Deviation Management
A systematic process for identifying, documenting, investigating, and resolving departures from established procedures and specifications.
What is Deviation Management?
- Deviation Management
- Deviation management is the systematic approach to handling any departure from approved procedures, processes, or specifications in a laboratory environment. It ensures that all unexpected events are properly documented, investigated, and resolved while maintaining product quality and regulatory compliance.
Types of Laboratory Deviations
Planned Deviations
Intentional, pre-approved departures from SOPs due to equipment unavailability, temporary process changes, or experimental variations.
Unplanned Deviations
Unexpected departures discovered during or after testing, including equipment failures, sample issues, or procedural errors.
Deviation Categories by Severity
Deviations that may affect patient safety or data integrity. Require immediate investigation and reporting.
Significant departures that may impact quality but don't directly affect patient safety. Require prompt investigation.
Small departures with minimal impact on quality. Documented and reviewed during routine quality assessments.
Deviation Management Process
Detection & Reporting
Immediately document the deviation with who, what, when, where details
Initial Assessment
Evaluate severity and potential impact on results, patients, or processes
Investigation
Conduct root cause analysis using appropriate methodologies
Impact Assessment
Determine effects on affected samples, batches, or reported results
Corrective Action
Implement immediate corrections and long-term preventive measures
Documentation
Complete all deviation records with investigation findings and actions
Closure & Review
Verify effectiveness and close deviation with appropriate approvals
Common Laboratory Deviations
LIMS Integration
Modern LIMS systems can automate deviation detection, trigger automatic documentation workflows, track investigation progress, and generate deviation reports for quality management review.