One of the controversial issues with interpretation of ISO 9001:2000 Standard and others is control of forms. Many companies, by some reason, treat forms differently than documents, leaving them not controlled. Per ISO 9001:2000, element 4.2.3, "Documents required by the quality management system shall be controlled." Let's see if a form qualifies to be a "document" that shall be controlled.
Organizations use forms and tables as lower-level documents. Often, it is not necessary to prepare a traditional instruction or a procedure with all its sections, such as scope, purpose and instructions if a simple table can provide this information. Frequently companies get non-conformities during audits of their QMS because forms used are not controlled.
Repeatedly I discuss this issue with my clients. Regularly I hear the same answer "This is just a form." Honestly, I do not understand this! Why should a form be different from any other instruction or a procedure? How would one know that we need a form if it is not referenced in our QMS documentation structure? If forma are not managed by your documentation system, and decide to modify them, how can you be confident that you make changes to the latest revision? Will be difficult What is a form? A quick quiz will help answer this question. If we have a list of directions telling us to:
- draw a two-column table
- enter your company name into the first column
- enter your company?s URL into the second column
Most likely, we all would call this three-line direction an instruction. So, since this is an instruction, it shall be controlled.
Now, let's assume, somebody gave us a two-column table. We also were asked to fill it out. The first column is titled "You company name" and the second column "Company URL". I bet, most of us would enter our name in the first column and our phone number in the second. Does it mean that we treated the table as an "instruction"? We did!
If we concur that the first three-line instruction in written in English was a "real" instruction, that needs to be controlled, the other, completed form, resulting in the same output, must also be an instruction! Shouldn't this type of an instruction be controlled also?
It appears that the puzzlement about forms and their control comes from the fact that forms serve two purposes. Blank forms are instructions in tabular language. After a form is filled out, it becomes a record. Records, as a rule, do not have a part or document number or a revision level. Records are controlled by different processes. Remember this and treat your forms as instructions controlled by your documentation procedure. There are a couple of tests you may take when you are thinking about not controlling your form.
- If you created a form and found it had been changed, would you like to know who did it and why?
- If you changed your form, would you like personnel to use the most resent revision?
- If you were on vacation, would you like folks to be able to find your form just by finding a reference to it?
Just one "Yes" answer to the above questions indicates that your form perhaps is a candidate for a document control.
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