Deviation Management

Deviation Classification & Due Date Calculator

Work through a few key questions to arrive at a preliminary deviation classification, and calculate the corresponding investigation due date.

How Classification Typically Works

Most Quality Systems classify deviations into three tiers, each driving a different investigation timeline and level of oversight. The exact criteria and timelines vary by site procedure, but generally follow this pattern:

Classification	Typical Criteria	Typical Investigation Timeline
Critical	Direct patient safety impact, product already distributed, or regulatory reporting implications	3–5 calendar days for initial assessment; full investigation per procedure
Major	Potential product quality impact, contained to the batch/lot, no immediate patient exposure	15–20 business days
Minor	No product quality impact; procedural, documentation, or housekeeping in nature	30 business days

Classification Worksheet

1. Could this deviation have affected product already released or distributed? No Yes

2. Is there a potential direct patient safety impact? No Yes

3. Does this affect a Critical Quality Attribute (CQA) or Critical Process Parameter (CPP)? No Possibly / indirectly Yes, directly

4. Is the deviation contained to a single batch/lot, with no wider system impact? Yes, fully contained Uncertain / partially contained No, potentially systemic

5. Nature of the deviation Documentation/administrative only Procedural, no product contact Process/product-related

Deviation Identification Date

Preliminary Classification

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This worksheet provides a preliminary, illustrative classification only. Final deviation classification and investigation timelines must follow your site's approved deviation management SOP — actual criteria, scoring, and due dates vary by organization and must be confirmed by QA before formal classification.