Steel Sutures Finished Good Test Sampling Optimization Initiative

Abstract

Regulated organizations have the challenge to reduce cost and increase value while complying with regulatory mandates. Quality history, process capability, and life cycle of a given suture produce for a medical device company was used to build a business case to eliminate Finished Good Level testing which will result in waste reduction and cost saving. The level of managerial interactions at internal and corporate level requires a change management strategy that portrays the need of the organization evolution and risk mitigation plans. Key Terms ⎯ Change management, Finished Good Test, life cycle management, process capability, sampling plan, sutures.