Quality management
Basic concept
Under the RC promotion system, the Tosoh Group strives to enhance customer satisfaction by ensuring comprehensive quality control and logistics safety, reliable operation of our quality management system, and the timely and stable provision of products and services that reflect customer needs. Moreover, we are committed to continuous quality improvement while complying with legal and regulatory requirements applicable to our products.
List of RC Activity Target Results: Quality Assurance
Maintaining and improving quality management
The Tosoh Group has established a quality management system (QMS) appropriate for its products and organizational structure, and has attained (ISO 9001 (quality management), ISO 13485 (international standard for quality management systems related to medical devices), and other certifications in the aim of raising product quality and customer satisfaction. To improve the QMS itself, certified complexes and group companies are subject to internal audits of their QMS-related activities, followed by external audits and management reviews conducted by senior general managers of complexes and plants.
Internal audits
Tosoh conducts annual internal audits within its complexes, to ensure the QMS is functioning properly and with the aim of constantly improving its operation. The company audited 63 of its departments in fiscal 2023, on areas such as confirmation of the process for receiving raw materials, filling and shipping processes, and the appropriateness of efforts to meet quality targets set by each division. In addition, head office conducts annual RC audits at complexes. In fiscal 2023, these audits examined the reduction of product complaints and the strengthening of the initial response system in the event of a complaint, ensuring the accuracy of inspection data, and so forth.
Group company support
Parent company Tosoh Corporation supports the quality management of its group companies, and to this end provides regular opportunities for the exchange of opinions. Tosoh strives to maintain and improve the quality level of the entire group, by providing advice to suppliers on conducting audits and supporting the strengthening of quality assurance systems. In fiscal 2023, we conducted a voluntary survey of 25 group companies regarding their quality control systems. No violations of laws or regulations, or cases that could negatively impact the environment or product safety when utilized by end users, were found across the Tosoh Group.
And, starting in November 2022, the Quality Control department at Tosoh headquarters, in collaboration with the corresponding department at the Yokkaichi Complex, has been conducting questionnaires of Group companies regarding quality management systems. Based on these results, it has launched a two-year program involving activities designed to improve these systems. (In fiscal 2023, this had been implemented concerning 11 of 23 companies.)
Supply chain initiatives
The Tosoh Group also conducts audits of its key suppliers and manufacturing contractors to confirm the efficacy of their quality management systems, quality control status, status of response to prevent recurrence of complaints, maintenance, and management of measures to prevent recurrence of past nonconformance cases, and of quality compliance activities. In fiscal 2023, Tosoh conducted on-site, online, and paper document audits of a total of 83 suppliers and production contractors. We are currently working to address the issues and problems detected. Moreover, we have completed quality control checks for external tank bases, generally establishing a quality assurance system. We will continue to check the status of quality control maintenance through periodic audits.
Product quality improvement
Initiatives at complexes
Each complex has its own policy for maintaining and improving quality, reducing product-related complaints, and increasing customer satisfaction. Complaints that occur at our complexes and group companies are shared as monthly bulletins, with the goal of avoiding similar complaints and issues.
In fiscal 2023, Tosoh followed up on measures to prevent recurrence of previously detected nonconformities, and confirmed the implementation status of measures against foreign matter contamination based on risk assessment, and performed a thorough review of delivery specifications. The company also conducted QMS training to raise awareness of quality control. In total, there were 15 product complaints. We will continue our workplace quality inspections with the aim of eliminating product complaints and improving quality. There were no product liability incidents or violations of quality-related laws and regulations in fiscal 2023.
Further, in order to reduce the number of complaints regarding foreign matter contamination, soiling of product packaging materials, or other damage, Tosoh conducts quality site inspections to confirm the status of countermeasures against contamination originating from the manufacturing process, the management status of raw materials, packaging material storage areas, product storage areas, and warehouse facilities. The company further ensures that measures are properly implemented to prevent the recurrence of complaints.
