Do you control your forms within your ISO 9001 quality management system? One of the divisive issues with interpretation of ISO 9001:2000 and other standards is control of forms. Various organizations treat forms differently than other QMS documents and do not control them. Per ISO 9001:2000, element 4.2.3, "Documents required by the quality management system shall be controlled." Let's investigate if a form qualifies to be a "document" that "shall" be controlled.
Very often, companies use forms as lower-level documents. Frequently, it is not necessary to write a typical, instruction with the purpose, scope and details if a simple table will do the job. Very often companies receive audit non-conformities because their forms are not controlled.
Often, being asked about not controlled forms, my clients reply: "This is "just a form" a form." I always wonder why should a form be treated differently than any other instruction or a document? If a form is not controlled, how would we know that we need it? If it is not controlled, it cannot be referenced! If your forma are not controlled, how would you know that you use the latest revision of it? Well, exactly 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
Hardly anybody will argue that this three-line direction is an instruction to make and complete this form. So if this is an instruction, it "shall" be controlled, right?
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!
These two examples, demonstrate that our first three-line instruction in English (that needs to be controlled), serves the same function, resulting in the same output, as the second form. Therefore, the form as an instruction and "shall": be controlled as well.
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.
