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Temporary locations are a routine part of medical device manufacturing. Facilities frequently rely on overflow racks, floor staging areas, mobile carts, and QA backlog zones to manage space constraints and keep production moving during peak pressure. While these buffers are operationally necessary, they often operate outside of formal quality monitoring, creating a significant temporary locations compliance risk under the new FDA Quality Management System Regulation (QMSR).
The core issue is visibility. When a location is not explicitly defined within your quality system, the product entering that space effectively "disappears" from process control. Under QMSR, FDA inspectors are actively targeting these gaps to verify if product status truly governs physical movement at every step of execution.
In this blog, we will examine why these "hidden factories" trigger audit findings, how the shift from QSR to QMSR changes the burden of proof for material handling, and how manufacturers can bring these temporary zones under control without sacrificing operational flexibility.
Why Temporary Locations Exist and Why FDA Accepts Them
FDA and ISO auditors are not disconnected from how manufacturing actually works. They understand that idealized warehouse storage compliance models, where every item sits neatly in a permanent, barcoded location, often break down in high-speed, high-mix production environments.
Temporary locations emerge because material flow is rarely linear. In practice, several operational realities force manufacturers to create short-term buffers, including:
- Throughput protection at bottlenecks
Work-in-progress is often staged ahead of constrained operations such as sterilization, curing, or final inspection to prevent critical equipment from sitting idle. - Uneven cycle times across processes
When upstream assembly moves faster than downstream inspection or release, material accumulates temporarily while waiting for capacity to catch up. - Sudden quarantine volume spikes
A single quality event affecting a large lot can exceed the physical capacity of designated nonconforming material areas, pushing material into nearby floor or overflow space.
From a regulatory standpoint, these behaviors are not inherently problematic. FDA inspectors generally accept temporary staging because they recognize that continuous one-piece flow is an objective, not always a practical reality.
The regulatory concern under QMSR is not buffering. It is a loss of control.
Auditors draw a clear distinction between a controlled buffer and an uncontrolled blind spot. Temporary locations are acceptable only when they remain governed by the same execution rules as permanent storage. When a temporary space introduces ambiguity around product status, segregation, or environmental requirements, it becomes a compliance risk.
Under QMSR, the moment a product enters a location where status is assumed rather than enforced, or segregation depends on proximity rather than system identification, process control is considered weakened. Temporary locations are tolerated. Suspending traceability, even briefly, is not.
The Failure Pattern FDA Identifies During QMSR Inspections
Under QMSR, findings related to temporary locations rarely stem from a single incorrect decision. They follow a repeatable execution pattern that develops over time.
A lot fails inspection and is placed on hold. The approved quarantine or nonconforming material area is at capacity, so the material is staged temporarily in a nearby space to keep production moving. At this point, warehouse storage compliance appears intact and the decision aligns with operational needs.
As execution continues, control begins to fade:
- Material is repositioned to relieve congestion or keep aisles accessible
- Subsequent shifts encounter the product without full visibility into its hold status
- Similar inventory is staged nearby without enforced segregation
- System records remain accurate, but physical placement is no longer governed
What emerges is a gap between the system of record and physical reality. Documentation remains correct, but the product now resides outside defined location compliance boundaries.
During walkthroughs, inspectors from the FDA verify that product status actively governs physical placement. When temporary locations are not subject to the same controls as approved storage or quarantine areas, they are identified as a temporary locations compliance risk. Under QMSR, using temporary buffers is acceptable. Allowing products to remain in ungoverned storage conditions is not.
Why Temporary Locations Break Control Under QMSR
Temporary locations introduce a temporary locations compliance risk when they fall outside execution-level controls. This happens for five common reasons.
1. They are not defined in controlled location hierarchies
Temporary areas are often missing from approved layouts and location master data, making location compliance unenforceable.
2. They are excluded from warehouse storage compliance rules
Because they are informal, temporary locations are not governed by the same segregation and access controls as approved storage areas.
3. They are not reflected in the eDHR execution context
Movement into temporary locations is rarely captured in eDHR workflows, breaking the link between recorded status and physical placement.
4. They bypass environmental and area qualification controls
Temporary staging may occur in areas that have not undergone compliance testing for hazardous locations or required environmental qualification.
5. They persist beyond their intended duration
Without dwell time limits or alerts, temporary locations quietly become long-term exposure points where control degrades over time.
Why FDA Walkthroughs Focus on Temporary Areas
Under the new QMSR regulations, FDA inspections place greater emphasis on physical walkthroughs than on record reviews alone. Inspectors are trained to verify that documented controls are actively enforced on the shop floor.
During walkthroughs, inspectors routinely:
- observe overflow and temporary staging areas
- examine carts, totes, and mobile racks
- look along walls, behind lines, and near aisles
- ask operators where product is currently waiting
These actions are not informal spot checks. They are deliberate probes into areas where location compliance is most likely to break down.
When temporary locations appear unmanaged, inspectors infer that execution controls may not be fully enforced. Common concerns include:
- segregation relying on proximity rather than defined rules
- potential for unauthorized access
- product status not actively governing placement
In these situations, documentation alone cannot restore inspection confidence.
