Quality and Customer Safety

Policy and Basic Approach
System
Targets and Results
Initiatives

Policy and Basic Approach

So as to deliver high-quality, safe and secure products to society at large, we have fixed as our basic policy, under the KAYAKU spirit, our Declaration on the Environment, Health, Safety and Quality, and built up our Quality Assurance System. Using these as the base for appropriate operation of our Quality Management System, we are working towards thorough quality governance which includes indicators laid down in our Key Sustainability Issues. We also recognize the importance of being responsible throughout every product’s life cycle, from planning, development and production to disposal and recycling, as well as with respect to resources, energy and the handling of information. As such, we are focused on raising the quality awareness levels of our employees.

Our Declaration on the Environment, Health, Safety and Quality

System

The Nippon Kayaku Group has integrated its quality management practices by setting up an Environment, Safety and Quality Management Committee to serve as an advisory body to the Sustainable Management Meeting chaired by our President. This Committee is comprised of Quality Assurance Managers from each business unit and representatives from back-office headquarters departments. It engages itself in strengthening the entire Group’s Quality Assurance System through discussing quality assurance policies and the status of quality improvement activities, then reporting to the Sustainable Management Meeting.

International Certifications

The Nippon Kayaku Group is developing its presence through its three business units of Mobility & Imaging, Fine Chemicals and Life Science. We have constructed appropriate quality management systems for our various forms of business, with each business unit acquiring certification for international quality assurance standards in order to develop and provide high-quality products and services.
In the Mobility & Imaging Business Unit, the Safety Systems Group, the Safety Head Plant (Himeji) and the Research and Development Division have all acquired IATF16949 certification, an international quality management system standard for the automotive industry devised by the International Automotive Task Force (IATF). Our overseas Group companies engaged in the manufacture of automotive parts have also acquired this certification as they work on providing yet higher-quality products. In the Fine Chemicals Business Unit, October 2020 saw the commencement of our unified quality management system for the Fukuyama Plant, Asa Plant, Tokyo Plant, headquarters and research labs, and Taiwan Nippon Kayaku. This system gained integrated certification for ISO9001 in July 2021.
Meanwhile, in the Life Science Business Unit’s Pharmaceutical Group, our Takasaki Plant and Medical Research Laboratories have integrated certification for ISO9001 and integrated certification for ISO13485 - the quality management system standard for medical device and IVD (In Vitro Diagnostics). Furthermore, October 2022 saw our NIPPONKAYAKU FOOD TECHNO Group company acquire ISO22000 certification pertaining to food safety management system standards. Meanwhile, in our Agrochemicals Group, the Kashima Plant and Agrochemicals Laboratories commenced their unified quality management system in March 2021, and gained ISO9001 certification five months later.

Business Sites with Certified Quality Management Systems

Quality Audits

So that the Nippon Kayaku Group can operate appropriate quality governance aligned with the characteristics of each business, the Quality Assurance Department set up for each business unit conducts quality audits of the business sites under its remit. Additionally, each Quality Assurance Department is periodically subjected to core quality inspections^* by the Responsible Care and Technology Unit’s Production Technology Managers TQM Group, which makes suggestions on how to improve quality assurance levels and confirms whether quality management systems are functioning effectively and efficiently.

*Our Group sets up quality audits in the form of Quality Inspections.

Targets and Results

Scroll sideways for an overview of the table below.

Indicator	FY2028 Target	FY2035 Target	Scope
Number of serious complaints *Losses of JPY 10 million or greater	0 cases	0 cases	Consolidated
Number of Major Quality Process Abnormalities *Losses of JPY 10 million or greater	0 cases	0 cases	Consolidated

FY2025 Sustainability Targets and Results

Initiatives

Promoting Quality Assurance and Quality Improvement Activities

Our Responsible Care and Technology Unit’s Production Technology Managers TQM Group lends support to each business unit’s Quality Assurance Division, and promotes both quality assurance and quality improvement activities.
We are working on strengthening the requisite technical skills for quality management and aiming to decrease customer complaints and production process abnormalities through conducting Quality Inspections, quality-themed education and training, and quality improvement activities.
Nippon Kayaku’s quality management story begins in 1948, when a plant technician voluntarily began looking into quality control statistical methods. The passionate continuation of such activity was eventually rewarded with a Deming Prize in 1963. This spirit of quality improvement has been handed down to the present day, with the quality improvement activities steered by onsite technicians yielding many improved outcomes. These results have been shared and horizontally expanded across the organization via our KAYAKU Technology Forum and Manufacturing Engineering Awards. We have also updated our textbook "Quality Management for Everyone" from the time of the Deming Award to fit the present day, and continue to use it for education and training.

