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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 issues and recurrence through insights from 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 before they occur and to avoid recurrence. 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 greatly contribute to the prevention of issues and recurrence in products. ★Achieving certainty and efficiency in accordance with ISO 26262 (Functional safety standard for automotive electronic control)! ISO 26262 requires the 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 safety design. Additionally, the analysis sheets aligned with the workflow enhance the intuitiveness for designers, improve work efficiency, and prevent rework due to analysis omissions.

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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: - Unification 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 displayed as candidates from past knowledge. This promotes efficient awareness, unification of terminology, and structuring of knowledge, creating a positive cycle where "if designers find it easy," knowledge accumulates. - Support for various risk analysis methods, with abundant examples of compliance with international standards. It accommodates various risk analysis methods such as FMEA, FTA, FMECA, FMEDA, DRBFM, APQP, HAZOP, HACCP, QFD, and has examples that comply with numerous 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 integrated. - Multilingual support. It supports major languages including Japanese, English, and Chinese. It can be used for technology transfer to overseas design bases as well as for synchronizing technical information.

Price information

Annual license version for small-scale PCs, with prices varying based on the number of licenses for medium to large-scale enterprises. 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

Over 3,000 companies worldwide have implemented our solutions, primarily in the following industries: automotive, manufacturing, oil and gas, medical devices, high-tech industry, 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 analysis (accident probability) of plants and risk management. - Major Chemical Manufacturers Process risk management and aggregation and sharing of risks across all plants. - Pharmaceutical Manufacturers Quality risk management of pharmaceuticals (ICH-Q9). - Plant-related Companies Analysis of functional safety (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 are required to meet increasingly sophisticated and diverse customer needs, the greatest challenge and opportunity lies in Business Process Re-engineering (BPR), which involves reviewing and restructuring 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 industry BPR," we are steadily building trust.

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