Quality by Design American Medical Device Summit · Unrestricted © Siemens AG 2014 All rights...
Transcript of Quality by Design American Medical Device Summit · Unrestricted © Siemens AG 2014 All rights...
Unrestricted © Siemens AG 2014 All rights reserved. Smarter decisions, better products.
Quality by Design American Medical Device Summit
Tisha Tomlinson Business Consultant Quality Management Solutions Jim Thompson Director, Industries Business Development & Solution Management Medical Devices & Pharmaceuticals
September 10, 2014
2014-06-16_18
Unrestricted © Siemens AG 2014 All rights reserved.
Page 2 Siemens PLM Software
Agenda
• Industry Challenges with Quality
• Quality by Design
• Cross-Industry Best Practices Overview
• Questions and Answers
• Contact Information
2014-06-16_18
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The business case for Quality – McKinsey “compliance by inspection is becoming obsolete”
The medical device business has grown so competitive, and its products so complex, that “compliance by inspection” is becoming obsolete.
Modern practices in quality assurance could lead to a 10 to 15 percent increase in the earnings of medical device companies and even more in the years ahead.
By adopting cross-industry best practices in quality assurance, the industry could improve patient outcomes, capture $5 to $6 billion in incremental EBITA, and reduce risk.
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8 Dimensions of Quality (Garvin, 1987) How can Siemens PLM help improve quality?
1. Performance
2. Features 3. Reliability
4. Conformance 5. Durability
6. Serviceability
7. Aesthetics
8. Perceived Quality
Holistic View of Quality
Focus of QMS
& Regulatory Compliance processes
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Siemens PLM Answer: Quality by Design through Integrated Quality processes
Quality by Design 1. Embed quality data & analytics throughout the product lifecycle
2. Integrate quality management system processes to your PLM platform
Identify & Resolve Quality Issues
early & efficiently
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Siemens PLM Answer: Quality by Design through Integrated Quality processes
Quality by Design 1. Embed quality data & analytics throughout the product lifecycle
2. Integrate quality management system processes to your PLM platform
Identify & Resolve Quality Issues
early & efficiently
Leading Cross – Industry Business Process & Solutions
Enabling Medical Device companies to:
• Focus on Quality earlier & proactively
• Lower the cost of Quality
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Siemens PLM Answer: Quality by Design through Integrated Quality processes
Quality by Design 1. Embed quality data & analytics throughout the product lifecycle
2. Integrate quality management system processes to your PLM platform
Identify & Resolve Quality Issues
early & efficiently
Leading Cross – Industry Business Process & Solutions
Enabling Medical Device companies to:
• Focus on Quality earlier & proactively
• Lower the cost of Quality
PLM & QMS integration “blueprint”
Enabling Medical Device companies to:
• Establish a “culture of change”: controlled + encourage optimization
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Quality by Design through Integrated Quality processes
2. Integrate quality management system processes to your PLM platform
PLM & QMS integration “blueprint”
User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
1. Embed quality data & analytics throughout your product lifecycle:
Leading Cross–Industry Business Process & Solutions
2014-06-16_18
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Quality by Design through Integrated Quality processes
Digital Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
Digital Product
Verification
User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
1. Embed quality data & analytics throughout your product lifecycle: Leading Cross–Industry Business Process & Solutions
2. Integrate quality management system processes to your PLM platform
PLM & QMS integration “blueprint”
2014-06-16_18
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Page 10 Siemens PLM Software
Quality by Design through Integrated Quality processes
Digital Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
Digital Product
Verification
User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
1. Embed quality data & analytics throughout your product lifecycle: Leading Cross–Industry Business Process & Solutions
2. Integrate quality management system processes to your PLM platform
PLM & QMS integration “blueprint”
CAPA Change Control
2014-06-16_18
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Quality by Design through Integrated Quality processes
Digital Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
Digital Product
Verification
User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
1. Embed quality data & analytics throughout your product lifecycle: Leading Cross–Industry Business Process & Solutions
2. Integrate quality management system processes to your PLM platform
PLM & QMS integration “blueprint”
CAPA Change Control
CAPA process integration is the key to bridge
PLM & QMS
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User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
Quality by Design through Integrated Quality processes
1. Embed quality data & analytics throughout your product lifecycle Digital
Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
2. Integrate QMS processes on your PLM platform
CAPA Change Control
Digital Product
Verification
Systems-Driven Product Development
Capture & manage connections: VOC Risks & Design Inputs Design Outputs V&V
“Live” Req Spec Mgmt, Traceability & Reporting Proactive mgmt of V&V processes Promote predictive Quality Assurance
Risk Assessments/FMEAs Define & Control all Compliance Documentation
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Siemens Diagnostics “Requirements Engineering” Case Study
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Quality by Design through Integrated Quality processes Risk Assessment & FMEA
Process/Product/Hybrid FMEA Easy system-supported FMEA
creation within the FMEA tree structure: defect cause and effect definition via drag ‘n’ drop Working within the tree
structure or worksheet
FMEA
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User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
Quality by Design through Integrated Quality processes
1. Embed quality data & analytics throughout your product lifecycle Digital
Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
2. Integrate QMS processes on your PLM platform
CAPA Change Control
Digital Product
Verification
Digital Product Verification Simulate product behavior early in the lifecycle Predict product performance, reliability, durability Earlier & increased knowledge of product physics Reduce investment / reliance on prototypes
2014-06-16_18
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User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
Quality by Design through Integrated Quality processes
1. Embed quality data & analytics throughout your product lifecycle Digital
Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
2. Integrate QMS processes on your PLM platform
CAPA Change Control
Digital Product
Verification
3D Product & Manufacturing Information (PMI) Reduce dependency on 2D Drawings and re-use 3D “master” data
Reduce errors in interpreting design intent Proactive control of product & mfg data Enable predictive simulation Re-use downstream for validation
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Variation Analysis: Surgical Laparoscope Case Study
Product & Manufacturing Information
Capture and communicate design intent in a single 3D “master” definition Use JT files (ISO standard) for collaboration & sharing lite-weight files with partners & suppliers
1. PMI Definition
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User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
Quality by Design through Integrated Quality processes
1. Embed quality data & analytics throughout your product lifecycle Digital
Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
2. Integrate QMS processes on your PLM platform
CAPA Change Control
Digital Product
Verification
Digtial Mfg Process Verification: mBOM + BOP + 3D Tolerance Analysis Simulate manufacturing assembly processes
Predictively reduce the risk of non-conformances
& complaints that lead to recalls, CAPA’s, and engineering changes
Predictively validate product & process spec’s with production data
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Variation Analysis: Surgical Laparoscope Case Study
• Assembly operations define the assembly process
• Static or kinematic (moving) assemblies
• Measurement operations define the critical to quality characteristics
• Clearances, gaps, angles, computed values, etc.
