Issue link: https://iconnect007.uberflip.com/i/1111672
MAY 2019 I SMT007 MAGAZINE 65 specified operating ranges. All items in the test plan are tested individually and their performance documented • Performance qualification (PQ): The final validation phase involves verifying and documenting that the equipment is working reproducibly within a specified working range Table 1 provides a practical checklist of items that should be considered as require- ments for each of the phases where applica- ble. The manufacturer should define the extent of documentation for each item, and it is rec- ommended to maintain simplicity to allow for ease of implementation and sustainability. The process validation program's effective- ness is measured by product yield consis- tency and reduced process variation in a vali- dated process where IQ, OQ, and PQ protocols are completed before the process was released to production. Process validation reviews should be carried out regularly and incorpo- rated into the manufacturer's standard man- agement review procedure. Organizations that adopt this approach to process validations will achieve higher product quality consistency and customer satisfaction. Customers place significant value to process validation pro- grams when assessing the risk of a manufac- turer. SMT007 Figure 2: Recommended approach to categorize each process between verification and validation. Table 1: Items to consider when creating validation protocols for each phase.