qms-deviation

Deviation Management

Capture. Investigate. Prevent.

Stop accepting 'human error' as a root cause. AI-powered pattern detection finds the systemic issues behind individual deviations.

Deviation Management

"Human error" isn't a root cause. A deviation log full of "operator error" and "retrain operator" tells regulators you don't understand your processes. The question isn't who made the mistake—it's what made the mistake possible.

AI finds what humans miss

You log a deviation: "pH excursion during hold step, Batch 2847." Before you finish typing, AI searches your deviation history and surfaces: "12 similar deviations in the past 18 months. 8 involved the same hold tank. 6 occurred during shift change. Common root cause: calibration drift on pH probe PT-401."

Pattern Detection

You were about to investigate this as an isolated event. AI showed you it's the thirteenth instance of a systemic problem. The investigation shifts from "what happened to this batch" to "why does this keep happening."

Context captured automatically

A deviation in Seal isn't a form—it's a snapshot of everything happening at that moment. Batch ID, equipment status, operator training records, process values, environmental conditions. When an auditor asks "what happened?", you show them the complete picture. When AI analyzes the deviation, it has the same context.

Equipment sensors detect out-of-spec conditions and create deviations automatically: temperature excursion duration and range, pressure spike timestamp, alarm trigger conditions. The system captures objective data. The operator adds interpretation.

Investigation with AI assistance

You start a 5-Why. AI suggests the next question based on your deviation history and industry patterns.

5-Why Investigation

Why did the operator skip the step? AI suggests: "In 73% of similar deviations, procedure clarity was cited. The current SOP was revised 6 months ago." You investigate and confirm—the procedure was confusing. Why was it confusing? It was updated without usability review. Why wasn't it reviewed? No review process exists. Now you have something systemic to fix.

AI drafts the investigation summary: "Root cause: Procedure SOP-2847 section 4.3 lacks clear hold time specification, leading to operator interpretation variability. This is the fourth deviation linked to this procedure revision. Recommended action: Revise SOP with explicit hold parameters and operator verification step." You review, edit, approve.

Pattern detection across your system

Individual deviations are noise. Patterns are signal. Seal's AI continuously analyzes:

  • Equipment patterns: Which assets generate the most deviations? Is Bioreactor 3 trending worse than Bioreactor 4?
  • Procedural patterns: Which SOPs cause confusion? Which steps get skipped?
  • Temporal patterns: Do deviations cluster by shift, day of week, time since last maintenance?
  • Personnel patterns: Not to blame individuals, but to identify training gaps

When a pattern emerges, the system alerts before you've accumulated enough deviations to notice manually. The signal that took 12 incidents to see? AI flags it at 4.

Classification and escalation

Critical deviations notify QA leadership immediately and require VP approval to close. Minor documentation gaps close with QA specialist review. AI suggests classification based on deviation details and historical outcomes—you confirm or override.

Timelines are enforced. Aging deviations escalate automatically. Nothing sits in a queue waiting for someone to remember it exists.

Capabilities

01Contextual Capture
Deviations link to batches, equipment, operators, and process steps. Full context in one click, not buried in attachments.
025-Why Analysis
Structured root cause investigation that goes beyond 'human error.' Documented reasoning that auditors can follow.
03Impact Assessment
Automatic identification of affected batches, products, and materials. Trace forward through your entire inventory.
04Pattern Detection
AI-powered trend analysis across deviations. Identify equipment issues, procedural gaps, and training needs before they become systemic.
05Classification & Escalation
Configurable severity levels with automatic escalation. Critical deviations notify leadership immediately.
06CAPA Linkage
Seamless connection to corrective actions. Deviations that reveal systemic issues trigger CAPAs automatically.
07AI Investigation Assistant
AI finds similar deviations, suggests root causes, and evaluates corrective action effectiveness. Learns from your history.
08Mobile Capture
Operators log deviations in under a minute from the floor. Voice notes, photo evidence, barcode scanning.
09Equipment Integration
Connect monitoring systems. Out-of-spec conditions create deviations automatically with objective sensor data.
01 / 09
Contextual Capture
Contextual Capture

Entities

Entity
Description
Kind
Deviation
Something unexpected happened. Not 'who made the mistake' but 'what made the mistake possible?'
type
Process Deviation
Operator skipped a step. Why was it possible to skip? That's the question.
template
DEV-2023-089
Investigation inconclusive. No root cause. No corrective action. Just... sat there. Auditor found it.
instance
Equipment Deviation
Equipment sensor triggered. Objective data attached automatically—no operator recollection needed.
template
DEV-2024-001
Temperature spike: 78°C for 12 minutes. Sensor data attached. Facts locked in while fresh.
instance
Environmental Excursion
Temperature, humidity, particles. Duration and range captured by monitoring system.
template
Investigation
5-Why until you hit something systemic. 'Human error' isn't an acceptable final answer.
type
Root Cause
Why did the operator skip the step? Procedure unclear. Why? Never reviewed. Now you can fix it.
type
Impact Assessment
What else is affected? Raw material lot implicated → which batches → which products → which shipments?
type
Immediate Action
Stop the bleeding. Containment while investigation proceeds.
type
Classification
Critical deviations notify leadership immediately. Minor documentation gaps close with QA specialist review.
type
Critical
Product impact, patient safety. QA VP approval to close. Can't just disappear in the queue.
template
Minor
Documentation gap. Simplified investigation. But still investigated—not ignored.
template
Pattern Detection
Individual deviations are noise. Patterns are signal. Which equipment generates the most? Shift, time of day, batch size?
type

FAQ

The 5-Why framework requires you to keep asking why until you reach a systemic cause. 'Human error' isn't an acceptable final answer—the system prompts you to investigate what made the error possible. Was the procedure unclear? Was training inadequate? Was the operator fatigued? These are actionable root causes.