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Applying System Theoretical Process Analysis Method to

Change Programs in Integrated Enterprise

by Tan Shuijian

B.Eng., Electrical and Electronics Engineering Nanyang Technological University at Singapore, 2007

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SUBMITTED TO THE MIT SLOAN SCHOOL OF MANAGEMENT AND SCHOOL OF ENGINEERING IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE

OF

MASTER OF SCIENCE IN ENGINEERING AND MANAGEMENT IN CONJUNCTION WITH THE

SYSTEM DESIGN AND MANAGEMENT PROGRAM AT THE

MASSACHUSETTS INSTITUTE OF TECHNOLOGY FEBRUARY 2014

C 2013 Tan Shuijian. All rights reserved

The author hereby grants to MIT permission to reproduce and to distribute publicly paper and electronic copies of this thesis document in

whole or in part in any medium now known or hereafter created.

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Signature 01 AUtU r... Certified by... Accepted by... .4

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,Oem Design and Management (SDM)

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17, 2014

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jV Eric Rebentisch, PhD

Research Associat n Systems esearch Center, MIT , c2_ % R esis Supervisor

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Pat Hale Senior Lecturer Engineering Systems Division, MIT

Director SDM Fellows Program C

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Applying System Theoretical Process Analysis Method to

Change Programs in Integrated Enterprise

By Tan Shuijian

Submitted to the System Design and Management Program on January 17, 2014 in Partial Fulfillment of the Requirements for the Degree of

Master of Science in Engineering and Management

ABSTRACT

Thesis Supervisor: Dr. Eric Rebentisch

Title: Research Associate, Sociotechnical Systems Research Center

Manufacturing and life science enterprises need a flexible and effective approach to respond to industrial compliances and high complexity in stakeholder communication. The paper proposes a system engineering approach in System Theoretical Process Analysis (STPA) as an

enterprise transformation method adopted by IT consultancy firms to better define enterprise requirements for transformation and integrate change interventions into organizational structure. Despite STPA being a hazard analysis method, its corresponding hierarchical control structure applies to organizational structures, with adaptations to value x-matrices based on stakeholder value theory and process models necessary to match operators' mental models for control actions and attain information reusability and harmonized processes. Through alignment of the infological and socio-cultural aspects of integrated enterprises led by change program

management, potential flaws in organizational structures and information systems are identified and proposed for resolution. A qualitative and visual approach using 2 change program cases and lean concept was adopted in this study. Surveys were conducted with program participants, and semi-structured interviews were held with program management to explore perspectives on utilizing the enterprise-adapted STPA. The outcomes are the validation of this method, and lean practice in change interventions as recommendations for integration of processes and

enterprise functions and promotion of program flow.

Keywords: Enterprise Architecture, System Engineering, Change Management, Program Management, Stakeholder Theory, STPA, Architectural Alignment, Communication, lean

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ACKNOWLEDGEMENTS

I would like to thank my advisor Dr Eric Rebentisch for providing me the opportunity to work on this thesis and for providing valuable advice and guidance. Along the journey of the research,

he has consistently expressed confidence, allowing me the autonomy and motivation to approach this topic with vigor and focus. I would also like to thank Tata Consultancy Service, and especially Sathish Kumar Thirugnanam for continually reviewing my work by providing valuable feedback, and Raja Banerji and Anurag Jain for providing support for exploration of this

interesting topic.

Many classes I took at MIT have helped to shape my approach for this research and thus covered in this thesis. Some of the classes include Integrating Lean Enterprise by Prof. Deborah J Nightingale, The Economics of Information: Strategy, Structure and Pricing by Prof. Erik Brynjolfsson, System Safety by Prof. Nancy G. Leveson. I have to especially mention that Prof. Nancy G. Leveson's book Engineering a Safer World - Systems Thinking Applied to Safety has been the motivating factor for this research approach.

The SDM program has provided me with the platform to engage thought leaders in their fields namely Prof. David Simchi-Levi in supply chain and operations, Jeanne W. Ross in IT

architecting, who are worthy of mentions in this thesis. All these would not be possible without the direction of SDM Program director Pat Hale for his dedication to make this program a success today. A personal note of thanks has to be extended to Pat for ensuring the individual needs of us international students are taken care of, so that we can focus on showcasing our talents and exploring our interests. Likewise, I would like to express my deepest gratitude to Singapore University of Technology and Design (SUTD), a fantastic organization which sponsors my graduate studies in MIT.

Finally, I would like to thank my parents, Eng Hua and Lay Pin, for always being supportive of what I strive to do.

And in memory of my granddad who passed away on the week of this thesis submission.

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Table of Contents

Table of Figures...8

Table of Tables ... 9

List of Abbreviations... 10

1 Introduction ... 11

1.1 M otivation for this Thesis... 11

1.1.1 Challenges facing Enterprises ... 11

1.1.2 M anaging for Complexity and Flexibility ... 12

1.1.3 Lean Principles for Change Program Management ... 14

1.2 Research Objective... 15

1.3 Organization of Thesis... 16

2 Industrial Trends and Enterprise Transformation ... 18

2.1 W hat's in for the Industries?... 18

2.1.1 M anufacturing in Automotive ... 18

2.1.2 M edical Devices & Diagnostic in Life Science ... 19

2.2 Enterprise Transformation ... 21

2.2.1 Consulting for Integrated Enterprises ... 21

2.2.2 Enterprise Architecting... 24

2.2.3 Enterprise System Engineering ... 31

2.2.4 ESTPA... 35

2.2.5 Summary... 37

3 Lean on Change Program M anagement ... 39

3.1 Lean Change Programs... 39

3.1.1 Change M anagement M odels... 39

3.1.2 Lean Principles for Change Programs... 44

3.2 Lean M anagement...53

3.2.1 M anaging Change Programs... 53

3.2.2 Process M odel Used in Analysis... 59

3.2.3 Change Program M anagement... 63

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3.2.4 ESTPA in Lean M anagem ent ... 65

