7 Habits of Highly Effective Programs

Valarie King-Bailey, M.B.A.VP Sales & MarketingApril 7, 2011

CAPA Challenges & Opportunities

Establishing An Effective CAPA Program Framework

7 Habits of Highly Effective CAPA Systems

Summary

Does Your CAPA Program Include Risk Assessment?

Yes

No

Why CAPA?

Regulatory RequirementsBoth FDA And ISO Require An Active CAPA Program As An Essential Element Of A Quality System.

Customer SatisfactionThe Ability To Correct Existing Problems Or Implement Controls To Prevent Potential Problems Is Essential For Continued Customer Satisfaction

Good Business PracticeQuality Problems Can Have A Significant Financial Impact On A Company.

Effective Management Of Problems, Events, Resources, And Time

Prioritization Of Problems According To Degree Of Severity And Risk

Defines Process, Test Methods, And/Or Product Improvements

“FDA investigators cited problems with corrective and preventive action (CAPA) systems in 88% of the Warning Letters issued to medical device firms last year, according to FDA quality system expert Jan Welch .”

Jan Welch

“It only makes sense that CAPA system compliance issues show up in almost every Warning Letter, because each time we inspect a firm now, we look to see that a CAPA system is in place and operating effectively, Welch told AAMI News.”

Jan Welch

Compliance-Focused OrganizationTop-Down Compliance LeadershipCollaborationCompliance Process ControlEffective Management ControlsContinuous ImprovementActionable Compliance IntelligenceDedication To Quality

“Though the vast majority of firms we inspect have effective CAPA systems in place, a few companies actually have no system set up at all. Others may have just a small, specific problem such as lack of documentation for a procedure,” Welch

says.”

“Firms need to have a mindset that appreciates the importance of having an operational CAPA procedure in place. This isn’t just a regulatory issue, this is a business issue.”

Jan Welch

20%

50%

30%

Records

CAPA

PAPC

Top 10 FDA 483 Items

Typical Causes Of Failed CAPA Programs Include Inadequate “Buy-in” From Key Stakeholders:

Over-ambitious Custom CAPA System Development

Insufficient Labor Resources Or Delegation Of ResponsibilityPoor Communication

Faulty Or Missing ProceduresLack Of Closed Loop System

Failure To Enforce ProceduresSystem Or Equipment Malfunction Due To Lack Of Monitoring Or Maintenance

Inadequate Training

Inadequate Compliance Awareness

Correct (“Correction”) Nonconforming Product And Other Quality Problems

Prevent Recurrence (“Corrective Action”) Of Nonconforming Product And Other Quality Problems

Eliminate The Cause Of Potential (“Preventive Action”) Nonconforming Product And Other Quality Problems

Action Taken To Eliminate The Causes Of An

Existing Non-conformity, Defect Or Other

Undesirable Situation In Order To Prevent

Recurrence.

[ISO 8402]

Action Taken To Eliminate The Cause Of A

Potential Non-conformity, Defect, Or Other

Undesirable Situation In Order To Prevent

Occurrence

[ISO 8402]

Preventive

Action

CA Review

CA Review

Corrective

ActionInvestigateSubmit

Export

.HTML

.TXT

Report

Design Controls

MaterialControls

Records,Documents, &

Change Controls

Equipment & Facility Controls

ElectronicSubmissions

Corrective &Preventive

Actions

Management

Controls

Source: Quality System Inspection Techniques, U.S. FDA

Provides Clear Guidance To Help:

Manage Problems, Events, Resources And Time

Prioritize Issues/Problems

Manage Product/Process Design

Important DefinitionsRisk – Combination Of The Probability Of Harm And The Severity Of That Harm

Severity – The Degree Of Patient Harm Or The Loss Of Efficacy Caused By Failure

Probability Of Harm – The Probability Of Physical Injury Or Damage

Degree Of Remedial Action Taken Must Be Appropriate And Commensurate With The Risks.

