standardization of new product introductions to achieve
TRANSCRIPT
Standardization of New Product Introductions to Achieve Zero Defect Lines
by
William Geoffrey Winegar
B.S. Chemical Engineering, University of California, Berkeley, 2015
Submitted to the Civil and Environmental Engineering Department and the MIT Sloan School of
Management in Partial Fulfillment of the Requirements for the Degrees of
Master of Science in Civil and Environmental Engineering
and
Master of Business Administration
in conjunction with the Leaders for Global Operations Program at the
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
May 2020
© 2020 William Geoffrey Winegar. 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
Signature of Author
MIT Department of Civil and Environmental Engineering, MIT Sloan School of Management
May 8, 2020
Certified by
David Simchi-Levi, Thesis Supervisor
Professor of Civil and Environmental Engineering at MIT
Certified by
Retsef Levi, Thesis Supervisor
J. Spencer Standish (1945) Professor of Operations Management at MIT Sloan
Accepted by
Colette L. Heald, Professor of Civil and Environmental Engineering
Chair, Graduate Program Committee
Accepted by
Maura Herson, Assistant Dean, MBA Program
MIT Sloan School of Management
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Standardization of New Product Introductions to Achieve Zero Defect Lines
by
William Geoffrey Winegar
Submitted to the MIT Sloan School of Management and the MIT Department of Civil and
Environmental Engineering on May 8, 2020 in Partial Fulfillment of the Requirements for the
Degrees of Master of Science in Civil and Environmental Engineering and Master of Business
Administration.
Abstract Consistently high quality is important to any manufacturing environment, and especially so when
operating in the highly regulated medical space, which typically targets zero defects in products
serving patients. The New Product Introduction (NPI) process is a complex one, with many
potential failure modes than can result in unanticipated costs, delays, and defective products.
This project sought to streamline the NPI process through achieving three main objectives. First,
NPI tools, processes, and checklists in current use were characterized. Second, insights for
improving the NPI process were collected. Third, a new playbook was introduced to improve a
specific aspect of the NPI process. Finally, recommendations were provided to direct future areas
for potential improvement.
While many of the tools in use were useful project management aids, recurring issues were
identified, particularly at the front end of NPIs. A due diligence checklist was developed to
structurally align the different parties involved with NPIs, facilitate communication, organize
information, and increase the effectiveness of decision-making. This checklist was implemented
using i- nexus, a software-based project management tool.
This paper is focused on the manufacturing environment within Flex Inc.’s medical
manufacturing division. However, this paper also discusses the relevance of checklists and other
tools outside of this context. Project management environments in which these tools could
improve quality, timeline, financial, and customer service outcomes are explored as potential
areas for additional future work.
Thesis Supervisor: Retsef Levi
Title: J. Spencer Standish (1945) Professor of Operations Management
Thesis Supervisor: David Simchi-Levi
Title: Professor of Civil and Environmental Engineering
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Acknowledgements
I would like to acknowledge my MIT faculty advisors, Professors Retsef Levi and David Simchi-
Levi, for all the support they have given me. They were extremely helpful in advising me as I
developed the scope, methods, analysis, and final development of this thesis.
I would also like to thank everyone at Flex for their guidance during my thesis development. My
supervisor, Stefan Osswald, was an incredible help and mentor throughout my project. Tim
Howell was instrumental in getting me settled in at Flex. I’d also like to thank Alejandro Leyva
and the entire PM team at the Tijuana site for their friendship throughout my time at Flex. Plus, I
never would have found the best tacos in Tijuana without Juan.
I’d also like to thank the staff and my classmates in the Leaders for Global Operations program
for their friendship, support, and advice. Finally, I would like to express my deepest thanks for
my family – my sister Allegra, my parents Brad and Suellen, and my wife Angela. Without them
I most certainly would not have made it to MIT, let alone produced this thesis.
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Table of Contents
Abstract ......................................................................................................................................................... 3
Acknowledgements ....................................................................................................................................... 5
Table of Contents .......................................................................................................................................... 7
List of Figures ................................................................................................................................................ 9
1 Introduction ........................................................................................................................................ 13
1.1. Company Background and Project Context ................................................................................ 13
1.2. Project Motivation – NPIs in the Medical Device Industry ......................................................... 15
1.2.1. New Product Introductions ................................................................................................. 15
1.2.2. Quality in The Medical Industry .......................................................................................... 15
1.2.3. Flex’s Medical NPIs .............................................................................................................. 16
1.3. The Tijuana Site ........................................................................................................................... 17
1.4. Problem Definition ...................................................................................................................... 18
1.5. Hypotheses, Approaches, and Results ........................................................................................ 19
2 Literature Review ................................................................................................................................ 20
2.1. Introduction ................................................................................................................................ 20
2.2. Industry Standards for NPIs ........................................................................................................ 20
2.3. NPI Tools and Resources ............................................................................................................. 21
2.4. Cost versus Quality Trade-off ...................................................................................................... 24
2.5. Common Failure Modes .............................................................................................................. 27
3 Current State of NPIs at Flex ............................................................................................................... 28
3.1. Introduction ................................................................................................................................ 28
3.2. The NPI Process at Flex ............................................................................................................... 28
3.2.1. Program Management at Flex ............................................................................................ 29
3.2.2. NPI Types at Flex ................................................................................................................. 29
3.3. Flex NPI Tools .............................................................................................................................. 30
3.3.1. RASCI Charts ........................................................................................................................ 30
3.3.2. SHIELD ................................................................................................................................. 31
3.4. Research Approach ..................................................................................................................... 34
3.4.1. Interviews ............................................................................................................................ 35
3.4.2. Survey .................................................................................................................................. 36
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3.5. Analysis of Current State ............................................................................................................. 40
3.5.1. Interview Results ................................................................................................................. 40
3.5.2. Survey Results ..................................................................................................................... 41
NPI Issues ............................................................................................................................................ 41
3.5.3. Quote versus Actual ............................................................................................................ 46
4 Implementation and Results ............................................................................................................... 47
4.1. Introduction ................................................................................................................................ 47
4.2. NPI Due Diligence Checklist ........................................................................................................ 48
4.2.1. General Program Information ............................................................................................. 48
4.2.2. Process Development ......................................................................................................... 50
4.2.3. Materials, Equipment, and Logistics ................................................................................... 52
4.2.4. Resource Availability ........................................................................................................... 53
4.2.5. Design Handoff .................................................................................................................... 54
4.3. Checklist Implementation: Software Tool Evaluation ................................................................. 54
4.3.1. I-Nexus ................................................................................................................................ 55
4.4. Pilot Implementation .................................................................................................................. 57
4.5. Evaluation Criteria ....................................................................................................................... 57
4.5.1. Feedback Collection ............................................................................................................ 58
4.6. Future Metrics Outline ................................................................................................................ 59
5 Conclusions ......................................................................................................................................... 64
5.1. Review of the NPI Process .......................................................................................................... 64
5.2. Future Work ................................................................................................................................ 64
5.2.1. Status of Implementation and Expected Next Steps .......................................................... 64
5.2.2. Recommendations for Future Implementation at Flex ...................................................... 64
5.2.3. Continuous Improvement Opportunities ........................................................................... 65
5.3. Applicability Beyond Flex ............................................................................................................ 66
6 Bibliography ........................................................................................................................................ 67
Appendix 1: NPI Exploration Survey Questionnaire ................................................................................... 70
Appendix 2: NPI Checklist ........................................................................................................................... 84
Appendix 3: NPI Due Diligence Checklist Feedback Form .......................................................................... 95
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List of Figures
Figure 1. Flex’s organizational structure ...................................................................................... 15
Figure 2. Microsoft Project Instance [8] ....................................................................................... 22
Figure 3. Agile PLM Instance – General Part Management [9] ................................................... 23
Figure 4. Agile PLM Instance – Specific Part Management [9] ................................................... 24
Figure 5. Cost of Quality Curve[12] ............................................................................................. 25
Figure 6. Cost of Quality Curve where quality is “free” .............................................................. 26
Figure 11. Flex Product Life Cycle Overview .............................................................................. 28
Figure 12. Typical RASCI matrix used at Flex ............................................................................ 31
Figure 13. Overview of a program’s timeline and issue tracking in SHIELD ............................. 33
Figure 7. Interview Sample .......................................................................................................... 36
Figure 8. NPI Types and Categories ............................................................................................ 38
Figure 9. NPI Issue Categories (“shorthand” indicates labels that will be used in forthcoming
figures for concision) .................................................................................................................... 39
Figure 10. Survey Sample ............................................................................................................ 40
Figure 14. Average NPI Issue Severity and Frequency; 3 indicates high severity and/or
frequency, 1 indicates low severity and/or frequency .................................................................. 42
Figure 15. NPI Issue Severity by NPI Type ................................................................................. 43
Figure 16. Average of self-reported confidence in ability to use SHIELD for program
coordination .................................................................................................................................. 45
Figure 17. Customer Contacts and General Info Checklist .......................................................... 49
Figure 18. Statement of Work Checklist ....................................................................................... 50
Figure 19. Software Tool Comparison.......................................................................................... 55
Figure 20. NPI Due Diligence Checklist instance in i-nexus ....................................................... 56
Figure 21. Checklist Feedback Survey results (sample of 3 PMs) ............................................... 59
Figure 22. Illustrative example of measurement and potential checklist outcomes ..................... 63
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Glossary
These terms may not be explicitly defined in the text but are useful in the context of the research
presented.
Definitions
Pilot Study – A sustained engagement over a period of time, during which specific interventions
are implemented and studied.
Program – A highly complex project or a group of related projects managed in a coordinated
way.
SHIELD (Simplified Handshake to Inform, Execute, Launch, and Deliver) – An online NPI
management tool developed internally by Flex’s High Reliability Solutions group. Its purpose is
to provide a centralized location for documenting and tracking the progress of a program from the
beginning to the end of the NPI phase. It includes features for program management such as
volume targets, milestone and action item trackers, and risk registers.
Zero Defect Line – A Zero Defect Line is a line that does not allow a defect to be produced or
passed on from one station to the next; a ZDL will not allow any defects to arrive at the customer
or even worse, the patient.
