What My QC Surprise Taught Me About Communicating Expectations

I have a very clear definition of what it means when someone is going to perform a quality control (QC) check of a document. Sure, scope can vary depending on the document type and the timelines, but I generally know what needs to be provided to the person performing the QC, what they will be checking for, and the types of comments I'm likely to receive in the QC'ed document.

For over a decade, I have had documents that I've written be QC'ed by other medical writers or quality team members - at large companies, small companies, and everything in between. I have also been asked to QC documents written by other medical writers. And while the scope varies, the general consensus (in my experience) is that the QC'er notes everything they find, but it is up to the medical writer along with the subject matter experts (SMEs) on the team to decide what needs to be fixed and why.

As it turns out, not everyone has that same expectation.

Recently, I was working with a newer client to develop a data heavy document. As we were nearing finalization of the document, we of course needed it to be QC'ed. The company had worked with a particular person for awhile who does much of their QC, so I annotated the document with source, provided all of the source files, and handed off our document to that person.

We had done a few manual calculations from the listings (note that some companies don't allow this at all) and some of the nonclinical figures did not exactly match the figures used in the source reports. No big deal, I thought. The manual calculations were pretty straightforward, so could be checked (even though it would be a bit time-consuming). The nonclinical SME could vouch for the accuracy of the figures and have someone on their team double-check. These were MY expectations.

When I received the QC findings, I was not surprised to see that there were comments on the nonclinical figures. I pulled in the nonclinical SME, had them confirm in writing (in comment bubbles in the QC'ed document) that they confirm the accuracy of the figures. Once other findings were addressed and I had SMEs confirm some of the outstanding concerns (meeting MY expectations), I finalized the document and had it routed for approval. Whew - almost done!

What I need to point out here is that, at this particular company, the QC'er is one of the document approvers. The QC'er refused to approve the document, stating that the QC findings were not addressed. "They are addressed right here in the file I archived" - I explained. This did NOT meet the QC person's expectations.

We were, of course, in a time crunch -- when are regulatory documents not in a time crunch?!?!

[Insert mad scramble to have a vendor create new figures, replace the ones in the reports, finalize/approve the updated reports, then replace the figures in our document.]

At the end of the day, we got the document done and approved, but it was a good lesson.

Just because you think you know how something should be done doesn't mean that's the only way it is or can be done. Don't assume, and always make sure expectations are mutually agreed upon up front.

In regard to QC in particular, a well defined and documented process is ideal. A QC checklist can be used to clarify scope of the QC and provide a format for documenting exactly what the QC'er checked during their QC. The entire team should be aligned on (1) how QC'ed versions are archived, (2) when a QC finding is considered addressed, and (3) who makes the final call as to whether content is appropriate, accurate, and well supported.

Having a documented QC process or, at minimum, clarifying responsibilities and expectations ahead of time can save a lot of frustration, rework, and a mad scramble to get documents to the finish line.

This lesson wasn't exactly new to me. I've been working in this field for a long time, but it's easy to forget when working under pressure. Sometimes a near disaster is a good reminder!