corrective action – the heart of continuous quality
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Corrective Action: The Heart of Continuous Quality
IBS AmericaT H E P R O D U C T I V I T Y A D V A N T A G E
THE PRODUCTIVITY ADVANTAGEIBS Overview
Agenda and Introduction
Agenda and Introduction
Getting Management Buy-In / What Makes a Good System
CAPA Solutions Demonstration
Q&A – 10 minutes
What is CAPA & 7 Essentials of CAPA
THE PRODUCTIVITY ADVANTAGEIBS Overview
What is CAPA?
© IBS AG Slide 3
Method to communicate, evaluate, analyse, resolve current and potential problems in products, materials, processes, suppliers.
Key tactic in continuous improvement
Tool for cost reduction
Provides foundation for increased customer satisfaction and market share
THE PRODUCTIVITY ADVANTAGEIBS Overview
7 Steps of an Effective CAPA
© IBS AG Slide 4
Analyze DataCustomer ComplaintsInspection InformationSupplier PerformanceLegal IssuesEmployees
Identify Appropriate ActionsClear step by step planRisks, Impact
THE PRODUCTIVITY ADVANTAGEIBS Overview
7 Steps of an Effective CAPA
© IBS AG Slide 5
Get to the Root CauseDesign MaterialsProcessTrainingMultiple
Validate ActionsMeasure effectiveness Did it help?
Adjust actions based on findingsRethink processes
THE PRODUCTIVITY ADVANTAGEIBS Overview
7 Steps of an Effective CAPA
© IBS AG Slide 6
Communicate changes to appropriate personnelProcess changesTraining changesMaterial changes
Management ReviewManagement is aware of issuesManagement signs off on CARS/PARS
THE PRODUCTIVITY ADVANTAGEIBS Overview
Agenda and Introduction
Agenda and Introduction
Getting Management Buy-In / What Makes a Good System
CAPA Solutions Demonstration
Q&A – 10 minutes
What is CAPA & 7 Essentials of CAPA
THE PRODUCTIVITY ADVANTAGEIBS Overview
How Does CAPA Support the Organizations Initiatives?
© IBS AG Slide 8
Market Share
EPS / Shareholde
r Value
Sustainability
Manage Liability
Higher Quality = Higher Market Share
Quality Systems act like levers to reduce cost
Compliance To Standards
Records, ControlsSchedules, Training and Verifiable Proof
THE PRODUCTIVITY ADVANTAGEIBS Overview
Operational Management
© IBS AG Slide 9
New Product Introduction
Asset Performance
Operating Budget vs. Plan
Operating Margins vs. Plan
Employee Safety & Asset Protection
Compliance to Standards
Increase productivity
Reduce scrap and rework
Lower Costs
Prevent Accidents
ISO & Governmental
Refine processes
THE PRODUCTIVITY ADVANTAGEIBS Overview
Users
Do Jobs Correctly
Efficiency
Know How
Safety
Input / Feedback
Work instruction change notification
Communicate new training needed
Best Practices
Videos / Graphics / Pictures
Handling and safety info changes
Corrective and Preventative action requests
THE PRODUCTIVITY ADVANTAGEIBS Overview
Strategy
Alignment with Executive and Operational Strategies and
Plans
THE PRODUCTIVITY ADVANTAGEIBS Overview
Example 1
Top Management Increase Market Share
Operational Management
Product Quality
New Products /
Features
Increase Production
Analyze Data
Identify Issues
Fix Problems
Increased Quality
Analyze Process Data
Identify Issues
Fix Problems
Improve Efficiency and Initial Quality
Less Rework
Less Scrap
Less Labor
Increase Throughput
THE PRODUCTIVITY ADVANTAGEIBS Overview
Example 2
Top Management Increase EPS
Reduce Warranty
Costs
IncreaseMargin
Increase Throughput
Indentified Problems
Quickly Fix
Reduce # of Problems in cost hands
Reduce Scrap
Reduce Labor
Reduce Rework
Increase Productive Time
Decrease Non-Productive Activities
THE PRODUCTIVITY ADVANTAGEIBS Overview
Example 3
Top ManagementReduce Liability
Product OH&S
Preventative
Corrective
Preventative
Corrective
THE PRODUCTIVITY ADVANTAGEIBS Overview
• Inspection Analysis
• Employee Suggestions
• Compliance Issues
• Customer Complaints
INPUTS are Varied and Many….
• Change Requests
• Supplier Issues
• Government Regulations
• Audits
• Non-Conforming Material
THE PRODUCTIVITY ADVANTAGEIBS Overview
Workflows
Internal / External Assignments
Containment
Evaluate / Remodel / Long Term
Containment
Root Cause Problem Solving
Review and Verification
Management Review
CAPA Functionality
THE PRODUCTIVITY ADVANTAGEIBS Overview
System Functionality
Document Integration
Alerts and Escalations
Security
Flexibility
Notifications
Communication
Change Procedures
Documentation
Workflow
Audit Trail
THE PRODUCTIVITY ADVANTAGEIBS Overview
Agenda and Introduction
Agenda and Introduction
Getting Management Buy-In / What Makes a Good System
CAPA Solutions Demonstration
Q&A – 10 minutes
What is CAPA & 7 Essentials of CAPA
IBST H E P R O D U C T I V I T Y A D V A N T A G E
Corrective Actions Compliant Pro
THE PRODUCTIVITY ADVANTAGEIBS Overview
Corrective and Preventive Action
© IBS, 2006 Page 20
The bedrock of a healthy quality system
A barometer of system health
Mitigates risk
Assures control
THE PRODUCTIVITY ADVANTAGEIBS Overview
Energy Management as Part of a Total Solution
© IBS, 2006 Page 21
THE PRODUCTIVITY ADVANTAGEIBS Overview
Integrated Functionality
© IBS, 2006 Page 22
THE PRODUCTIVITY ADVANTAGEIBS Overview
High Level Approach to Corrective Action
© IBS, 2006 Page 23
THE PRODUCTIVITY ADVANTAGEIBS Overview
CAPA
© IBS, 2006 Page 24
THE PRODUCTIVITY ADVANTAGEIBS Overview
Information is Power
CAPA
Data
Reports
&
Analysis
Effective anticipatory & remedial management decisions
© IBS, 2006 Page 25
THE PRODUCTIVITY ADVANTAGEIBS Overview
Thank You! Questions?
IBS America, Inc. www.ibs-us.com(781) 862-9002
PRESENTER: Tim Gamble – tim.gamble@ibs-ag.com (781) 862-9002 ext. 137
Quality Management 2.0http://info.ibs-us.com
@IBSAmerica
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