This document provides an overview of Corrective Action Preventive Action (CAPA) and how to implement an effective CAPA process. It defines CAPA and explains the difference between corrective and preventative actions. It outlines the benefits of a mature CAPA system, including increased quality, reduced costs from problems, and improved customer satisfaction. The document then discusses various tools that can be used in the CAPA process, including root cause analysis techniques like 5 Whys, fishbone diagrams, and Pareto charts to identify causes and prioritize actions. Examples are provided for how to apply these tools to analyze specific business processes.

1. Thank You
Corrective Action Preventive Action
A Framework

2. Agenda
 CAPA
 Problem Solving Process
 Root Cause Analysis
 RCA Techniques
 Solution Effectiveness
 CAPA Template & Examples

3. What is CAPA?
Correction
Action taken to eliminate the detected non-conformity
Corrective Action
Action taken to eliminate the root cause and symptom of an
existing deviation or nonconformity to prevent recurrence
The horse has already escaped the barn
This is a REACTIVE action that eliminates proble
ms identified in products, services, or processes
and takes care of the immediate problem
Preventive Action
Action taken to eliminate the potential causes of a nonconformity,
defect, or other undesirable situation in order to prevent
occurrence
Non-Conformity (NC)
Unexpected, unwanted events affecting Standard, rules and laws
This is a PROACTIVE action which avoids
deviation through planned activities.
It also eliminates or reduces the recurrence of
the problem.

4.  A mature CAPA system can serve as a useful tool for analyzing past
events, correcting existing non conformities and preventing future
events.
 A mature CAPA system goes beyond regulatory compliance to positively
impact our customers by increasing the value of our products and
services.
Proposal
CAPA Process - structured, formalized way to investigate NC and determine
appropriate corrections, corrective actions and preventative actions and
measure their effectiveness. (With records)
Mature CAPA Process

5. What are the benefits of using CAPA?
If used properly, the CAPA system will provide a means to
prevent the deviation from recurring.
How…?
 It provides a structured platform to conduct a systematic investigation of the
deviation.
 The investigation provides the means to develop a permanent corrective action
 It provides a framework for documentation that the corrective actions are
indeed effective.
Additionally, a CAPA system is the cornerstone of the organization’s
Quality Management System (QMS).

6. Why CAPA?
DescriptionObjective
 Quality problems can have a significant financial impact on a
company.
Good Business
Practice
 Discipline among employees about importance of qualityEmployee
Involvement
Customer
Satisfaction
 The ability to correct existing problems or implement controls to
prevent potential problems is essential for continued customer
satisfaction.

7. When to use CAPA ?
• External Customer (ie., Vendor, Symantec) Escalations / Complaints on calls /
phone / emails
• Internal Customer (ie., downstream processes, peers) Escalations /
Complaints on calls / phone / emails
• QC errors / Spot check errors
• Any red / yellow in any performance metrics
• Negative / development feedback in NPS action responses
Any negative metric or comment (“real or perceived”) reported , logged or
escalated should be part of the CAPA to analyze and address the business
issue and manage customer perception effectively

8. Steps to be followed
Step No Description of the Steps to be followed Aspect
1  Register the complaint
Correction
2  Make correction on immediate basis on the issue
3
 Analyze as to why the mistake happened to find the “Root Cause” of
the issue
Corrective
Action4
 Identify the best possible Corrective Action on the root cause to
prevent the error from recurring
5  Implement the same on the shop floor
6  Check if the same issues can occur in other areas/process/department Preventive
Action
7
 If yes check the feasibility to implement the same corrective action as
a preventive action in the other areas/process/departments

9. Problem-
Solving
Process
Become Aware of
Problem
Establish Team
Describe Problem
Contain Systems
Select & Verify
Corrective Actions
Implement and
Validate Corrective
Actions
Prevent Recurrence
Recognize Team
Find Root Cause
Identify Potential Causes
Select Probable Causes
Is Probable
Cause a Root
Cause?

11. What is the Problem Definition?
The Problem Definition is a detailed description of the relevant facts of the problem,
assembled from information readily available, as well as additional fact finding and
data collection.
The Problem Solving Approach
What is a “Root Cause”?
A root cause is the reason for a condition or an action at its origin or source.
In the context of problem solving, a root cause is one considered to be far enough into
the sequence of causes and effects, that removing it will eliminate the effect completely
and permanently.
Information must be factual, not inferred.

12. Inability to detect the problem at a control point is NOT a root cause.
(Conversely, the ability to detect the problem does not remove the root cause)
Which is (NOT) the Root Cause?
 The root cause is the one identified… that satisfies the requirement of completely
explaining the effect. It is the single verified reason that accounts for the problem.
 The root cause is supported by the facts without contradiction.
 The root cause is the one whose removal should make the effect stop permanently.
Which is the Root Cause?