4 Research Overview and M ethodologies ... 68

4.1 Research Procedure ... 68

4.1.1 Research Hypotheses ... 68

4.1.2 Selection of Research Participants and Subjects ... 68

4.1.3 Description of Research Design ... 71

4.1.4 Assum ptions, Lim itations & Delim itations ... 73

4.1.5 Proposal w ith TCS ... 74

4.2 ESTPA Execution on TCS Programs... 75

4.2.1 Defining Value for TCS Integrated Enterprise... 75

4.2.2 Generation of Value M atrix ... 76

4.2.3 Hierarchical Control Structures and Process M odels... 81

4.2.4 Evaluating Survey and Interview Outcom es... 84

4.2.5 Extraction of Information from the Engine Manufacturer Change Program...86

5 Research Findings and Validation... 88

5.1 Analysis Results... 88

5.1.1 Findings from Tractor Program's Control Structure ... 88

5.1.2 Findings from Tractor Program's Process M odel... 94

5.1.3 Findings from Engine M anufacturer ... 100

5.2 Lessons Learnt for Change Program s...109

5.2.1 Review of ESTPA in TCS Change Programs ... 109

5.2.2 Im pact on Program M anagem ent... 111

6 Thesis Conclusion ... 115

6.1 Thesis Sum m ary ... 115

6.2 Lim itations of Thesis...115

6.3 Future W ork...117

Bibliography ... 119

Appendices... 124

Appendix A - Survey Questionnaire (Part 1)... 124

Appendix B - Survey Description (Part 1)...131

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Appendix C - Program Manager Interview Questions ... 134

