P
pbell0000
Is quarterly dose verification (for e-beam) an on-going monitoring requirement or must be performed prior to release of product? Problem is dose verification takes a month (one week to build product, three weeks to get test results), not exactly a quick test. This came up in a recent audit and ISO 11137-1 and -2 were sited.
If its a requirement of release, how do people handle this requirement logistically? Can you build product and test one month before the quarter starts, proving out the next three months? Being unable to build "on demand" a third of the time sucks big time.
Any help appreciated.
If its a requirement of release, how do people handle this requirement logistically? Can you build product and test one month before the quarter starts, proving out the next three months? Being unable to build "on demand" a third of the time sucks big time.
Any help appreciated.
