Design and Validation of a Comprehensive Model for Risk
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Design and validation of a comprehensive model for risk-assessment in product development Amalgamation of Risk Management Standards as a Blueprint for Management of Risk in product development by Dipl.-Ing. Rainer Vieregge A thesis submitted in partial fulfilment of the requirements for the degree of Doctor of Philosophy in Electrical Engineering Approved Dissertation Committee Prof. Dr. Werner Bergholz Professor of Electrical Engineering Jacobs University Bremen Prof. Jens Froese Professor of Logistics Jacobs University Bremen Prof. Dr. Julia Bendul Professor of Logistics Jacobs University Bremen Prof. Dr. Wilfried Lux Professor of Financial Management and Controlling University of Applied Sciences St. Gallen (CH) Dipl.-Chem. Dr. Bernd Siemensmeyer Centre of Competence Accessories & Consumables Dräger Safety AG & Co. KGaA Date of Defense: January 12th, 2016 Computer Science & Electrical Engineering 0 Statutory Declaration Statutory Declaration (Declaration on Authorship of a Dissertation) I, Rainer Vieregge, hereby declare, under penalty of perjury, that I am aware of the consequences of a deliberately wrongly submitted affidavit, in particular the punitive provisions of § 156 an § 161 of the Criminal Code (up to 1 year imprisonment or a fine at delivering a negligent or 3 years or a fine at a knowingly false affidavit). Furthermore, I declare that I have written this PhD thesis independently, unless where clearly stated otherwise. I have used only the sources, the data and the support that I have clearly mentioned. This PhD thesis has not been submitted for conferral of degree elsewhere. Bremen, June 06th, 2017 Signature ___________________________________________________________ Page 3 of 163 0 Abbreviations Abbreviations AIAG Automotive Industry Action Group AS Australian Standard CMMI Capability Maturity Model Integration CPk Process Capability Index CRS customer requirement specification [Lastenheft] D Detectability (E Entdeckung) DGQ Deutsche Gesellschaft für Qualität DPEA Deutscher Project Excellence Award DRAM Dynamic Random Access Memory EFQM European Foundation for Quality Management ETA Expected Time of Arrival FMEA Failure Mode and Effect Analysis GPM Gesellschaft für Projektmanagement ICV Internationaler Controller Verein eV IGC International Group of Controlling ILEP Initiative Ludwig-Erhard-Preis IM:PULS IM Impact P Plan (Planen) U Do (Umsetzung) L Check (Lernen) S Act (Stabilisieren) ITRS Technology Roadmap for Semiconductors MIL Military Standard NDP New Product Development Process Page 5 of 163 0 Abbreviations NZS New Zealand Standard O Occurrence (A Auftreten) PDCA Plan – Do – Check – Act (Deming Cycle) PR Project Review PTA Planned Time of Arrival QFD Quality Function Deployment QM Quality Management R&D Research & Development RADAR Results Approach Deployment Assessment Review RM Risk Management RPF Risk Priority Figure (RBZ Risiko Bewertungs Zahl [SxO]) RPN Risk Priority Number (RPZ Risiko Prioritäts Zahl [SxOxD]) S Severity (B Bedeutung) SPC Statistical Process Control SPICE Software Process Improvement and Capability Determination TC Technical Committee TRM Technical Risk Management TRS technical requirement specification [Pflichtenheft] TQM Total Quality Management USP Unique Selling Proposition VDA Verband der Automobilindustrie Page 6 of 163 0 Abbreviations VDI-GSP Verein Deutscher Ingenieure - Gesellschaft Systementwicklung und Pro- jektgestaltung Page 7 of 163 0 Glossary Glossary Potential Effect(s) of Failure: „Effect(s), which may be caused by the occurrence of a potential failure. The consequences can be for one of the following opera- tions (internal customers) or the end customer experience (external cus- tomer).“ Severity: „The degree of severity of the Potential Effect(s) of Failure. Failures appear with serious consequences as high risk, i.e. with a high ranting number for the risk (rating value). “ Cause: „Potential cause for failure. “ Occurrence: „Probability of the occurrence of the potential cause. Frequent occur- rence appears to be risky, i.e. it is assigned a high-risk number (rating value)“ Object: The term "object" is used for all the concrete items in a development project: samples, project planning, prototyping, costing, risk analysis, etc. Maturity: The term maturity is commonly described in terms of the ability of an organ- ization or of a particular method or action. Quality: DGQ: „Realisierte Beschaffenheit einer Einheit bezüglich der Qualitätsforder- ung“- „Implemented Characteristics of a unit with respect to the quality require- ments“ ISO 9000: „Grad, in dem ein Satz inhärenter Merkmale Forderungen erfüllt“ - “Degree to which a set of inherent characteristics fulfills requirements” Fachkreis „Qualität & Controlling“: „Qualität ist der Grad der Erfüllung von Vereinbarungen (Forderungen) und Erwartungen“ (Wünschen) bezüglich Merkmalen, Terminen und Kosten“- „Quality is the degree of fulfillment of agreements (requirements) and expectations (wishes) with respect to charac- teristics, deadlines and cost“ Control Board (Dräger 2012, page 15): The Control Board is - if necessary - a com- mittee from the project sponsor that takes over for the project, the project man- agement tasks and responsibilities of the project principal. The members of Page 9 of 163 0 Glossary the Control Board are selected so that they represent the most important peo- ple and groups involved in the project. The project manager will inform the members of the Control Board regularly about the current status of the project, so they can react in time in case of deviations from the project plan. The Con- trol Board is the first escalation path for the project manager (except for Project Change Request, 7.4). Complexity vs. Complicatedness: The main difference is the following: Assuming that an item or issue is complex, one needs to research / learn something new or innovative or understand the issues in order to overcome the issue and take the appropriate corrective actions. When an item or an issue is complicated, it requires "only" extended efforts to cope with, all based on existing knowledge. Risk: The word "risk" appears in several languages Arabic: "Gift, random and unexpected, but some luck" Ancient Greek: "root, Cliff" Chinese: "probability of danger" Italian (15th century): "danger, risk"; Italian from older. ris (i) co, actually "cliff (which a vessel is circumnavigating)" Page 10 of 163 0 Table of figures Table of figures Figure 1: List of risks ................................................................................................ 27 Figure 2: Risk evaluation – initial – expected after corrective action – after corrective action ........................................................................................................................ 27 Figure 3: Stage Gate Process at Dräger Safety (Dräger 2012) ................................ 28 Figure 4: Exemplary risk categories and classification of technical risks (Wißler 2005, page 25) ................................................................................................................... 34 Figure 5: Toyota – start up and pre-production cost depending on Quality Function Deployment (QFD) (Sullivan, Lawrence P. 1986) ..................................................... 40 Figure 6: Reduction in the early fail rate of central processing units (CPUs) at Intel over 2 decades (Crook, D.L. 1990, page 2-11): ........................................................ 41 Figure 7: Reduction of ramp up times for the successive generation of Dynamic Random Access Memories (DRAMs) ....................................................................... 42 Figure 8: Relationships between the risk management principles, framework and process (ISO 31000, 2009)....................................................................................... 46 Figure 9: Classification regarding the research method and description of relatively recent academic papers relevant for this thesis ........................................................ 47 Figure 10: Economic relevant quality (English text – see list above) ........................ 51 Figure 11: Deming Cycle .......................................................................................... 52 Figure 12: RADAR of the EFQM model – illustration of the context between RADAR and Deming Cycle .................................................................................................... 53 Figure 13: IM:PULS model ....................................................................................... 54 Figure 14: Cost per failure along product life cycle (Pfeiffer, T. 2010) ...................... 55 Figure 15: The KANO model (extended) .................................................................. 57 Figure 16: Mean percentage change in the performance of the award-winning companies compared to the comparison companies for (Boulter, L. et al. 2005) ..... 60 Figure 17: cost estimation regarding defect prevention and failure cost for changes (DGQ 2008) .............................................................................................................. 63 Figure 18: Examples for functional requirement categories (in terms of severity). The format is derived from an Excel tool which has been developed as part of this project which will be introduced later and which serves to reduce the administrative overhead to the proposed tool for product development risk management. ............. 69 Page 11 of 163 0 Table of figures Figure 19: Examples for non-functional categories