M
Hi all,
Has anyone experienced the following scenario with unannounced audits?
We recently had our NB send 2 auditors to audit our OEM. Upon arrival at the manufacturing site, the auditors were told that the production of they device they intend to audit was already at the end stage (printing and packaging).
Because of this, they decided not to conduct the audit, had a brief look around the site and left.
Our NB then called and told us that they will need to re-audit the facility during active production of the medical device because the audit could not be completed, and the we will have to bear the cost.
This seems utterly ridiculous to us, because they could have at the very least checked on the documentation of the current production.
Any thoughts?
Has anyone experienced the following scenario with unannounced audits?
We recently had our NB send 2 auditors to audit our OEM. Upon arrival at the manufacturing site, the auditors were told that the production of they device they intend to audit was already at the end stage (printing and packaging).
Because of this, they decided not to conduct the audit, had a brief look around the site and left.
Our NB then called and told us that they will need to re-audit the facility during active production of the medical device because the audit could not be completed, and the we will have to bear the cost.
This seems utterly ridiculous to us, because they could have at the very least checked on the documentation of the current production.
Any thoughts?