APiS North America: Impeccable FMEA & Functional Safety Software

Dr. Lynn M. Johnson, PharmD, President, APiS North AmericaDr. Lynn M. Johnson, PharmD, President It is yet another day for Dr. Lynn M. Johnson, the president at APiS North America, LLC as she answers a call from an engineer who has previously used the IQ-Software. "Hi Lynn, I have recently changed companies, and surprisingly my new colleagues aren't using the IQ-Software. As a matter of fact, we need it here as well," says the voice at the other end.

"At APiS North America, our vision, from the beginning, is to continually improve our services to deliver a solution that improves efficiency, efficacy, and robustness of FMEA, FTA, DRBFM, and other quality and safety-related activities."

For a company that has continually exceeded its customers' expectations by adding innovative functionalities into its core services, along with the APIS® IQ-Software product it distributes, recommendations like these are not surprising . The focus of APiS North America is to provide the customer service and support to IQ-Software users across the Americas. APIS Informationstechnologien GmbH has, since 1992, been focused on building the best suite of tool possible, including the IQ-Software, for performing robust risk analyses and mitigation plans for products and processes–whether they be Functional Safety Analysis, Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), or Design Review by Failure Mode (DRBFM)–all from a single, model-based data set. "At APiS North America, our vision, from the beginning, is to continually improve our services and deliver solutions that improve efficiency, efficacy, and robustness of quality and safety-related activities," says Lynn. The APIS® IQ-Software, helps clients to see their products and processes in a way that spreadsheets cannot deliver.

An All-encompassing and Robust Product

APiS North America has a broad client base of product design and manufacturing/assembly process customers spanning a broad array of sectors including traditional automotive, aerospace, electronics, electric and autonomous vehicle, alternative energy, lithium ion battery, medical device, and healthcare industries. These customers share a common set of goals and objectives to capture and analyze design and process knowledge and (sometimes costly) lessons-learned, in a synchronized and comprehensive manner. Utilizing the APIS® IQ-Software and best practice methodology backed by years of practical engineering experience, APiS North America guides its clientele to identify, prioritize, and address important areas of risk, and ultimately comply with their respective industry’s FMEA requirements. By using model-based, graphical, tools and robust methods, the software focuses the activities and enables clients to provide comprehensive summaries of where the risk is, what the plan is to minimize or remove the risk, and when and how that plan will be implemented back to their management and end-customers. "We work with customers to ensure that they have addressed everything and that they can convey this with confidence! Yet, this activity absolutely must happen within the timing constraints of the program and, as such, must be efficient AND effective" states Lynn.
Chad M. Johnson, Vice PresidentThe APIS® IQ-Software elegantly provides this solution space with redundancy-free handling of data ensuring consistency across different documents without additional adjustments. For instance, if the client changes a process characteristic within a process, the information will immediately reflect in the Control Plan and the FMEA without any additional work. The APIS IQ-Software developers work daily with customers and industry experts to deliver a robust, integrated workflow and document management system environment.

Model. Analyze. Plan. Execute.

Delivered as a one-time purchased software, the IQ-Software can be directly installed into a company's network, which makes it highly secure as the purchaser gets the ability to define user access policies for moderators and engineers. It enables clients to analyze complex systems and processes in different ways; as a graphical tree structure that offers unparalleled process clarity. For large systems, focusing on the parts of the structure that are currently under consideration allows the team to give more attention to relevant data that can be optionally displayed. The users can also create process models by graphically dragging icons into place on the Process Flow Diagram.

A crucial factor for the high quality of our training services is the great personal and professional commitment of our colleagues to each of our customers

To build the functional model used as the foundation for the risk analysis, the IQ-Software uses the function net editor. Further, through the software's failure net editor, users build relationships between failure modes, causes and effects, and derive the resultant causal model.

