The Importance of Quality Control in Medical Writing

No one is perfect. 

Even the best medical writers make the occasional mistake. That is why it is important to use every tool at our disposal to make sure that each project’s content, style, and format are high quality.

Luckily, many medical writers have access to quality control (QC) specialists. QC specialists look at documents with “fresh eyes” that can spot mistakes authors may overlook. They may also have specific expertise in editing styles, data formatting, data presentation, or document design.

That’s why QC reviews are a must-have for medical writers.

What is a QC review?

The point of a QC review is to make sure everything in the document is up to standard. And “everything” does really mean everything. There are so many details in medical documents it can feel overwhelming, so many QC specialists and medical editors use a medical editing checklist to make sure that not a single item is missed. Checklists ensure that:

• Data are verified against a reliable source
• Written language accurately represents the source
• Links (internal and external) are all working as intended
• Grammar, punctuation, and abbreviations are checked against a style guide
• Document style, layout, and formatting are checked for consistency

“Fresh Eyes” for Quality Control

The person who handles your QC review depends on your organization. Sometimes, various aspects of a QC review may be divided up into sections and assigned to multiple people—for example, one part could go to an editor, another to a data accuracy reviewer, or a design reviewer. Your QC specialist could be another writer who can perform this review task because they are not the author (remember those critical “fresh eyes”), or they could be a dedicated specialist with specific training and expertise.

Meet Your QC Specialist

It’s a good idea to touch base with your QC specialist at the beginning of the project. It could be an in-person meeting or a virtual one. It helps to take the time early on to discuss expectations and what is needed to ensure you have everything prepared for a successful QC.

Here are the key things that need to be made crystal-clear at the beginning of the project:

• Who will be performing the QC review(s)? Will one person be your main point of contact, or will there be multiple QC specialists? If so, who will coordinate that effort?

• When should the QC review(s) occur? It should occur before your project is submitted to your review team for the first time, but you should look at the project timeline and try to identify which day you plan to send your document and source files to your QC specialist—and when they will return their comments to you. This can be tentative, but it is important to stay in contact with your QC specialist and adjust timing as needed throughout development and making sure you both agree and understand.

• What does your QC specialist need from you? In addition to your project document and your source files, what else might your QC specialist need from you? One example is annotation guidance. For each claim in your project, this tells you which source file supports it, and its exact location in that source file. Your QC specialist may prefer one form of annotation guidance over another to optimize their QC process.

Don’t Rush It

You or your project manager should make sure the QC specialist understands the full scope of the project so they can plan enough time during the project timeline to complete a thorough review of the document before your reviewers see the first draft. 

If the QC review ends up taking more time than the QC specialist expected, it is best to identify that as soon as possible so you can investigate solutions. For example, you could divide the work among multiple QC specialists.

QC Process

Hopefully, you already have an established QC process. If you’re part of an organization, there may be a standard operating procedure (SOP) that you can review to understand your organization’s process.

But if you don’t have a specific process, don’t despair! You can develop one that works for you.

Building a QC Checklist

A great way to start developing your own QC process is by building a QC checklist. This checklist should identify every item that needs to be checked on your documents. For a start, AMWA has a free Medical Editing Checklist that covers the essentials. You may begin with a simple list of the key aspects of a QC review, like the one already provided under “What is a QC Review?” It may also be useful to take a deep dive into the specific details of each item.

For example, a more detailed checklist for verifying data might look like this:

1. Check graphs

   • If the graph is recreated from a source, does it match the source file?
   • If the graph was created from a data table, is it accurate?
   • Are the formatting and layout consistent?
   • Are the axes labeled?
   • Is there a header?
   • Is there a legend?
   • Is the message clear?
   • Is the caption style correct?

2. Check tables

   • Do the data in the table match the source file?
   • Are the formatting and layout consistent?
   • Is there a header?
   • Are column/row headers labeled correctly?
   • Is the message clear?
   • Is the caption style correct?

3. Check written claims

   • Is the claim supported by the source? (Is it fully accurate?)
   • Do any data in the claim match the source?

What if I Don’t Have a QC Reviewer?

No need to panic! You can use your Medical Editing Checklist to do a thorough final review yourself before sending the document to your reviewers. This tool ensures that your project’s content, style, and format are up to par. It’s okay to do your best with the resources available to you.

What’s Next?

Quality control is one of the many ways that medical communication professionals can guarantee that every project down to formatting and style, meets the highest standards in the industry. Make sure to budget time for QC into your publication schedule, it’s worth it! Using tools as simple as a checklist helps sharpen your writing and strengthens the underlying message.

Absolute perfection is an unreasonable goal, but these handy tools make sure we are always performing at our best!

Editor’s Note: This blog was originally written by Callie Leuck in 2019. It has been rewritten/updated by AMWA for republication.