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Abbreviations
Business Development Representative BD
Contract Manufacturer CM
Electronics Manufacturing Services EMS
Design for Manufacturing DFM
Food and Drug Administration FDA
General Manager GM
Global Account Manager GAM
Global Program Manager GPM
High Reliability Solutions HRS
International Organization for Standards ISO
New Product Introduction NPI
Original Equipment Manufacturer OEM
Operating Profit OP
Process Failure Mode Effects Analysis PFMEA
Product Lifecycle Management PLM
Program (Project) Manager PM
Project Management Body of Knowledge PMBOK
Net Promoter Score NPS
New Product Development NPD
Non-recurring Engineering Costs NREs
Simplified Handshake to Inform, Execute, Launch, and Deliver SHIELD
Zero Defect Line ZDL
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1 Introduction
1.1. Company Background and Project Context
Flex’s Historical Background
Flex LTD is a contract manufacturing company that designs, engineers, produces, and delivers a
wide range of products for Original Equipment Manufacturers (OEMs) spanning several
industries. Originally founded in 1969 as Flextronics, Inc., the company initially produced only
printed circuit board assemblies (PCBAs), capitalizing on the nascent yet rapidly growing Silicon
Valley market. In the 1980s, the company went public, broadened its product base to include other
electronics and electronic components, and expanded its operations geographically by launching
manufacturing facilities abroad. In 1990, the company transitioned into private ownership through
a leveraged buyout, and reorganized as Flextronics International Ltd. Flextronics went public again
in 1994, raising capital that allowed the company to complete a series of acquisitions that again
continued to widen the scope of its geographic footprint and contracted product offerings. This
development reached an inflection point in 2015, when the company officially rebranded from
Flextronics to Flex, clarifying its expertise in manufacturing products besides electronics.[1]
In conjunction with this shift, Flex introduced a new strategic focus branded as Sketch-to-ScaleTM,
through which the company would take customers’ ideas (sketches) and transform them into go-
to-market products. In that process Flex performs design-for-manufacturing services to improve
the effectiveness of its outsourced manufacturing services while also capturing a slice of the
manufacturing value chain that yields higher margins and lower risk of substitution. Flex now
operates across 100 sites in 30 countries with over 200,000 employees and net revenue of over
$26B in fiscal year 2019. The company currently operates in two core segments: High Reliability
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Solutions (HRS, consisting of health solutions and automotive business) and Integrated Solutions.
The Integrated Solutions group is further subdivided as Industrial and Emerging Industries (IEI,
consisting of energy and capital intensive industrial equipment), Communications and Enterprise
Compute (CEC, consisting of telecommunications and networking products), and the Consumer
Technologies Group (CTG, consisting of consumer-related computing, printing, mobile, and IoT-
enabled devices). The latter two segments have historically comprised the bulk of Flex’s business,
as they have been in existence since Flex’s early days. HRS has received increased attention from
Flex’s management in recent years, partly due to the higher margins and longer lifecycles
associated with highly regulated automotive products and medical devices. As a result of this
increased focus, HRS has experienced rapid growth recently and is now one of the company’s
most important segments.
Flex’s Organizational Structure
Since factories perform most of Flex’s core operating activities, they serve as critical junctions
within Flex’s organizational structure. Factories are designated members of one of Flex’s
segments, and therefore factory management report to their respective segment management.
Many factories, however, report to the Global Operations group with a dotted-line reporting
relationship to their respective segment. These relationships are outlined in Figure 1.
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Figure 1. Flex’s organizational structure
1.2. Project Motivation – NPIs in the Medical Device Industry
1.2.1. New Product Introductions
New Product Introduction, a term that is sometimes used interchangeably with New Product
Development (NPD), refers to all the resources that must be collected and prepared, and all the
activities that must be performed, in order to bring a new product to market. NPIs are a critical
function of nearly any manufacturing company whose product portfolio either grows or changes
over time. Because of the large amount of cross-functional communication and teamwork that is
typically required, companies that perform NPIs typically institute many processes to keep teams
on track and achieve targets for timeline, costs, output volume, and quality.
1.2.2. Quality in The Medical Industry
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Consistently high quality is important to any manufacturing environment. This is especially so
when operating in the medical space, which is highly regulated by the Food and Drug
Administration (FDA). Medical device manufacturers typically target zero defects in products
serving patients to properly serve patients and comply with regulations. Furthermore, additional
care must be taken to prevent potential supply disruptions which could cause patients to be unable
to receive proper care. Given these standards and stakes, medical device companies typically have
particularly stringent NPI processes.
1.2.3. Flex’s Medical NPIs
While contract manufacturing for electronics Original Equipment Manufacturers (OEMs) began
to take hold in the 1970s, OEMs began to outsource medical device manufacturing only around
the year 2000 as they realized that contract manufacturers could reduce costs while producing
products that were still safe, reliable, and compliant.[2]
Flex was one of the earliest contract manufacturers to capitalize on this opportunity. Despite being
Flex’s smallest division by net revenue, HRS has consistently produced more net income for Flex
than any other division the last four years running, and is the company’s second fastest growing
segment by revenue.[3] Flex is considered a market leading CM in the medical device industry.
The entrance of other CMs has placed increasing competitive pressure on Flex, whose leadership
is constantly pursuing means of making its NPI teams more effective at quickly bringing new
products to market at competitive prices while ensuring as high of quality and reliability as
possible.
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1.3. The Tijuana Site
As labor and transportation costs have risen for manufacturers in China, compounded by the
increase of tariffs initiated by the U.S. government, Mexico has become an attractive country for
contract manufacturers for products sold in the U.S. market. Tijuana’s manufacturing scene in
particular has enjoyed significant growth in recent years. The number of direct jobs in Tijuana’s
medical device sector has almost tripled in 10 years, growing from 15,000 workers in 2006 to
42,000 workers in 2016.[4] The city now has the greatest concentration of medical device
manufacturers in North America, while automotive, electronics, consumer products, industrial
products, and aerospace have been rapidly growing as well. [4] Situated directly across the border
from San Diego, California, Tijuana offers manufacturers the benefits of geographic proximity to
the United States market in addition to access to affordable yet skilled labor.
Flex’s Tijuana site manufactures medical devices for a wide range of customers. The Tijuana site
specializes in manufacturing non-electric, high and low volume, disposable products such as
catheters, infusion sets, and insulin pump cartridges. Since steep quality requirements are
demanded by customers and stringently enforced by regulatory bodies, essentially any program
has multiple vulnerable points and potential failure modes that can cause product non-
conformance. Despite the abundance of potential failure modes, many of the manufacturing steps
are conducted manually by human workers, increasing the potential for errors. While opportunities
for increased automation exist, the upfront capital investments they would require are often
difficult to justify given the low labor cost advantage of manufacturing in Tijuana.
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Tijuana was selected as the focal point for this study for three primary reasons. First, the Tijuana
site is particularly important to Flex from a strategic standpoint, given its capacity to produce high
volumes of medical devices which are typically profitable for many years given the barrier to entry
imposed by medical regulations. Second, successful execution of NPIs is a necessary capability
for the Tijuana site, given the nature of the highly regulated medical industry. Finally, NPIs at the
Tijuana site have faced difficulties due to a wide range of challenges in recent years. While Tijuana
presents manufacturers like Flex with many opportunities and benefits, they come with a
significant associated drawback, such as labor turnover. The Tijuana plant experiences higher
employment attrition than most other sites in Flex’s portfolio, largely due to its location near the
US border, where the benefits of economic and geographic mobility result in plentiful employment
options. As a result, it is difficult for Flex Tijuana to retain experienced talent, and in turn, many
manufacturing lines are designed by employees who are unfamiliar with mistakes that have been
made in the past, and operated by employees who, while trained, lack the kind of skills and
consistency that only experience can offer. This issue, compounded with the high proportion of
manual labor required by the lines run at the Tijuana plant, has resulted in many quality issues in
recent years, which Flex has made a high priority to resolve. While a typical NPI at Flex Tijuana
can take over 12 months to complete, making post-intervention measurement impossible in the
case of this research project’s scope, the site’s program management team is open to conducting a
pilot study with interim check-ins to gauge an intervention’s success.
1.4. Problem Definition
This thesis will focus on addressing Flex’s need for a more consistent and structured set of
processes, frameworks, and best practices for NPI project management. Solutions will be presented
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that are suited to the cross-functional nature of Flex’s work. The primary goal of the project is to
improve the effectiveness of Flex Tijuana’s NPI programs, as measured by their quality outcomes
and their ability to meet timeline and cost expectations. A secondary goal is to develop a solution
that is scalable and transferrable for sites requiring perfect or near-perfect quality performance –
that is, a solution that can be easily adapted to be applied in any Flex HRS site.
1.5. Hypotheses, Approaches, and Results
The hypothesized solution for improving Flex Tijuana’s NPI process was more clearly outlined
responsibilities and procedures, especially at the outset of all projects. The hypothesized solution
for scaling this process to other Flex sites was a new software-based project management tool,
though other solutions were considered.
These hypotheses were further developed and tested through a Mixed Methods Research design,
using a qualitative research phase employing interviews with a broad audience of Flex employees
followed by a quantitative research phase employing a survey of Flex Business Development
Representatives, Global Account Managers, and Program Managers.
In addition to outlining these recommendations, experimentation was conducted to determine ideal
methods for putting these structures into practice. This experimentation took place through an
iterative pilot implementation with a feedback loop for continuous improvement.
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2 Literature Review
2.1. Introduction
The NPI frameworks, processes, and tools presented in this thesis build upon other research that
has been conducted. Previous research has focused on the relationship between OEMs and CMs,
as well as general best practices that should be used by NPI teams.
Before understanding the best practices for NPIs, it is helpful to distinguish between NPIs and
New Product Development (NPD). NPD refers to a more creative, variable function, typically in
search of a new and future business success. Some process rigidity is needed to stay on track, but
enough flexibility is needed to allow the evolution of new ideas into new products. In contrast,
New Product Introductions refer to the development of a manufacturing process for a concrete
product with well-understood specifications. Successful NPIs require disciplined execution of
tasks that are interrelated and carefully planned.[5]
2.2. Industry Standards for NPIs
A typical NPI involves many different individuals and teams. While some individuals and teams
may be involved throughout the entire NPI process, specific responsibilities typically shift at
different stages of the NPI; for example, a quoting team may be fully engaged at the beginning of
an NPI, while some members of that quoting team may roll off of the program after the bulk of
quoting activities (which usually occur at the front end of an NPI) are completed.
According to Kieran et al, two of the top challenges in any NPI process are maintaining effective
communication among groups at hand-off steps in processes, and communicating changing
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priorities between OEMs and CMs. [6] Kieran supports the widely held belief that the program
manager should be the focal point of any NPI team, and that NPI teams should strive for as much
standardization as possible among projects. This thesis explores the implementation of a checklist
that can be used by PMs to standardize launches of NPIs.
2.3. NPI Tools and Resources
Program Managers (PMs) typically organize and manage all timelines, activities, and budgets
associated with a program or product. Managing the many moving parts of an NPI is a difficult
task for even the most qualified and experienced PMs. As such, PMs typically lean on a variety of
tools that facilitate communication with different stakeholders, organization of resources, and
execution of tasks.
Given the importance of the PM role, the Project Management Body of Knowledge (PMBOK) has
been developed by the Project Management Institute (PMI) with the intent of providing guidance
for PM best practices in planning, organizing, staffing, executing, and controlling operations. Nine
knowledge areas are defined in the PMBOK: project integration management, scope management,
time management, cost management, quality management, human resource management,
communications management, risk management, and procurement management.[7] The PMBOK
serves as the standard for PM frameworks in many work environments, and manufacturing is no
exception.
