I am working with a medical device manufacturer to develop a process validation strategy. The devices are assembled from many small parts but at the end of the day they make only a few of them. For each product line they make 1 -2 lots / week with 25 to 50 units per lot. Any suggestions on a sample size justification for PQ?
Thanks
Does the company have an approved sampling plan? If not, use an industry standard. Use the sampling plan as you would for any validation: define your AQL, inspection level, etc. and determine sample size. If the sample size is greater than the lot size, then 100% inspection must be performed. If 100% inspection is not feasible based on the inspection time, take a risk based approach and determine the portion of the inspection that has the highest risk and perform 100% on that portion.