Standard Work for Manufacturing Areas using Lean Methodology

Abstract

Evaluating the structure of Batch Record Review is an attempt to improve batch release time. Many researches have been implemented Lean methodology to reduce the cycle time by automating the documentation process, for example, using Electronic Batch Record (EBR). However, though the tool is offered for manufacturing process, there is still waste in cycle time for the offline Quality Assurance (QA) Batch Record Reviewer. The purpose of this research was to design a standardization tool for the Batch Record Review and for the reduction of the review cycle time. The principal problem was that the review process has many ways to be done and this could represent a problem since not everyone performs the Batch Record Review in the same way. With the design of this standard work, the researcher wants to accomplish that everyone reviews with the same standard and verify the same critical parameters. Key Terms ⎯ Batch Record Review, Cycle Time, EBR, Standardization