Insights into the St.Gallen OPEX and Quality Metrics Research

Transcription

1 Insights into the St.Gallen OPEX and Quality Metrics Research GSIA SSPI New Year Event & New Member Welcome Drink Prof. Dr. Thomas Friedli Nicolas Ponce January 23, 2018

2 Agenda Introduction St.Gallen OPEX Model & Benchmarking Insights from FDA Quality Metrics Research QC Lab OPEX Benchmarking Contact 2 ITEM-HSG

3 The University of St.Gallen Production Management at the Institute of Technology Management University of St.Gallen (HSG) Founded in 1898 Ranked 1st in the German speaking area in the Handelsblatt ranking for business management research, Ranked 4 th in FT Ranking European Business Schools 39 institutes and 5 schools (Management, Economics and Political Science, Finance, Law, Humanities and Social Sciences) students (25% international students), 719 research associates, 93 professors Institute of Technology Management (ITEM-HSG) 4 professors for Production Mgmt., Innovation Mgmt., Operations Mgmt. and Entrepreneurship with 40+ research associates Biggest Institute at the University of St.Gallen Production Management (ITEM-PM) Led by Prof Dr. Thomas Friedli Currently 12 research associates Competence Centers: Global Production Networks, Operational Excellence, and Smart Manufacturing & Services High industry focus with 20+ industry-, 4+ benchmarking- and 4+ industry related research projects per year 3 ITEM-HSG

4 Division of Production Management Prof. Dr. Thomas Friedli Professor of Management with special focus on Production Management ' +41 (0) * thomas.friedli@unisg.ch Manuela Landert Personal Assistant ' +41 (0) * manuela.landert@unisg.ch Dr. Lukas Budde Project Leader ' +41 (0) * lukas.budde@unisg.ch Operational Excellence/Pharma Stephan Köhler Research Associate ' +41 (0) * stephan.koehler@unisg.ch Nicolas Ponce Research Associate ' +41 (0) * nicolas.ponce@unisg.ch Paul Buess Research Associate ' +41 (0) * paul.buess@unisg.ch Julian Macuvele Research Associate ' +41 (0) * julian.macuvele@unisg.ch Steffen Eich Research Associate ' +41 (0) * steffen.eich@unisg.ch Global Production Michael Wiech Research Associate ' +41 (0) * michael.wiech@unisg.ch Marian Wenking Research Associate ' +41 (0) * marian.wenking@unisg.ch Christoph Benninghaus Research Associate ' +41 (0) * christoph.benninghaus@unisg.ch Christian Elbe Research Associate ' +41 (0) * christian.elbe@unisg.ch Smart Manufacturing & Services Lorenz Stähle Research Associate ' +41 (0) * lorenz.staehle@unisg.ch Dominik Kohr Research Associate ' +41 (0) * dominik.kohr@unisg.ch Philipp Osterrieder Research Associate ' +41 (0) * philipp.osterrieder@unisg.ch 4 ITEM-HSG

5 Former and Current Research and Project Partners Industry Research 5 ITEM-HSG

6 Agenda Introduction St.Gallen OPEX Model & Benchmarking Insights from FDA Quality Metrics Research QC Lab OPEX Benchmarking Contact 6 ITEM-HSG

7 Our Definition of Operational Excellence The St.Gallen understanding The Division of Production Management at the University of St.Gallen defines Operational Excellence as a philosophy directing an organization towards continuous improvement. It is the balanced management of cost, quality and time focusing on the needs of the customer. It comprises structural & behavioral changes to support the needed activities the best way possible. To be sustainable it has to be pushed by Top Management and to be designed to engage every single employee. Operational Excellence is not only about performance, it is also about the way an organization achieves superior performance and about how it continuously improves itself 7 ITEM-HSG

8 The St.Gallen Operational Excellence Model A Framework for thinking about OPEX The St.Gallen OPEX model consists of a technical and a social sub-system 8 ITEM-HSG

