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IATF 16949 Clause no. 8.5.6.1.1 Temporary Change of Process Controls

Discussion in 'IATF 16949:2016 - Automotive Quality Systems' started by Pongsakorn, Apr 23, 2019.

  1. Pongsakorn

    Pongsakorn Active Member

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    I understand that the IATF 16949 Clause no. 8.5.6.1.1 "Temporary Change of Process Controls" is applicable for the temporary change of Test or Inspection method, sample size, frequency defined in control plan. It is NOT applicable for the change of manufacturing process.
    The first paragraph confuse me and make me understand that the Mfg process change is included.
    (e.g. change from Automatic machine to Manual machine)
    upload_2019-4-23_18-44-25.png

    The following paragraph is more clear as it mention about Test/Inspection only.
    upload_2019-4-23_18-44-1.png

    Please let me know if I understand the scope of this requirement correctly.
     

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  2. Himanshu Patel

    Himanshu Patel New Member

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    Yes, you understood currectly. even it is not a requirement to have an alternative process control for every primary control.
    When introducing new products, an organization should consider the risk of the primary control potentially failing and, based on risk and severity of failure mode, decide where alternative process controls are needed. When back-up or alternate process controls are needed, then both the primary and alternative process controls should be defined in the process flow, PFMEA, control plan, and the standardized work available.
    For existing processes, where there is a failure in the primary process control, and no alternative process control is defined, the organization should consider risk, (e.g. FMEA) and if approved, develop standardized work for an alternative process control, implement the controls, verify effectiveness through daily management, and then revalidate when the primary control is restored.
    Periodically, the organization shall review instances of where alternative process controls have been used and consider this as an input to update the process flow, FMEA, and control plan.
     
  3. Daniel Attwater

    Daniel Attwater Member

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    Hi, Can someone clarify the best way to achieve compliance on this point. Is the contingency plan suitable evidence?
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Firstly, we have to understand the basic premise: "The factory of the future will be run by a man and a dog. The man is there to feed the dog and the dog is there to keep the man away from the machines..."

    The auto industry want suppliers to establish robust, capable and in-control processes. But then we know that sometimes there's a variation, perhaps in raw materials, which needs a process to be run outside of the prescribed conditions. This is where a temporary change is used. It's to ensure that control isn't (inadvertently) lost. You may not encounter such a situation, in which case you'll have a redundant document. Or not...
     
  5. johnnymo77

    johnnymo77 Active Member

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    I don't think so.

    They are to be approved back-up or alternate control methods. The 3rd paragraph of the clause says the alternate process controls and are referenced in the control plan. This makes me think it's a specific statement/method for each control.
     
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