total cost of quality and industry 4.0: the bi-modal challenge facing quality leaders ... ·...
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Steve McCarthy
VP of Digital Innovation
Total Cost of Quality and Industry 4.0:
The Bi-Modal Challenge Facing Quality
Leaders Today
13th FDA Inspections Summit, Bethesda, MD
“The future is still so much
bigger than the past.”
- Sir Tim Berners-Lee
Growth of the Internet of Things
3
4 billion
Connected People
$4 trillion Revenue
Opportunity
25+ million
Apps
25+ billion Embedded
& Intelligent Systems
50 trillion
GBs of Data
2020 Opportunity
Source: Mario Morales, IDC
Industry 4.0
Industry
4.0
Industry 4.0 Framework & Contributing Digital Technologies
6
Cloud computing
Augmented reality/wearables
Multilevel customer interaction & customer profiling
Big data analytics & advanced algorithms
Smart sensors 3D printing
Authentication & fraud detection
Advanced human-machine interfaces
Location detection technologies
IoT platforms
Mobile devices
Source: PwC
Top Drivers of Cloud Adoption
7
Enhanced Customer
Experience
70% Deriving
Actionable Insights From
Your Data
Reducing Cost Through
Automation & Efficiency
Improving Customer
Acquisition & Retention
Improving Security or Minimizing
Risk
Source: IDG Survey
71% 71% 77% 72% 70% 72% 71% 71% 77%
8
Healthcare Reimagined
Continuous Manufacturing
Additive Manufacturing
Personalized Medicine
Continuum of Care
Customer Will Shape Products & Services
14
Change
Unprecedented Change
Velocity of Change Scope of Change Scale of Change
Key Change Drivers
Cost
Speed
Scalability
Security
Reliability
Regulations
Innovation Collaboration
17
Bi-Modal Challenge
Five Imperatives Shared by all Quality Leaders
18 Mode 2 - Exploratory Mode 1 - Traditional and Proven
Quality
Efficacy
Safety Continuity
Compliance
Achieving the Optimal Quality Cost
“Many organizations will have true quality-related costs as high as 15 to 20 percent of sales
revenue, some going as high as 40 percent of total operations. A general rule of thumb is that costs of poor quality in a thriving company will be about 10 to 15 percent of operations.” - ASQ
Measuring Total Cost of Quality
Total Cost of Quality
Cost of Poor Quality (Non-Conformance)
Cost of Good Quality (Conformance)
Internal Failure Costs
External Failure Costs
Prevention Costs
Appraisal Costs
Internal Failure Costs
Cost of Poor Quality (Non-Conformance)
Cost of Good Quality (Conformance)
Internal Failure Costs
External Failure Costs
Prevention Costs
Appraisal Costs
External Failure Costs
Cost of Poor Quality (Non-Conformance)
Cost of Good Quality (Conformance)
Internal Failure Costs
External Failure Costs
Prevention Costs
Appraisal Costs
Appraisal Costs
Cost of Poor Quality (Non-Conformance)
Cost of Good Quality (Conformance)
Internal Failure Costs
External Failure Costs
Prevention Costs
Appraisal Costs
Prevention Costs
Cost of Poor Quality (Non-Conformance)
Cost of Good Quality (Conformance)
Internal Failure Costs
External Failure Costs
Prevention Costs
Appraisal Costs
The One Constant is Change
Mode 2 Mode 1
Why is This So Hard to Measure?
27
Hidden Costs – Hidden Factories
[CATEGORY
NAME] [PERCENTAGE]
[CATEGORY
NAME] [PERCENTAGE]
[CATEGORY
NAME] [PERCENTAGE]
KNOWLEDGE
Knowledge
Patient-Centric Value Chain
The Patient-Centric Value Chain
Patient
Payer
Purchaser
Provider
Combo / Biologic Product
3D Printed Drug / Device
IOT-enabled Digital Wearable / Implantable Device
Continuous Manufacturing
Gene Therapy
Personalized Medicine
Shift of POC
Advancing the Patient-Centric Value Chain
Discover Pre-Clin / Clin Patient
Payer
Purchaser Provider
Manufacture Distribute
CRO Regulator CMO
R&D - Clinical - Medical - RA – Operations - Quality - Compliance - PMS
Analytics – Signal Detection - Visualization
QBN
Realizing the Vision with TrackWise Digital Platform
Digital Ecosystem
Value Chain
IoT Interfaces Data
Insights SaaS
Hybrid Tenancy
Flexible & Agile
Time to Value
Digital Platform
Validation & GxP Compliance
Conclusion
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