customer success stories - sphera · fmea fault tree analysis root cause analysis apqp control plan...

FMEA Fault Tree Analysis Root Cause Analysis APQP Control Plan

CUSTOMER SUCCESS STORIESAdvancing Operational Excellence

through Quality Risk Management

Spherasolutions.com Operational Risk │Environmental Performance │ Product Stewardship

Manufacturing Industry

Case Study

Semiconductor Manufacturer Reduces

Product Defects and Lost Profits through

Consistent Risk Assessment

For one of the world’s leading semiconductor manufacturing companies, a focus

on quality and continuous improvement is necessary to meeting the needs of its

global customer base. With nearly 300 worldwide customers and 20,000

employees, this company manufactures microchips that make their way into an

enormous variety of electronic devices – from automobiles to smartphones.

The impact of a defective product can be extremely costly, ranging up to

$1 billion. Therefore, the ability to identify, analyze and mitigate risks involved in

product manufacturing is of the utmost importance. Like its peers, this company

had a goal of zero defects, so it began a search for a better process to mitigate

risks and deliver quality products to its customers.

Moving to a Consistent Quality Risk Assessment Process

With several business units spanning three continents, the semiconductor

manufacturer lacked a consistent process for managing risk related to the

thousands of products it produces. Instead, each business entity had its own

homegrown solution. Over time, it realized that each business unit was using a

unique process that provided no consistency as information was rolled up to

reports across the enterprise. The Director of Quality began looking for an

external partner to provide a consolidated operational risk management solution,

which it found with Sphera.

The semiconductor business is especially complex because of the variety of products and the many risk analyses performed at

various levels: component, equipment, technology and overall business processes. Everything is related, so an unmitigated risk at

the smallest level could have a huge impact on something at a much higher level.

Through a series of design sessions, Sphera was able to identify the nine interrelated factors, including such factors as fabrication

and technology, involved in risk assessment analyses and map them into a global context matrix.

In the past, the company had no centralized way of tracking these factors so the teams started from scratch with every FMEA, failure

modes and effects analysis. “The team would be working in Excel to analyze what could potentially go wrong in relation to designing

and manufacturing a product, but there were always multiple considerations for every row of information across the analysis. Any

time one factor changed, they effectively had to undertake a whole new analysis,” remarked the Sphera consulting manager on the

project.”

CHALLENGE

Consolidate disparate quality risk

processes into a centralized system

Decrease employee time spent on FMEAs

Reduce product defects and associated

costs

SOLUTION

Quality Risk Management

Failure Modes and Effect Analysis (FMEA)

Global Context Matrix

RESULTS

Reduced number of FMEAs from

thousands to hundreds, enabling

employees to focus on higher-value tasks

Potential for saving billions of dollars in

lost profits due to product defects

Provided company with a tool to measure

the value of reduced product defects and

improved quality going forward

Semiconductor

Manufacturer

Semiconductor Manufacturer Reduces Product Defects


Connecting Global Operations

One of the challenges of conducting stand-alone FMEAs was

that the company didn’t know how a risk in one area might

affect another. For example, if a local team did an

equipment-level FMEA in Singapore, no one would know that

it might also affect the U.S. operations.

”The centralized system and context matrix solved this issue

of information in silos. Now, they can see the impact of the

risk created by local process changes at any one of their

manufacturing locations on a global level, and not only at the

equipment level, but also on the process and the technology.

This means they can now put a dollar figure on the risk and

see that what had seemed like a small risk in Asia for

instance could have a $100 million risk impact across sites,

technologies, products,” explained the Sphera consulting

manager.

Reducing the Workload and Inefficiencies

In the past, conducting FMEAs was a labor-intensive process

that involved multiple people at each site. As the Sphera

solution architect explains, “For example, they might have

had a design FMEA person, a process flow FMEA person and

someone responsible for manufacturing FMEAs. In some

cases, each of these people might have to develop an FMEA

for each of the nine risk analysis factors for a total of 27

separate risk assessments. Now, the company can conduct

one FMEA. We’ve helped the company reduce the risk

assessment workload by a ratio of 27:1. That’s an enormous

time savings.”