Quality patrol
Product complaints, product liability incidents, number of legal violations (Tosoh Corporation)
|
Fiscal 2020 |
Fiscal 2021 |
Fiscal 2022 |
Fiscal 2023 |
| Product complaints |
18 |
10 |
11 |
15 |
| Product liability incidents |
0 |
0 |
0 |
0 |
| Legal violations regarding product quality |
0 |
0 |
0 |
0 |
Pharmaceutical and medical device initiatives
Tosoh manufactures and sells in vitro diagnostics and medical devices for the diagnosis of various diseases including heart disease, cancer, and diabetes, and for the treatment of infertility. Among these products are reagents for genetic testing, and antigen quantification tests for COVID-19. To manufacture and sell in vitro diagnostic drugs and medical devices, we have obtained the appropriate manufacturing and sales licenses for as stipulated by the Pharmaceuticals and Medical Device Act. We have further established a management system to ensure product efficacy and safety.* In fiscal 2023, we conducted audits at six sites of manufacturing partners aimed at strengthening the quality assurance system.
*Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
List of RC Activity Targets and Achievements: Pharmaceutical Affairs Act
Reducing logistics complaints and issues
Tosoh's products are delivered to customers mainly by road and sea freight. Since some products contain substances such as hazardous and toxic materials that are regulated by law, appropriate management of cargo is essential: from loading to transportation, then unloading at the delivery destination. Therefore, the logistics department is taking the initiative in activities aimed at reducing both the number of accidents and the annual incidence rate of logistics complaints and problems.*
*Incidence rate = number of logistics accidents, complaints, and problems / number of products transported x 1 million.
List of RC Activity Targets and Achievements: Logistics Safety
Initiatives toward reducing complaints and issues
The Logistics RC Promotion Committee convenes once each quarter to discuss the causes of complaints and problems, as well as countermeasures which are subsequently rolled out group-wide. Tosoh regularly educates, instructs, and audits its logistics subcontractors, with a total of 45 companies audited in fiscal 2023. Specifically, in addition to supplying comprehensive manuals and checklists for the loading and unloading of hazardous and poisonous materials, Tosoh also provides safety education on chemical product handling. Further, the company surveys hazardous areas at delivery sites, and based upon this proposes improvements in the interest of preventing industrial accidents and other issues at these locations. Tosoh is also working on the hardware aspect, and is actively implementing safety devices into its transportation equipment.
Chemical substance management
Basic concept
The Tosoh Group promotes activities related to chemical substance management under the RC promotional structure. To ensure that customers can use our products safely and with peace of mind, the Tosoh Group ascertains accurate information on chemical substances, and provides information on the chemical content of its products. Tosoh gathers information and shares the latest updates with its complexes, related departments, and group companies through briefings and educational programs, to ensure compliance with both Japanese and overseas laws and regulations relating to chemical substances.
Compliance with laws and regulations
When a new product is released on the market, it has to be reported, registered, and quantified according to each country’s laws and regulations. Tosoh is responding to revisions to laws and regulations being studied and implemented in various countries, which requires the submission of data on existing substances.
In Japan, we submit applications for new chemical substances under the domestic Act on the Regulation of Manufacture and Evaluation of Chemical Substances (as well as tendering quantity notifications under this act), and the Industrial Safety and Health Act. In fiscal 2023, the company confirmed the management status of sales and transfer of poisonous and hazardous substances.
With regard to overseas laws and regulations, we continued to manage export volumes in accordance with EU REACH1 and initiated measures as appropriate after having confirmed revisions to the regulations, and we initiated registration under Turkey REACH2. In fiscal 2023, there were no violations of laws and regulations regarding the registration and notification of chemical substances.
1.Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals in Europe.
2.Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals Introduced in Turkey.
Education on chemical substance regulations
Tosoh provides education to related divisions and group companies to ensure proper compliance with chemical substance laws and regulations. In January 2009, the European Union (EU) implemented the CLP Regulation, which entails new classification, labeling, and packaging regulations for hazardous chemicals. In fiscal 2023, we conducted safety data sheet* (SDS) briefings on compliance with the revised Industrial Safety and Health Act (for around 230 attendees) and an explanatory session on the Poisonous and Deleterious Substances Business Control Act (for around 110 attendees). We further provided Group companies (25 companies took part) with education on risk assessment related to chemical substances.
