deviation management

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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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New risk-based deviation management system can save members an average of 22,200 hours per site

Under a traditional deviation management system (DMS), all events are considered equal and usually require a 30-day closure, regardless of complexity. However, treating them the same drives poor behaviors and promotes a check-the-box mindset because users do not have to think about the real reasons for an event. This is why BioPhorum’s Deviation Management Systems (DMS) Workstream has published its Guide to implementing a risk-based deviation...

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Focusing Deviation Management on the big wins

Current methodologies which conduct check-the-box “investigations” for every minor deviation, can lead to companies unintentionally instilling an over reliance on basic tools and running the risk of losing the point as to why deviation management is performed — to find and fix problems.

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

Conventional methodologies which conduct check-the-box “investigations” for every minor deviation, can lead to companies unintentionally instilling an over reliance on basic tools and running the risk of losing the point as to why deviation management is performed — to find and fix problems. They do little to help companies understand minor slips/lapses, nor do they enhance product quality or assure patient safety.

This article published in the BioProcess International, proposed this risk based approach and provides guidance on how to make track and trend work in away that is consistent with other companies involved in the program.

This risk based approach is based on dropping the investigation of each minor, low-risk events but effectively track and trending them, to free up significant resources to work on prevention, and driving improvement of quality at source.

This has been implemented successfully by early adopters and they have had successful inspections from multiple authorities.

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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 (HuP): Training for biotech manufacturing operator competence

For decades, the biopharmaceutical industry has trained its workforce with a ‘read and understand’ approach. This approach is outdated and ineffective at delivering effective learning and competent staff. This ‘Training for competence’ guidance enables companies to understand how their organisation compares to their peers, and to identify what ‘best in class’ looks like for operator training, and will help to identify how to implement this approach across their networks

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

In 2015 when the BioPhorum Human Performance team started to understand how the industry could reduce error rates many were seeing a plateau of performance. Industry data showed 50% of deviations were attributable to human error and that the error rate has been constant over several years. Comparing us to other high-risk industries with unparalleled levels of reliability, such as nuclear power and aviation, the team saw that changes that could be made with the integration of HuP into our operations.

This article utilizes the experience of two large, global biotech companies, at the time to illustrate the pathways to integrate HuP and the benefits realized not just in human error reduction, but also to quality, safety, compliance, and on-time delivery—the critical measures that will make or break a biotech company’s performance.

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