performance qualificationの例文
- A vital component of process qualification is Process Performance Qualification Protocol.
- In addition to preparatory coursework, personnel are required to complete Performance Qualification Standards ( PQS ) common to all qualifying units as well as a PQS specific to the type unit assigned.
- One example of a scientifically sound statistical sampling and analytic plan is based on a binomial approach ( see Table 1 : Product Performance Qualification Criteria for the Platelet Component Collection Process ).
- This is done by executing a Component Qualification on the packaging components, an Operational Qualification to demonstrate that the process performs at the operational extremes and finally a Performance Qualification that demonstrates that what happens in the real world is within the limits of what was demonstrated in the Operational Qualification limits.