- Describe the deviation: begin by providing context for the deviation, including the date, time, location, and personnel involved. Describe clearly the specific quality process, guideline or specifications that was deviated from. Include information such as what went wrong, how it deviated from the established process or other, the potential impact on product quality or safety, the potential impact on supply chain.
- Involve stakeholders/communication: involve relevant stakeholders, such as quality assurance personnel, production managers etc, in the deviation documentation process. Seek input and collaboration to ensure a comprehensive understanding of the deviation and its implications.
- Deviation evaluation and impact/risk assessment: determine the severity (criticality) of the deviation and its potential consequences for stakeholders, product quality and the quality system. Evaluate the impact or risk of the deviation on stakeholders, product quality – safety – efficacy, quality system, regulatory compliance, business image, and customer satisfaction.
- Identify root causes: investigate the root causes of the deviation and document them thoroughly. This may involve conducting a root cause analysis to determine underlying factors such as equipment malfunction, human error, or inadequate procedures.
- Implement corrective and preventive actions: develop and implement corrective actions to address the root causes of the deviation and prevent recurrence. Clearly outline the corrective actions taken, including who is responsible for implementation, timelines, and follow-up procedures.
- Document follow-up activities: document any follow-up activities conducted to verify the effectiveness of corrective actions and ensure compliance with quality processes. This may include retesting products, conducting audits, or reviewing process documentation.
- Maintain traceability: maintain traceability by documenting all relevant information related to the deviation, including supporting documentation, test results, and communication records. This ensures transparency and accountability throughout the deviation management process.
- Review and approval: ensure that deviations from processes are reviewed and approved by appropriate personnel, such as quality assurance managers and operations managers, before finalizing documentation. This helps to validate the accuracy and completeness of the deviation report.
- Continuous improvement: analyse trends and patterns in deviations to identify systemic issues and implement preventive measures to enhance overall quality and compliance.
By following these tips, organizations can effectively document deviations from processes etc, mitigate risks, and drive continuous improvement in product quality and regulatory compliance.
