quality assurance at the API manufacturing site where process or system risks need to be assessed using FMEA methodology.

3. Responsibilities

• QA Department: Facilitates and coordinates the QRM process, maintains documentation, and monitors implementation of risk mitigation actions.
• Functional Heads: Participate in the risk assessment exercise, provide inputs and data, and implement agreed actions.
• Risk Assessment Team: A cross-functional group responsible for identifying failure modes, scoring risks, and defining mitigation plans.

4. Accountability

The Head of Quality Assurance is accountable for the overall execution, compliance, and effectiveness of the QRM process using FMEA methodology.

5. Procedure

5.1 Risk Management Principles

1. QRM shall be applied in accordance with ICH Q9 principles: risk identification, risk analysis, risk evaluation, risk control, risk communication, and risk review.
2. FMEA shall be used as the primary tool for structured risk evaluation in process design, change control, equipment qualification, and deviation investigations.

5.2 FMEA Team Formation

1. QA shall form a cross-functional team comprising representatives from:
   • Production
   • QA
   • QC
   • Engineering
   • Warehouse
   • Regulatory (if required)
2. The team leader shall be from QA to ensure impartiality and coordination.

5.3 Define Scope of FMEA

1. The objective and scope of the FMEA exercise must be defined and documented in the FMEA Worksheet (Annexure-1).
2. Typical applications include:
   • New equipment or process introduction
   • Change in raw material supplier
   • Recurring deviations or quality failures
   • New facility or layout modifications

5.4 Identify Failure Modes and Effects

1. The team shall list all process steps or equipment functions.
2. For each step, potential failure modes and their possible effects shall be identified.
3. Causes and current control mechanisms should also be documented.

5.5 Risk Scoring and Risk Priority Number (RPN)

1. Each failure mode shall be rated for:
   • Severity (S): Impact of failure on product quality (scale 1–10)
   • Occurrence (O): Likelihood of failure happening (scale 1–10)
   • Detection (D): Ability to detect failure before impact (scale 1–10)
2. The Risk Priority Number (RPN) is calculated as: RPN = S × O × D.
3. Based on RPN values:
   • RPN > 100 – High Risk (Immediate action)
   • RPN 50–100 – Medium Risk (Action required)
   • RPN < 50 – Low Risk (Acceptable, monitor only)

5.6 Risk Mitigation Plan

1. For each medium and high-risk failure mode, the team shall define:
   • Recommended action
   • Responsible department
   • Timeline
   • Re-evaluation of RPN after action implementation
2. Actions shall be tracked in the FMEA Action Tracker (Annexure-2).

5.7 Documentation and Review

1. QA shall compile the complete FMEA report, including all worksheets, action trackers, and conclusions.
2. The report shall be reviewed by the Site Head or designee and filed in the QRM repository.
3. Periodic review of the effectiveness of risk control measures shall be conducted (e.g., every 12 months).

5.8 Change Control and Linkages

1. All changes arising from risk control shall be documented through formal Change Control procedures.
2. The FMEA outcome must be referenced in associated change control, validation, or deviation records.

6. Abbreviations

• QRM: Quality Risk Management
• FMEA: Failure Mode and Effects Analysis
• RPN: Risk Priority Number
• QA: Quality Assurance
• QC: Quality Control

7. Documents

1. FMEA Worksheet (Annexure-1)
2. FMEA Action Tracker (Annexure-2)

8. References

• ICH Q9: Quality Risk Management
• 21 CFR Part 211 – Subpart F: Production and Process Controls
• EU GMP Chapter 1 – Pharmaceutical Quality System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: FMEA Worksheet

Process Step	Failure Mode	Effect	Severity	Occurrence	Detection	RPN
Weighing	Wrong raw material	Batch failure	9	4	3	108

Annexure-2: FMEA Action Tracker

Failure Mode	Action	Responsible	Due Date	Status
Wrong raw material	Implement barcode scanning	Warehouse	30/04/2025	Open

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
14/04/2025	2.0	Included scoring matrix and annexures	Compliance with ICH Q9	QA Head