Design of Workflow and the Identification of Waste in the Reinstatement Process

Abstract

The reinstatement process is the procedure and has documentation of shutdown in pharmaceutical, activities that arise when a system facility fails. The documentation process involves how to return the manufacturing facilities to the controlled conditions. This documentation involves the manufacturing, validation, microbiology, quality, and maintenance-engineering departments. It was designed a workflow process diagram of the reinstatement documentation process and identified steps that involved a waste of time of motion and waiting. It was collected data on how much time passed since the microbiology department delivered its reports to the final closure of the reinstatement documentation process. The reasons that cause this waste of time involve errors in documentation, the evidence required is not complete, and people forgetting to start the process for the final approval. The project emphasized and brought a future research recommendation of developing a manufacturing electronic system to document the whole process. Key Terms ⎯ Documentation process, Reinstatement process, Shutdown, Waste time.