Governance Governance

Quality Assurance Management

Updated March 2026

Quality Assurance Management

Basic Policy (Quality Policy)

The Denka Group has established quality policies in line with its management plan Mission 2030 and is conducting quality assurance activities for a wide range of products from organic chemistry using synthetic resins and resin processing, inorganic chemistry using high-performance powder control technologies, to the bio field with technologies for culturing bacteria and viruses and producing antibodies and antigens.

Quality Policy (Fiscal 2025)
The Denka Group aims to achieve zero occurrence of serious quality accidents by establishing measures to prevent recurrence of inappropriate quality practices and ensuring compliance with quality standards through the promotion and improvement of quality management and the provision of safe, stable, and high-quality products and services. Through these efforts, we will earn the satisfaction and trust of our stakeholders and contribute to the creation of new value.

Quality assurance system and recurrence prevention measures for inappropriate quality

Promotion of measures to prevent recurrence of inappropriate quality

The Denka Group sincerely accepts the full extent of inappropriate quality conduct that has come to light, as well as the points of indication and suggestions from the external investigation committee, and has established the four "Implementation of Measures" items below to address these issues. The Denka Group will continue to put forth its utmost efforts as a group to address these issues, strengthen compliance, prevent recurrences, and restore trust.

Management
Governance, management strategy, and company-wide systems
Quality assurance function
Quality assurance systems, quality assurance programs, certification standards management, audits/surveillance
Quality assurance
Passing on of technology/De-personalization/Strengthening of workplace
HR
HR Strategy and Development of HR
  • Results of external investigation committee on inappropriate quality

Quality assurance system through collaboration among three divisions

The Company has established a Quality Assurance Department at its head office, business divisions, and factories. By promoting organic collaboration among these three layers of Quality Assurance Departments, the Company is working to improve overall quality levels across the Denka Group.

Quality assurance system through collaboration among three divisions

Product safety and quality risk assessment

The quality risks of each product are changing due to the ongoing changes in quality requirements and laws and regulations. As part of our response to these risks, we review our quality risk assessment from market and business environment perspectives every year, and implement initiatives to reduce quality risks in a planned manner according to the nature and magnitude of the risks.

Management of chemical substances and product safety

Our Group constantly monitors domestic and overseas legal revision information regarding chemical substances. For the information of chemical substances contained in products subject to legal revision, we provide revised SDSs and notify customers of the information on the contents of the products. If changes to product components or production processes are required to comply with revised laws and regulations, we will respond swiftly and appropriately.

Quality and safety of pharmaceuticals

The Denka Group has established the Quality Assurance Policy, the highest corporate standard for quality assurance, which states that "the Denka Group must ensure compliance with laws and regulations and improve customer satisfaction regarding products." To comply with this policy, the Denka Group conducts its pharmaceutical business under management in accordance with the GMP Ordinance (Standards for Manufacturing Control and Quality Control for Pharmaceuticals), GQP Ordinance (Standards for Quality Control of Pharmaceuticals), GVP Ordinance (Standards for Post-Marketing Safety Management for Pharmaceuticals and Medical Devices), and QMS Ordinance (Standards for Manufacturing Control and Quality Control for Medical Devices and In Vitro Diagnostic Reagents) to manufacture and provide reliable products.
Furthermore, the Denka Group is a member of and supports the following organizations to promote the safety and responsible distribution of pharmaceuticals: the Japan Vaccine Industry Association, the Japan Clinical Laboratory Industry Association, and the Japan Medical Device Industry Association. In the future, the Denka Group will continue to support the promotion codes and guidelines of these organizations, conduct manufacturing and provision of pharmaceuticals under responsible management systems that ensure safety, and contribute to the improvement of health and welfare of people.

Establishment of quality control systems and efforts to improve customer satisfaction

To provide reliable products and services, we are promoting the establishment of quality control systems.
By using systems such as the Complaint Management System, which integrates and manages customer complaint information to facilitate ongoing quality improvement, and the Chemical Substance Management System, which links information on chemical substances to product safety, we are raising our level of management and striving to further improve quality and ensure product safety.

Complaints Management System

Complaints Management System

Chemical substance management system

Chemical substance management system

Activities to Improve Customer Satisfaction

In order to reflect customer feedback in our quality assurance activities, the Electronics and Innovative Products Division conducts a customer satisfaction survey once a year.
We analyze customer feedback from the aspects of sales, technology, quality, and delivery, and implement strategic actions for quality improvement.
Through customer satisfaction surveys, we aim to gain further trust from our stakeholders.

DFF Inc., Denka Company Limited CSR and Public Relations Office, Denka Company Limited IR Office, Seiwa Business Link
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Activities to Improve Customer Satisfaction

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In the Electronics and Innovative Products Division, we conduct a customer satisfaction survey once a year to accurately respond to customer requests and reflect the evaluations received in our quality assurance activities...