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Temporary change of process controls
I am new to IATF standards and was wondering if you could help me understand the requirements for 8.5.6.1.1. Our current process is all Plex system driven. For example, when a deviation request is approved through Plex, it will rigger QE to review and update the control plan for temporary process control with an expiration date. Once it xpires, the control plan will go back to the normal process. Our process routing also includes approved alternate presses that can be used for a given operation (e.g. stamping, finebalnking, etc.). All products manufactured thru deviation are learly identified as such. Your guidance is greatly appreciated.
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Ivan Pribicevic
Nov 07, 2018
Answer:
IATF 16949 brings new requirements for an organization to comply. One of them is 8.5.6.1.1. Temporary change of process controls.
The main reason behind this requirement is a need for a temporary change of documented process controls that organization has used, due various of reason, it is important that organization can control process with alternative methods and get back to regular once as soon as a normal operations resume.
This process must be documented with the list of manufacturing control actions that contains both the planned methods and the approved alternative methods of process control. Alternative process control must be reviewed at least once a day and all products must be traceable.
If Plex system assures all mention requirements, and some obviously do, it can be used for fulfilling this requirement.
For more information please look at:
- How to Develop a Control Plan According to IATF 16949 https://advisera.com/16949academy/blog/2017/09/27/how-to-develop-a-control-plan-according-to-iatf-16949/
- Procedure for Document and Record Control https://advisera.com/16949academy/documentation/procedure-for-document-and-record-control/
-Control Plan https://advisera.com/16949academy/documentation/control-plan/
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Nov 07, 2018
Nov 07, 2018
Nov 07, 2018