As a QA professional I scrutinize the systems, processes, and results (data) of my client groups (the operational areas….i.e., the people who do the real work). This can be very frustrating for people; especially those who work hard, do good work, and aren’t used to having someone doubt them or subject them to the third degree….physicians often have a particularly difficult time with this.
I understand this and strive to make my intrusion on their daily work as unobtrusive as possible. I also try to explain to them exactly what my thought processes are and the rationale for my questions. One of the things I like to tell my client groups/auditees is that I am an optimist who’s paid to be a pessimist. That’s simple and to the point and it seems to convey my position to my client groups/auditees rather well.
More accurately, I’m an optimist who’s paid to be the exact right combination of the guy who sees the glass half full, the glass half empty, and the cracks in the glass. They pay me to see the good, the bad, and the ugly; to take a good system and try and break it…..just to see if someone can.
Below, I’ve assembled a few (real) scenarios that I think illustrate my role:
1) In this case, I was auditing at a Clinical Investigators site (a doctor’s office). At one point in our exit interview he felt that I (a non-physician) was questioning his medical opinion. To which I told him, “I would never question your medical opionion; I’m not qualified…..but based on your source notes, I can’t tell what your medical opinion was….or even that you had one”. Understanding stole across his face…..Documentation. That’s what was missing. He was doing the work in a stellar fashion, but not documenting it sufficiently.
2) Another physician was less convinced of the need to explicitly document his diagnosis. “Any clinician would immediately have the same diagnosis…its self-evident!”. Again as a non-physician, I told him that I was sure he was right, but that FDA would likely send a “non-clinician”; someone who would look at his documentation in a manner more akin to that of an attorney than of a medical professional….”Oh, I think I understand what you’re telling me now.”
3) A third physician tried to correct me on calling study participants “subjects” rather than “patients”….”subject sounds so cold and uninvolved”. To this, I explained my position that a “patient” is someone who comes to a doctor looking for something tried and true to make them better. A study “subject” is someone who is taking a gamble out of philanthropy, desperation, or a combination of both….someone that, with their informed consent, we are putting in some measure in harms way. They deserve our highest respect and greatest level of care. Patients are very important; study Subjects are doubly so. This doctor seemed a little irritated at my little philosophical tirade (short though it was), but he seemed to understand the point I was making…I guess he thought I was an idealist of some sort…
4) While meeting with a team that was conducting validation testing on a clinical computer system, some on the team were frustrated by the level of testing that I was recommending (requiring?). “Well in an ideal world, we would test everything…..”….I had to correct him, “In an ideal world, software testing wouldn’t be necessary because everything would work right out of the box in a perfect and unqualified way…We test our software to ensure that it is actually working like we think it is”. He didn’t like that response, but at least he was quiet”.
Are there any others with anecdotes or questions relating to GxP?