FDA QMSR Audit Strategy 2026: Execution Vs. Reconstruction

FDA audits rarely fail because a procedure is missing.

They fail at the moment an inspector asks a simple question and the system cannot answer it.

“Show me where this product was during the hold.”

What follows is familiar. Emails are referenced. Logs are reviewed. Supervisors explain what should have happened. The explanation sounds reasonable and aligns with documented decisions.

But under a QMSR audit 2026, reasonable explanations no longer establish control.

As FDA inspections shift under the Quality Management System Regulation (QMSR), audit confidence is built on what can be demonstrated automatically, not what must be reconstructed after the fact. When product movement, containment, or segregation has to be explained rather than shown, FDA assumes the system is vulnerable under pressure.

This is why reconstruction has become one of the fastest ways to lose inspection confidence under QMSR. Not because teams acted improperly, but because the quality system could not prove continuous control during execution.

This blog examines why reconstruction fails QMSR audits, how FDA evaluates control differently under QMSR, and what audit ready execution actually looks like when inspections follow product behavior rather than documentation flow.

Why Reconstruction Felt Acceptable Under QSR and Fails Under QMSR

Under the legacy Quality System Regulation, audit confidence was often built on documentation completeness. If decisions were recorded, approvals were traceable, and outcomes were documented, inspectors could infer control even when execution details had to be reconstructed after the fact.

That inference no longer holds under the Quality Management System Regulation.

QMSR aligns FDA inspections more closely with ISO 13485, where control is evaluated as process behavior, not just documented intent. It is no longer sufficient to show that the right decision was made if the system cannot demonstrate how that decision was enforced during execution.

Most quality systems are still optimized for the QSR era. They reliably capture:

• Decisions and approvals
• Disposition outcomes
• Corrective actions and closures

What they do not consistently capture is how execution unfolded between those points, including:

• Interim product movement
• Temporary staging locations
• Informal handling during handoffs
• Physical access to product during holds or rework

When inspectors ask how a product moved between two documented events, these gaps become visible. Teams respond by reconstructing the sequence through emails, notes, and verbal explanation. The explanation is usually logical and consistent with documented intent.

Under QMSR, however, reconstruction is no longer treated as evidence of control.

The issue is not diligence or accountability. It is system design. A quality system that can only explain control after the fact was not enforcing that control continuously. Under QMSR, FDA evaluates control based on how execution actually occurred, not how convincingly it can be explained later.

Also Read: Medical Device QMSR Compliance: Why FDA Now Expects Proof of Physical Control for your 2026 QMSR gap analysis.

A Failure Pattern FDA Auditors Recognize Immediately

This scenario appears repeatedly during FDA audits and QMSR walkthroughs:

1. A production lot fails inspection and is placed on hold.
2. The decision is documented in the QMS and inventory status is updated.
3. The material is moved to an approved quarantine area, consistent with expectations for an FDA audit for medical device operations.
4. As space tightens, pallets are shifted to an overflow or temporary location.
5. To keep production moving, the material is relocated again during a shift change.

No procedures are intentionally violated. No system records are changed.

However, during audit preparation, an inspector asks: “Where was this product physically stored during the hold period?”

The response relies on emails, QA notes, and verbal explanation. While this reconstruction aligns with documented intent, it does not establish control.

Under QMSR audit expectations, control must be demonstrated through execution. When physical containment cannot be shown directly, FDA treats the gap as a failure of enforcement.

How FDA Inspection Teams Evaluate Control Under QMSR

Under QMSR, FDA inspection teams evaluate quality systems as operating environments, not collections of records.

Inspections increasingly begin by following product and process execution on the factory floor. Inspectors observe how material moves through inspection, quarantine, rework, temporary staging, storage, and release, and whether those movements align with documented controls.

During QMSR audits, FDA inspection teams focus on three questions:

• Where was the product allowed to be at each stage
• Were location and access restrictions enforced across shifts and handoffs
• Does the system show execution directly or require post-audit explanation

This approach reflects QMSR’s alignment with ISO 13485, where control is assessed as process behavior over time, not just documented outcomes. When system records cannot demonstrate how controls were enforced during execution, inspection confidence erodes.

Location intelligence becomes relevant in this context not as a reporting tool, but as evidence of enforcement. It allows inspectors to see that segregation, containment, and access controls were applied consistently, including during space constraints and production pressure.

Facilities that perform well reduce reliance on explanation by making execution visible. When product movement and dwell time can be shown directly, inspection discussions shift from justification to system reliability.

The False Comfort of “We’ve Always Passed Audits This Way”

Once teams recognize how QMSR audits evaluate control, a common response surfaces.

“We’ve always handled audits this way.”

That history creates confidence, but under QMSR, it can be misleading.

QMSR changes how FDA audit teams interpret evidence. Inspection confidence is no longer built on whether records can be reconciled, but on whether control was maintained continuously during execution.

Inspection practices now emphasize how products moved, where they were held, and whether restrictions were enforced as conditions changed. When answers rely on reconstruction rather than direct evidence, inspectors treat that as a signal of fragility in the system.

Organizations that once relied on explanations to bridge execution gaps now face a different reality. FDA audit preparation is no longer about justifying past decisions, but about whether execution can be reviewed directly as it occurred.

