A longtime MedTech expert is urging manufacturers to include a technical writer on their team to ensure effective communication in all documents, including standard operating procedures (SOPs) for quality systems.
That expert, QualityHub Principal Consultant Elisabeth George, also advises against using emojis in company documents – although she wouldn’t be surprised if there are companies that are currently using them in SOPs and other written communications.
While in her view, George says the use of emojis should be avoided, she nevertheless notes that linguistic culture has shifted to a point where an emoji might be considered appropriate by some, but not necessarily by regulators such as the US Food and Drug Administration (FDA).
“If an organization is going to use emojis, they would have to be careful as to which ones they use and why,” George said, adding that emoji use in manufacturer documents is something that should be addressed and “well defined” in a document management program.
“It wouldn’t surprise me if, in some cases, people may be using emojis now as part of some documents, especially by people using online procedures. There could be, say, a flashing red siren emoji or a flame emoji, or something like that, to draw attention to something that’s important,” George said. “So, again, in some respects it wouldn’t surprise me at all if a company has used emojis. I have not personally seen that happen, though.”
Rather than rolling the dice on slipping an emoji or two (or more) into company procedures and other documents, George recommends using technical writers to drive home important points in written materials. After all, just because a regulatory affairs or quality assurance professional is great at their specific RA/QA jobs, doesn’t mean they have adequate writing or communication skills.
“Technical writing competency is imperative,” she said. “There should be a communications professional or technical writer, or whatever title you want to give them, as part of your team. And that doesn’t just mean they’re selecting words for a page – it’s also about making sure they understand sentence structure and formatting.”
After all, run-on sentences, a failure to appropriately separate paragraphs, and/or not understanding when to properly use a particular font size, highlighting, or underlining can lead to potential problems down the line.
“Consider Microsoft Word – it has wonderful formatting capabilities but people don’t often use them or understand how to use them. They don’t necessarily understand that if something is structured in a proper manner, it will be a far more powerful document and far more easily embraced by stakeholders who must read it,” George said.
Well-Functioning Document Management Program A Must
Having even the best technical writer on staff won’t make much difference, however, if a company doesn’t have an adequate document management program in place that directs a manufacturer on how to develop documents, explain requirements that each document should meet, how documents should be reviewed and who should review them, and how to approve and implement documents, among other document control activities.
“Having a document program that’s well defined is, to me, one of the real basics,” George said. “You need to understand the audience that’s going to be using that document. Is it better to have a million words, or is it better to have a hundred words and 20 pictures? Those are the types of decisions that a well-rounded document management program will help a company immensely.”
She went on: “If somebody writes a document and they put it into a document control tool, what they might lack is, ‘Did we roll it out? Did we determine when we were going to implement it? Did we determine who needs to be trained? Did we determine why maybe one site does or does not have to implement this new procedure?’ All those things are in what I call that ‘basic’ document management program, and that’s why I jokingly call it a basic program – because we all know that it’s clearly anything but basic.”
George reiterated that knowing who will read and use various documents is of the utmost importance.
“For example, if I’m designing a requirements document or a specifications document, is it R&D [research and development] that’s going to be the users of that document when they’re designing the product, or is it going to be a supplier they’re buying a component from, or is it going to be the company’s own production personnel that are going to be using that document?” she said.
“That’s why it’s so important to ask questions, such as, ‘What is the purpose of this document? Is it to be used by marketing to help sell the product? Is the purpose of the document to help build or design the product?,’” George added. “That’s how you start to assess who will be the users of that specific document.”
FDA Inspections and Document Control
How laser-focused an FDA investigator is on document control often depends on what they discover as the facility inspection unfolds.
Nevertheless, document control is a part of a quality system that is “always looked at,” George said. “For example, if an investigator is on the production floor and they’re looking at what records there are and what documents are being used, what an investigator will likely do is jot down the document number and the revision that was on the floor. They’ll later determine when was that document revision was released and look at training records to learn if the people who were using it on the production floor were trained to that specific version.
“So, investigators look at actual records; that’s usually how they go through it – they rarely sit down and read your document management program,” she added.
[Editor’s Note: Making sure documents are properly controlled can be a sticky wicket for MedTech and pharmaceutical companies. Contact QualityHub today if your firm needs assistance with document control or other quality systems activities, and learn how our deep bench of regulatory, quality, and compliance consultants can help.]