While the PMBOK is the most widely adopted resource for best practices in NPI project
management, other tools exist for implementation of these guidelines. Two categories are
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primarily referred to: general purpose project management tools, and Product Lifecycle
Management (PLM) tools.
One of the most frequently used general purpose project management tools is Microsoft Project.
An example of a Microsoft Project instance is depicted in Figure 2 below. This project
management tool permits a PM to organize in one location a set of tasks that must be completed.
The PM can designate the amount of time required for each task (including target start and end
dates), as well as the resources that should perform those tasks. A Gantt chart feature allows for
quick and easy visualization of how tasks’ timing compares. Resources can flag certain tasks as
complete or requiring attention.
Figure 2. Microsoft Project Instance [8]
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While general purpose project management tools like Microsoft Project are used in many
manufacturing environments, Product Lifecycle Management tools are gaining popularity and are
often used alongside Microsoft Project, as is the case at Flex, Inc. As the name suggests, PLM
tools are typically focused on products being developed and manufactured. PLM tools provide a
trackable record of all changes that are made to a product during development and introduction.
They also integrate with Enterprise Resource Planning (ERP) systems, allowing for live
information visibility and modification with respect to component parts of products – including
amounts, suppliers, location, import and export requirements, etc. Figure 3 below depicts how
lists of parts can be managed at scale, and Figure 4 shows how specific parts can be analyzed and
updated using Agile PLM, a PLM tool that Flex uses.
Figure 3. Agile PLM Instance – General Part Management [9]
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Figure 4. Agile PLM Instance – Specific Part Management [9]
Traditionally, the data stored and accessed using these tools was housed in on-prem servers. While
accessible to all members of an organization using the tool who had access to these servers, access
for third parties was typically difficult to provide. However, as these tools have migrated to cloud-
based storage, their utility has been amplified as suppliers, logistics providers, and customers have
been empowered to more actively engage in usage. This thesis will explore the costs and benefits
associated with using different cloud-based software tools for NPI program management.
2.4. Cost versus Quality Trade-off
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Consistency and reliability are hallmarks of any successful manufacturing operation. First
published in 1975, Juran’s Quality Handbook argued that the traditional view of costs associated
with quality was too narrow. Rather than limiting poor quality costs to areas such as scrap, rework,
and returns, other areas must too be considered, including prevention, appraisal, and failure
costs.[10] Typically, manufacturing firms strive to find the right balance between costs of quality
assurance (prevention and appraisal), and costs of internal and external failures. This balance can
be represented using optimum quality cost models and curves, such as the one depicted in Figure
5 below. [11]
Figure 5. Cost of Quality Curve[12]
According to the model depicted in Figure 5, there exists an optimal level of quality at the
economic conformance level (ECL), at which costs are minimized. However, others such as
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Crosby and Deming have argued that quality is “free,” or that the model is better depicted with
minimal costs at an ideal state of 100% quality and conformance.
Figure 6. Cost of Quality Curve where quality is “free”
Different manufacturing environments will have differently behaving costs vs. conformance
curves, depending on the nature of potential failures and the feasibility of prevention and appraisal.
Since this research is being conducted in the context of a medical device manufacturing plant
whose products can mean the difference between life and death for patients, highly regulated by
the FDA, quality is particularly important. External failure costs are extremely high –
complementing the need to serve patients as flawlessly as possible, medical products are highly
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regulated by the FDA. Defective products that could harm patients and failures to meet regulatory
standards can be met with swift retribution in the form of fines, damaged customer relationships,
returns of entire batches of products that could potentially be compromised, and potentially
irreparable harm to a company’s reputation. As such, in the setting of Flex’s Tijuana site, the
“Quality is Free” perspective is an understatement, at a minimum.
2.5. Common Failure Modes
Common failure modes for NPIs is a commonly discussed and researched issue in the
manufacturing industry. Industry Forum, a consultancy that focuses on manufacturing excellence,
identifies five common reasons for NPI failure: lack of formal launch processes, lack of project
management approach and resource commitment, design and development issues and delayed
design freeze, and manufacturing process design being unable to achieve desired ramp up volumes.
[13] Success or failure in each of these areas is often dictated by the performance of the project
or program manager. This research will focus primarily on the activities organized and performed
by program managers at the outset of a program, typically during quoting.
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3 Current State of NPIs at Flex
3.1. Introduction
The first step during the research process associated with this thesis was to understand the current
state of NPIs. A combination of interviews and surveys were conducted, both at a high level
through the lens of Flex Corporate and a granular level through the lens of Flex’s site in Tijuana.
3.2. The NPI Process at Flex
The Flex Product Life Cycle (FPLC) is a project management model in use company-wide. The
FPLC provides guidance throughout the development of a program by defining phases of a
program, task lists and deliverables for phases, and gate reviews that must occur before proceeding
to subsequent phases. As shown in Figure 17, there are 6 phases in the FPLC:
Figure 7. Flex Product Life Cycle Overview
Business development and account managers own the feasibility stage, during which Flex explores
with the customer which Flex site or sites would be the best suited to launch the customer’s
program. At the opportunity stage, site NPI program managers work with quoting program
managers to define key deliverables and begin setting expectations around timeline and costs.
During the concept stage, site NPI program managers work with site engineers to clarify key
manufacturing decisions such as personnel involvement and process flow. During the development
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stage, the manufacturing process is actually constructed (again, directed by site NPI program
managers) – supplies are received, machinery is set up, and trial production runs are conducted.
Then, once the customer is satisfied with these trial production runs, the site NPI program manager
hands off responsibility to a sustaining program manager who directs the program from the
production phase until production ramps down during phase out.
3.2.1. Program Management at Flex
Further supporting the standard observed in many other manufacturing organizations, Flex’s
program management organization is a significant player in the introduction of new initiatives,
tools, and processes at Flex. The program management organization as a whole dictates the tools
that different participants in the NPI process use in order to collaboratively execute tasks, manage
timelines, share information, flag risks and issues, and provide updates for one another. The
program managers, in turn, lead the usage of these tools, ensuring that each member of the NPI
team is engaged and fulfilling necessary responsibilities.
3.2.2. NPI Types at Flex
Flex performs a range of different activities for its customers, depending on the engagement. NPIs
are categorized depending on the degree to which Flex is involved, ranging from little
involvement, where Flex simply provides manufacturing space and labor to perform a process
completely designed by the customer, to significant involvement, where Flex partners extensively
with the customer by contributing design-for-manufacturing expertise to make product and process
improvements that improve scalability and cost efficiencies. The degree of Flex involvement is
determined through negotiations between the customer and Flex business development and
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account managers. Factors such as the maturity of the customer’s manufacturing process and
differences between the customer’s status quo manufacturing site and the intended Flex site are
typically the primary determinants of Flex’s involvement.
The five specific categories of NPIs and the associated Flex involvement are as follows:
• Sketch to Scale: Aspects of product design are owned by Flex
• Industrialized Product: Customer owns design, Flex industrializes (scales up) production,
typically with many changes to manufacturing strategy
• Unmodified Transfer: Product line from customer site is transferred to a Flex site with
minimal changes
• Modified Transfer: Product line from customer site is transferred to a Flex site with some
changes, i.e. to manufacturing strategy
• Duplication: Product line at Flex site is built to duplicate an existing line at a customer site
(the customer site’s line continues to run, typically unchanged)
3.3. Flex NPI Tools
3.3.1. RASCI Charts
Charts that designate who is responsible, accountable, supportive, consulted, and informed
(RASCI charts) are frequently used by program managers to clarify responsibilities for programs.
Flex institutes a standardized RASCI chart that is meant to be a reference for PMs that can be
applied in most NPI environments. However, PMs typically have the flexibility to modify the
standard RASCI chart depending on a program’s specific needs.
31
Figure 8. Typical RASCI matrix used at Flex
3.3.2. SHIELD
Two years ago, Flex implemented a project management tool called SHIELD, which stands for
Simplified Handshake to Inform, Execute, Launch, and Deliver. The online program management
tool was developed internally by Flex’s High Reliability Solutions group. Its purpose is to provide
32
a centralized location for documenting and tracking the progress of a program from beginning to
the end of the NPI phase. It includes features for program management such as volume targets,
milestone and action item trackers, and risk registers.
As quoting details for a new program are finalized, the creation of that program in SHIELD is
triggered, with a PM designated to organize and lead program tracking for that program. As shown
in Figure 9 below, a program’s SHIELD instance is composed of a top area for high-level program
information for reference (including the program’s overall status according to Flex and according
to the customer, which can be green for on track, yellow for minor risks and issues, and red for
major risks and issues), a middle section for the program timeline, and a lower section for risk,
issue, and timing tracking and commentary. The PM works with her/his team to specify an
appropriate timeline, outlined with milestones according to the FPLC. Members of the associated
business development and account management team are notified when milestone timing is
changed, so that they in turn can notify the associated customer. Similarly, the PM can enter issues
and risks as they arise, and BD and account managers can then explain, as needed, what these
issues and risks could impact timing and cost expectations on the customer side. A previous study
at Flex focused on adoption of SHIELD as a risk management tool and demonstrated how an
intervention increased compliance and utilization of SHIELD – however, SHIELD activity
remains lower than management would like and efforts across Flex continue to encourage greater
utilization. [14]
33
Figure 9. Overview of a program’s timeline and issue tracking in SHIELD
Since SHIELD’s core purpose is to facilitate project management at the program-specific
execution level, it is also a promising source of data that can be used to identify areas for
improvement at a company-wide level. In addition to tracking milestones and program progress,
program managers can also flag risks and issues as they arise throughout the course of a program.
Again, the main reason for issue flagging is to inform supervisors and managers of potential
problems as they arise so that they can be resolved accordingly. However, these “flags” of specific
risks could be used to identify central issues that most frequently arise during NPIs, as well as
common failure modes. This can hopefully inform certain mitigation actions and processes.
All of HRS has been trained on how to use SHIELD. However, because its usage is still fairly new
and unfamiliar to Flex, full compliance is still a work in progress. While all or nearly all programs
within HRS have an associated SHIELD instance, because of the relatively low organizational
34
maturity, risk and issue creation is relatively sporadic as demonstrated by Kehne in 2018. [14] For
example, according to an analysis of an export of all SHIELD programs on November 11, 2019,
there were ten programs that were marked as having a red overall status (a signal used to flag a
program for additional oversight by global account managers and increased discussion cadence
with customers), but only three of these programs had any descriptive category areas (such as
finance, materials, IT solutions, and manpower) marked as yellow or red. These descriptive
category areas could be a promising way to make SHIELD a more effective tool for internal
communication. In particular, diligent reporting of the issues that typically arise in a program in a
yellow or red status, could enable account managers, business development representatives, and
others throughout Flex to more quickly respond to the root causes driving NPI issues. Furthermore,
greater compliance in reporting specific issues could allow a more comprehensive analysis of the
issues that have occurred across Flex using SHIELD data. The lack of robust, reliable reporting in
SHIELD was a primary motivator for instead using interviews and surveys to quantify the
frequency and severity of issue categories.
