How to address Clause 8.5.6.1.1 of IATF16949:2016

Regarding Clause 8.5.6.1.1 Temporary change of process controls, based on my understanding, the main body is "process controls". And again, based on my understanding, SPC is a kind of process control, so are the Sampling Inspection and full inspection.
However from a bestseller book about IATF16946 (of course it is not in English.), the author use a "process control temporary change management regulation" to address 8.5.6.1.1. This regulation should be implemented in the following situations:
1) temporary change to the processing method
2) temporary use of alternative equipment when key equipment fails
3) temporary use of alternative tooling or method when key tooling malfunctions
4) using the alternatives when inspection, measuring, test, fool-proof device fail,
5) temporary use of other alternative methods.

If the above situations happen, the organization should go through the process stated in this regulation, notify the customer and ask for the consent. And after getting the consent, change all the relevant documentation and do other stuffs.

My question ① is that in the original clause, just temporary change of process controls is mentioned. It is necessary that other situations above(1,2,3,5) need to be addressed in the manner as situation 4) is.

What is more, I have also checked how it is done in my company. The triggering events are as bellows,
1) Incoming material from approved suppliers fails to conform to the requirements. Use the material from non-qualified suppliers.
2) due to equipment malfunction or/and increase of production demand, use non-designated equipment.
3) use alternative processing methods
4) other situation where deviation from requirements in CP happens.

My question ② is that in my company`s case, whether the determined triggering events are appropriate or not.

Looking forwards to your guys` opinions on this matter. Thanks.

 

Good day @judegu

Please allow me to first make a comment regarding the "bestseller book". I commend you for reading, researching, and gleaning council and input on the subject of IATF 16949. Please allow me to encourage you to continue to do so. I would, however, caution, that you only utilize books, consultants, forums, etc... to build an understanding based on the actual IATF 16949 standard. The standard is the only auditable requirement. Be careful not to accidentally assume requirements beyond the standard.

Now let us take a look at your questions and attempt to provide you some guidance...

1) temporary change to the processing method
2) temporary use of alternative equipment when key equipment fails
3) temporary use of alternative tooling or method when key tooling malfunctions
4) using the alternatives when inspection, measuring, test, fool-proof device fail,
5) temporary use of other alternative methods.

If the above situations happen, the organization should go through the process stated in this regulation, notify the customer and ask for the consent. And after getting the consent, change all the relevant documentation and do other stuffs.

My question ① is that in the original clause, just temporary change of process controls is mentioned. It is necessary that other situations above(1,2,3,5) need to be addressed in the manner as situation 4) is.

1-
The standard requires the organization to "...identify...maintain a list of the process controls...
Is "...the processing method..." a process control? (1)
Is "...equipment..." a process control? (2)
Is "...tooling..." a process control? (3)
Is "...alternative methods..." (one would assume the writer means methods of process control) a process control? (5)

Remember, the standard requires your organization to "... identify...maintain a list of the process controls..." I doubt that your list would exclude items 1,2,3,5, and if that is true then the author's list is likely correct.

"notify the customer and ask for the consent. And after getting the consent, change all the relevant documentation and do other stuffs.

Note that the standard qualifies this with the with the statement "...if required..." in regards to customer notification and consent. It is likely that your customer's DO require this, however, the author appears to be stating this as an always given, when in fact, it is only "...if required..." by the customer.

1- Summary: The short answer to your question is YES, assuming that your organization's list of process controls includes items 1,2,3,5 (which one would assume they must).

What is more, I have also checked how it is done in my company. The triggering events are as bellows,
1) Incoming material from approved suppliers fails to conform to the requirements. Use the material from non-qualified suppliers.
2) due to equipment malfunction or/and increase of production demand, use non-designated equipment.
3) use alternative processing methods
4) other situation where deviation from requirements in CP happens.


My question ② is that in my company`s case, whether the determined triggering events are appropriate or not.

2-
Again, it is difficult to speak specifically for your organization, but yes, these are triggering events that are consistent with the intent of the standard.
2- Summary: The short answer to your question is YES.

Looking forwards to your guys` opinions on this matter. Thanks.[/QUOTE]

Commentary:
Allow me to give you some pointer's based on my professional experiences.
a) If an input into your product manufacturing is "wrong or gone" , then it is likely a necessary process control. Your organization should know what these are and assess (via risk assessment,) what could go wrong if they are "wrong or gone" and what alternatives (and their methods) are approved.

b) Don't forget your control plans. Note the name..."CONTROL plans". If created and maintained correctly, these should already be providing a "list" of process controls.

c) Regarding "...alternate CONTROL methods". I frequently recommend that, instead of creating yet ANOTHER fragmented set of documentation, organizations simply add columns within existing control plans for, e.g. ALTERNATE evaluation technique, ALTERNATE sample frequency, ALTERNATE control method, etc...

Hope this helps.
Be well

 

Hi John. I really posted a quite stupid thread here. Another awkward moment for me.
And thank you for your advice.
I have been working on the IATF requirements for a while (on and off). Sometimes the clauses are just quite abstract to me which
makes it a little bit difficult for me to memorize them and recognize them as a whole and know them in details.
Some examples of how each clause works in reality would be a great help. That is the reason why I looked elsewhere to find
some examples. And obviously it also led me to ignoring the requirements themselvse.
Again thank you for making this reply to me.

 

No such thing as a "stupid thread" or question...@judegu.

Your question was worthy of the forum and these type of questions help me (and others) stay sharp. Thanks for posting it.