Read More: FDA QMSR Audit Strategy 2026
What Effective Control of Temporary Locations Looks Like
Manufacturers that perform well under QMSR do not eliminate temporary locations. They ensure that temporary staging remains governed by the same execution controls that support eDHR and DMR requirements.
Effective control is characterized by:
- Location-aware execution records: Product location changes are captured as part of execution, ensuring eDHR reflects where material actually resides, not just its intended status.
- Time-bound containment: Temporary staging is constrained by dwell time and disposition rules so containment remains enforceable throughout execution.
- Execution visibility: Product movement into and out of temporary locations is visible during execution, allowing deviations to be detected early rather than during inspection.
When location data reinforces eDHR accuracy and DMR conditions, temporary locations remain auditable and controlled rather than informal exceptions.
Why Manual Control Cannot Scale Under QMSR
Many manufacturers still rely on manual methods to manage temporary locations, including:
- checklists and sign-offs
- visual controls and floor markings
- daily walkthroughs
- verbal handoffs between shifts
These approaches can work in low-volume, stable environments. They do not scale under real production conditions.
In high-mix operations with multiple shifts and constant throughput pressure, manual control breaks down in predictable ways:
- dwell time overruns go unnoticed
- control depends on individual memory and awareness
- handoffs dilute context and intent
Under QMSR, this distinction matters. The regulation does not evaluate whether teams intended to maintain control. It evaluates whether control can be objectively demonstrated during execution.
For this reason, manufacturers increasingly treat location awareness as supporting evidence of process control, not as an operational convenience. When location and movement are observable, control can be verified without relying on explanation.
Read More: Why FDA Now Expects Proof of Physical Control
Executive KPIs That Reveal Temporary Location Risk
As manufacturers begin to address temporary locations, a different set of performance indicators becomes visible. These KPIs focus on execution and location compliance, not documentation volume.
Key indicators include:
- Unmodeled location dwell time
How long the product remains in locations that are not formally approved under warehouse storage compliance rules. - Ad-hoc staging frequency
How often material is placed in temporary or undefined areas outside controlled storage or quarantine locations. - Mean time to detection
How long a loss of control persists before it is identified and corrected during execution.
These indicators correlate strongly with inspection outcomes because they expose a temporary location's compliance risk early, before it surfaces during an FDA walkthrough. Yet most organizations do not track them, as traditional quality dashboards focus on records rather than physical behavior.
Why QMSR Surfaces This Risk Quickly
Under QMSR, FDA inspections prioritize how a product is controlled as it moves through space, not just how it is documented in systems.
Inspectors consistently:
- expect a clear, defensible understanding of where product may physically reside
- challenge informal assumptions about temporary storage and staging
- verify that warehouse storage compliance and environmental requirements remain enforced, including where compliance testing for hazardous locations applies
When temporary locations fall outside formal control, inspectors interpret this as a systemic weakness, regardless of intent or procedural justification.
QMSR does not prohibit temporary staging.
It exposes uncontrolled temporary staging.
Also Read: How Organizational Silos Break Production Quality Control Under QMSR Compliance
Conclusion
QMSR has fundamentally shifted the FDA’s focus from documented procedures to continuous execution. In this environment, temporary locations are no longer simple operational conveniences. They are one of the most common sources of compliance exposure.
If a quality system loses visibility the moment a product enters a temporary buffer, control is left to assumption. Under QMSR, these blind spots are treated as a loss of process control, and inspectors are trained to identify them during walkthroughs.
Temporary overflow zones do not cause findings by themselves. Uncontrolled temporary locations do.
LocaXion helps manufacturers close this execution gap by making physical movement observable and enforceable. By combining RTLS and Digital Twin technologies, LocaXion enables teams to ensure that temporary locations remain governed, traceable, and aligned with quality intent during execution.
FAQ on QMSR and Temporary Locations
Does FDA QMSR ban the use of temporary staging areas?
No. FDA accepts that temporary staging is often necessary. Under QMSR, the requirement is location compliance, meaning product status must remain known and enforced even when material is staged in temporary areas.
Why are temporary locations considered high risk during audits?
Temporary locations are considered a temporary locations compliance risk because they frequently fall outside defined controls. When product is staged in informal or undefined areas, segregation and placement rely on assumption rather than enforcement, which inspectors quickly identify during walkthroughs.
How does location compliance differ from standard inventory tracking?
Inventory tracking shows what exists in the system. Location compliance confirms whether a product is allowed to be in a specific physical location based on its quality status. Under QMSR, inspectors evaluate whether placement rules are actively enforced, not just documented.
What does compliance testing for hazardous locations mean in this context?
Compliance testing for hazardous locations refers to area qualification and environmental suitability. If a device requires specific storage or handling conditions, moving it into a temporary area that has not been qualified or monitored can violate DMR requirements, even if the move is intended to be short term.
How do manufacturers control temporary locations under QMSR?
Manufacturers increasingly rely on execution-level visibility to maintain control. LocaXion supports this approach by using RTLS and Digital Twin technologies to ensure temporary locations remain visible, governed, and aligned with quality records during execution.