Human Performance

This community of practice concentrates on embedding human performance practice and assessment into drug substance operations.

Human error is too often attributed as a root cause of a failure. The industry is lagging behind in process resilience when compared to other industries and should be rectified

As an industry, we waste efforts and respond reactively and ineffectively to failures that have been miscategorized as human error (HE). HE is a top root cause category in the industry and is seen as a cause and not a symptom. Compared to other industries, process resilience is severely lacking. We continue to follow the traditional view of failures based on assumptions that are no longer valid in this modern and highly complex work environment.

Many companies that have introduced human performance (HuP) have found sustaining focus is difficult following the initial period of adoption with cultures tending to drift back towards their original state.

Implement a human performance culture to minimize failures and maximize productivity

As a group continue to discuss best practices for implementing and maintaining a human performance culture. The team is developing a standardized tool for assessment of the state of integration and adoption of a human performance culture. They conduct continual reviews to compare growth and development year after year and utilize the expertise of the group to generate a better understanding of implementing human performance measures.

Human Performance deliverables

DeliverableDateDetailsDownload

Applying the power of human performance to documentation for successful outcomes

28 February, 2022
286.67 KB
182 downloads

Human Performance: Investigation root cause analysis best practices

8 October, 2020
343.25 KB
220 downloads

Deviation Management (DMS): Guide to implementing a risk based deviation management system

1 September, 2020
493.21 KB
568 downloads

Human Performance: ‘Blue sky’ thinking in human performance and how to get there

31 March, 2020
255.08 KB
156 downloads

Human performance (HuP): Human performance assessment (HPA) pack

1 July, 2019Member only

Human performance (HuP): Guide to implementing and maintaining a leader observation and coaching program

18 October, 2018
482.63 KB
161 downloads

Human performance: HuP Members Toolkit

12 August, 2018Member only

Human performance (HuP): A new measurement approach to better drive, safety, quality, reliability in biopharmaceuticals

8 August, 2018
232.78 KB
219 downloads

Deviation management system (DMS): Transforming deviation management, a paper

19 September, 2017Link

Human performance (HuP): Lonza error prevention system (EPS) – Changing human performance in pharmaceutical operations

9 September, 2016Link

Human performance: Investigation effectiveness drives HuP excellence

12 May, 2016Link

Human performance (HuP): Training for biotech manufacturing operator competence

26 March, 2016
217.92 KB
376 downloads

Human performance (HuP): Changing the performance paradigm in pharma/biotech: Integrating human performance in global organizations

28 September, 2015
2.17 MB
243 downloads

More related workstreams

Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.

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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.

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An industry perspective on understanding AAV capsid content variants
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An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
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The Drug Substance 2.0 Strategic Value Framework
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BioPhorum’s holistic approach to container closure integrity
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Digital Plant Maturity Model 3.0
Investigation Digital Workstreams
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Peer to peer practical guidance on remote inspections and audits
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The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
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A visionary strategic framework for future patient-centric outbound biopharmaceutical supply chains
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A vision for the biopharmaceutical industry’s inbound supply chain
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BioPhorum environmental sustainability roadmap 2022
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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