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

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!:agree: :ko: :smokin:

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.

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) :frust:

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.

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

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.

Phil

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

Well done !

Jim

Yes.

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).

M Greenaway said:

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 ?



Any requested change to a document is discussed with all cognizant users. No surprises. No need to sit them all down and "train" them in the use of the form. "They own it". All changes here are I/A/W released Control of Documents Procedures. See attached. This is a Universal Form for reporting problems of any kind. They are not required to fill it all out because of access rights. However, with the available information from the various groups, we can track accordingly. Granted, the page 2 is a PIA, but we state that page 2 is for approval use only on the first page and the current revision and date is on sheet one. If someone asks where page 2 is, I would point them to the note that explains what's on it. After that, they can always access our documents/procedures on the Company Intranet where all that good stuff is. It's too easy to have 3 revisions floating out there in the "unknown" and when filed as records, give Mr. Pinhead Auditor an unnecessary course of inquiry. Heavens, they already have their hands full searching for that low hanging fruit.:vfunny:
JMHO
:ko: :smokin:

Jim

If your form had a reference, revision number and date, how would the user know if they were using the current form anyway ?

Maybe the order taking procedure is not documented, but would the process be defined ? A form is just a vehicle for conveying the output of a data manipulation process from one process to the next. If I have mapped my order taking process well, and I require a new output of information from this process I should include it on my map. If I define my process in such a way why control the format of the piece of paper so long as it contains all the information required by the process map (or procedure).

The only real exception is for large automated data processing where not only information, but its relative position on a page is important.

Come on Jim I thought you were a free thinking radical ;)

M Greenaway said:

Jim

If your form had a reference, revision number and date, how would the user know if they were using the current form anyway ?



The same way you know that your "map" is the latest. :rolleyes:

If that paper is absolutely needed, 4.2.3 States "Documents required by the QMS shall be controlled. Some forms turn into records, and they shall be controlled. Now, if they are discarded because the information is entered elsewhere and they are not ever needed to verify that the information entered is correct, don't list it as a form at all. You can use dinner napkins. Your map may well say "enter information received from >>>>>", without reference as to how this information is received.
:ko: :smokin:

Jim

My argument was born in the days of the 1994 standard, and perhaps needs to be revised in line with the 2000 standard.

But back in the days of the 1994 standard we used to have a procedure that defined the process steps within which the form operated. We then also had a work instruction that detailed how to fill out the form. Finally we had the form itself. All documents requiring 'control' within the QMS in the traditional sense of references, revision status, date, etc.

Now in this scenario it made sense to me to only control one document, and as in the 1994 standard we 'shall' have procedures, but work instructions were optional, and forms not even mentioned, it seemed a good argument to define in the procedure the information required, and leave the format 'open'.

Clearly in the 2000 standard we no longer have mandatory procedures, and our forms may well actually define the procedure. Also many forms these days are filled in electronically, and instruction for completing the form can be embeded in the 'software' itself. In such cases the form clearly does need to be controlled if there is no higher level document defining what the form does and the information it carries.

Most of my forms are formally uncontrolled but informally controlled by an issue date just to help me keep things straight. Maybe I'm missing something/making this too easy?

Here are my "rules" FWIW:

If the form gives instructions in performing the process, I control it formally. (In some cases, my "form" is actually a simple "procedure".)

If the form were changed without me knowing it and that would likely cause a process problem, I control it formally.

Otherwise, I don't control it formally.

For example, let's say the SOP/WI says "record the lot number and the weight of the widgets, the date, and the name of the person taking the readings". I have a form to record the weight readings of the widgets. If the form is simply used as a nice easy, organized, consistent way to record the data without everyone just scribbling the data on a paper in their own way and format, it is formally uncontrolled. If someone added a place to put the employee ID number of the person taking the readings, or changed the form to allow more readings to be logged on 1 piece of paper, no harm can come to the process. If someone used the "old" form it would not be a matter of any significance.

If the form has instructions on it such as "use scale # 321-6 after calibrating with std. weight # 65-212" then I control it formally because it is giving instruction in addition to the SOP/WI and if this instruction were changed without proper approval this could cause process/quality problems. Even if the form repeats some of the same instructions from the SOP/WI, I think it should be controlled.

Am I missing something?:confused:

Mike

That sounds like a very good approach. Unfortunately a lot of organisations I have worked for decide to control ALL forms, and have taken the concept to ridiculous extremes.

Hi,
What I understand is that you are only changing the asthetics of the form and not the content.

What I did was made a Change Request for the form and mentioned the details of the changes made to the form and also mentioned that there will be " NO VERSION CHANGE " since there is no change in content.

The Change Request contains the Date of Actual Implementation.
So this helps in using up all the printed forms available and then writing in the actual date of implementation of the new form though you have made the changes somtime back. ( ONLY because it is not really required for immediate implementation- no content change).

I also maintain the change request Index on the intranet as Read Only for all concerned so that they are aware of the changes being made and their implementation dates, apart from the email intimation sent to the concerned about the changes.

Hope this helps.
rgds,
Roopa

We are currently changing over to ISO 9001:2000 from 9002:1994. I am currently re writing procedures and instructions. I plan on keeping the same numbering system. should I start revision history over or just keep it going?

Thanks

Hi Kim, and welcome to the Cove.

FWIW I'd keep the rev. history going -- i.e. if you have Rev. C now and you re-write it for 9001:2000 for some reason, I'd make it Rev. D. You may find some docs that do not need re-writing, so this would allow you to keep that doc. as-is with no change needed whatsoever. If you re-start the rev. history you would have to change every doc. In short, I can think of more reasons to keep it going than to re-start it.

Make sense?

Hi Kim,

I think you got good advice from Mike there. Don't change it unless you see a good reason to do so.

/Claes

Trick question:

Tell me exactly where it states in the QS9000 standard that you SHALL control your fmeas, control plans, and flow diagrams forms, also nonconforming material forms with a document number and revision?:frust:


2nd request 3/13/03 Anybody?????