More on IATF 8.5.6.1.1 - Temporary Change of Process Controls

Golfman25

Trusted Information Resource
Looking for help on the applicability to our organization. We make stamped components. Our process controls are basically inspection with the various standard hand gages -- mics, calipers, etc. -- of which we have multiple available.

Standard provides "The org. shall identify, document, and maintain a list of the process controls, including inspection, measuring, test, and error-proofing devices, that includes the primary process control and the approved back-up or alternate methods." Blah, blah, blah.

What is our alternate control method?
 

Marc

Fully vaccinated are you?
Leader
My apologies. You correctly did so and I was not being a good steward here by simply referring you to another discussion and a search.

As I read it (and folks, by all means correct me if I'm wrong, or improve on my response):

You have an inspection and/or test point on your control plan (which is a process control). As you develop your control plan you consider the more critical inspection and/or test points and in a "disaster recovery" or "risk analysis" of some type, whether you need a potential alternative should the system or gage (or what ever) cease to function. In your case standard hand gages -- mics, calipers, etc. are't a problem. You just go get another one.

But - Let's say you have a vision system at one point. What happens if it goes down? To keep production going what alternative method(s) do employees have? It may be just a visual check rather than the automated vision system. This must be documented (which is typically done anyway, not necessarily because a standard requires it - It's just good manufacturing practice). Some vision systems are simple and easy to repair quickly. Others are much more complex and a human eye visual check will not suffice. In some cases it will be to keep production going and by-pass that inspection and/or test but to isolate the un-checked product and have a plan to check product after the inspection device is repaired.

In metal forming, for example, it was common at the places I worked with for WIP area to be used. I could use the word "quarantine", but that doesn't have to be an area separate from all others so I think the word is a bit misleading. In a situation it was a documented process to prominently label lots/containers/etc. with regard to their status (as it everything in a WIP storage/holding area).
 

Golfman25

Trusted Information Resource
My apologies. You correctly did so and I was not being a good steward here by simply referring you to another discussion and a search.

As I read it (and folks, by all means correct me if I'm wrong, or improve on my response):

You have an inspection and/or test point on your control plan (which is a process control). As you develop your control plan you consider the more critical inspection and/or test points and in a "disaster recovery" or "risk analysis" of some type, whether you need a potential alternative should the system or gage (or what ever) cease to function. In your case standard hand gages -- mics, calipers, etc. are't a problem. You just go get another one.

But - Let's say you have a vision system at one point. What happens if it goes down? To keep production going what alternative method(s) do employees have? It may be just a visual check rather than the automated vision system. This must be documented (which is typically done anyway, not necessarily because a standard requires it - It's just good manufacturing practice). Some vision systems are simple and easy to repair quickly. Others are much more complex and a human eye visual check will not suffice. In some cases it will be to keep production going and by-pass that inspection and/or test but to isolate the un-checked product and have a plan to check product after the inspection device is repaired.

In metal forming, for example, it was common at the places I worked with for WIP area to be used. I could use the word "quarantine", but that doesn't have to be an area separate from all others so I think the word is a bit misleading. In a situation it was a documented process to prominently label lots/containers/etc. with regard to their status (as it everything in a WIP storage/holding area).

Yeah, that sounds like what they where getting at -- specialized types of systems. Our neighbor does a lot of auto and every job has a special 100% inspection contraption. So unavailability in that case could be a problem.

But for us, we are simpletons. Hit it with a mic or caliper and get on with it. We don't really have a bunch of special stuff. But the standard mandates a documented process -- and thus it's hard to envision such a process when there is little to no effect on the operation.
 
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