10/30/2014. Definitions. Definitions. Leadership s role in enabling a Quality Culture CULTURE LEADERSHIP

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1 Leadership s role in enabling a V E R ONICA C R UZ, P H D E X E C U T IV E V P/ C O O Quality Workshop - October 29, 2014 Elizabeth, NJ 1 Definitions Dictionary: Leader: A person who guides a group Culture: The beliefs and behaviors characteristic of a particular group (social, ethic, age, etc.) Quality: High grade, superiority, excellence, a distinctive characteristic or attribute, grade of excellence Presenter s definition: The beliefs and behaviors characteristic of a particular company that define and enable the superiority and excellence of their operations and of the products they produce. 2 Definitions Leadership s role in enabling a stated differently. LEADERSHIP CULTURE The role of those who provide guidance in the company to enable beliefs and behaviors that promote: product quality operational excellence adherence to regulations QUALITY 3 1

2 What Does it Mean to Have a Culture of Quality? Quality is not only the responsibility of the Quality Unit Product quality is owned by every employee ALL functions are accountable for identifying, correcting and preventing issues Management is responsible for creating an environment that promotes beliefs and behaviors that enable product quality Quality is a business imperative Poor product quality can result in operational disruptions, recalls and regulatory enforcement Disruptions, recalls and regulatory enforcement are expensive and tarnish company reputation, customer trust and consumer/patient loyalty 4 The Regulator s Point of View The importance of a quality culture to enable assuring product quality has been extensively addressed by FDA It seems as though industry s objective today is to continue to meet regulatory standards, which are minimal expectations, versus adopting a commitment to high quality medicines. Janet Woodcock, MD Director, Center for Drug Evaluation & Research Janet Woodcock s comments made during and after the June 4, 2012 FDA/ISPE Conference and report by FDA Webview. 5 Integrating Quality into your Culture Integrating quality into your culture is to think beyond compliance It is about behavior and decision-making at all levels in the organization 6 2

3 A Culture of Quality Enables Sustainable Compliance Culture of Quality Emphasize the right behaviors and decisionmaking at all levels in the organization Product Quality Meet more than the regulator s minimum standard Set YOUR standards to reliably produce high quality products Sustainable Compliance Focus beyond achieving GMP certification 7 Quality Drives Results Quality Key Benefits Consistent product quality results in minimal interruptions to supply Employees do the right thing, consistently and sustainably Consumer safety Company reputation Competitive advantage The cheapest way to manufacture product is to do it right the first time. 8 Leadership s role How Can Leadership enable a Culture of Quality? 9 3

4 Enablers of a Quality-based Culture Integrating quality into the organizational culture can be aided by: Governance Systems Mechanisms to escalate and resolve issues Metrics to monitor and address performance Well-defined quality systems framework IT systems that enable real time data collection, evaluation and reporting Process Current facilities and manufacturing processes People Knowledgeable employees who are educated, experienced and trained for the task they perform Above all, management involvement is key! 10 Leaders Play a Key Role Cross-functional leaders must have a close and active partnership and share common goals Create an environment where every employee owns product quality Enforce the focus on quality through consistent and active communication Is quality everyone s responsibility when things go wrong? Do you talk of risk management or of taking risk? 11 can be Measured Leading and lagging indicators Surveys (quantitative and qualitative data) Extent of investment in facilities, equipment, technology Extent of product and process knowledge Activities/priorities compromised under financial pressure How issues are managed: do you investigate to release a lot or to learn from the deviation to avoid reoccurrence? 12 4

5 # of Investigations Count Success Story A Company s Journey Investigations Overview Field Alerts YTD level 1 Investigations Level 2 Investigations Right First Time: 2011 <60% 2013 > 90% Line item fill rate: Improved > 40% Employee engagement index: Improved > 15 points 13 Key Takeaways Ownership of quality by management and all functions Close, active partnership, leadership and common goals Product quality plays a key role on how you behave and the decisions you make Alignment throughout the company consistency and standardization Use metrics to measure progress Understand expectations Regulations and customer needs change over time Meeting regulatory requirements is not enough- hold yourselves to your own standards Communication Well informed, knowledgeable employees that understand the role they play Transparent and timely flow of information related to quality issues 14 THANK YOU Q & A vcruz@recomspr.com office: mobile: