Senin, 19 September 2011

ISO 9001 Controlling forms

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Do you control your forms within your ISO 9001 quality management system? If you do, you are on the right track. One of the divisive issues with interpretation of ISO 9001 and other standards is control of forms. Various organizations treat forms differently than other QMS documents and do not control them. Per ISO 9001 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".

Forms and tables are frequently used as quality management system documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instruction sections, if a simple table is sufficient to provide these instructions. One of the typical non-conformities that companies get during audits of their quality management systems is against forms that are not part of the documentation system.

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 ISO 9001 quality management structure? If forms are not controlled by your documentation system, and you decide to modify them, how can you be confident that you make changes to the latest revision? That will be difficult! Anyway what is a form? A quick exercise will help answer this question. If we have a list of directions telling us to:

- use a two-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.

Here as another look 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" and 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 appears that the puzzlement about forms and their control comes from the fact that forms serve 2 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 your employees 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 these questions shows that your form perhaps is a good candidate for a document control.

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