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Strengthening of Nissan Group's business base

Improvement of Products Quality


Our Quality Policy is "Providing products and services that satisfy customers". Based on this policy, we set mid-term quality targets and KPIs for materiality, and are working on quality activities. In addition, we are continuously improving our management system and operations every year by implementing an annual plan in line with PDCA cycle.

We will continue to strengthen our ability to respond to increasingly diversified and sophisticated market demand and aim for further growth as a company that contributes to society.

PDCA in Quality Assurance

Quality Policy

"Providing products and services that satisfy customers"

Quality Target (Achieving Quality Policy)

  • Elimination of Quality Risks with Through Governance
  • Logistics and Supplier Management to Maximize Quality Performance
  • Visualization of Quality Management and Quality Activities that Leads to Enhancement of Corporate Value

Materiality; Efforts to Improve Product-quality and KPIs

  • Prevention of Serious Complaints: Zero Cases of Serious Complaints
  • Prevention of Quality Fraud and Data Tampering: Attendance Rate of Quality Education of at Least 90%


Our quality assurance management system is based on ISO9001 (QMS). Each plant has acquired ISO9001 certification, and continue to maintain and update their certification through the certifying body.

We have established a quality assurance division at each plant that is independent of the manufacturing divisions. Each quality assurance division is responsible for inspecting the quality of each product. Furthermore the quality assurance division of the head office conducts quality audits to each plant and affiliate.

The Quality Assurance Committee is held regularly as an organization to promote quality assurance activities on a company-wide basis. In the committee, the results of our activities and our affiliates activities, the results of quality audits and the status of improvements, and complaints and status of corrective actions are reported. The committee discusses the policies for activities of quality assurance for next year. Contents of the discussions are reported to the Board of Directors meeting, and quality management systems are in place under management review.

  • An international standard on quality management system


Number of complaint cases

Classification FY2020 FY2021 FY2022
Functional or Ingredient 7 5 4
Foreign-substance 5 3 3
Packaging 20 20 13
Delivery 11 3 12

Number of complaint cases

Number of complaint cases: A same kind of complaints is counted as one case.

Number of complaint cases: A same kind of complaints is counted as one case.

In FY2020, the number of complaints cases increased, therefore we conducted improvement activities focusing change control in product manufacturing and product design. As a result, the number of complaints cases have decreased slightly since FY2021. The percentage of complaints attributable to contract logistic suppliers, such as packing and delivery, remains high.

The numbers of serious complaints have been decline, with three cases in FY2020, two cases in FY2021, and one case in FY2022. In FY2023, we aim to achieve zero case.


Prevention of Quality Fraud and Data Tampering

In FY2020, we established the guidelines aimed to prevent fraud and tampering regarding quality control of products for sales, and started it under operation. In FY2021, we confirmed the status of operations through internal audits. In recent years, due to becoming a major social issue regarding quality fraud and data tampering of inspection data. Therefore, in FY2021 and FY2022, we confirmed the consistency of inspection results, inspection data, the basis of the specification, manufacturing records, registration matter like approval document and quality agreements with customers. No fraud and inconsistency were found, and we provided guidance for improvement regarding minor deficiencies and potential risks.

In addition, each plant is working to develop a framework that is less likely to cause errors, fraud, or tampering by reducing manual operations and work, and by enhancing data integrity through the introduction of laboratory information management system (LIMS), etc.

Quality Assurance of Data at the Laboratories

Biological Research Laboratories is confirmed for compliance by the Ministry of Agriculture, Forestry and Fisheries as a testing facility capable of filing data for the application for registration of agrochemicals. In addition, Chemical Research Laboratories and Biological Research Laboratories prepare documents for pharmaceutical application in accordance with the standards established by the Ministry of Health, Labour and Welfare. The quality assurance department located in the head office, which is highly independent, audits these data to create highly reliable application documents to enable to submit them to regulatory authorities.

Fostering Quality Culture

We established the “Quality Behavior Model” in FY2021 with the purpose of enhancing the quality of employee behavior and improving corporate quality. In FY2022, we did in-house education on “Non-conformity on Quality” for whole company. And aim to reduce the quality risk due to “Changes”, we provide the education program on “Change control” for our all business departments and plants. We will continue the in-house educations focused on “Quality compliance” for whole company.

Logistic and Supplier Management

Not only the quality of the products themselves, we also interpret packaging, transportation, attached documents, and demonstration of function at customers as parts of our products, and aim for total quality assurance.

Our abnormal quality is attributable to a high percentage of packaging and transportation work process, however human errors do not easily decrease by the review of work methods and training of workers. We will analyze abnormal cases, share improvement targets with the contract logistic suppliers, and work to improve them.

In addition, we established the internal guideline for the management of our suppliers including contract manufacturers of our products. And we manage suppliers conducting quality audits based on the guideline.

Response to Regulatory Authorities

We obtained various pharmaceutical-related business licenses and are subject to the U.S. Food and Drug Administration (FDA) inspections, the Pharmaceuticals and Medical Devices Agency (PMDA) inspections, and prefectural agency inspections to ensure that our quality assurance system for pharmaceutical products meets regulatory requirements.

Internal Network of Product-quality Intelligence

We established the corporate network to collect and evaluate customer’s complaints for our products promptly and take necessary corrective actions. Customer feedbacks are promptly communicated to the sales, manufacturing, and quality control divisions through this network to enable response to customers and quality improvements.

In FY2023, we introduced the new company-wide quality-information system that unifies, in addition to customer’s complaints management, the management of documents related to quality, all internal quality problems, corrective & preventive actions and supplier information, and transferred from our previous systems. We will continue to make further improvements to provide customers with safer, higher-quality products in the future.

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