Standard Operating Procedure for Root Cause Analysis in Transdermal Patches Production
1) Purpose
To establish a procedure for conducting root cause analysis (RCA) in the production of transdermal patches to identify and address the underlying causes of quality issues.
2) Scope
This SOP applies to all personnel involved in the production, quality control, and quality assurance of transdermal patches.
3) Responsibilities
3.1 Production Department: Responsible for reporting any issues to QA.
3.2 Quality Assurance (QA) Department: Responsible for overseeing RCA process.
3.3 Quality Control (QC) Department: Provides data and analysis for RCA.
3.4 RCA Team: Cross-functional team including representatives from QA, Production, and QC.
4) Procedure
4.1 Issue Identification:
4.1.1 Identify and document quality issues, deviations, or non-conformances related to transdermal patches.
4.1.2 Report issues to QA for further investigation.
4.2 RCA Team Formation:
4.2.1 Form an RCA team with relevant stakeholders.
4.2.2 Assign a team leader responsible for coordinating RCA activities.
4.3 RCA Methodology:
4.3.1 Use tools like Fishbone Diagrams, 5 Whys, or Fault Tree Analysis to identify root causes.
4.3.2 Gather data from production records, testing results, and
4.4 Root Cause Identification:
4.4.1 Analyze data to determine root cause(s) contributing to the issue.
4.4.2 Document findings in the RCA report.
4.5 CAPA Implementation:
4.5.1 Develop corrective actions to address identified root causes.
4.5.2 Implement preventive actions to prevent recurrence.
4.6 RCA Report Review:
4.6.1 Review and approve the RCA report.
4.6.2 Ensure all actions are implemented and effective.
4.7 Documentation:
4.7.1 Maintain RCA report and related documents for record-keeping.
4.7.2 Periodically review RCA findings for continuous improvement.
5) Abbreviations, if any
SOP: Standard Operating Procedure
RCA: Root Cause Analysis
CAPA: Corrective and Preventive Actions
QA: Quality Assurance
QC: Quality Control
6) Documents, if any
RCA Report
Production Records
Testing Results
CAPA Plan
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
