Handling of Incidents, Root Cause Analysis (RCA), and CAPA

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STANDARD OPERATING PROCEDURE (SOP)

Handling of Incidents, Root Cause Analysis (RCA), and CAPA

SOP No. QA/SOP/___ Effective Date ___
Revision No. 00 Department Quality Assurance

1. Purpose

To define a comprehensive, structured, and regulatory-compliant procedure for identification, reporting, numbering, investigation, root cause analysis (RCA), corrective and preventive action (CAPA), and closure of incidents to ensure product quality, data integrity, and patient safety.

2. Scope

This SOP applies to all GMP-related incidents, deviations, abnormalities, data integrity events, and failures occurring in Quality Control, Manufacturing, Engineering, Warehouse, and support departments.

3. Regulatory References

  • FDA 21 CFR 211.100 and 211.192
  • WHO GMP – Quality Assurance
  • EU GMP Part I – Chapters 1 and 8
  • ICH Q10 – Pharmaceutical Quality System

4. Definitions

Incident: Any unplanned event or deviation from approved procedures, specifications, or expected results.

Root Cause: The fundamental reason which, when corrected, prevents recurrence.

CAPA: Corrective and Preventive Action.

5. Responsibilities

  • All Employees: Immediate reporting of incidents
  • Department Head: Initial assessment and containment
  • Quality Assurance: Classification, numbering, investigation oversight, approval
  • Investigation Team: RCA execution and CAPA proposal

6. Detailed Procedure

6.1 Identification and Immediate Containment

Any deviation, abnormal result, equipment malfunction, documentation error, or data integrity concern shall be immediately identified and reported. Immediate actions shall be taken to prevent further impact, including activity stoppage, material isolation, equipment labeling, or data protection.

6.2 Incident Reporting

The incident shall be verbally reported immediately and documented within one (01) working day using the approved incident reporting format.

6.3 Incident Classification

  • Critical: Direct impact on product quality, patient safety, or data integrity
  • Major: Potential impact requiring investigation
  • Minor: No direct impact but procedural non-compliance

6.4 Incident, RCA, and CAPA Numbering System

6.4.1 Responsibility

Quality Assurance shall assign and control all incident, RCA, and CAPA numbers. Numbers shall be unique, sequential, and non-reusable.

6.4.2 Incident Number Format


INC / Department / Year / Sequential Number

Example: INC/QC/2025/0012

6.4.3 RCA Number Format


RCA / Incident Number / Sequence

Example: RCA/INC-QC-2025-0012/01

6.4.4 CAPA Number Format


CAPA / Year / Sequential Number

Example: CAPA/2025/0045

7. Root Cause Analysis (RCA)

7.1 Selection of RCA Tool

  • Simple issues → 5-Why Analysis
  • Complex or recurring issues → Fishbone Analysis
  • Critical/systemic issues → Combination of tools

7.2 5-Why Analysis – Step-by-Step

  • Define the problem clearly
  • Ask “Why?” and document factual answer
  • Repeat until root cause is identified
  • Avoid blame and assumptions

Problem: System suitability failure

Why 1: %RSD high

Why 2: Flow rate unstable

Why 3: Pump seal worn

Why 4: Preventive maintenance overdue

Root Cause: Preventive maintenance not performed as scheduled

7.3 Fishbone (Ishikawa) Analysis

Fishbone Categories
  • Man
  • Machine
  • Method
  • Material
  • Measurement
  • Environment
Fishbone Diagram (Text Format)

                    Man --------|

                Machine --------|

                 Method --------| 

                 Material ------|----> INCIDENT

             Measurement -------|

              Environment ------|
Execution Steps
  • Define problem at the head
  • Brainstorm possible causes
  • Verify causes using evidence
  • Identify true root cause(s)

8. Impact Assessment

The investigation shall assess impact on product quality, patient safety, data integrity, regulatory compliance, and previously released batches.

9. Corrective and Preventive Action (CAPA)

9.1 Corrective Action

Actions taken to correct the immediate issue and restore compliance.

9.2 Preventive Action

Actions taken to eliminate the root cause and prevent recurrence.

9.3 CAPA Effectiveness Check

Effectiveness shall be verified through monitoring, trending, or audit.

10. Approval and Closure

Incidents shall be closed only after completion of investigation, CAPA implementation, and effectiveness verification. Final approval shall be provided by Quality Assurance.

11. Data Integrity

All records shall comply with ALCOA+ principles. Failure to report incidents or perform effective RCA is a critical GMP violation.

12. Revision History

Revision Date Change Description
00 ___ Initial Issue

*** END OF SOP ***

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