Risk Assessment Is An Important Element of A CAPA Program

Top Level Risk ManagementProvide Guidance Regarding The Risk Management Lifecycle

Quality System Risk AnalysisHelps Identify The Impact Of An Event Prior To Investigation

Implementation Of Corrective And Preventive Actions

Completion Of Effectiveness Checks

ID Existing Problems (Corrective Actions)

Quality Data Sources Are Identified

Data From Sources Are Analyzed

ID Potential Problems (Preventive Actions)

Quality Data Sources Are Identified

Data From Sources Are Analyzed

Statistical And Non-statistical TechniquesDetect Recurring Quality Problems

Results Of AnalysesCompared Across Different Data Sources

Identify And Develop Extent Of Problems

Statistical And Non-statistical Techniques

Detect Recurring Quality Problems

Results Of AnalysesCompared Across Different Data Sources

Identify And Develop Extent Of Problems

1. Identification – Clearly Define The Problem (CAR)

2. Access – Access Problem Magnitude And Impact

3. Investigation – Investigate Facts and Cause

4. Analysis – Analyze & Determine Root Cause

5. Action Plan – Develop Corrective Action Plan (CAP)

6. Implementation – Execute Corrective Action Plan

7. Follow Up – Verify And Assess The Effectiveness Summarize & Close The Event

1. Identification – Clearly Define The Problem (CAR)

2. Access – Access Problem Magnitude And Impact

3. Investigation – Investigate Facts and Cause

4. Analysis – Analyze & Determine Root Cause

5. Action Plan – Develop Corrective Action Plan (CAP)

6. Implementation – Execute Corrective Action Plan

7. Follow Up – Verify And Assess The Effectiveness Summarize &

Close The Event

Develop Comprehensive Corrective Action Report (CAR)

Initial Step Of The CAPA Process

CAR Includes:

Problem Source

Time, Date, Person Reporting Problem

Detailed Explanation Of The Problem

Link To Supporting Documentation Supporting The Nature of Problem

Document Specific Source Of Information. Sources Include:

Information Used To Investigate & Develop CAP

Useful For Effective Evaluation & Communication of Problem Resolution

Service Requests Customer Complaints

Internal Quality Audits Staff/Audit Observations

Trend Data QA Inspections

Process Monitoring Risk Analysis

CAPA System Should Facilitate The Ability To Record Written Detailed Problem

Effective Descriptions Should Be:

Concise

Detail-Oriented

Accurate

Factual

1. Identification – Clearly Define The Problem (CAR)

2. Access – Access Problem Magnitude And Impact

3. Investigation – Investigate Facts and Cause

4. Analysis – Analyze & Determine Root Cause

5. Action Plan – Develop Corrective Action Plan (CAP)

6. Implementation – Execute Corrective Action Plan

7. Follow Up – Verify And Assess The Effectiveness Summarize & Close The Event

Carefully Study Problem To Determine The Need For Action & The Level Of Action Required

Evaluation Should Include:

Potential Impact Of The Problem

Risk To The Company Or Its Customers

Remedial Action That May Be Required

Evaluation Should HighlightNature of the Problem

Why The Problem Is A Concern

Impact To The Organization/Customers

Other Considerations:

Costs

Function

Product Quality

Safety

Reliability

Customer Satisfaction.

Evaluate Level of RiskProblem Severity

Problem Priority

May Influence Recommendations In The CAP Stage

Potential Impact & Risk Assessment May Indicate A Need Immediate Action Until A Permanent Solution Can Be Implemented

Remedial Action May Be Adequate

1. Identification – Clearly Define The Problem (CAR)

2. Access – Access Problem Magnitude And Impact

3. Investigation – Investigate Facts and Cause

4. Analysis – Analyze & Determine Root Cause

5. Action Plan – Develop Corrective Action Plan (CAP)

6. Implementation – Execute Corrective Action Plan

7. Follow Up – Verify And Assess The Effectiveness Summarize &

Close The Event

Develop Written Procedure

Procedure Should Include:

Objectives For The Action

Investigation Strategy

Assignment Of Responsibility & Required Resources

Strategy Includes:Set Of Specific Instructions For Determining Root Cause & Contributing Factors

Comprehensive Review Of All Circumstances Related To The Problem Considering:

- Equipment - Materials

- Personnel - Procedures

- Design - Training

- Software - External Factors

Assign Responsibility For Each Aspect Of The Investigation

Identify Any Additional Resources (Financial, Equipment, etc.) Required

The Workflow Can Be Routed Based On User Entry. Checking The “Investigation Required” Will Automatically Launch An

Investigation

1. Identification – Clearly Define The Problem (CAR)

2. Access – Access Problem Magnitude And Impact

3. Investigation – Investigate Facts and Cause

4. Analysis – Analyze & Determine Root Cause

5. Action Plan – Develop Corrective Action Plan (CAP)

6. Implementation – Execute Corrective Action Plan

7. Follow Up – Verify And Assess The Effectiveness Summarize &

Close The Event

Primary Goal is Determination of Root Cause

Record Problem Investigation and Analysis

Every Possible Cause Is Identified And Appropriate Data Collected.

