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Quality

Otsuka’s approach to product quality extends beyond safety and security in manufacturing. Striving also to enhance the quality of its social initiatives, the group is focused on a broad range of activities, from information transparency and disclosure to working with suppliers and other collaborators, respecting local communities, and ensuring compliance with regulations.

Risk Management

In order to fulfill its social responsibilities as a healthcare company, the Otsuka group works to manage risks under normal conditions and prepares to continue operations safely even at times of disaster or emergency.

BCP and BCM Establishment

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Otsuka Pharmaceutical Factory: Full-circumference seawall installed at Matsushige Factory

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Otsuka Pharmaceutical Factory: Emergency LED lights along evacuation routes and at evacuation sites automatically turn on during a power outage.

The Otsuka group has business continuity plans (BCP) in place to ensure that the group continues to operate as effectively as possible and is able to maintain a stable supply of its products, even when large-scale earthquakes and disasters strike.
Major Otsuka group companies such as Otsuka Pharmaceutical, Otsuka Pharmaceutical Factory, Taiho Pharmaceutical, and Otsuka Warehouse have jointly acquired ISO 22301 certification (the international standard for business continuity management systems). This certification verifies that the Otsuka group provides a framework capable of ensuring the stable supply of pharmaceuticals, food products, and beverages in both ordinary and emergency conditions. In 2016, major Otsuka group companies conducted joint desktop exercises simulating a severe earthquake along the Nankai Trough. Company offices in Tokushima, Tokyo, and Osaka communicated via video conferencing to test the group’s collaborative structure for ensuring a stable supply of products under simulated conditions, and results were extremely close to projected scenarios.
As a manufacturer of the IV solutions that would be especially required for initial treatment when an emergency situation occurs, Otsuka Pharmaceutical Factory has designated business continuity management (BCM) as a key management strategy. The company has enacted basic BCM rules and implements a variety of measures to preempt risk factors and limit damage should an unavoidable crisis occur. Otsuka Pharmaceutical Factory does not focus exclusively on its own BCM. The measures the company implements encompass the entire group to forge a united front on risk management. The company works with companies in the Otsuka group that distribute and sell its products, holding regular BCP meetings to address risks associated with Otsuka Pharmaceutical Factory business activities.
In May 2016, Taiho Pharmaceutical acquired ISO 22301 certification, which verifies that the company provides a framework capable of ensuring the stable supply of anticancer drugs. This follows certification in 2015 of Otsuka Pharmaceutical Factory’s framework for guaranteeing a stable supply of IV solutions, effectively strengthening the Otsuka group’s overall capacity for business continuity.
Otsuka Techno has developed crisis management plans (BCP/BCM) to address the potential of a severe earthquake along the Nankai Trough and other major disasters. As part of its efforts to assist employees during emergencies, the company has distributed and stored emergency water and food supplies at the Naruto head office and plant, the Wajiki plant, and the Tokyo office, as well as evacuation equipment at the Naruto head office and the Naruto and Wajiki plants.
Otsuka Electronics maintains stockpiles of emergency supplies at all of its business locations for employees who are unable to return home. These supplies are regularly checked and restocked as needed.
Otsuka group

Formulating BCP and BCM—EN Otsuka Pharmaceutical

With firsthand experience of the Great East Japan Earthquake in March 2011, EN Otsuka Pharmaceutical has enacted a business continuity plan (BCP) to ensure a stable supply of the enteral nutrition and medical foods it manufactures even during times of crisis. In fiscal 2016, the company conducted a BCP simulation focused on getting the emergency power supply system up and running following a disaster at the Hanamaki plant. The company also attended outside BCP seminars and participated in Otsuka group BCP meetings to test its emergency response and identify continuity issues. At the Workshop on Enteral Nutrition, an event that brings together the four companies involved in the manufacture and marketing of enteral nutrition, the company took the lead on compiling a disaster response manual addressing enteral nutrition products. EN Otsuka Pharmaceutical also contributes to initiatives designed to ensure the stable supply of these products, including sharing of information concerning the impact of earthquakes on the manufacture and distribution of enteral nutrition products.
EN Otsuka Pharmaceutical

Formulating BCP and BCM—Otsuka Chemical

Otsuka Chemical has formed a BCM Committee consisting of directors of the production, sales, quality assurance, materials, and administration divisions. The committee meets once every three months to review progress on BCP compliance and reports once a year to the Crisis Management Committee, chaired by the president, on its activities and upcoming fiscal year plans. The company’s BCP formulated in May 2011 has been revised to reflect the latest damage and injury projections for Tokushima in the event of a potential severe earthquake in the Nankai trough. In November 2016, the Otsuka group held a joint BCP simulation via video conferencing between offices in Tokushima, Tokyo, and Osaka. This simulation also focused on ensuring a stable supply of products in the event of an earthquake along the Nankai trough.
Otsuka Chemical

