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Controlled Documents and Records - Overdue NCR/CAR Forms


Dan De Yarman

While trying to clean up all of the overdue NCR/CAR forms, I ran into a problem. I am trying to explain to my MR what we need to control and what 'controlled' actually means. I'm not being very sucessful. If anyone has any suggestions, please let me know.

Here's the scenario: We have one page 'document', if you will, which informs our manufacturing floor which jobs to work on first. It is called the "Priority List". I am trying to explain that this list has to be controlled because it affects delivery. I think, all though I'm not sure, that I got my point across on that part of the topic. However, since this list is issued every Tuesday, with 15 or more controlled copies being made, we are looking for a better way to control the list than using 'controlled' paper. We are going to go through a lot of expensive paper if we don't find a different method. Any suggestions?

The controlled copies are for the Vice President of Operations, Manager of Machining Services, and the Machine Shop employees. Our routings and drawings are put in a clear plastic pouch, which is labeled with a colored sticker. The color of the sticker corresponds with the color on the "Priority List", thereby establishing what detail should be worked on first. The "Priority List" and pouches get updated weekly.

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Tom Goetzinger

When you generate your new Priority List, do you collect all of the old ones to ensure that they are not used in error? Are there times when it is not printed at all during the week or not printed on Tuesday?
While you do have to make sure that everyone is using the most recent Priority List, I am not sure that it has to be a "controlled" document,in the sense that it appears on your Master List and is subject to some sort of revision control.
Would it make sense to modify the procedure that covers its use to say that "Priority List printed on the most recent Tuesday will be used". You could substitute "second working day of the week" for "Tuesday" or whatever else makes sense to your operation.
I firmly believe (MHO) that the use of the "Controlled Paper" method to identify the controlled copy of a document is very prone to non-conformance.

Tom Goetzinger

barb butrym

Quite Involved in Discussions
A date on the printed list, is sufficient. Don't get into control of stuff that doen't need it. The list is a working sheet, and I would guess updated on the system live, so that whenever its printed it will be current..or viewed people have access?
In most cases, this would not even be in a procedure or maybe just referenced as would be common knowledge of the supervisor/facilitator and part of his/her training for that job. Or do the workers pull their own work from it.... so many variables to consider...anyway, a date of issue is sufficient even for worse case scenarios.

Dan De Yarman

We have been using in the past, until it was put on the ridiculous 'controlled' paper (by me of course), a date as a form of control. The Vice President of Operations (who is also the MR) is the only person who has the authority to change the "Priority List".

The machine shop employees physically go to the shelves that have the material matched with the appropriate routing and drawing, and take it back to their machine. They prioritize which details they are to make by the color of the sticker on the routing pouch. Every week when the "Priority List" is updated, someone goes around and changes the pouches, if needed.

Currently all we are doing is putting the "list" on controlled paper with a date on it stating it is coming from our VP of Operations. As of right now, it doesn't appear on any master lists or in any procedures. If you are telling me that it doesn't need to be "controlled", that would be terrific. Otherwise it looks like I have a lot of work to do.

I thought we had to control any documents or data that pertained to the quality, price, and delivery of the machine. Am I wrong in my interpretation?


Tom Goetzinger

The intent of Document Control is to ensure that only the most current and correct
information is used, where failure to use the most current data would conflict with the intent of the standard.
Basically, that means that you need to provide a way so that employees will know what the current level of a document is, and that they will have access to it when it is needed.
With that said, it makes sense to accomplish that in the simplest, easiest, least expensive way possible. You have to determine what that is. If you used date control before and that worked, don't change it just for the sake of changing it. Document how you do it, and then fix it or improve it later using your Corrective Action process if you discover evidence that it has failed.
Don't change things just for the sake of changing. Look for evidence that how you have been doing things works for your customers and your company, and then document it; create records as evidence that what you are doing works, and you should be fine with most auditors.
You do not need to control that document. Simply state in your procedure that this form is used. Give it a document number and specify how it is used. Don't worry about controlling it. State in the shipping procedure/work instruction that it is distributed to whomever and updated as required. Done. Relax-you are trying too hard.

Dan De Yarman

Having discussed this issue in a course I just attended, this is what we came up with.

Fully control the document, as mentioned here. This includes master lists, revision numbers, etc. The next idea, I think, was the best. Issue the "Priority List" as a controlled document that expires in one week. This way there are no revision levels and control is more generic. Also everyone knows when the document is obsolete and can be disposed of. Or is this the kind of document we have to save for a few years?

Another idea I came up with is to issue a one time work instruction explaning the priority sequence of the colors on the pouches. (Right now the "Priority List" has the job number cross-referencing the color of the pouch.) That way the number of employees that would receive the weekly distribution would be reduced. Only a few individuals would need the list that assigns each job to a color or priority number. I have yet to present this idea to everyone involved, but this is the way I'm leaning.

Thank you all, for your input.

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