Human Tissue Authority

The regulator for human tissue and organs

Advice and learning

63. Forty nine items of advice were provided against standard GQ2.

64.  The largest proportion of advice items was linked to the audit approaches taken by establishments. In most cases, even though establishments had audit schedules, and were carrying out suitable audits, advice was given in relation to how audit findings, or any actions arising, should be documented and closed.

65.  To strengthen the audit process, establishments with PDs in several research groups were advised to audit one another’s research areas to help promote shared learning, improve consistency across groups and to provide an independent audit perspective. 

66.  Establishments may use vertical and horizontal audits to assure themselves that human tissue samples and records are fully traceable from consent to disposal and that SOPs accurately reflect current practice. Establishments can also use process or observational audits to assess whether or not procedures take place in accordance with documented procedures.

67.  A robust quality management system (QMS) enables staff carrying out licensed activities to have access to the most current procedures and be notified of changes. Although all establishments had a QMS in place, this was not always being used effectively, leading to inadequate control of documents as well as inconsistent approaches to reviewing documents.

Last updated on: 3 Aug 2016