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.
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
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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
18.
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
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
Also known as Fishbone diagram or Ishikawa diagram
Example:
We discussed the problem of the PC board with unsoldered pins.
We could construct a cause and effects analysis in which the problem
stated is that 3 connector pins were unsoldered.
We can examine the methods: Repair, instructions, etc.
Machines: Connector insertion machine
Manpower: Repair person, inspectors
Materials: PC board, connector, etc.