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# FDA ‘Holistic’ Approach to QMSR
- URL: https://www.fdaweb.com/fda-holistic-approach-to-qmsr/
- Published: 2026-10-06T19:40:31.000Z
- Updated: 2026-10-06T19:40:31.000Z
- Author: David McFarland
- Tags: Devices

After working on over 25 medical device Form FDA-483s and Warning Letters for clients this year, attorneys **Jodi Scott** and **Mike Heyl** (Hogan Lovells Cadwalader) say it is clear that FDA has changed its approach to inspections under the QMSR to focus on a “holistic evaluation of quality system effectiveness.” Writing in an online [post](https://www.hlc.com/en/publications/fda-is-inspecting-more-than-just-proceduresfda-is-inspecting-systems-?ref=fdaweb.com), Scott and Heyl say the most effective company responses to FDA inspection observations have been those that demonstrated that management understood the broader systemic issues FDA was identifying and was making changes to improve quality system effectiveness.

“The manufacturers that will be best positioned for future inspections are those that can demonstrate not only that their procedures exist, but that their systems work together to identify risk, make decisions, implement meaningful corrective actions, and improve over time,” the attorneys write.

The post says that while many inspection observations look familiar — CAPA deficiencies, complaint handling issues, supplier management concerns, etc. — the more telling point is the path FDA follows to get to the observations. “Increasingly,” the attorneys say, “investigators seem to be tracing an issue across the quality system rather than stopping at the first procedural gap. They’re following the flow of information through the organization.”

Scott and Heyl say that in many of the observations they have reviewed, the problem was not that every individual step was absent. Rather, the problem has been that the handoff from one step to the next is weak, undocumented, delayed, or ineffective. “A company may be able to show that it investigated a complaint, opened a CAPA, updated a risk file, or reviewed a metric,” they write. “What FDA increasingly wants to understand is whether those activities were connected in a way that produced a meaningful quality outcome. “That’s a different inspection paradigm, and it requires a different state of readiness.”

The post says the attorneys are seeing that risk management is becoming the operating system of the quality management system and should drive how other components of the quality system are managed.

Scott and Heyl conclude that companies should change the pre-inspection readiness question. Rather than asking if their procedures are compliant, they say, companies should be asking whether they can demonstrate how information moves through the quality system and results in effective action. They say companies should be evaluating: 

- whether complaint trends consistently feed CAPA activities;
- whether CAPAs result in risk reassessments;
- whether supplier performance influences risk management decisions;
- whether management reviews are driving meaningful actions;
- whether cybersecurity findings are integrated into quality processes;
- whether quality data is being used to inform business decisions;
- whether effectiveness can be objectively demonstrated; and
- whether risk drives quality evaluations and whether quality evaluations feed back into risk management.

Most importantly, they say, companies should be looking for disconnects between subsystems, and not just deficiencies within them. “That’s where FDA increasingly appears to be finding the more significant story,” they write.