Scope

This SOP is applicable to all deviations—planned or unplanned—that occur within QA operations, including batch record reviews, validation activities, document control, internal audits, and QA checks in sterile manufacturing.

3. Responsibilities

• QA Officer: Identifies and reports deviations, initiates deviation forms, and assists in investigation.
• Department Head: Participates in root cause analysis and proposes CAPA actions.
• Investigation Team: Conducts detailed deviation assessments and RCA.
• QA Manager: Reviews, approves, and tracks the deviation records until closure.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that all deviations are addressed and documented according to this SOP, and that corrective and preventive actions (CAPA) are implemented effectively.

5. Procedure

5.1 Deviation Classification

1. Planned Deviation: A pre-authorized deviation from an SOP or process, approved in advance for justified reasons (e.g., equipment replacement).
2. Unplanned Deviation: An unanticipated event or variance from standard procedures (e.g., environmental deviation, human error, documentation error).

5.2 Initiation of Deviation

1. Any staff member identifying a deviation must immediately inform the QA Officer.
2. QA Officer fills the Deviation Form (Annexure-1), assigns a unique deviation ID, and notifies the QA Manager.
3. Deviation is logged into the Deviation Register (Annexure-2).

5.3 Investigation Process

1. The QA Manager forms an investigation team including representatives from relevant departments (production, QC, maintenance, etc.).
2. Conduct Root Cause Analysis (RCA) using tools like:
   • 5 Whys Analysis
   • Ishikawa (Fishbone) Diagram
   • Brainstorming sessions
3. Document findings and potential root causes in the deviation report.

5.4 Risk Assessment

1. Assess the impact of deviation on product quality, patient safety, and regulatory compliance.
2. Risk is categorized as:
   • Critical – significant risk to product quality/safety
   • Major – moderate risk, may require rework/reprocessing
   • Minor – low/no impact, procedural issue

5.5 Corrective and Preventive Action (CAPA)

1. Propose CAPA based on the investigation outcome.
2. Assign responsibility and timeline for implementation.
3. QA monitors CAPA effectiveness and documents completion status (Annexure-3).

5.6 Review and Approval

1. QA Manager reviews the complete deviation report including investigation findings, risk assessment, and CAPA.
2. After satisfactory review, the deviation is marked as Closed.

5.7 Trend Analysis

1. QA shall conduct quarterly trend analysis on all deviations to identify patterns or systemic issues.
2. Findings are used for continual improvement and training programs.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• RCA: Root Cause Analysis
• GMP: Good Manufacturing Practice

7. Documents

1. Deviation Form – Annexure-1
2. Deviation Register – Annexure-2
3. CAPA Implementation Record – Annexure-3

8. References

• WHO Technical Report Series No. 986 Annex 2 – GMP
• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – Subpart F: Production and Process Controls

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QA Executive	QA Manager	Head QA
Department	Quality Assurance	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Deviation Form

Deviation ID	DEV-QA-0175
Date	21/06/2025
Reported By	Sunita Reddy
Description	Missing signature on final batch record page
Type	Unplanned

Annexure-2: Deviation Register

Deviation ID	Date	Type	Status
DEV-QA-0175	21/06/2025	Unplanned	Closed

Annexure-3: CAPA Implementation Record

CAPA No.	CAPA-QA-0192
Description	Training on documentation completeness conducted
Responsible	Rajesh Kumar
Implementation Date	23/06/2025
Status	Implemented

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial SOP Release	New SOP	Head QA
24/06/2025	2.0	Added RCA tools and risk assessment classification	Annual Review	Head QA