Quality Management
Policies and Systems
Policy (Our fundamental view)
We have established our Quality Policy in order to “provide the highest quality products and services” as stated in the first clause of the Code of Conduct of the NOF Group Corporate Philosophy and Guiding Framework.
Organizational setup
In April 2019, NOF established the Quality Management Committee to supervise quality management and continue to secure the trust of society. It is chaired by the general manager of the Corporate Technical Division (concurrently director and executive officer) and has nine other members (business division managers, related corporate division managers). In April 2023, the Quality Management Department was established in the Corporate Technical Division to maintain and improve the quality control level of the entire Group by educating employees on quality management and providing guidance on quality management systems (QMS*) operated by works, plants, and Group companies.
* Acronym for Quality Management System. A system by which an organization formulates policies and sets targets in order to dictate and manage its quality, and achieve such targets.
| Quality Policy |
|---|
| The NOF Group provides the highest quality products and services that are based on our considerations of achieving harmony with society and customer satisfaction through our unrelenting quality management. １．Harmony with society We shall comply with laws, regulations and rules, respect the environment, and produce safe and secure products using manufacturing processes that themselves are safe and secure. ２． Customer satisfaction practices We shall listen to our customers’ requirements and provide products that meet their expectations and useful information. ３．Unrelenting quality management We shall maintain stable quality with continuous improvement and proper process management and enhance the management level through education. ４．Execution of quality assurance We shall fulfill our commitment with our customers and sincerely respond to inquiries and complaints. |
Development status of QMS
NOF’s works and plants are externally certified for the QMS most appropriate for their business. The Functional Materials and Metal Coatings businesses are certified under ISO 9001, the Explosives & Propulsion business is certified under JIS Q 9100, and the Functional Foods business is certified under FSSC 22000 (Food Safety Management System). The Life Science business utilizes ICH-Q7 (active pharmaceutical ingredients GMP guidelines). Fifteen Group companies have obtained ISO 9001 and other external certifications.
| Works and plants | Quality management systems | Certification number | Latest recertification date | |
|---|---|---|---|---|
| Kawasaki Works | Chidori Plant | ISO 9001 | JP022495 | May 2022 |
| Daishi Plant | FSSC 22000 Food Safety Management System |
JMAQA-FC270 |
December 2021 |
|
| DDS plant | ICH-Q7 active pharmaceutical ingredients GMP guidelines |
- |
- |
|
| Aichi Works | Taketoyo Plant | JIS Q 9100 | JQA-AS0183 | July 2022 |
| Kinuura Plant | ISO 9001 | JPO22549 | June 2022 | |
| Amagasaki Plant | Functional Materials Division | ISO 9001 | JPO22753 | August 2022 |
| Life Science Division | ICH-Q7 active pharmaceutical ingredients GMP guidelines |
- |
- |
|
| Oita Plant | ISO 9001 | JP023986 | September 2023 | |
| Name | Quality management systems | Certification number | Latest recertification date | |
|---|---|---|---|---|
| Nippon Koki Co., Ltd. | ISO 9001 | JSAQ2282 | September 2023 | |
| Nippon Koki Co., Ltd. Shirakawa Plant | JIS Q 9100 | JQA-AS029 | September 2023 | |
| NiGK Corporation | ISO 9001 | 66885 | March 2023 | |
| NOF METAL COATINGS ASIA PACIFIC CO., LTD. | ISO 9001 | JP023061 | November 2022 | |
| Showa Kinzoku Kogyo Co., Ltd. | ISO 9001 | 02479-2011-AQ-KOB-JAB | March 2024 | |
| YUKA SANGYO CO., LTD. | ISO 9001 | 19823082 | April 2024 | |
| JEUNE BEAUTY CORPORATION, Amagasaki Factory | ISO 22716 （cosmetics materials GMP） |
JPO24379 | January 2024 | |
| JEUNE BEAUTY CORPORATION, Chita Factory | ISO 22716 （cosmetics materials GMP） |
JPO4609 | March 2024 | |
| Nichiyu Techno Co.,Ltd. | ISO 9001 | JP024473 | February 2024 | |
| NIKKA COATING | ISO 9001 | 3357 | January 2022 | |
| Changshu NOF Chemical Co., Ltd. | ISO 9001 | CN20/21619 | January 2024 | |
| PT.NOF MAS CHEMICAL INDUSTRIES | ISO 9001 | ID00/18019 | April 2023 | |
| NOF METAL COATINGS NORTH AMERICA INC. |
ISO 9001 | 66561- IS8 | July 2023 | |
| NOF METAL COATINGS EUROPE S.A. | ISO 9001 | BR040177 | December 2023 | |
| NOF METAL COATINGS EUROPE N.V. | ISO 9001 | 10477422 | November 2022 | |
| NOF METAL COATINGS KOREA CO.,LTD | IATF 16949 | RTS0250 | November 2023 | |
| NOF METAL COATINGS SOUTH AMERICA IND.E COM.LTDA. |
ISO 9001 | N° 1994/2984.9 | December 2023 | |
| NOF METAL COATINGS SHANGHAI CO., LTD. | ISO 9001 | 016SH22Q33019 R3S |
September 2023 | |
(production volume basis)
《FY2023》Domestic Group：98％、 NOF Group：97％
Approach to pharmaceutical-related products
NOF currently handles pharmaceutical-related products based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (“Pharmaceuticals and Medical Devices Act”), and has obtained the various business licenses listed below. In order to properly carry out these licensed business operations, the Pharmaceutical Management Task Force has been established under the Quality Management Committee to appropriately manage medical supplies.
