Hi All,
I need a little help with a NC from a customer.
The finding was put against section 8.3.4 of ISO 9001:2015 which we exempt ourselves from. They requested we carry out a validation of a new machine back in 2015. the audit has since thrown up the following finding:
The Validation of the Hawkes machine (Atom) equipment in Control room 1 contains the following deficiencies:
Part 1: No protocol exists to define upfront the acceptance criteria for the validation or to describe and justify testing required or specify the sample size
Part 2: No deficiency report process exists to recognise and document appropriately any out of specification results reported during the validation activity
Part 3: Support print outs or data were not signed or dated. Original data was not attached to the report
Part 4: Validation of process procedure OP21 Rev. 01 reviewed and found to be not fit for purpose of driving effective protocols, contemporaneous data generation and reporting or a process for dealing with out of specification data
I can provide some limited info if required
Thanks
I need a little help with a NC from a customer.
The finding was put against section 8.3.4 of ISO 9001:2015 which we exempt ourselves from. They requested we carry out a validation of a new machine back in 2015. the audit has since thrown up the following finding:
The Validation of the Hawkes machine (Atom) equipment in Control room 1 contains the following deficiencies:
Part 1: No protocol exists to define upfront the acceptance criteria for the validation or to describe and justify testing required or specify the sample size
Part 2: No deficiency report process exists to recognise and document appropriately any out of specification results reported during the validation activity
Part 3: Support print outs or data were not signed or dated. Original data was not attached to the report
Part 4: Validation of process procedure OP21 Rev. 01 reviewed and found to be not fit for purpose of driving effective protocols, contemporaneous data generation and reporting or a process for dealing with out of specification data
I can provide some limited info if required
Thanks