Controlled Form Font Change - No information is being added or removed - Commments?

[Bob_M]

Controlled Form Revision - Help

OK I'm still new at this quality/control arena so bare with me

We have Controled Forms with form numbers and revisions numbers that are protected on the system. ISO9001:94 going to 9K2K

Some of these forms are used for inspections incoming, in process, etc. These forms have part number and detailed information. (The forms are "templates" for detailed forms).

When the forms are updated (new fields, different font, whatever) should ALL of the detailed versions be updated?

Example1: In coming raw material inspection form has part number and all relavant info for the inspector to check.
I want to update the form so it will be easier to fill out (bigger spaces etc). No information is being added or removed. Do I NEED to update all the part specific inspection forms (which serve as our records)?

Example2: Control Plans - Updated form so additional customer/print information MAY be added where appropriate. Should I update all control plans to use the new "template"?

I'm talking about 1500 part numbers and only me to do everything (I AM the QA dept).

Did this make any sense?

Do I need to update all detailed forms, when I have updated the blank "template" or can I update them as needed?

The old version will in no way hurt production or quality, but they won't visually match the current revision.

Thanks
Bob_M

 

[energy]

I wouldn't

Use the same form. Contain the revision within. If you mention the revision in any other document, such as a Master List, you must change it. You said it yourself. It doesn't matter if the old one gets used. For example, they are printed already. use them up. Save a tree. If it's on a Company Intranet, only the latest will be used. No biggee. Welcome to the Cove!

 

[M Greenaway]

Bob

You have answered your own question in that the change of form will not affect production or quality for those documents bearing the old form template, so only change on an 'as needed' basis - thats what we do.

 

[Bob_M]

Energy:
To clarify my own post...
The "template" is up to date on the system.
The detailed form is the (excel) form partially filled out with part specific details - Example Control Plan "template" vs. Part Specific Control Plan.

Saving the tree... Yes I'm hoping to minimize the paper copies soon. (We need acrobat 5.0)


M Greenaway

I may have answered my own question, but I wasn't sure that's why I asked

Do I NEED to state in our document control policy that we CAN use old revisions of forms IF the information contained within is still valid? 9k2k (soon I hope)

 

[M Greenaway]

I personally dont think you have to necessarily explicitly state that in a policy or procedure, but if it gives you peace of mind then do so. Your argument that there is no effect on quality is as sound an argument as you could wish for, and an auditor would have to prove this wrong in order to raise a non-compliance - which would be nigh on impossible.

 

[Bill Ryan - 2007]

Hi Bob

In example #1 - You have only changed the format (I do the same just about daily) without changing any of the "required" information. You haven't changed a thing!!!!! IMO - You don't need to get all part specific forms updated.

In example #2 - The Control Plan is a different story in my eyes. Your registrar may "decide" that you need to update all part specific (or generic) Control Plans to the new format (I'm assuming you're change was in the header??). Yes, in my eyes, you need to change your Master and work toward getting all existing documents upgraded ("my eyes" have been changed due to too many "discussions" (being nice) with our auditor. Our last audit (TS) had a "minor" because we didn't have the 3rd edition PFMEA format on ALL our PFMEAs. The time period to "comply" was "yesterday". When I asked how he thought that might happen, he said he didn't know but it had to happen (apparently my registrar interprets the TS standard as not allowing "grandfathering" - but that's in a different thread). I didn't jump him on it, but we still don't have our Masters (part specific) updated to 3rd edition. If we get another finding Monday or Tuesday (our next surveillance audit) I will have to give him the old "where does it say that?" (although it might be too late then)).

I realize I got off the subject with example 2 but I think the two documents are closely related, concerning format, in an auditor's eyes.

Happy surrogate Friday and Happy Thanksgiving.

Bill

 

[Phil Schoner]

I have successfully argued that forms need not be controlled. They are simply a conveniently formatted piece of paper to enter records. When they are filled out, they become a record and are controlled as such. Otherwise, how do you enter information on a controlled form without revising it by so doing?. This in itself is revising the document and requires all the rules of document control (approval, etc.).

Just be sure you don't include any instructions on the forms. Put this in the document that generates the form.

 

[M Greenaway]

Phil

I totally agree with this approach, and it is something I have argued for years.

Well done !

 

[M Greenaway]

Jim

Yes.

 

[M Greenaway]

Jim

A change to a form, such as you describe, is in effect a change to the process.

If we are changing a process shouldnt we do more than just update a document and fire it off into the unknown ?

Shouldnt there be some form of training following a process change ??

If we need to document our process wouldnt it be simpler and less beaurocratic to update our documented process description (whether it be procedure, flow chart or even PROCESS MAP).