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FMEA, Control Plan and Work Instructions Alignment

Discussion in 'IATF 16949:2016 - Automotive Quality Systems' started by luckycharm, Mar 4, 2016.

  1. luckycharm

    luckycharm Member

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    Hi guys!
    I'm new to this forum and I want to bench mark from your best practises in case my issue at work applies to you as well.

    How is your system of revising your FMEA, CP and Work Instructions in cases of Specifications or Process Changes? How do you make this 3 docs aligned? In my organization, we always have a problem of one doc being left behind during changes. I hope I can get improvement for us from your input. Thanks!
     
  2. MCW8888

    MCW8888 Well-Known Member

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    First of all if you have your original PFD, PFMEA and CP aligned and have been approved by the OEM, if you make changes to the CP, look at the PFMEA and review the RPN of that particular line item in the CP. You also need to have a Revision History and identify the changes made.
     
  3. QAengineer13

    QAengineer13 Member

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    The way we handle it is through Change Request Process, any change as to have a Change Request (CR) with details such as
    Change summary
    Reason for change
    Affected Document [or] Docs to be changed by this CR (This is the place where you identify all the existing, in your case its the FMEA, CP, WI, etc)
    Impact/Cost assessment which includes:
    is V&V required? if no state reason
    Risk Profile change? if yes attach risk assessment doc, if no state the reason
    Re-training required?
    Is there UL/EMC impact?
    manual update required?
    PCP update required?
    Affect stock in hand etc....

    Please note: In-order to be efficient in change management process a preliminary requirement is to have a Good Design History File with tractability of the Docs , which can only save you form not missing doc's when reacting to change.

    My 2C's.
     
  4. luckycharm

    luckycharm Member

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    Hi QAEngineer13

    We have basically the same system in handling change management process.
    However, our problem lies in revising the affected documents identified.
    We find it difficult to have an efficient process of revising. Can you share what do you mean of a
    Good Design History File?

    Thanks
     

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