C A PA

CORRECTIVE ACTION
&
PREVENTIVE ACTION
INTRODUCTION
• What is CAPA

• CAPA workflow

• CAPA tools
WHAT IS CAPA?
• “CAPA is a quality assurance system, which
addresses quality events, which may occur or
could be anticipated to occur during healthcare
manufacturing products
• Activities not intended to correct defects, but to
eliminate the root cause of those defects.
REALITY CHECK...
How can we see into the future and fix problems that
have not yet occurred?
• Corrective - fix past problems
• Preventive - predict potential problems
WHAT IS CAPA?
CORRECTION, CORRECTIVE ACTION
AND PREVENTIVE ACTION

Action to eliminate a detected

non-conformity. Corrections
Correction typically are one-time fixes. A
correction is an immediate
solution such as repair or rework
Issue

Investigation Corrective action Preventive

action
 CORRECTIVE OR PREVENTIVE
Name it corrective action only if you already • Product failing specifications
have a product non-conformance or process
• Confirmed customer complaint
non-compliance
• Use of obsolete documents
• Audit finding
Name it preventive action whenever the Developing adverse trends from
product, process or system is still in monitoring systems
conformance but you discover root cause with o Shifts
the potential to create non- conformities
o Trends
o High Variability, and so on
Name it preventive action if it is purely a • Changing to new material or new
recommendation to enhance or improve design
any product, process or system
• Implement new (enhanced) processes
QUALITY SYSTEMS CENTRE - CAPA
Deviations

Regulatory
inspection Stability

Supplier Environmental
audits monitoring
CAPA

Continuous
Complaints product
verification

Customer Internal
Audit Audit
WHY CAPA
• As per EN ISO 13485:2012
• 8.5.2 Corrective Action – Corrective actions shall be appropriate to the
effects of the nonconformities encountered. A documented procedure
shall be established to define requirements for
a) reviewing nonconformities (including customer complaints)
b) determining the cause of nonconformities
c) evaluating the need for action to ensure that nonconformities do not
recur
d) determining and implementing action needed, including, if appropriate,
updating documentation
e) recording of the results of any investigation and of action taken, and
f) reviewing the corrective action taken and its effectiveness
WHY CAPA
As per EN ISO 13485:2012
8.5.3 Preventive action – The organization shall determine action to eliminate the
causes of potential nonconformities in order to prevent their occurrence.
Preventive actions shall be appropriate to the effects of the potential problems.
• It is also determine potential nonconformities and their causes
a) evaluating the need for action to prevent occurrence of nonconformities
b) determining and implementing action needed
c) recording of the results of any investigations and of action taken, and
d) reviewing preventive action taken and its effectiveness
CAPA PROCESS WORK FLOW
• Define the nonconformity
• Correct the immediate problem
• Investigate
• Identify the initiating cause (Root Cause )
• Assess the significance and risk
• Identify appropriate corrective action
• Implement and monitor for reoccurrence

Identify
Define Assess the Assess Monitor for
the root significance recurrence
the NC the risk
cause
DEFINE THE NONCONFORMITY
• Document the event
– Concise
– Only the facts
– Don’t point fingers
• Communicate and Assign Responsibility
– Supervisor
– Quality Assurance
– Management
IMMEDIATE CORRECTION OF PROBLEM

• The immediate correction may include;

– performing rework.
– contacting the client.
– issuing a corrected report.
INVESTIGATE
• Use available documentary evidence
– Maintenance logs
– Control charts
– Customer complaint logs
– Performance test results
– Training logs
– Corrective action logs
– Test Reports
– Etc…
IDENTIFY THE ROOT CAUSE
• Investigate
– Use available documentary evidence
– Interview
• Involve the appropriate individuals
• Use available root cause tools
ROOT CAUSE ANALYSIS TOOLS

TOOLS WILL BE EXPLAINED IN UPCOMING SLIDES

INVESTIGATE
• Interview
– Don’t be a cop
– No personal agenda
– Be friendly
– Explain the process
– Listen
EXAMINE THE EVIDENCE

• Understand how the process is intended to work.

