> ## Documentation Index
> Fetch the complete documentation index at: https://docs.elevatedsignals.ai/llms.txt
> Use this file to discover all available pages before exploring further.

# Raise a deviation

> Create, classify, and start investigating a deviation.

## 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.

## 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.

## Classify

Classify the deviation (planned / unplanned) with a rationale. Classification is a signed action.

## 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.

## Investigate & document root cause

Record a **structured RCA** (5-Whys or Fishbone): problem statement,
contributing factors, and a root-cause conclusion.

<Note>
  A deviation cannot be closed without a documented RCA conclusion and a linked disposition (CAPA).
  This is an enforced completeness gate, not a convention.
</Note>

## 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.