9 New Technology-specific Performance Assessment New segmentation by technologies of pharmaceutical manufacturing Drug Substance Drug Product & Primary Packaging Secondary Packaging Chemical API Biologics Solids Creams Suppositories Sterile Liquids Non-Sterile Liquids Patches Inhalers Packaging An aggregated average over all technologies becomes no longer necessary! 9 ITEM-HSG

10 Key Performance Indicators in the Benchmarking Different KPIs are used in order to get a holistic picture of the status quo Total Preventative Maintenance KPIs Total Quality Management KPIs Just in Time KPIs KPIs in the technical and social sub-system Split into Formulation, Primary Packaging and Secondary Packaging: Setup and Cleaning Dedicated Equipment Unplanned Maintenance Shift Model & Length, Line Staffing OEE Maintenance Costs per Conversion Costs Split into Formulation, Primary Packaging and Secondary Packaging: Yield Release time Deviations per Batch Deviation Closure Time Reoccurring Deviation Cpks Complaint Rate (Customer) Complaint Rate (Supplier) Right First Time Rejected Batches Mean time between failure Scrap Rate Number of tests Critical TO Quality (CTQ) Quality Costs per Conversion Costs Split into Formulation, Primary Packaging and Secondary Packaging: Order Lead Time Production Lead Time (Waiting, Production & QC/QA) Replacement Time to Customer Days on Hand (DOH) Service Level Delivery (OTIF) Service Level Supplier Forecast Accuracy Production Schedule Accuracy Priority orders Production Freeze Period Number of Stockouts Cycle Time Material Turns (Raw Material; Work-in- Progress; Finished Goods) Changeover Time (Country, Format & Product Change) Number of Changeovers (Country, Format & Product Change) Effective Management System Management Layers Management Span of Control Group work Functional Integration Quantity of Suggestions Quality of Suggestions per employee Employee Fluctuation Sick Leave Overtime Training Level of Qualification Level of Safety 10 ITEM-HSG

11 What We Also Investigate Enabler Categories, sub-categories and Enabler Sub-Categories Categories Total Productive Maintenance Preventative Maintenance Technology Assessment & Usage Total Quality Management Just-In-Time Effective Management System Basic Elements Housekeeping Enabler 11 ITEM-HSG

12 A Balanced Approach for the Performance Calculation Consideration of a variety of KPIs to capture the performance holistically Performance Calculation Sample Normalization Categorization Calculation All site KPIs All site KPIs normalized Category scores Overall Performance score KPI 1 KPI 2 KPI 3 KPI n Percentile Rank KPI 1 (%) KPI 2 (%) KPI 3 (%) KPI 4 (%) KPI 5 (%). (%) (%) (%) KPI n (%) Addition* TPM TQM JIT Addition* Performance Absolute values Relative value (%) Scores (%) Overall score (%) 12 ITEM-HSG

13 OPEX Benchmarking Report Your benefit: A personalized benchmarking report TPM Performance TQM Performance JIT Performance Table of Content For each element (TPM, TQM, JIT, and EMS) the personalized report comprises multiple KPIs comparing you with your peer-group for each technology. 13 ITEM-HSG

14 Agenda Introduction St.Gallen OPEX Model & Benchmarking Insights from FDA Quality Metrics Research QC Lab OPEX Benchmarking Contact 14 ITEM-HSG

15 Quality Metrics Goals defined / Questions asked by the FDA Goals Identify situations in which there may be a risk for drug supply disruption Improve FDA s evaluation of drug manufacturing and control operations Improve the efficiency and effectiveness of established inspections Further develop the FDA s risk-based inspection scheduling FDA questions to be answered What is the state of quality in the pharma industry? Which sites are the highest risk? Which products are at risk of shortage? How do we best utilize our resources? How do we optimize inspections? How do we encourage companies to improve? Source: Presentation on Draft Guidance for Industry: Request for Quality Metrics 15 ITEM-HSG

