Safety / Quality

Product Responsibility

• Quality Management
• Quality Assurance Initiatives
• Chemical Substance Management
• Certification Acquisition Status

Quality Assurance Initiatives (Fiscal 2022)

• We held quality management conferences on four occasions, inviting personnel in charge of quality management in each business division, to instill the Company-wide policy and instructions and to exchange views on product quality assurance and share quality information.
• Through the Product Safety Review Committee, we put in place a system to ensure product safety and service for product launches, such as those of new medical devices and products related to Kaneka biodegradable polymer Green Planet™. To further enhance product safety, we have revised the review committee’s standards for pharmaceutical intermediates.
• We assessed the testing status of antibody drug purification products, products related to genetic testing and diagnosis, and raw milk at Betsukai Wellness Farm. We confirmed that the determined items were being carried out in the correct manner.
• For teams in our food business-related operations, we engaged with external experts to deepen their knowledge of hygiene management and increase their focus on delivering safer products to customers throughout the supply chain.
• We reviewed the self-check format internal audit checklist used by the production, sales, and administration divisions of Group companies to ensure that questions align with the actual activities of each division. Any weaknesses flagged by the quantitative evaluations can then be addressed through improvement efforts in cooperation with the supervising business department.
• We held a Quality Internal Audit Secretariat Division Meeting. We confirmed the operational status of our system for design and development activities for each project as a common confirmation item for each business division in the current fiscal year.
• 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 workshops for the purpose of understanding the importance of consumer perspectives and improving the level of internal auditors.

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

We take appropriate action at all stages of product development, manufacturing, transportation, sales, and disposal based on a clear grasp of the requirements of Japanese and international laws and regulations on the management of chemical substances, with each division adapting its response to its particular circumstances. For raw material procurement, we have established the Green Procurement Standards to prevent mixing of chemicals prohibited under the Control Act.(*1) When supplying products, we take active measures to convey information on the hazard level of the chemical substances, including displaying a GHS(*2) label and providing a product safety data sheet.
We held a new division meeting for people in charge of chemical substance management, reviewing designated chemical substances in accordance with the revision of the Chemical Substances Control Law (*3). We circulated information internally on the addition of substances subject to labeling and notification due to revisions to the Industrial Safety and Health Law. In our internal training, we worked to improve the level of practitioners related to the preparation of major domestic laws and regulations such as the Chemical Substances Control Act and GHS labels and yellow cards (*4). To deepen knowledge among our employees, we also arranged for a guest speaker from outside the Company to give a lecture on the topic of chemical substances related laws in major countries overseas, which covered new chemical substance notification systems in key markets such as China, Korea, and the EU.

*1 Chemical Substances Control Act: Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.

*2 GHS: A worldwide system for classifying and labelling chemicals according to their hazardous properties.

*3 Chemical Substances Control Law: A law on the assessment of releases of specified chemical substances into the environment and the promotion of improvements in their management.

*4 Yellow Card: A document describing first aid measures, etc., for use in the event of an accident during land transportation of chemical substances.

Certification Acquisition Status (as of March 31, 2023)

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.

ISO22716 Certification (*4)

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

ISO17025 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.