Auditing numerous companies of different sizes in medical device manufacturing industries, I found that control of forms is one of the notorious issues with maintenance of ISO 13485:2003 QMS. Various companies, by odd reasons, treat forms in a different way than other instructions, leaving them not controlled. ISO 13485:2003, element 4.2.3, requires: "Documents required by the quality management system shall be controlled." Now let's find out if forms are the same as "documents"
Organizations use forms and tables within their quality management systems Often, it is not necessary to prepare a traditional instruction or a procedure with all the sections, such as scope, purpose and process description if a effortless 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.
How can we define a form? A quick quiz will help answer this question. If we have a list of directions telling us to:
- prepare 2-column table
- write down your business name into the 1-st column
- put your business's URL into the 2-nd 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, 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".
If we concur that the first three-line instruction in written in English was a "real" instruction that needs to be controlled, the other, empty form, resulting in the same output, must also be an instruction! Should not this type of an instruction be controlled also?
It appears that the puzzlement about forms and their control comes from the fact that forms serve 2 purposes. Not completed forms are instructions in tabular language. After a form is filled out, it becomes a record. Records do not have a part number, document number or a revision level. Records are controlled by different processes. Remember this and treat your forms as instructions controlled by your Document Control Procedure. There is a simple test you may take when you are thinking about not controlling your form.
- If in the past you developed a form and found it had been changed, would you want to know why it was done?
- If you updated your form, would you like users to know about your change?
- If you were absent, would you like folks to find your form just by finding a reference to it in your ISO 13485:2003 quality management system?
Just one "Yes" to the above questions indicates that your form is definitely a candidate for Documentation Control practices.
Organizations use forms and tables within their quality management systems Often, it is not necessary to prepare a traditional instruction or a procedure with all the sections, such as scope, purpose and process description if a effortless 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.
How can we define a form? A quick quiz will help answer this question. If we have a list of directions telling us to:
- prepare 2-column table
- write down your business name into the 1-st column
- put your business's URL into the 2-nd 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, 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".
If we concur that the first three-line instruction in written in English was a "real" instruction that needs to be controlled, the other, empty form, resulting in the same output, must also be an instruction! Should not this type of an instruction be controlled also?
It appears that the puzzlement about forms and their control comes from the fact that forms serve 2 purposes. Not completed forms are instructions in tabular language. After a form is filled out, it becomes a record. Records do not have a part number, document number or a revision level. Records are controlled by different processes. Remember this and treat your forms as instructions controlled by your Document Control Procedure. There is a simple test you may take when you are thinking about not controlling your form.
- If in the past you developed a form and found it had been changed, would you want to know why it was done?
- If you updated your form, would you like users to know about your change?
- If you were absent, would you like folks to find your form just by finding a reference to it in your ISO 13485:2003 quality management system?
Just one "Yes" to the above questions indicates that your form is definitely a candidate for Documentation Control practices.
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