16 FDA Funded Quality Research of University of St.Gallen Learning from the St.Gallen OPEX Benchmarking database WP1: FDA metrics Analysis - In-depth examination of current FDA metrics - Statistical evaluation of hypotheses Initially, a 1-year research project on quality metrics University of St.Gallen is the only awarded institution to do quality research for FDA St.Gallen OPEX Benchmarking database comprises numerous quality metrics and structural factors for comprehensive analysis that takes into account context characteristics of different PharmaCos Industry Advisory Board allows St.Gallen project team to discuss intermediate outcomes throughout the research period WP2: STG Quality Metrics Evaluation - Development of a research-driven set of quality metrics - Gap analysis between St.Gallen and FDA metrics WP3: Align outcomes and draw conclusions - Derive modified set of metrics - Examination of implementation challenges WP4: Testing & Refining of proposed metrics - Use access to industry to check practicability - Discuss implementation hurdles Industrial Advisory Board Meetings Project fund of FDA was awarded to St.Gallen for a second-year to continue and deepen our research in the field of Quality Metrics 16 ITEM-HSG

17 FDA Final Report Year 1 Final Report Management Summary with key findings Detailed explanation of research approach, scope and findings Outlook on second-year research focus Report available at Final Report for industry was recently made available during the ISPE Annual Meeting end-october ITEM-HSG

18 Pharmaceutical Production System Model - House Customer Complaint Rate PQS Excellence APQR on-time rate Invalidated OOS Lot Acceptance Rate/ 1-Rejected Batches PQS Effectiveness PQS Efficiency Supplier Reliability Operational Stability CAPA Effectiveness Lab Quality & Robustness Structural Factors Cultural Excellence CAPA: Corrective And Preventive Action PQS: Pharmaceutical Quality System 18 ITEM-HSG

19 Pharmaceutical Production System Model Next Step: Improving the understanding of PQS Excellence Market Compliance KPIs: Number of recalls, number of supply stops, others (e.g. withdrawals) Regulatory actions: Number of warning letters, number of 483 s, Others (e.g. Field Alert Reports), Observation of health authorities PQS Excellence: Score build from PQS Effectiveness & PQS Efficiency PQS Effectiveness: Service Level Delivery (OTIF) Customer Complaint Rate Operational Stability: Unplanned Maintenance OEE (average) Rejected batches Deviation Yield Scrap rate Release time (formerly DQ) Deviation closure time (formerly DQ) Lab Quality & Robustness: Analytical Right First Time Engagement Metrics Sick leave Suggestions Training (Quantity) Level of qualification Suggestions (Quality) Level of safety Employee turnover (Incidents) Cultural Excellence: Quality Behavior Preventive maintenance [4] Housekeeping [1] Process management [1] Cross functional product development [1] CAPA: Corrective And Preventive Action PQS: Pharmaceutical Quality System No. of Observations: - From internal audit Cultural Excellence: Quality Maturity Preventive maintenance [3] Housekeeping [2] Process management [6] Cross functional product development [3] Customer involvement [2] Supplier quality management [5] Set-up time reduction [1] PQS Efficiency: Maintenance Cost/Total Cost Quality Cost/Total Cost Cost for Preventive Maintenance/Total Cost FTE QC/ Total FTE FTE QA/Total FTE Inventory Supplier Reliability Service level supplier (OTIF) Complaint rate supplier Lab Investigations Invalidated OOS Total OOS Lab Deviation Events Recurring Deviation CAPAs Overdue Customer Complaints CAPA Effectiveness Number of CAPAs Number of critical overdue CAPAs Number of non-critical overdue CAPAs Requiring Investigation Product Re-Tests due to Complaints Routine Product Re-tests Annual Product Quality Reviews (APQR) APQR On Time Rate Stability Reports Audits 19 ITEM-HSG

20 Overview of Analyses Completed to Date Pharmaceutical Production System Model- House Customer Complaint Rate PQS Excellence Intra-category analysis Inter-category analysis Invalidated OOS Lot Acceptance Rate/ 1-Rejected Batches PQS Effectiveness PQS Efficiency FDA Metrics Supplier Reliability Operational Stability CAPA Effectiveness Cultural Excellence Lab Quality & Robustness Quality Behavior Quality Maturity Structural Factors PQS: Pharmaceutical Quality System, CAPA: Corrective And Preventive Action 20 ITEM-HSG

