Quality control (QC) is an essential step in developing regulatory documents. However, not all QCs can be done in a standard way or on usual documents. In this blog, we’ll discuss how to set yourself up for success when you need bespoke QC.
What is Quality Control (QC)?
In medical writing, quality control is the set of systematic quality control processes undertaken to ensure that errors and inconsistencies in regulatory documents are eradicated and that the documents meet pre‑specified criteria of accuracy.
Why is Quality Control (QC) important, and when is it high impact?
Poor writing quality or formatting, even if they are just small errors in a document, can lead to misinterpretation or questions regarding the validity of the contents. These problems can obstruct the regulatory review, potentially leading to rejection, and harming an organization’s reputation.
Conducting a QC review can catch all of the large and small errors that the author has missed and ensures confidence in the document’s quality and the integrity of the data it contains.
While all QCs of regulatory documents are important, some QCs are higher in impact – maybe because they’re for key documents in a submission or relate to a meeting with a regulator or health authority that will be under particular scrutiny.
What are standard and bespoke QCs, and why might a high-impact QC need to be bespoke?
A standard (non-bespoke) QC is an extensive and structured review process that focuses on several pre-determined and validated checks. These might include data accuracy in text or in manually created tables, internal consistency, abbreviations, formatting and style checks, cross references and citations. Generally, a standard QC is a regulated process that can expect to be completed in a relatively well‑understood period of time.
A bespoke QC, on the other hand, is a customized QC where the type and level of checking are determined according to the document’s particular needs, which depend on the document type and audience. The focus of a bespoke QC might be narrow, such as verifying certain data against a source or performing internal consistency and formatting, or broad, such as ensuring all subjects are included in an important list of safety narratives.
The unifying factor of a bespoke QC is that it will require the development of a once‑only plan that fits the need of this particular project. Following a discussion with a Sponsor, understanding the issue underlying this QC project, and who the document’s intended audience is, the QC-required checkpoints are designed.
How do you target your QC checks so that it meets the needs of the document’s high-impact status?
The key is to focus on the end goal – decide what purpose the QC is serving and what the essential elements of the final product are. From there, brainstorming check ideas can be a useful approach. Getting ideas on paper allows other ideas to flow. When ideas have been exhausted, the list of checks can be reviewed and, after being weighed against the end goal, either be kept or discarded. This step can be redone until a sensible number of key checks is agreed upon.
Keep the list under review and make changes as needed but be methodical if adding new checks. It’s important to ensure the QC team is not doing excessive rework. Instead, keep new ideas to one side and then do those checks as a block at the end.
Bespoke checklist creation:
- Always have a checklist so that everyone is clear on what checks are agreed on and your QC team marks off the checks that have been completed
- Create the list right the first time, so everyone understands the QC scope – this saves time doing rework!
- Don’t reinvent the wheel! If you can, make it easier by reinventing existing checklists to create new ones.
Does high impact mean urgent?
High-impact QC doesn’t necessarily mean urgent QC. Remember: it’s better to be accurate and a little slower than doing it fast and getting it wrong!
How can you balance urgency with accuracy?
High‑impact QCs may require patience to ensure things are done right – so plan early! The constant assessment and planning for your project needs will ensure you have time for your high‑impact QCs. Be prepared in advance to develop your bespoke process and ensure you have the specialized resources with the appropriate skillsets ready to go.
What does this mean for Sponsors?
Understanding when and why bespoke QC is needed will save your organization time and money and help Sponsors be ready with high-quality regulatory documents for key and high‑impact situations.
When might bespoke QC be needed? Here are some ideas:
• QC of literature summaries
• Creating a list of abbreviations and references
• Style checks
• Formatting documents
• Performing internal consistency checks across documents
Author By: Soumya Shivaswamy, Senior Manager of Quality Control