Purchasing and Supplier Controls

Supplier qualification

MO 169 requires that purchasing controls ensure that purchased products and services conform to specified requirements. The extent of supplier control depends on the effect of the purchased product or service on device quality.

Suppliers of critical components and services must be evaluated and selected on the basis of their ability to supply conforming products. The criteria for evaluation, selection, and re-evaluation must be established and records maintained.

Purchasing information

Purchasing documents must describe the product to be purchased, including requirements for approval, qualification, and quality system requirements where applicable. Before release, purchasing documents must be reviewed and approved.

Incoming inspection

Receiving inspection activities must verify that purchased products conform to requirements. The extent of inspection is proportional to the supplier's established performance and the criticality of the component.

Outsourced process control

The MAH and manufacturer must maintain control of all outsourced processes that affect product quality — including contract manufacturing, sterilization, testing laboratories, labeling, packaging, and other outsourced activities. The type and extent of control applied (supplier qualification, incoming verification, audit frequency, quality agreement requirements) must be defined in the QMS. Outsourcing does not remove the MAH's or manufacturer's regulatory responsibility, and outsourced sites must comply with MO 169 requirements.

Supplier qualification

Supplier changes and re-qualification. Any change in the supplier of a critical component or service must be treated as a change to the QMS. The new supplier must be evaluated and qualified using the same criteria as the original supplier. Re-qualification records must demonstrate that the new supplier's process produces components equivalent to the previous supplier.