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Improving Compliance and Effectiveness Through Leaner Documentation

Life science professional inspecting lean documentation through a digitized eQMS like MasterControl’s Quality Excellence.

I recently talked about this subject at Masters Summit 2023 in Salt Lake City. For anyone who couldn't make it, I'll do my best in this article to give you a quick summary of the important points.

What’s Wrong With Our Documentation?

Not surprisingly, when I asked the audience to raise their hands if they loved their organization’s quality manual, not a single hand went up. Asking the same question about their standard operating procedures (SOPs) produced only slightly better results (two hands out of an audience of 40 people). These types of documents, while a regulatory and quality certification requirement, are often created more as a means to check a requirement off a list rather than as tools to achieve the intents of the requirements. The first key to better, more effective documentation is to remember that these documents belong to their intended audiences; not to the auditors who visit the organization maybe once a year, nor to the part of the organization that “owns” them. I’m fond of reminding people that the auditors don’t work here.

Over time, documents seem to just keep getting longer, more prescriptive, and more complex. This is usually a result of addressing process nonconformance. Surely, the cause of every problem is a lack of clear instructions, correct? It’s the same reason that root cause is so often cited as “user error” solved by “re-training.” This kind of lazy root cause analysis is a whole other article for another time. Focusing back on the documentation, the problem is that the more content that gets added to a document, the less people want to read it, the harder it is for them to find the information they need, and the more likely it is for them to forget the critical elements (if they can even identify them).

Compounding this is the likelihood of widely varying reader comprehension levels, whether due to non-native language speakers, level of education, degree of experience, cognitive abilities, or even impacts due to health, stress, or motivation. As contradictory as it might seem, the root cause of poor documentation is the reliance on words. Upon hearing the word “document,” it is natural to immediately visualize a traditional 8.5 x 11 paper-oriented MS Word document. However, as often as our regulations and standards state something along the lines of, “the manufacturer must document a procedure for…,” they never set a requirement, or even a suggestion, for how.

What Is a Document Anyway?

I prefer to think of documents as just a structured compilation of information. That leaves lots of room for interpretation and innovation. Using that definition, artifacts including spreadsheets, presentations, video, diagrams, illustrations, and websites could all be defended as meeting the requirement. During my Masters Summit presentation, one attendee got a discussion going regarding whether the workflow defined and enforced by an electronic quality management system (eQMS) like MasterControl would count as a documented procedure. The consensus was a resounding “yes!”

Moving Away From Words

This innovative thinking allows us to move past our reliance on words. Ask the intended audience whether they prefer carefully worded step-by-step paragraphs or a flowchart with short activity descriptions for a process, procedure, or work instruction. When shown a side-by-side comparison, the audience at Masters Summit clearly agreed that the flowchart was much clearer. For those worried about how to communicate critical or necessarily detailed information, the answer is that the short descriptions could include pointers or hyperlinks to later sections or appendices in the document. Otherwise, starting with fewer words and paragraphs in favor of bullets, tables, and visual elements will allow readers to comprehend the context of the document more easily, and then know where to go for more detail (if they need to).

Thinking About How Readers Want to Engage With Document Content

The concept of lean documentation then leads to the consideration of how document content should be structured. One of my managers once called me into their office after reviewing a procedure I had written for him. He asked me what part of the document was most important to the readers, to which I responded that it was the actual procedural details. He agreed and then asked me why the most important part of the document didn’t start until page 7. I didn’t have an answer. Traditionally, every SOP starts with sections on Purpose, Scope, Roles & Responsibilities, Definitions, Reference Documents, Revision History, and so on, until we finally let the readers see what they came for. It’s been that way for decades. While all of those sections provide value, do they have to come first? What do you think the readers would say? The reality is that most of those sections are for reference and could just as easily be at the end of the document as appendices. Purpose, Scope, and Roles & Responsibilities are important to establish up front so that readers can quickly determine whether they’re in the right document and whether they actually have a role, but after that, they typically just want to get into the procedure itself, or at least an overview of it with links to the details, if needed. Those first three sections can likely fit on one page, putting the procedure on Page 2. I’m also a proponent of including a Table of Contents, to help readers understand what else is in the document (even in short documents).

And that leads us to the last point of consideration; which is better, fewer but bigger documents or lots of short documents? Bigger documents have the advantage of putting everything in one place (think end-to-end process clarity), but as noted before, are more daunting to the reader, harder to find specific content, may be unclear which content applies to the larger number of reader roles, and harder for readers to remember. Also, because of the larger intended audience, document changes require more approvers and even targeted changes require re-training everyone. Smaller documents solve those problems by being narrower and more targeted but result in a larger number of documents to manage, and readers may have to access multiple documents to get all of the information needed. However, any good eQMS is capable of establishing document links.

Lean Documentation

We’re essentially talking about applying Lean concepts to documents, much the same way we would to process improvement; doing one may actually facilitate the other. If you think about the 8 Wastes of Lean (Defects, Overproduction, Waiting, Unused Talent, Transportation, Inventory, Motion, and Over-Processing), you should see elements of each of them in the ideas presented above. Defects, overproduction, and over-processing can each be addressed by improving clarity through reduced reliance on words. Unused talent can be addressed by more targeted lean documentation content. Transportation, waiting, inventory, and motion wastes can all be addressed by better information structure (flow). Apply process approach thinking to your document content, and you’ll realize more than just better documents.

Steve Gompertz headshot

Steve Gompertz (CQM, CBA, RAC-US, CMII) is a leader in quality systems management with over 30 years’ experience in the medical technology industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical, Boston Scientific, Medtronic, Vital Images, and Control Data. He is now a consultant to the industry providing guidance on quality systems and regulatory compliance. Steve holds a B.S. in mechanical engineering from Lehigh University, and certifications in quality management, medical device auditing, regulatory affairs, project management, and configuration management. Steve started his professional career in software development and then moved into systems implementation project management. After joining the medical device industry, he transitioned from implementing quality-related IT solutions to managing quality organizations and processes. Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in the “M.S. in Medical Technology Quality” program.

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