3.4. Research Approach
Many organizational studies employ a Mixed Methods Research design, a two-pronged approach
to better understand a target organizations structures, processes, strengths, and weaknesses.[15]
This research project employed such an approach, beginning first with high-level, open-ended
interviews that informed a more quantitative study’s objectives and composition afterwards. These
two research phases provided the foundational understanding of the NPI process at Flex and
35
informed the solution hypotheses. Following the exploratory interviews and survey, the scope of
the problem was narrowed and an intervention was conducted to address the problem.
3.4.1. Interviews
In order to gain a better understanding of Flex’s structure and design, as well as gain a qualitative
understanding of the current state of NPIs, a total of 50 interviews were conducted. The purpose
of these interviews was to develop a more targeted set of hypotheses for what the current
challenges and opportunities of the current NPI process at Flex are and how this process could be
improved.
The first set of interviews took place at Flex’s corporate headquarters in San Jose, CA. One purpose
of these interviews was to provide high-level background information about Flex’s strategic
positioning, organizational hierarchy and structure, and culture. The primary objective, however,
was to understand the NPI process from a corporate perspective. That is, to map the goals,
expectations, processes, tools, and involved stakeholders (and their respective responsibilities) and
develop a corporate-level view of the NPI process that cuts across all divisions, sites, and products.
The second set of interviews occurred at the Flex Tijuana site. These interviews provided views
about the unique circumstances, processes, problems, strengths, and weaknesses associated with
the Tijuana site as compared to the other sites in Flex’s portfolio.
36
Figure 10. Interview Sample
3.4.2. Survey
37
Survey Purpose
Following the qualitative interview stage of research, a survey was developed and distributed to
collect information in a more targeted, large scale manner. The purpose of the survey was two-
fold. First, the survey could reveal insights that are statistically significant, and, therefore, more
convincing for justifying a resultant course of action. Second, the survey could be used to highlight
differences between different roles, sites, divisions, and NPI types.
The research objective of the survey was to reveal insights regarding the issues that occur during
NPIs. Program Managers can indicate and categorize issues as they occur during an NPI using an
internally developed project management tool called SHIELD (Simplified Handshake to Inform,
Execute, Launch and Deliver). Over time, this will allow for a more robust analysis that could
identify which issues are most common depending on site, division, and NPI type. However,
because SHIELD was implemented in the last couple years, insufficient data has been entered into
the tool. As such, an alternative method of collecting information in a more quantitative way (a
survey) was necessary.
Survey Composition
The survey had two core parts. The first served to classify respondents while retaining their
anonymity. Respondents were asked to indicate their role, region, division, and the types of NPIs
they worked on. NPI types were categorized as follows:
NPI Type Broader NPI
Category
Description Sample
Size
Sketch to
Scale
Complex NPI Aspects of product design are owned by Flex 19
38
Industrialized
Product
Complex NPI Customer owns design, Flex industrializes
(scales up) production, typically with many
changes to manufacturing strategy
22
Unmodified
Transfer
Simple NPI Product line from customer site is transferred to a
Flex site with minimal changes
11
Modified
Transfer
Simple NPI Product line from customer site is transferred to a
Flex site with some changes, i.e. to
manufacturing strategy
7
Duplication Simple NPI Product line at Flex site is built to duplicate an
existing line at a customer site (the customer
site’s line continues to run, typically unchanged)
8
Figure 11. NPI Types and Categories
As shown in the figure above, the five NPI types can be broadly categorized as “complex” NPIs,
including Sketch to scale and industrialized product NPIs, and “simple” NPIs, including
unmodified transfers, modified transfers, and duplication NPIs. This categorization was used for
data analysis on the back end to allow for larger category sample sizes, and because differences
within the broader categories was marginal compared to differences across these categories.
The second portion of the survey served to collect information regarding the root causes of NPI
problems. Survey respondents were asked to rate on a 1 to 3 scale how frequently issues in different
categories occur, and how severe those issues are when they occur. Two of the core questions were
as follows, with a full list of the questions in the survey included in Appendix X:
• How often do issues in each of the following areas occur during NPIs? (Rarely, about half
the time, or most of the time)
• When issues in each of the following areas occur, how much of an impact do they have on
the NPI's success (i.e., costs, timeline, etc.)? (Minimal/minor, moderate, significant/major)
39
Respondents answered these questions with respect to a list of issue categories. This list of issue
categories was compiled during the interview phase, and includes the following:
Issue Category Shorthand Description
Quoting Quoting Decisions made impacting cost and timeline
estimates
CapEx Approval CapEx Approval Approval process for making capital
expenditures
Design to manufacturing
hand-off
Design Handoff Hand-off from design site to manufacturing
site
Raw material sourcing Raw Materials Identifying source of raw materials, as well as
all necessary steps to deliver at manufacturing
site
Equipment sourcing
and/or installation
Equipment Identifying source of equipment, as well as all
necessary steps to deliver and install at
manufacturing site
Process Development Process Dev Development of manufacturing system – either
from scratch in case of a complex NPI, or
changes introduced to prior process in case of
simple NPI
Shop Floor Control Control Decisions regarding control of material flow
and traceability
Direct labor staffing /
resource availability
Direct Labor Decisions regarding number and types of
frontline operators to assign to an NPI
Indirect labor staffing /
resource availability
Indirect Labor Decisions regarding number and types of
engineers and managers to assign to an NPI
Packaging Packaging Decisions regarding design of packaging as
well as the sourcing of packaging materials
Outbound logistics Outbound Sterilization and final delivery of finished
product to customer
Transition from NPI to
sustaining
Sustaining Hand-off from NPI team to steady production /
sustaining team once initial ramp-up has been
completed
Figure 12. NPI Issue Categories (“shorthand” indicates labels that will be used in forthcoming
figures for concision)
Survey Distribution
40
The survey was distributed to 110 business development representatives, general account
managers, global program managers, and program managers, through email invitations that linked
to the actual survey which was designed and hosted in Qualtrics. The survey remained open for
responses for three weeks following the initial invitations, and two reminder emails were sent. At
the close of the survey, 74 responses had been collected, yielding a response rate of 67%. The final
sample representation by role, region, and division is summarized in the figure below.
Figure 13. Survey Sample
3.5. Analysis of Current State
3.5.1. Interview Results
While the interviews that were conducted were intentionally open-ended, several patterns
emerged. Nearly all site interviewees pointed to the early stages of the NPI process as the critical
junction at which likely performance of the program is determined. That is, NPIs that started well
typically ended well. Interviewees frequently cited the quoting stage of an NPI as a root cause for
problems that surfaced later. During the quoting stage, a site-based team works cross-functionally
with a global quoting team and negotiates with the customer to determine critical pricing and
program timeline estimates. As part of this process, key decisions regarding process design and
implementation are made. A critical finding from the interview stage was that this quoting process
lacked the structure and discipline necessary to ensure decisions were made properly.
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A hypothesis for the root cause of this failure is that there is a misalignment of incentives and
performance metrics between site teams and global teams. Site teams (comprised primarily of
program managers and engineers) tend to be incentivized and measured based on their ability to
deliver program objectives on a timely and cost-effective basis. Global teams (comprised of
business development reps and account managers) on the other hand tend to be incentivized and
measured based on sales performance. As such, global teams may be willing to overpromise with
customers, suggesting rapid timelines and low costs are possible, in order to win deals. Then, site
program managers downstream realize later during the NPI that contracted timelines and costs are
infeasible. A significant aspect of the solution approach for this problem will involve a
standardization of the quoting process to align these two parties.
3.5.2. Survey Results
NPI Issues
The core objective of the survey was to quantitatively assess the impact of different types of issues
(problems) that occur during NPIs at Flex. Two factors were considered, including the respective
issue severity and how frequently it occurs. Figure 14 demonstrates that the most problematic issue
areas are those that have both a high frequency of occurrence as well as a high severity.
42
Figure 14. Average NPI Issue Severity and Frequency; 3 indicates high severity and/or
frequency, 1 indicates low severity and/or frequency
The NPI categories clustered toward the upper right quadrant of Figure 14 are the categories that
have the greatest need to be addressed with process improvements. As such, these categories
(quoting, raw materials, design handoff, capex approval, and equipment) merit the greatest
attention in an intervention.
Respondents were also asked which issues most frequently jeopardize NPI success – while figure
14 depicts issues respondents were facing for the specific NPI they were working on at the time of
the survey, this question elicited a more general view of the most problematic NPI categories. The
categories that were most problematic in Figure 14 above were confirmed to be frequent issues for
the question posed in this manner. However, upon splitting responses based on the type of NPI
handled, a more nuanced view emerges, as shown in Figure 15 below.
43
Figure 15. NPI Issue Severity by NPI Type
While quoting remains a significant issue overall, it is less problematic for simple NPIs. This
makes sense, as costs and timeline expectations are typically better understood for transfers.
Surprisingly, however, raw material sourcing and shop floor control issues have an outsized impact
on simple NPIs. Follow-up interviews confirmed this finding.
In the case of simple NPIs, contract manufacturers like Flex will often defer raw material source
selection, costs, and risks to the customer. The customer provides Flex with an initial purchase
order, which Flex can execute and re-execute as production proceeds. Issues often arise when the
customer does not perform the proper diligence required to ensure raw materials are of sufficient
quality, or are able to be delivered to the contract manufacturer’s site (often requiring an involved
duty and import process). Similarly, contract manufacturers will often assume the same shop floor
control techniques that the customer has been using will function properly at the contract
manufacturer’s site and at scale. In reality, this two-fold assumption typically does not hold. Much
44
tighter shop floor control techniques than those employed by the customer are typically needed for
multiple reasons. First, the customer’s operators have experience with their product and process,
while a contract manufacturer will be ramping up production for the first time – as such, greater
controls are necessary to catch mistakes that may occur. Second, sites like Flex Tijuana have
significantly higher turnover, so operators are more likely to be newer and less experienced. Third,
simple transfers are typically conducted to ramp output significantly. While a customer may be
producing with one manufacturing line, the contract manufacturer may need to produce using
several lines. This scale requires increased control as traceability becomes complicated by raw
materials that may flow through different lines.
SHIELD Confidence
Since SHIELD is Flex’s primary project management tool, respondents were also asked to rate
how confident they are in their ability to use SHIELD. Respondents were asked to rate their
confidence in using SHIELD on a scale from 1 to 5 with 1 indicating they are “Not at all confident,”
3 indicating they are “Somewhat confident,” and 5 indicating they are “Extremely confident.”
These results are provided, broken down by role and region, in Figure 16.
