Quality Issues in Mobility and Medical Devices
First written in FY2020. 1 of 3 entries say "Mitigated", first in FY2024. Latest entry: FY2025.
No other company in this theme has enough history to compare yet.
- FY2025WorsenedAnnual report
「Particularly in the pharmaceutical market, the company takes every precaution in managing product quality. However, if product defects, design defects or unexpected side effects arise for any reason, product recalls, discontinuation of sales and liability for compensation relating to health damage could have a significant impact on the group’s business performance and financial position.」
In addition to the existing quality risks involving mobility and medical equipment, the company identified risks of product defects, design defects, side effects, recalls and compensation for health damage associated with entering the pharmaceutical CDMO business. - FY2024MitigatedAnnual report
「The group has established a regulatory affairs group within the quality management division overseen by the Chief Quality and Production Officer (CQPO), as well as rules for responding to serious quality incidents, thereby putting in place a framework to minimize risk.」
As a response to quality risks involving mobility and medical products, the company disclosed the quality management division under the CQPO, the regulatory affairs group, and its rules for responding to serious quality incidents. - FY2020First statedAnnual report
「The group produces and sells a diverse range of products at production sites in Japan and overseas, including products for the mobility market, such as automobiles and transportation equipment, and for the medical equipment market, where a high level of safety is required. A major quality issue caused by an unforeseen event could affect the group’s business performance and financial position.」
The company newly identified major quality issues involving mobility and medical equipment products subject to high safety requirements as an ESG risk and intends to reduce this risk through a quality management framework aligned with customer requirements, ISO standards and other requirements, together with continuous improvement.