Planning for a Supplier AuditIt is recommended to follow a risk-based approach to supplier audits, which should account for the established supplier audit methodology. Supplier audits interpret risk by identifying the applicable requirements and ensuring communication with the supplier’s management

Criteria for Supplier Audit Evaluation:1. Critical DefectsDefects identified in the quality system that would result in regulatory authorities determining that the system has collapsed, is not in a "controlled state," and/or would result in a high risk of products on the market or released to the ma

Supplier Audit Process:1. Qualification of Audit PersonnelAudit personnel consist of the audit team leader and auditors. The audit team leader is responsible for overseeing all activities throughout the audit process. The QA department selects the audit team leader and auditors based on requirements