45
Figure 16. Average of self-reported confidence in ability to use SHIELD for program
coordination
Nearly all groups, with the exception of Global Program Managers (GPMs, who tend to be the
most aware of new program management tools due to their involvement in rolling them out),
reported they were less than “Somewhat confident” in their ability to use SHIELD for program
coordination, on average. These results may be particularly telling since as demonstrated, for
example, by Sandroni and Squintani, survey respondents tend to overstate confidence. [16] As
such, slightly less than somewhat confident is likely an optimistic picture of SHIELD user’s
comfort with using this tool. Given SHIELD’s critical importance for NPI coordination, this study
highlights the importance for continued skills development in this area. It is hypothesized,
however, that supplemental software tools may be necessary due to functional failures of the
SHIELD platform. As such, alternative software tools will be explored.
46
3.5.3. Quote versus Actual
Quote versus Actual (QvA) is an internally built analytics application that allows Flex managers
to compare what has been quoted to customers versus the actual performance at Flex sites. This
allows for the identification of costly gaps and variances between the two, and in turn, the
generation of recommended action plans. Key measures center around profit components such as
sales volumes, material costs and loss, direct materials, freight, labor, and overhead. Storage of
these data along with their analysis require a collaborative effort among site management teams
(especially including PMs), finance teams, and segment account managers.
The QvA initiative at Flex, like SHIELD is new – compliance is a work in progress. A company-
wide memo from Flex’s President of Global Operations stressed the urgency of increased diligence
in using this tool. At present, most sites (including Flex Tijuana) have data entered for actuals (the
actual costs associated with past projects for which delivery has reached completion), but are
missing data for quoted numbers (the costs numbers estimated for the project at the outset of the
NPI). It is hypothesized that greater accountability to the difference between quoted cost and actual
cost could result in improved performance but holding program managers accountable to this
standard cannot be done until collection of the requisite data is institutionalized. As such, an outline
for storing this data will be included in the Due Diligence Checklist, and an outline for using these
numbers to evaluate performance will be presented along with the Pilot Implementation of this
checklist.
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4 Implementation and Results
4.1. Introduction
Due Diligence Checklist Development Approach
A due diligence checklist was developed through a collaborative and iterative process with Tijuana
Program Managers to address the issues outlined above. The motivation and thinking behind the
checklist were that many of the issues could be avoided if considered and pre-empted early in the
NPI process. As such, the checklist was intended for use at the outset, during and shortly after the
quoting stage of an NPI. The checklist was developed by conducting follow-up interviews with
site program managers and engineers, as well as global program managers and business
development representatives. Chapters were dedicated to pre-empting different issue areas, with
additional focus given to those issue areas which survey results indicated were causing the most
significant issues during NPIs.
The primary diagnosed issue that the checklist actions sought to resolve was the misalignment of
incentives between business development (sales) and site program management (execution). Since
this is a common issue beyond Flex, the general approach of standardizing tasks and
responsibilities in this manner could be applied in other manufacturing environments.
Checklist Implementation
While the quoting due diligence checklist’s content was iteratively developed in a series of
Microsoft Word documents, other software tools were considered for actual implementation. Over
50 different software tools are currently in use across Flex – while each additional tool can
48
complicate workflows by requiring additional training and care to ensure integration and to
minimize repeat work, software tools that are well fit for the jobs that need to be performed can
drastically increase a team’s effectiveness through enhanced collaboration and communication.
4.2. NPI Due Diligence Checklist
Structure
The NPI due diligence checklist was composed of 5 chapters, each one addressing different issue
categories including General Program Information; Process Development; Materials, Equipment,
and Logistics; Resource Availability; and Design Hand-off. The content of these chapters is
discussed in sections 3.7.1 through 3.7.5. Each chapter was structured similarly, serving four
functions: a checklist of tasks, task designation, discussions, and approvals. Task checklists
specified the list of tasks that should be performed for every NPI. Task designation specified the
roles and resources best suited to perform those tasks. Discussions designated the group of 3-5
individuals who should come together at the close of each chapter to review tasks that had been
completed and key decisions that had been made. These discussions would include certain
authority figures in some instances, and in others would include subject matter experts from whose
experience lessons could be learned. Finally, each chapter designated a specific authority figure
who would need to sign off before that chapter of the checklist could be considered complete. The
first two checklists are provided in figures 17 and 18 – other checklists can be found in the
Appendix.
4.2.1. General Program Information
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Customer Contacts and General Info
Centralizing contact and general program information enables quick understanding of the nature
of a program and relevant point people for obtaining additional information. Further, this stage
requires the specification of program type (i.e., transfer, duplicate, or new) which is helpful for
initial quoting estimates, program development and execution, and analysis of Flex’s programs in
aggregate.
Figure 17. Customer Contacts and General Info Checklist
Statement of Work
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Keeping a record of the Statement of Work allows Flex and the customer to hold one another
accountable to key targets, estimates, and dates. Furthermore, recording these key timelines and
estimates allows for quick reference, keeping all parties on the same page. This information is
critical for finalizing numbers for quoting.
Figure 18. Statement of Work Checklist
4.2.2. Process Development
Customer Quality or Regulatory Requirements
Understanding the product’s quality and regulatory requirements upfront is critical to setting the
stage for process development later on. Unforeseen requirements can dramatically impact project
scope, timing, and cost. While many factors must be checked to ensure thorough consideration of
51
these requirements, spending the time to understand these factors at the quoting stage typically
ends up saving both Flex and its customers significant resources later on.
Shop Floor Control
Shop floor control systems are software systems, methods, and tools that are implemented to
monitor and report on the flow of materials through a manufacturing process. These systems
should be considered early in the quotation period. Consideration of these invaluable tools later in
the development process is frequently cited as a reason for delays and cost overruns. While Flex
has decided to absorb costs of implementing Flex Flow in new programs (quoting costs into
MOH), explaining Flex Flow and other techniques to the customer during quotation is critical to
ensure timely buy-in and approval for necessary changes to product (e.g., through the inclusion of
a serial bar code) and process (e.g., addition of process steps for tracking and controlling movement
of materials).
Handling and Special Requirements
Determining the proper handling and other special requirements that are specific to a new program
is essential to enabling design and process development to properly plan for unique circumstances.
Other Process Development Considerations
One of the core value propositions of Flex as a company is its ability to develop efficiently scaled
manufacturing processes. Simply copying the processes that customers have in place – even when
a program is considered a duplicate transfer – is not enough for success. Flex should assume that
all processes, including customer processes, are imperfect, and that any process can be further de-
risked and debugged. Each process step of a new program should be thoroughly analyzed and
discussed among various manufacturing professionals, with the underlying assumption that
52
anything that can go wrong will go wrong. Even the simplest of tasks can have many avenues for
resulting in nonconformance. Properly “poke yoking” a process involves instituting measures that
“mistake-proof” the process. Its purpose is to eliminate product defects by preventing, correcting,
or drawing attention to human errors as they occur.
4.2.3. Materials, Equipment, and Logistics
Bill of Materials
The Bill of Materials (BOM) is a necessary resource for beginning to execute a program. The
BOM should include the Approved/Qualified Vendor Listing (AVL/QVL).
Equipment
Procuring correct equipment that is in proper shape is a critical step for initiating any
manufacturing program. At the quoting stage, it is important to verify what equipment has already
been obtained (and ensure proper due diligence will be conducted to understand the exact condition
of that equipment), and what equipment has yet to be procured.
Import and Export
Most of Flex’s programs involve transnational movement of raw materials, equipment, and
finished products. While Flex typically outsources much of the work associated with moving
materials across borders, verifying the timelines and costs associated with this facet of the
manufacturing process is critical, as missteps have been known to result in materials requiring
extensive wait times before being able to move across borders.
Mechanical Assembly and Test
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While considerations for mechanical assembly may seem like a step that belongs later in the Flex
Product Lifecycle, some planning up front can help to point out potential risks and issues ahead of
time. At this stage, it is important for PMs to have a thorough understanding of the end-to-end
assembly and test process in order to properly estimate non-recurring engineering costs (NREs,
such as labor associated with setting up the NPI). Furthermore, while the customer may have a
plan for automation or controls that functions or would function properly at a customer-owned
site, additional considerations are often relevant when shifting production to a CM like Flex as
output is often scaled, staff may be trained differently, and site-specific dynamics (such as
electrical inputs and outputs) may differ.
Packaging, Logistics, Outbound Freight, and Sterilization
Packaging, outbound freight, and sterilization are critical factors that are often overlooked.
Responsibilities and ownership should be clearly defined during the quoting stage.
4.2.4. Resource Availability
Labor
NPIs are labor intensive projects, and labor is often a significant factor that weighs heavily in the
margin Flex is able to achieve. As scuh, efficient use of human resources directly impacts Flex’s
bottom line. Clear plans for headcount utilization are necessary to make proper quoting estimates,
and for sites to be able to plan resources accordingly. This section of the checklist directs PMs to
outline resource needs, as well as begin to designate and reserve these needs in i-nexus.
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Transitions, Training, Attrition
Continuity of staffing is ideal under most circumstances for NPIs. However, at times changes will
need to be made – either driven by attrition, changing site needs, or changing customer needs.
Plans should therefore be made to ensure smooth transitions so that contingency plans can be
enacted without inhibiting the success of the NPI.
4.2.5. Design Handoff
Scope of Design Work
Design sites perform work that is often integral to the success of an NPI. However, not all aspects
of process development should be owned by design teams, which are typically unfamiliar with the
specific requirements, strengths, and attributes of manufacturing sites. As such, careful
coordination between design and manufacturing NPI teams is critical to ensuring that the design
team understands what will work and what will not work once implemented.
Design-Manufacturing Handoff
While less likely than other factors to impact the actual quoting costs, having clarity regarding the
timeline for transition from design to manufacturing will allow for clearer lines of responsibility,
and more accurate overall timeline and schedule determination within quoting.
4.3. Checklist Implementation: Software Tool Evaluation
Four software tools – Agile, SHIELD, Microsoft Word, and i-nexus – were considered when
determining the ideal mode for implementing the quoting due diligence checklist. Four factors
were used as selection criteria: (i) ease of collaboration; (ii) flexibility; (iii) speed of development;
55
and (iv) organizational maturity. Ease of collaboration refers to the ability of users to communicate
with and provide updates to one another. Flexibility refers to the ability to change layouts,
workflows, and overarching structures of tasks and communications. Speed of development refers
to the agility with which changes can be made to specific tasks – for example, adding or removing
a specific step in a workflow. Organizational maturity refers to how comfortable Flex employees
are with each software tool. A meeting was conducted with all Flex Tijuana PMs in which rough
ratings of each product according to each performance category were agreed upon, shown in Figure
19. Despite having the lowest rating for familiarity, the PMs agreed that i-nexus should be used
for implementation the quoting due diligence checklist due to its ease of collaboration, flexibility,
and speed of development.
