Common use of CONTROL PLAN Clause in Contracts

CONTROL PLAN. ▇▇▇▇▇ shall collaborate with Medtronic to ensure a thorough understanding and identification of critical process steps, transfer function relationships, acceptable measurement capability and process capability of process input/outputs as to their impact on the critical features. ▇▇▇▇▇ shall collaborate with Medtronic to design an appropriate Control Plan that will ensure the long term stability and capability of the Manufacturing processes. At the time of Qualification, ▇▇▇▇▇ shall incorporate the foregoing into a Control Plan which will be mutually agreed upon and approved by Medtronic. ▇▇▇▇▇ shall provide a measurement system analysis (e.g. gage repeatability and reproducibility, gage to part ratio), for each measurement process utilized in the Control Plan. These analyses and Control Plans will be filed with ▇▇▇▇▇ with a copy to Medtronic. On an ongoing basis, ▇▇▇▇▇ will monitor production and complete inspection of each Lot/batch per the Control Plan to ensure conformance. ▇▇▇▇▇ will include a Certificate of Conformance for each Lot/batch based on conformance to the Control Plan.

CONTROL PLAN. ▇M▇▇▇▇ shall collaborate with Medtronic to ensure a thorough understanding and identification of critical process steps, transfer function relationships, acceptable measurement capability and process capability of process input/outputs as to their impact on the critical features. ▇M▇▇▇▇ shall collaborate with Medtronic to design an appropriate Control Plan that will ensure the long term stability and capability of the Manufacturing processes. At the time of Qualification, ▇M▇▇▇▇ shall incorporate the foregoing into a Control Plan which will be mutually agreed upon and approved by Medtronic. ▇M▇▇▇▇ shall provide a measurement system analysis (e.g. gage repeatability and reproducibility, gage to part ratio), for each measurement process utilized in the Control Plan. These analyses and Control Plans will be filed with ▇M▇▇▇▇ with a copy to Medtronic. On an ongoing basis, ▇M▇▇▇▇ will monitor production and complete inspection of each Lot/batch per the Control Plan to ensure conformance. ▇M▇▇▇▇ will include a Certificate of Conformance for each Lot/batch based on conformance to the Control Plan.