Before the consolidated system was in place, FMEAs were

conducted on an ad-hoc basis, leading to thousands of un-

standardized de-centralized FMEAs worldwide. The

centralized process has helped the company dramatically

reduce the number of risk analyses it undertakes, while

improving the quality.

Today, each team defines the business case for the FMEA

before they conduct it. Therefore they know how to apply the

findings to equipment, process flows and technology across

the company. “If the teams are conducting 100 FMEAs now,

they are more valuable than the thousands they used to do,”

said the Sphera solution architect.

Decreasing Lost Profits

In addition to gains in workforce efficiency, the centralized

risk assessment process helps the semiconductor

manufacturer dramatically reduce lost profits associated with

shipping defective products.

The amount of potential loss depends upon when the defect

is discovered. The Sphera consulting manager explains, “The

most affordable time to catch an error is at the design phase,

although losses can still be in the millions of dollars. If they

don’t find the defect before it is shipped to their customers,

they have probably lost $100 million. But, if the defective

chip ends up in a consumer product, they could be looking at

losses of $1 billion.”

The business imperative is to identify the defect as early as

possible – ideally before the product is shipped. The

company now has a much stronger process for assessing risk

and identifying defects before they become even more costly

Improving Global Business Flexibility

Installing a common risk analysis system across three global

units of the organization had an unintended benefit. It allows

the company to transfer goods from one facility to another

across the globe, which is sometimes advantageous due to

currency fluctuations. Having common risk analysis rules

governing how a specific product should be manufactured

has led to more flexibility in inventory and manufacturing

operations.

Tracking Progress into the Future

Because reducing defects is a major corporate goal, senior

management was involved in the decision of moving to the

centralized risk assessment system. Ongoing, metrics

related to defect reduction are shared globally with senior

leaders.

“The risk assessment system we developed for this customer

is the cornerstone of their process for improving quality and

reducing product defects. They should continue to see

workforce efficiencies and cost savings in the future,”

concluded the Sphera consulting manager.

“This means they can now put a dollar figure on

the risk and see that what had seemed like a

small risk in Asia for instance could have a $100

million risk across sites, technologies, products.”

Sphera Consulting Manager


Automotive Industry

Case Study

Global Automotive Company Standardizes Tools and Methodologies This global automotive company continues to develop innovative technologies to shape the future of the automotive industry. From

electric and mini-cars to heavy-duty full-size trucks, monocabs and convertibles, it offers vehicles in more than 120 countries around

the world. 202,000 employees work in 158 facilities touching six continents, speaking more than 50 languages and touching 23

time zones.

The company needed to link design and manufacturing, allowing for improved collaboration and insight into quality data across

teams. Standardizing and centralizing tools and methodologies ensures quality trends and lessons learned are shared across the

enterprise.

The Sphera Quality Risk Solution enables them to streamline continuous process improvement, leveraging knowledge between

teams and reducing risk assessment efforts

CHALLENGE

Lack of communication between design and manufacturing departments

Expensive risk assessment efforts

Lack of visibility into top risks

Manual compilation of Top 10 RPN monthly report is costly and inefficient

SOLUTION



RESULTS

Design and Manufacturing are now linked and they are able to view risk assessments

across the enterprise

Risk Assessment effort reduced by 40% or $1.2M annually

Eliminated manual compilation of Top 10 RPN monthly report; a $90K annual savings

RPN trend can now be reported against to measure improvement

Global

Automotive

Manufacturer


Automotive Industry

Case Study

Automotive Supplier Reduces Time to Market

A global full service supplier and integrator of automotive interior and closure components, systems and modules was

faced with the challenge of increasing the value of Design Failure Mode and Effects Analysis (FMEA) and other

documents to support Advanced Product Quality Planning (APQP) regulations. They needed a tool that would both

create the documents and improve the content within them.

