Retrospective validation should be performed in order to validate a well established process which has not been validated before or if validated already, then to re-check and reassure the validation work. Retrospective validation can also be performed to keep an eye on a track record and consistency in the performance of a process. A retrospective validation study report on applying control charts and trend analysis method; had proved that a manufacturing process under consideration was consistent throughout selected retrospective validation batches. Control charts showed that all process parameters were well within the control limits and also the values for few of the selected process parameters doesn’t show deviation out of three sigma (3σ) level of control. Process capability Indices (Cp, Cpk) were having values very near to that of 1.33, which is a benchmark value of capability indices accepted by many companies around the world. Thus, with Cp and Cpk values of 1.43 and 1.08 & the sigma level achieved was of four sigma (4 σ), that means process can be capable of producing process yield of up to approximately 99.99 % or process can show a process fallout of approximately 63 PPM.
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