SMB Validation

Performance Qualification Protocol

The SMB Validation & Compliance Services Group can develop Performance Qualifications to validate a complete integrated process (e.g. a packaging line consisting of several pieces of equipment). Performance Qualification Protocols test the performance and critical parameter testing for each individual piece of equipment on an integrated process. All set-up information is documented and samples are collected at the end of the integrated process based on ANSI/ASQC Z1.4-1993 general inspection levels and acceptance quality levels established by the end user.

“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. This will accomplish two important goals. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation. Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.”