Technical writing, in the context of the therapeutic goods industry, applies to those documents which instruct, define or report on regulated manufacturing activities; that is Standard Operating Procedures, forms, validation reports, and Design History Files, to name so very few and which are also referred to as “controlled documents”.
So that these documents can be of assured and consistent quality, there are several best practices you can adopt to help you create documents which are clear, concise and useful to your personnel and assure that your compliance with regulations is clearly documented. Adopting these practices will also make regulatory inspections go a deal more smoothly.
It is expected that the process of generating controlled documents is managed following your internal document management SOP which complies with the requirements of your specific regulatory body. It might include steps such as creating, identifying, drafting, reviewing, approving, releasing, training and withdrawing controlled documents.
Often these SOPs do not touch on linguistics, despite the PIC/S Guide to Good Manufacturing Practice having some clear requirements:
PIC/S PE 009-15, Part 1, Chapter 4: Documentation
4.4 Documents containing instructions should be laid out in an orderly fashion and be easy to check. The style and language of documents should fit with their intended use. Standard Operating Procedures, Work Instructions and Methods should be written in an imperative mandatory style.
Perhaps some of you have worked with a technical writer who has irritatingly insisted on the use of “must” in SOPs. But perhaps some of you have also heard the phrase “Oh, I didn’t know I had to do it. It’s not in the SOP.” Have you found these misunderstandings have led to delays, or even deviations, in your processes?
e.g. The deviation form will be forwarded to QA for approval.
Will it? By whom? And when? This practice is very reminiscent of the much-vaunted phrase in international politics “lessons will be learned”, which not only abdicates blame but also responsibility. The English language is indeed a wily beast.
There are a few very simple rules that will ensure your personnel know exactly when and how they need to complete an activity:
|Identify your audience||Who are you writing for? What is their skill level? Ensure your approach is appropriate for them.|
|Understand the process||This might require that you engage Subject Matter Experts and/or create a process map to ensure that all steps of the procedure are documented. Be sure to understand each decision point and its outcome.|
|Identify the document type||Identify what type of document you’re preparing (as per your internal document management SOP) and select the right template – this will ensure you include all the required fields and sections for your document.|
|Prepare the document structure||Draft the structure by identifying section headings - a section is usually identifiable as a discrete activity within the process. Whenever possible, ensure each section (and each step within it) is presented in chronological order with respect to the process.|
When you’re ready to put “pen to paper”:
|Front and back matter||Follow your template with regards to content additional to the main section of the document. e.g. Purpose, scope, definitions, references|
|Identify the actor first||Who is responsible for completing the action? Put them at the start of the sentence to make them the subject of the sentence. e.g. The technician must record the temperature in the log.|
|Use mandatory imperative language||Always use “must” as the modal verb to show that the action is compulsory.|
|Use plain language||This is not a poetry competition; use the same term to describe the same item or activity throughout the document to prevent confusion. e.g. Standard Operating Procedure, SOP, procedure, process, method, document – pick one and stick with it!|
|Exploit formatting||Don’t make users read parts that they don’t need to - if/then tables can be a useful tool here.
Bullet points used as signposts can break up long text and identify pertinent points.
The QA officer must complete section 1 of the form, sign to indicate their approval, scan a copy for the records, forward the paper copy to the QA Manager for approval,
The QA officer must:
|Consider length||Section length
A section might typically include up to 9-12 steps. Any longer than this and you should consider breaking the activity into smaller sections.
If your document is becoming unwieldy, there might be a need to break the process or task into further discrete documents:
Getting the input of others
Some document changes are easy – you know what you’re doing. Increasing complexity, or subjects outside of your specific field, will require the input of others.
Subject Matter Experts can be consulted to help you better understand the process at hand, and interdepartmental requirements, before you even start writing. Once you’ve completed your first draft, their feedback can be invaluable. Watch out for the upcoming blog Engaging with Your SMEs and Mapping Processes for Technical Writing for some hints and tips on getting the most out of this part of the process.
So that brings us back to our original example. Which of the following do you think is the best option for presenting an instruction in a technical document?
- The deviation form will be forwarded to QA for approval by the deviation owner.
- The deviation form must be sent to QA who must approve it.
- The deviation owner must forward the deviation form to QA. The receiving QA Officer must review and sign the deviation form to indicate their approval.
There will always be documents that try their hardest to escape these rules – highly technical documents, for example, may have specific requirements regarding style, content or presentation sometimes linked to regulatory demands. But generally, adhering to these concepts will help you produce consistent documents where your users know exactly where their responsibilities lie.
Technical Writing Further reading
PharmOut has a number of other blogs to help you make the best of your controlled documents:
- Form design: It’s all about the white space
- Form Use: The right way to fill in a form
- GMP Documentation – Top Tips for Writing User-friendly GMP Documents
Technical Writing Support from PharmOut
If you think you or your personnel need help to get the linguistic aspect of technical writing right, PharmOut can help you prepare an internal style guide. It would include further detail on implementing the above rules and more, but is also a great place to record company-specific documentation rules such as referencing, displaying units of measurement, using internal templates etc.
PharmOut can also offer document writing assistance, ongoing advice, mentoring and/or support as you develop and implement your PQS at your site; we have a team of experienced GMP technical writers who can help.
Or if you’d like some training, please visit our website: Technical Writing Training Courses