Corrective and preventive action

CORRECTIVE AND
PREVENTIVE ACTION
(CAPA)
CORRECTIVE AND PREVENTATIVE
ACTION (CAPA)
PRESENTED BY MS. SNEHA S. GHADIGAONKAR
M.PHARM
(PHARMACEUTICAL QUAILITY ASSURANCE)

Corrective and Preventative Action (CAPA) is a system of
quality procedures required to eliminate the causes of an
existing nonconformity and to prevent recurrence of
nonconforming product, processes, and other quality
problems.
The ultimate purpose of CAPA is to assure the problem can never be experienced
again. CAPA can be applied in many disciplines. A few of these disciplines are:
 Manufacturing
 Product Design
 Testing Verification and Validation
 Distribution, Shipping, Transport and
Packaging
 Use-Applications
INTRODUCTION TO CAPA

Nonconforming Material or Process (Discrepancy) - Any
material or process that does not meet its required
specifications or documented procedure.
 Correction – Refers to repair, rework, or adjustment and
relates to the disposition of an existing nonconformity.
Corrective Action - To identify and eliminate the causes of
existing nonconforming product and other quality problems.
 Preventive Action - To identify and eliminate the causes of
potential nonconforming product and other quality
problems.
TERMINOLOGY

 Corrective Action is an extension of Root Cause Analysis (RCA).
 The first goal of CA is to find the root cause, base event or error that preceded
the problem.
 second goal is to take action directed at the root cause or error.
COMPONENTS OF CORRECTIVE ACTION
 Collect and analyze data to identify nonconforming product, incidents, concerns
or other quality problems that would be worth the effort to correct
 Investigate and identify root cause
 Implement the correct solution
 Verify or validate effectiveness
CORRECTIVE ACTION

 Preventive action includes the prediction of problems and attempts to avoid such
occurrences (fail safe) through self-initiated actions and analysis related to the
processes/products.
 This can be initiated with the help of :
 an active participation by staff members/workers through improvement teams,
 Improvement meetings,
 opportunities for improvement during internal audits, management review,
 customer feedback and
 deciding own goals quantized in terms of business growth,
 reducing rejections,
 utilizing the equipment effectively, etc.
 The primary goal of PA is to inform an organization and prevent the problem from
returning in other facilities lines or products.
PREVENTIVE ACTION

THE 10 OBJECTIVES OF CAPA IMPLEMENTATION ARE:
 Verification of a CAPA system procedure(s) that addresses the requirements of the quality
system regulation. It must be defined and documented.
 Evidence that appropriate sources of product and quality problems have been identified.
 Tracking of Trends (which are unfavorable) are identified.
 Data sources for Corrective and Preventive Action are of appropriate quality and content.
 Verify that appropriate Statistical Process Control (SPC) methods are used to detect
recurring quality problems.
 Verify the RCA work performed is aligned to the level of Risk the problem has been
identified with.
 Actions address the root cause and preventive opportunities.
 CAPA process actions are effective and verified or validated prior to implementation.
 Corrective and preventive actions for product and quality problems are implemented and
documented.
 Nonconforming product, quality problems and corrective / preventive actions have been
properly shared and included in management review.
WHY IMPLEMENT CAPA?

Corrective and preventive action

 ROOT CAUSE AND THE “WEED” : Weeds can be difficult
to remove once they start to grow and spread. On the
surface, the weed is easy to see.
 However, the underlying cause of the weed, its root, lies
below the surface and is not so obvious.
 To eradicate the weed you have to get below the surface,
identify the root, and pluck it out.
 Thus, you have to go beyond the obvious, ascertain an
accurate route cause, so the appropriate corrective action
can be pursued to prevent recurrence.
ASCERTAINING
ROOT CAUSE

