Standard Operating Procedure for Deviation Handling in Aerosol Production
1) Purpose
The purpose of this SOP is to establish procedures for identifying, documenting, investigating, and resolving deviations from established processes or specifications during aerosol production. Effective deviation handling ensures product quality, regulatory compliance, and continuous process improvement.
2) Scope
This SOP applies to all deviations encountered during aerosol production processes at [Company Name], including deviations related to equipment, materials, personnel, and environmental conditions.
3) Responsibilities
Quality Assurance (QA) Manager: Oversee deviation handling procedures and ensure timely resolution.
Production Supervisor: Notify QA of deviations and collaborate on investigation and corrective actions.
Operators: Report deviations promptly and assist in providing accurate information for investigation.
Quality Control (QC): Verify the impact of deviations on product quality and compliance.
4) Procedure
4.1 Deviation Identification:
4.1.1 Operators or supervisors identify and document deviations from standard procedures, specifications, or expectations.
4.1.2 Record initial observations, including date, time, location, and description of the deviation.
4.2 Notification:
4.2.1 Immediately notify QA and relevant personnel upon discovery of a deviation.
4.2.2 Use designated forms or electronic systems to document and communicate deviation details.
4.3 Initial Assessment:
4.3.1 QA conducts a preliminary assessment to determine the severity and potential impact of the deviation.
4.3.2 Classify deviations based on risk assessment criteria (e.g., critical, major, minor).
4.4 Investigation:
4.4.1 Establish an investigation team, including representatives from QA, production, and other relevant departments.
4.4.2 Conduct a thorough root cause analysis to identify the underlying cause(s) of the deviation.
4.4.3 Document investigation findings, including contributing factors and corrective actions.
4.5 Corrective and Preventive Actions (CAPA):
4.5.1 Develop and implement appropriate corrective actions to address the root cause of the deviation and prevent recurrence.
4.5.2 Determine effectiveness of corrective actions through verification and follow-up.
4.5.3 Implement preventive actions to mitigate potential future deviations based on lessons learned.
4.6 Documentation:
4.6.1 Maintain detailed records of all deviation reports, investigations, and CAPA activities.
4.6.2 Archive documentation in a controlled manner for traceability and regulatory inspections.
4.6.3 Review and update SOPs based on findings from deviation investigations and CAPA implementation.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
6) Documents, if any
Deviation Report Form
Investigation Report
CAPA Plan and Verification Records
SOP for Deviation Handling
7) Reference, if any
ICH Q9: Quality Risk Management
FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
ISO 9001: Quality management systems – Requirements
8) SOP Version
Version 1.0
