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clause 10.2 (b) Evaluate the need for action to eliminate the cause(s) of the nonconformity

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by sunrize, Jan 10, 2020.

  1. sunrize

    sunrize Member

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    Dear friend

    1. In clause 10.2 (B) Evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere

    is this mean that take a corrective action for any nonconformity is optional and as per evaluation of the needs for taking corrective actions?

    if this is ok, how to make this evaluation?

    2. what is the difference between nonconformity in clause 10.2 and non conforming output in clause 8.7?
     
  2. tony s

    tony s Well-Known Member

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    For #1:

    The requirement says "evaluate the need for action to eliminate the cause of the nonconformity, in order that it does not recur or occur elsewhere..." If corrective action is defined by ISO 9000:2015 as "action to eliminate the cause of the nonconformity and to prevent recurrence", then my answer would be: Yes, because not all NCs can be addressed by corrective actions. ISO 9002:2016 also has this statement:

    "When evaluating the action needed for a nonconformity the organization could consider that there
    might be instances where the cause of a nonconformity cannot be eliminated, therefore, the organization
    should consider taking actions to be able to detect and minimize the effects of the nonconformity if it
    were to occur again".

    Evaluating the need can be done by using cause analysis tools. Once the cause/s is/are known, the organization will be able to determine whether the cause/s can be eliminated or not.

    For #2:

    Nonconforming output is a result, since output is defined as "result of a process". Nonconformity is defined as "non-fulfillment of a requirement". So, if there is a requirement to produce a desired output and was not fulfilled then, technically, there is a nonconformity. Nonconforming output can be considered as a consequence of a nonconformity. There are process nonconformities, system nonconformities, including product/service nonconfomities. A reject product is a nonconforming output. The defect of the reject product is a nonconformity.
     
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  3. Leonid

    Leonid Well-Known Member

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    The corrective action is not needed if the organization is not sure that the root course of the nonconformity is determined correctly.

    The term “nonconformity” is used in 8.7.1 and 8.7.2 as the synonym of nonconforming product. Nonconforming product is the nonconformity itself.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I think Tony said it best...
     
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