AUDIT ACTION B Action B CONSENT AUDIT (REVERSE)

Manchester Metropolitan University

Human Tissue Act

AUDIT ACTION B – Action B – CONSENT AUDIT (REVERSE)

Laboratory: ______Lead Auditor: ______

Person Designated: ______Audit Date: ______

Sample ID Number / Date Collected / Proof of Consent
Y/N/3rd Party / Non-Conformance Details
Corrective Action
Target Date / Owner
Details
Follow Up
Details
Audit Closed By / Audit Closed Date

Manchester Metropolitan University

Human Tissue Act

AUDIT ACTION B – CONSENT AUDIT (REVERSE)

Action B Choose 5 samples at random from the database and record the required information on this form

Desired Outcome Available signed consent form

Third Party Consent If consent is held by a third party there must be a ‘reasonable belief’ that informed consent was obtained

Corrective Action Decide on any corrective action to be implemented in light of any non-conformance found. Assign a date and person responsible for the action

Follow Up Enter the details of agreed follow up on this form (e.g. corrective actions completed). When all corrective actions have been completed the audit is closed.

Note Corrective action and follow up must not be done by the same person

Audits, Corrective Actions and Follow-Up will be checked on a random basis by the DI or PD