13. A thorough investigation will provide the needed information to establish the
root cause.
The following questions are useful in gathering data during a Root Cause
Analysis (RCA).
– Who was involved in the deviation?
– What was the deviation?
– Where did the deviation occur?
– When did the deviation occur?
– How did it happen?
– How frequently does it happen?
The questions serve to capture the maximum amount of detail regarding the
deviation or occurrence.
They help provide data to understand why the deviation occurred
RCA Questions

14. The Root Cause Analysis is also aided by asking questions that relate to
controls to deviation.
 Describe any physical, organizational, or process controls in place to
detect deviations.
 Were the controls in place?
 What was their level of effectiveness?
 Describe any barrier failures.
 Are there environmental problems?
– Are the work conditions suitable?
– Are there process flow problems?
– Are there facilities problems?
 Are instructions for use clear?
 Are there problems with staff communication or staff training?
– Is there adequate supervision?
 Are there problems with the methods, SOPs, forms, or task analysis?
– Do the steps performed match the operating procedures?
– Has a process recently changed?
More RCA Questions

15. Analysis Tools - Pick a Systematic Technique
The Problem Solving Approach
Pareto Diagram
Separate Vital few from Trival Many
Cause-and-Effect Diagram
Used to structure data collection
and analysis to find the
root cause of a problem
RootCause
W hy -1
W hy -2
W hy -3
W hy -4
W hy -5
5 Whys?
Analysis techniques
 Brainstorming
 Repeated Whys
Why it happened, why it wasn’t detected etc.,

16. 5 Why analysis
1
• Formalize the problem on which the team will focus (a
simple opportunity statement).
• Involve everyone with relevant experience
2
• Ask Why the problem occurs and write the answer
down below the problem (visible to the team such as
on a white board).
3
• Continue to ask why until it seems improbable that the
team can reasonably drill down further.
• Note that 5 is a standard and iterations may take more
or less than 5 whys to get to the root cause of the
problem.
Most effective when
day to day business
process problems
involve human
interactions or
factors.
When to use it? Steps Outcome
Used to determine the root cause of a problem by drilling
down through several repetitions of “Why” a problem exists.
Purpose
A question-asking technique used to explore underlying cause
and effect relationships to problems.
Definition
The final why will
quickly lead the
team to a root cause
upon which action
can be taken while
dissuading the
participants from
getting stuck in logic
traps.
This root cause
should be changed
to improve and
controlled to
sustain the
improvement.

17. Business Process Example- 5 Why analysis
Observation: Major part of the billing errors are contributed by 4 locations
Why?
Observation: Users citing the ERP system as challenging
Why?
Observation: Pricing capture process for ERP too complicated
Why?
Observation: Users not sure about the price to be input into ERP
Why?
Observation: Multiple price list provided to user, mainly from Sales, Corporate
and Distributions
Investigation: When was the last refresher training conducted. Are SOPs
followed for the Pricing capture process?
Result: Refresher Training was conducted approx. 2yrs back.
Conclusion: To reduce the billing errors, SOPs has to be reinforced
with robust refresher training plans
Billing Errors
ERP Challenges
Complicated Process
Users unsure about
Process
Reinforce SOPs &
Refresher trainings

18. RootCause
Why-1
Why-2
Why-3
Why-4
Why-5
RCA 1 - 5 Why Analysis Example
Problem Statement:
Wrong Attachment was sent to the customer. (Instead of invoice Copy a
Purchase order Copy was sent).
Why 1- Why was wrong attachment sent to the customer?
Because Processor inserted the wrong file into the mail.
Why 2- Why did the processor insert the wrong file?
Processor was not able to distinguish between a Invoice Copy and a Purchase order Copy
Why 3- Why processor is not able to distinguish between these two?
Because the title of the file saved is almost similar
Why 4- Why is the file name almost similar?
Because there is no specific prefixes identified to save these copies
5 Why Analysis: Example

19. Repeat Errors – Detect multiple causes
 There can be N number of reasons for an error.
 A B C… source of errors (Can be any of the 5 Ms from Cause and
effect).
 A1, A2, A3… exact cause in that particular source of error.
 Consequences of acting on one source of errors root cause will
help us to identify the exact particular source of a error, but there
can also be other potential sources through which the same error
can occur
C
B
D
A
A2
C2
D2
B2
RCA 2 - Fish bone

