Malfunctions of Production Facilities and the Quality Management System
First written in FY2016. 2 of 5 entries say "Worsened", first in FY2018. Latest entry: FY2024.
Japan Tissue Engineering moved to the "Worse" side of this theme in 2018, 3 years before the typical company in this theme (2021).
The whole theme swung hardest in 2021: 5 of 10 companies on the "Worse" side.
10 other companies' latest entry also says "Restated".
- FY2024RestatedAnnual report
「The head office and production facilities are concentrated at a single location, creating the possibility that both functions could be halted by a disaster.」
The company continues to explicitly identify the concentration of its head office and production facilities at a single location, and the risk of production stoppages caused by disasters. - FY2020RestatedAnnual report
「In addition, because the only production site is the head-office plant in Aichi Prefecture, the company may be unable to supply products if the manufacturing infrastructure ceases to function due to a natural disaster such as a major Nankai Trough earthquake or an accident.」
The company continues to face the risks of concentrating production at its main plant, supply disruptions caused by natural disasters or accidents, and insufficient equipment and personnel due to a sudden increase in orders. - FY2019WorsenedAnnual report
「The company has established a production system that balances manufacturing facilities and equipment, or hardware, for producing high-quality, safe products with operational controls, or software, such as managing the movement of people and materials and maintaining standard operating procedures. However, if orders increase sharply beyond production capacity, facilities and personnel may become insufficient, making it impossible to fulfill orders.」
In addition to the existing single-site and disaster risks, the company explicitly identified the possibility of insufficient facilities and personnel, and an inability to fulfill orders, if orders increase sharply beyond production capacity. - FY2018WorsenedAnnual report
「In addition, because production is conducted solely at the head-office plant in Aichi Prefecture, if the manufacturing infrastructure ceases to function due to a natural disaster such as a major Nankai Trough earthquake or an accident, this may affect the company's business strategy and operating results.」
The production system risk was specified as concentration at a single site, with production conducted only at the head-office plant, and the possibility of a shutdown caused by a major Nankai Trough earthquake or other event. - FY2016First statedAnnual report
「However, if the manufacturing infrastructure fails to function as expected due to an accident or other reason, or if the quality management system cannot be operated as expected, this may affect the company's business plans, operating results and other aspects of its business.」
While establishing facilities, personnel and procedures compliant with GCTP, the company identifies production stoppages and quality issues caused by accidents or operational failures as risks.