Quality Improvement Activities

Our Group investigates the reasons behind quality defects and customer complaints. Effectively preventing recurrence requires not individual efforts, but all workplace employees pooling their thoughts together and proposing appropriate measures. With this aim in mind do we incorporate the Why? Why? Analysis Method. Specifically, this has involved creating a Why? Why? Analysis Manual which currently helps revitalize our improvement activities.

Business Unit Initiatives

The Nippon Kayaku Group not only provides training programs to each business unit through its Responsible Care and Technology Unit’s Production Technology Managers TQM Group, but is rolling out various quality assurance activities aligned with each industry type.

Fine Chemicals Business Unit

Initiatives to Strengthen Product Quality Credibility

Our Fine Chemicals Business Unit has set up a Quality Assurance Division to serve as its Quality Department and, through linking up with production sites and business sections both domestically and overseas, undertakes initiatives to guarantee product quality in line with customer expectations. To increase the credibility of quality inspections at the Fukuyama and Asa plants, we have introduced the Laboratory Information Management System (LIMS) in our push to expand operations. Through its digitalization of quality inspection work, LIMS offers efficiency by minimizing the need for human involvement, thereby preventing human error during data transfers, and ensuring that processes are performed as determined by the inspection.
Furthermore, in order to prevent production process abnormalities before they happen, we are making use of various risk assessment methods such as Failure Mode and Effects Analysis (FMEA). Quality patrols are an indispensable initiative in our drive to strengthen production area quality management and overall product quality. They occupy an important place in our efforts to detect potential problems and devise appropriate response measures, and are therefore conducted at each production site. Going forward, we shall continue, through various activities, to promote the fostering of a quality culture which sees employees voluntarily act on quality issues and feel a sense of quality responsibility while carrying out their jobs, so as to deliver products that everyone can trust.

Quality Crisis Management

The Nippon Kayaku Group views opinions and observations on quality submitted by our customers as not only issues that need solving but as valuable opportunities to improve product and service quality overall. All quality-related information submitted by customers is internally shared, with root causes promptly and accurately examined, and remedial measures then taken. Such information is then horizontally rolled out so as to prevent reoccurrences. In the unlikely event of an incident that poses serious quality issues or threats to customer safety, we follow our crisis management process, promptly set up a response team on the instructions of our Crisis Management Committee Chair, and make every effort to minimize the effect on our customers. With customer safety and trust at the forefront of our minds do we strive for highly-transparent information disclosures and sincere responses to quality issues.

Risk Management (Responses to Emergencies and Crisis Management System Construction and Administration)

Quality Education and Training Initiatives

Our Responsible Care and Technology Unit’s Production Technology Managers TQM Group draws together the necessary issues that accompany quality assurance and quality improvement activities under a Quality “Mandalart” chart based on our KAYAKU spirit corporate vision, clarifies said issues, and delivers the relevant quality training on a systematic basis.

In a further subdivision of the mandalart chart, the necessary knowledge and skills required to resolve issues A to H and realize the company we wish to be are also defined. The resultant quality education programs are delivered in both group-session and online-meeting formats so that every business unit’s R&D and plant employees can efficiently and effectively join regardless of where they move. Through, for example, dispatching instructors to every business site and delivering the contents to multiple locations simultaneously in a hybrid format, we are also devising training methods which make adept use of both online and offline formats.
We also conduct post-training surveys to help us further improve the quality and volume of training delivered.

Quality Mandalart

Nippon Kayaku continuously provides training on quality across the employee spectrum, from new recruits to management classes. Each and every employee is studying to improve their quality awareness on a daily basis in the quest to achieve high-quality products and services.

Training Contents include…

e-learning seminars with the aid of our internal quality training textbook: “Quality Management for Everyone.”
Field Data Analysis: Learning School～
Internal quality auditor training

Quality Training Attendance Results(Japan)

Training Type	Contents	Attendees in FY2025	Total
Why? Why? Analysis Training	Root cause analysis at the time of a problem Drafting reoccurrence prevention measures Practical exercises	47(41 males, 6 females)	310(Since FY2020)
Measures Against Human Error Training	Extracting human error risks Drafting advance prevention measures Horizontal expansion of prevention activities	63 (51 males, 12 females)	973(Since FY2020)
Quality Training for New Hires	The relationship between Quality the KAYAKU spirit "Quality Control for Everyone"; 7 tools for Quality Control ISO standards and accreditation	46(32 males, 14 females)	363(Since FY2021)
Monthly Quality Lecture	Seminar on Quality Defect Prevention "Communication and Psychological Security protect Quality and People"	189(146 males, 43 females)	492(Since FY2023)

