IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

bkirch

Involved In Discussions
#1
For the IATF 16949 requirement for temporary change of process controls, does anyone have an example of a document that they have used to meet this requirement?

Also, does anyone have an example of how they have documented the process that manages the use of alternate control methods?
 
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tongxiaozhi

Involved In Discussions
#2
I have a similar question. I am in the injection moulding industry for automotive. For us, we only have one standard process parameter for each machine, that means that we don't have an alternate control method, my understanding is that we don't have to manage it.
 

Sebastian

Trusted Information Resource
#5
No, it is not a question of back up control equipment, it is question of alternative control method.
Let's take example of process parameter - temperature. Standard control method described in control plan is automatic system with thermocouple connected with heaters regulators. In case of failure of this system you will implement manual measurement e.g. every 5 minutes and manually adjust heater setup value to keep current temperature value within specification. Instead of stopping the process, waiting for replacement and restarting of the process, what mights endanger your customer due to sudden drop of manufacturing capacity, you implement other method of process control.
 

tongxiaozhi

Involved In Discussions
#6
No, it is not a question of back up control equipment, it is question of alternative control method.
Let's take example of process parameter - temperature. Standard control method described in control plan is automatic system with thermocouple connected with heaters regulators. In case of failure of this system you will implement manual measurement e.g. every 5 minutes and manually adjust heater setup value to keep current temperature value within specification. Instead of stopping the process, waiting for replacement and restarting of the process, what mights endanger your customer due to sudden drop of manufacturing capacity, you implement other method of process control.
Thank you very much for your examples.

Normally, we use the automatic CMM machine to measure the part. If something is wrong with it, we use the manul CMM machine to check the key dimensions. Can I take this as an alternate control method?
 

rkk2014

Starting to get Involved
#7
Hello,
As per 8.5.6.1.1
The organization shall document the process that manages the use of alternate control methods.
Does it mean, that, we should have a separate Process for use of alternate control methods ??

:confused:
 

Andrei77

Starting to get Involved
#8
Hello,

we`ve just had our IATF transition audit and I`ve been given a major non-conformity for not having the List of all the process controls and the alternate control methods. As I see things, right they are very difficult for me as we have a large number of control plans (the best place to find your process controls). I am convinced that not even the auditors understand this requirement clearly.
Yes, it does say to have a list of all process controls (which like I said they are detailed in each control plan) but also to have an approved back-up or alternate methods.
So, what does "approved" mean, keeping in mind that all these control methods have been previously part of a PPAP and thus validated? Do we need to validate these alternate methods as well? If not, how do we prove that they are right for our intentions? If we have to include severity based on FMEA and internal approvals does it mean it will be another control plan?
The auditor has given us some hints about having only a generic list of alternate control methods, but I smell new non-conformities if we stick only to this.

I`ll welcome everyone's thoughts on this as I believe its a pretty complicated requirement.

Thank you
 

rkk2014

Starting to get Involved
#9
Hello,

1. Organization to have a list of alternate Process Controls( including Error Proofing devices.....where bypassing can be done & is acceptable ), these are to be approved from Customer during APQP Stage......."Pre Approved"

2. These are to be addressed in PFMEAs / CP and if needed in Contingency Plan or Risk Analysis.
3. Apply Stringent inspection / Layered Audit , maintain trace ability of Lot, inform Customer before dispatching the Lot.

:rolleyes:
 
#10
Hello,

we`ve just had our IATF transition audit and I`ve been given a major non-conformity for not having the List of all the process controls and the alternate control methods. As I see things, right they are very difficult for me as we have a large number of control plans (the best place to find your process controls). I am convinced that not even the auditors understand this requirement clearly.
Thank you for sharing this information. This helped me a lot!

I'm trying to figure out what I need to do for the list of the process control and alternative process control. This points me in the direction I needed to go in, especially reading that a major was written for this. :thanx:
 
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