Human Tissue Authority

The regulator for human tissue and organs

Independent audits

The HTA’s HA licensing standard, GQ2c, requires an audit to be conducted in an independent manner at least every two years. We do this to verify compliance with protocols and HTA standards and that any findings and corrective actions are documented.

We are often asked whether HTA site visit inspections satisfy this requirement - they do not.

Establishments carrying out licensable activities in the HA sector are expected to have a system for auditing their activities in an independent manner that is separate from any inspections carried out by the HTA. 

The HTA is often asked whether our own site visit inspections satisfy this requirement; they do not.

Establishments carrying out licensable activities in the HA sector are expected to have a system for auditing their activities in an independent manner that is separate from any inspections carried out by the HTA. 

Similarly, the HTA is often asked whether audits carried out by other licensing or accrediting bodies can be used to meet the requirements of this standard. Whilst in principle they can, if an establishment relies on such an approach, the HTA will seek evidence that the audits verify compliance with protocols and applicable HTA standards. 

If the audits assess compliance with unrelated standards, or only a subset of applicable HTA standards, then it is unlikely that the HTA will consider that this standard has been met unless additional steps have been taken to assess compliance with the full range of relevant HTA standards. 

When reviewing compliance with this licensing standard, the HTA will seek evidence that audits have been carried out by people who are independent of the activities and documentation being audited. The HTA does not require audits to be carried out by third parties (i.e. for them to be ‘external’ audits). However, if audits are conducted by establishment staff, the HTA will seek assurance that licensable activities are being audited independently.

What should an independent audit look like?

For example, a member of staff at an establishment involved in the writing and revision of licence-related governance documents, would be unlikely to be considered sufficiently independent of these activities to conduct the required independent audit of them. However, the same individual may be able to audit an establishment’s tissue processing activities if they are not routinely involved in this area of work. 

Independent audits do not have to be carried out by individuals holding formal audit qualifications. However, establishments must take steps to ensure that auditors are suitably trained and competent. 

The HTA does not have set requirements for the duration or structure of independent audits.

For example, establishments carrying out a limited range of activities under their HTA licence, may choose to conduct such an audit as a single exercise over a relatively short period of time. Alternatively, an establishment that carries out a wider range of activities may opt to conduct the audit in several phases, each focused on a different area of work.

In each case, the HTA will seek evidence that over a two-year period, compliance with protocols and all HTA standards relevant to the establishment’s licence, has been audited independently.

Establishments should ensure that independent audits are appropriately documented.

Records should set out clearly how compliance with protocols and applicable HTA standards has been verified, and what evidence was reviewed in order to make these assessments; findings and actions must be clearly documented.

Corrective and preventative actions must be initiated and completed in a timely manner and they should be assessed for effectiveness after implementation.

You can find further guidance on independent audits in paragraphs 35 – 37 of the HTA’s Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment.

Description: 
Guidance on HTA’s HA licensing standard GQ2c
Last updated on: 30 Sep 2019