Deviations Process

Managing deviations effectively is critical for maintaining compliance, product quality, and operational efficiency. Our system provides a structured approach to identifying, classifying, investigating, and resolving deviations.

Deviation Identification & Documentation

Each deviation is assigned a unique tracking number and documented for full visibility and regulatory compliance.

• Deviation Number – Ensures traceability of each case.
• Investigation Number – Tracks the investigation separately.
• Short Description – Provides a brief summary of the deviation.

Affected Product, Material, or Equipment

Identifies what was impacted by the deviation.

• Product Name – Specifies the affected product.
• Batch Number – Links the deviation to a specific production batch.
• Asset Number – Captures deviations related to equipment.

Deviation Classification

Each deviation is classified based on its type and severity.

• Planned vs. Unplanned – Determines if the deviation was anticipated.
• Critical, Major, or Minor – Defines the impact level and urgency.

Risk Assessment

Risk assessment helps determine the potential consequences of the deviation.

• Impact Severity – High, Medium, or Low.
• Probability of Recurrence – How likely the deviation will happen again.
• Detectability – How easily the deviation can be detected.

Investigation & Root Cause Analysis

A structured investigation is conducted to determine the cause of the deviation.

• Risk Impact Analysis – Evaluates potential contributing factors.
• Root Cause Determination – Identifies the fundamental issue.
• Investigation Summary – Documents key findings.

Corrective & Preventive Actions (CAPA)

If a deviation requires corrective or preventive actions, a CAPA plan is initiated.

• CAPA Required? – Determines if action is necessary.
• CAPA Justification – Documents why CAPA is or isn’t required.
• CAPA Responsible Person – Assigns ownership.
• CAPA Closure Date – Ensures timely resolution.

Approval & Final Resolution

Before a deviation is closed, it must be reviewed and approved.

• Investigation Leader – Oversees the investigation.
• Head of Department Approval – Confirms resolution is adequate.
• Quality Director Approval – Ensures compliance.
• Qualified Person Final Closure – Confirms the deviation is fully resolved.

Conclusion

Our deviation management system provides a structured, compliant, and efficient way to track, investigate, and resolve deviations. It ensures full traceability, risk assessment, and alignment with GMP best practices.

For more details or to see the system in action, contact us to schedule a demo.