To prepare for an audit, the supplier is given key information, such as purpose, duration (usually 1-3 days on site with 2 auditors), agenda proposal, and a list of documents needed for the audit. The supplier is also asked to complete the Self-Assessment Questionnaire (SAQ).
Taking part in a PSCI Audit
A clear process has been defined to ensure PSCI Audits are consistent and rigorous. A suite of tools are available to support and guide through the process.
Key Audit Resources
The PSCI has developed guidance tools tailored for our industry for assessing performance and risk.
For auditing purposes, suppliers are categorized according to their activities: A - service providers, B - component & material suppliers, C - core suppliers & contract manufacturers.
For A suppliers, the abbreviated PSCI Self-Assessment Questionnaire (SAQ) and Audit Report Template are used, as these supplier have less complex operations and requirements, especially in health, safety and environment. For B and C suppliers, the full PSCI SAQ and Audit Report Template should be used due to the complexity of their operations and requirements in all areas.
How To Get Started
PSCI Audits may be initiated by PSCI members or suppliers. Members will invite a supplier to participate in an audit and provide them with the information they need to get started. Suppliers cam make their own request to be audited according to our Audit Framework by asking a member to sponsor their audit or by nominating themselves to the PSCI Secretariat under the self-paid model.
What's In Scope
PSCI Audits generally consider all or part of the pillars described in the PSCI Principles (i.e. Ethics, Labor & Human Rights, Health & Safety, Environment and Management Systems) and in the PSCI Audit Guidance.
The audit will typically cover a clearly defined supplier location (e.g. a pharmaceutical or chemical production site, a warehouse, an R&D site, or an office building). It covers all internal and external areas of the facility, such as key production areas, laboratories, storage areas, utilities, infrastructure areas, waste handling and storage facilities, waste water treatment units, workshops, security and fire service arrangements, canteens, kitchens, dormitories and office areas.
Our 5-step audit process outlines exactly what is involved in a PSCI Audit:
The audit itself will include the following stages:
- Opening meeting
- Site tour
- Interviews with management and employees
- Review of documents and records
- Pre-closing meeting
- Closing meeting, including final wrap-up
After the on-site audit, the audit will be documented in a standardized PSCI Audit Report Template, which includes: an overview of the audited facility, the completed questionnaire and a summary of positive and negative findings.
The Corrective Action Plan (CAP) contains all findings and their proposed corrective actions (including timeframes for completion), agreed upon by the auditor and the supplier.
As outlined in the PSCI Audit Guidance, the supplier may choose to share the audit documents with either all current and future PSCI members, or just with selected PSCI members. The first option is strongly recommended, as it maximizes the benefits both for suppliers and PSCI member companies. Furthermore, the supplier may choose to share digitally via our audit sharing platform (preferred) or using the PSCI Data Sharing Agreement
The supplier is responsible for correcting any findings listed in the CAP and must provide appropriate supporting documentation on the implementation of any corrective action.
Depending on the type of audit findings, a follow-up audit might be necessary to verify if adequate corrective actions have been taken in response to an audit finding.