They implemented the Sphera Quality Risk Solution, which allowed them to incorporate built-in data checking, user

authorization, revision tracking, and other security protocols to ensure data accuracy and integrity.

“Our Sphera solution has proven to reduce development time while increasing the quality and consistency of our Advanced

Product Quality Planning (APQP) documents.”

DFSS Master Black Belt

CHALLENGE

Create risk documents and improve the content within them

Increase the value of Design FMEAs and other documents to support APQP regulations

Ability to synchronize information and create an engineering knowledge base

SOLUTION



RESULTS

Saved time and effort required to develop APQP documents

Customized FMEA templates quickly and easily

Incorporated built-in data checking, user authorization, revision tracking, and other

security protocols to ensure data accuracy and integrity

Established an expert knowledge base of FMEA data

Global

Automotive

Supplier


Pharmaceutical Industry

Case Study

Leading Pharma Company Implements Enterprise Quality Risk

One of the top 10 largest global pharmaceutical companies was looking to implement an enterprise wide quality risk management

system in order to standardize quality across all of its facilities and product lines, eliminate product recalls, and protect its patients.

In response to a major recall crisis, the company established best practices corporate wide to standardize and improve their risk

evaluation processes. They chose Failure Mode and Effects Analysis (FMEA) as their primary methodology to support their program

“because when you are in the early phases, it’s cheaper to correct, and you end up with a better product”.

This process was a large undertaking which spanned several years and resulted in well over 100,000 FMEA analyses being

performed. After initiating the project, they quickly came to understand the shortcomings of using spreadsheets for performing risk

assessments; they then chose to implement the Sphera Quality Risk Solution. They determined that without the Sphera solution,

there was a lack of control over different users adding or removing columns, they were unable to answer important questions such

as ‘where do I have the same failure mode in my 25 facilities?’, and they could not produce reports in a timely fashion. The Sphera

solution allowed them to implement standard templates to ensure consistency, link critical attributes across lifecycle stages,

streamline the process of creating new assessments by leveraging a common library of lessons learned, and gain visibility into all

FMEAs across the company.

“The Sphera Solution provides us with visibility into risks across all divisions and sites, enabling management to easily

understand top risks and control the associated prevention strategies.”

- Head of Global Risk Management

CHALLENGE

Avoid product recalls (average is $10 million per recall)

Reduce cost / effort for product risk reports required by FDA

Provide management with top risk visibility

Standardize risk assessment methodology and templates.

Reduce risk assessment effort

SOLUTION



RESULTS

Product recalls reduced from 21 to 0 over a 3 year period

Product risk report creation reduced from 3 months to minutes $225K savings

Risk assessment effort reduced by 55% or $2,750,000 annually

Dashboards provide management with clear visibility of top risks

Global

Pharmaceutical

Company



Case Study

Appliance Manufacturer Streamlines FMEA Process

A $4.5B consumer appliance manufacturer with 23,000 employees worldwide had numerous challenges. In order to face increasing

global competition, they developed a strategy that centered on research and development and a culture of innovation.

In order to preserve quality from product conception through to manufacturing, post-market upgrades and productivity changes, they

were performing Failure Mode and Effects Analysis (FMEA) that helped them reduce errors throughout the product lifecycle. FMEAs

allowed them to design out defects earlier in the production process, but required many man-hours of calculation and formatting in

order to produce a report using standard spreadsheet software. The Sphera Quality Risk Solution provided a way for them to

continue to conduct FMEAs on their products while providing employees with an easy user interface to complete their assessments.

They are now able to optimize quality, productivity and safety, while providing an effective way to review the complete product design

process and ensure that it exceeds industry standards. “Prior to using Sphera we were operating from manual spreadsheets, which

proved to be a tremendous time waster” said the Lean Six Sigma Leader “We are now able to drive actions more efficiently and save

a great amount of time. The best way for us to tell that the solution is working, is when a problem doesn’t occur”.

