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