21 Management Summary of Year 1 Final Report Retrieve report from: PQS Excellence comprises both, PQS Effectiveness and PQS Efficiency. A positive correlation between these two elements of the PPSM exists. The key performance indicator Service Level Delivery (OTIF) has been identified as suitable surrogate for the effectiveness of the Pharmaceutical Quality System. Lot Acceptance Rate and Customer Complaint Rate are reasonable measures for Operational Stability and PQS Effectiveness Operational Stability has a significant impact on PQS Effectiveness. Supplier Reliability has a significant impact on Operational Stability. PQS Effectiveness high performing sites have a significantly higher Cultural Excellence compared to PQS Effectiveness low performing sites. The developed Stability-Inventory Matrix (ISM) allows for a better understanding of the impact of inventory High level of inventory (Days on Hand) can compensate for stability issues but may cover an insufficient process capability. Operational Stability high performing sites have a significantly lower level of Customer Complaints and a significantly lower level of Rejected Batches compared to Operational Stability low performing sites. Sites with low stability and low inventory have the highest risk profile regarding Rejected Batches, Customer Complaint Rate and Service Level Delivery (OTIF). 21 ITEM-HSG

22 OTIF, a Suitable PQS Effectiveness Surrogate! Model interrelations: PQS Effectiveness is the aggregation of Supplier Reliability and Operational Stability. Surrogate reasoning: In order to derive conclusions of the impact of Supplier Reliability and Operational Stability on PQS Effectiveness a surrogate is needed. Objective: Identify a suitable KPI as a surrogate for PQS Effectiveness that has the same characteristics. KPIs Aggregation 1 Aggregation 2 Complaint Rate Supplier Service Level Supplier Supplier Reliability Score Unplanned Maintenance OEE Rejected batches Aggregated PQS Score Yield Operational Stability Score Scrap Rate Release Time Deviation Closure Time Surrogate On-Time-In-Full (OTIF) Perfect order fulfillment (percentage of orders shipped in time from your site (+/- 1 days of the agreed shipment day) and in the right quantity (+/- 3% of the agreed quantity) and right quality) to your customer. 1. St.Gallen Benchmarking On-Time-In-Full definition includes a Time, Quality and Quantity dimension 2. Statistical confirmation of a significant difference of the aggregated PQS Effectiveness between OTIF High and Low Performers 1 1 High Performer (HP): Top 10% for OTIF, Low Performer (LP): Bottom 10% for OTIF PQS: Pharmaceutical Quality System 22 ITEM-HSG

23 2 Delivery Reliability Drivers: Stability and Inventory What impact has inventory on the service delivery level (OTIF)? DOH = 30 days Operational Stability Unplanned Maintenance OEE Rejected batches Yield Scrap Rate Release Time Deviation Closure Time High Stability 1 High stability, low inventory 3 2 High stability, high inventory 4 OS = 50 % Low Low Low stability, low inventory Inventory Low stability, high inventory High Inventory Days-on-Hand Level (DOH) 23 ITEM-HSG

24 Impact of Inventory on Service Level Delivery Inventory-Stability Matrix Service Level Delivery (OTIF) Inventory (Days on Hands) Low Stability, Low Inventory sites (3) have a significantly lower Service Level Delivery (OTIF) compared to all other peer-groups (1, 2, 4) 24 ITEM-HSG

25 Customer Complaint Rate Relation Inventory-Stability Matrix Low Stability, Low Inventory sites (3) have the highest complaint rate. 1 Customer Complaint Rate (CCR) Operational Stability High Stability sites (1, 2) have significant lower CCR compared to Low Stability sites (3, 4). 1 Statistically significantly higher CCR compared to all other peer-groups (1, 2, 4). 25 ITEM-HSG