“We reviewed other vendors’ solutions, but the Sphera solution proved to have the most configurable libraries, drove actions

more efficiently and allowed us to save a great amount of time.” - Lean Six Sigma Leader

CHALLENGE

Support R&D and innovation strategy to fulfill the needs of their customers

Increase the efficiency of creating FMEAs for their products and eliminate manual

spreadsheets

Uphold high quality standards and reduce the risks of product recalls

Ensure adherence to industry, company and customer quality standards

SOLUTION



RESULTS

Supported their R&D process by more accurately analyzing product designs and

manufacturing processes

Provided a way to continue to conduct FMEAs on appliances while providing employees

with an easy user interface to complete their assessments in a fraction of the time

Optimized quality, productivity and safety, while providing an effective way to review the

complete product design process and ensure that it exceeds industry standards

Appliance

Manufacturer



Case Study

Electronics Manufacturer Improves Risk Visibility

As a global leader of sophisticated electronic components and solutions, this electronics manufacturer operates in nearly

20 countries and delivers high-quality products generating annual sales of more than $3 billion.

In the past, each product group, at its dozens of manufacturing locations worldwide, had performed product quality risk assessments

and stored the related information locally in thousands of spreadsheets and word processing documents. That approach made it

impossible to ensure consistency and share knowledge across different teams. It also raised concerns in terms of their ability to

keep sensitive product data secure across various locations both within and outside of their U.S. manufacturing sites.

The company adopted the Sphera Quality Risk Solution to lay the foundation for bottom-up proactive quality risk assessments and

enforce a standardized process and templates that ensure global consistency. The company’s design centers now use the solution

to conduct standard, systematic FMEAs that identify risk of failure more easily and effectively. This helps catch problems earlier in

the lifecycle when they are less costly to fix. Data flows between quality documents throughout Product Development Process (PDP)

Phases and the knowledge transfer between design centers and manufacturing sites is more seamless

Its engineers increasingly rely on the solution to easily generate FMEAs that support the company’s methodology by offering access

to specific libraries, helping enforce a standard taxonomy and making it easier to share best practices. “Our major customers were

asking if we had FMEAs on their products,” said the quality manager, the solution enables us to check for FMEAs, ensure we have all

the quality planning documents, and even to know how many FMEAs we have across the company. It serves as a central repository

to help us run regular reports on our quality improvement program”.

“The Sphera Solution has put more overall visibility on our FMEA process. The ability to measure performance then gives us the

ability to improve it.” - IT Director

CHALLENGE

Ensure the security of sensitive product data

Improve quality across over one hundred thousand products

Respond to customer requests for Failure Modes and Effects Analysis (FMEAs)

SOLUTION



RESULTS

Eliminated 1000s of disparate documents, stored locally at 45 different locations

Ensured consistent templates for thousands of product risk assessments

Shared risk and failure modes across teams

Protected data by leveraging an enterprise risk solution

Electronics

Manufacturer

About the Sphera Quality Risk Solution

Our Quality Risk solution helps you strengthen and improve your quality

processes. It provides you with the platform you need to create knowledge-

driven, data-centric quality specifications and control plans that are

consistent across the enterprise and helps you effectively conduct proactive

risk assessment methodologies such as:

• Failure Modes and Effects Analysis (FMEA)

• Fault Tree Analysis (FTA)

• Root Cause Analysis (RCA)

More importantly, the solution offers a holistic approach using standard

libraries and templates to promote standardization and a common

language, while providing the flexibility to link and connect information

together – for example dFMEA and pFMEA, Process Flow Diagram/Chart,

pFMEA and Control Plan. This allows you to perform quality risk assessment

activities more efficiently and effectively, accelerating productivity and

ensuring data integrity.

Contact us for more information on how we can help you with your quality

risk processes.

For more information email us at:

[email protected]

www.spherasolutions.com

© 2016 Sphera. All Rights Reserved.

About Sphera

Sphera is the largest global provider of software and information

services in the operational risk, environmental performance and

product stewardship markets. For more than 30 years, we have

helped over 2,500 customers, and hundreds of thousands of

individual users, across more than 70 countries to optimize

work-flows and navigate the complex and dynamic global

regulatory structure.

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