1️⃣ Hazard Description
Visual inspection is a critical step for detecting:
- Particulate contamination
- Container closure integrity defects
- Labelling errors
- Cosmetic defects (cracks, chips, missing components)
Failure to perform visual inspection can result in defective or non-compliant products reaching patients.
2️⃣ Potential Causes
- Operator oversight or negligence
- Lack of training or competency
- Poor lighting or inadequate visual aids
- Time pressure / workload
- Equipment failure (e.g., vision systems not functioning)
- Missing or skipped process steps
- Inadequate procedures or unclear responsibilities
3️⃣ Potential Consequences
- Patient safety risks (contamination, incorrect dose)
- Regulatory non-compliance (FDA, EMA, GMP violations)
- Product recalls
- Loss of product quality
- Reputation damage
- Financial loss
- Legal liability
4️⃣ Risk Evaluation Matrix
| Aspect | Assessment |
|---|---|
| Severity | High (potential harm to patients) |
| Probability | Medium (depends on control measures) |
| Detectability | Low (if no secondary check or automation) |
| Overall Risk Rating | HIGH |
5️⃣ Existing Controls
- Standard Operating Procedures (SOPs) defining inspection steps
- Operator training & certification
- Line clearance checks
- Recording of inspection in batch records
- Supervision and periodic audits
- Use of automated or semi-automated inspection systems
- Lighting & magnification aids
6️⃣ Recommended Risk Mitigation Measures
1. Reinforce training and periodic requalification
2. Implement visual aids / checklists at workstations
3. Improve lighting and ergonomics
4. Introduce second-person verification where feasible
5. Use automated inspection systems with alarms for incomplete inspection
6. Conduct regular line and process audits
7. Enforce batch record documentation and review
8. Establish clear accountability and supervision
7️⃣ Residual Risk Assessment
If mitigation measures are properly implemented:
- Severity: Remains High (inherent risk)
- Probability: Reduced to Low
- Detectability: Increased (i.e., easier to detect issues)
- Residual Risk: MEDIUM (acceptable with controls)
8️⃣ Conclusion
Visual inspection not performed is a high-risk deviation that requires:
- Robust process design
- Strong training and oversight
- Reliable detection methods (automation and manual verification)
Continual monitoring and reinforcement of Good Manufacturing Practice (GMP) behaviors are essential.
Risk-Assessment-for-Visual-Inspection-not-Performed