PSCI audit promotes sustainable development of the pharmaceutical industry

PSCI is a leading association of pharmaceutical and healthcare companies. Provide a responsible value chain through its three impact modes - audit, capability, and project - as one voice. PSCI was established as a project among six founding members in 2006 and was legally established as a non-profit member organization in the United States in 2013.

PSCI's vision is to achieve outstanding safety, environmental, and social outcomes in theglobal pharmaceutical and healthcare value chain.

The purpose of PSCI is industry collaboration, using one voice to define, instill, and drive responsible value chain practices.

PSCI Supply Chain Management Principles

PSCI has established the principles of responsible supply chain management to clarify industry expectations for the supply chain. These principles involve five responsible areas of business practice: ethics, labor, health and safety, environment, and management systems.

In each field, this principle sets out the relevant practices that any enterprise in the pharmaceutical supply chain should adhere to. All members should support these principles and incorporate them into key supplier documents and agreements.

Governance and management systems: culture, commitment, and accountability; Legal and customer requirements; Risk management; Traceability and control; Training and skills; Documents; Continuous improvement; Emergency preparedness and response; Appeal mechanism; Response and remedy; Effective communication.

Moral Code: Patient Safety and Information Access; Anti bribery and anti-corruption; Fair competition; Animal welfare; Data privacy and security; Avoidance and management of conflicts of interest; Product protection and quality.

Human rights: free choice of work; Child labor and young workers; Non discrimination; Fair treatment; Salary, benefits, and working hours; Freedom of association and collective bargaining rights; Local community.

Health and safety: the safety of the work environment; Worker protection, health, and welfare; Process safety.

Environment: Environmental authorization and reporting; Management of waste and emissions; Climate change; Resource efficiency; Biodiversity conservation; Prevent leakage and release.

PSCI audit

The PSCI audit model, self-assessment questionnaire, and supporting tools are recognized social and EHS supplier evaluation frameworks in the pharmaceutical and healthcare industries. The PSCI audit aims to evaluate the performance of suppliers based on PSCI principles, international standards and agreements, as well as local regulatory requirements in areas such as ethics, labor and human rights, health and safety, environment, and management systems.

Audit process

1. Pre audit activity announcement and preparation

2. PSCI audit execution

3. PSCI audit report and CAP (Corrective Action Plan)

4. Sharing of PSCI audit reports and related documents

5. Follow up on CAP

Three audit methods

1. Complete remote audit: The entire audit, including the verification of problem responses in SAQ, is verified through remote methods such as live streaming videos, phone/video calls, etc.

2. Partial remote audit: Some audits are conducted remotely, while others are conducted on-site.

3. On site audit: Review and verify the answers to SAQ questions through on-site visits.

The objectives of the PSCI audit plan

1. By sharing structured audit information, we aim to avoid duplicate audits of suppliersas much as possible, thereby improving the efficiency of suppliers and PSCI member companies;

2. Provide consistent methods for supplier performance evaluation based on PSCI principles, international standards and agreements, and local legal requirements;

3. Obtain an audit report (including CAP) that helps suppliers understand their performance and improvement potential, while serving as a source of information for PSCI member companies, evaluating their business relationships with suppliers, and independently deciding on further actions to be taken.

4. Collect and evaluate data to form and further improve the PSCI supplier capacity building plan.