USING OPERATIONAL EXCELLENCE (OPEX) AND LEAN MANAGEMENT TO IMPROVE ORGANIZATIONAL INTELLIGENCE

Transcription

1 PHARMATALK 11 TH MAY 2015 BERLIN USING OPERATIONAL EXCELLENCE (OPEX) AND LEAN MANAGEMENT TO IMPROVE ORGANIZATIONAL INTELLIGENCE Dr. Joerg Tautrim Strategic Lean consultant, Director Lean Institute Germany Dedicated to Lean Management since 1992 LI Logo Global Lean Institute Firmenprofil Referenzen und Praxisbeispiele 2015 Dr. Jörg Tautrim Engineering

2 SENIOR MANAGEMENT CONSULTANT PROFILE JOERG TAUTRIM Contact Joerg Tautrim Mobil: Office: Fax: Degrees Dipl.-Ing. automatiion engineer and industrial software PhD TPM Consulting Certificate iwi Prof. Scheer Career / Functions Age: 49 years Siemens AG PhD Siemens / Ford Motor Company 2001 Lean Institute (Owner and founder) Photo Industries / Sectors Pharmaceutical / medical device industry (GMP / FDA) Food and Beverage Industry Chemical industry Automotive supplier Electro- / Electronics Printing and paper processing Administration, Sales, Engineering, Languages German (mother tongue) English (contractual level) French (fluently) Spanish (beginner) Projects (Excerpt) Project management many Lean projects; Efficiency improvement; OPEX E.g. Lean Production System implementation for 2 sites (Chemical) Master plan and strategic investment planning; factory evaluation Lean Green Belt Executive program international group Lean Green Belt Administration program Lean Production Tools (TPS) and Lean Administration Tools Lean Leadership seminars and Workshops Value Stream Mapping, Policy deployment, KPI-systems Lean Management Process, Personal statement to Lean / customer value (My_LEAN) It s our mission to assist customers to become independent of consultancy; furthermore to develop the site for further employment and growth.

3 PHARMATALK 2015 BERLIN 11TH MAY 2015 Dr. Joerg Tautrim; Lean Institute Germany Co-Option Dottore Claudio E. Manzati; Lean Institute Italy ; Qualified Person (QP) LEAN and OpEx tools in an Integrated Management System (Quality management, Six Sigma and Lean management) - One size fits all or dedicated approach Employee development feeding into a process based lean management system Working with customers / suppliers across the lean management system to identify the needs and requirements Process re-design: Mapping out processes, identify potentials and fitting them Managing the change and anchoring in the organization: say what we do and do what we say - how to achieve a sustainable culture change

4 PHARMA List of Abbreviations ANOG Analysis of Goodness ANOVA Analysis of Variance API Active Pharmaceutical Ingredient APR Annual Product Review AQL Acceptable Quality Level AR Attrition Rate CAPA Corrective and Preventive Action CDER Center for Drug Evaluation and Research CFR Code of Federal Regulations (e.g. 21 CFR Part 11 cgmp Current Good Manufacturing Practice cgxp Current Good {Area, Function} Practice CMA Critical Material Attributes CPP Critical Process Parameters CQA Critical to Quality Attributes DMAIC Define, Measure, Analyze, Improve, Control DMADV Define, Measure, Analyze, Design, Verify EHS Environment, Health and Safety FDA Food and Drug Administration FMEA Failure Mode and Effects Analysis HACCP Hazard Analysis and Critical Control Points HAZOP Hazard and Operability Method HPLC High Performance Liquid Chromatography ICH International Committee on Harmonization ICH (Q8) Pharmaceutical development ICH (Q9) Quality Risk management (>> FTA; HACCP; HAZOP; FMEA) ICH (Q10) Quality management IQA Incoming Quality Assurance Inspections and Testing ISO International Standards Organization LIMS Laboratory Information Management System LSS Laboratory Summary Sheet LSS Lean Six Sigma MBR Manufacturing Batch Records MS Mass Spectroscopy PAR Proven Acceptable Range PAT Process Analytical Technology PDQC Product Development Quality Control PM Process Management PQS Pharmaceutical Quality System QRM Quality Risk Management SCADA Supervisory Control and Data Acquisition System SOP Standard Operation Procedure (Operational SOPs; Maintenance SOPs; etc.) QbD Quality by Design QC / QA Quality Control / Quality Assurance OpEx Operational Excellence QMS Quality Management System (Framework to demonstrate and to ensure QP Qualified Person that the drugs manufactured are safe and efficacious)

5 DETAILED PRACTICAL EXPERIENCE IN THE INDUSTRY (PHARMA) ANALYSIS OF THE COMPLETE SUPPLY CHAINS TO IMPROVE THE USE OF API Reduction in raw material losses OPTIMIZATION OF PLANNING AND CONTROL Batch-driven production in plants in interaction with central storage depots EFFICIENCY INCREASE IN MANUFACTURE AND PACKING Machine productivity (technology, machine setter) Shortening of the change-over times Reduction in the cleaning times Standards in batch manufacture Efficiency improvement in the laboratories, analytics Improvement in quality control, approval processes

