Standard Operating Procedure for Handling Equipment Failures and Deviations
1) Purpose
The purpose of this SOP is to establish a systematic approach for handling equipment failures and deviations in the manufacturing of dental dosage forms, ensuring timely identification, documentation, and resolution to maintain product quality and compliance with regulatory requirements.
2) Scope
This SOP applies to all equipment used in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry. It covers procedures for reporting, investigating, and resolving equipment failures and deviations.
3) Responsibilities
The Production Department is responsible for reporting equipment failures and deviations. The Engineering Department is responsible for investigating and resolving equipment issues. The Quality Assurance (QA) Department is responsible for reviewing and approving deviation reports and ensuring compliance with this SOP.
4) Procedure
4.1 Identification and Reporting of Equipment Failures and Deviations
4.1.1 Immediately stop using equipment when a failure or deviation is detected to prevent potential impact on product quality.
4.1.2 Report the equipment failure or deviation to the Production Supervisor and log the incident in the equipment logbook, noting the date, time, and nature of the issue.
4.1.3 Notify the Engineering and QA Departments to initiate an investigation and corrective actions.
4.2 Investigation of Equipment Failures and Deviations
4.2.1 The Engineering Department will conduct a thorough investigation to determine the root cause of the equipment failure or deviation.
4.2.2 Review equipment maintenance records, operating conditions, and previous incidents to identify potential contributing factors.
4.2.3 Document the investigation findings, including identified root cause(s) and any immediate corrective actions taken.
4.3 Corrective and Preventive Actions (CAPA)
4.3.1 Develop and implement corrective actions to address the identified root cause of the equipment failure or deviation, ensuring the issue is resolved before resuming equipment use.
4.3.2 Identify and implement preventive actions to reduce the likelihood of recurrence, which may include equipment modifications, procedural changes, or additional training for personnel.
4.3.3 Document all CAPA activities in the deviation report and update relevant SOPs, maintenance schedules, and training materials as necessary.
4.4 Review and Approval
4.4.1 The QA Department will review the investigation report and CAPA documentation to ensure completeness and compliance with regulatory requirements.
4.4.2 Approve the deviation report and authorize the resumption of equipment use once all corrective actions have been satisfactorily implemented.
4.5 Record-Keeping
4.5.1 Maintain detailed records of all equipment failures and deviations, including investigation reports, CAPA documentation, and QA approvals.
4.5.2 Store records in a manner that ensures easy retrieval for audits and inspections.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
CAPA – Corrective and Preventive Actions
6) Documents, if any
Equipment Logbook
Deviation Reports
Investigation Reports
CAPA Documentation
7) Reference, if any
Regulatory guidelines for equipment failure and deviation management
Manufacturer’s equipment manuals and maintenance recommendations
8) SOP Version
Version 1.0