The Importance of Quality Control in Medical Writing

    the-importance-of-quality-control-in-medical-writingIt’s hard being right all the time.

    In fact, we aren’t. Even the best medical writer makes the occasional mistake. It’s challenging to ensure that your project’s content, style, and format are high quality.

    That’s where our good friends the quality control (QC) specialists come in. QC specialists look at a document with “fresh eyes” that can spot mistakes an author may overlook. They may also have specific expertise in editing styles, data formatting, data presentation, or document design.

    That’s why QC reviews are critical to medical writers.

    What is a QC review?

    The point of a QC review is to make sure everything in the document is right. And “everything” means really, truly everything!

    • Data should be verified against a source
    • Written language should accurately represent the source
    • Links (internal and external) should be clicked to ensure they link where intended
    • Grammar, punctuation, and abbreviations should be checked against a style guide
    • Document style, layout, and formatting should be checked for consistency

    Meet your QC specialist

    The person who handles your QC review may vary across organizations. The different aspects of a QC review may even be broken out and assigned to multiple people—for example, an editor, 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.

    Seriously: Literally meet your QC specialist

    It’s a good idea to touch base with your QC specialist at the beginning of the project. This could be in a live meeting or through virtual meeting technology. However that meeting occurs, taking the time early on to discuss expectations and what is needed to QC the project will allow you time to ensure you have everything prepared for a successful QC.

    You’ll need to identify a few things at the beginning of the project:

    • Who will be performing the QC review(s)? Will be it 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 what day you plan to send your document and source files to your QC specialist and what day they will return their comments to you. This can be tentative, but you can stay in contact with your QC specialist and adjust timing as needed throughout development.
    • What does your QC specialist need from you? Besides your project document and your source files, what else might your QC specialist need from you? One example is annotation guidance that indicates for each claim in your project which source file supports it and exactly where in that source file. Your QC specialist may have preferences for what form that annotation guidance takes to best support their QC process.

    A rushed QC is unlikely to be a thorough QC

    You or your project manager should ensure the QC specialist understands the scope of the project and has enough time in the project timeline to complete a thorough review of the document before your reviewers see the first draft. If the time available for the QC review is less than the QC specialist expects to need, it is best to identify that sooner so you can investigate solutions. For example, you could divide the work among multiple QC specialists.

    QC Process

    Hopefully, you have a 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. You may begin with a simple list of the key aspects of a QC review, such as the one included above under “What is a QC Review?” It may also be useful to drill into each item with specific details.

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

    • 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?
    • Check tables
      • Does 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?
    • Check written claims
      • Is the claim supported by the source? (Is it fully accurate?)
      • Does any data in the claim match the source?

    What if there isn’t another person to perform my QC review?

    First of all, don’t panic! You can use your QC checklist to do a thorough final review yourself before sending the document to your reviewers. Remember, this is a tool to help you ensure that your project’s content, style, and format are of the highest quality. It’s okay to do your best with the resources available to you.

    What’s next?

    Quality control is how medical writers ensure that a project is well-formatted and has consistent style. Most critically, it’s also how we ensure that what we are writing is correct. 


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    Callie Leuck

    Callie Leuck is a medical writer in Indianapolis, Indiana, focusing on promotional medical education and medical storytelling. She holds a master's degree in science-medical writing from Johns Hopkins University. You can find Callie on LinkedIn at