Seven Steps to Implement an Affective and Integrated SOP and Training System

Abstract

Regulated industries such as Pharmaceutical, Biotechnology and Medical Devices, among others, require the use of Standard Operating Procedures (SOPs), to perform in the work place, consistently. For several years the Food and Drug Administration has observed that some of these industries do not have the ability to create specific and easy to follow SOPs. It results in process deviations, ineffective trainings and noncompliance. A research was performed to identify best practices and tools recommended by different experts from the Industry. As a result of this research, a model was developed and used to enhance SOPs used in a Packaging Operation. Two methodologies were integrated in this project: DMAIC (Define, Measure, Analyze, Improve, and Control) and HPT (Human Performance Technology). The model consists of seven steps and the associated tools required to implement effective SOPs and effective trainings. The model is available for future implementation in any industry to reduce errors and improve performance.