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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
Spherasolutions.com Operational Risk │Environmental Performance │ Product Stewardship
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
Spherasolutions.com Operational Risk │Environmental Performance │ Product Stewardship
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
Quality Risk Management
Failure Modes and Effect Analysis (FMEA)
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
Spherasolutions.com Operational Risk │Environmental Performance │ Product Stewardship
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
Quality Risk Management
Failure Modes and Effect Analysis (FMEA)
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
Spherasolutions.com Operational Risk │Environmental Performance │ Product Stewardship
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
Quality Risk Management
Failure Modes and Effect Analysis (FMEA)
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
Spherasolutions.com Operational Risk │Environmental Performance │ Product Stewardship
Manufacturing Industry
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
Quality Risk Management
Failure Modes and Effect Analysis (FMEA)
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
Spherasolutions.com Operational Risk │Environmental Performance │ Product Stewardship
Manufacturing Industry
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
Quality Risk Management
Failure Modes and Effect Analysis (FMEA)
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:
Operationalexcellence@spherasolutions.com
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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