Document Results Of Investigation

Root Cause Analysis Includes:

Determination of The Actual Cause Of The Problem

Establish Primary Cause -Essential For Determining Appropriate Corrective And/Or Preventive Actions.

1. Identification – Clearly Define The Problem (CAR)

2. Access – Access Problem Magnitude And Impact

3. Investigation – Investigate Facts and Cause

4. Analysis – Analyze & Determine Root Cause

5. Action Plan – Develop Corrective Action Plan (CAP)

6. Implementation – Execute Corrective Action Plan

7. Follow Up – Verify And Assess The Effectiveness Summarize &

Close The Event

CAP Includes:The Best Method(s) For Correcting The Situation (Or Preventing A Future Occurrence)

All Tasks Required To Correct The Problem And Prevent A Recurrence Are Identified

Summary Of Required Changes

Assignment Of Task Responsibility

CAP Should Also Include:Required Changes To Documents

Processes & Procedures

Other System Modifications

Must Be Detailed To Ensure Clear Understanding of Tasks And Desired Outcome Of Changes

Employee Training Is Essential

Effective CAPA Systems Should Facilitate:

Communication Of All Modifications And Changes To All Persons, Departments, Suppliers, and Other Affected Stakeholders

1. Identification – Clearly Define The Problem (CAR)

2. Access – Access Problem Magnitude And Impact

3. Investigation – Investigate Facts and Cause

4. Analysis – Analyze & Determine Root Cause

5. Action Plan – Develop Corrective Action Plan (CAP)

6. Implementation – Execute Corrective Action Plan

7. Follow Up – Verify And Assess The Effectiveness Summarize &

Close The Event

The Action Plan That Has Been Developed Is Executed And All Identified Tasks And Activities Completed.

The Actions That Were Taken Are Summarized And All Modifications To Documents, Processes, etc. Are Listed.

The CAPA leader can also create action plans with multiple tasks, setting notifications, due dates, and

priorities. The action plans can be created ad-hoc or can be copied from action plan templates in the

library to expedite the creation process.

1. Identification – Clearly Define The Problem (CAR)

2. Access – Access Problem Magnitude And Impact

3. Investigation – Investigate Facts and Cause

4. Analysis – Analyze & Determine Root Cause

5. Action Plan – Develop Corrective Action Plan (CAP)

6. Implementation – Execute Corrective Action Plan

7. Follow Up – Verify And Assess The Effectiveness Summarize &

Close The Event

CLOSE THE LOOP!

Fundamental Step In The CAPA Process Is Completing Summary Report

Evaluation Of The Actions Taken

Confirmation of Successful Completion of All Tasks

Assessment Of The Appropriateness And Effectiveness Of The Actions Taken

Have All Of The Objectives Been Met? (Did The Actions Correct Or Prevent The Problem With Assurances That The Same Situation Will Not Happen Again?)

Have All Recommended Changes Been Completed And Verified?

Has Training And Appropriate Communications Been Implemented To Assure That All Relevant Employees Understand The Situation And The Changes That Have Been Made?

Has An Investigation Demonstrated That That The Actions Taken Have Not Had Any Additional Adverse Effect On The Product Or Service?

Make Sure That Appropriate Information Has Been Recorded That Provides Proof That All Actions Have Been Completed Successfully.

Training is an essential part of any compliance program

Simple list reports are available quickly for the manager to

determine the status of all actions

Validation and Summary Report.

Summary Report Highlights:Root Cause Of The Problem

Summary of Secondary Problems Corrected

Confirmation of Established Proper Controls To Prevent A Future Occurrence

Confirmation That Actions Taken Had No Other Adverse Effects

Monitoring For Continuous Improvement

When The Follow Up Has Been Finished, The CAPA Is Complete.

System Should Facilitate Signing and Date Stamp By Appropriate, Authorized Personnel.

DON’T JUST BUY A “CAPA” SYSTEM – LOOK FOR AN

INTEGRATED SYSTEM

1. Process Focused, Closed Loop

2. Online Collaboration

3. Comprehensive Workflow

4. Electronic Signatures

5. Notification & Problem Escalation

6. Statistical Analysis

7. Integrated Content Management

Questions?

•Valarie King-Bailey, M.B.A.

VP Sales & Marketing

vkbailey@xybion.com

•Kevin Miller

Inside Sales Manager

kmiller@xybion.com