Deviations Workflow

This guide describes the step-by-step process for logging and managing deviations. Deviations, per ISO 17025 §7.10, occur when a procedure is not followed as documented — the record captures what happened, analyses the root cause, and determines whether a CAPA link is needed.

Prerequisites

Before you begin, make sure that:

#	Prerequisite	Why	Page
1	Users	Responsible person assignment	Users

Go to the Deviations page from the main menu. A table of existing deviation records is displayed.

The visible table columns are:

Column	Description
Deviation No.	Unique code (for example `DEV-YYYY-0001`)
Title	Short title of the event
Classification	Major or Minor
Detection Date	When the deviation was detected
Responsible	Person responsible for handling
Status	Open, Under Investigation, Resolved or Closed
Source	Where the deviation originated

There are also hidden columns (Deadline, Resolution Date, Detected By, Description, Root Cause, Immediate Action, CAPA Reference, Notes). You can show them from the column settings.

Step 2 — Identify the Deviation

A deviation is identified when a documented procedure was not followed correctly. Typical examples:

Situation	Example
SOP deviation	Wrong reagent used in an analysis
Method deviation	Calibration step skipped
Specification deviation	Sample stored outside temperature limits
Unauthorised change	Parameter modified without approval

Step 3 — Create a Record

Click the "+" button on the toolbar to open the creation form.

Fill in the fields:

Field	Description	Required
Deviation No.	Leave blank for auto-numbering (for example `DEV-YYYY-0001`)	No
Title	Short title of the event	Yes
Classification	Major or Minor	Yes
Source	Internal Audit, Proficiency Testing, Daily Operation, Management Review or Other	No
Detection Date	When the deviation was detected	Yes
Deadline	Deadline for resolution	No
Detected By	The user who detected the deviation	Yes
Responsible	Person responsible for handling	Yes
Status	Starts as "Open"	Yes
Resolution Date	When the deviation was resolved	No
CAPA Reference	Pick an existing CAPA record from a list (see Step 6)	No
Description	What exactly happened	Yes
Root Cause	Analysis of the underlying cause	No
Immediate Action	The measures taken to contain the impact	No
Notes	Additional remarks	No

If a competency requirement is configured for the "Deviation Handling" function in the staff competency matrix, the user assigned as Responsible must hold authorized competence — otherwise saving is rejected (ISO 17025 §6.2.3).

Step 4 — Root Cause Analysis

There is no separate "Impact Assessment" field. Open the record and document your assessment in the Root Cause field, considering:

Validity of results — Were analysis results affected?
Scope of effect — How many samples/reports were affected?
Safety — Is there a risk to personnel or sample safety?
Compliance — Was a regulatory requirement violated?

This analysis determines whether a link to a Corrective Action (CAPA) is needed or whether the immediate action is sufficient.

Step 5 — Immediate Action

Fill in the Immediate Action field with the measures taken to contain the impact.

Example: "Stopped use of the reagent. Re-ran the analyses with the correct reagent. Notified the laboratory supervisor."

The immediate action addresses the current problem — if a systemic fix is needed, create a CAPA record.

Step 6 — Link to CAPA (optional)

If the root cause analysis shows that a systemic correction is needed:

Create a CAPA record (see CAPA Workflow)
In the CAPA Reference field, pick the CAPA record from the list (shows CAPA number and title)
Change the status to "Under Investigation" until the CAPA is closed

Step 7 — Close

Closing is not done by simply changing the Status field in the edit form; it is a separate, gated action:

From the row's actions menu (⋮), select "Close"
In the dialog that opens, fill in the Closure Reason — the action cannot proceed without it
Confirm

The following restrictions apply:

Role — only the Lab Director, Quality Manager or Reviewer can close a deviation. Other roles can log and edit deviations, but not close them.
CAPA link — if the deviation has no linked CAPA Reference, closing is blocked. Only the Lab Director or Reviewer can override this restriction, by recording a mandatory override reason that is kept in the audit trail.
A deviation already in "Closed" status cannot be closed again.

The record permanently retains who closed the deviation, when, and the closure reason.

During ISO 17025 audits, assessors check whether each deviation was analysed, addressed, and fully documented.

Step 8 — Search & Filtering

Search

Type in the search field for quick text filtering.

Click the filter icon to open the filter panel:

Filter	Type	Description
Classification	Select	Show only Major or Minor deviations
Status	Select	Show only one status
Source	Select	Show only deviations from a specific source
Responsible	Select	Show only deviations for a specific responsible person
Max Records	Number	Record limit for print/export (default: 200)

FAQ

When should I record a deviation instead of a CAPA?

A deviation documents what happened — it is the factual record of the event. A CAPA is the fix — the systemic response. First record the deviation, then create a CAPA if needed to prevent recurrence.

Is a CAPA link always required?

By default the application blocks closing a deviation without a linked CAPA Reference. If the impact is genuinely minor and no systemic correction is needed, only the Lab Director or Reviewer can override this restriction, by recording a mandatory override reason.

How does auto-numbering work?

If you leave the "Deviation No." field blank during creation, the application assigns the next available code (format DEV-YYYY-NNNN). You can also enter your own code.