human performance

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Human Performance: Investigation root cause analysis best practices

The Human Performance Workstream recognized the importance of effective investigation techniques during their collaborative work in 2016. The team conducted a survey of member companies and shared within the workstream a report with 14 recommendations, and 11 best practice company case studies. These recommendations and case studies were used to create an investigator training package for the industry, and to inform the contents of the human performance
assessment tool, which the group uses to benchmark and improve human performance.

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

BioPhorum has developed a risk-based deviation management system (DMS). 13 member companies have implemented this approach, and summary data from these companies shows improved quality performance plus an average time saving of 22,200 work hours per site per year, which is equivalent to a $888k cost saving.

This guide outlines the work of the BioPhorum DMS Workstream in defining and creating a simplified and effective risk-based deviation management system with advanced RCA methodologies, and a track-and-trending process of low-risk events. It includes everything required to build a risk-based approach to DMS, including the business case for change, the new process, risk-based tools, and a detailed sharing of post-implementation benefit.

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

In any industry, quality is the building block of everything. People are relied on to deliver the services and products customers expect and need. This is especially so in biopharmaceuticals. But what happens when things go wrong? And what makes them go wrong in the first place? The reasons are myriad but ‘human error’ is often cited as the cause of problems such as accidents, product recalls and patient safety issues. Unfortunately, a human error is not seen as an opportunity to learn, but as something that drains time, money and resources. Changing this mindset is crucial to a better understanding of how success and failure happen within an organization, and how to improve its potential to anticipate, monitor, respond and learn – the cornerstones of resilience. This paper sets out to accelerate industry’s maturity by building a greater understanding of what is desired and explaining how to get there. It provides proven guidance and a case
study of why one company’s standard approaches to root cause analysis were ineffective at reducing repeat events – both minor events but also significant ones that caused a loss of product and production time, such as contaminations. It discusses how the culture of the company changed from one of ‘it only happened once’ with weak corrective and preventive actions, to one where ‘human errors’ were only considered symptoms of wider system-level problems in the organization.

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To err is human: How to improve risk management through ‘blue-sky’ human performance

In any industry, quality is the building block of everything. People are relied on to deliver the services and products customers expect and need. This is especially so in biopharmaceuticals. But what happens when things go wrong? And what makes them go wrong in the first place? The reasons are myriad but ‘human error’ is often cited as the cause of problems such as accidents, product recalls and patient safety issues. Unfortunately, a human...

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

The Human Performance Assessment (HPA) tool is designed to enable a biopharmaceutical organization to assess its maturity in implementing a human performance operating philosophy, as well as plan next steps toward the biopharmaceutical blue-sky for human performance. The maturity profile describes a number of stages towards blue-sky performance in seven dimensions, each containing multiple lever attributes.

This members only pack contains the, Human Performance Assessment too, a facilitator’s guide to running the assessment and a full set of blinded member industry assessment results covering 2014, 15, 16, 17 and 19 when the overall score for existing companies moved from a level of understanding to one of competence. The workstream goal of reaching competence by 2020 was reached in a year early

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

A well established Human Performance program will significantly reduce failures and deviations in any biomanufacturer’s operation. Critical to this is the creation of a culture where leaders partner with workers to learn about what enables success and what creates challenges. This learning is most effectively done through first-hand observation, active listening and ensuring candid discussions about systems’ issues related to risk. Written by BioPhorum’s Human Performance Workstream, this guide details how to implement and maintain a leader observation and coaching program, what such a program entails, the expected benefits, the expectations for leaders and a suggested implementation plan.

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Human performance: HuP Members Toolkit

This members only toolkit provides all the guidance, tools, assessments and case studies from across the industry to enable a site or biopharma corporation to implement the best human performance best practices. Developed through the collaboration of more than 20 corporations, the efforts of innumerable practitioners, over more that six years.  This body of work, that grew from benchmarking established practices in the nuclear and aerospace industries. Going deeper and wider then published guides.  This material has enabled member companies to realise reductions in deviations, growth in real capacity and reductions in lead-times from improve right first time rates in operations.

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

One of the dilemmas companies face when driving down failures and near misses to ‘zero’ is what to measure. Conventional approaches often fail to support ambitious ‘zero’ performance levels and can discourage the right type of debates and discussions. This guide from the Human Performance (HuP) team explains how biopharma operations can understand and measure performance in the most meaningful way and how to capture risks and enable sustainable learning and improvement through the ‘Family II’ mindset. Piloted by four companies the guide explains how to measure success rates and encourage employee reporting, how to implement such reports, and management the communication around the program to help everyone get closer to the target of zero failures.

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

Errors are a part of life. With human errors accounting for approximately 50% of quality incidents and related problems within the pharmaceutical industry, the need to improve human performance in manufacturing operations is obvious. The purpose of this article is to describe error-proofing ways of structuring and writing knowledge documents, procedures, batch records, as well as practices for structuring, conducting, and documenting training to assure competence. These practices are recommended for adoption to shift the current ‘training for compliance’ paradigm to a ‘training for competence’ paradigm. It will also be demonstrated that a training for competence focus achieves GMP compliance. Results at Lonza have been encouraging, with human error-related quality deviations and non-conformities reduced by more than 40% across 13 sites globally within the first two years of the implementation of its Error Prevention System.

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Human performance: Investigation effectiveness drives HuP excellence

In 2016 BioPhorum members came together to consider how to improve the efficacy of their investigation and root cause analysis approaches. Considerable scope for improvement existed in the industry from improving training of investigators and better tools to analyses complex problems. This article this written by Clifford Berry and published in BioPharm International socialized the recommendations to a wider audience.

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