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JACIE Inspector Handbook

This Handbook is the best reference for inspectors to help guide them through all the stages of a JACIE inspection.

JACIE Handbook Cover

JACIE inspectors are volunteers who work in the field of stem cell transplantation in clinical, quality management (QM), nursing or scientific roles. There are specific entry requirements for would-be inspectors and defined job descriptions for the different inspector roles (Clinical, Collection, Processing and QM). Some inspectors may be qualified to inspect more than one area. For example, a clinician might be qualified to inspect both clinical and collection facilities. All inspectors are asked to commit to 1-2 inspections per year.

The JACIE approach to using volunteer subject-matter experts, has been vital to the transplant community accepting and embracing the inspection process, as the inspectors are part of the community and peers of the clinicians and Allied Health Professionals (AHPs) working within the centres. This has also allowed the transplant community to use JACIE to educate Centres on quality management system working and best practice within the field of cell therapy. Moreover, it has helped to standardise practice and support an ethos of continuous improvement within transplant programmes.

This handbook is intended to be a ready reference for inspectors to help guide them through the tasks and responsibilities throughout all stages of a JACIE inspection.