Control of Forms - Do forms need to be controlled?

[Stijloor]

Hi,
My current control right now, is to issue a Corrective Action Report for incorrect form used.
Does it make sense? Or it is an overkill among ourselves.
raffy

Raffy,

I would look at the impact of using an incorrect form and the frequency of occurrence. No need to spend $500 worth of corrective action on a $10 problem... Some organizations are too quick with issuing CAR's, thus defeating the purpose of the process because people start viewing corrective action as a punitive measure.

Stijloor.

 

[Phiobi]

Re: Do forms really need to be controlled?

wouldn't an exit sign be an instruction? I usually think of forms as being something to be completed (filled in) to record some kind of information, either as a record that something was done, or a request that something be done.

A "form" is probably a bad term to use for this question. Any document that is referenced within a procedure or QM should be controlled.

Any document that can affect fit or function of a product or service should also be controlled.

Within the aerospace industry and more so since NADCAP got involved auditors are looking for notices and signs to be issue controlled if they have ANY reference to the process or a procedure.

I would ask:

If I change this document (what ever it is) will it have any affect on process or procedure?

Yes - Issue control
No - No issue control

Therefore an exit sign would not be controlled but a care point stating a slight devious in process should be issue controlled.

 

[Helmut Jilling]

Hi,
My current control right now, is to issue a Corrective Action Report for incorrect form used.
Does it make sense? Or it is an overkill among ourselves.
raffy

Well, maybe. That is not really doc "control," that is reaction to document failure. It might be a good idea in some cases, but maybe not in every case.

Corrective action is a tool to discover the cause of failure, and the solutions to eliminate those causes. It is sometimes used as a punisher or disincentive. That is a secondary purpose, not the primary.

It should also be applied appropriately to the level of failure or signiificance of risk involved.

If I have a breakdown in doc control, or the source of incorrect docs is not know, or there are repeated failures, intentional disregard for procedures...those are cases where I would suggest writing a CA would be beneficial. But, not to punish the culprit, but to investigate and document causes, motives, competencies, weaknesses, unnecesarily complicated methods, so that we can make solutions to those causes.

Doc control can be pretty easy and simple, if done right. I find people don't want to violate doc control as a principle. They don't want to intentionally use wrong documents. They develop shortcuts when the "proper way" seems too clunky or gets in their way of trying to do their jobs.

If controlling docs is a support process (supplier) to those who use the docs, then keep the user of the docs (internal customer) in mind when creating the rules. If the right way is also the easiest way, chances are they will follow the rules. Thus, knowing the true root cause (or motive in this case), will help you eliminate the root causes.

 

[Raffy]

Raffy,

I would look at the impact of using an incorrect form and the frequency of occurrence. No need to spend $500 worth of corrective action on a $10 problem... Some organizations are too quick with issuing CAR's, thus defeating the purpose of the process because people start viewing corrective action as a punitive measure.

Stijloor.

hI Stijloor,
I definitely agree with you, issuance of CAR is actually a punitive measure however, I cannot find ways to answer our Internal Auditor who is always looking for an evidence or document to control this issue.
Thanks for the inputs.
best regards,
raffy

 

[AndyN]

In our end, we have a dedicated folder for all the forms. We have it controlled however, there are still some undesirable personnel did save this forms in their own folders or PC that's why we cannot 100% control the said forms. i agree with QA Gremlin that "Controlling forms contribute to a sense of dicipline and control in an organization which I think is desireable for the QMS to be effective." there should be a sense of discipline on part of the user.
raffy

Raffy:

If you engage your IT personnel in this matter it is possible to prevent copies of forms being made from one drive to another. Users can open the file (I'd suggest .pdf format) and print as necessary. Otherwise, it can be protected from being copied.

It may also be that since you know who these people are, who made file copies, you could spend some time with them to make them aware of their folly. If you make it clear to them that they run the risk of the organization being put on 'probation' by the Certification Body - because of document control issues which they create - it may help them to see why they shouldn't copy files which may change later.

Of course, you must have created a system that they would want to have work for them, so make really sure that you have that, before you point a finger of doubt at a user.........