Standard Operating Procedure for Root Cause Analysis in Gels Production
1) Purpose
The purpose of this SOP is to establish procedures for conducting effective root cause analysis (RCA) of deviations, non-conformances, or quality issues encountered during gels production, aiming to identify underlying causes and implement corrective actions to prevent recurrence.
2) Scope
This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s gels production department, including Quality Assurance (QA), Quality Control (QC), Production, and Engineering personnel responsible for RCA activities.
3) Responsibilities
Quality Assurance (QA) Team: Oversee RCA process and ensure compliance with SOPs.
Quality Control (QC) Analysts: Perform initial data collection and investigation of deviations.
Production Supervisors: Provide operational insights and support RCA investigations.
Engineering Team: Assist in identifying equipment-related root causes and implementing corrective actions.
4) Procedure
4.1 Deviation Identification and Documentation
4.1.1 Identify and document deviations, non-conformances, or quality issues that require RCA based on established criteria.
4.1.2 Classify the issue based on severity, impact on product quality, and potential regulatory implications.
4.2 RCA Team Formation
4.2.1 Form an RCA team comprising multidisciplinary members with relevant expertise and knowledge related to the issue.
4.2.2 Designate a team leader responsible for coordinating RCA activities and ensuring timely completion.
4.3 Data Collection and Analysis
4.3.1 Gather relevant data, including production records, laboratory results, equipment logs, and any other pertinent information.
4.3.2 Analyze collected data to identify patterns, trends, or anomalies that may indicate potential root causes.
4.4 Root Cause Identification
4.4.1 Utilize structured RCA techniques (e.g., Fishbone diagram, 5 Whys) to systematically identify underlying root causes of the issue.
4.4.2 Prioritize and verify potential root causes based on data analysis and team consensus.
4.5 Corrective and Preventive Actions (CAPA)
4.5.1 Develop and propose appropriate corrective actions to address identified root causes and prevent recurrence.
4.5.2 Obtain approval from designated personnel, such as QA Manager or Production Manager, for implementation of CAPAs.
4.6 Implementation and Follow-Up
4.6.1 Implement approved corrective actions promptly and effectively, ensuring they are documented and communicated to relevant stakeholders.
4.6.2 Monitor the effectiveness of implemented CAPAs through follow-up activities and periodic reviews.
5) Abbreviations, if any
SOP: Standard Operating Procedure
RCA: Root Cause Analysis
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
6) Documents, if any
– RCA Investigation Report Form
– Root Cause Analysis Reports
– Corrective and Preventive Action (CAPA) Plans and Reports
7) Reference, if any
– FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
– ISO 9001:2015 Quality management systems – Requirements
– Company-specific RCA procedures and guidelines
8) SOP Version
Version 1.0
