O
omartinez
Guys I got I need a lityle help :
I did answer some NADCAP NC and get rejected by the auditor :
Here is the finding
Per AC 7108 Rev. F sections 3.10-3.10.1-a., 5.11.1 & AC 7108/2 Rev. B section 4.10.1 all shop equipment used to set, control or monitor the control of a process is to be calibrated and in this facility's calibration/recall system. All timers are to be available, suitable to the purpose, calibrated and visible or audible from the processing or testing area.
When the operators performed the process for the internally generated 10 seconds time period there was no timer used to ensure that the 10 seconds that process t was perform for this prescribed time. (adequacy)
My response was :
Immediate Corrective action
Procedure has been modified to ensure the use a calibrated Timer.
Personnel involved the process were trained to this new requirement.
Root Cause
The 10 seconds time requirement for the process is attached to our spec, but there?s no specific requirement into the procedure in order to use an available and calibrated timer.
Preventive action
Procedure has been reviewed to declare all the equipment needed for the monitoring of the process variables as Temperature, Time, Conductivity, TDS, pH
Procdure has been reviewed to include AC7108 & AC7108/2 as documents that will be reviewed. The responsibility of doing these revisions has been attached to the procedure
Manufacturing & Specials Process Engineers has been trained into new changes.
I found those as a Root Cause but got rejected Could you please help to clarify what exactly the auditor would like to see ?
I did answer some NADCAP NC and get rejected by the auditor :
Here is the finding
Per AC 7108 Rev. F sections 3.10-3.10.1-a., 5.11.1 & AC 7108/2 Rev. B section 4.10.1 all shop equipment used to set, control or monitor the control of a process is to be calibrated and in this facility's calibration/recall system. All timers are to be available, suitable to the purpose, calibrated and visible or audible from the processing or testing area.
When the operators performed the process for the internally generated 10 seconds time period there was no timer used to ensure that the 10 seconds that process t was perform for this prescribed time. (adequacy)
My response was :
Immediate Corrective action
Procedure has been modified to ensure the use a calibrated Timer.
Personnel involved the process were trained to this new requirement.
Root Cause
The 10 seconds time requirement for the process is attached to our spec, but there?s no specific requirement into the procedure in order to use an available and calibrated timer.
Preventive action
Procedure has been reviewed to declare all the equipment needed for the monitoring of the process variables as Temperature, Time, Conductivity, TDS, pH
Procdure has been reviewed to include AC7108 & AC7108/2 as documents that will be reviewed. The responsibility of doing these revisions has been attached to the procedure
Manufacturing & Specials Process Engineers has been trained into new changes.
I found those as a Root Cause but got rejected Could you please help to clarify what exactly the auditor would like to see ?