Appendix D - Stakeholder/Actor Value Role ... 138

Appendix E - TCS Tractor and Engine Manufacturer's Change Program ... 143

Appendix F - Major Data from Survey and Interview ... 144

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Table of Figures

FIGURE 1: PHARMACEUTICALS POSITION IN BIG DATA ... 12

FIGURE 2: TOGAF 9 CERTIFICATION FROM THE OPEN GROUP BLOG (22 JULY 2013) ... 13

FIGURE 3: CLINICAL TRIAL - SOURCE "WORLDWIDE MEDICAL & OUTCOME RESEARCH " ... 19

FIGURE 4: SIMPLIFIED INFORMATION FLOW OF PHRMA... 20

FIGURE 5: CONSULTING FIRMS' BUSINESS MODELS (CHRISTENSEN & WANG 2013)... 22

FIGURE 6: THE OPEN GROUP'S ARCHITECTURE DEVELOPMENT CYCLE ... 25

FIGURE 7 : CONTENT METAMODEL WITH U ML (SCHERER AND W IMMER 2012) ... 26

FIGURE 8: LEAN ENTERPRISE'S PROCESS ARCHITECTURE VIEW (SOURCE - NIGHTINGALE & MIZE 2002)... 29

FIGURE 9: HIERARCHICAL CONTROL STRUCTURE (LEVESON 2011) ... 32

FIGURE 10: CLASSIFICATION OF CONTROL FLAWS (LEVESON 2011)... 33

FIGURE 11: LEAN PRINCIPLES TO ENGINEERING (MCMANUS 2005)... 36

FIGURE 12: RELATIONSHIP BETWEEN MENTAL MODELS (LEVESON 2011) ... 40

FIGURE 13: KOTTER'S 8-STAGE CHANGE MANAGEMENT MODEL (KOTTER 2007)... 42

FIGURE 14: LEAN ESTPA... 44

FIGURE 15: HOSHIN KANRI MONTHLY REVIEW (TENNANT & ROBERTS 2001) ... 45

FIGURE 16: TCS's SOLUTION OBJECTIVE MATRIX ... 47

FIGURE 17: DEFINITION OF OBJECTIVES FROM STAKEHOLDER NEEDS (REBENTISCH 2000)... 48

FIGURE 18: EIGHT TYPES OF WASTE IN L EAN PD ... 54

FIGURE 19: FACTORS OF INFLUENCE FOR SOCIO-CULTURAL AND INFOLOGICAL ALIGNMENTS... 57

FIGURE 20: 4 TYPES OF OPERATING MODELS (Ross, W EILL, ROBERTSON 2006) ... 60

FIGURE 21: BUILDING BLOCK FOR PROCESS MODEL ... 61

FIGURE 22: ESTPA IN LEAN PROGRAM ... 66

FIGURE 23: TCS CCBT FRAMEWORK... 70

FIGURE 24: X-MATRIX FOR TCS - TRACTOR MANUFACTURER CHANGE PROGRAM ... 76

FIGURE 25: DESCRIPTION FOR STAKEHOLDERS... 78

FIGURE 26: VALUE MATRIX OF TCS TRACTOR MANUFACTURER ... 79

FIGURE 27: SIMPLIFIED PROGRAM STRUCTURE ... 81

FIGURE 28: DEMONSTRATIVE PROCESS MODEL ... 82

FIGURE 29: TERMINOLOGY FOR INFOLOG ICAL SPIDER DIAGRAM ... 85

FIGURE 30: EXTRACT FROM ENGINE MANUFACTURER ... 87

FIGURE 31: HIERARCHICAL CONTROL STRUCTURE FOR TRACTOR MANUFACTURER CHANGE PROGRAM ... 88

FIGURE 32: SOCIO-CULTURAL-INFOLOGICAL BACKGROUND OF TCS PROJECT MANAGER ... 91

FIGURE 33: SOCIO-CULTURAL-INFOLOGICAL BACKGROUND OF TCS PROGRAM MANAGER ... 93

FIGURE 34: TRACTOR PROGRAM'S PDR PROCESS MODEL ... 94

FIGURE 35: SOCIO-CULTURAL-INFOLOGICAL BACKGROUND OF FINANCE ... 96

FIGURE 36: SOCIO-CULTURAL-INFOLOGICAL BACKGROUND OF SMG ... 97

FIGURE 37: HIERARCHICAL CONTROL STRUCTURE FOR ENGINE MANUFACTURER ... 101

FIGURE 38: SOCIO-CULTURAL-INFOLOGICAL BACKGROUND OF TCS WORKGROUP MANAGER ... 103

FIGURE 39: MODIFICATION TO ENGINE HIERARCHICAL CONTROL STRUCTURE ... 104

FIGURE 40: NEW VALUE MATRIX FOR ENGINE MANUFACTURER PROGRAM ... 105

FIGURE 41: PROCESS MODEL FOR ENGINE PCM ... 106

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Table of Tables

TABLE 1: BENEFITS AND AREAS OF IMPROVEMENT FOR ENTERPRISE ARCHITECTING FRAMEWORKS ... 30

TABLE 2: DESCRIPTION OF STEP-BY-STEP STPA M ETHOD... 32

TABLE 3: STPA ALIGNMENTS IN ADDITION TO MAGOULES ET AL. 2012... 35

TABLE 4: BENEFITS AND LIMITATIONS IN CHANGE MANAGEMENT MODELS ... 43

TABLE 5: STEP SEQUENCE FOR M ODIFICATION A ... 46

TABLE 6: BENEFITS OF LEAN CHANGE MANAGEMENT APPROACH... 52

TABLE 7: FACTORS OF INFLUENCE FOR SOCIO-CULTURAL AREA OF INFLUENCE ... 58

TABLE 8: ESTPA-ASSOCIATED LEAN ENABLERS (EXTRACTED FROM OEHMEN & ET 2012)... 65

TABLE 9: INADEQUATE CONTROL ACTIONS FROM TRACTOR CONTROL STRUCTURE ... 89

TABLE 10: INADEQUATE CONTROL ACTION FROM TRACTOR P ROCESS MODEL ... 95

TABLE 11: PROPOSED ACTIONS FOR TRACTOR PROGRAM FLAW RESOLUTION... 100

TABLE 12: INADEQUATE CONTROL ACTION IDENTIFIED FROM ENGINE HIERARCHICAL CONTROL STRUCTURE ... 102

TABLE 13: SUM M ARY OF H 1, H2 HYPOTHESIS ... 110

TABLE 14: BENEFITS FOR A NALYSIS APPROACH... 112

TABLE 15: RATING OF ESTPA MODELING COMPONENTS FROM PROGRAM MANAGER INTERVIEW... 112

TABLE 16: COMPARISON BETWEEN TCS PROCESS MODEL AND ESTPA PROCESS MODEL ... 113

TABLE 17: PROGRAM MANAGER RATING OF ESTPA ON LEAN ENABLER ... 114

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List of Abbreviations

ADM: Architecture Development Method

CAST: Causal Analysis based on STAMP

CCBT: Customer-Centric Business Transformation

CR: Change Request

CCB/CRB: Change Control Board/Change Request Board DARPA: Defense Advanced Research Projects Agency DSM: Design Structure Matrix

ESTPA: Enterprise-adapted System-Theoretic Process Analysis FDA: Food and Drug Administration

ICA: Inadequate Control Action

INCOSE: International Council on Systems Engineering IS: Information System

IT: Information Technology

MD&D: Medical Devices and Diagnostic MIT: Massachusetts Institute of Technology NPI: New Product Introduction

PCM: Product Change Management

PD: Product Development

PDR: Product Definition Report

PhRMA: Pharmaceutical Research and Manufacturers of America PLM: Product Lifecycle Management

PMI: Project Management Institute R&D: Research and Development RWD: Real World Data

RWE: Real World Evidence

SMG: Senior Management Group

SO: Solution Objective

STPA: System-Theoretic Process Analysis

SUTD: Singapore University of Technology and Design TCS: Tata Consultancy Services

TOGAF: The Open Group Architecture Framework UDI: Unique Device Identification

UML: Unified Modeling Language VSA: Value Stream Analysis

VSM: Value Stream Mapping

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1 Introduction

1.1 Motivation for this Thesis

1.1.1 Challenges facing Enterprises

Product-oriented organizations today are constantly hearing the buzzword - Big Data - and how it can be a game-changer to their success. The explosion in "volume, variety, velocity and veracity" (Institute for Business Value 2012) in data available is a double-edged sword; how enterprises use these big datasets and multiple data sources are constant challenges that are dynamic and need a timely response as they come, yet they serve as competitive opportunities.

Take the consideration of the automotive industry that is at revolutionary crossroad. The emergence of cloud technology, electric vehicle (EV) and automated driving from technological advancement is bringing a new definition to the market automotive manufacturers are currently serving. This demands inflection to existing automobile innovation as they not only serve traditional automobile stakeholders such as Volkswagen and Chrysler, but also meet new demands such as a crowdsourcing channel like Rally Fighter (Munoz, 2013). In the midst of technological disruption, automotive manufacturers are thus exposed to emergent data points that could prove valuable, and demand they are better positioned to reap these communication opportunities. For Medical Devices and Diagnostics (MD&D) in biotechnological and healthcare industry, the Information Technology (IT) movement towards Big Data and Data Analytic is even more pronounced. Pharmaceuticals Research and Manufacturers of America (PhRMA)

members invested US$34.8 billion on Research and Development (R&D) in 2009, "representing

19.0% of domestic sales" (Anon 2013), but are they getting value for their investment?

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Figure 1: Pharmaceuticals Position in Big Data

Also, many companies such as Pfizer, Eli Lilly, Bayer and Daiichi Sankyo are already extracting value in various forms of Big Data analytics (Figure 11). As such, it is imperative that these organizations understand the risks and benefits from engaging these data channels as they are subjected to strict regulation.

1.1.2 Managing for Complexity and Flexibility

Consider organizations having to interface downstream with multiple customers on demands that can be conceptually different, and upstream with various suppliers and partners for support

in physical material and information, operation complexity immediately comes to mind as the number and types of channels to manage grow with complexity. This is made all the more interesting by studying integrated enterprises such as IBM, Accenture or Tata Consultancy Services (TCS), as it is paramount for consultancy organizations to understand clients' values in the form of business strategies and realize IT investments by enabling, supporting and enforcing these strategies (Simchi-Levi, 2010). Major data contribution for this paper thus originates from TCS to demonstrate the collaboration with their tractor manufacturing and engine manufacturing clients.

'This interview with the Pharmaceuticals is conducted in 2013 in fulfillment of course project for "15.571 Business Strategy & Role of IT" in MIT.

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Victor Tang, previously Senior Director and VP of IBM China, and Director of Winter Olympics Technology and Client Relation at IBM, reiterated the success of IT being an end-to-end

process and demonstrated the Zachmann Framework2 as his representation for holistic analysis. The Open Group's TOGAF, an extensive enterprise architecture methodology and framework for enterprise information infrastructure, is also growing in popularity in term of number of certifications attained worldwide (Figure 2).

26000TOGAFO Certication 26000+ d CFotoation STotal 10000 6000 '09 '09 '09 '09 '10 '10 '10 '10 '11 '11 '11 '12 *12 '12 '12 '13 .11 13 Figure 2: TOGAF 9 Certification from The Open Group Blog (22 July 2013)

All these trickle down to the argument for a holistic approach in enterprise and IT architecting, and possibly a systems theory methodology to support holistic thinking.

Why systems theory is considered is due to its foundational ideas of "Emergence and Hierarchy" and "Communication and Control"; its associated causality model called Systems-Theoretic Accident Model and Processes (STAMP) (Leveson, 2011) is adopted by this paper to

2 Zachmann Framework is a schema consisting a 2-dimensional classification matrix based on the intersection of 6

communicative questions What, Where, When, Why, Who and How, with 5 level of reification Contextual, Conceptual, Logical, Physical, Detailed.