These features allow users to dynamically generate an FMEA form in many different formats which helps them define the needed actions to reduce the likelihood of occurrence or completely eliminate high risk failures. The product also makes it possible for the user to open an empty form in any of the supported layouts and directly enter data into this form, but with support and user-friendliness which greatly surpasses that of a spreadsheet or any other tool. "The APIS® IQ-Software has been developed over the course of 28 years and is used globally such that the engineers can leverage the risk analysis results even after a long period, no matter how complex the analyzed system or process is," says Lynn. And she adds, “These data analyses serve as the central repository for all the product and process knowledge; effectively providing the foundation to link it all together.”

Core Focus on FMEA

APIS® IQ-Software has consistently set the highest standard for advanced risk analysis software. At the same time, the company provides qualified services to its customers globally. The company's experienced team provides customer service, sales, support, training, and expert consulting to help clients with all queries regarding the APIS® IQ-Software.
The services of the company range from individual consulting and team training to the facilitation of customer projects, as well as implementation and growth of the IQ-Software and customers' quality programs. These workshops teach participants everything about the methodologies and various facilitation techniques to create the FMEA and also optimally implement and professionally facilitate the involved process. The company increases the learning impact of its seminars and workshops using structured learning materials and hands-on learning units in the IQ-Software. "A crucial factor for the high quality of our training services is the great personal and professional commitment of our colleagues to each of our customers," says Lynn.

On the consulting side, APiS North America assists clients with all technical and methodology questions concerning the FMEA. The team has many years of practical application experience and expertise as engineers in the fields of safety and risk management. Together with the clients, APiS North America develops the basics in order to implement the FMEA into their business processes and projects. "It all boils down to helping the customer achieve their goals and objectives. The IQ-Software , helps us collectively achieve this because it provides the platform for the formal way of thinking and acting through the detailed steps of this very rigorous analysis,” mentions Lynn.

IQ-Software Version 7.0 and Beyond

IQ-Software Version 7.0 was released in mid-2019. Version 7.0 offers a huge volume of improvements, not the least of which include the inclusion of the AIAG and VDA alignment form sheets and improved reporting functionality in the form of the Management Report editor. This enables the creation/update of regular reports with key figures from the FMEA. New "quality rules" make it possible to find problematic data constellations automatically. There are also numerous optimizations to the IQ-Software's overall capabilities: context menu for hot-click symbols, toolbars in the workspaces, revised Object Inspector (including multi-inspection via matrix display, reduced view and improved handling of variants and languages), new input collector, new structuring of display options and settings dialogs, autocomplete in structure list and function/error analysis, fine zoom in all editors, background color for all objects, and much more.

There are further modifications to various form editors and action analysis, including multiple classifications, an improved Excel export (colors, symbols, graphics) and the ability to simultaneously open several forms. The Design Verification Plan and Report (DVP&R) now has its own administration, and actions can be directly integrated as tests. In the expansion stages IQ-FMEA PRO and IQ-RM PRO, the "Design for Six Sigma (DFSS)" is supported by various editors (Pairwise Comparison Matrix, House of Quality 1/2/3). In these expansion stages, there is also the "Audit Trail" feature, i.e., a computer-generated change protocol with document version release, which is used in the field of medical technology (GxP).

The release of the latest version will surely propel APiS North America to new heights. For the next 12 months, the company will focus on growing its presence across the industries, with healthcare and medical devices being a major priority, while maintaining excellent customer service and support to all industries and customers they currently serve. "We have been committed to the path of delivering a strong and robust solution for our clients, and we will continue to outperform every competitor to this end," concludes Lynn.
- Russell Thomas
    October 28, 2019
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APiS North America

APiS North America

Royal Oak, MI

Dr. Lynn M. Johnson, PharmD, President and Chad M. Johnson, Vice President

APiS North America's mission is to revolutionize how the clients leverage FMEAs within their risk management & functional safety efforts to improve their products and processes through their offering of innovative, high-quality software products, expert training & consulting, and impeccable attention to customer service. The company has a broad client base in traditional automotive, aerospace,, electronics, electric and autonomous vehicle, alternative energy, lithium ion battery, medical device, healthcare industries. Clients collaborate with the company to make sure that the entirety of their FMEA process is in compliance with the industry requirements and also to adequately provide information back to both the OEM companies and end-customers