Documentation is one of the most pervasive and inescapable facets of our highly regulated industry. Documents drive everything we do and are a critical part of ensuring quality.
Yet documentation has become an almost unmanageable beast. Teams are sometimes forced to navigate complexity, circular logic and references, and the ‘scar tissue’ left behind by deviations and knee-jerk corrective and preventive actions (CAPAs) implemented in response to failure. Often this is because documentation does not consider basic human performance needs.
Recent BioPhorum research has confirmed that documentation is a challenge affecting the whole industry. With the impact of these problems growing every year, we need to reimagine how documents can be used in the biopharmaceutical industry.
To address this situation BioPhorum has published Applying the power of human performance to documentation for successful outcomes , which outlines how to apply human performance principles to document design and provides guidance for implementing these in a biopharmaceutical manufacturing environment.
The paper describes how documents should be written based on how they are to be used and discusses how different documents serve different purposes when training and working. It also suggests an alternative to the typical reactive approach to audit findings and deviations, which often means frequent document updates resulting in long-winded documents.
The paper considers the importance of document hierarchies and how we use them to work successfully, as well as the business case for moving to a human performance approach. Importantly, the paper also looks at how to apply the five principles of human performance to documents:
- Error is normal
- Blame fixes nothing
- Learning and improving are vital
- Context influences behavior
- How you respond to failure matters.
Documentation of our policies, standards, and procedures has become the backbone for addressing compliance issues and deviations. Unfortunately, when we do not uncover the systemic drivers of deviations, our procedures become ‘Frankenstein’ documents, full of band-aid fixes, directives on what not to do, and potentially confusing instructions.
Changing how we use and adapt documents can be challenging but can be hugely beneficial. The paper will show how a more effective system for creating and revising documents – aligned with human performance principles – leads to reduced time spent on revisions, improved training and performance, and fewer deviations and CAPAs.
By investing the time to understand how work is done and creating documents that align with the needs of the end-user and the realities of how work is performed, we can harness the promise of a learning organization steeped in the principles of human performance.