CUSTOMER SUCCESS STORIES Advancing Operational Excellence through Quality Risk Management

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1 CUSTOMER SUCCESS STORIES Advancing Operational Excellence through FMEA Fault Tree Analysis Root Cause Analysis APQP Control Plan

2 Manufacturing Industry Semiconductor Manufacturer 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. Consolidate disparate quality risk processes into a centralized system Decrease employee time spent on FMEAs Reduce product defects and associated costs Global Context Matrix 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 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.

3 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 unstandardized 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. 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 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 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. 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

4 Automotive Industry Global Automotive Manufacturer 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 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 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

5 Automotive Industry Global Automotive Supplier 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 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 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

6 Pharmaceutical Industry Global Pharmaceutical Company 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 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 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

7 Manufacturing Industry Appliance Manufacturer 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 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 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

8 Manufacturing Industry Electronics Manufacturer 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 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) 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

9 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 knowledgedriven, 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. About Sphera For more information us at: Operationalexcellence@spherasolutions.com 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 Sphera. All Rights Reserved.