Deviation Investigation

A deviation is not a failure — it is information. Every non-conformance tells you something about your process, your controls, or your assumptions. The question is whether your investigation extracts that information or just documents the event and moves on.

Investigation Methodology

We bring structured investigation discipline to deviations of all categories — from minor documentation discrepancies to critical product quality failures.

• Event timeline reconstruction
• Data gathering and preservation (ALCOA+ principles)
• Impact assessment on product quality and patient safety
• Probable cause determination with supporting evidence

Non-Conformance Classification

Not every deviation deserves the same level of investigation. We help organizations build classification frameworks that direct resources proportionally to risk.

• Risk-based deviation categorization
• Impact assessment criteria (product, patient, regulatory)
• Investigation depth calibrated to deviation severity
• Escalation criteria for quality events

Batch Disposition Support

When a deviation affects product, the disposition decision must be scientifically justified and documented. We support your quality unit in making defensible batch disposition decisions.

• Impact assessment on affected batches and lots
• Scientific justification for release or rejection
• Retrospective review of previously released product
• Field alert and recall assessment when warranted

Trend Analysis

Individual deviations are data points. Patterns across deviations are intelligence. We help organizations move from reactive investigation to proactive prevention through systematic trending.

• Deviation trending by type, area, process, and root cause
• Signal detection for emerging quality issues
• Pareto analysis to prioritize improvement efforts
• Annual product quality review integration

Data Integrity in Investigations

Investigation records are among the most scrutinized documents during regulatory inspections. We ensure your investigation documentation meets ALCOA+ standards:

• Attributable — every entry traceable to the person who made it
• Legible — clear, unambiguous documentation
• Contemporaneous — recorded at the time of the activity
• Original — primary records preserved
• Accurate — truthful representation of what occurred
• Complete — all relevant information included
• Consistent — no unexplained contradictions
• Enduring — records maintained for their required retention period
• Available — accessible when needed for review