Implementing an

Effective CAPA Process

Sandeep Jangra, M.Tech. Aashish Arya, PhD

Management Representative CEO JBM Group
JBM Group aashish.arya@jbmauto.co.net
sandeep.mr@jbmauto.co.net 981.137.7933
836.802.4342

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Topics

 Elements of an effective CAPA process

 Data analysis
 Getting to probable cause
 CAPA timeliness
 Effectiveness checks
 Learning from experience

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Elements of an Effective
CAPA Process
 Documented procedure(s)  Documentation rules
 Defined CAPA inputs  Effectiveness checks
Complete? Effective? Timely
 Risk assessment and
prioritization  Defined criteria for
 Investigation disciplines Management Review
 Management escalation
 Verification / validation
 Metrics - ability to monitor
 Well defined action plan
progress
 Disseminate information

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CAPA Simplified

Initiate CAPA Verify / Validate

Define the Problem Implement

Conduct
Investigate Cause
Effectiveness Check

Solution Close CAPA

(Action Plan)

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CAPA Inputs
Quality
Complaints Servicing
Records

Nonconforming Supply Process

Product Chain Monitoring

Concessions
Audits
(Deviations)

Threshold met?
CAPA already exists?
Isolated occurrence?
Risk?
Collect more data?
Initiate
Can issue be resolved through: Evaluate
Containment?
Correction?
CAPA
Remediation?

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CAPA Data Analysis
 Analyze Processes, Work Operations
 Consider what is relevant to your business
 Product complexity
 Process complexity
 Risk associated with failure
 Leverage Design Control to drive CAPA
 Intended use, essential outputs
 Manufacturing process design
 Identification of hazards, estimation of risk
 Risk control decisions

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CAPA Data Analysis

 Monitor data directly linked to

decisions implemented to reduce
(control) risk
 Design FMEA
 Process FMEA
 Application FMEA
 Hazards and risk mitigation implemented

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Data Analysis Monitor

Design Production Post-market

Product & Process Controls Monitoring
Processes Incld. Supply Chain Complaints

Define
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CAPA Data Analysis (cont.)

 Concessions  Quality Records

 Use as is, deviations,  Evidence of compliance
temporary changes to your quality system
 Installation, Distribution,
 Audit Results
Change Control,
 Recurring audit
observations, internal  Post Market data
audits and external  Frequency and
audits occurrence as expected?
 Service Records
 Complaints
 Returned Products

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 Risk & Prioritization
 Establish a  Complaint Handling
 Nonconforming Product
prioritization method
 Supplier Performance
 Use the method  Change Control
consistently across  Environmental
the quality Monitoring
 Process Controls
management
 Servicing
system  Audits

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Investigating Cause
 Ultimate goal - determine WHY the problem
occurred
 Phases of Investigation
 Presumptive Cause
 apparent during early investigation, hypotheses that may
explain the effect but needs validation
 Contributing Cause
 secondary and possible causes
 Root Cause
 primary reason for the problem which if corrected will
prevent recurrence

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Investigating Cause

 A clear problem statement will establish

investigation boundaries
 The problem statement is the difference
between what is and what should be
 Focus on
 facts – not emotions
 what is wrong, not why it’s wrong

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Problem Definition
 State the problem in measurable terms
 how often, how much, when, and where
 Emphasize the effects (risk)
 safety, death, injury, rework, cost, etc.
 Avoid
 negative descriptors, inflammatory statements
 words that are broad and do not describe the
conditions or behavior such as careless,
complacency, neglect, oversight

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Plan the Investigation

 Define method of  Document

investigation  Dates of investigation
 Include quality tools used  Data reviewed (data
 Is/Is Not, sources, records, dates)
 Cause and Effect,  Corrections or Containment
measures
 5 Why’s, etc.
 Results: Statement of
IS
IS Cause
NOT
WHAT PEOPLE MATERIAL MACHINE

Cause
WHEN
Why

WHERE
EFFECT
EXTENT

Is / Is Not Diagram

ENVIRONMENT METHODS MEASUREMENT

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Investigating Cause

 Implement a solution to
address the cause … not the
symptom
 Implementation of a
solution that does not
address the cause of the
problem is costly

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Effectiveness Checks
 Effectiveness Checks
 Avoid applying the same criteria to all
CAPAs
 Plan the effectiveness check specific to the
CAPA
 Identify early detection points to monitor for
recurrence/occurrence

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Effectiveness Checks
 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?

