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Implementing an Effective CAPA Process. Sue Jacobs President QMS Consulting, Inc. Hoffman Estates, IL [email protected] 847.359.4456. Cecilia Kimberlin, PhD Medical Products Group VP Abbott Laboratories Abbott Park, IL [email protected] 847.937.7933. Topics.

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Implementing an effective capa process

Implementing an Effective CAPA Process

Sue Jacobs

President

QMS Consulting, Inc.

Hoffman Estates, IL

[email protected]

847.359.4456

  • Cecilia Kimberlin, PhD

    • Medical Products Group VP

    • Abbott Laboratories

    • Abbott Park, IL

    • [email protected]

    • 847.937.7933


Topics
Topics

  • Elements of an effective CAPA process

  • Data analysis

  • Getting to probable cause

  • CAPA timeliness

  • Effectiveness checks

  • Learning from experience


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 checksComplete? Effective? Timely

Defined criteria for Management Review

Management escalation

Metrics - ability to monitor progress

Elements of an Effective CAPA Process


Capa simplified
CAPA Simplified

Initiate CAPA

Verify / Validate

Define the Problem

Implement

Investigate Cause

Conduct

Effectiveness Check

Solution

(Action Plan)

Close CAPA


Capa inputs

Complaints

Quality

Records

Servicing

Nonconforming

Product

Supply Chain

Process

Monitoring

Audits

Concessions(Deviations)

CAPA Inputs

Threshold met?

CAPA already exists?

Isolated occurrence?

Risk?

Collect more data?

Can issue be resolved through:

Containment?

Correction?

Remediation?

Evaluate

Initiate

CAPA


Capa data analysis
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


Capa data analysis1
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


Data analysis
Data Analysis

Monitor

Design

Product & Processes

Production

Process Controls

Incld. Supply Chain

Post-market

Monitoring

Complaints

Define


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

CAPA Data Analysis (cont.)


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

Risk & Prioritization


Investigating cause
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


Investigating cause1
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


Problem definition
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


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

WHAT

WHEN

WHERE

EXTENT

Is / Is Not Diagram

Plan the Investigation


Investigating cause2

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

Investigating Cause


Effectiveness checks
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


Effectiveness checks1
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?


Effectiveness Checks

Was the Problem Statement well defined?


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

Timeliness


Timeliness1

- Major

- Moderate

- Minor

- Implementation Overdue

Solution

Verification/ Validation

- Aging Investigations

- Failed Effectiveness Checks

- Overdue Effectiveness Checks

Timeliness

Open

CAPA

Close

CAPA

Investigation

Implementation

Effectiveness Check


Capa system effectiveness learning from experience

CAPA SystemEffectiveness Learning from experience

Cecilia Kimberlin, PhD

Group VP QA/RA/MA/Compliance

Abbott Medical Products


A focus on execution
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


What should management do
What should management do?

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

HOW ?


What should we expect over time
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


What are the symptoms of a less than effective capa system
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


What s so hard about the capa process
What’s so hard about the CAPA Process?

Inputs

Detect

Analyze

Trend

Investigate

Identify Solutions

Communicate

Verify/Validate

Monitor Effectiveness

  • Many Sources of Quality Data

  • Internal

  • External

Outputs

Implement changes for correction/prevention

Take global actions

Disseminate information

Apply learning

Measure effectiveness

Management review

Apply risk

management

People

Records


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

Risk

Management

Total

QS

Performance

Design

Controls

CAPA

Human

Factors

Management

Responsibility

2007

1997/8

Refining/improving

Learning/ Implementation

Reactive

Proactive

Regulatory requirements business requirements


Design Control Products/Processes

Post-market monitoring

The CAPA System Quality Improvement

CorrectiveActions

PREVENTIVE ACTIONS

Corrections

CAPA

Production &

Process

Controls

Risk Management

CAPA

Now

CAPA

Process monitoring

MANAGEMENT CONTROLS


Business with low complexity
Business with low complexity

  • Analysis & ACTION

  • Products

  • Parts

  • Processes

  • Performance

  • Systems

Medical Device Company

Sites

Functions

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

Connect the dots ……………….


  • Oversight

  • Management Review

  • Analysis

  • Take action

  • Assure effectiveness

Internal

Data

External

Data

Inputs Into CAPA System

Evaluation

Design

Control, etc.

Correction

Investigation

Cause

Tracking And Trending

Corrective & Preventive Action

Effectiveness Check


More complexity
More Complexity?

Headquarters

DIV

DIV

DIV

DIV

DIV

DIV

Sites

R&D

OPS

QA

Functions

Now connect the dots ……………….


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


Thank you questions thoughts ideas
Thank-You !Questions? Thoughts? Ideas?

Sue Jacobs

QMS Consulting, Inc.

847 359 4456

[email protected]

Cecilia Kimberlin

Abbott Laboratories

847 937 7933

[email protected]


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