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Implementing an Effective CAPA Process

Sue JacobsPresidentQMS Consulting, Inc.Hoffman Estates, ILsue@QMSconsultant.com847.359.4456

Cecilia Kimberlin, PhDMedical Products Group VPAbbott LaboratoriesAbbott Park, ILcecilia.kimberlin@abbott.com847.937.7933

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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) Defined CAPA inputs Risk assessment and

prioritization Investigation disciplines Verification / validation Well defined action plan Disseminate information

Documentation rules Effectiveness checks

Complete? Effective? Timely Defined criteria for

Management Review Management escalation Metrics - ability to monitor

progress

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CAPA Simplified

Define the Problem

Initiate CAPA

Investigate Cause

Solution(Action Plan)

Verify / Validate

ConductEffectiveness Check

Implement

Close CAPA

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Evaluate InitiateCAPA

Complaints Quality Records Servicing

NonconformingProduct

Supply Chain

ProcessMonitoring

Audits Concessions(Deviations)

Threshold met?CAPA already exists?Isolated occurrence?Risk?Collect more data?

Can issue be resolved through: Containment?

Correction? Remediation?

CAPA Inputs

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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

DesignProduct & Processes

ProductionProcess Controls

Incld. Supply Chain

Post-marketMonitoringComplaints

Define

Monitor

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CAPA Data Analysis (cont.)

Concessions Use as is, deviations,

temporary changes

Audit Results Recurring audit

observations, internal audits and external audits

Quality Records Evidence of compliance

to your quality system Installation, Distribution,

Change Control,

Post Market data Frequency and

occurrence as expected? Service Records Complaints Returned Products

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Risk & Prioritization Establish a

prioritization method Use the method

consistently across the quality management system

Complaint Handling Nonconforming Product Supplier Performance Change Control Environmental

Monitoring Process Controls Servicing 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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A clear problem statement will establish investigation boundaries

The problem statement is the difference between what isis and what should beshould be Focus on

facts – not emotions whatwhat is wrong, not whywhy it’s wrong

Investigating Cause

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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 investigation 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

Is / Is Not Diagram

WHAT

WHEN

WHERE

EXTENT

IS IS NOT

EFFECT

PEOPLE MATERIAL

METHODS MEASUREMENT

MACHINE

ENVIRONMENT

Cause

Why

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Investigating Cause

Implement a solution to address the causecause … … not the not the symptomsymptom

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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Investigate CauseRe-assess Risk

Proposed Solution

Verify/Validate

Implement

EffectivenessCheck

NO

YES

Data Sourceindicates

problem stillexists.

DetermineAdditional

Action

NO

Action Plan Complete

?

?

Was the Problem

Statement well defined?

Effectiveness Checks

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Timeliness Not all CAPAs are

created equal CAPAs age for a

reason

Utilize a risk based approach to monitor key steps in the process Initiation Investigation Implementation Closure

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Timeliness

OpenCAPA

CloseCAPA

InvestigationVerification/ Validation

SolutionImplementation

- Major- Moderate- Minor

- Aging Investigations

- Implementation Overdue

- Failed Effectiveness Checks- Overdue Effectiveness Checks

Effectiveness Check

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CAPA SystemEffectiveness

Learning from experience

Cecilia Kimberlin, PhDGroup VP QA/RA/MA/Compliance

Abbott Medical Products

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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?

Detect

Analyze

Trend

Investigate

Identify Solutions

Communicate

Verify/Validate

Monitor Effectiveness

Inputs

Outputs

Many Sources of Quality Data•Internal•External Implement changes for

correction/prevention

Take global actions

Disseminate information

Apply learning

Measure effectiveness

Management review

Apply risk management

RecordsPeople

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20071997/8Learning/

Implementation Reactive

Refining/improvin

g Proactive

CAPA

RiskManagement

Human Factors

ManagementResponsibility

Regulatory requirements business requirements

TotalQS

Performance

DesignControls

How well have our systems evolved over the last 10 years?

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Design Control Products/Processes

Production & ProcessControls

Post-market monitoring

CAPA

CAPA

Now

Process monitoring

PREVENTIVE ACTIONS

CAPA

The CAPA System Quality Improvement

Corrective Actions

Corrections

MANAGEMENT CONTROLS

Ris

k M

anag

emen

t

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Business with low complexity

Functions

Sites

Medical Device Company

Fewer products, similar in type, fewer people, limited locations, etc.

Analysis & ACTION

•Products

•Parts

•Processes

•Performance

•Systems

Connect the dots ……………….

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ExternalData

InternalData

DesignControl, etc.

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

Inputs Into CAPA System

Evaluation

Correction Investigation

Cause

Corrective & Preventive Action

Effectiveness Check Trac

king

And

Tre

ndin

g

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More Complexity?

R&D OPS QAFunctions

Sites

DIV DIV DIV DIV DIV DIV

Headquarters

Now connect the dots ……………….

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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?

Sue JacobsQMS Consulting, Inc. 847 359 4456sue@qmsconsultant.com

Cecilia KimberlinAbbott Laboratories 847 937 7933cecilia.kimberlan@abbott.com