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  6. Quality Risk Management Solution Sphera

Quality Risk Management Solution Sphera

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Sphera Risk Management Solutions

last updated:Mar 28, 2022

構造計画研究所
構造計画研究所
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■Standardize, share, and inherit knowledge to foresee problems! Achieve prevention before they occur! ■Quantitatively visualize quality, risk, and reliability! Also compatible with functional safety!

★Realizing prevention of recurrence and issues through insights into design origins! Reducing the burden on the field! While the knowledge of veterans is being lost, products and services are becoming increasingly advanced and complex, leading to a growing burden on designers, making it very difficult to prevent issues from occurring or recurring. This product standardizes the terminology used by each designer and structurally accumulates knowledge, allowing successors and related designers to quickly and comprehensively recognize past cases and countermeasures against risks without omissions or delays. Efficient insights at the design origin significantly contribute to the prevention of issues and their recurrence in products. ★Achieving certainty and efficiency in compliance with ISO 26262 (Functional safety standard for automotive electronic control)! ISO 26262 requires a correct quantitative evaluation and implementation of product safety, including risk assessment, hazard and safety level analysis, reliability analysis, identification of functional safety requirements, accidental hazard side failure detection analysis, and design traceability. This product enables centralized management of a series of analysis data, allowing for steady accumulation of safe design practices. Additionally, analysis sheets aligned with the workflow enhance the intuitiveness for designers, improve work efficiency, and prevent rework due to omissions in analysis.

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Quality Risk Management Solution Sphera

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  • Related Link - https://solution.kke.co.jp/sphera/

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basic information

This product is a platform that achieves quality improvement and risk reduction with the following features: ○ Standardization of terminology used by designers and structured accumulation of knowledge. Easy sharing, inheritance, and utilization. Terms used in quality risk information, such as case studies and FMEA, are suggested from past knowledge. This promotes efficient awareness, standardization of terminology, and structuring of knowledge. A virtuous cycle is created where "if designers are comfortable," knowledge accumulates. ○ Support for various risk analysis methods and a wealth of examples compliant with international standards. It supports various risk analysis methods such as FMEA, FTA, FMECA, FMEDA, DRBFM, APQP, HAZOP, HACCP, QFD, and has numerous examples compliant with various international standards (ISO26262, IEC61508, TS16949, etc.). ○ Flexible customization. You can freely incorporate your own risk analysis methods and business processes. There are also cases where functions other than quality risk analysis, such as design requirement management, change management, and traceability, are incorporated. ○ Multilingual support. It supports major languages including Japanese, English, and Chinese. It can be used for technical transfer to overseas design bases as well as for synchronizing technical information.

Price information

Annual license version for small-scale PCs; prices vary based on the number of enterprise licenses for medium to large-scale businesses. Please feel free to contact us.

Delivery Time

P4

※We also provide support services such as implementation consulting. Please feel free to contact us.

Applications/Examples of results

More than 3,000 companies worldwide have adopted our solutions, primarily in the following industries: automotive, manufacturing, oil and gas, medical devices, high-tech industries, semiconductors, aerospace, chemicals, pharmaceuticals, and consumer products. In Japan, our solutions are utilized not only for simple risk assessments but also for quality risk management tailored to individual business operations. (Below are examples of domestic applications) ■ Manufacturing Industry - Automotive Manufacturers Used for safety design and reliability analysis in the development and design processes. - Automotive Parts Manufacturers Compliance with functional safety standards (ISO 26262) in the development and design processes. - Medical Device Manufacturers Quality risk management of products and traceability in design. ■ Plant-related Industries - Major Chemical Manufacturers Reliability (accident probability) analysis and risk management of plants. - Major Chemical Manufacturers Process risk management and aggregation and sharing of risks across all factories. - Pharmaceutical Manufacturers Quality risk management of pharmaceuticals (ICH-Q9). - Plant-related Companies Functional safety analysis (analysis of residual failure rates on the hazardous side) for systems.

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構造計画研究所

構造計画研究所

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The Structural Planning Institute will solve the problems of our manufacturing clients. Currently, the challenges faced by the manufacturing industry are no longer about "improving product quality and productivity." In today's situation, where flexible responses to increasingly sophisticated and diverse customer needs are required, the greatest challenge and opportunity lies in Business Process Re-engineering (BPR), which involves reviewing and reconstructing business processes through the use of information technology. In this field as well, our advanced system development technology and solution proposal capabilities have received high praise, and as the "Structural Planning Institute supporting manufacturing BPR," we are steadily building trust.

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