Business Technology

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 agree that our first three-line instruction in English was a ?real? instruction, that needs to be controlled, the second, completed form, resulting in the same output, must also be an instruction!

I think that the confusion regarding forms is based on the fact that forms serve two purposes. Blank forms are concise instructions written in tabular language. After a form is filled out, it becomes a record. Unlike instructions, records are not expected to have a part number or a revision level. Records are managed in a different manner. Let?s remember this and treat our blank forms as instructions letting the documentation management process govern them. There are a couple of simple tests you may take when you are tempted to use a form that has not been assigned a part number:

- 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?

If you answered, “yes” at least once, your form is a definite candidate for a part number, and falls under the scope of your documentation management process.

Tags: small business
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