Controlled Forms - To what extent do forms need to be controlled?

M

M Greenaway

#31
Its clear form some of these posts that for some of you guys your form is either in effect your product, or is integral to the product/service that you supply. In these instances control of forms is very important.

As for fax headers that is really going too far. The company I presently work for has gone some way down this path in the past. I have even seen a small label that measures about 8mm by 25mm with the word 'SPLICE' in red letters given a form number. This is utterly ridiculous, it is taking the letter of the law too far without understanding the purpose behind it, i.e. cause and effect - why do you need to contol the form ?, what effect would not controlling it have ?

If a 3rd party assessor made anything more than an observation soley on the point that a form seen in use was an earlier revision to the master form, without investigating the effect on quality of this, I would stop the audit there and request that he were removed from the audit.
 
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U

Unregistered

#32
Auditing old forms

One of my old auditor guys once told me that we (as a registrar) did not totally stress over the use of an old form. As long as the form was not adapted from the current approved version and yet represented as the same thing. (by an individual user or an outlying office). The form should be either the current one or one that had previously been approved, in other words.

The exception was if a form also contained instructions for its use. Such as a form used for a testing procedure. If the form actually gave instructions for the test that was being performed then it becomes more than a "form" and more like a "work instruction". It would be viewed more critically at that point.

James, the templates that are in the controlled area were placed there for the exact reason you describe : we want to maintain consistency with the material that is provided to the client. For the same reason, we have our "approved corporate font" as Arial 10pt. Also, changes were made to various templates for a reason, and if they were not maintained in a secure location someone might use an older version that does not contain the (ex. )additional paragraph related to risk assessment.

But I don't want to number and maintain revision levels on these. I want to simply place them into this secure electronic location and let that be the end of it. The problem is that my boss wants everything numbered,etc. Perhaps I can eventually convince him that it isn't necessary.

Greenaway, it may seem too far to provide this level of control over a fax header - but do you suggest that everyone create a new fax header everytime they want to send a fax? What a tremendous waste of time. And what possible objection could anyone have to accessing a lovely fax header already formatted for them, right at the click of a button??? Everyone here is quite happy to use whatever the company says to use and makes available. It is not an issue for us.
 
J

JodiB

#34
You are asking "why control the form?" ?

The form is what generates the record. If you fail to control the form, it can be adapted in a way that compromises the future record. A field deleted, etc. Now you no longer have the information that proves the procedure or process was accurately carried out.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#35
Lucinda said:

You are asking "why control the form?" ?

The form is what generates the record. If you fail to control the form, it can be adapted in a way that compromises the future record. A field deleted, etc. Now you no longer have the information that proves the procedure or process was accurately carried out.
Lucinda,

Maybe I'm a dunce, too, because I don't control most of my forms in a formal way -- no pun intended. Let's say a WI states that the quality record for a given test must show who did the test, the date, the test device s/n, and the result "X" of the test. In other words, the WI clearly states what the record must show. In this case why can't my blank "form" be uncontrolled -- i.e. anything from the bar napkin as Skullsike said to a fancy, controlled format form? What am I missing?:confused:
 
F

Fire Girl

#36
Gotta control the form!

I am in full agreement with Lucinda on this one. How can controlling the record maintain conformity! If everyone is using a different form and recording different information, I fail to see how that is "controlled". I understand what you are saying, why cover it twice, but you're not.

By controlling forms, you ensure that everyone uses the same version that has the same information fields. By controlling records you ensure that the information is retrievable in the future.

See what I mean...

FG
 
J
#37
skullsike,

A form is generally created to provide a common method of recording data. It assures that all pertinant data is recorded. It also makes record keeping easier by allowing you to look up things faster.

A record that is not generated on the common form may still be valid. (depends on how you've designed the procedure) But as Lucinda points out, this may lead to pertinant information being omitted.

Question: Who is Generating the form? Who has authority to chanage the form? If you are not creating a form, how do you assure that all the pertinanat information is recorded for your record?

Bottom line is that IMHO forms may not HAVe to be controlled, but it's generally easier to control the forms than the troops.

James
 

E Wall

Just Me!
Super Moderator
#38
Semantics

You should be controlling forms where you need to have the SAME information gathered to provide evidence. Whether you use the term format or content, the premise is that you don't want anyone changing the structure of the form other than those who know 1)what information must be kept, 2) what the reason or requirement is for it, and 3) what is being done with the data from the record. There have been several converations here at the cove discussing forms/records, I would encourage you to use the search feature to find additional posts.

Ultimatly, the method of controlling the form is up to your organization. For instance: if you are the only person with the electronic copy, all changes are made through you, and all previous version hardcopies are destroyed when putting an update out. Guess what? you are controlling the form. The electronic record is the form of control used. You don't necessary have to number/revision the form in order to control it.

We run a large operation here and several people have access to the electronic forms For us the best method is to number the form and use a rev letter & date to identify updates. Then we have a form log available so anyone (we keep a current list in the copier room) can verify they are using the current document when making more copies to be used (or referred too at any other time needed). During internal audits we check revision levels of forms when reviewing records. This closes the loop so to speak.
 
J
#39
Skullsike,

I cannot speak for your auditor, but as long as you can show that the records are controlled and the information is valid I guess you don't have to control the form format.

Are you using some sort of pre-existing forms? Like something off the internet, or something? Is that why you cannot control the format?

James
 
J

JodiB

#40
I'm having a hard time understanding how you are "controlling" your records. Records control is the control applied to make sure that the records are retrievable, legible, etc. It does not have anything to do with "controlling" content. Control of the content of the record information is covered as a function of document control 4.2.3 whether you describe the needed information in the text of a procedure or whether it is apparent by the format of a form.

Control of the records doesn't in any way provide a substitute for control of documentation. They are two separate functions.

I know what you are wanting to do, and I face some of the same issues. We have standard reporting forms for daily, weekly, monthly, etc. for our offshore systems. These forms have fields for gathering the majority of the information that we need from the job being carried out. But each job is slightly different and there are additional bits of information that the guys need to report. Prior to trying to maintain some doc control on our forms, the guys would just add a line here, remove a column there, rename a block this or that, etc... They aren't happy that the office has locked down the forms.

And that has me in a delimna too. How can we provide some flexibility without going back to a free-for-all? This is something we have to address - but doc control doesn't go away.
 
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