Figure 19. Software Tool Comparison
4.3.1. I-Nexus
I-nexus is a cloud-based project management tool that focuses on strategy execution. Of the four
tools considered, i-nexus is the least familiar to PMs as it has only recently begun being piloted in
a few Flex sites. However, the tool is versatile, with many features that can be swiftly rearranged
56
and modified. Templates for project workflows can be created that list steps that should be
completed. Each step can be assigned to a resource role (and subsequently, specific employees can
be assigned), an expected time to complete can be outlined, documents that should be referenced
or filled out can be appended, and authorities that must approve completion before subsequent
tasks can be tackled can be specified. These templates can then be applied to projects, and teams
can use the i-nexus project workflow to communicate progress towards completing steps.
The NPI Due Diligence Checklist was adapted to fit into the i-nexus framework as a project
template. This project template is depicted in Figure 20.
Figure 20. NPI Due Diligence Checklist instance in i-nexus
57
4.4. Pilot Implementation
While a thorough measurement of the results following complete implementation of the NPI Due
Diligence Checklist was not included in the scope of this project, a pilot implementation was
commenced, and remains ongoing at the time of this writing, for two NPIs. During this pilot
implementation, involved PMs are providing feedback and adjusting the checklist as needed.
One of the programs selected for the pilot implementation was a brand new NPI. The due diligence
checklist was begun for this NPI during the research phase, but has not yet been completed. The
other NPI selected for pilot implementation was in progress, but undergoing some revisions.
PMs were trained on how to use i-nexus and how to use the NPI due diligence checklist. Then,
two monthly check-ins were conducted during which feedback was collected. During the first
check-in, open-ended feedback was collected to make adjustments to the checklist. These
adjustments included the inclusion of tasks that had been missing, reordering of tasks, and removal
of tasks that were considered unimportant. During the second check-in, a more formal feedback
collection process was conducted to begin evaluating the effectiveness of the due diligence
checklist
4.5. Evaluation Criteria
The introduction of any significant process initiative should be paired with measurement processes
that can indicate whether the process is successful at achieving its intended goal. In order to
measure the success of the NPI due diligence checklist, one approach was conducted (the
58
aforementioned feedback collection), and one approach will be outlined for future use as these
NPIs which are in their early stages approach completion.
4.5.1. Feedback Collection
Feedback surveys were distributed to and collected from the PMs who participated in the pilot
implementation (see Appendix 3 for the specific content of these surveys). These feedback forms
focused on revealing the attitudes of the PMs and their subordinates towards this new process, as
well as collecting suggestions that could be used to direct future modifications and improvements
of the due diligence checklist. The results from surveying the three PMs who were most engaged
in the pilot implementation of the NPI Due Diligence Checklist are depicted in Figure 21 below.
These early results indicate that PMs consider this tool to be a valuable tool. However, continued
distribution of this survey will allow for continued measurement of attitudes to determine how
well the tool will scale across the Flex organization (such as to other sites with potentially different
processes and needs), as well as continuous improvement through the identification of
opportunities for enhancement of the checklist.
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Figure 21. Checklist Feedback Survey results (sample of 3 PMs)
4.6. Future Metrics Outline
In addition to the directional feedback and cultural insights gained from collecting PMs’ feedback,
an outline for a quantitative approach to evaluating this initiative’s success has been presented.
Different groups within Flex believe that different metrics are determinants of whether an NPI is
successful – there is not agreement across Flex regarding this matter. The difference of opinions
is generally demarcated by differing priorities for differing roles. For example, BDs are motivated
to drive topline revenue numbers and will therefore prioritize quicker production ramp-up
timelines and larger production volumes, GAMs are more focused on ensuring the customers for
60
whom they are responsible are happy and will therefore prioritize customer satisfaction, while site
PMs are motivated to ensure a program is holistically profitable and will therefore focus on profit
and margins. Instead of selecting just one of these areas to measure quantitatively, four areas are
recommended for consideration: (i) quality performance; (ii) financial performance; (iii) timeline
performance; and (iv) customer satisfaction.
Quality Performance
Given the context of operating in the medical space and the associated importance of delivering
defect free products to patients and care providers, quality performance is the most important
indicator of success for the NPI due diligence checklist. While instances of defects delivered to
customers and recalls were rare even prior to the institution of this checklist, their occurrence is
expected to decline even further following implementation.
Financial Performance
Several metrics are used to measure the financial performance of a program. Since programs will
vary drastically from one another (in terms of size, resources, strategic importance, and other
characteristics), the success of an NPI from a financial point of view is typically measured by how
much the program’s ultimate financial metrics differ from how that program was quoted. This is
because in many instances Flex will need to cover the difference between what Flex quotes and
what Flex delivers. For example, if a program ends up costing significantly more than what Flex
quoted that program, the NPI would be considered less successful as Flex would need to cover the
unanticipated costs. As such, Quote versus Actual (QvA) analysis will be a critical aspect of
evaluating the success of the NPI due diligence checklist. The checklist will be considered a
61
success if key financial QvA deltas such as operating profit (OP) and non-recurring engineering
(NRE) costs are reduced.
Timeline Performance
Time is an extremely valuable resource in any manufacturing setting. The amount of time spent
on an NPI is a key determinant of success for two reasons. First, time spent on an NPI equates to
money spent on utilized resources during that time. Second, the faster an NPI is completed, the
faster a customer can begin to service a market, which can often mean the difference between
market dominance and losing out to competitors. The NPI due diligence should accomplish two
goals with respect to timeline performance, specifically, reduce the amount of time an average NPI
takes to complete, as well as reduce the difference between planned and actual timeline (similar to
the financial QvA impact outlined above). The impact to the latter should be seen immediately –
the pilot programs that use the NPI due diligence checklist should be more accurate at predicting
timelines. The impact to the former will require a larger sample size across which to average
timelines, due to the varied nature of NPIs. As such, another measure of timeline performance will
be used: the number of problems flagged in SHIELD. While quantitative data was not collected,
interviewees indicated that whenever problems are flagged in SHIELD a timeline delay is typically
required.
Customer Satisfaction
Customer satisfaction is an important evaluation metric in many industries, and contract
manufacturing is no exception. A customer’s happiness is typically evaluated using a Net Promoter
Score (NPS). The NPS is determined by asking customers how likely they are to recommend the
company’s service to a friend or colleague, on a scale of zero to ten. Detractors are customers who
62
give a rating from zero to six, and promoters are customers who give a rating of nine or ten. The
NPS is calculated as the percent of customers who are promoters, minus the percent of customers
who are detractors[17]. Flex is currently using Viewpoint, an outsourced technology platform, to
collect its NPS from customers, among other customer satisfaction metrics.
Customer satisfaction is in some respects a catch-all summary measurement of NPI success, as
financial and timeline factors tend to impact whether a customer is happy with an NPI’s outcome.
However, customer satisfaction also captures aspects of an NPI that can otherwise be more difficult
to measure. While the NPI due diligence checklist is expected to improve NPI outcomes with
respect to financial and timeline measurements, it will be important to see whether the additional
steps, discussions, and authorizations introduce friction into the overall NPI process that is
detrimental to customer satisfaction.
Other Considerations
Operational changes within an organization often come with an observed J-curve Effect – that is,
an initial decrease in performance during early implementation as employees are being trained and
are familiarizing themselves with the changes, followed by a marked increase in performance (that,
over time, more than makes up for the momentary decline) once familiarity is established [18]. As
such, an outcome similar to the one depicted in Figure 22 may be observed, where financial,
timeline, and customer satisfaction metrics deteriorate before improving (note that quality
performance is unlikely to experience the J-curve effect). Hence, PMs and leaders have been
cautioned to allow a long enough trial period (one to two years, to allow completion of 10 or more
NPIs) to be completed before making a decision of whether to continue with this intervention.
63
Figure 22. Illustrative example of measurement and potential checklist outcomes
64
5 Conclusions
5.1. Review of the NPI Process
New Product Introductions are complicated endeavors that require interactions among many
different parties within an organization. This work presented several tools and frameworks that
can be used to facilitate communication and execution of NPIs. A new tool was introduced and
developed – the NPI due diligence checklist. This checklist was implemented, and its reception
was attitudinally positive. However, opportunities for further refinement and development exist,
and its quantitative impact on NPI success will be measured going forward to determine whether
it should be rolled out more broadly.
5.2. Future Work
5.2.1. Status of Implementation and Expected Next Steps
At the time of writing, the due diligence checklist was still in use for two NPIs at Flex Tijuana.
Two additional NPIs were preparing for launch, and the program managers for those programs
intended to use the checklist as well. A more thorough assessment of the checklist is planned for
when the pilot implementation NPIs come to a close in mid-2020, after which a plan for
deployment at other sites will be developed and considered.
5.2.2. Recommendations for Future Implementation at Flex
The exploration stage of this project included interviews with Flex employees at both the corporate
and site level. However, site-level interviews were predominantly conducted at Flex Tijuana.
Furthermore, development of the due diligence checklist was conducted solely at Flex Tijuana.
While early indicators (that is, attitudes of those involved in implementation) suggest that the
65
checklist should be applied more broadly, additional development may be necessary. While the
checklist was intended to be as generalized as possible, it should be vetted with PMs at other Flex
Medical sites first to ensure applicability. Once the checklist has been implemented at a selection
of other Flex Medical sites, a similar review process should be conducted by other divisions within
Flex (such as Flex Automotive) to begin exploring applicability outside of the medical division.
While Flex Medical is believed to be the division in which a checklist would make the greatest
impact (due to the quality requirements necessitated by the potential impact to patient health, as
well as those imposed by regulating bodies), other divisions would likely benefit from the
additional communication, coordination, and planning discipline enabled by this checklist
approach.
5.2.3. Continuous Improvement Opportunities
Several opportunities exist for improvement to the due diligence checklist. For example, different
types of NPIs ought to have different standard operating procedures. While most of the checklist
categories will likely remain the same or similar, specific tasks, required information, and
responsible parties will likely differ.
The development of different NPI checklists for different NPI types can be accomplished in
conjunction with a minor addition to the suggested evaluation approach. In addition to measuring
quality, financial, timeline, and customer satisfaction metrics for NPIs before and after checklist
implementation, these data should be categorized by NPI type. NPI types that end up
underperforming can then be given additional attention. Post-mortem discussions can allow a
determination of when, where, and why mistakes were made, and how adjustments to the checklist
could mitigate their future occurrence.
66
5.3. Applicability Beyond Flex
As competition steepens in the contract manufacturing space, Flex and its competitors will likely
find increasing utility in creating and continuously refining checklists to ensure products can be
developed on-time and defect-free. However, due diligence checklists are useful in a variety of
situations. Atul Gawande’s Checklist Manifesto presents numerous professional fields in which an
aggressively disciplined checklist approach can drastically reduce the occurrence of unfavorable
outcomes in complicated and high-stakes environments.[19] Checklists are applied in aviation,
military, construction, and many other fields. There is an opportunity for future work to assess
these and other industries to identify more concretely and quantitatively the contexts in which
checklists are most likely to improve outcomes.
