Standard Operating Procedure for Root Cause Analysis of Equipment Failures
1) Purpose
The purpose of this SOP is to establish procedures for conducting root cause analysis (RCA) of equipment failures in the manufacturing of dental dosage forms, including pastes, gels, and mouthwashes. The goal is to systematically investigate equipment failures, identify underlying causes, and implement corrective actions to prevent recurrence.
2) Scope
This SOP applies to all manufacturing equipment used in the production of dental dosage forms within the pharmaceutical industry. It includes procedures for documenting equipment failures, conducting RCA investigations, and implementing corrective and preventive actions (CAPA).
3) Responsibilities
The Engineering Department is responsible for leading RCA investigations and implementing CAPA measures. The Quality Assurance (QA) Department is responsible for overseeing RCA activities, reviewing investigation reports, and verifying the effectiveness of corrective actions. All personnel are responsible for promptly reporting equipment failures and contributing to RCA investigations as required.
4) Procedure
4.1 Equipment Failure Reporting
4.1.1 Promptly report any equipment failures or malfunctions to the Engineering Department using the designated reporting format.
4.1.2 Document details of the equipment failure, including date, time, affected equipment, symptoms observed, and initial assessment of impact.
4.1.3 Notify relevant stakeholders, including production teams and QA, of the equipment
4.2 Preliminary Assessment
4.2.1 Conduct a preliminary assessment to assess the severity and immediate actions needed to mitigate the impact of the equipment failure on production.
4.2.2 Secure the equipment and isolate affected areas to prevent further damage or contamination, if applicable.
4.2.3 Initiate temporary measures or workarounds to resume production while awaiting RCA investigation outcomes.
4.3 Root Cause Analysis (RCA)
4.3.1 Form an RCA team comprising of cross-functional members, including engineering, production, QA, and maintenance personnel.
4.3.2 Collect and review relevant data, including equipment logs, maintenance records, operating parameters, and environmental conditions leading up to the failure.
4.3.3 Use appropriate RCA tools and techniques, such as fault tree analysis, fishbone diagrams, and 5 Whys, to systematically identify the root cause(s) of the equipment failure.
4.4 Corrective and Preventive Actions (CAPA)
4.4.1 Develop a CAPA plan based on the findings of the RCA investigation, focusing on addressing root causes and preventing recurrence.
4.4.2 Prioritize and implement corrective actions promptly, ensuring that they are effective, feasible, and aligned with regulatory requirements.
4.4.3 Implement preventive actions to strengthen equipment reliability and resilience against similar failures in the future.
4.5 Documentation and Reporting
4.5.1 Document the RCA investigation process, including findings, analysis, conclusions, and implemented actions, in a comprehensive report.
4.5.2 Review the RCA report with relevant stakeholders, obtain approvals as necessary, and communicate outcomes to affected departments.
4.5.3 Maintain records of RCA investigations, CAPA plans, and verification activities for audit and regulatory purposes.
5) Abbreviations, if any
SOP – Standard Operating Procedure
RCA – Root Cause Analysis
CAPA – Corrective and Preventive Actions
QA – Quality Assurance
6) Documents, if any
Equipment Failure Reports
RCA Investigation Reports
CAPA Plans
Verification Records
7) Reference, if any
Manufacturer’s recommendations for equipment failure analysis and RCA
Regulatory guidelines for CAPA in pharmaceutical manufacturing
8) SOP Version
Version 1.0