Tosoh develops products that reflect the needs of its clients, and works to ensure timely and stable supply. Moreover, in addition to observing product-related laws and regulation, it continually strives to improve the quality of its products.
Quality Assurance
At Tosoh, we take the initiative to supply safe, secure, high-quality products at every stage of production, from R&D to product shipment.
In December 2017, in response to a request from the Japan Business Federation, we confirmed that no quality-related issues exist.
Quality Management System (QMS)
Our migration to the 2015 version of ISO9001 quality management earned us ISO9001 certification in fiscal 2018. The specifications, moreover, strengthened our quality management system (QMS) such that we are working to further the quality of our products and the satisfaction of our customers.
As a new initiative in fiscal 2018, we utilized external consultants in conducting risk evaluations for the purpose of strengthening measures to prevent contamination of products for medical applications. We will continue to strengthen measures and procedures accordingly based on the recommendations provided by the external consultants.
Quality Audit
Tosoh conducts an internal audit every year to ensure the proper functioning of its QMS.
It reviews its quality assurance systems, quality management conditions, complaint recurrence prevention methods, and related aspects.
The company also performs audits at its main raw material producers and manufacturing subcontractors to verify a consistent level of product quality from them. In fiscal 2018, Tosoh conducted audits at 48 raw material producers and manufacturing subcontractors.
Product Quality Improvement
Chemical Product Initiatives
By establishing quality policies related to chemicals at each complex, we work to improve the quality of our products and reduce the volume of complaints to enhance customer satisfaction.
Once a month, quality assurance representatives from headquarters and the Nanyo and Yokkaichi Complexes gather for quality assurance meetings. They share information about complaints, about rolling out complaint prevention methods, and about other quality management issues. Moreover, they share complaints that occur within group companies via a monthly report, with the objectives of sharing information and taking measures to prevent similar complaints.
Furthermore, in order to achieve annual reductions in occurrences of contamination, stains on product packaging, and damage-related complaints, we conduct workplace patrols relating to the state of contamination countermeasures at the heart of the manufacturing process, as well as where raw materials, packaging materials, and products are stored, and warehouse facility management, and whether or not measures to prevent the recurrence of complaints are being conducted appropriately.
Initiatives for Pharmaceuticals and Medical Devices
Tosoh manufactures and sells in vitro diagnostic products and medical devices useful in diagnosing various illnesses such as heart disease and cancer, lifestyle diseases such as diabetes, and infertility treatments. We also manufacture and sell pharmaceutical products containing calcium hypochlorite for sterilizing and disinfecting pools and for other applications.
We have acquired various licenses for the manufacture and sales of pharmaceutical products, in vitro diagnostic products, and medical devices, as designated in Japan’s Pharmaceutical and Medical Devices Act. 1
We have established the management structure necessary to ensure the effectiveness and safety of our products. Among those products is sodium bicarbonate, an important ingredient for medical drugs that we are licensed to manufacture and that we produce to the strictest standards for quality.
1 A law related to ensuring the quality, effectiveness, and safety of pharmaceutical products and medical devices, etc.
Logistics Quality Improvement
Major Accident Occurrences
Tosoh’s products are mainly delivered to customers by truck or ship. As Tosoh products incorporate substances regulated by the Fire Services Act and the Poisonous and Deleterious Substances Control Law, management during transportation is also important.
With logistics teams taking the lead, Tosoh is working to keep the occurrence of logistics incidents, complaints, and troubles below 20 annually (rate of incidence 50 ppm or below). 2
No major accidents occurred in fiscal 2018.
2 rate of incidence ppm; Number of logistics incidents and complaints ÷ number of items delivered × 1 million
Initiatives to Decrease Accidents, Complaints, and Issues
The Logistics RC Promotion Committee holds quarterly meetings to discuss causes and countermeasures for incidents and complaints, and to train, instruct, and audit carriers. In addition to preparing comprehensive manuals, we also conduct safety training related to the proper handling of chemical products, safety countermeasures for transport vehicles, and other logistics issues.
In fiscal 2018, in addition to adopting shipping human error prevention training (BRM training) as a new training method for carriers, we also began to consider switching to company-operated delivery from scheduled courier delivery trips for small quantities of hazardous materials and deleterious substances. 3
Moreover, we created a database of incidents, complaints, and close calls, and from the first half of fiscal 2019, we will roll out incident countermeasures to prevent recurrences. We are also proactively implementing new initiatives, such as joining hazardous materials accident response and safety services (HAZMATers 4, HMSS 5), enhancing our ability to respond rapidly to hazardous material accidents.
3 Bridge Resource Management; a type of training that aims to prevent maritime accidents due to human error with various resources that can be utilized effectively on bridges, in order to accomplish safe and efficient shipping.
4 Hazardous Material Emergency Response Service; a Maritime Disaster Prevention Center service that responds to accidents that occur during land transport when hazardous materials leak, spout, or catch fire.
5 Hazardous Material Safety Service; a Maritime Disaster Prevention Center service that responds to accidents that occur at land-based storage facilities such as warehouse terminals, when hazardous materials leak or catch fire.
Chemical Substance Management
Tosoh complies with domestic and foreign regulations, assesses product safety, and provides product information to customers in its efforts to ensure the safe handling of its chemical products.
For chemical management throughout the entire supply chain, Tosoh discloses and provides information about the chemical substances contained in its products.
Product Risk and Information Disclosure
In fiscal 2018, at each of its business establishments, Tosoh created SDSs and labels as well as implemented risk assessment concerning chemical substances newly specified by Japan’s Industrial Safety and Health Act. 6
In addition, Tosoh provides chemical safety information by creating and offering SDSs for all of its products and disclosing some of the SDSs on its official website. The company also complies with Japan’s Industrial Safety and Health Act and attaches labels to products that require their substances to be identified by label.
6 SDS stands for safety data sheet, which shows the substances contained in a product, potential hazards associated with the substances, and other relevant information.
Regulatory Compliance
When launching a new product, a company is required to submit a notification, fill out registration information, submit a notification of quantity, and follow other procedures according to the regulations of each country. Tosoh responds to revisions to laws and regulations requiring the submission of data on existing substances that are implemented or planned in each country.
In Japan, Tosoh submitted notifications of new chemical substances and applied for permission for such substances in accordance with the Industrial Safety and Health Act/Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc., submitted notifications of the quantity of general chemical substances and other substances pursuant to the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc., and followed other procedures to comply with laws.
Regarding overseas laws and regulations, Tosoh completed registration of existing substances in accordance with the EU regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) by the end of May 2018 and will have registered the required existing chemical substances under K-REACH of South Korea by the end of June 2018.7
Tosoh has also responded to the revised TSCA of the United States.8
7 REACH; A regulation on chemical products that was enforced to protect health and the environment
8 Toxic Substances Control Act, which is aimed at preventing damage to health and the environment
Education Concerning Chemical Substance Regulations
Tosoh trains its personnel to ensure compliance with regulations on chemical substances.
In fiscal 2018, Tosoh held meetings to explain overseas laws and regulations at the head office, complexes, laboratories, and group companies. Tosoh also held explanatory sessions on GHS at the head office and complexes.9
9 GHS: Globally Harmonized System of Classification and Labelling of Chemicals; a system established by the UN to unify the hazard classification and labelling of chemical products.
Product Safety Audit
In accordance with the intent of Japan’s Product Liability Act, all Tosoh employees work together in an effort to ensure the safety of products and provide appropriate product information.
In addition, the Product Safety Review Committee of the company deliberates on safety and laws and regulations at each phase from R&D to sales.