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The Deviation Register

All deviations are listed with severity (Critical/High/Medium/Low), status, source, and date opened. Deviations are the backbone of your quality system — regulators look at how quickly you detect, investigate, and resolve them. Filter by severity to prioritize Critical and High items, and review aging regularly so long-running investigations don’t stall.

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Create the deviation

  1. Go to Deviations → New deviation.
  2. Enter a title and description of what happened.
  3. Save. The deviation is created in open status and the creation is captured in the audit trail.

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Classify

New deviations start as Unplanned. To classify a deviation as Planned, QA records the classification with a rationale and a signature while the deviation is open.

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Start the investigation & assign the owner

When you start the investigation you assign the initial investigator who owns it (defaulting to you), so every deviation has a responsible owner from the moment investigation begins. Use Reassign investigator later to hand ownership to someone else — that reassignment is audit-logged with a reason for change.

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Investigate & document root cause

Record a structured RCA (5-Whys or Fishbone): problem statement, contributing factors, and a root-cause conclusion. Where guided RCA is enabled, 5-Whys is guided:
  1. In Record RCA, choose 5-Whys and enter the Problem statement.
  2. Select Start asking why and answer the first question.
  3. Select Ask why again for each further answer. You need three to five answers.
  4. Select This is the root cause.
  5. Review the Root-cause conclusion and any Contributing factors (optional).
  6. Enter a reason and select Save RCA.
A deviation cannot be closed without a documented RCA conclusion and a linked disposition (CAPA). This is an enforced completeness gate, not a convention.

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Close

Closure requires an independent approver (the author/owner cannot self-close) and an electronic signature. This creates a Part 11-style signature manifestation linking the signer, meaning, timestamp, and record transition — do not close a deviation while evidence, containment, impact assessment, or linked CAPA decisions are still unresolved. Reopening a closed deviation also requires an independent signer and a reason for change.