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6 Bibliography
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http://www.fundinguniverse.com/company-histories/flextronics-international-ltd-history/.
[Accessed: 10-Oct-2019].
[2] “Evolving Players in the Medical Device Supply Chain,” Medical Product Outsourcing.
[Online]. Available: https://www.mpo-mag.com/issues/2019-03-01/view_columns/evolving-
players-in-the-medical-device-supply-chain/. [Accessed: 15-Oct-2019].
[3] “Flex Ltd. 2019 Annual Report & Proxy Statement.” [Online]. Available:
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m. [Accessed: 14-Oct-2019].
[4] “Manufacturing In Tijuana, Baja California,” NAPS. [Online]. Available:
https://napsintl.com/manufacturing-in-mexico/mexico-manufacturing-
locations/manufacturing-in-tijuana/. [Accessed: 06-Nov-2019].
[5] “2016’s Best Practices for NPI and NPD Success.” [Online]. Available:
https://community.pdma.org/knowledgehub/bok/process18/2016-best-practices-npi-npd-
success. [Accessed: 14-Nov-2019].
[6] D. Kieran, D. Reed, and R. Bourdeau, “New product introduction of printed circuit
assemblies,” Circuits Assem. San Franc., vol. 10, no. 3, pp. 40–45, Mar. 1999.
[7] “On the utility of project management techniques for new product development projects,”
Eight to Late, 10-Jul-2008. [Online]. Available:
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techniques-for-new-product-development-projects/. [Accessed: 22-Nov-2019].
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[8] “Tavis Manufacturing.” [Online]. Available:
http://tavis.ca/en/Scheduling_Screenshot_MSProject.htm. [Accessed: 22-Nov-2019].
[9] “Oracle Agile PLM | 2019 Software Reviews, Pricing, Demos,” Software Connect. [Online].
Available: https://softwareconnect.com/plm/oracle-agile-plm/. [Accessed: 22-Nov-2019].
[10] J. M. Juran and A. B. Godfrey, Eds., Juran’s quality handbook, 5th ed. New York:
McGraw Hill, 1999.
[11] A. Schiffauerova and V. T. McGill, “Cost of Quality : A Survey of Models and Best
Practices,” 2004.
[12] “The Quality Cost Conformance Model.” [Online]. Available:
https://maaw.info/QualityCostConformanceModel.htm. [Accessed: 06-Nov-2019].
[13] “The Importance of New Product Introduction & Why It Can Fail.” [Online]. Available:
https://www.industryforum.co.uk/resources/blog/the-importance-of-new-product-
introduction-npi-and-common-reasons-for-its-failure/. [Accessed: 22-Nov-2019].
[14] E. T. Kehne, “Application of Risk Management Frameworks to Medical Device
Production Development,” p. 109.
[15] J. Schoonenboom and R. B. Johnson, “How to Construct a Mixed Methods Research
Design,” Kolner Z. Soziol. Sozialpsychologie, vol. 69, no. Suppl 2, pp. 107–131, 2017, doi:
10.1007/s11577-017-0454-1.
[16] A. Sandroni and F. Squintani, “A Survey on Overconfidence, Insurance and Self-
Assessment Training Programs,” p. 28.
[17] “Net Promoter Score,” Medallia. [Online]. Available: https://www.medallia.com/net-
promoter-score/. [Accessed: 09-Dec-2019].
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[18] David Anderson, “Organizational maturity & the J-Curve Effect | Kanban University.”
[Online]. Available: https://leankanban.com/organizational-maturity-the-j-curve-effect/.
[Accessed: 09-Dec-2019].
[19] “Atul Gawande’s ‘Checklist’ For Surgery Success,” NPR.org. [Online]. Available:
https://www.npr.org/templates/story/story.php?storyId=122226184. [Accessed: 09-Dec-
2019].
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Appendix 1: NPI Exploration Survey Questionnaire
Start of Block: Intro and Screeners
Q1 The purpose of this survey is to improve Flex's New Product Introduction (NPI) processes.
This survey is strictly voluntary. You have no obligation to answer every question: omit any
questions that you cannot or do not wish to answer.
All responses are confidential. The research team will use the aggregated data to identify areas
of concern and provide feedback to enhance the company’s ability to run NPIs more smoothly. If
you have any questions about this survey, please contact Geoff Winegar
Page Break
71
End of Block: Intro and Screeners
Start of Block: Body Questions
Q2 Which of the following best describes your current role within Flex?
o Business Development (BD)
o General Account Management (GAM)
o Manufacturing Program or Project Management (PM)
o Design Program or Project Management (PM)
o Global Program Management (GPM)
o Other, please specify: ________________________________________________
Q3 In which region are you currently based?
o Americas
o EMEA
o Asia
Page Break
72
Q4 What is the name of the NPI program or project on which you are currently spending most of
your time?
If you would prefer not to specify or if this question is not applicable, please enter "N/A".
________________________________________________________________
Q5 Which division does this NPI fall under?
o Medical
o Automotive
Q6 For how many months now have you been working on this NPI?
o Less than 3 months
o 3-12 months
o Over 12 months
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Q7 Which of the following categories best describes this NPI?
o Sketch to scale (aspects of product design are owned by Flex)
o Industrialized product (customer owns design, Flex industrializes production)
o Unmodified transfer (product line from customer site transferred to Flex site with minimal changes)
o Modified transfer (product line from customer site transferred to Flex site with many changes, i.e. to manufacturing strategy)
o Duplication (product line at Flex site built to duplicate existing line at customer site)
o Other, please specify: ________________________________________________
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Q8 Which of the following areas have encountered issues with this NPI?
Select all that apply
▢ Quoting
▢ CapEx approval
▢ Design to manufacturing hand-off
▢ Raw material sourcing
▢ Equipment sourcing and/or installation
▢ Process development
▢ Shop floor control
▢ Direct labor staffing/resource availability
▢ Indirect labor staffing/resource availability
▢ Packaging
▢ Outbound logistics
▢ Transition from NPI to sustaining
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▢ Other, please specify:
________________________________________________
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76
77
Q9 Which three areas do you believe most frequently jeopardize the success of NPIs in general?
Select three
▢ Quoting
▢ CapEx approval
▢ Design to manufacturing hand-off
▢ Raw material sourcing
▢ Equipment sourcing and/or installation
▢ Process development
▢ Shop floor control
▢ Direct labor staffing/resource availability
▢ Indirect labor staffing/resource availability
▢ Packaging
▢ Outbound logistics
▢ Transition from NPI to sustaining
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▢ Other, please specify:
________________________________________________
Page Break
79
Q10 How often do issues in each of the following areas occur during NPIs?
Rarely About half the time Most of the time
Quoting o o o CapEx Approval o o o
Design to manufacturing hand-
off o o o Raw material
sourcing o o o Equipment sourcing and/or installation o o o
Process development o o o Shop floor control o o o
Direct labor staffing/resource
availability o o o Indirect labor
staffing/resource availability o o o
Packaging o o o Outbound logistics o o o
Transition from NPI to sustaining o o o
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Q11 When issues in each of the following areas occur, how much of an impact do they have on
the NPI's success (i.e., costs, timeline, etc.)?
Minimal/Minor Moderate Significant/Major
Quoting o o o CapEx Approval o o o
Design to manufacturing hand-
off o o o Raw material
sourcing o o o Equipment sourcing and/or installation o o o
Process development o o o Shop floor control o o o
Direct labor staffing/resource
availability o o o Indirect labor
staffing/resource availability o o o
Packaging o o o Outbound logistics o o o Transition from NPI
to sustaining o o o
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Q12 Which of the following roles are typically involved in quoting decisions for NPIs you have
worked on?
Select all that apply
▢ Business Development (BD)
▢ General Account Management (GAM)
▢ Manufacturing Program or Project Management (PM)
▢ Design Program or Project Management (PM)
▢ Global Program Management (GPM)
▢ Engineering
Q13 Please rate your confidence in your ability to use SHIELD for program coordination.
o Not at all confident
o Not very confident
o Somewhat confident
o Very confident
o Extremely confident
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Q14 You indicated that the following areas most frequently jeopardize the success of NPIs.
What changes would you make to help Flex mitigate these issues?
o Quoting ________________________________________________
o CapEx approval ________________________________________________
o Design to manufacturing hand-off ________________________________________________
o Raw material sourcing ________________________________________________
o Equipment sourcing and/or installation ________________________________________________
o Process development ________________________________________________
o Shop floor control ________________________________________________
o Direct labor staffing/resource availability ________________________________________________
o Indirect labor staffing/resource availability ________________________________________________
o Packaging ________________________________________________
o Outbound logistics ________________________________________________
o Transition from NPI to sustaining ________________________________________________
o Other, please specify: ________________________________________________
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Q15 If you would be willing to be contacted to discuss this research further, please enter your
contact information below (if not, feel free to leave this space blank and proceed to the next
page to complete the survey).
o Name: ________________________________________________
o Email Address: ________________________________________________
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Appendix 2: NPI Checklist
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I. SHOP FLOOR CONTROL
1. Overview
Shop floor control systems should be considered early in the quotation period. Consideration of
these invaluable tools later in the development process is frequently cited as a reason for delays
and cost overruns. While Flex has decided to absorb costs of implementing Flex Flow in new
programs (quoting costs into MOH), explaining Flex Flow and other techniques to the customer
during quotation is critical to ensure timely buy-in and approval for necessary changes to product
(e.g., through the inclusion of a serial bar code) and process (e.g., addition of process steps for
tracking and controlling movement of materials).
2. Checklist
a. Should FlexFlow be used from end to end, or just for
packing?
End to End
Inbetween, explain:
86
Packing only, explain
why:
b. Have plans for Flex Flow (including serialization, process
changes, and cost estimates) been developed?
Serialization
Process changes
Cost estimates
c. Has a plan for Flex Flow (including need for serialization,
process changes, and costs) been presented to the customer?
Serialization (bar code
on product)
Process changes
Cost estimates (priced
into MOH)
d. Has the customer accepted the plans for Flex Flow? Serialization
Process changes
Cost estimates
No, Explain
e. Will DHR be automatic or manual? Automatic
Manual, explain why:
f. Will MES Pro be implemented? Yes No
g. If MES Pro will be implemented, has the plan been priced
into MOH costs that will be quoted?
Yes
f. Discussion among relevant parties conducted PM Dir Ops Eng
Dir
PM
II. HANDLING AND SPECIAL REQUIREMENTS
1. Overview
Determining the proper handling and other special requirements that are specific to a new
program is essential to enabling design and process development to properly plan for unique
circumstances.