20. Fishbone Analysis
1
• Define the problem/effect which the team understands
and agrees.
2
• Brainstorm all possible causes, bring in as many relevant
causes to the problem, do not try to critically evaluate
them for the moment.
3
• Start catagorizing the issues into logical subgroups.
• 4 Ps, 6 Ms
4
• Do a 5 Why analysis to understand the root cause of
each of the problems that the group comes up with.
5
• Map the root causes in sub-nodes or sub catagories.
List down all
potential causes.
Gain insights from a
larger group of
people.
To drive discussion
among many team
members.
As eliminate
possibilities of
leaving an unknown
cause.
To get better
understanding of a
metric or required
outcome
When to use it? Steps Outcome
To analyse a problem in details with the help of brainstorming among
end users, SMEs, stakeholders. It helps in finding all the relevent issues
affecting a business outcome.
Purpose
A structured problem solving approach to identify possible
problems/effects. Also called a Cause and Effect Analysis and
Ishikawa diagram. It looks like a de-skinned fishbone.
Definition
A skeleton of a fish
like structure where
the head of fish
starts the problem
and each bone
attached to the rib is
a major category of
problems. These
major categories
have various issues
which in turn has
root cause coming
out of 5 Why
analysis

21. Reasons for MSS
inaccuracy for
billing
Lack of training material
Policies
Ownership
People (Ownership/ Rigor)
Not 1st time right record
creation
Procedures
Universal
access
Algorithm to calculate
billing number
Technology
Allows mistakes
No formal training intervention
for HR (as doers or as mentors)
Access: COE level
No system validation
Policies
No Penalty
HR/FLM/SPOC
overlap
No changes
post exit login
Approval
hierarchies
No SOP on
billing related
fields
No hints
available while
making changes
No formal training
intervention for
Ops
Pre-populated default values
Excel sheet
corrections
allowed
No
dashboards
Bulk hiring
(growth)- billing
details not known
Back fill-
incorrect
alignment
Non usage of Employee database
for billing (alternate process for
billing allowed
Business Process Example

22. Pareto Analysis Chart
1
•Create a data table of factors and its
frequency sorted in ascending order
2
•Calculate the cumulative percentage for each
factor
3
•Create a bar chart from the data table with
cumulative %
4
•Change the chart style of cumulative % series
to line chart and select it as secondary axis
5
•Major factors will be represented as the
highest bars at the left hand side of the chart
To choose which
causes to eliminate
first.
When there are
many problems or
causes and you want
to focus on the most
significant
When analyzing data
about the frequency
of problems or
causes in a process
When you are
weighing options to
prioritize which one
would yield
maximum result
When to use it? Steps Outcome
Pareto chart helps to visually identify the important factors which
contributes to large portion of the outcomes by highlighting the most
frequent occurring ,among a set of factors. It is based upon the principle
that roughly 80% of the effects comes from 20% of the causes.
Purpose
A technique used for decision making based on the Pareto Principle, known as
the 80/20 rule. Pareto analysis is based on the idea that 80% of a project's
benefit can be achieved by doing 20% of the work or conversely 80% of
problems are traced to 20% of the causes.
Definition
Couple of bars will
be significantly
higher than the rest
which will enable to
select the vital few
items for further
actions

23. Business process example
To reduce the DSO from 84 days we have identified a project on
improving the Billing accuracy.
We need to know where to start or what is the focus area?
Use Pareto Analysis ( 80/20 rule) to depict the below graph
Seven steps to identifying
the important causes using
Pareto Analysis: ¹
 Form a table listing the causes and
their frequency as a percentage.
 Arrange the rows in the decreasing
order of importance of the causes,
i.e. the most important cause first.
 Add a cumulative percentage
column to the table.
 Plot with causes on x-axis and
cumulative percentage on y-axis.
 Join the above points to form a
curve.
 Plot (on the same graph) a bar
graph with causes on x-axis and
percent frequency on y-axis.
 Draw a line at 80% on y-axis parallel
to x-axis. Then drop the line at the
point of intersection with the curve
on x-axis. This point on the x-axis
separates the important causes on
the left and less important causes
on the right.
SL Operations Site
Billing
Accuracy
Billing
Errors
cum
1 Indianapolis 12% 176 20%
2 New York 17% 167 40%
3 Phoenix 22% 156 58%
4 San Jose 27% 147 75%
5 Philadelphia 82% 37 79%
6 Dallas 83% 34 83%
7 Jacksonville 85% 31 86%
8 Houston 85% 31 90%
9 Los Angeles 86% 29 93%
10 San Antonio 85% 30 97%
11 Chicago 92% 16 99%
12 San Diego 94% 12 100%

24. What about you and your team?
Rollout CAPA & Enjoy below benefits
 Your precious time
 Efficient & Effective process performance
 Gain Customer satisfaction, trust & loyalty
Do you have repeat issues that you
need to resolve?

25. Thank You