N
NHopkins
Need some guidance here, I'm routing my question through ISO due to the overwhelming amount of experience in it and will translate that over to API requirements after. Thanks in advance for any assistance.
ISO 7.5.2, Validation of processes.
In this section it states:
7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output
cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become
apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
The organization shall establish arrangements for these processes including, as applicable,
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures
My auditor is telling me that this (which is basically the same in API Q1) means that I should be referencing all of my critical suppliers procedures (our critical suppliers being fabrication/machining/paint/NDE/Calibration services) on my purchase orders...Is that accurate? We send a quality plan and or a specification to work to along with the purchase order and the PO references all of that info. Seems allot of time would be invested in getting the supplier to tell you what internal procedure they're going to use...
Thanks again,
N
ISO 7.5.2, Validation of processes.
In this section it states:
7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output
cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become
apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
The organization shall establish arrangements for these processes including, as applicable,
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures
My auditor is telling me that this (which is basically the same in API Q1) means that I should be referencing all of my critical suppliers procedures (our critical suppliers being fabrication/machining/paint/NDE/Calibration services) on my purchase orders...Is that accurate? We send a quality plan and or a specification to work to along with the purchase order and the PO references all of that info. Seems allot of time would be invested in getting the supplier to tell you what internal procedure they're going to use...
Thanks again,
N