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understand the enterprise's complexity in term of its hierarchical structure and control mechanism. The paper predicts that by using this model, analyzing an integrated enterprise system such as TCS and its network of clients within the constraints of its value streams would reveal insights about emergence of desired success attributes. This would be of practical value to program managers for their management of change programs to drive flexibility in client enterprises in the face of fast-changing landscape.

1.1.3 Lean Principles for Change Program Management

While there are many change management models - some well-known being Kotter's 8 stage Model for Change Management, Peter Senge's 5 Step Model of Learning Organizations,

KAIZEN change management, the common advice has been that application should be focused on organizational situational needs (Syeda and Naarananuja 2013). TCS provides the author the interesting proposition to analyze an integrated enterprise and its extension to individual clients such as a tractor manufacturer and engine manufacturer. Based on Customer-Centric Business Transformation (CCBT) Framework3, TCS strives to practice lean to introduce change intervention for its clients in its Product Lifecycle Management (PLM) programs. Organically, how this framework stacks up with lean principles (James P. Womack, 2003) will be of interest.

This learning would eventually be useful as insights to program managers and enterprise

stakeholders, as they grapple with IT demand and challenges of introducing changes within their organizations.

3 The Customer-Centric Business Transformation (CCBT) Framework is a Change Management Model created and

used by TCS to apply change interventions within their clients' organizations.

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1.2 Research Objective

Especially for IT consultancy agencies such as TCS, which relate to its multiple clients in an integrated enterprise environment, problems of missing functions and linkages between

designed processes can naturally impact on decision outcomes of PLM programs and customer satisfaction. This means performance is not optimized, information flow impeded and effort wasted, and reactions might be too late when consultants and business owners identify these lost values. The paper looks to identify an approach that would allow actors to timely identify missing gaps for remedies.

While process models are widely used in enterprise transformation models and, to some extent, organizational change programs, the paper also finds potential in the utilization of control

structures for enterprise modeling. To showcase this potential, the paper presents two TCS client cases in a tractor manufacturer and an engine manufacturer.

Applying these modeling based on lean principles, the paper aims to explore complex and dynamic consultancy programs and identify episodic improvements in complex organizational

systems. Using the completed tractor manufacturer's program, the paper expects to identify lessons learnt that can be translated to the ongoing engine manufacturer's program. All these lead to the paper's proposal for this systematic approach for analyzing enterprise transformation in TCS's change management programs.

This approach primarily draws inspiration from STAMP which mainly focuses on safety as an attribute in system design and analysis. The papers focus is on change program for enterprise design, and program management, and argues that its application of STAMP approach is relevant too.

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1.3

Organization of Thesis

Chapter 1 provides the background and context which the paper is based on, in order to allow

readers to appreciate the concurrence of the topics being discussed. Subsequently, it describes

the objectives of this thesis and how the author plans to fulfill this learning through research

activities and industrial collaboration. The structure of the thesis is laid out to facilitate holistic

exploration of the thesis topics, in line with the spirit of system thinking.

Chapter 2 continues from literature review and industrial cases to accumulate the key learnings

from scholars and industrial players. By drawing cases from emerging trends, the paper aims to

inform the readers about the urgency in application of our approach for change programs. By

drawing a rich repository of information about enterprise transformation, the paper introduces an

adapted approach based on Nancy Leveson's STAMP and evaluates how the proposed

approach stacks up against current practices.

Chapter 3 provides an overview of change management, and lean principles and methods

which forms the basis for the functioning and evaluation of lean change programs.

Subsequently, the paper introduces the concept of lean management, and how it adapts STPA

for the effective evaluation of enterprise changes with the recommended process model.

Enterprise-adapted System-Theoretic Process Analysis (ESTPA) is eventually proposed with a

couple of adaptations on STPA.

Chapter 4 describes the case studies with 2 enterprises in collaboration with TCS for the

purpose of evaluating ESTPA for effectiveness in enterprise transformation in lean change

programs. Emphasis is placed on Product Lifecycle Management (PLM) solutions in both

programs to realize Product Development (PD). Readers would better appreciate the ESTPA

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approach as the paper demonstrates the execution of the value matrix, hierarchical control structure, process modeling on the programs and the validation by survey outcomes.

Chapter 5 compiles the findings of ESTPA through the analysis of the tractor manufacturer's change program and extends these findings to that of the Engine manufacturer. From TCS interviews on program management, the paper collects lessons learnt from the execution of ESTPA and its implications on program management. This will provide the leverages for realizing the adoption of ESTPA in change management and program management.

Chapter 6 summarizes this paper with the appreciation of this approach on other forms of applications. By discussing on interesting findings from this approach and possible inclusions that could have been covered, the paper recommends extension to this research that would fuel its common application in the IT consultancy industry.

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2 Industrial Trends and Enterprise Transformation

2.1

What's in for the Industries?

2.1.1 Manufacturing in Automotive

Traditionally, the majority of the components used within an automobile is led and designed by automotive manufacturers. Henry Ford was famously quoted "People can have the Model T in any color - so long as it's black." And producers in the automotive industry duly defined how the automobiles function with their innovation, and how they are styled with their craftsmanship. As the complexity of the product development increased, more Tier-1 players such as Continental AG entered the industry providing components and engineering support to boast up

development efforts, and so were the manufacturers of other tier levels.

While the complexity of automobile development never let up with the emergence of semi-autonomous and semi-autonomous vehicles, startups and giants in other domains are entering this industry to introduce breakthrough products like the GOOGLE CAR (MARKOFF, 2010) and add more complexity into the mix. The Defense Advanced Research Projects Agency (DARPA) challenges (DARPA URBAN CHALLENGE, 2007) is one instance worth learning that

demonstrated successful partnerships among automotive manufacturers. More importantly, the voice of consumers is also getting stronger as these challenges were open to all participants willing to explore and innovate with autonomous vehicle application. Rally Fighter and OpenXC (OpenXC, 2012) are other cases of "crowdsourcing" platforms coined by Jeff Howe in 2006 -as functions normally undertaken internally by firms are outsourced to an undefined group of people that may be enthusiasts. Eric Von Hippel urged industry players to identify "what your most advanced users are already doing and understanding what their innovations mean for the future of your business" (von Hippel, 1986), which he referred to them as "lead users". With an exponential increase in points of contact for drawing information from partners, multiple-tier

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suppliers, lead users and customers, automotive manufacturers are facing an immense challenge to shore up their organizational structures, so as to keep up with the progression of innovation and pace of competition and cooperation.

