Role of Management to Drive Industry Improvement Industry Case Study. Anders Vinther, Ph.D. Vice President Quality Biologics, Genentech

Transcription

1 Role of Management to Drive Industry Improvement Industry Case Study Anders Vinther, Ph.D. Vice President Quality Biologics, Genentech 1

2 ICH Q10 Section III Management Responsibility (2) A. Management Commitment (2.1) company wide commitment to quality A. Sr. Management Commitment ultimately responsible for PQS, roles and responsibilities and authorities are in place and communicated B. Management does this by: 1) Involvement in PQS lifecycle design, implementation, monitoring and maintenance 2) Active support for PQS Walk the Talk 3) Communication timely and effective, known communication process 4) Roles & Responsibilities 5) Management Reviews assessment of PQS health and proactive 6) Continual Improvement don t accept status quo 7) Resource Management set & allocate resources according to priorities 2

3 ICH Q10 Section III Management Responsibility (2) B. Quality Policy (2.2) Overall intention and direction C. Quality Planning (2.3) Align objectives and KPIs with company strategy D. Resource Management (2.4) Determine and provide adequate resources E. Internal Communication (2.5) appropriate and timely communication at all levels F. Management Review (2.6) Continued review of suitability & effectiveness of PQS G. Management of Outsourced Activities and Purchased Materials (2.7) responsibility lies with company for outsourced activities and material H. Management of Change in Product Ownership (2.8) establish clear roles & responsibilities 3

4 Role of Management to Drive Industry Improvement Industry Case Study ICH Q10 can be used to: Drive consistency across the company and industry Integrate general business and quality processes Define the quality culture in the company and bring the company together in one direction Raw Materials Production Testing Disposition Distribution End to End Product Quality 4

5 A. Management Commitment Management that is fully engaged can change the behavior of the entire company Attending and actively participating in quality focused meetings Establishing governance structure with focused meetings including setting direction, lessons learned, etc. (example: Quality Councils) Establishing the PQS and reading the governing documents Writing goals and objectives that drive the right quality behavior By setting clear roles, responsibilities, and accountabilities employees are focused on the appropriate priorities Shifting mindset, quality issues are co owned by Operations and Quality When management understands the science of quality then compliance becomes an after thought 5

6 Role of Management vs Qualified Person Batch disposition decisions always the QP making the final decision, but what about impact outside EU and how is knowledge shared? Business processes usually management decides on business processes globally Issues Resolution need to think about requirements, regulations and reporting in each individual country Global Organizations sharing of information independent of reporting structure Is quality system working QPshave key input to the management reviews (Example: the concept of Product Quality Stewards) 6

7 B. Quality Policy Needs to be short and easy to understand so that all employees can relate to it and remember it Drives the mindset of quality being engrained in all stages of the business Establishing a Quality Philosophy as part of the Quality Policy can strengthen the quality culture, and be the foundation for aligning the business on a sound quality approach Quality Philosophy Quality is every patient s right and every employee s responsibility. Quality provides a competitive advantage and is engrained in everything we do, from concept through continuous improvement. Because our products touch human lives, quality is the true measure of our success. 7

8 C. Quality Planning Continual development of employees will drive continual improvement of your PQS, your compliance status and the company Training programs focused on understanding why requirements exist and understanding the overall importance of each role Management training to ensure full understanding of PQS Knowing your Cost of Quality can assist you in identifying areas where processes can be improved or where there is a need for additional focus (example: going from cost to value driven culture) Choosing the right KPIs throughout the organization can ensure focus of addressing issues with the highest impact; having a culture of openness can increase learning of the organization (example the importance of reporting green, yellow, red) Only when the quality and business strategies and objectives are the same quality is engrained in the general business 8

9 D. Resource Management Reporting structures show the commitment to and importance of quality in the organization Quality reporting to Quality throughout the organization ensures independent thinking and decision making Quality budget responsibilities independent of operations is important Balance of resources to ensure the right allocation between Proactive Using resources to drive continual improvement and prevent things from happening (can be budgeted) vs Reactive Using resources to fix issues (can t be budgeted) (Example: Role of corporate, global groups) 9

10 E. Internal Communication Employees are well informed which increases job satisfaction and encourages a dialog between management and employees (example: A speaking up culture) Decision making and escalation process being well defined enables faster and more informed decisions Quality communication should be delivered from management of both Operations and Quality to show alignment and consistency of message Communication needs to be relevant pointing to both issues and solutions/direction Sharing of information around issues can help avoid them in other areas and best practice sharing spreads knowledge (example: inspectional observations) 10

11 F. Management Review Management reviews ensure PQS remains current and adjustments are made timely Provides forum for assessing the health of PQS, products and process when focused on the most relevant parameters Important that both Operations and Quality are represented at the right management level Forum to identify sites that are falling behind and sites that have best practices to share (Example: PQS, PQM, Ops management reviews) 11

12 G. Management of Outsourced Activities and Purchased Materials Reliable supply (no stock outs) Establish control strategy per product rather than site Strong oversight of suppliers Dual supply strategy Drives suppliers to meet Q10 requirements Management should understand that for patients the product should be the same quality no matter whether produced inhouse or outsourced what are the controls in place? Will we have certified suppliers to Pharma? 12

13 H. Management of Change in Product Ownership Agility to act immediately when a situation arises Having a rigorous PQS strengthens your position in the market place Makes your company more valuable because it indicates modern quality thinking and cgmp compliance When changing elements of a PQS during change of product ownership it is important to honor prior Health Authority commitments 13

14 PQS Value Proposition Operating as one company with common processes, document and tools enables flexibility and agility Less compliance issues across the network when the same requirements are applied Reliable supply no stock outs, less supplier issues when rigorous oversight is applied Actively incorporating quality into general business processes can lead to waste reduction through continual improvement Employees are developed and motivated when quality becomes more than just compliance with the regulations