Validation begins with the product development phase. The initial validation development begins with a collaborative review between Jenitek's and customer's design teams or Jenitek alone doing a drawing review. Attention at this phase is focused on Critical to Quality (CtQ) design attributes as identified by the customer.
Utilizing this information, the project team weighs and considers various process options that will impact manufacturability. This exhaustive Design for Manufacturability (DfM) review provides a high level outline of the manufacturing process including materials, equipment, and environmental controls that will be the focus of subsequent validation.
This is followed by Installation Qualifications (IQ), Operational Qualifications (OQ), and Process Qualifications (PQ) for each process. Also, Design of Experiments (DOE) is frequently conducted to investigate a range of possibly significant input variables.
After refining and optimizing inputs, a stable process with maximum reproducibility and conducted statistical controls, including Gauge R&R studies to monitor process variation and improve capability is completed.
Lastly, data collected throughout the process validation is analyzed to provide insight on effectiveness of current sampling plans and lot acceptance criteria.