016 - Question of the Month #4, Quality & Operations

Alrighty, first question.

We just did an internal audit and found gaps everywhere.

Document control, batch records, supplier qualification, and CAPAs.

We don't have the resource to fix everything all at one time, so how do you prioritize? Well, this is exactly the right question to be asking at this time.

And the fact that you did an internal audit at all puts you ahead of most manufacturers your size.

Most people discover their gaps when they had an audit or an inspection or someone like myself or someone on my team finds them during a consulting discovery call or literally in one of our gap assessment services where we point out all of the things that aren't working, the things that can be improved on like for efficiency or cost savings.

And of course, the specific things that aren't working from a compliance perspective are and from an operational efficiency standpoint.

And this is where I land on the whole prioritization framework.

Start with the gaps that create direct product safety or patient safety risk.

A preservative efficacy testing gap on a leave-on product, a supplier qualification gap on a critical API or raw material where you have no specification verification at incoming, A batch record gap that means you can't trace a component back to its lot number if you had to execute a recall.

These are the gaps where something goes wrong and it has serious consequence that extends beyond your facility.

to really a consumer or patient, those should get addressed first, regardless of how difficult or time-consuming they are.

The second tier are the gaps that create regulatory exposure, areas where the FDA investigator or third-party auditor would issue a significant finding if they walked in tomorrow.

outdated procedures that don't match current practice, CAPA items that have been open for longer than your own SOP requires.

I'd say even deviation records that are missing the required elements.

These don't necessarily create immediate safety risk, but they create regulatory risks that can have serious business consequences.

And of course, there's the third tier, which is basically everything else.

Improvements that are valuable but don't carry immediate safety or regulatory urgency.

Better form design, more efficient batch record layouts, supplier performance dashboards.

These are all worth doing, but they can wait until the first two tiers are closed out.

And one of the more practical points I want to make on this question is, when you're resource constrained, the most efficient quality investment is usually in document control and training.

Fixing the foundation, like getting your procedures accurate, current, and followed, has a multiplier effect on everything else.

Fix the upstream root cause of it all, and the downstream effect will be felt profoundly.

A good procedure that's followed correctly prevents deviations.

Preventing deviations reduces kappa workload.