November's Professional Development Meeting (PDM)
"Cost Reductions and Improved Quality Performance
Case Study: Application of a Manufacturing Execution System"
Presented by Jerry Gonzalez, P.E., MBA, CSCP, CPIM, CQE
Business Systems Manager
B Braun Medical, Inc.
November 14, 2018
(Click for more information)
Standard operating procedures are designed to ensure that products regulated by the Food and Drug Administration (FDA) meet requirements for safety, integrity, and quality. All tasks identified in a procedure must be recorded in a batch history document; “If it is not recorded, it never happened”. Besides the out of compliance issues implicated, procedure deviations may cause backorders, material losses, and inefficiencies that have a significant impact on a company’s bottom line and reputation.
This case study shows how the implementation of a Manufacturing Execution System reduced costs and improved quality performance indicators.