NEWS

Taming the documentation beast using the power of human performance

28 February 2022
Drug Substance
BioPhorum

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.

Different needs

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:

  1. Error is normal
  2. Blame fixes nothing
  3. Learning and improving are vital
  4. Context influences behavior
  5. 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.

Our teams need well-designed, concise guidance that supports well-designed systems. Therefore, the paper will help readers focus on creating logical content standards and effective learning programs.

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.

NEWS
A major milestone – a harmonized approach to product carbon footprint data
NEWS
Combination products – MediPhorum’s ‘state of the nation’ report
NEWS
Inaugural BioPhorum Quality face to face – get involved
NEWS
Forecasting the demand for single-use systems
NEWS
The new Drug Substance Strategic Value Framework – addressing industry pain points

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

DOWNLOAD
An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
EXTERNAL-RESOURCE
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
DOWNLOAD
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
DOWNLOAD
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
NEWS
Inaugural BioPhorum Quality face to face – get involved
PODCAST
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
PODCAST
Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
DNA and Earth on blue background
DOWNLOAD
A vision for the biopharmaceutical industry’s inbound supply chain
NEWS
A major milestone – a harmonized approach to product carbon footprint data
Technology Roadmap V 2.0
DOWNLOAD
BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing