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

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

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

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

Example Product Quality & Risk Management Dashboard

Example Product Quality & Risk Management Dashboard

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

Culture Assessment Example

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?