2.1.2 Medical Devices & Diagnostic in Life Science

The Pharmaceuticals and MD&D manufacturers operating within the life science arena (or known as PhRMA) are highly regulated and supervised by the govemment agency Food and

Drug Administration (FDA) to ensure public health. Their products in prescription, over-the-counter pharmaceutical drugs, vaccines, medical devices are some of the items that go through multiple stringent levels of check in the form of clinical trials (Figure 3) as demanded by FDA before they become available in the market.

FA Pre-clinical studies

a

Provides a first assessment of the expected safety and efficacy of a compound using proven animal models

8 Early Phase Clinical trials IN

a Safety focus and the beginnings of efficacy, dose ranging, and tolerability * Pivotal Clinical trials

a Demonstrate safety and efficacy in well controlled (generally masked) randomized

studies sufficient for market authorization NDA Filed

I Phase IIIB

w Expanded trials In different use situations NOA APPrOVed

or populations * Phase IV

a Post marketing safety or "new" indications * Real World Data

* Evaluations of safety, effectiveness and outcomes In "routine" clinical practice

Figure 3: Clinical Trial -Source "Worldwide Medical & Outcome Research"

At each level, real world data (RWD) supplements clinical trials for effective modeling

approaches and also provides compliance, adherence and decision-making insights in the form of real world evidence (RWE) as interpreted by medical practitioners. Considering several characterizations of this data in terms of outcomes, sources and hierarchies of evidence, the

importance is not limited to the data content itself but ranges from understanding its context and

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circumstances to driving benefits in applying good processes from collecting, processing and utilizing the data (Garrison Jr. LP, Neumann PJ, Erickson P 2007).

Some of the challenges posed for life science in term of augmenting value from using RWD are variations in acquisition standards, differences in data formats, lack of access to existing data and lack of incentives to share and disseminate data. It is thus paramount for enterprises to set

up relevant information infrastructures to integrate available data, provide straightforward access to repositories and develop an integrated-enterprise-wide or community-wide system for data cataloging and monitoring (Kolker, Stewart, and Ozdemir 2012).

Approved Produwt

nolegeProdtr w,

D a

Figure 4: Simplified Information Flow of PhRMA

The paper (Figure 4) provides a simplified representation of the flow of data/information/product within the collaborative environment of PhRMA who pay for data from healthcare providers and

insurance agencies to collect insights for product development. There are also options like contracting independent research organizations for research and development (R&D), and

intelligence agencies to analyze data for derivation of RWE. Eventually, PhRMA organizations

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have to make strategic and business decisions on whether to roll out certain products to the market based on RWE, subjected to FDA approval based on outcomes of clinical trials.

While the automotive industry is subjected to technology and product uncertainties, life science is subjected to another uncertainty regulation. Two recent but major regulatory legislations -Obama-care and Unique Device Identification (UDI) integration - come into effect, demanding life science operators to meet compliance, yet encouraging them to coordinate internally with one another to sort out the technicalities. Obama-care looks to expand Medicaid coverage and expects operators' business model changed from 'Pay-for-service' to 'Pay-for-performance',

cumulating to lower cost and increased efficiency for business. UDI integration, on the other

hand, expects unique identifiers assigned to medical devices distributed within the states to improve patient safety and operators' accountability to their products and services. Both would organically lead to enforced changes on how product, services and customer information is

provided. Dependencies with all stakeholders have to be regularly assessed in the dynamic operating environment, and changes have to be actively managed to attain desirable outcomes

and respond to undesirable outcomes. This calls for a robust and effective management of changes.

2.2 Enterprise Transformation 2.2.1 Consulting for Integrated Enterprises

Traditionally, enterprises in these industries seek reputed and branded consulting firms to change their enterprises for the better by diagnosing and solving problems whose scope are not yet defined. These solution shops delivered values primarily through judgments from their brand-name consultants and charged clients fee-for-service. With them operating in the cloak of opacity which hinder clients from gauging the consultancy services in advance or the delivered performance, clients select external help based on reputation and branding to develop an

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enterprise network of communication and collaboration. However, as these industries mentioned earlier are on the "cusp of disruption", the increasing number and types of uncertainties had prompted these clients to rethink about how they should best engage the services of these solution shops.

As access to data is more distributed and democratized to larger extent, opacity in the operation of consulting firms fades. The clients become knowledgeable about the work activities needed to be done, and look to segregate work between high-value services which these firms can provide and other activities most appropriate to other service-providers. By disaggregating consultancy services, clients can assign to predictive technology and big data analytics service-providers to deliver value much more efficiently. As the pace of "productization" increases with

new intellectual properties, tool kits, frameworks, clients would seek "value-based pricing" (Christensen and Wang 2013).

Figure 5: Consulting firms' business models (Christensen & Wang 2013)

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The emergence of other business models other than the solution shop (Figure 5) and their possible disruption to incumbents prompted a rethink for consulting firms. Some

recommendations for deviation from traditional solution shops drawn from literature review are:

1. Increase modularization of the services on offer to meet evolving clients' needs 2. Shift from integrated solution shops to modular providers by specializing in supplying

specific links in the value chain drawn from client engagement

3. Focus on own boutique consulting services, offering advice based on specialization in research and data gathering

4. Assemble lean project teams to fulfill specific value proposition of clients

5. Conduct asset-based consulting through data- and analytics-enabled processes 6. Accumulate assets and processes with each successive client and reuse

7. Regular analysis and update of circumstances and data to maintain concurrency

Although traditional incumbents have the human, brand, technological and financial resources to solve complex problems posed by clients and drive block-buster change management

programs to address them, other emerging professional services provide client benefits in terms of speed and quantifiable output by automating customer relationship analysis or predictive technology. With consulting firms such as IBM, Accenture and TCS moving into this form of services, they would look to handle complex problems with quantifiable deliverables to their clients by supporting the latter in building dynamic capabilities for competitive advantage. This allows enterprises to better "sense opportunities and threats, to seize opportunities, and to maintain competitiveness through enhancing, combining, protecting, or reconfiguring a firm's intangible and tangible assets" (Teece 2007). It is also suggested that organizational processes be incorporated in enterprises to collect new technical information, tap environmental

developments, monitor competitive markets, customer needs and benefit while creating new

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products and processes. "Information must be filtered, and must flow to those capable to make sense of it."(Teece 2007) Especially for an integrated enterprise which preaches lean practice to their subsidiaries and partner units, more decentralization with greater local autonomy helps

participants to respond better to market and technological developments, but are subjected to information decay as information flows within the hierarchy. Procedures and controls must thus be constructed in place to keep management informed(Teece, Pisano, and Shuen 1997). Consulting firms play a key role in providing tangible implementation approaches based on successful strategies to transform client enterprises from 'as is' to 'to be' state.