• Evaluate all evidence for nonconformance.
• Involve individuals independent from the process if possible.
HOW TO CONDUCT CAPA
1. Information collection
2. Analysis of information
3. Development of improved methods
4. Implementation of improved methods
5. Follow-up
WHAT INFORMATION SHOULD BE ANALYZED

• Roundup the usual suspects…

• design review reports
• test reports
• project progress reports
• customer complaint records
• change requests and maintenance reports
• training follow-up reports
• But don't forget…
• special reports on quality / quality audits
• suggestions / observations by staff
CAPA OUTCOMES
• updating relevant procedures
• updating relevant work procedures
• changing tools
• improvement of reporting methods
• report contents
• report frequency
• changes in training
• probably, several of the above
TOOLS
• Cause Analysis
– 5 Whys
– Fishbone Diagram
– Fault Tree Analysis
• Risk Assessment
– Pareto analysis (80/20 rule)
– Failure mode and effects analysis (FMEA)
5 WHYS ANALYSIS
Cause and effect analysis
5 WHY ANALYSIS USING STANDARD
CHECKLIST
• 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?
EXAMPLE
• 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
FISHBONE OR ISHIKAWA OR CAUSE-
AND-EFFECT DIAGRAMS
• The system failure is described in a box to the right of the diagram.
• Add Bones
– Categories (4 M’s)
• Man Power (Personnel)
• Machines (Equipment)
• Materials (Reagents and Supplies)
• Methods
– Primary Causes
– Secondary Causes
FAULT TREE ANALYSIS

• Tool used to identify the key activity streams that may have led to the problem
being displayed.
• Top down analysis.
• Start with the system failure and work down to the root cause.
• Uses common logic symbols.
 Effect

Occurrence
Or gate

condition
And gate

cause
PARETO ANALYSIS
• When you have a large number of nonconformities, you should
categorize those problems and organize them into a Pareto Chart.
• The Pareto Analysis is used to organize a large number of nonconformities and
prioritize the quality problems based upon frequency of occurrence.
• The Pareto Chart presents each problem in descending order from the highest
frequency to the lowest frequency.
• Then open CAPA for major 2 quality problems, that will solve most of the non
conformances
• Pareto Principle - 80% of the problems are produced by 20% of the possible causes.
• 80% of the customer complaints arise from 20% of our services.
PARETO ANALYSIS
Customer Complaints (Pareto Analysis)

• To create a Pareto chart, you will list potential causes in a bar graph across the bottom - from
the most important cause on the left to the least important cause on the right. Then, you will
track the cumulative percentage in a line graph to the top of the table. The causes reflected on
the table should account for at least eighty percent of those involved in the problem.
FAILURE MODE AND EFFECTS ANALYSIS - (FMEA)
• The failure mode and effects analysis (FMEA) is a technique aimed to find
various modes for failure within a system. Many manufacturing companies
utilize this technique.
• FMEA requires several steps to execute:
1. All failure modes (the way in which an observed failure occurs) must be determined.
2. How many times does a cause of failure occur and what is its impact?
3. What actions are implemented to prevent this cause from occurring again?
4. Are the actions effective and efficient?
• FMEA is often performed and updated any time a new product or process is
generated, when changes are made to current conditions, or to the design, when
new regulations occur, or when there is a problem determined through customer
feedback.
FMEA
• Widely used as Medical Device Risk Analysis tool in Risk management
Programme
• Evaluate each of the possible system failures utilizing the following.
• Severity of Failure (Rank 1 – 5) (As per our risk management plan)
• Probability of Reoccurrence (Rank 1 – 5) (As per our risk management plan)

• (Severity) x (Probability) = Risk Priority Number

FMEA – FAILURE MODE EFFECT ANALYSIS
FAILURE MODE AND EFFECTS ANALYSIS
(FMEA)
Risk priority
Failure Mode Effect Severity Probability
Number (RPN)
Channel Insufficient seal Product loose sterility
creation in temperature 3 2 6
the seal
Insufficient Drug coating Intended use of the
3 3 9
drug release uneven product is not achieved
AFTER USING TOOLS
• Check the effectiveness of corrective action by PDCA
CAPA: PDCA
• PLAN
– Establish the objectives and processes necessary to deliver results in
accordance with the specifications.
• DO
– Implement the processes.
• CHECK
– Monitor and evaluate the processes and results against objectives and
specifications and report the outcome.
• ACT
– Apply actions to the outcome for necessary improvement. This means
reviewing all steps (Plan, Do, Check, Act) and modifying the process to
improve it before its next implementation.
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
PRACTICE
• Different balloon issued for NeoHexa other than defined as per Design File
• Employee are not aware of their own and related procedures
• Distal Shaft press during crimping machine
• Stent break during Electropolishing process
• Drug release profile is not achieved during the HPLC testing
• There is a labelling error in two lot sizes that are submitted to store.
COMMON MISTAKES
Lack of timeliness

Root cause not properly identified, or identified but not corrected

Lack of interim Corrective actions

Lack of effectiveness verification

Abuse of Human error and retraining

Correcting symptom instead of cause

Lack of true preventive action

ROOT CAUSE ANALYSIS TIPS

• 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
ANY QUESTIONS?.....