Establishing and Sustaining a Quality Culture Jacqueline Elbonne, Ph.D., Senior Vice President Global Quality, Merck. August 2016

Transcription

1 Establishing and Sustaining a Quality Culture Jacqueline Elbonne, Ph.D., Senior Vice President Global Quality, Merck August 2016

2 Merck s Mission Our Mission To discover, develop and provide innovative products and services that save and improve lives around the world Our First Priority To be a World Class Supplier of medicines and vaccines with high quality, low cost, shortest lead time We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. (George W. Merck: Address to the Medical College of Virginia, Richmond (1 Dec 1950)). 2 2

3 Merck s Commitment to Science and Innovative Medicines Focused on finding new ways to treat and prevent illness Ivermectin (Mectizan) River Blindness KEYTRUDA Oncology Ebola - Vaccine Commitment to meet unmet medical needs and help the world be well that inspires and motivates our employees 3 3

4 Our Manufacturing Network Operates Globally With A Broad Base Of Suppliers And Sites North America EMEA Asia Pacific Latin America Complex Network including internal and external suppliers Serving Patients Globally in 140 Countries 4 4

5 Common Industry & Regulator Goals Accelerate availability of products globally to the world s patients and healthcare providers Deliver compliant, safe, effective, and affordable product, on time, every time no patient left behind Regulators Industry 5 5

6 Pharmaceutical Quality System The pharmaceutical quality system assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded. ICH Q10, Section Commercial Manufacturing Merck s Quality Vision Our products are there when people need them, with the Quality they can trust 6 6

7 How Culture Drives Business Performance Attitude Behaviors Culture Performance Mindset & Behaviors 7 Culture of Quality 7 Our products are there when people need them, with the Quality they can trust

8 Leveraging Quality Culture to Drive Manufacturing Performance 1 Optimize operating performance and productivity while reducing compliance risk 2 Maintain a state of quality and compliance excellence at all levels in the organization 3 Run the business without disruptions to quality 8

9 Some Key Components of a Quality Culture Safety First, Quality Always Leadership Focus on Quality Everyone s a Quality Leader Safe to Speak Up Protect the patient, protect your co-workers Visibility and use of metrics to drive actions Proactive identification/mitigation of product risks Clear quality goals and expectations Everyone understands how their work contributes to Quality Go See Visible on the shop floor observing, coaching and teaching Strong focus on measuring performance by key metric reviews Personal ownership and accountability for quality of dally work Accountable for quality outcomes Solve problems and continuously improve at all levels Quality risk management actively in-use Safe to speak up and make problems visible Fix once and get to root cause Inclusion & Staff Engagement 9 Learning Organization Leaders as teachers and coaches Mistakes are seen as learning opportunities When mistakes are made what failed in the process, not the person Cross functional teamwork and joint accountability for quality Employees engaged because they understand the connection between their work and the patient

10 Quality Culture in Action Tier Process Improvement Process Integrated Quality Minded Leaders All Levels Our Leaders are teachers We make problems visible so we can solve them We use problems as opportunities to role model gosee and verify for ourselves Isolated Fire Fighting We engage our employees to understand problems deeply Every problem is an opportunity to develop someone as a problem solver We follow the scientific problem solving method until the problem is eliminated Our actions lead to standardized work methods Problem solving at the shop floor is part of our day to day work We create predictable, high performing processes We measure our product performance through Quality metrics 10 Increasing Quality Culture Evolution

11 Integrated, Accountable Quality Minded Leaders At All Levels Tied to business strategy, quality plans and promoting continuous improvement Leadership/ Inclusive Behaviors Define the principles and characteristics that all employees are expected to demonstrate every day to establish and sustain a quality culture An inclusive environment where it is safe to speak up and enables people to do their best work. Objectives Building Leaders Career Mapping Focused on opportunities to learn through assignments and train in tools that enable them to make the right quality decisions. Employee Development and Training Focused on defining core skills and abilities, core functional and sub-functional competencies for driving quality. Self assessments enable ownership and awareness of current capabilities and opportunities 11

12 Maturity Quality Culture Evolution Index Evolving People, Process and Systems Integrating Individuals are willing to make problems visible and adopt processes & systems. Inclusion is integrated into the way we interact. Institutionalizing: Everyone is a Quality Leader Employees, regardless of level or function, have ownership and accountability for Quality and Compliance. They recognize and verbalize that QMS is the foundation for the way business is conducted.. Building Key indicators are beginning to be defined. Quality Management Systems are evolving beyond core requirements. Complying Individuals have basic understanding of key Quality Management System (QMS) concepts. Comply with the minimum requirements. Transforming Individuals try working within new structures, processes & systems and understand how their work is affected. Processes are moving from complex to simple. Time 12 12

13 Sustaining a Quality Culture Strong quality oversight and key metrics that indicate a shift in compliance are visible Focus on executional excellence Rigorous management of people change control assuring appropriate training, mentoring and coaching System owners reviewing effectiveness and identifying opportunities for improvement Quality ownership and accountability at all levels Without a strong quality culture, risk to product and quality can t be fully mitigated 13 13

14 How to Measure Quality Culture Quantitative tools and data Data from interviews of leadership, supervisors, operational and technical employees Review of documentation Management commitment to quality is visible 14 14

15 Benefits of a Strong Quality Culture Drives employee behaviors that demonstrate personal ownership for quality outcomes and decision making every day Compliance risks are mitigated Product quality and patient safety ensured Protection of the product brand and reputation Build trust with regulators 15 15