Corrective & Preventive Actions (CAPA) Workflow

This guide describes the step-by-step process for logging and managing corrective and preventive actions. CAPA, per ISO 17025 §8.7, ensures that every nonconformity is identified, analysed, corrected, and prevented from recurring.

Prerequisites

Before you begin, make sure that:

#	Prerequisite	Why	Page
1	Users	Responsible person assignment	Users

Go to the Corrective Actions page from the main menu. A table of existing CAPA records is displayed.

The visible table columns are:

Column	Description
CAPA No.	Unique action code (for example `CAPA-YYYY-0001`)
Title	Brief description of the issue
Source	PT Failure, Audit Finding, Customer Complaint, etc.
Detection Date	When the nonconformity was detected
Responsible	Person responsible for implementation
Status	Open, In Progress, Closed or Verified
Priority	Critical, High, Medium or Low

There are also hidden columns (Deadline, Detected By, Completion Date, Effectiveness Verified, Verification Date, Source Description, Root Cause Analysis, Corrective Action, Preventive Action, Notes). You can show them from the column settings.

Step 2 — Identify the Nonconformity

Before creating a CAPA record, identify the source of the nonconformity. The most common sources are:

Source	Description	Example
PT Failure	Failure in proficiency testing	z-score > 2 in an interlaboratory comparison
Audit Finding	Finding from an internal or external audit	Instrument calibration not followed
Customer Complaint	Complaint or report from a customer	Inconsistent results in a report
Equipment Problem	Equipment malfunction or failure	Balance out of tolerance during calibration
Out-of-Bounds Result	Measurement outside acceptance criteria or QC checks	Control sample outside ±2σ
Other	Any other cause	Process review failure

Step 3 — Create a CAPA Record

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

Fill in the fields:

Field	Description	Required
CAPA No.	Leave blank for auto-numbering (for example `CAPA-YYYY-0001`)	No
Title	Brief description of the issue	Yes
Source	Select from the list (PT Failure, Audit Finding, etc.)	Yes
Source Description	Detailed description of the source	No
Detection Date	When the issue was detected	Yes
Detected By	The user who identified the issue	Yes
Responsible	Person responsible for implementation	Yes
Priority	Critical, High, Medium or Low	No
Status	Starts as "Open"	Yes
Deadline	Completion deadline	No
Notes	Additional remarks	No

Status is colour-coded in the table. The deadline is shown in red if overdue.

Step 4 — Root Cause Analysis

After creation, open the record for editing and fill in the Root Cause Analysis field. Root cause analysis is critical for effective corrective actions.

Common analysis methods:

5 Whys Method

Ask "Why?" repeatedly until you reach the root cause:

Why was the value out of limits? → Incorrect instrument calibration
Why was the calibration incorrect? → The correct procedure was not followed
Why was it not followed? → The analyst was not trained on the new procedure
Why were they not trained? → No training programme for procedure changes existed
Why did it not exist? → Root cause: Lack of a training needs management system

Cause-and-Effect Diagram (Fishbone / Ishikawa)

Categorise potential causes into:

People — training, experience, competence
Methods — procedures, work instructions
Equipment — calibration, maintenance, condition
Materials — reagents, standards, samples
Environment — temperature, humidity, vibrations

Record findings in the "Root Cause Analysis" field with clear structure, so they are available during ISO audits.

Step 5 — Define Actions

Fill in the action fields:

Corrective Action

Describe what was done or will be done to fix the specific issue.

Example: "Recalibration of spectrophotometer AAS-01 per SOP-CAL-003. Re-analysis of the last batch."

Preventive Action

Describe what measures are taken to prevent recurrence of the issue.

Example: "Updated calibration schedule from monthly to weekly. Added a check before each measurement run. Trained all analysts on the new procedure."

The difference: a corrective action addresses the current problem, while a preventive action stops similar problems in the future.

Step 6 — Track Implementation

During implementation:

Change the status to "In Progress" once actions begin
Check the deadline — overdue records are shown in red in the table
Update the notes with implementation progress
Monitor priorities — critical and high records need immediate action

Filter the table by status "Open" or "In Progress" to see only active records.

Step 7 — Verify Effectiveness and Close

After completing the actions:

Fill in the Completion Date
Assess whether the actions were effective — for example, check that subsequent QC results are within limits
Set the Effectiveness Outcome field to "Verified", "Failed" or "Not Required" (it stays "Pending" until you decide)
Once the Effectiveness Outcome changes away from "Pending", the Effectiveness Reviewer and Effectiveness Notes fields appear — fill them in
If you set the Effectiveness Outcome to "Failed", you must also link a Related Risk Assessment — without it the record cannot be closed (ISO 17025 §8.7.1(e))
Enter the Verification Date

During ISO 17025 audits, assessors check whether each CAPA was completed, whether effectiveness was verified, and whether preventive measures were implemented.

Closing a CAPA Record

Closing is not done by selecting "Closed" in the form's Status field — it is a separate action available from the "Close" button in the row's action menu:

Click "Close" on the record's row
Enter the closure reason — this field is mandatory; closing is rejected without it
Confirm

The system blocks closing when:

The Effectiveness Outcome is still "Pending" (ISO 17025 §8.7.1(d))
The Effectiveness Outcome is "Failed" without a linked Risk Assessment — only the Lab Director, Quality Manager or Reviewer can override this check, by entering a written override reason
The record is already "Closed" or "Verified"

Closing a CAPA is restricted to the Lab Director, Quality Manager or Reviewer roles. A failed CAPA (Effectiveness Outcome = "Failed") automatically spawns an improvement backlog item when it is closed.

Step 8 — Search & Filtering

Search

Type in the search field for quick text filtering (title, responsible person, etc.).

Click the filter icon to open the filter panel with the following options:

Filter	Type	Description
Source	Select	Show only one source
Status	Select	Show only one status
Priority	Select	Show only one priority
Responsible	Select	Show only one responsible person's records
Max Records	Number	Record limit for print/export (default: 200)

The "Max Records" filter only affects printing and CSV export, not the table display.

FAQ

When should I create a CAPA record?

Whenever a nonconformity is identified — a proficiency testing failure, a QC result outside limits, a customer complaint, an internal/external audit finding, or a deviation from a documented procedure. ISO 17025 §8.7 requires documentation of every nonconformity.

What is the difference between corrective and preventive actions?

A corrective action addresses the current problem (for example, recalibrating an instrument). A preventive action prevents similar problems in the future (for example, increasing calibration frequency). Both are required for a complete CAPA.

How long should I keep CAPA records?

Per ISO 17025, records must be retained for at least the period defined by the accreditation body (typically 5 years). The application retains all records in the database without automatic deletion.

Can I close a CAPA without verifying effectiveness?

No: the system blocks closing while the Effectiveness Outcome field is still "Pending" — you must first set it to "Verified", "Failed" or "Not Required". If it is set to "Failed", a linked Risk Assessment is also required before closing is allowed. The "Verified" status is a separate field from the Effectiveness Outcome.

How does auto-numbering work?

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