Vom Modell zur Realität From the Model to Reality

1. Vom Modell zur RealitätFromthe Model to Reality Gerd Dautel, 29. September 2011 • BPMN-Modelle im Zentrum eines integrierten Qualitätsmanagementsystems • BPMN Models in thecenterof an integrated QM system

2. The Regulatory Environment for Medical Devices is complex! ROW USA Europe Directives &Laws MDD Laws … QSR Laws … (Korea) Laws … (Japan) Laws … (China) Laws … Laws … MPG Standards Stan-dards … Stan-dards … AAMI Stan-dards … UL IEC ISO Guidance &Best Practice Guid-ances … Adva- Med FDA AAMI Guid-ances … GHTF Establish regulatory requirements Harmonize, standardize & establish Business Needs … CorporateRequirements Corporate QM System Policies Local QM Systems

3. Quality Management Systems in the Medical Device Industry - • Follow QSR & ISO structure. • They are diverse, use different notations, formats, language. • Procedures have unclear interfaces. • The quality system and the business (processes) live in parallel. • And they are : • complex, • burdensome, • confusing, • verbose, • redundant, • inconsistent, • ambiguous, …

4. What would we need? • A business oriented approach. • Regulatory requirements which are understandable and related to daily doing. • Procedures which are easy to find and to understand. • A system which does not become complex and burdensome over time. • A discipline for and a culture of continuous improvement. iQMS = an integrated Quality Management System

5. iQMS is constructed using BPMN Strategy

6. Level I – The Big Picture • Characteristics • Uses BPMN in a very loose manner. • Identifies all top level business processes. • Shows major interrelationships.

7. Level II – Business Process Maps • Characteristics • Use BPMN in a very simplistic manner. • Maps tell a “story” (the inner logic of a business process). • They are refined down to the level of procedures. • Help to find procedures quickly. • Are “design specs” for procedures. • Help to balance procedures. • Ensure consistent interfaces. • Helps to avoid silos.

8. Level III – Procedures • Characteristics • Use BPMN in a correct, descriptive manner. • Procedures start with their task flow description. • The task flow structures the procedure. • Integrate regulatory and business requirements on a task level. • Define the cooperation between different roles. • Have consistent interfaces.

9. Level IV – Instructions • Characteristics • Instructions (and training material) use BPMN in a detailed manner. • BPMN workflows may be supplemented by any helpful icons or notations. • Provide detailed directions and requirements for a specific task. • Keep interfaces consistent.

10. Level IV – Methods • Characteristics • Use BPMN in a descriptive manner. • Explain the principle, how a certain task shall be performed. • Don’t have the very detailed and prescriptive level of instructions. • Integrate regulatory and business requirements. • Define the cooperation between different roles. • Keep interfaces consistent.

11. Level IV – Training Material • Review Rules (from a training slide) • Purpose is to confirm that work is complete and accurate. • They are not meant to be a brainstorming session! • Perform them when the work is ready to be reviewed! • Individual reviews may be subdivided or combined as long as all requirements are met. • Additional activities may always be added to the scope of review. • Supported by SOP and form!

12. Procedures call Instructions (Excerpt from Product Design procedure)

13. Important iQMS building blocks • Further standardization, automation and effectiveness and efficiency measures. • Structures iQMS in a Business Process Hierarchy using BPMN. • Is a skeleton for future growth of the system. • The “Business Process Modeling and Notation” is our standard business process description language. • The “Information Mapping” method structures procedures and instructions for readability. • Interfaces need to be understood and properly modeled. • Procedures are the cradle of roles. • A unique definition of roles is important. • About how to express requirements simple and clear. Constructs & Modeling methods

14. Goals, Business Requirements, Risks and Objectives, Rules Standards, Controls ! § KPIs, Metrics Regulations Value Chains, Value Networks Products and Organizational Services Structure, Roles Business Processes, Procedures, Events Physical Business IT Systems Resources Objects, (Machinery, Data, Equipment) Documents Status & Outlook • Source: Prof. Dr. Allweyer, University of Applied Sciences Kaiserslautern

15. Lessons learned • BPMN is very valuable for creating a business process hierarchy! • All levels are “a unified whole”; • Rules or patterns for top down design would help; • All requirements (regulatory & business) are integrated, which makes them manageable. • BPMN supports a common “look & feel” across business process levels, procedures and specifications. • Used in procedures, instructions, training material, design specs, manufacturing specs, etc.; • BPMN rule set and patterns to be developed internally; • BPMN needs to be supplemented by documentation structure and writing rules.

16. Lessons learned, ctd. • Keep a BPMN based business process & QM system balanced and consistent. • Establish on top levels clear and simple interfaces, and refine those on lower levels; • Maps tell a story (the inner purpose of a business process); • Consider the rule of thumb for avoiding complexity ( 7+/- 2 elements / process map); • Keep process and task flow depictions clear and harmonic (e.g. aligned at grid); • Define the purpose of processes & procedures; • Define interfaces; • Procedures should have about the same length; • Establish a lectorate.