are a company based around marine industry, electrical/welding&fabrication.

    We also got NC for design and development but this was because the non accredited compnay ruled out design and developmnt but UKAS brought it back in - we have completed this non conformance but 8.1 i am stuck on.
     
  5. tony s

    tony s Well-Known Member

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    There is no standard approach in satisfying the requirements in 8.1. Even the standard mentions "The output of this planning shall be suitable for the organization’s operations".

    Before your company deliver your services to your client, do you briefly plan for the activities to be performed? The materials to be used? The number of people to be deployed? The fabrication drawings and the specifications to be met? Do you have records that these plans were implemented?

    If you answered yes to all of these, then there's no reason for the CB auditor to raise an NC against 8.1.
     
  6. Mia Langford

    Mia Langford New Member

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    You've helped me so much - Thank you, i really appreciate it :)
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hello Mia:

    Aha! The old "accredited/not accredited" story! That's certainly part of it. However, even being under UKAS accreditation, doesn't necessarily confer competency on the auditor you had auditing the organization. I see the same thing going on too. Let's deal with the 2 situations we're presented with:

    8.1 "The organization must plan, document, implement and control processes needed to meet the requirements of the service provision"

    If this is all the auditor wrote, then the auditor has only written a partial non-conformity statement. It should be rejected if there's nothing else describing it.

    Secondly,
    has nothing to do with service, the way the ISO 9001 requirements are written. I'm going to surmise that none of your contracts include "service" as a description of the scope of work you do. Hence, the auditor is wrong. Please confirm if service is what you do.

    Similarly, the whole "design and development" of product being in/out of scope is wholly abused by CB auditors. The simple acid tests are: 1) Do you have a product which you design and 2) can you change the specifications without customer approvals. If the answer to these is "No" then your organization IS NOT D & D responsible. It should not be in scope, your QMS will not describe a process you don't do (unless someone unwittingly included it for whatever reason) and there will be a statement to the effect that you customers own their product specifications. Indeed, before "jumping" to this conclusion, the auditor should have asked you do show them where in any customer contract/PO/Agreement the words "Design and Develop" were a line item. Simples!

    Sadly, even accredited CBs have auditors who are less than competent in their audit assignments and they believe, because clients lack confidence to dispute a findings, they must be correct in their assertions of non-conformity. Nothing is further from the truth.

    I'd highly recommend you seek out the Client Representative at your chosen CB (or lodge an appeal through their website etc.) and dispute the major (which it certainly IS NOT) and have them withdraw it based on service not being in your QMS scope.
     
    Last edited: Jan 21, 2021
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  8. Mia Langford

    Mia Langford New Member

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    Thank you for your help guys! Its so appreciated.
    I called the auditor on Friday and asked him to explain to me with some more details as the report wasn't clear and he said it was because we didn't have anything under that section in our manual.
    Once we showed him the manual on the day of the audit, we informed him that it was just a draft as we are in the middle of making it a integrated manual, so there was blank sections on some of the clauses.

    He told me on Friday that it was because we don't have anything documented in the manual under 8.1

    Is there anything you would be able to tell me that would help me. point me in the right direction into completing this major non conformance?
     
  9. tony s

    tony s Well-Known Member

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    Don't structure your manual using the clauses of the standard. In the Introduction of ISO 9001 it is stated that "It is not the intent of this International Standard to imply the need for: alignment of documentation to the clause structure of this International Standard".

    There is no requirement that you have to mention in your manual how your organization satisfies 8.1. Even the standard doesn't require documentation of a manual. A nonconformity can only be raised against a requirement. NC is defined as "non-fulfilment of a requirement". So, there must be a requirement first. Your auditor did not even comply with ISO/IEC 17021-1:2015 (Requirements for bodies providing audit and certification of management systems), where in section 9.4.5.3 mentions "A finding of nonconformity shall be recorded against a specific requirement, and shall contain a clear statement of the nonconformity, identifying in detail the objective evidence on which the nonconformity is based. Nonconformities shall be discussed with the client to ensure that the evidence is accurate and that the nonconformities are understood".
     
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi Mia. Firstly, I'd avoid addressing the question to the auditor. Take it to their operations management for resolution. Auditors who leave a client confused and then answer in the way they did, shouldn't be working for a CB, IMHO.

    If we consider the issues, firstly, you aren't REQUIRED to have a manual and, hence, there's no need to "address" 8.1 in the manual! He's thinking "old school" here. What is "in" and "out" should be specified in the "scope" of the Quality Management System. Now, since you have chosen a Quality Manual, then the scope could be in that. TBH the "draft" situation is a little non-sense at this point in your challenge to become certified - it should have been approved and if you are looking into "integration" revise it at that point... be that as it may.