Information Security Initiatives

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The Otsuka group has formed the Otsuka Group Information Security Committee for the purpose of sharing the latest information on information security and reviewing specific security measures. Otsuka focuses on boosting the level of comprehensive security throughout the entire group and continuously improving the information security process.
In order to counter the risk of cyber-attack, the Otsuka group has a number of measures, such as inspecting security of systems, diagnosing website vulnerabilities, conducting drills related to targeted email attacks, and monitoring the content of social media messages, with outside security companies. In addition, the group conducts regular emergency drills focusing on systems that are vital to database management.
The Otsuka group has established a privacy protection management system to protect customers’ valuable personal information and has acquired PrivacyMark certification and Information Security Management System (ISMS) certification in businesses where this certification is relevant.
Individual Otsuka group companies are involved in various initiatives. Otsuka Foods attends the Group Information Security Conference, where it shares information regarding information security and the protection of personal information with other group companies. Continuing with efforts from the previous year, the company conducted additional e-learning programs in December 2016.
November is designated as compliance strengthening month, and Otsuka Electronics marked this month with e-learning courses for all employees to review the list of absolutely mandatory rules, provide a basic familiarity with compliance, and raise awareness of information security.
Otsuka group

Information Security Initiatives—Otsuka Pharmaceutical

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Otsuka Pharmaceutical: PrivacyMark

Otsuka Pharmaceutical has established an Information Security Committee to share the latest information on information security, review specific security measures, and oversee all departments on this issue. The committee meets regularly to look at ways to boost the level of comprehensive security across the company and continuously improve the information security process.
The Otsuka group has introduced a number of initiatives to counter the risk of cyber-attack, including drills on handling targeted email attacks and monitoring the content of social media messages. The company also monitors inappropriate usage via access to the usage logs for devices containing information, on the basis of a policy designed to prevent information leaks and similar incidents.
Additionally, Otsuka Pharmaceutical has established a privacy protection management system to protect customers’ valuable personal information and has acquired Information Security Management System PrivacyMark certification.
Otsuka Pharmaceutical

Information Security Initiatives—Otsuka Pharmaceutical Factory

Recognizing the importance of information security, Otsuka Pharmaceutical Factory implements information security training for new employees joining the company, whether new graduates or mid-career hires. Microsoft Office training and other IT courses are also offered to employees interested in improving their IT literacy. Employees in charge of information security in each division undergo regularly scheduled training sessions. In 2016, the company conducted drills on handling targeted email attacks, which have become common in recent years. Otsuka Pharmaceutical Factory also carries out information asset management. It regularly reviews document management ledgers and personal information management ledgers; inventories computers, USB memory sticks, and other devices; and reviews the status of information security compliance with regard to relevant data and devices.
Otsuka Pharmaceutical Factory

Information Security Initiatives—Otsuka Techno

Otsuka Techno aims to achieve both information system safety and convenient usability. To accomplish this, information system officers and employees in charge of information systems in each division work together to promote information security. The team develops rules to be applied across the company, educates employees on these rules, and works on installing equipment, software, and other devices. Once every three months, the officers in charge of information systems meet at the Naruto or Wajiki offices to formulate, introduce and execute company-wide policy on information security, as well as to discuss execution of group-wide initiatives.
Otsuka Techno

CSR Procurement/Green Procurement

Recognizing the importance of working with suppliers to implement sustainability initiatives, the Otsuka group is committed to socially responsible business throughout the entire value chain, including all of the companies it collaborates with. Broadly, these initiatives encompass compliance, environmental initiatives, and safety and security initiatives. When initiating business with a new company, the group conducts investigations and verifications to ensure the quality of raw materials and stable procurement. In addition, it signs a basic transaction agreement in advance in an effort to prevent risk.
The company asks suppliers for their understanding and cooperation on CSR procurement for purchased goods, as well, to ensure that the goods procured have the most impact on reducing the company’s environmental impact and to promote green procurement under a comprehensive framework.
EN Otsuka Pharmaceutical complies with Japan’s Subcontract Act and related laws and regulations when procuring raw materials. Company policy is to purposefully purchase from multiple sources in order to ensure stable and continuous procurement and effective BCP implementation. With regard to raw materials and packaging materials for pharmaceuticals, the company reuses the boxes in which raw materials are shipped; reduces packaging and uses lighter packaging materials; and promotes efficiency in truck shipment schedules in order to conserve energy and reduce CO2 emissions.
Otsuka Electronics, a company that manufactures and markets electronic devices globally, strives to maintain product quality and prevent defects globally. The company first signs a basic transaction agreement and evaluates the subcontractor (reviewing capacity and conducting other surveys), then fully verifies quality via spec sheets, approval diagrams and prototypes. The company procures and manufactures products compliant with EU standards (RoHS and WEEE directives, etc.) according to the regulations in place in the area to which they are exported.
Otsuka Pharmaceutical Factory conveys its environmental initiatives to the suppliers from which it purchases materials and asks them to offer ideas and provide environmentally-friendly products.
Otsuka group