｜Licensing status of pharmaceutical-related products| Marketing | Second-class marketing license for pharmaceuticals | NOF |
| Marketing license for quasipharmaceutical products | NOF | |
| Sales | Wholesale pharmaceutical sales | NOF |
| Manufacturing | Pharmaceutical manufacturing | Kawasaki Works Aichi Works, Taketoyo Plant Amagasaki Plant |
Policy
| Basic Policy on Pharmaceutical-Related Products |
|---|
| Based on our Corporate Philosophy which states, “The NOF Group is dedicated to contributing to humanity and society as a corporate group that creates new value through the power of chemistry, from the biosphere to outer space,” NOF is developing pharmaceutical-related business that ensures high quality, reliability, and safety to all stakeholders, under our governance system that ensures thorough compliance with laws and regulations. |
Pharmaceutical management system
Based on the aim of the Act Partially Amending the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 63 of 2019, “Amended Pharmaceuticals and Medical Devices Act”), the officers with responsibility for pharmaceutical-related operations are clearly stated in the pharmaceutical management system. In addition, in accordance with the provisions of the Act, for marketing (second-class marketing license for pharmaceuticals, marketing license for quasi-pharmaceutical products), a general marketing manager, a quality assurance manager, and a safety management manager are appointed.
As a specialized task force of the Quality Management Committee, a deliberative body, NOF established the Pharmaceutical Management Task Force to oversee the pharmaceutical-related business of the entire company and to manage the manufacturing, marketing, and wholesaling in an integrated manner. The Pharmaceutical Management Task Force inspects the status of compliance with GQP, GVP, and GMP ordinances, and operates to ensure that the general marketing manager, manufacturing manager, and others provide appropriate opinions to the responsible officers regarding issues and problems related to legal compliance.
At NOF, all persons involved in pharmaceuticals take the required training every year.
Responsible officers：
Take the pharmaceuticals-related training (once per year)
People involved in pharmaceutical-related operations：
Take training based on GQP, GVP, and GMP ministerial ordinances as needed
After the training, a record is made and stored for use in the next fiscal year’s training plan to ensure continued acquisition of the necessary knowledge.
Risks and Opportunities
Quality targets：Zero serious complaints or inappropriate incidentsKey issue：Ensuring proper quality management at the NOF Group
｜Risks and opportunities in quality assurance
| Major risk | Risk description | Opportunities | Major activities |
|---|---|---|---|
| Quality fraud | ● Loss of public trust and damage to corporate value due to quality problems such as falsification of quality inspection results | ● Continuous improvement of quality management throughout the company and Group, and earning social trust through fair corporate activities | In 2023, we established a new Code of Conduct and issued a Message from the President to implement specific actions in accordance with the Corporate Philosophy, which defines the mission and ideal state of
the NOF Group, and the three values that are prioritized in implementing the Corporate Philosophy: Challenges, Fairness, and Harmony. ［Thoroughly ensuring proper quality management］ ●Development of a quality policy to “provide the highest quality products and services” ● Raise awareness and educate employees through compliance manuals, etc. ● Quality inspections and periodic surveys ● Thorough prevention of recurrence and horizontal development through reporting of quality anomalies (serious cases) ● Promotion of automation of quality management and inspections (creation of a system that prevents fraud and falsification, etc.) |
| Quality defects and product problems | ● Loss of customer trust due to quality anomalies causing delivery delays to customers or quality anomalies in customer products | ● Gain customer trust through quality improvement and a proven track record |