Applying the power of human performance to documentation for successful outcomes

This paper reimagines how documents are to be used in the biopharma industry. Instead of a reactive approach to audit findings and deviations with frequent document updates that can result in many long documents and overdue training, this paper describes how documents should be written and designed based on how they are to be used, and that different documents serve different purposes when training and working.

A document update is a quick fix but can be the wrong solution for the problem. While it may anchor a process requirement in a written procedure, it may not be the best way to ensure long-term compliance. What happens when a new approach brings together training experts and operators running the process with process experts in document writing? This paper incudes a case study in which a packaging area successfully connected document writing with end-user learning needs from the outset, creating a strong link between content and training, reducing process variations, reducing the amount of ‘read and understand’ training, reducing the number of deviations while also building operator competencies, and enabling faster onboarding of new employees and more satisfied, competent operator