26 PQS Effectiveness Operational Stability Relation Does the make-to-strategy impact the effectiveness of the PQS? Make-to-Stock (MtS) sites do not show a dependability on Operational Stability to achieve a high PQS Effectiveness 1. PQS Effectiveness Surrogate: Service Level Delivery (OTIF) Operational Stability Make-to-Order sites (MtO) demonstrate an higher PQS Effectiveness 1 when there is a greater level of Operational Stability. 26 ITEM-HSG

27 Operational Stability, Supplier Reliability Relation What is the relation between OS, SR and PQS Effectiveness? Surrogate On-Time-In-Full (OTIF) Operational Stability Unplanned Maintenance OEE Rejected batches Yield Scrap Rate Release Time Deviation Closure Time Perfect order fulfillment (percentage of orders shipped in time from your site (+/- 1 days of the agreed shipment day) and in the right quantity (+/- 3% of the agreed quantity) and right quality) to your customer. Positive relation between these dimensions No direct relation between these dimensions Supplier Reliability Complaint rate (supplier) Service level supplier The relation represents the order of the value chain from supply through operations to delivery. OS: Operational Stability SR: Supplier Reliability Tools: Correlation Analysis, Linear Regression 27 ITEM-HSG

28 PQS Effectiveness, Efficiency Relation Model interrelations: PQS Effectiveness is the aggregation of supplier reliability and operational stability. PQS Efficiency is defined by Cost and FTE Efficiency. Together these dimensions define PQS Excellence. Objective: Identify if the St.Gallen data confirms the theory that a high effectiveness is accompanied with a high efficiency. 1 PQS Efficiency PQS Efficiency Maintenance Cost/Total Cost Quality Cost/Total Cost Cost for Preventive Maintenance/Total Cost FTE QC/ Total FTE FTE QA/Total FTE Operational Stability Supplier Reliability Aggregated PQS Effectiveness Aggregated PQS Effectiveness Positive relation between PQS Effectiveness and PQS Efficiency confirming theory 1. 1 Ferdows and De Meyer (1990) 28 ITEM-HSG

29 Cultural Excellence Introduction Quality Maturity and Quality Behavior Relation Objective: Improve the understanding of quality maturity and quality behavior within pharmaceutical companies across the industry using St.Gallen OPEX Benchmarking database. Research question: What is the relation between Quality Maturity and Quality Behavior? Approach: Matching St.Gallen OPEX enabler to PDA defined categories Quality Maturity and Quality Behavior. Quality Behavior Quality Maturity Definitions Engagement Metrics Quality Behavior: Specific behaviors of individuals in the organization or on site supporting a positive quality culture. Quality Maturity: Objective characteristics of a quality system that can be observed or verified upon inspection that have a positive relation with quality behavior. PDA Categories Quality Behavior Quality Maturity St. Gallen Enabler TPM Enabler TQM Enabler JIT Enabler Preventive Maintenance Technology Assessment and Usage Housekeeping Process Management Cross-functional Product Development Customer Involvement Supplier Quality Management Set-up time Reduction Pull Production Layout Optimization Planning Adherence Effective Management System Direction setting Management Commitment and Company Culture Employee Involvement and Continuous Improvement Functional Integration and Qualification Basic Elements Standardization and Simplification Visual Management In total 59 of more than 100 enablers were assigned to quality behavior or quality maturity. TPM: Total Preventive Maintenance, TQM: Total Quality Management, JIT: Just In Time, EMS: Effective Management System 29 ITEM-HSG

30 Quality Maturity and Behavior Relation The Role of Cultural Excellence in the PPSM PDA Survey Analysis St.Gallen Analysis 2017 A higher Quality Behavior is accompanied with a higher Quality Maturity. R 2 = 0.34 Adjusted R 2 = pharmaceutical sites of different size and focus within St.Gallen database confirm PDA analysis results. 1 Patel, P., Baker, D., Burdick, R., Chen, C., Hill, J., Holland, M., & Sawant, A. (2015). Quality Culture Survey Report. PDA Journal of Pharmaceutical Science and Technology, 69(5), ITEM-HSG