*Safety Data Sheet includes information on chemical substances and their hazardous properties.
Enhanced chemical substance management
Countries worldwide are enacting and amending laws and regulations relating to chemical substances, in order to realize goals adopted at the 2002 World Summit on Sustainable Development (WSSD). Companies are mandated to manage chemical substances across the breadth of their supply chains, and have been undertaking similar measures since 2021. Meanwhile, in Japan, the Industrial Safety and Health Act has been revised to reinforce the management of chemical substances.
Tosoh continues to collect information on the enactment and revision of laws and regulations, and to implement chemical substance management appropriately, to include risk assessment and exposure control. Furthermore, through the provision of information on chemical substances contained in products to our customers, we strive to strengthen chemical substance management and minimize risks throughout the supply chain.
Chemical substance management system
Tosoh introduced a chemical substance management system to centrally manage chemicals handled within the company, and ensure compliance with international laws and regulations. This system involves the building of a database of the chemical substances contained in each Tosoh product. This database enables us to search for laws and regulations applicable to both a given product, and the chemical substances it contains.
Additionally, to enable a rapid response to customers wishing to know the chemical content of a product, Tosoh has certificate-issuing authority for certain of its products. This enable us to issue response letters or certificates from the department in charge of the particular product. In fiscal 2023, we augmented the system with a function that enables the creation of data for notification of items such as production quantities under the Act Concerning the Evaluation of Chemical Substances and Regulation of Their Manufacture.
We will continue to improve this system while adding new features.
Chemical substance risk management
With the aim of achieving the WSSD’s 2020 targets, the Japan Chemical Industry Association (JCIA) promotes voluntary initiatives by chemical makers in Japan to strengthen chemical management. These initiatives include the Global Product Safety (GPS) strategy, and the Japan Initiative of Product Stewardship (JIPS).
Tosoh has been a member of the JCIA's GPS/JIPS working group since its establishment, and implements appropriate risk management throughout the entire product lifecycle. The JCIA's focus is on publishing safety summaries—summarized results of risk assessments of chemical products manufactured and sold by a company—for 31 major products. When safety data sheets (SDS) describing the chemical content of products and related hazards are revised, the summaries are reviewed and updated accordingly.
In addition, in fiscal 2023 Tosoh appropriately conducted risk assessments for chemical substances handled by the company, in accordance with Japan’s Industrial Safety and Health Act. Group companies are requested to complete risk assessment implementation questionnaires, and we have confirmed that there are no issues.
Product safety audits
In accordance with the intent of Japan’s Product Liability Act, Tosoh Group employees in Japan work together to ensure product safety and provide appropriate product information.
Our Product Safety Review Committee verifies the safety of products and raw materials, and deliberates on laws and regulations at each stage from R&D to sales. In fiscal 2023, the committee met 85 times.
Disclosure of Chemical Substance Safety Information
Safety information disclosure
The Tosoh Group prepares and provides SDS for all of its products, and has made some of these available on its website to help ensure the safe handling of the products. Following the Japanese Industrial Standard revisions enacted by the government in May 2019, we completed the revision of all SDSs by the May 2022 deadline for compliance.
Regarding the labeling of products under Japan’s Industrial Safety and Health Act, in addition to products that contain substances already subject to mandatory labeling, we are gradually including additional products that contain other hazardous substances.*
*The Industrial Safety and Health Act stipulates that containers and packaging for hazardous substances specified by Cabinet Order must be labeled with the name, ingredients, effects on the human body, and precautions for storage and handling.
Dissemination of information on chemical substances contained in products
Tosoh is a member company of the Joint Article Management Promotion-consortium (JAMP). Since 2018, we have been promoting the acquisition, management, and communication of information on chemical substances in products in our supply chain using the chemSHERPA system promoted by JAMP. We will continue to provide information in a proactive, prompt, and reliable manner to meet our customers' needs.