Temporary Change of Process Controls - IATF 16949 Clause 8.5.5.1.1

[tongxiaozhi]

Thanks for your information. For example, we produce plastic parts. if one out of 4 cavities is blocked due to mould issue, can i take it as a temporary process change?
thanks.

 

[Golfman25]

Thanks for your information. For example, we produce plastic parts. if one out of 4 cavities is blocked due to mould issue, can i take it as a temporary process change?
thanks.

Technically I would say yes. You'll need to change your process parameters such as shot size, transfer pos, maybe speed, etc. Ypu would probably need to reverify parts.

 

[Johnnymo62]

It is a process change, but not a process controls change.

I think you need to PPAP a blocked cavity. Your need to verify the changed process settings make 3 good parts.

 

[tongxiaozhi]

It is a process change, but not a process controls change.

I think you need to PPAP a blocked cavity. Your need to verify the changed process settings make 3 good parts.

Thanks for your answer. Currently we manage it as a temporary change of process controls as defined in IATF and the auditor is Ok with it . But, from the definition, I think you are right, blocking one cavity should be defined as a process change instead of temporary change of process controls.

Blocking cavities to produce occurs in injection moulding industry sometimes. We need to revalidate the process and parts before production. While, I prefer not to re-PPAP as it will be too complicated.





8.5.6.1.1 Temporary change of process controls

The organization shall identify，document，and maintain a list of the process controls，including inspection，measuring，test，and error-proofing devices，that includes the primary process control and the approved back-up or alternate methods.



The organization shall document the process that manages the use of alternate control methods. The organization shall include in this process，based on risk analysis（such as FMEA），severity，and the internal approvals to be obtained prior to production implementation of the alternate control method.

 

[UncleFester]

Note that there is both a Sanctioned Interpretation (no.11) that changes the wording of the clause above, and a FAQ (17) which may help in understanding the requirement in 8.5.6.1.1.

 

[ramar1985]

Any one have templates

 

[Mikey324]

SI 15 says:

"The list of process controls shall include the primary process controls and the approved back-up or alternate methods, if back-up or alternate methods exist."

Rationale for change: Clarified that not every primary process control has a back-up or alternate method. Clarified that if a back-up or alternate method exists, that those back-up or alternate methods are included on a list maintained by the organization. It is not a requirement to have an alternative process control for every primary control.