While documentation is often viewed as a necessary evil, it is a very important aspect of any quality system but needs to be functional. The documentation system needs to be lean, mean, and user-friendly to the workforce.
The KISS Principle
Documentation can make or break a quality system and is usually the source of most unfavorable audit results in some way, shape, or fashion. A robust document control system can not only minimize unfavorable results but with some critical thinking and a little creativity, your documentation system can become a competitive weapon. One of the best ways to make your documentation as bulletproof as possible is to follow the KISS Principle: Keep it simple, Steve.
Big Hairy Monster
Over time, a company’s QMS documentation system becomes bloated, overgrown, and ineffective. What typically happens is that with every customer complaint and external audit, things get added to the system in a knee-jerk reaction, and the documentation set grows, grows, and grows until it is an unrecognizable big hairy monster.
It is not uncommon to find procedures 30+ levels high and just as many transactional work instructions. It is also typical to find many of these documents to be over 20 pages long, begging the question: “Is anyone really going to read and use these?” I suggest a resounding, “No.” If that is true, then what is the point?
Procedures and work instructions need to be user-friendly, clear, concise, and as brief as possible while remaining functional. The magic—and difficulty—is to make the complex into the simple. This requires a particular skill set and a vast knowledge of quality systems and customer expectations. As Steve Jobs famously said, “That has been one of my mantras: focus and simplicity. Simple can be harder than complex. You have to work hard to get your thinking clean to make it simple.”
Employing the KISS Principle to the document naming and numbering system will become an invaluable asset and continue to pay ongoing dividends with each and every audit and customer visit. The way to structure the system is a continuous hierarchy that flows down from the top-level procedures. Whatever the hierarchy structure is called, they typically have the levels identified (Figure 1).
If the system is going to be based on ISO or AS9100, I strongly recommend the numbering to follow in some way the requirements of the standard. Prior to the 2015 and 2016 respective revisions of the standards, this would be problematic, as each new revision would require a renumbering/naming of the entire QMS, and disconnecting from the standard was advisable. While ISO 13485 was late to the harmonization party, the next revision should align with the others.
That being said, aligning with the standard simplifies internal comprehension and correlation with external auditors compared to random sequential numbering. With the harmonization of the 2015/2016 revisions, we are told the numbering and naming of requirements will remain the same (harmonization) through future revisions. Changes in requirements will simply fall into one of the current “buckets,” if you will, so renumbering will thankfully be a thing of the past. In other words, requirement 9.3 will always be management review going forward, etc.
The key to an effective documentation system is to employ an intelligent numbering convention. One very effective approach to applying the KISS Principle to the documentation hierarchy is to tie each procedure or work instruction numerically to all forms and attachments used in the execution of each. I have a passion for simplification and take the same approach with document control.
For example, continuing with management review, the QMS procedure could be “P-920 Management Review.” The “P” stands for “procedure,” the “920” stands for requirement 9.2, and “management review” is the name of the requirement. This would be the name and number of the procedure and the name of the electronic document file. It’s simple and easy to correlate to the standard.
The next KISS Principle would be to assign an intelligent number to associate every form and attachment used in the appropriate QMS procedure. Continuing with the management review example, the first form under this procedure would be F-930-1; the second form would be F-930-2, and so on. The “F” stands for “form,” the “930” ties this form to the procedure “P-930 Management Review,” and the “1” designates this as the first form under this procedure. Attachments use an “A” in place of the “F” in the numbering convention.
A Note About Forms, Attachments, and Records
This is often a point of confusion. A form is any document that requires data to be added to it, such as a log, checklist, or inspection report. It is a form when blank and becomes a record once data has been added. A form does not change revision after data has been added; it only changes revision when the “structure” of the form changes. An attachment is a static document that does require a new revision when any of the contents of the document change. An example of an attachment would be the quality policy.
Work instructions would follow the same convention, except the standard requirement number would be replaced with the department the work instruction controls. For example, WI-DRL would be the work instruction for the drilling department, WI-DRL-1 would be the first form for this work instruction.
The KISS Principle will get you started on the simplification of your QMS documentation. Part 2 will continue with additional recommendations.
This column originally appeared in the November 2020 issue of PCB007 Magazine.