“I Pay Attention,” my friend said when I asked him how he knew about a program that was several states away from where he lived. “Hmmm, interesting..” I remember thinking.
When I was working in the business world, in computer based testing, we had a unifying statement at work—“you get what you focus on,” which helped the leadership focus on the priorities of the business. This means more than just having goals, it includes paying attention to what’s going on right now and focusing on the desired state.
We can apply this to cGMP, where we can pay attention to what’s going on (current documentation, deviations, change controls, annual product reviews, quality metrics), focus on priorities (quality planning, quality goals, remediations), and focusing on the desired state (project planning, Quality by Design). Paying attention also applies to audits and quality overall, where for example, it is helpful to have an outside person perform an audit because they will typically see what others don’t, and quality has to pay attention to differences, changes, and issues/problems that arise and figure out how to address them.
Although the above may sound like a lot, companies/sponsors can start in a simplified way by introducing Quality Planning to the QA Team. Quality Planning can be as simple as having a few goals for the year and focusing on those and the future desired state. For example, a sponsor’s Quality Plan could include changing from a paper-based to a computer-based deviation system, remediating observations from last year’s audit, and improving record-keeping for the training database.
In cGMP and in life in general, we get what we focus on. Let’s focus on Quality Planning, on paying attention, and on the desired state as we set our priorities and plans for QA and cGMP.