Deviations Workflow

This guide describes the step-by-step process for logging and managing deviations. Deviations, per ISO 17025 §8.9, occur when a procedure is not followed as documented — the record captures what happened, assesses the impact, and determines whether a CAPA 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`)
Date	When the deviation occurred
Description	Brief description of the event
Area Affected	Which area/process was affected
Responsible	Person responsible for handling
Status	Open, Under Review or Closed

There are also hidden columns (Impact Assessment, Immediate Action, Linked CAPA, 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
Date	When the deviation occurred	Yes
Description	What exactly happened	Yes
Area Affected	Which area/process was affected	Yes
Responsible	Person responsible for handling	Yes
Status	Starts as "Open"	Yes
Notes	Additional remarks	No

Step 4 — Assess Impact

After creation, open the record and fill in the Impact Assessment field. Consider:

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?

The impact assessment determines whether 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 impact assessment shows that a systemic correction is needed:

Create a CAPA record (see CAPA Workflow)
Fill in the Linked CAPA field with the CAPA record number
Change the status to "Under Review" until the CAPA is closed

Step 7 — Close

After completing the immediate action (and the CAPA if applicable):

Make sure all fields are filled in
Change the status to "Closed"

During ISO 17025 audits, assessors check whether each deviation was assessed, 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
Status	Select	Show only one status
Date (from)	Date	Deviation date from
Date (to)	Date	Deviation date to
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?

No. If the impact is minor and the immediate action is sufficient, the deviation can be closed without a CAPA. A link is only needed when a systemic issue is identified.

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.