Human Tissue Authority

The regulator for human tissue and organs

Advice and learning

54.  Eighty one items of advice were given in relation to standard GQ1. This standard received the highest number of advice items compared to the other standards. 

55.  Importantly, establishments must ensure that SOPs contain accurate information, reflecting current practices. It was found during inspections, that documents had not always been updated following a change in a procedure, posing a risk that staff may inadvertently follow out-dated practices.

56.  The value of governance meetings is reinforced above (refer to paragraph 53). Notes (or minutes) of meetings should be made to record what was discussed and enable agreed actions to be captured, as well as to provide an opportunity for any changes to be communicated to staff undertaking licensed activities.

57.  All documents should be subject to version control and managed to maintain a revision history of all changes. As good practice, documents should also be reviewed regularly, whether or not a change in procedure is required. This acts as a confirmation that procedures have been reviewed. Documents should also contain the following:

  • ‘effective from’ date;
  • review date;
  • pagination;
  • author and reviewer names.
Last updated on: 3 Aug 2016