Corrective and Preventive Actions (CAPA). Quality deviations shall be recorded and analyzed by the Supplier to enable early detection of any concentration of errors. Recurring deficiencies and those that affect the requirements of the Customer shall be reported and remedied in accordance with the Supplier’s CAPA process. The CAPA report shall include details of containment, root-cause analysis, corrective and preventive actions implemented (or to be implemented with proposed implementation schedule) together with proof of effectiveness. Customer may issue a Supplier Corrective Action Request to the Supplier to formally report quality issues related to supplied material and request Supplier corrective action. The Supplier shall perform root-cause analysis and formally respond with proposed containment, corrective, and preventive actions.
Appears in 2 contracts
Sources: Supply Agreement (NeuroPace Inc), Supply Agreement (NeuroPace Inc)