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PSCI Audit Program

PSCI Audit Program

Enabling you to demonstrate responsible supply chain management and conformance with the PSCI principles

In the pharmaceutical industry, PSCI principles are increasingly recognized as the social and ethical standard for supply chain management. Proving conformance with these five principles governing ethics, working conditions, health and safety, environmental protection and management systems can boost your company’s position in the field.

As a global approved audit service provider of the Pharmaceutical Supply Chain Initiative, our experience is wide-ranging, giving us the expertise to partner effectively with companies throughout the pharmaceutical industry, including yours.

Make an appointment with us to initiate the PSCI auditing process in your company.

Our PSCI audit program stands for ethical practices and provides the tools for meeting industry expectations

PSCI Principles | TÜV Rheinland PSCI audit program
Our auditing services are based on the 5 PSCI principles.

In an industry where health, safety and environmental concerns are defining the future, undergoing a PSCI audit is a clear signal to your business partners that your company prioritizes responsible practices and effective supply chain management. Our auditing services give you access to qualified, experienced audit teams around the world and ensure transparency in the auditing process. It’s a proven way to build trust among organizations active in the pharmaceutical industry, and enables your company to communicate the values it stands for.

There are internal benefits as well. A PSCI audit pinpoints concrete risks along the supply chain and can identify and prioritize areas for improvement. It can lead to better awareness of both international and local regulations and industry expectations. By proving that you meet PSCI standards, you can qualify as a supplier to the industry, and members of the Pharmaceutical Supply Chain Initiative trust the PSCI supplier database to find reliable partners.

Our PSCI audit program

We conduct PSCI audits throughout the entire supply chain of international sourcing companies and for individual suppliers. Managed by a dedicated project team, we offer continuous and transparent reporting as well as central invoicing. To get started, contact us directly.

There is a 3-phase audit process, beginning with a pre-audit phase, continuing with the on-site audit and concluding with the post-audit phase. For large audit programs, status tracking is part of our transparent, holistic reporting process. It includes:

  • Periodically updated tracking-lists for a clear overview and efficient control of the audit process.
  • Periodic status-calls to ensure close communication between clients and our global project management.

As its global approved audit service provider, the PSCI trusts us and so can you

The Pharmaceutical Supply Chain Initiative recognizes our expertise in conducting social and ethical and health, safety, and environment (HSE) audits. We have already conducted more than 400 PSCI audits in over 50 countries, and we continue to work closely with pharmaceutical companies, suppliers and PSCI members to promote better social, economic, health and safety and environmental outcomes.

Our central project management and global project structure is a one-stop shop and guarantees high process quality at the same time. Our auditors are highly qualified and experienced in CSR, and HSE and undergo continuous professional development.

Make an appointment now! We look forward to showing you how a PSCI audit can benefit your company.

What you should know about the PSCI initiative and audit program

1. What does PSCI stand for?
The Pharmaceutical Supply Chain Initiative (PSCI) is a nonprofit membership organization formed by a group of major pharmaceutical companies that share a vision of better social, economic, and environmental outcomes for all those involved in this industry. To get started, contact us directly or reach a PSCI member company.

2. What is the PSCI audit program?
The PSCI audit program is a unique opportunity for suppliers to demonstrate conformity with sustainability standards in the pharmaceutical industry. The PSCI principles are an increasingly important criterion for the selection of suppliers. TÜV Rheinland is globally approved as an audit service provider of the PSCI initiative, and so our audit reports are recognized by 18 large international pharmaceutical producers.

3. What are PSCI principles?
The PSCI audit program is designed to assess a supplier’s performance against the PSCI principles as well as against international standards and agreements, and local regulatory requirements in the areas of ethics, labor, health and safety, environmental protection, and management systems. The PSCI principles are consistent with industry expectations and applicable both in developed and developing countries for all suppliers in the pharmaceutical and healthcare supply chain.

PSCI audit process flowchart | TÜV Rheinland
The PSCI audit process consists of 3 phases: the pre-audit, the on-site audit, and the post-audit.

4. What does a PSCI audit include?
Central project management and local scheduling of audits with client and suppliers are focused on under the initiative. The audit process consists of three phases: the pre-audit, the on-site audit, and the post-audit. Audit status tracking for PSCI members is an essential part of a transparent and holistic reporting process. Periodically sent tracking-lists give clients a better overview and more efficient control of the audit process. Additionally, periodic status-calls ensure close and clear communication between client and global project management.

5. Who benefits from the PSCI audit program?
The PSCI audit program is especially important for three specific groups. Firstly, global supply chain audits carried out by experienced and qualified auditor teams can benefit pharmaceutical producers and companies. Regular project communication and reports ensure maximum transparency on progress.

Secondly, pharmaceutical suppliers that undergo an audit can demonstrate conformance with the PSCI principles. Audits give suppliers the opportunity to develop their expertise, identify and solve social, environmental and ethical issues, and thus meet industry expectations.

Thirdly, audits strengthen credibility, integrity and drive leadership practices at PSCI member companies by enabling continuous improvement throughout the supply chain. Member access to a supplier database and shared audits help reduce audit costs and efforts.

6. How does a PSCI audit benefit clients?

Auditing facilitates decision-making regarding supplier acceptability. Companies can actively qualify as suppliers and distinguish themselves from competitors. Risks connected with the way on site operations can be identified and prioritized. Furthermore, supplier companies are educated about requirements and regulatory expectations. As a result of auditing, trust with customers and business partners is built through access to information, transparency and accountability.

7. Can a supplier voluntarily request to be audited according to the PSCI audit standard?

Yes. As a PSCI approved third party audit company, suppliers can contact us to initiate an audit. We will submit a quotation, and subsequently plan and execute the audit and provide the final PSCI audit report and corrective action plan to the supplier. The audited company can share the PSCI Audit Report with all PSCI members by providing submitting a signed Data Sharing Agreement.

It is also possible to contact any PSCI member company and ask them to sponsor an audit. Alternatively, a company may nominate themselves to the PSCI Secretary requesting that they be audited under the self-paid model. The PSCI Secretary will then inform them about PSCI Shared Audit processes and provide a list of PSCI approved third party audit companies.

8. What is a SHE or HSE audit?
The label Safety, Health and Environment (SHE) is often interchangeably used for Health, Safety and Environmental (HSE) audits. SHE management systems and HSE audits aim to protect employees, the public, and the environment by complying with applicable laws and guidelines, which in turn build customer trust in the company. Such programs seek to prevent incidents resulting from abnormal operating conditions and reduce risk posed by normal operating conditions in industrial contexts.

9. What is a CSR or social / ethical audit?

Corporate social responsibility, or CSR is a form of corporate self-regulation integrated into a business model. CSR includes social and environmental guidelines to advise companies on the best way and practices to treat stakeholders such as customers, employees or business partners. A CSR audit helps assess a company‘s performance on social, ethical and environmental objectives through scalable and measurable criteria.

10. What do the PSCI audit and HSE audit have in common?
An HSE auditor is present during a PSCI audit. He has the necessary experience and qualification relevant to the type of supplier being audited and are knowledgeable in key local and national HSE regulations as well as in international standards (e.g. ISO 14001, OHSAS 18001). A PSCI audit also requires inspection by a Corporate Social Responsibility (CSR) auditor, who ensures sustainable development that goes beyond compliance requirements.

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