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 Effectiveness Checks
Investigate Cause
Re-assess Risk
Was the
Problem
Statement well
defined?
Proposed Solution

NO

Data Source
indicates
problem still
exists.
? Verify/Validate
Determine
Additional
Action
YES

Implement

? Action Plan Complete

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NO
Timeliness
 Not all CAPAs are  Utilize a risk based
created equal approach to monitor
 CAPAs age for a key steps in the
reason process
 Initiation
 Investigation
 Implementation
 Closure

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Timeliness
- Major
- Moderate
- Minor - Implementation Overdue

Open Investigation
Solution
Effectiveness Close
Implementation
CAPA Verification/ Check
CAPA
Validation

- Aging Investigations - Failed Effectiveness Checks

- Overdue Effectiveness Checks

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 CAPA System
Effectiveness
Learning from experience

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A focus on execution
 The challenges of implementing and
sustaining an effective CAPA process
 Many sources of Quality Data
 Dissemination of information
 Connecting the dots
 Driving global actions
 Demonstrating Effectiveness AND Efficiency
 Applying Risk Management principles

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What should management do?

 Evaluate the CAPA system and

ability to meet business needs and
be in compliance

HOW ?

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What should we expect
over time ?
 A reduction in quality issues
 A reduction in the severity of issues
 More preventive actions over time
 Better designed products/processes
 Improved customer satisfaction
 Better business results

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What are the symptoms of
a less than effective CAPA
system?
 Recurring issues
 Inability to “manage” the many sources of
quality data to understand early trends and
issues
 More reaction than prevention
 Resources ($$$) are spent on “handling”
failure rather than learning from it and
preventing “more of the same”
 Field issues
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 What’s so hard about the CAPA
Process?

Inputs Detect
Many Sources of Analyze
Quality Data
•Internal Trend Outputs
•External Investigate Implement changes for
correction/prevention
Identify Solutions
Apply risk Take global actions
management Communicate Disseminate information
Verify/Validate Apply learning
People Measure effectiveness Records
Monitor Effectiveness
Management review

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How well have our systems
evolved over the last 10 years?
Risk
Design Management Total
Controls QS
Human
Factors Performance
CAPA
Management
1997/8 Responsibility 2007
Refining/improving
Learning/ Implementation
Reactive Proactive

Regulatory requirements business requirements

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The CAPA System Quality Improvement

Corrective Actions
PREVENTIVE ACTIONS

Corrections

Design Control Production &

Process Post-market
Products/Processes
Controls monitoring
Process
monitoring

MANAGEMENT CONTROLS 28
 Business with
low complexity
Medical Device Company Analysis &
ACTION
•Products
•Parts
Sites •Processes
•Performance
Functions
•Systems

Fewer products, similar in type, fewer people,

limited locations, etc.

Connect the dots ………………. 29

 •Oversight
•Management Review
•Analysis
•Take action
•Assure effectiveness

Internal External
Data Data

Inputs Into CAPA System

Evaluation

Tracking And Trending

Correction Investigation Design
Control, etc.
Cause

Corrective & Preventive Action

Effectiveness Check
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 More Complexity?
Headquarters

DIV DIV DIV DIV DIV DIV

Sites

Functions R&D OPS QA

Now connect the dots ………………. 31

Some points to consider
 The right people: training,qualifications,
recognition, accountability, communication
 IT system – can really help but is not the only
answer
 Basic good quality and business practices –
PDCA, DMAIC, ROI, etc.
 Has to work as a closed loop system
 Scale the system to fit the business
 Keep it simple and straightforward !
 Continuous improvement is the goal

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 Thank-You !
Questions? Thoughts? Ideas?
Aashish Arya, PhD
CEO JBM Group
aashish.arya@jbmauto.co.net
981.137.7933

Sandeep Jangra, M.Tech.

Management Representative
JBM Group
sandeep.mr@jbmauto.co.net
836.802.4342

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