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Criteria and resources in 8.1 Operational planning and control

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by judegu, Oct 11, 2018.

  1. judegu

    judegu Well-Known Member

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    Hi guys. Here is something strange I found in sub cl. 8.1.

    First, I have noticed that in the beginning of this clause, it said that "The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6." It indicates that meet the requirements of the provision of products and services is the focus, and the processes are the tools to make this happen.

    However, with regards to the objects of the CRITERIA and RESOURCES, there is a strange thing.
    - In the bullet b) the organization should "establishing the criteria for 1) the process 2) the acceptance of the products and services". Here as for criteria, it involves the process and the product & services.
    - In the bullet c) the organization should "determining the resources needed to achieve conformity to the product and services requirements;". Here as for resouces, there is only presence of the products and services.

    I wonder why this difference happened. If we need to determine the criteria for the process, why there is nothing about the resources which the control of the processes needs in the bullet c)?

    Please help me on this matter. Thanks.
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    A3- The difference is that "b" requires us to establish the criteria (pass/fail requirements), while "c" requires us to determine the necessary resources (this could be equipment, tools, personnel, gages, etc...).
    A4- Also, "c" indicates resources needed to achieve conformity. Those resources could be (and likely are) inputs (i.e. process resources)…necessary to achieve conformity (outputs). Therefore, "c" does indeed indirectly refer to BOTH.
    i.e. resources (Process inputs) and conformity of product/services (outputs)


    I hope this helps.

    Be well.
     
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  3. judegu

    judegu Well-Known Member

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    @ John C. Abnet

    Thank you for your correction(A1, A2).:) I did use the wrong words which definitely changed the nature of the requirement.

    Just see A3 alone, it seems to be not sufficient enough. However, when taking the A3 and A4 together, it becomes quite convincing.
    In this sub cl., "Processes" and "Products and services" are not two same-level terms. Here "Products and services" are the output of the "Processes".
    In this way, "c" dose indeed indirectly refer to BOTH.

    Besides this case, I found a similar one in 7.1.5.1.

    "The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements."

    And there is an example, in the manufacturing line I am working at, there are ovens which are used to cure the silicone. And in this curing process, of course, temperature is a crucial factor which determine whether the whole process works or not. And to ensure the correct temperature, first the setting needs to be correct, and then the reading from the thermal sensor needs to be accurate.

    So here the question, based on the content I quoated from 7.1.5.1, does this thermal sensor embeded in the ovens belong to the monitoring and measuring resources?;)
    (the thermal sensor doesn`t verify the conformity of the products to requirements, it just ensure the process critera to be met.)

    What is your opinion on this case?
     
  4. tony s

    tony s Well-Known Member

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    Definitely Yes. But, does 7.1.5.1 cover this type of monitoring and measuring resource? Definitely No. This kind of monitoring and measuring resource is covered by 8.5.1b and 8.5.1c.
     
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