IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change)

[tongxiaozhi]

For the " Temporary change of process controls“， is it just related to the control method, I mean monitoring and measuring of process.

For example, If the automatic CMM machine doesn't work, we use the manual CMM machine, my understanding this is a kind of temporary change of proces controls.

But , for the injection moulding, if we block 1 cavity out 4 to produce, does it also fits into the definition of temporary change of process control?

I still don't really understand this chapter. thanks very much for your clarification.

thanks.

 

[Sebastian]

In control plan there are product and process characteristics, which have to be controlled during manufacturing, storage and shipment of product. There are defined evaluation/measurement techniques used for their control. This requirement is related to risk of unavailability of equipment listed in evaluation/measurement techniques column.

There are two options:
1. Determine during APQP back-up equipment or determine back-up process and product characteristics and related back-up equipment.
2. Implement kobesteelism.

 

[Azaarus]

In control plan there are product and process characteristics, which have to be controlled during manufacturing, storage and shipment of product. There are defined evaluation/measurement techniques used for their control. This requirement is related to risk of unavailability of equipment listed in evaluation/measurement techniques column.

There are two options:
1. Determine during APQP back-up equipment or determine back-up process and product characteristics and related back-up equipment.
2. Implement kobesteelism.

But, no one can anticipate having to block off 2 of 4 cavities on a tool to incorporate an approval from the customer for APQP. How would one establish back-up equipment for blocking off cavities?

Sorry, just curious.

 

[Sebastian]

Quantity of cavities is one of controlled process parameters? Poor me, I was thinking that it is a material volume.
SPC on quantity of cavities is definitely worth of trying. It is joke, before you start to consider it.

 

[Mikey324]

We use a spreadsheet we can Management of Change. I cant share the form, but can explain the format.
We note any proposed changes, what internal process it impacts, whether its permanent or temporary, etc. If its temporary change we list the alternate method. This just shows what we are doing in the meantime. For example, if a piece of equipment goes down, we use a modified process to complete the job. This would require us to do some additional checks to make sure the alternate process is producing an acceptable part.

 

[Sebastian]

This is standard process change management and it has separate section in IATF 16949. This is not evidence of addressing requirement we talk about.

 

[Golfman25]

It seems to me this is one where you can go completely nuts. Obviously if you have some type of specialized control system you may need a backup system if the specialized system goes down. But for those of us who use standard store bought measuring tools (calipers, mics, etc.) it seems overkill.

If you have an in line inspection system, and that goes down -- sure you probably need a backup procedure. I know from my experience, companies who guarantee defect free products use automated inspection systems built into their process. Logic tells me that is what the focus on alternates really is about.

If you have a single cmm that's on the fritz, your backup might be hand gages?

If you have hand gages, is there really a backup? Other hand gages?

 

[GRCracker]

That's my question. We had a consultant come in and stated that we needed to add "alternative method and error-proofing" to the internal laboratory scope. Question is why can't I just say alternate control method is replacement of same device. Caliper for caliper and mic for mic.

 

[Sebastian]

Your consultant is partially right. Laboratory can perform measurement, testing activities mentioned in product control plan. You have to have back-ups or determine alternate control method. When alternate method is not one of already used and included in laboratory scope, you have to revise it.
Caliper for caliper is a back-up, but one testing machine for another testing machine when both require pressured air and your pressured air supply system might go down, it is not a back-up. For this case you have to determine alternate control method.

 

[malasuerte]

Your consultant is partially right. Laboratory can perform measurement, testing activities mentioned in product control plan. You have to have back-ups or determine alternate control method. When alternate method is not one of already used and included in laboratory scope, you have to revise it.
Caliper for caliper is a back-up, but one testing machine for another testing machine when both require pressured air and your pressured air supply system might go down, it is not a back-up. For this case you have to determine alternate control method.

Great inputs Sebastian.

Just wanted to chime in and say this is not as difficult as it sounds. Make yourself a quick table of you Control Methods today. Then simply determine what the "alternate" method would be if you were w/o that primary method.

i.e. - Note, there are only random examples off the top of my head to illustrate a point.
Primary method for 'inspection of defects': MIK - microscope
Alternate method: Manual visual inspection


Primary method of control of product dimensions: Caliper
Alternate method: Ruler

Primary method of controlling product output: SPC - statistical process control
Alternate method: FDC - fault detection classification