Read More: Medical Non-conforming Products by FDA: Why QMSR Triggers FDA 483s

Where FDA Inspections Focus Under QMSR

Inspection Focus Area	What FDA Examines	Why Gaps Trigger Scrutiny
Warehouse and staging areas	How nonconforming and conforming materials were physically segregated during storage, staging, and movement	Mixed or temporary locations raise risk of unintended use and weaken FDA warehouse audit confidence
Temporary holding and overflow locations	Whether carts, buffer zones, and overflow racks were governed under approved controls	Areas outside formal governance often rely on assumption rather than enforced control
Nonconforming product containment	Whether holds were enforced continuously across shifts, handoffs, and locations	Reconstruction during a QMSR audit signals loss of real-time control
Electronic Device History Record (eDHR)	Alignment between eDHR entries and actual product movement and handling	Discrepancies suggest execution gaps uncovered during a QMSR gap analysis checklist
Design History File (DHF)	Whether design controls and risk assumptions were upheld during manufacturing execution	If execution diverges, DHF intent alone does not establish compliance
Medical Device File (MDF)	Consistency across records replacing DMR, DHF, and DHR under QMSR	Inconsistencies indicate fragmented control across systems
Risk control execution	Whether documented risk controls were enforced operationally	Explaining intent does not satisfy documenting risk control measures for FDA audits
Audit traceability	Ability to trace product behavior without emails or verbal explanation	FDA audit guidelines treat reconstruction as evidence of system weakness

What Audit-Ready Control Looks Like Under QMSR

When FDA inspections follow product behavior rather than paperwork, audit readiness becomes an execution discipline, not a documentation exercise.

Organizations that perform well under QMSR audits do not eliminate deviations. They remove ambiguity around how those deviations were controlled and resolved during execution.

Audit-ready control consistently shows up in three ways.

1. Product movement is observable, not reconstructed. Location and containment can be reviewed across time and shifts without relying on explanation.
2. Status actively governs behavior. A product’s quality state determines where it can be stored or moved, reducing reliance on manual coordination.
3. Loss of control is surfaced during execution. Containment breaks are identified as they occur, supporting a proactive approach rather than reactive audit response.

When these conditions exist, inspections move faster and require fewer clarifications. Confidence is established through observable execution, not interrogation.

How LocaXion Supports QMSR Execution Readiness

QMSR shifts inspection focus toward whether execution can be reviewed directly, not inferred from records alone. LocaXion helps close the gap between documented intent and physical reality.

• Execution context for eDHR
  Real time location data adds objective execution context to eDHR entries, showing where product and equipment resided during holds, rework, and staging.
• Verifiable segregation and containment
  RTLS enables continuous visibility across warehouses, quarantine, and production zones, supporting FDA warehouse audit checklist expectations for medical device operations.
• Digital Twin for controlled review
  Digital Twin models combine live location data with approved workflows, allowing teams to review execution behavior and deviations without post audit reconstruction.
• Aligned with existing quality systems
  Location intelligence complements QMS, MES, and ERP records, strengthening documented risk control measures for FDA audits without replacing core systems.

Conclusion

When QMSR takes effect in February 2026, the standard for audit confidence changes. Control must be demonstrated through observable execution, not inferred through explanation.

Most quality systems reliably capture decisions, approvals, and outcomes. What they often lack is continuous visibility into where product moved, how long it remained there, and whether containment was consistently maintained. Under QMSR, these execution gaps no longer stay hidden.

Location intelligence closes this gap by making product movement, dwell time, and containment observable in real time. Reconstruction is replaced with verifiable evidence of control, allowing execution to be reviewed directly rather than explained after the fact.

QMSR does not raise expectations for documentation alone. It raises expectations for proof of execution.

Prepare for QMSR Audits With Execution Visibility Understand where location intelligence fits into your QMSR audit readiness before inspections begin.

Identify Your QMSR Execution Gaps with LocaXion

FAQs about FDA’s QMSR Audit Readiness

What does FDA focus on during a QMSR audit?

During a QMSR audit, FDA inspection teams follow product behavior across storage, staging, rework, and release, not just records. FDA audit guidelines prioritize execution evidence over reconstructed explanations.

How is the FDA warehouse audit checklist different under QMSR?

The FDA warehouse audit checklist for medical device facilities now emphasizes physical segregation, containment, and movement enforcement. Inspectors assess whether controls were maintained continuously across shifts and temporary locations.

Why do FDA audits fail even when documentation is complete?

Under QMSR, documenting risk control measures for FDA audits is insufficient if execution cannot be shown. When eDHR entries align with records but not physical movement, FDA treats this as a control gap.

How does QMSR affect eDHR, DHF, and MDF expectations?

FDA reviews whether eDHR reflects actual execution, DHF risk assumptions were upheld during manufacturing, and MDF records remain consistent across systems. Misalignment often surfaces during a QMSR gap analysis review.

What should manufacturers prioritize for FDA audit preparation under QMSR?

Effective FDA audit preparation focuses on execution visibility rather than post-audit reconstruction. Systems must support traceability that satisfies FDA audit checklists without relying on emails or verbal explanation.