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Results of survey on incorporation of Quality Mangers to JACIE Inspection Teams.

posted 18 Sep 2014, 02:00 by Eoin McGrath   [ updated 9 Jul 2015, 00:59 ]
14-11-2014 Summary of results now available here.

Survey closed 10-10-14

JACIE is evaluating a new role for Quality Managers as part of JACIE Inspection Teams. Currently, teams are typically made up of physicians and scientists drawn from the clinical, cell collection and cell processing areas. The proposal is to add an experienced Quality Manager to this team since a significant part of the Standards in each of these areas concentrate on quality management and are currently assessed by the respective inspectors alongside the other standards. This represents a significant workload for the inspector.

The hypothesis is that
  1. a Quality Manager is an expert in quality management in the same way as the other inspectors are experts in their respective fields and so will ensure a more thorough assessment of the QM system; and
  2. that the other inspectors will have more time to assess their main areas of competence (clinical, collection and processing) which will raise the overall quality of the inspection and reduce the time required on-site and reporting.

This survey is now closed. The deadline for participating was 10 October 2014.