FDA 21 CFR Part 820 – Control of QMS Forms

Does your business control forms within your 21 CFR 820 quality management system? One of the divisive issues with interpretation of 21 CFR 820:and other regulations and standards is control of blank forms. Various organizations treat forms differently than other QMS documents and do not control them. Per 21 CFR 820, section 820.40, states that a process shall be established to “control all documents…” required by the Regulation. Let’s investigate if a blank form qualifies to be a “document” that “shall” be controlled.

Forms and tables are frequently used in medical device manufacturing industry as lower-level documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instructions if a simple table is sufficient to provide these instructions. One of the typical non-conformities that companies get during audits of their 21 CFR 820 quality management systems is against forms that are not part of the documentation system.

Often, being asked about not controlled forms, my medical device clients reply: “This is “just a form”. I always wonder why a form should be treated differently than any other 21 CFR 820 QMS instruction or a procedure. If a form is not controlled, how would we know that we need it? If it is not controlled, it cannot be referenced within one’s QMS.If your forma are not controlled, how would you know that you use the latest version of it? Well, exactly what is a Part 21 management system form? A quick quiz will help answer this question. If we have a list of directions telling us to:

1) Draw a two-column table,

2) Enter our company name into the first column,

3) Put one’s business’s Web address into the 2-nd column.

I would bet that most of us would call this three-line direction an instruction. So, if this is an instruction and it shall be controlled, right?.

Now, let’s imagine that we were given a two-column form, only being asked to complete it. The first column is titled “Your company name” and the second column “Applicable regulations”. Obviously, we would enter our company name in the 1st column and our 21 CFR 829, Canadian MDR, etc. in the second column. If we were able to complete such a form, 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, form, resulting in the same output, must also be an instruction!

It seems that misunderstanding concerning forms is because forms serve two purposes. Blank CFR 21 820 forms are short directions written in a tabular language. When a form is completed, it becomes a record that is controlled by 820.180 Records, General requirements. Let’s realize this difference and treat not completed forms as any other procedure or instruction controlled by our CFR 820 documentation management procedure. If you want to have a not controlled form, you may consider evaluating these issues:

- Let’s say that somebody changed your favorite form. Would you want to know why?

- If you revised your FDA 21 VFR 820 form, would you like your assemblers use the latest revision?

- If you were on vacation, would you like folks to be able to find your form just by finding a reference to it within your quality management system?

If you answered, “yes” at least once, your form is a definite candidate to being a part of your official Part 820 documentation management system.

Ready to start working on your 21 CFR 820 Quality Management System? Check our 21 CFR 820 consulting services.

Related posts:

1. Steps To Replace A Porch Roof Column The columns of your porch roof render the required support...

Tags: 21 cfr 820, 21 cfr part 820, 21 part 820, Business, cfr 21 820, cfr 21 part 820, fda, fda quality system requirements