2.2.2 Enterprise Architecting

Before consultancy firms are capable of realizing new or modified enterprise architectures to transform their clients' enterprise, the activities to define several architectures and evaluate these architectures for selection are prevalent in most firms' change programs, en-route to the delivery of the architectures to their clients. However, the approaches adopted by these firms

can be highly differentiated.

ANSIIEEE P1471-2000

As defined by ANSI/IEEE P1471-2000 that "architecture is the fundamental organization of a system embodied in its components, their relationships to each other and to the environment and principles guiding its design and evolution"(Maier, Emery, and Hilliard 2000), architectural stakeholders and concerns, architectural views and viewpoints are of interest to the ANSI/IEEE P1471-2000 conceptual framework. The architect must consider the architecture from the standpoints of the users, acquirers, developers, and maintainers of the system, and address their "concerns" such as user needs, design constraints and corporate strategies. He should

also model for multiple architectural views based on specific concerns and capture viewpoints to

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analyze specific views (Maier et al. 2000). It is noted that ANSI/IEEE 1471 is method-independent.

The Open Group's TOGAF@

Figure 6: The Open Group's Architecture Development Cycle

TOGAF is more practitioner-oriented as it provides a framework with "a detailed method and a set of supporting tools" drawn from learning and contributions in multiple industries. It

establishes enterprise architecture that covers entities in "information and technology services, processes, and infrastructure" (Welcome to TOGAF® Version 9.1, an Open Group Standard).

Page 25 Figure 5-1: Architecture Development Cde

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Its method - Architecture Development Method (ADM) - is iterative, covering the views of business, information system, technologies, and risks as shown in Figure 6. Especially of interest to this paper is the utilization of content metamodel in TOGAF where entities with their key dependencies are represented in traceability matrices (Scherer and Wimmer 2012), exclusive of the dark-colored boxes which represent the Unified Modeling Language (UML) diagrams (Figure 7). In place of UML, the paper suggests hierarchical control structures or value flow diagrams that can complement the usage of content metamodel in TOGAF.

igure 7 :Content Metamodel with UML (Scherer and Wimmer 2012)

Control structures allow viewing of change programs' stakeholders as entities within the

architecture, the linkages between entities representing concerns. This captures the multiple

views of inter-related stakeholders with their addressed concerns, and establishes viewpoints with specific references to different classes of stakeholders or interactions between

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stakeholders. With this proposed structured modeling, it would support stakeholder theory in bringing core stakeholders together to cultivate the shared sense of creating value for

businesses (Freeman, Wicks, and Parmar 2004) in either producing successful enterprises or developing products among complexity.

While hierarchical control structures refer program stakeholders' actions to extending controls and receiving feedbacks, value flow diagrams are similar in term of exchange of values and

"concerns". The paper will primarily use hierarchical control structure in this research, and only

represent value flow in the format of matrices. Value flow is important to be represented as

there is a prevalence of value deficiencies that are reflected as the discrepancy between the 'as

is' and 'to be' state for an enterprise, driving enterprise transformation initiatives to address what work needs to be done by the enterprise and how to accomplish it; This results in change programs focusing on improving the performance of existing work, modifying the approaches to existing work or performing different work processes, with the last being most transformative (Rouse 2005). Additionally, enterprise transformation does not only apply to individual work processes but also relationships between processes. This demands the addition of process models in addition to control structures and value flow diagrams.

Of significant note is how processes are described to be highly inconsistent and difficult to reuse due to the lack of knowledge in them, or uncertainties and misunderstanding towards them (Day and Lutteroth 2011), thus the modeling of process models using Rational Unified Process (RUP) for visualization and analysis. However, there are drawbacks:

1. Extracting information from enterprises return a low level of abstraction which results in modelers filling in substantial higher level of details

2. Missing details due to workers' internalization of details through routines

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3. Does not show activities over time

4. Visual models saturated with entities and their relationships which make reading and scaling difficult

5. Missing context and relationships with other RUP roles

While points 1 and 2 are challenges which modelers should manage continuously, points 3, 4 and 5 are mitigated by the approach proposed by the paper as discussed in the next chapter. Likewise, the need for hierarchical control structure is endorsed for ease of navigation and clear overview of the roles within the structure, which partially mitigates point 5.

Nightingale Rhodes Enterprise Systems Architecting

Nightingale and Rhodes further emphasized the holistic approach with Enterprise Systems Architecting (Nightingale and Rhodes 2004). The description of activities, processes, entities and the information flow required to support enterprise functions are represented holistically, and characterized in term of hierarchies. Specifically, processes are categorized as Life Cycle Processes, Enabling Infrastructure Processes and Enterprise Leadership Processes in Nightingale's Process architecture view of lean enterprise (Nightingale and Mize 2002), as summarized in Figure 8. Design of an enterprise demands the analysis of the "interrelationship and interdependencies" of all these processes. This might prove challenging to an IT

consultancy firm which provides PLM system or software but its role is on realizing requirements definition, product development, information technology, organizational structure and integration, transformation management processes for its client enterprise.

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Figure 8: Lean Enterprise's Process Architecture View (Source - Nightingale & Mize 2002)

Enterprise architecture is defined as "the organizing logic for business process, data, and IT capabilities reflecting the integration and standardization requirements of the firm's operating model with the operating model being the desired level of business process integration and business process standardization for delivering goods and services to customers" (J. Ross, 2006). Processes are related and dependent on other enterprise entities such as strategies, information, knowledge, business model. These interrelationships needed to be analyzed would only increase exponentially, and are possibly unique to individual enterprises for integration and standardization of selected processes. This leads the paper to consider enterprise architecture as a system of high complexity as aligned to The Systems Architecting Working Group of the

International Council on Systems Engineering (INCOSE)'s definition of architectures as the fundamental and unifying system structure defined in terms of system elements, interfaces,

processes, constraints, and behaviors (INCOSE, 2000). A system engineering approach is thus considered and adapted for enterprise architecting in this paper.

Page 29 nt

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Zachman Framework

The earlier-mentioned Zachman Framework (Zachman 1999) provides a structural way of defining an enterprise based on its information system by asking fundamental interrogative words "who, what, when, where, why and how" to induce thinking and learning, and endorses

the delivery of model artifacts in multiple perspectives of the planner, owner, designer, builder and programmer (Scherer and Wimmer 2012). As it is primarily a schema, there is a lack of clarity in "socio-cultural, functional, structural, infological and contextual alignments" (Magoulas et al. 2012).