31 Top 10 St.Gallen Maturity Attributes These Maturity Attributes drive Quality Behavior 1. Optimized set-up and cleaning procedures are documented as best-practice process and rolled-out throughout the whole plant. 2. A large percentage of equipment on the shop floor is currently under statistical process control (SPC). 3. For root cause analysis we have standardized tools to get a deeper understanding of the influencing factors (e.g. DMAIC). 4. Goals and objectives of the manufacturing unit are closely linked and consistent with corporate objectives. The site has a clear focus. 5. We have joint improvement programs with our suppliers to increase our performance. 6. All potential bottleneck machines are identified and supplied with additional spare parts. 7. For product and process transfers between different units or sites standardized procedures exist, which ensure a fast, stable and complied knowledge transfer. 8. Charts showing the current performance status (e.g. current scrap-rates, current uptimes etc.) are posted on the shop-floor and visible for everyone. 9. We regularly survey our customer`s requirements. 10. We rank our suppliers, therefore we conduct supplier qualifications and audits. Total number of maturity attributes: 36; Statistical Tool: Multi-Linear Regression 31 ITEM-HSG

32 What s Next? Individual Projects and OPEX Research Group Industry Active interaction Academia FDA Quality Metrics Research Source: Derived from Quality Metrics Session - ISPE Annual Meeting San Diego, CA (2017) 32 ITEM-HSG

33 Agenda Introduction St.Gallen OPEX Model & Benchmarking Insights from FDA Quality Metrics Research QC Lab OPEX Benchmarking Contact 33 ITEM-HSG

34 Why QC Lab Benchmarking? Need for a differentiated approach Motivation In the past, performance measurement was only/ mainly focused on manufacturing In recent time, the awareness for QC performance increased tremendously and first initiatives started Measuring QC performance is demanded across all pharmaceutical companies Objective Address the increased importance of QC Lab performance for the overall OPEX performance of a pharmaceutical company Develop a new benchmarking project deduced from the well-established and industry-tested St.Gallen OPEX Benchmarking 34 ITEM-HSG

35 QC Lab Benchmarking Project started back in 2016 Brief introduction Current effort focused on roll-out of benchmarking exercise across industry with interested pharmaceutical companies (already 43 QC labs in current database) 35 ITEM-HSG

36 QC Lab Benchmarking Model Operational Excellence in Quality Control Labs Overall Quality Control Lab Performance Productivity Quality Service Maintenance & Quality System Planning & Steering System Management System Cost Structural Factors QC Lab Benchmarking is a holistic approach for the assessment of your Lab Performance comprising a comprehensive set of different focus areas for both, KPIs and Enabler 36 ITEM-HSG

37 Key Performance Indicators in your Report Overview on performance KPIs Key Performance Indicators Productivity Handled samples/qc FTE Batches processed/qc FTE Tests/Direct QC FTE 1 Tests/Batch 1 Number of samples per run Dedicated equipment Equipment utilization rate Stock-time for Consumables Organization Span of Control Reporting Layers Qualified Technicians Quality Lab Deviations/1 000 Tests Analytical Right First Time 1 Investigations/1 000 Tests 1 Invalidated OOS/Confirmed OOS 1 Invalidated OOS/ Tests 1 Confirmed OOS/ Tests 1 Recurring Deviation CAPAs Overdue Customer Complaints Requiring Investigation/ Tests Product Re-Tests due to Complaints Annual Product Quality Reviews (APQR)/Products tested APQR On Time Rate Change Controls/Batches processed Batches/Audit Batches/Method Transfer Batches/Method Validation Stability Batches/Stability Report Employee Fluctuation Cross-trained Analysts Group Work Service Lead time 1 Cycle time 1 Release time 1 Adherence to Schedule (ATS) 1 Adherence to Lead Time (ATL) 1 Training Sick Leave Share of Direct QC FTEs 1 Cost Efficiency Total QC/Total QO Cost QO Cost/Plant Absorption QO Cost/QO FTE QC Cost/QC FTE QO Cost/Test QC Cost/Test QC Cost/Batch Overtime 1 Split into Overall and Drug Substance testing, Intermediate testing, In Process Control Testing, Raw Material Testing, Stability Testing, Drug Product Testing, Packaged Product Testing, Microbial Environmental Testing, Microbial Product Testing, Component & Packaging Material Testing 37 ITEM-HSG

