Quality

Product Responsibility

• Quality Management
• Quality Assurance Initiatives
• Chemical Substance Management
• Product Responsibility

Quality Management

We coordinate quality assurance activities throughout the Kaneka Group and drive quality management, including product safety assurance, at all stages from product design and development to raw material procurement, manufacturing, storage, transportation, sales, and disposal.
In fiscal year 2023, we conducted ESG safety and quality inspections across all parent manufacturing sites and 16 departments of our domestic and overseas Group companies, and implemented improvements for the identified issues.
We confirmed that the 12 newly launched products were being inspected according to the established criteria using appropriate methods.

Quality Assurance Initiatives

In fiscal 2023, we focused on the following initiatives.

• We held quality management conferences on four occasions, to instill the Company-wide policy and instructions and to exchange views on product quality assurance and share quality information, including customer satisfaction.
• We held a product safety review conference for the launches of new medical devices and organic milk, confirming that there were no issues with the quality assurance system and product safety.
• As part of our commitment to food safety, we conducted ESG safety and quality inspections on the design and development of our food business and confirmed that there were no issues.
• We confirmed that 12 products, including medical devices, COVID-19 treatment drug intermediates, and lactic acid bacteria products, were tested according to the prescribed items using appropriate methods.
• We held a Quality Internal Audit Secretariat Division Meeting as a common review framework to confirm change management during design and development for each business.
• We invited external experts to lead a seminar on consumer-oriented management for our food business teams, aiming to sharpen their focus on delivering safe products to customers.
• Aiming to raise the quality assurance level of each employee, we sent employees to outside seminars, used e-learning materials on internal rules and standards, and brought in outside lecturers to hold in-house seminars on topics such as the circular economy and product safety.

Going forward, we will continue working to enhance the quality management system, through audits, inspections, and other checks and human resource training. In this way, we aim to ensure full compliance and product safety throughout the entire supply chain.

Chemical Substance Management

In each division, we clearly identify domestic and international legal requirements for regulating chemical substances according to the characteristics of our business and manage these substances accordingly. For example, we properly handle the registration of chemical substances, management of production and import volumes, and performance reporting in compliance with laws such as Japan’s Chemical Substances Control Law (*1) and the EU’s REACH regulation (*2).
For raw material procurement, we have established Green Procurement Standards to prevent the inclusion of prohibited substances under the Chemical Substances Control Law and other regulations. In product distribution, we actively disclose information on the hazards and risks of chemicals through GHS (*3)-compliant labeling and Safety Data Sheets (SDS).
In fiscal 2023, we convened two meetings with chemical substance management representatives from eight business divisions handling chemical products. During these meetings, we disseminated information on updates such as the Occupational Safety and Health Law (addition of SDS-targeted substances), the Food Sanitation Law (revision of the positive list), and the EU REACH regulation (addition of SVHCs). We also shared concerns and challenges from each division and engaged in discussions.
In our internal training, we conducted seminars on the Occupational Safety and Health Act, the Chemical Substances Control Law, UN Dangerous Goods, and SDS. Additionally, we provided e-learning education on GHS labels, Yellow Cards, SDS, domestic laws such as the Chemical Substances Control Law, and international regulations such as the EU REACH regulation.

*1 Chemical Substances Control Act: Act on the evaluation of chemical substances and regulation of their manufacture, etc.

*2 REACH regulation: Regulation concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals.

*3 GHS (Globally Harmonized System of Classification and Labelling of Chemicals) : A globally unified system for classifying and labeling chemicals according to their hazardous properties.

Product Responsibility (as of March 31, 2024)

ISO 9001 Certification

ISO 13485 Certification（*1）

*1 ISO 13485 is an international standard covering the comprehensive management system requirements for the design and manufacture of medical equipment.

ISO 22000 Certification（*2）

*2 ISO 22000 is an international standard for food safety management systems.

Food Safety System Certification 22000 (FSSC 22000)（*3）

*3 The Food Safety System Certification 22000 (FSSC22000) offers a complete certification Scheme for Food Safety Management Systems based on ISO 22000, ISO/TS 22002-1, and additional FSSC 22000 requirements.

ISO 22716 Certification（*4）

*4 ISO 22716 is guidelines on the Good Manufacturing Practices (GMP) of cosmetic products.

 ISO 17025 Certification（*5）

*5 ISO 17025: General requirements for the competence of testing and calibration laboratories; Criteria based on which an accreditation body assesses whether the relevant testing and calibration laboratory can produce accurate measurement and calibration results.

IATF 16949 Certification（*6）

*6 IATF 16949 is a sector standard for quality management systems based on ISO 9001 with the addition of automobile industry-specific requirements.

JISQ 8901 Certification（*7）

*7 JISQ 8901: Defines requirements for reliability assurance system (design, manufacturing and performance assurance) for ground-mounted solar cell (PV) modules.