1. MDIC- Case for Quality Forum
June 27, 2018
Scott Ugran
Grant Thornton – Director Risk Analytics Healthcare and Life Science

2. Benefits of a Mature Quality Management System
Quality Beyond Compliance
Promote the development of actionable strategies to improve quality
Enhance Patient, Customer, and Employee Experience
Promote Big "Q" philosophy and focus on "doing the right things", not just "doing things right"
Predictability and Flexibility
Identify improvement areas and predicting/ planning next steps while remaining flexible and agile
Alignment
Shift the quality focus so it aligns – rather than conflicts – with speed and cost objectives
Consistency
Enable standardization while promoting a strong functional orientation to drive improvements
Transparency
Improve communication and streamline interactions with other functions
Increased Effectiveness at Lower Cost
Work toward higher maturity levels by promoting improved effectiveness and reducing variability and cost
Business Partnering
Track and monitor progress and ROI to improve clarity and communication with leadership through cross-functional partnerships
High Quality Medical Products
Improved Patient Safety
Promote consistent and predictable delivery of brand promise

3. Information to Intelligence
How organizations can transform themselves into insight driven organizations for product quality and risk management
Hindsight
Establish baseline metrics
Identify what quality opportunities exist today
Establish data sources and verification process
Foresight
Predict future quality opportunities
Identify ways to prevent quality issues
Create new data to model behavior
Insight
Determine the root causes of the quality opportunities
Determine patterns and correlations
Merge disparate data sets to drive analysis
Leverage visual mappings and machine learning to uncover new perspectives
Leading Practices
Establish common organizational goals
Keep consistency across sites
Leverage actionable metrics
Continue to refresh and evolve with the business
Business Value
Analytical Maturity

4. Compliance vs. Quality Indicators
Metrics that less or differently regulated industries use to monitor and manage quality and performance
Metrics pilot participants have shared
Target audience: Operators, leadership, customers
NCR
NCR trends
NCR resolution timelines
CAPAs
Counts open vs. closed vs. overdue
Field actions open per site
ECO#/turn time
Scrap rate trends (positive vs. negative trend events)
Projects exceeding planned timeline
Yield trends (positive vs. negative trend events)
Description
KPI examples
# improvement ideas implemented
# defects raised by product/line
“Effectiveness of improvement actions (% of KPIs selected achieving target)”
KPIs to ensure quality improvements
Root-cause/problem-solving cycle time
# preventive actions to avoid complaints
Mean-time to complaint resolution
Indicators to assess timeliness of response and actions taken
Cost of poor quality: recalls, reputational cost, scrap, rework
Cost of good quality
Cost of detection: testing tools, detection personnel
Cost of prevention: trainings, prevention personnel, prevention projects, mistake-avoidance tools
Customer return/reject rates
On-time delivery
Metrics to evaluate financial impact to prevent quality problems
Metrics to evaluate manufacturing quality and operational effectiveness - semiconductors
Line yield per 20 layers (monitored per line)
Defect density (defects per sq cm) varied by technology type and was monitored for major processes
Cycle times (per tool, per process, per operator)  varied depending on the technology, tooling, changeovers, etc.)
First pass yield
Overall equipment effectiveness (capacity utilization)
# recurring deviations with root cause identified
# quality issues identified in-house vs. complaints ratio
Turn-over rate
Time to fill vacant positions
Culture survey score
Metrics to assess organization culture and capabilities to achieve quality excellence

5. Example Product Quality & Risk Management Dashboard

6. Example Product Quality & Risk Management Dashboard

7. Can You Assess and Influence Culture?
Cultural norms guide employee behavior and, inevitably, an organization's ability to execute its strategy of transforming from a "Culture of Compliance" to a "Culture of Quality"
Evaluate an organization against multiple dimensions
Identify aspects of an organization’s culture that are in and out of alignment with their strategy
Leverage assessment data to develop targeted Change Management strategies
Align at-risk dimensions to the organization's strategy, moving from a "Culture of compliance" to a "Culture of quality"
Gain a detailed understanding of an organization's unique characteristics in order to develop a tailored approach to Culture Transformation
Opportunities

8. Culture Assessment Example

9. Questions Concerning Achieving Continuous Visibility
Can we use quality metrics to "move the needle" and significantly advance product quality and patient safety?
What are the challenges and barriers to establishing and reporting quality metrics internally?
How can we align and standardize on quality metrics across the industry?