More on IATF 8.5.6.1.1 - Temporary Change of Process Controls

Golfman25

Trusted Information Resource
#1
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?
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#4
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
#5
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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