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.

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



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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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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early & efficiently

Leading Cross – Industry Business Process & Solutions


• Focus on Quality earlier & proactively

• Lower the cost of Quality

PLM & QMS integration “blueprint”


• Establish a “culture of change”: controlled + encourage optimization

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Quality by Design through Integrated Quality processes



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




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)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support

1. Embed quality data & analytics throughout your product lifecycle: Leading Cross–Industry Business Process & Solutions



2014-06-16_18





3D PMI


Intelligent DHF

Global DMR


& Audits


Digital Product

Verification

User Reqmts (VOC)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support




CAPA Change Control

2014-06-16_18





3D PMI


Intelligent DHF

Global DMR


& Audits


Digital Product

Verification

User Reqmts (VOC)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support




CAPA Change Control

CAPA process integration is the key to bridge

PLM & QMS

2014-06-16_18



User Reqmts (VOC)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support


1. Embed quality data & analytics throughout your product lifecycle Digital

Mfg Process Verification

3D PMI


Intelligent DHF

Global DMR


& Audits


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)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support




3D PMI


Intelligent DHF

Global DMR


& Audits



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



User Reqmts (VOC)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support




3D PMI


Intelligent DHF

Global DMR


& Audits



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)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support




3D PMI


Intelligent DHF

Global DMR


& Audits



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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• 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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• 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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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

2014-06-16_18



User Reqmts (VOC)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support




3D PMI


Intelligent DHF

Global DMR


& Audits



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

2014-06-16_18



User Reqmts (VOC)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support




3D PMI


Intelligent DHF

Global DMR


& Audits



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



User Reqmts (VOC)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support




3D PMI


Intelligent DHF

Global DMR


& Audits



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



User Reqmts (VOC)


Product Design

Mfg Planning

Design Outputs

Verification &

Validation


Support




3D PMI


Intelligent DHF

Global DMR

Supplier Data

Exchange


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



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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


Intelligent DHF

Global DMR


& Audits


Training & Qualification

CAPA Change Control


Digital Product

Verification

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Siemens PLM Software Pa

Questions and Answers

2014-06-16_18



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



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.

mailto:[email protected]

Quality by Design American Medical Device Summit · Unrestricted © Siemens AG 2014 All rights...

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