Quality Improvement Activities Conducted with Suppliers

The need to rapidly deliver high-quality products to market makes continuous quality improvement activities based on relationships of mutual trust with suppliers essential.
In the Safety Systems business, our Quality & Safety Division gets involved from the initial supplier selection stage, conducting process audits, confirming quality situations, and offering education sessions to provide advice on quality improvement. Nippon Kayaku Group Quality Manuals are also distributed to all suppliers, who must sign a form confirming their acceptance of manual stipulations.
The Purchasing Division conduct regular audits of suppliers according to the type and importance of materials purchased. These audits involve reinforcing the Nippon Kayaku Group’s basic approach to quality assurance, confirming quality management standards and the supplier’s quality situation, and offering advice on quality improvement.
FY2025 saw a total of 19 such supplier audits conducted (9 onsite and 10 by document submissions only), with the emergence of zero cases connected to serious quality issues. Where points of issue arose, the suppliers in question were made to submit a Process and Product Audit Improvement Plan with Relevant Measures Form, and we are currently confirming whether those remedial measures are in fact being enacted.
Stronger relations with suppliers are of key importance in the quest to maintain and improve quality. We will continue to hold consultations on problems and concerns as part of wider opinion exchanges, and work in tandem with our suppliers to maintain and improve quality.

Quality Education for Suppliers

We believe that providing our customers with high-quality products and services necessitates cooperation with suppliers to deliver quality assurance through investigations and audits, and the promotion of continuous quality improvement activities. As Nippon Kayaku supplier industries differ from group to group, we compile all quality assurance approaches and demands for each separate business group and distribute to the suppliers concerned. We also, in accordance with the type and importance of items procured, conduct audits on our suppliers with appropriate frequency, with departments related to Purchasing and Quality teaming together for this purpose. Any issues identified through audits are followed up with suppliers until corrective actions have been implemented and their effectiveness has been verified.

In its quest to drive forward initiatives to maintain and improve manufacturing contractor product quality, our Agrochemicals Group enlists the cooperation of both domestic and overseas contractors in conducting periodical audits and thorough information exchanges. Quality Assurance and Technology departments join forces to conduct these audits, with the R&D department participating when necessary. Such audits are preceded by a questionnaire covering matters such as compatibility with laws and regulations, quality assurance systems, and quality management and production process conditions, allowing us to grasp any low self-evaluations submitted by contractors and, to the best of our abilities, confirm situations for ourselves onsite. Furthermore, the sharing of information on past internal or manufacturing-contractor-related near-misses and subsequent response measures helps us take steps to prevent reoccurrences. Through such links with our manufacturing contractors are we contributing to the development of sustainable farming through working on improved product quality and customer satisfaction, and supporting food supplies.

Responses to Customers

Life Science Business Unit

Responses to Enquiries from Patients and Medical Professionals

Our Medical Information Service Center has a toll free number for fielding all kinds of enquiries from patients and medical professionals on Nippon Kayaku pharmaceutical drugs and medical devices, including anti-cancer drugs, autoimmune disorder drugs and endovascular embolization materials. The Center handled 18,133 enquiries in FY2025. With the aim of ensuring that all our products come to serve customers even better, the Center’s staff endeavor to handle each enquiry with speed, accuracy and politeness. We also strive for daily service improvements through surveying our customers on whether our Center’s answers have met their expectations.
In addition to linking up with our medical representatives tasked with visiting medical institutions so that patients can be presented with the most helpful information possible, the Center also relays the requests and opinions of customers to relevant internal departments along with its own suggestions. Under its slogan of: “Doing everything to promote appropriate use and improve customer satisfaction” is the Medical Information Service Center contributing towards yet better medical care.

Our Pharmaceutical Products Information Center

Trends in Numbers of External Enquiries

Enquiry Type Breakdown (FY2025)

Information for Patients and their Families

Patients and the Public（Japanese）

Participation in External Initiatives

Japan Pharmaceutical Manufacturers Association (JPMA)

The Nippon Kayaku Group holds membership of the Japan Pharmaceutical Manufacturers Association (JPMA) having agreed to its principles of contributing to the health and healthcare of both the Japanese and the world population through developing innovative and highly useful drugs and supporting the healthy development of the pharmaceuticals industry. As a pharmaceuticals manufacturer, we are contributing to the healthy development of the pharmaceuticals industry through code compliance, increased appropriate use, promotions, clinical evaluations, PMS, quality, involvement in pharmaceutical affairs, and R&D.

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