A pharmaceutical manufacturer contacted Dellshire to improve their raw material yield and accountability practices. The company reported an unacceptable variation in yield calculation which had resulted in CAPA’s and nonconformances which were open for an unacceptably long period of time.

The Dellshire business process improvement SMEs leveraged LEAN/Six Sigma methodologies and multiple tools throughout the project execution. Work sessions with a cross functional team were conducted to methodically investigate the contributing factors which resulting in significant learning related to causes for the current performance.

Issues relating to process equipment variation, data entry documentation and calculation errors, and inadequate specifications were identified and characterized at a detailed level. An action plan was created and implemented which included the development of a new yield worksheet with improved, simplified, calculations. Process capability studies provided additional control and benefits and also were used to establish the acceptance limits for yield calculations and reestablished process limits.

The company piloted the changes and later reported greater yield of raw material; reducing costs significantly and also superior compliance as accountability methods and accuracy were improved.