TAI #2: Compliance is not control
Passing an audit doesn’t mean your process is in control. It only means it was in compliance at that moment.
Dear colleagues:
Compliance is necessary, but it does not guarantee control or true effectiveness.
Too often, we celebrate “no audit findings” as a measure of success. But compliance offers only a snapshot in time, and even that view is filtered through a single auditor’s lens.
You can manage an audit flawlessly and still leave the inherent vulnerabilities untouched. The underlying risks don’t vanish; they just stay hidden until the next failure or recall brings them to light.
With the FDA’s upcoming Quality Management System Regulation (QMSR), aligned with ISO 13485:2016, the spotlight is shifting from Did you follow the procedure? to Did it achieve its intended outcome?
That is the fundamental difference between compliance and a risk-based system that consistently delivers effectiveness and control.
So let’s think about it and discuss in comments:
👉 Which part of your quality system looks compliant, but might not be effective?
You might also enjoy thinking about this:
Completely agree, just like a policy is not a control.
Training programs are an excellent example of compliance not equalling effectiveness.
Sure, I read the dozens of SOPs you assigned to me within their respective due dates, but how much information did I actually retain in the following days and weeks? Did my behaviours actually change to reflect the training?