    This certainly doesn't warrant a Major. What was the outcome of the stage 1? This type of thing should have surfaced at that point. Be bold, reject the finding and if you have any emails, forward them to the CB too. As Tony says there's little/no justification for this to be a non-conformity at all, let alone a major. I wouldn't be welcoming the auditor back anytime either...
     
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  11. Gilbert

    Gilbert Member

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    ISO 9001: 2015, need your advice or expertise on this, is the clause 8.1 applicable to Top Management and QMS committee to be audited? since here also mentions the clause 6 , 4.1 and 4.4 of the ISO stds.
     
  12. tony s

    tony s Well-Known Member

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    If they are involved in planning for the operation of a certain product to be produced, or service to be delivered, or project to be implemented, then the answer is YES.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Firstly, what's a QMS committee? We can't give a clear answer without knowing what that is, since it's not mentioned in ISO 9001:2015. Secondly, Top Management will always be audited, certainly internally and (should be) by the CB auditors (but they are notorious for avoiding that) otherwise how will anyone know if they understand the QMS? For 8.1? Yes, for 4.1 and 4.4 and 6? Of course! All clauses in fact. No-one else is going to be able to explain how the system works are they? Not with any responsibility. That would be like asking the kids in the family how the monthly budget is managed at home...
     
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  14. Gilbert

    Gilbert Member

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    - they are not directly involved in the operation, but i'm just confused since in ISO9001:2015, it links to clause 6, and 4.1 & 4.4, which addresses the risk and opportunities.
     
  15. Gilbert

    Gilbert Member

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    one of our auditors said that the clause 8.1 is not applicable to Top Management, but more applicable to production operations or direct line operations like manufacturing products or services
     
  16. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Gilbert ;

    Your auditor is way off base here. ISO 9001:2015 specifically references to “Top Management” eight times and there are a total of 24 top management associated "shalls".

    Indeed, clause 5.1 places ALL responsibility (overall) for the effectiveness of the QMS directly on top management. Therefore, there is no aspect of ISO 9001 that is not part of top management's responsibility (as
    @Andy Nichols stated above).

    Yes, the application/execution of clause 8.1 generally falls onto some middle management category . Inferring from your references that you are a manufacturing organization, then yes, 8.1 typically applies to the establishment of process parameters, any applicable work instructions or methods, people and equipment, etc... but none of this absolves top management from their required "ownership" of all.



    Hope this helps.

    Be well.
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Gilbert, is that an internal auditor or a CB auditor?
     
  18. Gilbert

    Gilbert Member

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    Internal auditor
     
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Phew! That's more easily rectified. BTW it's not their place to "call" such issues. It's Management's.
     
  20. NISHITH NEEMA

    NISHITH NEEMA Member

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    (The organization must plan, document, implement and control processes needed to meet the requirements of the service provision)

    I’m stuck I don’t understand what I need to provide as evidence or what I have to create.
    Mr.Gilbert From a manufacturing and service organisation this can help you
    Clause 8.1Operational Planning and Control
    The organization plans, implements and controls the processes needed to meet the requirements for the
    provision of products and services, and to implement the actions taken to addresses risk and opportunities.
    1) Org. determines the requirements for products and processes in accordance with the QMS,
    Quality Management System .
    2) Each department determines the requirements for the products and services by making "Departmental Quality
    Management System" in which the implementation items of the department and there interfaces are shown
    clearly and the basics of quality planning is clarified.
    a) Organization determines , plans and meets the requirements for products and services during new model
    phase & Mass production Phase , the new model prepares the , manufacturing management plan
    (build - up plan), identifying quality objectives & requirements for the new product and services , promote
    activities to ensure conformity with the required quality requirement.
    b) The manufacturing sections establishes process quality control items, inspection and test
    activities specific to the new product & the criteria for new product acceptance.
    c) New product realization activities are implemented in accordance with the Manufacturing management
    plan & records needed to provide evidence that product meets requirements are maintained.
    3) Manufacturing sections prepare Quality Plan which includes measurement plan and criteria such as :
    PQCT, Operation Standards. PQCT and operation standards are used as tool to ensure the built in quality
    in process.
    4) Org. determines the resources needed to achieve conformity to the product and service requirement
    through project planning & budgeting. In case a new project is initiated, not planned in original
    fiscal year plan, resources are allocated for the same & budget is approved.
    5) For control and effectiveness of the manufacturing processes , measurement at regular frequency of
    equipments and system in accordance with the criteria are planned and implemented.
    by departments based on process control requirements. Monitoring of identified process parameters is done
    by the respective department.
    6) Documents are determined, maintain and retained as appropriate to have confidence that the processes have
    been carried out as planned and to demonstrate the conformity of products and services to their requirements.
    7) The Org. controls planned changes and review the consequences of unintended changes, take action
    to mitigate any adverse effect through internal reviews by top management.