An 8D approach is a problem solving tool from the LEAN tool box (www.lean.org). It is a tool that you can use when you encounter a problem. It is a structured approach that analysis the problem, focuses on the origin of the problem by determining the root cause and established permanent corrective actions. It is an effective method to stop complex recurring problems without a real root cause from happening again.
You can find a document to help you perform this 8D here. You can find a general introduction on the root cause analysis and 8D in the presentation of Stephanie Herring here.
Failure Mode and Effects analysis is a methodology to perform a thorough risk assessment. This methodologies allows your organization to anticipate failures by identifying all the possible failures that could happen in a process.
FMEA is a structured approach to discover potential failures that may exist of could occur.
You can find a published example of FMEA here and a presentation on how to perform an FMEA by Alessandra Alteri here.
If you want to start with FMEA in your organization, look at the non-conformity list. Detect the processes where the most failures occur and go through an FMEA for these processes.
It is important to do this in a team exercise.
Read more about FMEA and ART on PubMed >
The 5th edition of the Council of Europe Guide to the quality and safety of tissues and cells for human application was published in December 2022.
The Guide contains technical information and guidance for professionals working in tissue establishments, inspectors auditing these establishments, and Health Authorities responsible for tissues and cells for human application. It collates the most up-to-date information to provide a comprehensive overview of the most recent advances in the field, with the aim to support professionals at a practical level and contribute to improving the rate of successful and safe clinical application of tissues and cells of human origin.
Two chapters are specific for Medically assisted reproduction (Chapter 29) and Fertility preservation (Chapter 30) and have been written with the collaboration of ESHRE. General requirements for all tissues and cells are written in the general Chapters (Part A of the Guide).
The guide can be downloaded online for free at the EDQM Freepub website (https://freepub.edqm.eu/publications/AUTOPUB_17/detail), please click on the image. Paper copies can also be purchased at the EDQM Store (http://store.edqm.eu).
EuroGTP II intended to provide practical tools which will assist Tissue Establishments and Organisations Responsible for Human Application, in the implementation of technical requirements defined for the assessment and verification of the quality, safety and efficacy of therapies with human T&C. Moreover, these tools are developed in accordance with the regulatory principles, legislation and good practices, and is made available to National Competent Authorities (NCAs), hence facilitating also the evaluation and the authorisation procedures. You get information on this risk assessment by accessing the website: http://www.goodtissuepractices.eu/
On the left side, you can find the guide explaining the risk tool and the link to the online free accessible interactive tool.
This proceedings report presents the outcomes from an international workshop supported by the European Society of Human Reproduction and Embryology (ESHRE) and Alpha Scientists in Reproductive Medicine, designed to establish consensus on definitions and recommended values for Indicators for the assisted reproductive technology (ART) laboratory. Minimum performance-level values (‘competency’) and aspirational (‘benchmark’) values were recommended for a total of 19 Indicators, including 12 Key Performance Indicators (KPIs), five Performance Indicators (PIs), and two Reference Indicators (RIs).
Interested? Download the manuscript and take a look! [free download]
and more >
The Agence de Biomedicine (ABM) releases recommendations for all areas of medicine, including assisted reproductive technologies, Zika virus, tissue banking and genetics. Read here >
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