[Hulinks Blog] Risk Management for Medical Devices Using APIS IQ (FMEA): A Case Study of Cardiovascular Catheters

Integrated FMEA software that supports the promotion of quality management and functional safety.

APIS IQ is a standard product in the field of FMEA and risk analysis, having met the high demands of over 2,000 companies worldwide for many years. APIS IQ addresses issues that were difficult to achieve with traditional spreadsheet procedures. Unlike conventional tabular forms of FMEA, it enhances efficiency by clearly defining the relationships between components and processes in a tree structure. [Features] - Fully compliant with the international standard for the automotive industry, AIAG&VDA FMEA - Visualizes causal relationships through a network representation of structure, function, and failure - Mutual synchronization between the network and FMEA sheets - Management and support of documents in 31 languages - Supports automotive international safety standards ISO26262 and IATF16949 - Output functionality for FMEA sheets in AIAG/VDA and DRBFM formats - Statistical functions capable of outputting various statistical graphs - Ability to generate and synchronize process flow diagrams and control plans from PFMEA trees *Product names and other terms are trademarks or registered trademarks of APIS Informationstechnologien GmbH.

• Other production management systems

FMEA - Introduction of Case Studies Using Automated Driving Monitoring Systems

[Steps in APIS IQ] FMEA consists of seven steps. Here, we will focus on the three most important and fundamental steps for conducting FMEA: structural analysis, functional analysis, and failure analysis. 1. Planning and Preparation: FMEA Scope Analysis 2. Structural Analysis: Create a structure tree from the selected system elements 3. Functional Analysis: Describe the "functions" of the system elements and create a function network 4. Failure Analysis: Describe the "failures" corresponding to the functions of the system elements and create a failure network 5. Risk Analysis: Management responsibilities, failure ranking: AIAG/VDA form / AP correspondence 6. Optimization: Measures to mitigate risks: AIAG/VDA form / AP correspondence 7. Documentation: Output and communication of results: AIAG/VDA form For more details, please check below. https://www.hulinks.co.jp/support/apis/gs/index.html

• Process Control System
• Other production management systems

FMEA - Application Example for Cylindrical Lithium-Ion Secondary Batteries

Lithium-ion batteries are high-energy-density secondary batteries used in various fields such as onboard applications for HEVs and EVs, backup for power systems, and storage for renewable energy. As their range of use expands, safety has also become a focus of attention. Particularly, due to the high energy density of the batteries, caution is necessary as internal short circuits and thermal runaway can lead to major accidents. Against this backdrop, the quality of onboard batteries is regulated by the automotive-related standard IATF16949, and when exporting, the submission of documents (FMEA sheets) in accordance with the IATF16949 standard is mandatory. Additionally, for stationary secondary batteries, the safety standard IEC 62619 has been established. There are several shapes of lithium-ion batteries, but here we will explain cylindrical lithium-ion secondary batteries. The components of cylindrical lithium-ion secondary batteries can be broadly classified into eight elements.

• Secondary Cells/Batteries
• Other production management systems

Fukuda Corporation has been pursuing leak detection for 60 years and is dedicated to advancing the future of leak testing. 【 Supporting Various Leak Tests: Air Leak Test / Gas Leak Test (Hydrogen Gas, Helium Gas) 】 We develop, manufacture, and sell leak testing equipment to inspect airtightness and sealing performance. We will propose suitable testers and devices for each inspection target. 【 Target Industries and Examples of Inspection Targets 】 - Automotive Industry: Engines, FC components, valves and piping, various parts - Electronic Components Industry: Smartphones, keyless switches, various small sensors - Pharmaceuticals / Food / Cosmetics Industry: Bottle containers, syringes, vials, eye drop containers, pillow packaging, PTP packaging We will propose the most suitable leak testers for each industry. 【 ISO Certification 】JIS Q 9001:2015 (ISO 9001:2015)

In civil engineering sites such as mountainous areas and construction sites, it may be necessary to use wooden boards on slopes or inclined access roads. Hyper CLT boards are civil engineering materials utilizing wood CLT, which can be laid not only on flat ground but also on sloped terrain. They can be used for temporary roads, access routes, heavy machinery entry paths, and measures against muddy conditions, creating a driving environment that takes advantage of the unique surface characteristics of wood. The 5×10 board weighs approximately 230 kg, and the 5×20 board weighs about 460 kg, making them lightweight and easy to install and remove even with small machinery, which is a notable feature for maneuverability in narrow sites. This wooden board is registered as a technology under the Ministry of Land, Infrastructure, Transport and Tourism's NETIS system as "TH-250021-A," and can also be utilized for safety measures and innovative ideas in public works.

Metal cracks are one of the concerns in equipment maintenance operations. Repairs using conventional welding methods can alter the base material around the crack due to heat, leading to residual stress and deformation, which always carries the risk of "crack recurrence" or "secondary damage." Hinode Waterworks Equipment Co., Ltd.'s "Mechanical Stitching Method" is a new technique that allows for the repair of metal cracks without applying heat. By using special bolts and reinforcement plates, the crack is physically removed without affecting the base material with heat. Repairs can be performed even in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. For more details, please contact us or download the catalog.

● The production time for cast prototypes can be shortened! Since model making is not required, the production time for prototypes, which previously took about a month, can be significantly reduced. ● Model costs can be reduced! By directly producing sand molds from 3D data, there is no need for model production costs. If changes to the model are necessary, they can be addressed by modifying the 3D data. ● Similar products with different shapes and dimensions can be prototyped simultaneously! Different products, such as similar shapes or varying dimensions, can be molded at the same time in one molding process. This allows for the verification of multiple types in a short period.

● To determine the sealing and waterproofing of sealed products based on pressure changes, it is not necessary to conduct tests that involve spraying water on the product or immersing it in water. ● Once the product is placed in a dedicated fixture within the inspection device, waterproofing can be quantitatively confirmed through automatic measurement. ● The target product size is W 300 × D 210 × H 100 mm or smaller. ● The target products include automotive cameras, smartphones, ECUs, small motors, and other packaging containers, and are effective for any products that require confirmation of sealing, waterproofing, and airtightness. ● For product specifications and details, please contact us.