Outline

Introduction

What is CAPA?

CAPA Tools

CAPA Workflow

Slide 1
What is CAPA?

“… CAPA is a quality assurance system, which addresses

quality events, which may occur or could be anticipated to
occur during products manufacturing.”

An improvement tool
Aims to prevent
used within good
issue recurrence CAPA is the core of
manufacturing
(corrective action) or continuous
practice (GMP)
to prevent issue improvement
principles and
occurrence systems
various ISO
(preventative action)
standards

Slide 2
Correction, corrective action and
preventative action

Corrective Action

Issue Investigation

Preventative Action

Correction

Slide 3
Key CAPA definitions
CAPA

Corrective and Preventative Action

A systematic approach that includes actions needed to
correct (correction), avoid recurrence (corrective
action), and eliminate the cause of potential non-
conforming product and other quality problems
(preventative action)

Correction

Action to eliminate a detected non-conformity.

Corrections typically are one-time fixes. A correction is
an immediate solution such as a repair or rework.
• Also known as remedial or containment action.

Slide 4
Key CAPA definitions

Corrective Action

Action to eliminate the causes of a detected

nonconformity or other undesirable
situation. The corrective action should
eliminate the recurrence of the issue.

Preventative Action

Action to eliminate the causes of a potential

nonconformity or other undesirable potential
situation. Preventative action should prevent
the occurrence of the potential issue.

Slide 5
Corrective or preventative?

Name it corrective action only • Product failing specifications

if you already have a product • Confirmed customer complaint
non-conformance or process • Use of obsolete documents
non-compliance • Audit finding

Name it preventative action • Developing adverse trends from

whenever the product, process monitoring systems
or system is still in conformance o Shifts
but you discover root cause o Trends
with the potential to create o High Variability, and so on
non- conformities

Name it preventative action if •

Changing to new material or new
it is purely a recommendation design
to enhance or improve any • Implement new (enhanced)
product, process or system processes

Slide 6
The Quality System and CAPA

Quality System
• Defines processes to fulfil product requirements, customer satisfaction
and continuous improvement
QMS
• How quality policies are implemented and quality objectives are
achieved
Continuous Improvement
• Ongoing activities to evaluate and enhance the Quality System

Data Analysis
• Demonstrates the suitability and effectiveness of the QMS

Corrective Actions
• Identifies action needed to correct the causes of identified
problems
Slide 7
Quality Systems Centre - CAPA

Deviations
Internal
Audits Complaints

Continuous
Customer &
Product
Supplier Audits
Verification
CAPA
Annual Product Regulatory
Reviews
Inspections

Environmental
Stability
Monitoring

Slide 8
Tools for identifying causes

Tools Tools
• 5 Whys • Flow charting
• (Who, What, When, • Root Cause Mapping
Where, Why, How) • Simple Checklists
• Cause & Effect • Fishbone diagrams
• Problem Description • Pareto chart
• Change Analysis • Failure Mode & Effect
• Brain storming Analysis

Slide 9
Tool: 5 Why’s

• Step 1:
Establish a problem statement
E.g. “I was late to CAPA training today”

• Step 2:
Ask (and answer) the question “Why” 5 times

• Step 3:
The root cause becomes apparent by the 5th Why

Slide 10
Tool: Fishbone Diagram
Example: CAUSES OF BURNT TOAST

Environment People

Morning – Didn’t read

in a instructions
hurry
Didn’t know correct
No security on
Toasting Setting
Toaster Settings
Burnt
Procedure not New Toaster
Bread of followed/ Toast
poor Quality/ available
Too dry
Process not No Testing of
tested/ Settings
validated done before
use
Material Proce
ss Equip
ment
Slide 11
Tool: Problem Description
Date (week of) Facts
October 12 Results within specifications
October 19 Floor maintenance housekeeping performed during the
weekend
October 26 High variability of results. The two balances were found
out of tolerance. Balances were calibrated.
November 2 Results within specifications
November 9 Results within specifications
November 16 Results within specifications
November 23 Results within specifications
November 30 Results within specifications
November 7 Floor maintenance housekeeping performed during the
weekend
November 14 High variability of results. The two balances were found
out of tolerance. Balances were calibrated.
November 21 Results within specifications
Slide 12
 Tool: Change Analysis
Change Analysis Graph
80

70

60

50

40

30

20

10

0
February March April May June July August September October November December

Slide 13
Tool: Standard Checklists

Checklists are beneficial in providing a standard,

consistent list of potential sources of error.
For example:

• Was the correct procedure followed?

• Was the person trained in the procedure?
• Does the procedure match actual practice?
• Is this a recurring issue?
• Was there an equipment problem?
• Was the equipment calibrated?

Slide 14
Tool: Brainstorming

 Brainstorming can be used in association with other

Root Cause Analysis tools
 Brainstorming is a method for
generating a large number of
creative ideas in a short period
of time

Approach:
• Unstructured shout-out ideas
• Thinking “outside the box”
• Structured rotation around the
room for ideas

Slide 15
Tool: Comparison Matrix
Comparison Matrix
• Tool aimed at focussing on the key areas implicated in the
problem and remove areas of investigation not
implicated

Slide 16
Root Cause Analysis (RCA) tips

Root Cause Analysis (RCA) is a key element to a site’s

Quality System.

Important considerations include:

• Don’t forget the past – has this occurred previously?
• Don’t stop at the first plausible explanation – complete
the process to eliminate all other possible causes
• There may be more than one root cause
• If you do not find a confirmed root cause, address the
potential root causes and monitor the issue
• Monitor – follow-up on implemented actions

Slide 17
CAPA work flow

Assess the
Identify Assess the Assess the potential
Root Cause risk for
significance recurrence

Slide 18
CAPA form

Section 1– Issue Details

Section 2 – Immediate actions

Section 3 – Investigation

Section 4 – Root Cause

Section 5 – Corrective actions

Section 6 – Preventative actions

Section 7 – CAPA Implementation Plan

Section 8 – CAPA Effectiveness Check and Summary

Section 9 – Approval

Slide 19
Final CAPA Approval

Slide 20
10 common mistakes
1. Timeliness (lack of)

2. Everything is an isolated event

3. Root cause not identified

4. Correcting the symptom instead of the cause

5. Lack of interim corrective actions

6. Root cause identified by not corrected

7. Lack of true preventative action

8. Lack of effectiveness verification

9. Multiple CAPA systems without correlation

10 Abuse of human error and retraining

Slide 21