Anybody who has compiled a package of qualification documents from three or four separate OEMs has surely encountered the following problem.
Each OEM will have its own proprietary form of FAT protocol, its own definition of "critical" versus "non-critical" criteria, its own vocabulary of acceptance criteria and its own numbering system for the I/O points.
The FAT protocol of one OEM will call an interlock "Safety Interlock 4" while the I/O list of the automation integrator will call that very same I/O point with a totally different tag name.
Nothing can be done about this because it is just the way things are.
According to the survey among pharmaceutical manufacturers regarding their FAT/SAT practices, 92% of respondents use vendor documentation for equipment qualification.
But nearly half replicate FAT/SAT tests during equipment IQ/OQ owing to the insufficient involvement of Quality … or because company policy does not allow using it.
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