Enterprise Architecting Framework Summary

The paper proceeds to summarize the enterprise architecting frameworks in terms of their useful applications and areas of improvement in Table 1.

Framework Benefits Area of Improvement

ANSI/IEEE - Aligned to stakeholder value theory - Practicality limitation due to lack of P1471-2000 - Focus on development and operating methods

views of systems - Feasibility to apply to IS and enterprise transformation

TOGAF - Operational with methods and tools - Lack of specificity to stakeholders - Focus on business, IS, technologies - Lack of focus on the

inter-view for enterprise transformation dependencies between organizational entities and stakeholders

- Reactive to transformation outcomes Nightingale - Holistic representation of - Limited in extending approach to Rhodes' organizational and informational complex enterprises due to scaling

entities issue

- Focus on dependencies between - Lack of specificity to stakeholders

organizational

entities

Zachman - Focus on IS for enterprise - Practicality limitation due to lack of

transformation methods

- Endorse organizational learning - Lack of focus on the

inter-dependencies between organizational

entities Table 1: Benefits and Areas of improvement for Enterprise Architecting Frameworks

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Consequently, the paper proposes a new approach in the context of transforming IS for an enterprise by incorporating the mentioned benefits in Table 1 and exploring options to resolve the mentioned weaknesses in the described frameworks.

2.2.3 Enterprise System Engineering

The discussion of the available enterprise architecting frameworks leads the paper to propose system engineering for the purpose of enterprise transformation, in view of the frameworks'

shortcomings. As such, the paper considers Nancy Leveson's STAMP, primarily a causality model that emphasizes promoting system safety based on system theory. Its adoption is found in accident investigations in the form of Causal Analysis based on STAMP (CAST) like the analysis of the 2008 Coast Guard aviation mishap for a HH-65 helicopter (Hickey and Hommes 2013) or System-Theoretic Process Analysis (STPA) - a system safety engineering design approach (Hommes 2012). STPA is selected as the method of interest over CAST as the paper attempts to study the effectiveness of using the former in designing enterprise transformation within the progression of change programs. However, the paper hypothesizes that CAST can be applied equally well in the analysis of a failed change program but that would not be the focus of this paper. The paper proceeds to describe STPA in Table 2:

Steps Descriptions

Step 2 - Construct the hierarchical control structure, with processes as connecting

arrow, and actors as recipients or producers of these processes (Figure 9).

- Align control structure to closely match organizational structure or enterprise trqnfnrmaqtinn nnvarnqnrP structure.

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- Expand control structure containing potentic,( ICA with process models.

- Identify mental models of controllers involved in potentially ICA.

- Pinpoint ICA by comparing actual process models with controllers' mental models

- Identify causes by tracing through process models and hierarchical control structure from inadeauate control action Doint.

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Page

32

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1 A aiaione of control laMws leading to hazarhd Figure 10: Classification of Control Flaws (Leveson 2011)

The 4 ICA suggested by STPA in Table 2 Step 3 as demonstrated in Figure 10 are of interest to enterprise transformation due to its relevance to control of information exchange within the enterprise:

ICA# Relevance to Information Action

information activity or process is absent in hieracia ctrot itructore or process model.

ICA2 Specific information that is supposed to be received by or sent to specific actors in hierarchical control structure or process model is received by or sent to incorrect actors. Page 33 Conroiler Inmaopiete. ineftective, or missing control action Inadequate or rmissing feedback Feedback Delays Continer 2 I or no tion provikK monte ck delays

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ICA4 Information that is received or sent is suspended sooner than it is supposed to.

The paper proceeds to explain the interactions between organizational entities based on the concept of alignment in term of harmonious interrelationships between any 2 areas of entity categories and within the enterprise as a whole (Magoulas et al. 2012). Organizational entities comprise of enterprise controllers, processes, functions, programs, information, and activities

with regard to enterprise design, governance, and operation. The paper thus describes how STPA addresses the socio-cultural, functional, structural, infological and contextual alignments between organizational entities within enterprise architecture in Table 3:

Alignment Benefits Area of Improvement

Socio-Cultural Requirements and constraints for Shared values, mutual goals are not Alignment business, IS, technologies on directly communicated and aligned.

development and operating views of Little practical guidance on alignment enterprise system are expected to be of stakeholders with requirements

defined. and constraints.

Functional Modelling of entities and associated Insufficient guidance how IT services Alignment processes within enterprise augment are integrated into processes is

visualization for development and aligned for subsequent evaluation for generated architectures implementation, as based on or solutions. decisions and interpretation of

development team. Structural Based on program's codification of

Alignment responsibilities, roles of functional areas and relationships between these areas to provide overview and system boundaries, and if necessary, focus of details from associated process models.

Infological ICAs' identification focuses on quality Insufficient guidance regarding how Alignment of information to stakeholders and information quality and availability

weaknesses of information flow. should be defined to impact on communication outcome and

capabilities of processes which are

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dependent on stakeholders' response.

Contextual Contexts are required to be defined in Advocate safety as emergence, and Alignment term of operating conditions and not program outcomes.

exceptions of enterprises for basis of interpretation for both current state and future state.

Advocate regulatory, legal, ethical and discretionary viewpoints and equal emphasis on development and operation of systems.

Table 3: STPA Alignments in addition to Magoules et al. 2012

In Table 3, the paper reviews the benefits for STPA, and identifies the gap of STPA being a holistic system engineering approach for enterprise architecting. Infological alignment is defined

as the efficient use of information systems and capabilities utilized in the enterprise to achieve

the 'informational, transactional and relational' requirements for the stakeholders (Magoulas et al. 2012). The paper also defines socio-cultural alignment as the harmonious interaction of stakeholders to meet the enterprise's changing expectations. Both alignments are of interest as improvements on alignment of stakeholders with enterprise requirements and constraints, and dependencies of communication outcomes to definition of information actions are desired. These become the motivations for the adaptation to STPA, and the outcome is Enterprise-adapted STPA (ESTPA). For the rest of the shortcomings such as guidance how IT services are

integrated into enterprise processes and focus on program outcomes, the paper predicts that the endorsement of change program to realize enterprise transformation adhered to the lean

principles of 'Flow' and 'Pull' would provide an intuitive solution to improve them.

Subsequently, the paper discusses about ESTPA, which is the resulting framework from adapting socio-cultural and infological alignment into STPA.

