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Risk assessment mentioned in clause 7.1.5.2.1 c)

Discussion in 'IATF 16949:2016 - Automotive Quality Systems' started by morteza, Aug 23, 2017.

  1. morteza

    morteza Member

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    Hi all,

    There is a problem with me in understanding the requirement mentioned in clause 7.1.5.2.1 c):

    b) any out-of-specification readings as received for calibration/verification;
    c) an assessment of the risk of the intended use of the product caused by the out-of-specification condition

    If I would understand the requirement correctly, it says that if you find out that your gauge is out of specification (during calibration/verification), you must do a risk assessment about the usage of the products checked by the failed gauge.
    my questions are as follows:

    1- What is the difference between this risk assessment and FMEA? in FMEA?

    Rationale for this question: Gauge out of specification is a cause that that its event would be product conformity or nonconformity. conformed product has no consequence on customer or organization, but nonconforming product has some consequences on customer or organization which are analyzed in FMEA.

    2- Is this risk assessment done after the presence of any out of specification gauge or before it?

    Rationale for this question
    : Based on Risk concept. any risk assessment should be done before its occurrence.

    Thanks all
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It seems pretty simple to me (others may have a different thought) but if, for example, an item of measuring equipment is found to be out of specification when calibrated and you take a look at the value the lab measured and compare that to the part specification and tolerance, if the the dimension is a key characteristic then there's a risk of failure - like the diameter or surface finish of a brake caliper piston. On the other hand, it might be an open toleranced feature on a part which has no affect on the actual function, it's simply a general value to keep the fit/form/function to the correct value.

    A review would identify the risk impact on the correct functioning of the product.
     
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  3. MCW8888

    MCW8888 Well-Known Member

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    My understanding of clause 7.1.5.2.1 c: If the gauge was found to be out of calibration (I hope the Control Plan says to use calibrated gauges); need to assess the validity of the previous results measured by an out-of-calibrated gauge.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This has always been the case. In 7.1.5.2.1 states:

    c) an assessment of the risk of the intended use of the product caused by the out-of-specification condition;
     
  5. morteza

    morteza Member

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    Hi Andy,
    Thanks for your answer.
    what is your idea about my perception on clause 7.1.5.2.1:

    Risk: usage of product with incorrect reading of the specification
    cause: gauge failure (out of specification gauge)
    consequences: 1- no negative consequence (reading "good part" as "bad"), 2- effect mentioned in PFMEA, such as safety problems, customer dissatisfaction, etc (reading "bad part" as "good")
    severity: as mentioned in PFMEA (for consequence #2)

    finally, based on severity number (from 1 to 10) we take the necessary action (from taking no action to product recall).

    is my perception right? is it enough for meeting this requirement?
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm not certain this is one of those things that needs your approach, but go ahead if you think it's worthwhile. My thoughts are that this is such a low occurrence that you'd be wasting a lot of time going back through a lot of PFMEA forms and up dating them. Indeed, there may be ZERO effect on the product...
     
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