3. Assembly & Measurement Operation Definition
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Variation Analysis: Surgical Laparoscope Case Study
• A run of assemblies is simulated using a Monte Carlo methods
• Tolerances are represented by a statistical distribution
• 6 sigma normal, historical as-measured, etc.
• Variation contribution is determined using a DOE set of simulations
4. Simulation
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Variation Analysis: Surgical Laparoscope Case Study
Conclusion: Sharp Corner between trigger and slider will prevent full closure in 7% of builds Recommendations: Investigate if the slider can accommodate a larger radius to ensure full closure of tip
Results: Tool Tip Closure at Full Stroke
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User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
Quality by Design through Integrated Quality processes
1. Embed quality data & analytics throughout your product lifecycle Digital
Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
2. Integrate QMS processes on your PLM platform
CAPA Change Control
Digital Product
Verification
Collaborate with Suppliers Enable very fast, efficient, and controlled collaboration with suppliers Improve accuracy of supplier deliverables
while protecting intellectual property Self-administered + formal
Supplier Audits/Evaluations Improve visibility of supplier performance
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User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
Quality by Design through Integrated Quality processes
1. Embed quality data & analytics throughout your product lifecycle Digital
Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
2. Integrate QMS processes on your PLM platform
CAPA Change Control
Digital Product
Verification
Intelligent Design History File (DHF) Index & re-use Systems-driven
Product Development deliverables / data
Global Device Master Record (DMR) Configure eBOMs, mBOMs, & BOPs to enable
“design anywhere, build anywhere”
2014-06-16_18
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Page 24 Siemens PLM Software
User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
Quality by Design through Integrated Quality processes
1. Embed quality data & analytics throughout your product lifecycle Digital
Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
2. Integrate QMS processes on your PLM platform
CAPA Change Control
Digital Product
Verification
Dimensional Planning & Validation (DPV) Real-time shop floor aggregation and reporting on quality data Identify and resolve manufacturing quality issues
more quickly and more proactively Enhance continuous improvement by feeding
data back to production and process design
2014-06-16_18
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User Reqmts (VOC)
Risks & Design Inputs
Product Design
Mfg Planning
Design Outputs
Verification &
Validation
Design Transfer Production Service &
Support
Quality by Design through Integrated Quality processes
1. Embed quality data & analytics throughout your product lifecycle Digital
Mfg Process Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Data
Exchange
Systems Driven Product Development
CAPA Change Control
Digital Product
Verification
Quality Issue Mgmt & CAPA PLM-hosted QMS processes for CAPA and Change Control “Close the loop” on complete
product lifecycle quality System consolidation for PLM,
Change & CAPA
2. Integrate quality management system processes to your PLM platform
PLM & QMS integration “blueprint”
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Quality by Design through Integrated Quality processes
Quality Issue
CAPA
Root Cause Analyses Change Requests
Impacts on Product & Mfg Data Change Implementation Seamless & easy-to-use systems
to progress from Issues CAPA’s Change
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Recommended Improvement Levers from McKinsey Call to Action
Digital Mfg Process
Verification
3D PMI
Production Validation
Intelligent DHF
Global DMR
Supplier Collaboration
& Audits
Systems Driven Product Development
Training & Qualification
CAPA Change Control
Systems Driven Product Development
Digital Product
Verification
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Questions and Answers
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Contact Information
Tisha Tomlinson Business Consultant Quality Management Solutions
24 Hartwell Avenue Lexington, MA 02421
Phone: +1 781-676-8124 Mobile: +1 781-835-8020
E-mail: [email protected]
Smarter decisions, better products.
2014-06-16_18
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Contact Information
Jim Thompson Siemens PLM Software Director, Industries
Business Development & Solution Management Medical Devices & Pharmaceuticals
Chicago, Illinois Mobile: +1 (630) 667-8299
E-mail: [email protected]
Smarter decisions, better products.