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QW Academy - Forms: to control or not to control

One of the controversial issues with interpretation of ISO 9001:2008 Standard is control of forms. Many companies, by some reason, treat forms differently than documents, leaving them not controlled. I believe the Standard clearly defines requirements of control of documents in element 4.2.3:

     “Documents required by the quality management system shall be controlled.”

Forms and tables are frequently used 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 assessments of their quality systems is against forms that are not part of the documentation system. 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 (PN) and decide to modify them, how can you be sure that the latest revision is being used? 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: What would you call the list in the Figure 1 below?

Figure 1

  1. Draw a rectangle approximately one inch high and approximately four inches wide.

  2. Write words “Top left” in the upper left corner of the rectangle

I would bet that most of you would call this two-line direction an instruction. If we follow this instruction, we most likely will end up with a figure like this:

Figure 2

Top left

Now, let’s imagine that we were given, without any further instructions, a form with a table that looks like this:

Figure 3

Your Company name

Your Website

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What would we do in this case? Most likely we would enter our company name and our Website address in the table. Our completed form may look like this:

 

Figure 4

Your Company name

Your Website

  Quality Works

  www.quality-works.com

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It means that we interpreted the table in Figure 3 as an instruction:

 

Figure 5

  1. Enter your company name in the left column

  2. Enter your company's Website address in the right column

 

If we agree that Figure 1 is an instruction, then Figure 5, due to its overwhelming similarity to Figure 1, should be considered an instruction too. Since Figure 5 is a product of Figure 3, we can call Figure 3 an instruction as well.

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 and, therefore, should be treated as any other instruction, even though their appearance is different from a traditional line-by-line instruction in English, Spanish, Russian or any other language.

After a form is filled out, it becomes a record. Unlike instructions, records are not expected to have a document or a part number or a revision level. Records are managed by different means. Let’s treat our blank forms as instructions letting the documentation management process govern them. There are a couple of simple tests you may use when you are tempted to have a form that has not been assigned a document 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 know that they are using the most resent revision?

  • If you were on vacation, would you like folks to be able to find your form just by reading a procedure where your form is referenced?

If you answered, “yes” at least once, your form is a very good candidate for a document or part number, and falls under the scope of your documentation management system.

Call us today if you have questions about ISO 9001, ISO 13485 or ISO 14001 management systems!

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