 THE FIVE WHYS, a simplistic approach exhausting the question “Why?”.
 FISHBONE DIAGRAM, a cause and effect diagram also known as the
Ishikawa diagram.
 PARETO ANALYSIS, the 80/20 rule premised on a predefined database of
known problems.
 FAULT TREE ANALYSIS, a quantitative diagram used to identify possible
system failures.
 FAILURE MODES AND EFFECTS ANALYSIS (FMEA), which lists all
potential failure modes and the potential consequences associated with
each failure mode.
TOOLS FOR INVESTIGATING
ROOT CAUSE

 The 5 Whys technique is a simpler form of fault tree analysis for
investigations, especially investigations of specific accidents as
opposed to chronic problems.
 The 5 Whys technique is a brainstorming technique that identifies
root causes of accidents by asking why events occurred or
conditions existed.
 The 5 Whys process involves selecting one event associated
with an accident and asking why this event occurred. This
produces the most direct cause of the event.
 Drill down further indicating if their were any sub-causes of the
event, and ask why they occurred.
 Repeat the process for the other events associated with the
accident.
THE 5 WHYS

 DISADVANTAGES
This time consuming brainstorming process may be
tedious for team members trying to reach
consensus. This is especially true for large teams.
Results are not reproducible or consistent. Another
team analyzing the same issue may reach a
different solution. The particular brainstorming
process that was utilized may be difficult, if not
impossible, to duplicate.
The 5 Whys technique does not provide a means to
ensure that root causes have been identified.

 A fishbone diagram is a cause and effect diagram that looks much like a
skeleton of a fish. It is also called a Ishikawa diagram after the inventor
of the tool, Kaoru Ishikawa who first used the technique in the 1960s.
 To draw the diagram, first list the problem/issue to be studied in the head
of the fish. Label each bone of the fish.
 The major categories typically used are: The 6 M’s: Machines, Methods,
Materials, Measurements, Mother Nature (Environment), Manpower
(People).
 Repeat this procedure with each factor under the category to produce
sub-factors. Continue asking, “Why is this happening?” and put
additional segments under each sub-factor.
A FISHBONE DIAGRAM
(ISHIKAWA DIAGRAM)

 Continue adding sub-factors to your diagram until you no longer get
useful information as you ask, “Why is that happening?” . Analyze the
results of the fishbone after team members agree that an adequate
amount of detail has been provided under each major category.
 Do this by looking for those items that appear in more than one category.
These become the ‘most likely causes”. For those items identified as the
“most likely causes”, the team should reach consensus on listing those
items in priority order with the first item being the most probable” cause.

ADVANTAGES
organize potential causes
help a team to think through causes they might otherwise
miss
provide a living document that shows the status of all
potential causes and whether they have been
proved/disproved/acted upon.
DISADVANTAGES
One danger with fishbone diagrams is that they create a
divergent approach to problem solving, where the team
expends a great deal of energy speculating about potential
causes, many of which have no significant effect on the
problem.
This approach may leave a team feeling frustrated and
hopeless.

 The Pareto chart is a bar graph whose invention is attributed
to the Italy economist, Mr. Vilfredo Pareto.
 Pareto principle – that for many phenomena, 80% of
consequences stem from 20% of the causes.
 In the Pareto chart, the lengths of the bars represent
frequency or cost (time or money), and are arranged with
longest bars on the left and the shortest to the right. In this
way the chart visually depicts which situations are more
significant (a Pareto analysis).
THE PARETO CHART

ADVANTAGES
Easy to understand as well as to present.
Many managers prefer to see an analysis that is easy to
represent and understand and a Pareto chart is strong tool
for that.
DISADVANTAGES
Focusing on the Pareto chart alone may lead to the
exclusion from further consideration of minor sources driving
defects and non-conformances.
They cannot be used to calculate the average of the data, its
variability or changes in the measured attribute over time.
Without quantitative data it isn't possible to mathematically
test the values or to determine whether or not a process can
stay within a specification limit.

