Context of Observation:

During inspection, the inspectors identified the following deficiencies:

• Several pallets were present without quarantine labels.
• Some materials carried obsolete status labels.
• ERP system status did not match physical labels.
• Physical segregation between quarantine and released materials was inadequate.
• Material movement records lacked proper authorization.
• Warehouse personnel relied on verbal communication rather than documented status.
• Periodic verification of quarantine areas was not consistently performed.
• Status label reconciliation records were incomplete.

Although no actual mix-up occurred, the existing control system presented a potential risk.

4. Root Cause Analysis (Detailed)

The investigation team applied:

• 5 Why Analysis
• Fishbone Diagram
• Human-Machine-Method-Material-Environment Analysis

A. Human Factors

Warehouse personnel were not consistently verifying material status before movement.

Training emphasized material receipt but insufficiently covered quarantine control.

Temporary personnel were unfamiliar with quarantine requirements.

Periodic GMP refresher training was inadequate.

 

B. Procedure Deficiencies:

The SOP lacked:

• Dual verification requirements
• Daily quarantine reconciliation
• Barcode verification
• Escalation procedure for missing labels
• Periodic status audits

C. Warehouse Layout:

The quarantine area boundaries were not clearly defined.

Floor markings had faded.

Some quarantine pallets were temporarily placed near released material due to space constraints.

Visual controls were inadequate.

D. Label Management:

Manual labels increased the possibility of:

• Missing labels
• Damaged labels
• Delayed replacement
• Human error during updating

No automated label generation existed.

E. ERP Control Weakness:

ERP material status was updated separately from physical labelling.

No electronic verification prevented material movement when physical status differed.

 

 

F. Supervisory Oversight:

Routine warehouse inspections focused primarily on inventory accuracy rather than GMP status verification.

Management review did not include quarantine compliance KPIs.

5. Root Cause Conclusion:

The investigation concludes that the primary root cause was:

Inadequate implementation of an integrated quarantine status management system due to procedural weaknesses, insufficient visual controls, limited personnel training, and lack of periodic supervisory verification.

Contributing factors included:

• Manual labelling system
• Inadequate warehouse segregation
• Weak supervisory oversight
• Incomplete SOP requirements
• Lack of electronic status verification