ISO 9001:2000 – Forms control
Auditing numerous companies of different sizes in various industries, I found that control of forms is one of the notorious issues with maintenance of ISO 9001:2000 QMS. Various companies, by a strange reason, treat forms differently than other instructions, leaving them not controlled. ISO 9001:2000, element 4.2.3, requires: “Documents required by the quality management system shall be controlled.” Now let’s find out if a form is the same as a “document”
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.
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:
– 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, what if we were given a two-column table where the first column was titled “You company name” and the second column “Company’s 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”.
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 seams to me that misunderstanding concerning forms is because forms serve two purposes. Blank forms are short directions written in tabular language. When a form is completed, it becomes a record. Not like instructions, records are controlled by different means. Let’s realize this difference and treat not completed forms as any other document controlled by our documentation management procedure. 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 should be controlled per your documentation management procedure.
Filed under: Business