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IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)
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IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)
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change control, iatf 16949:2016, process changes and change notifications, process controls and control plans
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  Post Number #1  
Old 29th March 2017, 09:51 AM
bkirch

 
 
Total Posts: 30
Please Help! IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

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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  Post Number #2  
Old 5th April 2017, 01:04 AM
tongxiaozhi

 
 
Total Posts: 85
Re: IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

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.
  Post Number #3  
Old 7th April 2017, 05:19 AM
Sebastian

 
 
Total Posts: 302
Re: IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

I can not share document, but for me it could be contingency plan or reaction plan part of control plan.
Thanks to Sebastian for your informative Post and/or Attachment!
  Post Number #4  
Old 7th April 2017, 06:12 AM
tongxiaozhi

 
 
Total Posts: 85
Re: IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

Quote:
In Reply to Parent Post by Sebastian View Post

I can not share document, but for me it could be contingency plan or reaction plan part of control plan.
If we have a backup machine for one project, it means we need to manage alternat control methods?

thanks.
  Post Number #5  
Old 7th April 2017, 11:23 AM
Sebastian

 
 
Total Posts: 302
Re: IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

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 to Sebastian for your informative Post and/or Attachment!
  Post Number #6  
Old 7th April 2017, 10:13 PM
tongxiaozhi

 
 
Total Posts: 85
Re: IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

Quote:
In Reply to Parent Post by Sebastian View Post

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?
  Post Number #7  
Old 20th November 2017, 11:40 AM
rkk2014

 
 
Total Posts: 15
Re: IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

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 ??

  Post Number #8  
Old 21st November 2017, 04:32 AM
Andrei77

 
 
Total Posts: 11
Re: IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

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
Thank You to Andrei77 for your informative Post and/or Attachment!
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