SOP for Addressing Non-Conformance in Aerosol Manufacturing
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/174/2025 |
| Supersedes | SOP/Aerosol/174/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define a structured process for identifying, documenting, investigating, and addressing non-conformances in aerosol manufacturing. The goal is to ensure product quality, regulatory compliance, and continuous improvement.
2. Scope
This SOP applies to all manufacturing operations in the aerosol department, including raw material handling, formulation, filling, crimping, packaging, and final product inspection.
3. Responsibilities
- Production Team: Responsible for identifying and reporting non-conformances during manufacturing.
- Quality Assurance (QA) Team: Responsible for investigating non-conformances and approving corrective actions.
- Engineering Team: Responsible for resolving equipment-related non-conformances.
- Regulatory Affairs Team: Responsible for ensuring that non-conformance handling aligns with regulatory requirements.
4. Accountability
The QA Manager is accountable for ensuring that all non-conformances are documented, investigated, and corrective/preventive actions are implemented.
5. Procedure
5.1. Identifying Non-Conformance
- Non-conformances can include:
- Product defects (e.g., incorrect fill volume, valve malfunction).
- Process deviations (e.g., incorrect mixing time, temperature variations).
- Equipment failures (e.g., crimping defects, pressure inconsistencies).
- Packaging errors (e.g., mislabeling, seal integrity issues).
- All non-conformances must be recorded in the Non-Conformance Log (Annexure-1).
5.2. Immediate Action
- Quarantine the affected batch to prevent further processing.
- Notify the QA team and document the incident in the Immediate
Action Log (Annexure-2).
Identify potential safety risks and implement containment measures.
5.3. Investigation and Root Cause Analysis
- The QA team will conduct a preliminary investigation within 24 hours.
- Root cause analysis should use appropriate tools:
- 5 Whys Analysis
- Fishbone Diagram
- Failure Mode and Effects Analysis (FMEA)
- Investigation findings should be documented in the Investigation Report (Annexure-3).
5.4. Corrective and Preventive Actions (CAPA)
- Based on the investigation, corrective and preventive actions should be implemented.
- All CAPA activities must be recorded in the CAPA Log (Annexure-4).
- Corrective actions may include:
- Process adjustments.
- Equipment maintenance or recalibration.
- Additional training for personnel.
5.5. Verification and Closure
- The QA team will verify that corrective actions have been effectively implemented.
- If successful, the non-conformance case is closed, and the details are recorded in the Non-Conformance Closure Log (Annexure-5).
6. Abbreviations
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- FMEA: Failure Mode and Effects Analysis
- CAPA: Corrective and Preventive Action
7. Documents
- Non-Conformance Log (Annexure-1)
- Immediate Action Log (Annexure-2)
- Investigation Report (Annexure-3)
- CAPA Log (Annexure-4)
- Non-Conformance Closure Log (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- ISO 9001 – Quality Management Systems
- FDA Guidance on Non-Conformance Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Non-Conformance Log
| NC ID | Issue Description | Reported By | Date | Status |
|---|---|---|---|---|
| NC-001 | Incorrect fill volume | Rajesh Patel | 06/02/2025 | Open |
Annexure-2: Immediate Action Log
| NC ID | Action Taken | Performed By | Date |
|---|---|---|---|
| NC-001 | Batch quarantined | Amit Sharma | 06/02/2025 |
Annexure-3: Investigation Report
| NC ID | Root Cause | Investigated By | Date |
|---|---|---|---|
| NC-001 | Valve malfunction | Ramesh Kumar | 07/02/2025 |
| NC-002 | Incorrect propellant ratio | Anita Sharma | 08/02/2025 |
Annexure-4: CAPA Log
| NC ID | Corrective Action | Preventive Action | Responsible Person | Date |
|---|---|---|---|---|
| NC-001 | Replaced faulty valve | Regular valve inspection | Amit Sharma | 08/02/2025 |
| NC-002 | Adjusted propellant ratio | Automated calibration system | Rahul Mehta | 09/02/2025 |
Annexure-5: Non-Conformance Closure Log
| NC ID | Verification Date | Verified By | Closure Status |
|---|---|---|---|
| NC-001 | 10/02/2025 | Sunil Verma | Closed |
| NC-002 | 11/02/2025 | Priya Sharma | Closed |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma |
| 01/01/2025 | V 2.0 | Updated CAPA and verification process | GMP Compliance | Anjali Sharma |