Standard Operating Procedure for Root Cause Analysis in Aerosol Production

1) Purpose

The purpose of this SOP is to define the procedures for conducting root cause analysis (RCA) to systematically identify underlying causes of deviations, out of specification results, or other issues encountered during aerosol production. RCA aims to implement effective corrective actions to prevent recurrence.

2) Scope

This SOP applies to all root cause analysis activities conducted for deviations, out of specification results, complaints, or other quality issues related to aerosol production processes at [Company Name].

3) Responsibilities

Quality Assurance (QA) Manager: Oversee RCA procedures and ensure timely completion of investigations.
Production Supervisor: Facilitate RCA investigations and coordinate with cross-functional teams.
Operators: Provide input and assist in gathering data for RCA investigations.
Quality Control (QC): Verify findings and participate in RCA discussions as necessary.

4) Procedure

4.1 Issue Identification:
4.1.1 Identify and document the issue or deviation that requires RCA, including initial observations and impact.
4.1.2 Classify the severity of the issue based on potential impact on product quality and compliance.

4.2 RCA Team Formation:
4.2.1 Form an RCA team comprising representatives from QA, production, QC, engineering, and other relevant departments.
4.2.2 Assign roles and responsibilities within the RCA team, including a designated leader for the investigation.

4.3 Data Collection:
4.3.1 Gather relevant data, documentation, and records associated with the identified issue.
4.3.2 Conduct interviews with personnel involved and review procedures, batch records, and equipment logs.

4.4 Root Cause Analysis:
4.4.1 Utilize appropriate tools and techniques (e.g., Fishbone diagram, 5 Whys, Failure Mode and Effects Analysis) to systematically identify potential root causes.
4.4.2 Analyze collected data and information to validate root causes contributing to the issue.
4.4.3 Document findings and conclusions from the RCA process.

4.5 Corrective Action Plan (CAPA):
4.5.1 Develop a CAPA plan based on identified root causes to address the issue and prevent recurrence.
4.5.2 Prioritize and implement corrective actions with clear objectives, responsibilities, and timelines.
4.5.3 Verify the effectiveness of implemented corrective actions through follow-up and monitoring.

4.6 Documentation:
4.6.1 Maintain detailed records of RCA investigations, including data collection, analysis, and CAPA implementation.
4.6.2 Archive RCA reports, CAPA plans, and verification records in a controlled documentation system.
4.6.3 Review and update SOPs based on insights gained from RCA findings and CAPA outcomes.

5) Abbreviations, if any

SOP: Standard Operating Procedure
RCA: Root Cause Analysis
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective Action and Preventive Action

6) Documents, if any

RCA Investigation Report
CAPA Plan and Verification Records
SOP for Root Cause Analysis
Training Records for RCA Team Members

7) Reference, if any

ICH Q9: Quality Risk Management
ISO 9001: Quality management systems – Requirements
FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

8) SOP Version

Version 1.0