Common use of Process Control Clause in Contracts

Process Control. Supplier shall control the quality and strive for the continuous improvement of its manufacturing processes and those of its subcontractors through the use of monitoring techniques and tools in Supplier’s reasonable business judgment, which may include: process-flows, Root Cause Analysis, capability studies, risk analysis, failure mode and effect analysis, reliability calculations, measurement system analysis, gage R&R studies, statistical process control (SPC), corrective actions and preventative actions, and process and product audits. Supplier shall establish and maintain a quality measurement system and quality analysis process as determined in Supplier’s reasonable business judgment, executed by appropriately skilled personnel. Supplier approach and results will be communicated to Distributor in a mutually agreed format on a quarterly basis. This report at minimum shall contain mutually agreed data, CAPA plans and results. Supplier will be fully responsible to ensure that all process changes affecting Products, including process or design changes, changes to manufacturing processes (including geographic location) changes affecting electrical performance, mechanical form or fit, function, environmental compatibility, chemical characteristics, life, reliability or quality of Products or changes that could have significant impact upon Supplier’s quality system will be in accordance with this Attachment. Supplier shall provide to its employees training courses to ensure that Supplier’s employees keep abreast of technical, regulatory and other developments as determined in Supplier’s reasonable business judgment.

Appears in 3 contracts

Sources: Distributor Agreement (Corindus Vascular Robotics, Inc.), Distributor Agreement (Corindus Vascular Robotics, Inc.), Distributor Agreement (Corindus Vascular Robotics, Inc.)