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One of the controversial issues with interpretation of ISO 9001 Standard is control of forms. Many companies, by some reason, treat forms differently than documents, leaving them not controlled. Per ISO 9001 standard, 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, ther is no need to prepare a traditional "human language" instruction or a procedure with all its sections, such as scope, purpose and instructions if a simple table can result in the same output. Frequently auditors leave companies with nonconformities during audits of their QMS because forms are not controlled.
When questioning the validity of a form without a number, I often hear: "This is just a form." It always escapes me, why should a form be different from any other instruction? How would we know that we need a form if it is not referenced in our documentation system? After all, if you are not managing forms by assigning document or part number and decide to modify them, how can you be sure that the latest revision is being revised? At best it would be difficult. In practice it would be impossible. Well, exactly what is a form? A quick quiz will help answer this question. If we have a list of directions telling us to:
- use a 2-column table
- enter your company name into the first column
- enter your company's Web address into the 2nd column
Most likely, we all would call this three-line guidance an instruction. So, since this is an instruction, it shall be controlled, right?.
Another angle at the same form. What if we were given a two-column table where the first column was called "You company name" and the second "Business URL". We were asked to complete the form. Easy to imagine, we would enter our company's name and our URL in the table. It means that we interpreted this table as an "instruction".
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 helpfull form and found it had been changed, would you like to know who did it and why?
- If you changed your, let's say, test results 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 using a reference to it?
Just one "Yes" answer to these questions shows that your form perhaps is a good candidate for a document control.
Organizations use forms and tables as lower-level documents. Often, ther is no need to prepare a traditional "human language" instruction or a procedure with all its sections, such as scope, purpose and instructions if a simple table can result in the same output. Frequently auditors leave companies with nonconformities during audits of their QMS because forms are not controlled.
When questioning the validity of a form without a number, I often hear: "This is just a form." It always escapes me, why should a form be different from any other instruction? How would we know that we need a form if it is not referenced in our documentation system? After all, if you are not managing forms by assigning document or part number and decide to modify them, how can you be sure that the latest revision is being revised? At best it would be difficult. In practice it would be impossible. Well, exactly what is a form? A quick quiz will help answer this question. If we have a list of directions telling us to:
- use a 2-column table
- enter your company name into the first column
- enter your company's Web address into the 2nd column
Most likely, we all would call this three-line guidance an instruction. So, since this is an instruction, it shall be controlled, right?.
Another angle at the same form. What if we were given a two-column table where the first column was called "You company name" and the second "Business URL". We were asked to complete the form. Easy to imagine, we would enter our company's name and our URL in the table. It means that we interpreted this table as an "instruction".
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 helpfull form and found it had been changed, would you like to know who did it and why?
- If you changed your, let's say, test results 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 using a reference to it?
Just one "Yes" answer to these questions shows that your form perhaps is a good candidate for a document control.
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