6 MORE EFFICIENCY IN PRODUCTION, LOGISTICS, OFFICE, MAINTENANCE, LEAN ENTERPRISE Lean Institute Germany Technology leader for sustainable success Result: YOUR SUCCESS At the end it s the bottom-line that counts! Organization: Management: Lean Systems Thinking: Our Competencies: Our Services: Organization Consultancy Senior Lean Management Best Practices for Production & Service depts. companies The best Lean or Six Sigma Methods only function in the right, organizational framework! We don t know the Lean Sigma Best Practices from the books, but from our own leadership experience and responsibility! Lean Production / TPM Consultancy Training Workshops Lean Office Consultancy Training Workshops Lean Logistics Consultancy Training Workshops Six Sigma Data analyses & Black Belts E-Learning / web-based training One Standard for all sites! LI Logo Global Lean Institute Firmenprofil Referenzen und Praxisbeispiele 2015 Dr. Jörg Tautrim Engineering

7 THE PHARMACEUTICAL INDUSTRY IS PARTLY CHARACTERIZED BY Why you should think about a new focused, integrated strategy General legal conditions (FDA, GMP, ); large amount of documentation (manufacturing records, etc.); very high quality (documentation) costs Batch production; batch operation and complex planning High-grade active ingredients; API (active pharmaceutical ingredients); no API management Interfaces between company and contract manufacturer Increasing international division of the value creation process; SCM risks and complexity High amount of destroyed raw materials, packaging, finished goods; batch rejections; CopQ High inventories of raw materials, packaging and finished goods Elaborate quality processes, laboratory, analytics; high personnel costs in indirect areas Low machine productivity; special packaging area (picking and packing) Low manufacturing productivity in the clean room; batch production, mixing, coating, weighing,

8 PQS AND LEAN MANAGEMENT: HISTORY Some important milestones Pharma Quality System PQS Milestone(s) Evolution of regional GMPs Evolution of ISO 9000 approaches Year(s) 1970s 1980s FDA 21 st Century initiative 2002 ICH Quality Vision / Q8, Q Guidance for Industry - Quality System Approach to Pharmaceutical cgmp Regulations ICH Q10 Pharmaceutical Quality System (PQS) Year(s) Lean Sigma OpEx Milestone(s) 1920s Integrated production cycle; assembly line 1950 Statistical Quality (Shewart, Deming) 1960 TPS Toyota Production System (Ohno) 1980 JIT Just In Time (TPS) 1990 Kaizen, «Lean Manufacturing» 1990 BPR Business Process Re-engineering 1990 Six Sigma (Motorola, GE) 2000 Lean Sigma 2000 Lean + GMP 2005 Toyota Way Toyota Thinking (4P) Integrated Management Systems (IMS)

9 THE LEADING QUALITY SYSTEM Source: Quality Systems Approach to Pharmaceutical CGMP Regulations FDA UCM pdf Production System Management responsibilities Packaging and Labeling System Quality system [Six-system Inspection Model] Facilities and Equipment System Evaluation Activities Quality systems model Resources Materials System Laboratory Control System Manufacturing Operations

10 THE PHARMACEUTICAL INDUSTRY AND FDA DIRECTION FDA paradigm shift (FDA 2003): Pharmaceutical manufacturing is evolving from an art to one that is now science and engineering based. Effectively using this knowledge in [ ] can substantially improve the efficiency of both manufacturing and regulatory process. This initiative is designed to do just through an integrated systems approach to product quality regulation founded on sound sciences and engineering principles for assessing and mitigating risks of poor product and process quality [ ]. Question 1: Can Lean Management / Six Sigma support? Question 2: What else is Lean Management / Six Sigma if not a structured, scientific approach to approach and solve problems?

11 THE PHARMACEUTICAL INDUSTRY AND OPPORTUNITIES IN LABORATORIES Laboratories and Lean Management implementation Typical opportunities for improvement in laboratories 1. Stressed analysts, hurry to complete testing and deliver test results; overtime costs 2. Highly variable lead times 3. Highly variable incoming workload 4. Lack of resource planning and allocation 5. Poor laboratory layout 6. Poor analyst cross-training 7. Too much work-in-process 8. Poorly implemented laboratory information management systems (LIMS); e.g. interfaces 9. Poor transparency about department status / performance, testing equipment status / performance Overall: poor use of lean tools; lean management thinking

12 THE PHARMACEUTICAL INDUSTRY Conclusion In a lean pharma manufacturing environment, cgmp, Six Sigma and Lean must be equal partners. It s evident that, not only due to regulations, with regards to product quality and product safety, cgmp is the binding, non-negotiable standard. The cgmp standards, Six Sigma together with Lean methods and principles must be embedded into the culture of an organization and the business strategy must reflect this. Lean Tools and Methods are Best Practices to increase efficiency in all areas of a company and involves every employee in structured problem solving. Six Sigma Tools and Methods are Best Practices to reduce variation in all processes and to investigate problems scientifically to achieve a breakthrough success