 Fault tree analysis was first introduced by Bell Laboratories and is
one of the most widely used methods in system reliability,
maintainability and safety analysis.
 It is a deductive procedure used to determine the various
combinations of hardware and software failures and human errors
that could cause undesired events (referred to as top events) at
the system level.
 The deductive analysis begins with a general conclusion, then
attempts to determine the specific causes of the conclusion by
constructing a logic diagram called a fault tree. This is also known
as taking a top-down approach.
 The main purpose of the fault tree analysis is to help identify
potential causes of system failures before the failures actually
occur. It can also be used to evaluate the probability of the top
event using analytical or statistical methods.
FAULT TREE ANALYSIS
(FTA)

 Define the fault condition, and write down the top level failure.
 Using technical information and professional judgments,
determine the possible reasons for the failure to occur. These are
level two elements because they fall just below the top level
failure in the tree.
 Continue to break down each element with additional gates to
lower levels. Consider the relationships between the elements to
help you decide whether to use an "and" or an "or" logic gate.
 Finalize and review the complete diagram. The chain can only be
terminated in a basic fault: human, hardware or software.
 If possible, evaluate the probability of occurrence for each of the
lowest level elements and calculate the statistical probabilities
STEPS IN FTA

ADVANTAGES
FTA focuses on the judgment of experts from varied
disciplines and provides a common language and
perspective for the problem.
Both agreements and differences in opinion on the inputs
and importance are accounted for in FTA.
Members are not likely to feel threatened, due to the focus
on how the system operates, not personnel.
 Graphic description clearly communicates the possible
causes of failure.
DISADVANTAGES
FTA relies on several expert opinions and judgments at
several stages. This makes it very prone to inaccuracy.
In large systems, computer algorithms are needed to
accomplish the quantitative analysis.

 FMEA is a step-by-step approach for identifying all possible
failures:
 in a design (“design FMEA”),
 in a manufacturing or assembly process (“process FMEA”),
 in a final product or service (“use FMEA”).
 “Failures” are any errors or defects, especially ones that affect the
customer, and can be potential or actual.
 “Failure modes” means the ways, or modes, in which something
might fail.
 “Effects analysis” refers to studying the consequences, or effects,
of those failures.
FAILURE MODES AND
EFFECTS ANALYSIS (FMEA)

 Failure can be represented by a Risk Priority Number
(RPN).
 Risk Priority Numbers (RPN’s), can be ranked according to
the following: RPN = (Potential Severity) x (Likelihood of
Occurrence) x (Ability to Detect).
 For all numerical weights, a common industry standard is to
us a 1 to 5 scale. For likelihood of occurrence for example
use 1 to represent “practically impossible” and 5 to indicate
“occurs frequently.”
 When applying FMEA, the high-priority failures—identified
by higher RPN’s—are examined first.
 For the failure, a root cause is identified and a corrective
action is developed to eliminate the root cause .

RECOMMENDED ACTIONS TO ADDRESS POTENTIAL
FAILURES THAT HAVE A HIGH RPN COULD INCLUDE:
specific inspection
testing or quality procedures
selection of different components or materials
limiting the operating range or environmental stresses
redesign of the item to avoid the failure mode; -monitoring
mechanisms
performing preventative maintenance
operator retraining
inclusion of back-up systems or redundancy.
Assign responsibility and a target completion date for the
above actions. This makes responsibility clear-cut and
facilitates tracking.

ADVANTAGES
 Stimulates open communication of potential failures and their
outcomes.
 Requires that all known or suspected potential failures be
considered.
 Ranks failures according to risk.
 Results in actions to reduce failure.
 Results in actions to reduce risk.
 Includes a follow up system and re-evaluation of potential failures
that favors continual improvement.
DISADVANTAGES
 FMEA may not be able to discover complex failure modes
involving multiple failures or subsystems.
 Without follow up sessions, the process will not be effective.
 Follow up RPNs may be less instructive regarding improvement
from severe failure since detection and occurrence can always be
reduced but it is only in rare cases that severity ratings can be
reduced.

Corrective and preventive action

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