ISO 9000 Question

I acutally asked this same question elsewhere and was suprised at the response I got so I wondered what you guys have to say about my same question:

If your company is ISO cerfied and your an OEM....

When you release electrical drawings to your assembly team. Are those drawings stamped as CONTROLLED? Or does your company release the drawings as UNCONTROLLED?

If you release the drawings as CONTROLLED, then I assume you are having to track revisions on the electrical drawings as your machine is built on your shop floor. However, if you have released the electrical prints as UNCONTROLLED, then you are probablly not tracking revisions on the electrical prints until after the machine ships then do you call that print REV 1? Or no Revision until after you make the first field wiring change?

Can you describe to me if your ISO certified how your company flows electrical drawings to your assembly team?

At one time we were issuing controlled drawings to out manufacturing department, but then when the machinery shipped the drawings would often have several ECO (engineering change order) notes on them to record the changes for the "as built". Currently we are issuing uncontrolled copies and the drawings are cleaned up and "locked down" when the machinery ships so the customer sees a clean set of prints for their machinery. I believe ISO just requires a company to document the procedures used not the specific process.

Sekeeley said:

I believe ISO just requires a company to document the procedures used not the specific process.

Click to expand...

This is correct. Reason I asked is because if we did release them CONTROLLED, then we would have alot of hassles of tracking the "ECO" as you call them or red line changes made on the floor during our build time. Since we never build the same machine twice, it seems to me it would make more sense for us to release the drawings UNCONTROLLED, and make final changes to the drawings and call them "AS BUILT" when the machine ships to the customer.

I agrue the fact that these changes aren't revisions. We've all made mistakes or we want to add a valve or photoeye here and there, it doesn't make sense to have an electrical drawings at revision 14 already when it ships out the door. It shouldn't have any revisions on the drawings unless it's changed in the field or after it ships our facilty. That's just my thoughts however, maybe I am blowing smoke again.

Of course it makes it easier not to track revisions in an ISO type "modeled" procedure is what I was wondering if anyone else does this too. Having to mark the drawings as CONTROLLED while during our build time on the floor seems like alot of paperwork trail to keep track off then staying in the ISO spirit, those drawings would already have revisions even before the customer turned the machine on for the first time.

I agree completely with you. The actual revisions start when the machine hits the asphalt.

Devil's Advocate

So Chako -

You seem to be saying that the drawings should reflect the machine that was built, rather than the machine being built to reflect the drawings. Is that it?

So then, how do you know how to build the machine correctly? Your answer seems to be: "Use the drawings".

So that means that those original drawings were in control of the process, right?

Of course, sometimes there are mistakes in the drawings - of either design or mere typos. So then the process takes control of the drawings, right?

And when you ship the machine and the drawings, how do YOU know that they describe the same thing. Do you make red-lined changes to the drawings, print a fresh copy, and then verify that the machine and the drawings match?

If not, how how do you know which one is supposed to be right?
If you do, then why don't you stamp the drawings as CONTROLLED when they are being marked-up by the panel builders?

I look at 'uncontrolled' documents as if they were marked 'for reference only'. Definitely not something you want to be making construction descisions off of. But with most custom equipment manufacturers there is a much tighter coupling between engineering and manucfacturing than with your run-of-the-mill toaster manufacturer. Discrepencies will usually get caught before the machine gets to the customer.
I think the issue is that ISO9000 and its spawn do not translate well to one-off or limited production run items. If I'm making 1 million widgets and I want them all to be the same (good or bad, by the way) then ISO9000 will help me do that. But if I'm going to make 1 million of these things I've probably prototyped them and have MOST of the obvious bugs worked out. So I can tell someone with a great deal of certainty what needs to be done to build the widget; I've done it already.
Design, verification, prototyping and manufacturing all tend to flow togther with one-off designs. So the letter of the law restrictions of ISO9000 are kind of bogus.
One of Sekeeley's points highlighted the difference between procedure and process. Chako, if your manufacturing procedures allow you to use an uncontrolled document to manufacture a saleable product AND your ISO inspector lets you get away with that, by all means have at 'er. Just because you bring this up is proof enough to me that you care enough about your process that ISO900 won't help you do your job any better anyway. Besides, it's not in the best interested of those vested in ISO9000 to revoke ANYONE'S certification. Where would the recurring fees from evaluations and inspections come from if companies started losing their certification? The financial model would just fall apart. It won't happen.
By the way, we use a modified drawing revision code for in-house stuff so we can track it without influencing the true revision level. But like you, the revision level is one past original when the thing goes out the door.

Keith

Re: Devil's Advocate

Allen Nelson said:

So Chako -

You seem to be saying that the drawings should reflect the machine that was built, rather than the machine being built to reflect the drawings. Is that it?

Click to expand...

Great questions Allen. Let me clarify a few things.

When drawings are released of a custom machine we build they are released to the panel building teaming on the floor. We have a sheet with sheet numbers of every drawing on it.

I initial and date EACH sheet number column on that single piece of paper, then I grab a red stamp that says "Released for Assembly", sign and date each page of the electrical prints before I hand the prints over to the head electrical dude.

Also on that same piece of paper is a an extra column called updated and a spot to initial it again indicating that I looked at the returning prints after the job was complete and I updated the red line changes.

The guys on the floor know that if there is a change to the job electrically, to red line in red penicl ONLY the prints with the stamp "Released for Assembly". This is considered the master electrical prints for the job. No other red lines should be drawn on any other print but the print set that has that stamp on the page.

So yes I know that the red lines need to be added to the final prints.

When the job is over, I look at the "Released for Assembly" prints and check for red lines on each sheet, when I update them in CAD, I get back out that first piece of paper above, and by each sheet number I initial my name next to the sheet number I updated meaning that I looked at the prints, I updated them in CAD and they are considered "AS BUILT" or "FINAL". Once all the columns are check, this means I got back ever piece of paper that I released to the panel building team with red line changes, and I updated every single piece of paper. So now I can destroy the red line copies and print my FINAL "as built" set of prints and ship the prints with the job.

Now my question is the revision tracking. My understand is if we change our ISO flow to CONTROLLED copies on the floor we have to track revisions or each red line change that is on the floor. I am against this change because I don't think we should have revision 14 or revision 5 or how many other red line changes we made to a print while it was being built. CONTROLLED copy prints are generally better fit for a manufacture place that produces widgets, not for an OEM custom machine building shop.

So my question is, am I thinking right and asking any other OEMS that are ISO certified because you deal with Tier 1 suppliers too that require you to be ISO to do business with them, do you release your prints UNCONTROLLED but still have some "process" in place that satisfies your ISO inspector and not have to mark the prints CONTROLLED?

If they are marked CONTROLLED, our ISO inspector will force us to track each and every red line change as a revision and note the red line change on the prints even BEFORE they are shipped final to the customer.

To get around the jargon terms and ISO requirements, I suggested that we stay UNCONTROLLED, and keep our print tracking in place as described above and then when the prints are updated and sent out the door with the final "as built" machine, they are considered CONTROLLED prints. At this point if we make a change in the field or add on something to the electrical panel, then I have no problem calling that a revision 1 to the sheet page I added my addition too in the field or after the final prints were updated.

With all that said, does anyone else do what I am proposing? Or do I need to go lay down and shut up?

ISO 9000.1

I get it now.

One thing we used to do (back when I worked at an ISO integrator) was to issue internal revisions as 0.0, 0.1, 0.2, etc. Once the thing was ready to ship, then we issued 1.0.

We did this for documents, but I don't see why it couldn't be applied to drawings.

I don't beleive that there's any law that says that revisions have to start with 1, or that you can't have "minor revision levels" (.1, .2) instead of "major revision levels" (1, 2, 3).

Perhaps that will work for you.

ISO 9001 Document Control

Hi Chakorules,

There are a couple of items that need to be addressed:

4.4.6 Design Review

Depending the ISO procedures for your organization and how the contract was made with your customer, design changes may have to be approved by your customer before implementation. ISO strives to make sure that we give the customer what he is asking for, and not what we think is best for him.

4.5.2 Document and Data Approval and Issue

Basically, the correct drawings and programs must be available at all locations (at all times). And all obsolete information is to be propmtly retrieved. This is really a tough one for machine builders.

We were able to solve this stipulation by red-lining the changes immediately. However, the Project Manager needed to collect the marked up drawings daily for redrawing and reissue. AutoCAD was a big help.

The customer and the Project Manager worked out the customer review part.

Good Luck!