IATF 16949 - 8.5.6.1.1 Providing a list of process controls: Does this requirement add value to QMS?

[morteza]

Hello all;

Based on SI#11, IATF 16949 states:

The organization shall identify, document, and maintain a list of the process controls, including inspection, measuring, test, and error-proofing devices. 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.

Here is two questions:

1- As we know all process controls (primary and alternative) are listed in control plan. Does having a separate list of process controls add any value to the organization? I think the list (or number of process controls and their alternatives) would not indicate manufacturing process status (good, bad, etc.). For processes without any alternative control method, providing a list of process controls in addition to control plan would be boring.

2- Are “back-up” and “alternative” the same or “back-up method” is different from “alternative method”?


Thanks all.

 

[Jimmy123]

Hello all;

Based on SI#11, IATF 16949 states:

The organization shall identify, document, and maintain a list of the process controls, including inspection, measuring, test, and error-proofing devices. 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.

Here is two questions:

1- As we know all process controls (primary and alternative) are listed in control plan. Does having a separate list of process controls add any value to the organization? I think the list (or number of process controls and their alternatives) would not indicate manufacturing process status (good, bad, etc.). For processes without any alternative control method, providing a list of process controls in addition to control plan would be boring.

2- Are “back-up” and “alternative” the same or “back-up method” is different from “alternative method”?


Thanks all.

In my understanding means alternative, two standard way’s. You can use your car or the car of your wife to drive to your company. The back-up is the public transportation in case of a accident, means the battery on your car is damaged and your wife’s car is in the garage for service.

 

[Sebastian]

This requirement is one of risk management related requirements. For manufacturing equipment, infrastructure there are contingency plans. What we have for inspection, monitoring systems? "We would run a process, send parts to customer, if we have this device. It is broken now, so we will not."
1. There is a device which has been never used. Why? Because cheaper, easier to use devices are still in place. One day someone has an idea to sell it as it is not used, or there is no will to pay for its calibration when current one lost its validity. Then short look at this list shows, that it is a back up, so it is worth to keep it. All these devices are elevated from individual part control plan level to separate document, just to make them easier to notice and manage.
2. For me back up has identical construction, alternative has identical or similar purpose.

 

[Jimmy123]

This requirement is one of risk management related requirements. For manufacturing equipment, infrastructure there are contingency plans. What we have for inspection, monitoring systems? "We would run a process, send parts to customer, if we have this device. It is broken now, so we will not."
1. There is a device which has been never used. Why? Because cheaper, easier to use devices are still in place. One day someone has an idea to sell it as it is not used, or there is no will to pay for its calibration when current one lost its validity. Then short look at this list shows, that it is a back up, so it is worth to keep it. All these devices are elevated from individual part control plan level to separate document, just to make them easier to notice and manage.
2. For me back up has identical construction, alternative has identical or similar purpose.

I think the opposite is right. On your computer you use also a backup. This will be never used, only you have a reason. If your computer is damaged, you have a backup to use. The word alternative comes from Latin and means OR you have the option to use A and B both are nearly identical. In mass production you have very often such alternatives. A is located in country A and B is located in your location in country B.

Alternativ I can use camera system from company A or camera system from company B, both are capable to control. My back up, if both are not available is double visual check by inspectors for a temporary time (emergency plan)

 

[joekirk]

This requirement (interpreted) has swung from extreme (everything on the control plan must have an alternate "back-up" method) to now common sense. Yes, this requirement does add great value to your QMS if interpreted correctly. It should be done based on risk and must companies are already doing this, just not documenting it.

Basically, review all your processes including inspection, measuring, test, and error-proofing devices. Note those that are of a risk due to common breakdowns, age of equipment, experience, etc... and plan for what to do when those processes are not available or not working.