Initiatives with Suppliers

The Otsuka group is committed to working and growing with suppliers whose operations are rooted in corporate social responsibility. It focuses on providing solutions for the issues that communities face through its suppliers and making sure that transactions do not cause social issues.
The Otsuka group enacted a group-wide procurement policy in 2016 and distributes a CSR procurement questionnaire to evaluate CSR activities within the supply chain. Working together with suppliers, the Otsuka group is determined to build relationships of even greater mutual trust by upholding its social responsibilities. This effort is based on ensuring a clear understanding throughout the supply chain of the current status of human rights, labor, environmental circumstances, and corruption prevention.
In order to ensure a stable supply of safe, quality products, each group company works with its suppliers to maintain and improve product quality, regularly monitoring the companies that supply raw materials to the Otsuka group. These companies are careful to maintain good business relations by communicating and sharing information on a daily basis.

Procurement Policy
1.Building Relationships of Trust
We respect all suppliers equally as valuable collaborators; conduct procurement transactions fairly, justly and transparently; and pursue mutually sustainable development as we build positive relationships of trust.

2.Stable Supply
We ensure the reliable level of quality that our customers expect; provide fair and honest opportunities for bidding by suppliers around the world that provide safe, quality, environmentally friendly, and cost competitive raw materials; and select the bid winners based on rational and fair criteria.

3.Product Development Ideas
We actively evaluate proposals for new materials, new technologies, and revolutionary ideas that will lead to new products.

4.Boosting Competitiveness
We aim for products that are optimal in every respect, not only optimal in certain respects. We evaluate all economically rational ideas for boosting competitiveness.

5.Environmental Measures, Human Rights, and Labor
We actively pursue initiatives that address corporate social responsibility and environmental issues, aiming to help build a sustainable society. At the same time, we support internationally recognized norms within the scope of our impact on respect for basic human rights, the elimination of forced labor, and the prevention of child labor, and we pursue initiatives toward these goals.

6.Protecting Confidentiality
We do not use confidential information from suppliers obtained in the course of doing business for any purpose other than the original purpose for which it was provided. We do not leak confidential information to third parties.

7.Promoting Compliance
We conduct our operations in accordance with socially accepted norms, complying with all relevant laws, rules, and regulations and upholding high ethical standards.

8.Risk Diversification
As a basic rule, we purchase major items from multiple companies to reduce risk and ensure that we deliver a stable supply of products to our customers regardless of weather, natural disasters, or other conditions.
Otsuka group
Quality
Safety Initiatives
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Safety Initiatives
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Listening to Customers —Taiho Pharmaceutical

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Listening to Stakeholders—Otsuka Pharmaceutical Factory

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Corporate Governance
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Basic Position on Corporate Governance

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Corporate Governance
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Corporate Governance Structure

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Compliance
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Promoting Compliance

The Otsuka group of companies formulates their own individual programs to p...

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Compliance
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Promoting Compliance—Otsuka Pharmaceutical Factory

Otsuka Pharmaceutical Factory has established the Otsuka Pharmaceutical Fac...

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Compliance
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Promoting Compliance—Otsuka Chemical

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Compliance
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Expanding the Internal Whistle-blowing System

Japan’s Corporate Governance Code calls for establishing a whistle-blowing ...

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Compliance
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Enhancing the Whistle-blowing System—Otsuka Pharmaceutical Factory

To maintain sound and highly transparent management, companies must create ...

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Compliance
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Implementing Otsuka Group-Wide Training—Global Code of Business Ethics and a Global Anti-Corruption Policy

In order to promote and achieve group-wide compliance under the banner of i...

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Risk Management
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BCP and BCM Establishment

The Otsuka group has business continuity plans (BCP) in place to ensure tha...

Quality
Risk Management
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Formulating BCP and BCM—EN Otsuka Pharmaceutical

With firsthand experience of the Great East Japan Earthquake in March 2011,...

Quality
Risk Management
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Formulating BCP and BCM—Otsuka Chemical

Otsuka Chemical has formed a BCM Committee consisting of directors of the p...

Quality
Risk Management
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Information Security Initiatives

The Otsuka group has formed the Otsuka Group Information Security Committee...

Quality
Risk Management
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Information Security Initiatives—Otsuka Pharmaceutical

Otsuka Pharmaceutical has established an Information Security Committee to ...

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Risk Management
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Information Security Initiatives—Otsuka Pharmaceutical Factory

Recognizing the importance of information security, Otsuka Pharmaceutical F...

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Risk Management
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Information Security Initiatives—Otsuka Techno

Otsuka Techno aims to achieve both information system safety and convenient...

Quality
Risk Management
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CSR Procurement/Green Procurement

Recognizing the importance of working with suppliers to implement sustainab...

Quality
Risk Management
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Initiatives with Suppliers

The Otsuka group is committed to working and growing with suppliers whose o...