GQ1 Governance and quality system standards

a)    Ratified, documented and up-to-date policies and procedures are in place, covering all licensable activities.

• Overarching HTA SOPs, see Human Tissue Documentation.

• Local SOPs as required.

b)    There is a document control system.

Note: HTA Guidance

Governance documents should include:

• Revision history and version number
• ‘Effective from’ date
• Review date (at least every three years)
• Pagination
• Author and reviewer names

• Local SOPs and policies need approval and follow document management guidelines outlined in SGUL_SOP_GEN 1. 

• Keep a document control database that lists all documents with review dates.

• Have systems in place to confirm document access (like self-inspection).

• Maintain an audit trail to track changes in electronic records, including who made the changes and the date.

• Distribute new document versions and archive old ones.

c)    There are change control mechanisms for the implementation of new operational procedures.

• If there are suggested changes to the overarching HTA SOPs, they must go through a formal process, coordinated and controlled by the SGUL Human Tissue Licence Review Group.

• For both overarching HTA SOPs and local SOPs, the change control system should assess the risks, validate new techniques and procedures before implementation, and monitor the impact of multiple minor changes over time.

d)    Matters relating to HTA-licensed activities are discussed at regular governance meetings, involving establishment staff.

• The Human Tissue Licence Review Group meets every quarter. Any issues should be reported to the HTA designated individuals (DI), Dr. Priya Madhou.

 e)   There is a system for managing complaints.

•  Complaints should be made according to SGUL_SOP_R11.

• Inform the DP / DI of the complaint and provide a written record.