2.2.4 ESTPA

Leveson suggests that quality can be another emergence property to be emphasized from using

STPA (Leveson, 2011). Quality is an abstract attribute to achieve but it can be defined for

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enterprise transformation by aggregating the needs of all participants involving in the

development and governance of the enterprise. The paper thus assumes that quality can be perceived and measured against the values the enterprise stakeholders have defined. While change programs are constructed and advanced to realize enterprise transformation, the enterprise continues to fulfill its business obligation in product development or engineering. As such, the paper endorses stakeholder value theory (Freeman et al. 2004), and adopts STPA with the emphasis to assist change programs in defining values and achieving emergent goals

through the process of enterprise transformation (Mcmanus 2005). This approach is necessary for IT consultancy firms which are guided by the lean principle of 'Value' in Figure 11.

Manufacturing Engineering

Value Visible at each step, Harder to see, emergent

defined goal goals

Value Stream Parts and material Info n and

Flow Iterations are waste Planned iterations must

be efficient

Pull Driven by

takt time

Driven by needs of

enterprise

Perfection Process repeatable Process enables

without errors enterprise improvement

Figure 11: Lean Principles to Engineering (McManus 2005)

Instead of the limitation in the bilateral communication between enterprise leadership team and consultants managing enterprise requirements, Modification A endorses a communication network that regularly engages all stakeholders that also include solution architects, process operators, development team, third-party suppliers based on their individual benefits derived from enterprise transformation programs. With these benefits and information of participating stakeholders codified and updated actively, the involvement of necessary participants ensures focus on the correct program value to be realized. Modification A eventually improves the socio-cultural alignment in change programs using ESTPA.

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Additionally, the consultancy firms rely on lean principle of 'Pull' to collect requirements and change interventions' verification, and lean principle of 'Flow' to analyze for controls and communication. The analysis of controls and communication is essential to ensure desired outcome for emergence (Hommes 2012). Originally, STPA focuses on the weaknesses of the information processes based on mental models of the involved controllers in the context of operational safety. However, this is lacking to define the desired or correct information

processes as the mental models of the stakeholders are influenced by a disparate set of factors in human communication and communication technologies. Modification B adapts these guiding factors to identify design and operational flaws, and endorse correct information activities and reduce information waste with the endorsement of lean principle of 'Flow'. To explicitly relate the emergence of quality in the transformation of an enterprise to controls, communication and hierarchies, it is insufficient to derive solely from entities such as processes in information systems, process stakeholders, data, contexts et al. Modification B considers the dependencies of communication and enterprise outcomes to the arrangement of the information and information actors operating in the enterprise or IS.

ESTPA is thus generated as the holistic framework for enterprise transformation utilized in lean change program, with the adaptation of Modification A and Modification B into STPA. Design and operational details would be forthcoming in subsequent chapter.

2.2.5 Summary

This chapter acknowledges that there is numerous enterprise architecting frameworks available to propose solutions for enterprise transformation. TOGAF is popular due to learning from extensive libraries compiled from multiple industries, but the challenge is to focus on the relevant aspects of enterprise transformation. Nightingale Rhodes' framework implies a system engineering approach which follows system theory to provide a holistic view. However,

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considering the explosion of information in 'Big Data' era, this framework faces difficulties in extending its approach. In view of the limitation in the methods of these frameworks or challenges to extend to complex programs, the paper considers the best approach in STPA, which is equipped with the described benefits of the frameworks, and has most of the described shortcomings mitigated.

STPA is a causal analysis approach which explores the enterprise holistically as a system and focuses on multiple organizational entities. It uses hierarchical control structure to provide an overview of the system and identify potential flaws. Subsequently, it focuses on these potential flaws by looking into the details from the process models. Root causes of the enterprise's flaws are eventually identified. However, there are 2 major shortcomings that need resolution, so as to achieve inclusiveness of all stakeholders and clear definition of correct information activities for change programs. As such, new tools or methods are proposed to modify STPA's existing ones

in the form of Modification A and Modification B. The end product from the literature review and research experimentation is eventually that of ESTPA, as adapted from STPA.

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3 Lean on Change Program Management

3.1

Lean Change Programs

3.1.1 Change Management Models

Introducing change interventions in organizations requires overcoming challenges to conflicts of stakeholders' interests, misalignment of mental models towards disruption of routine operations and gaps in availability of both dynamic and core capabilities among other. There are thus multiple change management models to provide guidance towards overcoming these challenges and achieving success outcomes of change interventions.

Earlier, the paper had mentioned Teece's theory on the equipping of dynamic capabilities to build core capabilities as organizations triggering for transformations normally identify that they lack certain competencies and capabilities to act effectively in the market or to adopt certain new technologies. Some enterprises build their own enterprise transformation function within their organizations while others engage consultants, or enter into alliances, joint ventures or partnerships to oversee the necessary transformations. All these change functions are expected to build or be equipped with dynamic capabilities, so that they can move to the next step of building core capabilities for enterprises.

The next challenge comes from understanding and adapting to the existing mental model of operators and stakeholders within enterprises and change function actors. One is equipped with a mental model on how routine work should be performed or how a decision should be made. This is necessary to interpret subjects of interest with fundamental assumptions and goals.

However, with the introduction of change, works may have to be performed differently and decisions may have to be made with different contexts, altering the behavior of the enterprise

systems so as to overcome market and technological challenges. Without the conciliation with

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their current mental model, organizational actors become insensitive to these change interventions, and attempts to change fails (Forrester 1995). Works performed by the

organization are essential to be modeled by process models, together with the consideration of controllers who exert control over these processes and receive feedback. Critically, these controllers are equipped with a mental model on how works should be performed (Leveson, 2011). Designer deals with ideals or averages, not constructed system

manufacturing evolution and

and construction changes over time variances ACTUAL SYSTEM original operational design experience spec operational

DESIGNER'S - procedures,-* OPERATOR'S

MODEL training MODEL

Figure 12: Relationship between Mental Models (Leveson 2011)

The complexity for change intervention emerges when the mental models of the designers that introduce changes and operators that act under the constraint of these changes require

alignment. This alignment in the form of operational procedures and training (Figure 12) is necessary to speed up understanding the inherent change interventions to make the

transformation live sooner. There is the motivation to analyze and align both perspectives of

Page 40 Operators continually test

their models against reality

Figure

Figure  1:  Pharmaceuticals Position  in  Big Data
Figure  3: Clinical Trial  - Source "Worldwide  Medical & Outcome  Research"
Figure  4:  Simplified  Information  Flow  of PhRMA
Figure  8: Lean  Enterprise's  Process Architecture View  (Source  - Nightingale &  Mize  2002)
+7

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