1

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

2

Topics

Elements of an effective CAPA processData analysisGetting to probable causeCAPA timelinessEffectiveness checksLearning from experience

3

Elements of an Effective CAPA Process

Documented procedure(s)Defined CAPA inputsRisk assessment and prioritizationInvestigation disciplinesVerification / validationWell defined action planDisseminate information

Documentation rulesEffectiveness checksComplete? Effective? Timely

Defined criteria for Management ReviewManagement escalationMetrics - ability to monitor progress

4

CAPA Simplified

Define the Problem

Initiate CAPA

Investigate Cause

Solution(Action Plan)

Verify / Validate

ConductEffectiveness Check

Implement

Close CAPA

5

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

6

CAPA Data Analysis

Analyze Processes, Work OperationsConsider what is relevant to your business

Product complexityProcess complexity Risk associated with failure

Leverage Design Control to drive CAPAIntended use, essential outputsManufacturing process designIdentification of hazards, estimation of riskRisk control decisions

7

CAPA Data Analysis

Monitor data directly linked to decisions implemented to reduce (control) risk

Design FMEAProcess FMEAApplication FMEA

Hazards and risk mitigation implemented

8

Data Analysis

DesignProduct & Processes

ProductionProcess Controls

Incld. Supply Chain

Post-marketMonitoringComplaints

Define

Monitor

9

CAPA Data Analysis (cont.)

ConcessionsUse as is, deviations, temporary changes

Audit ResultsRecurring audit observations, internal audits and external audits

Quality RecordsEvidence of compliance to your quality systemInstallation, Distribution, Change Control,

Post Market dataFrequency and occurrence as expected?

Service RecordsComplaintsReturned Products

10

Risk & Prioritization

Establish a prioritization methodUse the method consistently across the quality management system

Complaint HandlingNonconforming ProductSupplier PerformanceChange ControlEnvironmental MonitoringProcess Controls ServicingAudits

11

Investigating Cause

Ultimate goal - determine WHY the problem occurredPhases of Investigation

Presumptive Cause apparent during early investigation, hypotheses that may explain the effect but needs validation

Contributing Causesecondary and possible causes

Root Causeprimary reason for the problem which if corrected will prevent recurrence

12

A clear problem statement will establish investigation boundariesThe problem statement is the difference between what isis and what should beshould be

Focus on facts – not emotionswhatwhat is wrong, not whywhy it’s wrong

Investigating Cause

13

Problem Definition

State the problem in measurable termshow 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

14

Plan the Investigation

Define method of investigation

Include quality tools usedIs/Is Not, Cause and Effect, 5 Why’s, etc.

DocumentDates of investigation Data reviewed (data sources, records, dates)Corrections or Containment measuresResults: Statement of Cause

Is / Is Not Diagram

WHAT

WHEN

WHERE

EXTENT

IS IS NOT

15

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

16

Effectiveness Checks

Effectiveness ChecksAvoid applying the same criteria to all CAPAs Plan the effectiveness check specific to the CAPAIdentify early detection points to monitor for recurrence/occurrence

17

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?

18

Was the Problem

Statement well defined?

Effectiveness Checks

19

Timeliness

Not all CAPAs are created equalCAPAs age for a reason

Utilize a risk based approach to monitor key steps in the process

InitiationInvestigationImplementationClosure

20

Timeliness

OpenCAPA

CloseCAPA

InvestigationVerification/ Validation

SolutionImplementation

- Major- Moderate- Minor

- Aging Investigations

- Implementation Overdue

- Failed Effectiveness Checks- Overdue Effectiveness Checks

Effectiveness Check

21

CAPA SystemEffectiveness

Learning from experience

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

Abbott Medical Products

22

A focus on execution

The challenges of implementing and sustaining an effective CAPA process

Many sources of Quality DataDissemination of informationConnecting the dotsDriving global actionsDemonstrating Effectiveness AND EfficiencyApplying Risk Management principles

23

What should management do?

Evaluate the CAPA system and ability to meet business needs and be in compliance

HOW ?

24

What should we expect over time ?

A reduction in quality issuesA reduction in the severity of issuesMore preventive actions over timeBetter designed products/processesImproved customer satisfactionBetter business results

25

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 issuesMore reaction than preventionResources ($$$) are spent on “handling”failure rather than learning from it and preventing “more of the same”Field issues

26

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/preventionTake global actionsDisseminate informationApply learningMeasure effectiveness Management review

Apply risk management

RecordsPeople

27

20071997/8

Learning/ ImplementationReactive

Refining/improving

Proactive

CAPA

RiskManagement

Human Factors

ManagementResponsibility

Regulatory requirements business requirements

TotalQS

Performance

DesignControls

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

28

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

ana g

e men

t

29

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 ……………….

30

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

31

More Complexity?

R&D OPS QAFunctions

Sites

DIV DIV DIV DIV DIV DIV

Headquarters

Now connect the dots ……………….

32

Some points to considerThe right people: training,qualifications, recognition, accountability, communicationIT system – can really help but is not the only answerBasic good quality and business practices –PDCA, DMAIC, ROI, etc. Has to work as a closed loop systemScale the system to fit the businessKeep it simple and straightforward !Continuous improvement is the goal

33

Thank-You !Questions? Thoughts? Ideas?

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

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