A company recently received this 483 observation:
…. Potential suppliers were not evaluated and selected based on their ability to meet specified requirements.
Specifically, The SOP…, “Supplier Management and Approved Supplier List Criteria and Maintenance”, states that a quality agreement, audit, terms and conditions, and code of conduct are required for High ASL Risk Level suppliers.
There was no documentation showing that all requirements for High ASL risk level were completed prior to adding high risk suppliers to the approved supplier list. Section …, “Approved Supplier” requires verification that all activities are complete, documented and approved per the Supplier Addition/Change form and Section …, “Supplier Requirements”, requires a review of the supplier addition/change form and a check of all requirements needed to approve the suppler. During our review, multiple suppliers were approved as “High ASL Risk Level” suppliers without all of the requirements having been met.