The document discusses the Corrective Action and Preventive Action (CAPA) process. It defines CAPA as a structured way to investigate non-conformities, determine appropriate corrections and actions, and measure their effectiveness. It outlines the key steps in the CAPA process including defining the problem, investigating the root cause, determining corrective and preventive actions, implementing solutions, and measuring effectiveness. The document emphasizes that the goal of CAPA is to eliminate causes of issues in order to prevent recurrence and notes that a mature CAPA system can help continuously improve products, services, and compliance.

1. PRANEET SURTI
Quality Consultant
Lead Auditor ISO 9001:2015
B.E Mechanical
by

2. “A man learns from his mistakes”
CAPA helps us to simplify the above !

3. CAPA process is a structured, formalized way to
investigate NC and determine appropriate corrections,
corrective actions and preventative actions and
measure their effectiveness. (With records)

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.

5.  ISO 9001:2008 : Clause 8.5.2
“The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.”
 ISO 9001:2015 : Clause 10.2 Nonconformity and corrective action
Clause 10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable: [Correction]
b) take action to control and correct it;
c) deal with the consequences;
[Nonconformity can be anything deviating from the standard requirements]
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur
[Corrective Action] or occur [Preventive Action] elsewhere, by:
a) reviewing and analyzing the nonconformity; [Description of NC]
b) determining the causes of the nonconformity; [RCA of NC]
c) determining if similar non conformities exist, or could potentially occur; [Platforms at Risk]
d) implement any action needed; [Correction]
e) review the effectiveness of any corrective action taken; [Effectiveness Measure]
f) update risks and opportunities determined during planning, if necessary; [Update Risk Documented
Information]
g) Make changes to the quality management system, if necessary. [Update Changes in the Documented
Information]
h) Corrective actions shall be appropriate to the effects of the nonconformities encountered. [Effectiveness
Measure]
 Clause 10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.

7. 7

8.  Complaint Handling
 Nonconforming (Unexpected, unwanted events with a Quality
System) Product
 Supplier Performance
 Accidents
 Equipment Monitoring
 Process Controls
 Cost Reduction Effort
 Audits
 Suggestions
 Continuous Improvement Effort
8

9.  State the problem in measurable terms
 how often, how much, when, and where
 Emphasize the effects (risk)
 safety, death, injury, rework, cost, etc.
 Avoid
 words that are broad and do not describe the conditions or
behavior such as careless, neglect, oversight.
 Do not use abbreviations of words, acronyms.
 Do not state solution in issue statement.
 Do not state root cause in issue statement.
9

10.  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.
10

11.  Define method of
investigation of root
cause
 Include quality tools used
▪ Is/Is Not,
▪ Cause and Effect,
▪ 5 Why’s, etc.
 Document
 Dates of investigation
 Data reviewed (data sources,
records, dates)
 Corrections or Containment
measures
 Results: Statement of Cause
11
Is / Is Not Diagram
WHAT
WHEN
WHERE
EXTENT
IS
IS
NOT

12. Is Is Not
What
What object has the problem?
What is the defect?
What similar object could have the problem but
does not?
What defect could the object have but does not?
Where
Where is the object located geographically
when the defect is noticed?
Where is the defect located on the object?
Where could the object be located but it is not?
Where could the defect be located but it is not?
When
When was the defective object first noticed?
When has it been observed since?
What is the timing pattern (continuous,
random, or cyclical) and trend?
When could the defective object been noticed, but
was not?
What could the timing pattern and trend be but is
not?
Extent
How many objects have the defect?
How extensive is the defect?
How many objects could have the defect but do
not?
How extensive could the defect be but is not?

13. E.g. Problem - Flat Tire
 Why? Nails on garage floor
 Why? Box of nails on shelf split open
 Why? Box got wet
 Why? Rain thru hole in garage roof
 Why? Roof shingles are missing

14. 14
Used to structure data collection and analysis to find the
root cause of a problem.
Methods
EnvironmentMaterials
ManMachines
Problem definition and analysis
Analysis Tool : Cause & Effect Diagram
Effect

15. 15
Effect
Cause (Machine) Use for grouping ideas. Any grouping that make sense
can be used. The most common are:
Methods, Machines, Materials, People and
Environment
The Problem
1st why?
2nd why?
3rd why? 4th why?
5th why?
Cause (Method)

16. The problem statement is the difference
between what isis and what should beshould be
 Focus on
 Facts finding, not fault finding !
 whatwhat is wrong, not whywhy it’s wrong
16

17. Implement a solution to address the cause not
the symptom
 Lists corrective and preventive actions (if applicable)
 Clearly addresses root causes
 Commensurate with the risk of the issue
 Identification of task owners and task due dates
 Implementation due date
 CAPA Monitoring
 Keep records

19. Implementing a verified solution
Testing during formation of action plan
Validate
Tracking (where, how many, who)
Keep records

20. CAPA is useful if and only when the
implemented action plan is effective, so
before freezing the CAPA the effectiveness
of the implemented plan is measured.

21. Monitor performance indicators and
compare “before” and “after” by assigning
a particular time frame
Achieve specific targets - achieving a pre-
determined PPM level
Statistical Data Analysis-Performance
must lie within a set of statistically derived
control limits
Emphasis should primarily be on
identifying the most effective fix

22.  Recurring issues
 Resources ($$$) are spent on “handling” failure
rather than learning from it and preventing
“more of the same”
 Field issues
22

23.  What to do when a effectiveness check fails,
and what are the consequences?
 Close the CAPA and open a new one?
 Get an extension?
 Leave the CAPA open and investigate why?
23

24. 24
Was the
Problem
Statement
well defined?
Effectiveness Checks

25.  CAPA will be closed after measuring the
effectiveness set at the particular value.
 The effectiveness of CAPA with be discussed
with all personnel in team meetings
organized monthly.
25

26.  Reduction in quality issues
 A reduction in the severity of issues
 Better designed products/processes
 Improved customer satisfaction
 Better business results
26

27. “Your mistakes can be your
Stepping Stones
for Success if appropriate
actions are taken at proper time”
27

28. 28
​PRANEET SURTI​
Management Auditor l Quality Consultant
[​Lead Auditor ISO 9001:2015, ​B.E Mechanical Engineering​]
ANM Strategic & Management Consultants Pvt. Ltd.​
​Raipur, Chhattisgarh IND​
Cell : +91 8109773774 (Personal), +91 7024154549 (Official)
​Gmail: praneetsurti20@gmail.com
​LinkedIn: http://in.linkedin.com/in/praneetsurti​
Twitter: twitter.com/praneet20
About the Trainer