38 Enabler Categories, subcategories and example Maintenance & Quality System Preventive Maintenance Technology Assessment & Usage Housekeeping Process Management Standardization and simplification Planning & Steering System Set-up reduction Pull approach Layout optimization Planning adherence Visual management Management System Management Commitment and company culture Employee involvement and continuous improvement Functional integration and qualification Operationalized example question Preventive Maintenance To what degree is there a formal program for maintaining your lab equipment? There is no formal maintenance program Formal program exists but is not widely visible Formal program exists and is visible but is adhered to unevenly Formal program is regularly adhered to but not regularly updated Formal program strictly adhered to and updated regularly Don't know In total, we ask 68 different qualitative self-assessment questions! 38 ITEM-HSG

39 Personalized Benchmarking Report Insights on your lab s performance compared to the relevant peer-group Comprehensive Report with focused Performance Assessment Management Summary with most relevant insights for Productivity, Quality and Service Performance and Enabler implementation level Heat maps showing your relative performance for all KPIs Comparison to your peer-group median and High Performer 1 Detailed overview on structural factors of your lab compared to peergroup Charts illustrating selected efficiency distribution (e.g. cost) An extract of a dummy report is available to get a first impression of the project outcome 1 High Performer represent peer group of Top-Quartile for Overall Lab Performance. 39 ITEM-HSG

40 QC Lab OPEX Benchmarking Database Overview as of today and to-be until late Q1/ ITEM-HSG

41 Agenda Introduction St.Gallen OPEX Model & Benchmarking Insights from FDA Quality Metrics Research QC Lab OPEX Benchmarking Contact 41 ITEM-HSG

42 Upcoming Publication 21c Quality Management No Chapter Title 1 Introduction 2 Understanding the impact of the Changing Regulatory Environment on the cgmp s and the Industry 3 Quality of Pharmaceuticals and Outsourcing: Understanding the inherent risks to the Patient 4 From Compliance to Quality Excellence: Shifting the Pharmaceutical Industry Paradigm 5 Managing Quality in other industries: Lessons for the Pharmaceutical Industry 6 The St.Gallen OPEX Benchmarking Model: Understanding the role of performance measurement in driving continuous improvement 7 The St.Gallen Quality Benchmarking Model: Developing a Quality system analysis 8 Managing beyond Compliance: Overcoming the divide between quality and excellence through integrated system management 9 Fostering a Healthy Culture of Quality: Achieving Cultural Excellence /Examing an Excellence Framework Knowing, Doing, Being 10 Managing Effective Organizational Change 11 Measuring and Managing Quality Proactively 21c Qualtiy Management Friedli, T., Basu, P. K., Mänder, C., & Calnan, N. (2017). 21c Quality Management in the Pharmaceutical Industry. 12 Applicability of the St. Gallen Quality System model case study reflection 13 Continuous Quality Improvement 14 It ain t Eisai Quality the foundation for OPEX 16 The story of John and his black belt project 17 Summary 18 Outlook The St.Gallen Pharmaceutical Production System Model and its Contribution to the FDA Quality Metrics Initiative 42 ITEM-HSG

43 Thank you very much for your attention and contributions! Source: srf.ch (2017) 43 ITEM-HSG

44 Contact Find more information: Prof. Dr. Thomas Friedli Director ITEM-HSG Phone: +41 (0) Paul Buess Operational Excellence Team Phone: +41 (0) Nicolas Ponce Operational Excellence Team Phone: +41 (0) Stephan Köhler Operational Excellence Team Phone: +41 (0) Julian Macuvele Operational Excellence Team Phone: +41 (0) Steffen Eich Operational Excellence Team Phone: +41 (0) ITEM-HSG