Never Skip Root Cause Analysis During GMP Deviation Investigations

Root Cause Analysis Is Mandatory in All GMP Deviation Investigations

Remember: Every deviation must undergo root cause analysis to implement meaningful corrective and preventive actions (CAPAs).

Why This Matters in GMP

When deviations occur, simply documenting them is not sufficient—underlying causes must be identified and addressed to prevent recurrence. Skipping root cause analysis (RCA) results in superficial fixes that may fail to eliminate the actual issue. RCA allows teams to understand process gaps, training needs, equipment failures, or human errors. Effective RCA enhances process control, prevents repeat deviations, and strengthens the quality culture. GMP requires thorough deviation investigation to maintain compliance, ensure product safety, and support continuous improvement. Lack of RCA also indicates that the quality system lacks depth and maturity.

Also Read: The Future of EMA GMP Standards and Their Impact on Pharma Manufacturing

Regulatory and Compliance Implications

FDA 21 CFR Part 211.192 requires thorough investigation of deviations with documented conclusions. WHO GMP and EU GMP Chapter 1 emphasize risk-based RCA and evidence-based CAPA systems. Schedule M mandates detailed investigation and closure of all reported deviations. Auditors focus on whether RCA was conducted, tools used (e.g., 5 Whys, fishbone diagram), and how CAPAs are linked to root causes. Failure to conduct RCA is viewed as a systemic quality gap and often results in regulatory observations or enforcement actions.

Implementation Best Practices

Use structured RCA tools such as 5 Whys, cause-effect diagrams, or fault tree analysis.
Train cross-functional teams in investigation techniques and documentation requirements.
Define timelines for deviation closure and RCA within SOPs.
Review effectiveness of CAPAs with defined metrics and follow-up audits.
Involve QA in review, approval, and trending of root causes across departments.

Also Read: The Impact of FDA GMP Compliance on Pharmaceutical R&D Processes

Regulatory References

FDA 21 CFR Part 211.192 – Production Record Review
EU GMP Chapter 1 – Pharmaceutical Quality System
WHO GMP – Deviation and CAPA Guidelines
Schedule M – Investigation and CAPA Management