2. Checklist
3. Handling and Special Requirements
a. a. What type of Controlled Environment is required for
Mfg
ISO Class ____
CER.
Other, explain
Temp Req:
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b. b. What, if any special Environmental Controls are
required?
Consider the entire process; RM Receipt & WH, SA &
FG Mfg, SA & FG Storage, Handling, Shipping?
No Special Requirements were communicated /
Flex Standard is acceptable.
Humidity Req:
Gowning Req:
Shelf Life Req:
Disposal Req:
Other Req:
c. What, if any special facility systems/utilities are
required?
No special requirements were communicated / Flex
Standard is acceptable.
Compressed Air Quality
Water Quality
Dedicated/Segregated
Physical Space
Access / Security
Controls
Temp Storage
Other Req:
d. What, if any special lot numbering system is required?
No Special
Requirements were
communicated / Flex lot
numbering is acceptable
and will be used
Other, explain
e. What, if any special timing is required for responding
to complaints?
No Special
Requirements were
communicated / < 30 days
is acceptable and will be
used.
Other, explain
f. What are the current best practices for sourcing foreign
materials in use at the current production location?
Explain:
g. What is the shelf life of the product? Explain:
h. What is the shelf life of the raw materials? Explain:
i. Are there any processing/manufacturing time
limitations or constraints?
Yes, explain:
No
j. What, if any, special / extra steps in process validation
are required?
No Special
Requirements were
communicated / Flex
Validation Process and
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Templates are acceptable
and will be used
Other, explain
k. What, if any, special document retention policies are
required?
No Special
Requirements were
communicated / Flex
process is acceptable and
will be used.
Other, explain
l. What, if any special / extra personnel training practices
are required?
No Special
Requirements were
communicated / Flex
Training is acceptable and
will be used
Other, explain
m. What, if any, special Product Release / Certification
requirements?
No Special
Requirements were
communicated / Flex
process is acceptable and
will be used.
Other, explain
n. What, if any special approvals are required for NC
disposition
No Special
Requirements were
communicated / Customer
will approve all UAI
Dispositions only.
Other, explain
o. What, if any special approvals are required for changes
to the DMR
No Special
Requirements were
communicated /
Other, explain
p. What, if any special inspection and testing is required? No Special
Requirements were
communicated.
Other, explain
q. What, if any special product / sample retains are
required?
No Special
Requirements were
communicated.
Other, explain
r. Is there are any requirements for change control? No Special
Requirements were
communicated.
Other, explain
s. Discussion among relevant parties conducted PM Dir Materials
Dir Ops Dir
PM
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III. OTHER PROCESS DEVELOPMENT CONSIDERATIONS
1. Overview
One of the core value propositions of Flex as a company is its ability to develop efficiently scaled
manufacturing processes. Simply copying the processes that customers have in place – even when
a program is considered a duplicate transfer – is not enough for success. Flex should assume that
all processes, including customer processes, are imperfect, and that any process can be further
derisked and debugged. Each process step of a new program should be thoroughly analyzed and
discussed among various manufacturing professionals, with the underlying assumption that
anything that can go wrong will go wrong. Operators work long hours performing repetitive tasks.
As such, even the simplest of tasks can have many avenues for resulting in nonconformance.
Properly “poke yoking” a process involves instituting measures that “mistake-proof” the process.
Its purpose is to eliminate product defects by preventing, correcting, or drawing attention to human
errors as they occur.
2. Checklist
a. Have meetings to fully poke yoke the process been conducted
with the following?
Mfg Site Dir PM
Mfg Site PM
Mfg Site Dir Ops Eng
Mfg Site Dir Quality
I. BILL OF MATERIALS
1. Overview
The Bill of Materials (BOM) is a necessary resource for beginning to execute a program. The
BOM should include the Approved/Qualified Vendor Listing (AVL/QVL); excel format is
strongly suggested for timely return of quotation.
2. Checklist
a. Customer Part Number, Quantity Per, Reference
Designators, Package Type/Description
b. Assembly level showing mechanical assembly
c. Assembly Drawings or Manufacturing Instructions Applicable Not
Applicable Other,
explain.
d. System level showing hardware, sub-assembly,
packaging, etc.
e. Will the current supplier base be used? Yes No
Partially
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f. Supplier or Manufacturer Name and Part Number for
AVL/QVL
g. Contact information (name, phone number) for
unique or custom parts (or plug pricing)
h. Letters of Authorization (LOA) for contract
pricing, customer owned designs and registration
ownership. (Or plug pricing)
Applicable Not
Applicable Other,
explain.
i. Discussion among relevant parties conducted PM Dir
PM
Materials Dir
Ops Eng Dir
II. EQUIPMENT
1. Overview
Procuring correct equipment that is in proper shape is a critical step for initiating any
manufacturing program. At the quoting stage, it is important to verify what equipment has
already been obtained (and ensure proper due diligence will be conducted to understand the exact
condition of that equipment), and what equipment has yet to be procured.
2. Checklist
a. Who is responsible for sourcing equipment? Flex
Customer, already owns
Customer, needs to
purchase
b. Equipment source and status specified? Yes, indicate: ________
Status: ________
c. Timeline and cost for Factory Acceptance Test agreed with
customer
d. Timeline and cost for Site Acceptance Test agreed with
customer
e. Discussion among relevant parties conducted PM Dir
PM
Facilities Manager
Ops Dir
III. IMPORT/EXPORT
1. Overview
Most of Flex’s programs involve transnational movement of raw materials, equipment, and
finished products. While Flex typically outsources much of the work associated with moving
materials across borders, verifying the timelines and costs associated with this facet of the
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manufacturing process is critical, as missteps have been known to result in materials requiring
extensive wait times before being able to move across borders.
2. Checklist
a. Import broker is specified, along with expected costs Broker Expected
costs
b. Timeline for import is clarified with customer and broker Customer Broker
c. Timeline for export is clarified with customer and broker Customer Broker
d. Discussion involving all relevant parties completed Customer Broker
PM Dir of Materials
Dir of Facilities
IV. MECHANICAL ASSEMBLY AND TEST
1. Overview
While considerations for mechanical assembly may seem like a step that belongs later in the
FPLC, some planning up front can help to point out potential risks and issues ahead of time.
2. Checklist
a. Provide Mechanical Assembly & Detailed Part 2D & 3D
Drawings in soft copy PDF format for all assemblies to
include all relevant data. All specs or processes must be
called out on the drawings
Applicable Not
Applicable Other,
explain.
b. Requests for plastic parts must have resin, cavitation, part
weight, cycle time, and secondary operations specified within
the request.
Applicable Not
Applicable Other,
explain.
c. Functional Verification Test (FVT) Procedure required? Yes No
d. Are System Test Instructions required? Yes, explain:
No
e. Have visual inspection requirements and rules been
documented thoroughly to ensure any operator can
determine pass/fail?
Yes
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f. Any other "special" testing requirements not mentioned Applicable Not
Applicable Other,
explain.
g. Discussion among all relevant parties conducted Dir Ops Engineering
Dir of Quality
PM Dir of Materials
Dir of Facilities
V. PACKAGING, LOGISTICS, OUTBOUND FREIGHT, AND STERILIZATION
1. Overview
Packaging, outbound freight, and sterilization are critical factors that are often overlooked.
Responsibilities and ownership should be clearly defined during the quoting stage.
2. Checklist
a. 2D drawing specifications required for quoting either new
design and/or Off-AML packaging. To include final
dimensions, weight of unit, any special protective
requirements, double or single stack pallets, ship
quantities. Is the packaging customer specific or generic?
Applicable Not
Applicable Other,
explain.
b. All quotes will be Ex Works unless otherwise requested;
outbound freight requires established Incoterm along with
the address of destination, weight and dimension of
complete unit and the number of units per pallet
Ex Works Not Ex
Works, explain Incoterm
c. How will the Product be sterilized? [ ] Non-Sterile [
] Gamma [ ] ETO [ ] E-Beam
Current Sterilizer:
d. Has the product been Validated for 2x Sterilization? Yes No
e. Has sufficient capacity for sterilization been quoted and
planned?
Yes
f. Discussion among all relevant parties conducted PM Dir Global PM
PM
I. LABOR
1. Overview
NPIs are labor intensive projects. Clear plans for headcount utilization are necessary to make
proper quoting estimates, and for sites to be able to plan resources accordingly.
2. Checklist
a. Plan for staffing necessary direct labor complete
b. Plan for staffing necessary indirect labor complete
c. Discussion among relevant parties conducted PM Dir HR Dir
PM
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1. Overview
Continuity of staffing is ideal under most circumstances for NPIs. However, at times changes
will need to be made – either driven by attrition, changing site needs, or changing customer
needs. Plans should therefore be made to ensure smooth transitions so that contingency plans can
be enacted without inhibiting the success of the NPI.
2. Checklist
2. Transitions, Training, Attrition
a. Plan for transitions and attrition complete
b. Plan for training complete
c. Discussion among relevant parties conducted PM Dir HR Dir
PM
I. SCOPE OF DESIGN WORK
1. Overview
Design sites perform work that is often integral to the success of an NPI. However, not all
aspects of process development should be owned by design teams, which are typically unfamiliar
with the specific requirements, strengths, and attributes of manufacturing sites. As such, careful
coordination between design and manufacturing NPI teams is critical to ensuring that the design
team understands what will work and what will not work once implemented.
2. Checklist
a. Meeting clarifying design work conducted with design
team
b. Plan for manufacturing team’s involvement in design
complete
c. Meeting among all relevant parties conducted PM Dir Design
PM
PM
II. DESIGN-MANUFACTURING HANDOFF
1. Overview
While less likely than other factors to impact the actual quoting costs, having clarity regarding
the timeline for transition from design to manufacturing will allow for clearer lines of
responsibility, and more accurate overall timeline and schedule determination within quoting.
2. Checklist
a. Timeline for handoff complete and agreed upon by both
design and manufacturing sites
94
b. Transition plan complete
c. Meeting among all relevant parties conducted PM Dir Design
PM
PM
95
Appendix 3: NPI Due Diligence Checklist Feedback Form
Program Name: [Indicate here]
High-level Feedback
1. On a scale of 1 to 5, where 1 means “Not at all helpful” and 5 is “Extremely helpful,”
how helpful do you think this checklist will be for the following:
a. Avoiding issues later on during the NPI:
b. Quoting an accurate price to the customer:
c. Quoting an accurate timeline to the customer:
d. Doing my job as a PM:
e. Satisfying our customers:
2. How could the checklist be improved overall (i.e., functionality, ease of use, etc.)?
3. Anything else you would like me to know? Any ways I can help you?
Section-Specific Feedback
A1: Customer Contacts and General Info
Checklist items that should be added:
Checklist items that should be removed:
Sources of information (i.e., role) that should be identified/provided for certain checklist items:
[Section-Specific Feedback questions repeat for each section of the Due Diligence Checklist]