Serious Product Quality Issues
First written in FY2016. 10 of 15 entries say "Restated". Latest entry: FY2026.
Eiken Chemical moved to the "Worse" side of this theme in 2026, 3 years after the typical company in this theme (2023).
The whole theme swung hardest in 2025: 13 of 34 companies on the "Worse" side.
3 other companies' latest entry also says "Reframed".
- FY2026ReframedAnnual report
「However, if a quality problem were to arise in a core product or high-margin product and prevent the company from supplying products for an extended period, it could affect its financial position and operating results.」
The quality problem risk has been prioritized as the potential impact on operating performance if supply of core or high-margin products is suspended for an extended period. - FY2022MitigatedAnnual report
「In light of these risks, the Group is working to strengthen quality assurance by stabilizing quality through enhanced production engineering capabilities, ensuring the proper operation of its quality management system, and researching and analyzing market assessments of product quality.」
In addition to quality control based on ISO 13485 and MDSAP certification, the company explicitly identifies enhanced production engineering capabilities and research and analysis of market assessments of product quality as countermeasures. - FY2021MitigatedAnnual report
「In light of these risks, the company mainly monitors the proper operation of its quality management system through the quality assurance department and monitors market assessments of product quality.」
In addition to quality control based on ISO 13485 and MDSAP certification, the company describes operational monitoring by the quality assurance department and monitoring of market assessments of product quality. - FY2020ReframedAnnual report
「The Group works to assure product quality under quality control based on its quality management system (ISO 13485). However, if a quality problem were to arise in a product, it could affect the Group's financial position and operating results.」
The disclosure has shifted from the previous reference to “serious quality problems” to the possibility of impacts from quality problems generally, and also indicates monitoring by the quality assurance department. - FY2019-Q3RestatedAnnual report
「During the nine-month cumulative consolidated period under review, there were no new business or other risks, and no material changes to the business or other risks described in the securities report for the previous fiscal year.」
The company has determined that there are no newly arising risks or material changes concerning serious quality problems with its products. - FY2019-Q2RestatedAnnual report
「During the six-month period ended the second quarter of the current consolidated fiscal year, there were no new business risks or material changes to the business risks described in the previous fiscal year's Annual Securities Report.」
The company has determined that there are no newly arising risks or material changes concerning serious quality problems with its products. - FY2019-Q1RestatedAnnual report
「During the first quarter of the current fiscal year, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the previous fiscal year.」
The company has determined that there are no newly arising risks or material changes concerning serious quality problems with its products. - FY2018RestatedAnnual report
「The Group works to assure product quality under strict quality control based on its quality management system (ISO 13485). However, if a serious quality problem were to arise in a product, it could affect the Group's financial position and operating results.」
The company continues to disclose quality assurance based on ISO 13485 and the risk that serious quality problems could affect operating performance. - FY2018-Q3RestatedAnnual report
「During the nine-month cumulative consolidated period under review, there were no new business or other risks, and no material changes to the business or other risks described in the securities report for the previous fiscal year.」
The company has determined that there are no newly arising risks or material changes concerning serious quality problems with its products. - FY2018-Q2RestatedAnnual report
「During the six-month period ended the second quarter of the current consolidated fiscal year, there were no new business risks or material changes to the business risks described in the previous fiscal year's Annual Securities Report.」
The company has determined that there are no newly arising risks or material changes concerning serious quality problems with its products. - FY2017RestatedAnnual report
「However, if a serious quality problem were to arise in a product, the company may have to take measures such as discontinuing production or conducting a recall. This could affect its financial position and operating results through lower sales, higher costs and other factors.」
The risk of production discontinuation, recalls, lower sales and higher costs resulting from serious quality problems continues to be disclosed. - FY2017-Q3RestatedAnnual report
「During the nine-month cumulative consolidated period under review, there were no new business or other risks, and no material changes to the business or other risks described in the securities report for the previous fiscal year.」
The company has determined that there are no newly arising risks or material changes concerning serious quality problems with its products. - FY2017-Q2RestatedAnnual report
「During the six-month period ended the second quarter of the current consolidated fiscal year, there were no new business risks or material changes to the business risks described in the previous fiscal year's Annual Securities Report.」
The company has determined that there are no newly arising risks or material changes concerning serious quality problems with its products. - FY2017-Q1RestatedAnnual report
「During the first quarter of the current fiscal year, there were no new business or other risks, nor any material changes to the business or other risks described in the securities report for the previous fiscal year.」
The company has determined that there are no newly arising risks or material changes concerning serious quality problems with its products. - FY2016First statedAnnual report
「However, if a serious quality problem were to arise in a product, the company may have to take measures such as discontinuing production or conducting a recall. This could affect its financial position and operating results through lower sales, higher costs and other factors.」
While describing quality assurance based on laws and regulations related to the Pharmaceuticals and Medical Devices Act and ISO 13485, the company also identifies the possibility of serious quality problems.