134 - Implementation of a program for the external audit of contracted suppliers by AusCord—The Australian Public Cord Blood Collection and Banking Network

Abstract

Contracted suppliers of critical materials, reagents, services and equipment must be audited and qualified to verify compliance with written agreements and relevant standards. External audits may be challenging for cellular therapy facilities faced with large numbers of contracted suppliers and often limited resources. As part of an operational alignment project, AusCord created a system to integrate and coordinate the audit of external suppliers. A master register was established and included a list of suppliers and services provided, a uniform process for risk assessment and an audit schedule. A procedure and forms were developed to manage the process. Each cord blood bank (CBB) registered their suppliers to identify common contractors and performed risk assessment of individual suppliers. Results were compared between the three CBBs to develop consensus on a single scale and risk rating matrix. Each supplier was then rated based on the degree of regulatory oversight, criticality of their service and the presence of prior non-conformances. The level of risk was used to determine whether an audit was required and if so the type of audit to be performed (on-site audit, desk-top audit or a questionnaire). Audits were allocated to each CBB and scheduled. A total of 27 audits were allocated in the first year. The results of completed audits are reviewed at face to face AusCord meetings. To date we have had 100% compliance with respect to supplier cooperation. Audit outcome will be used to determine the frequency and type of subsequent audits for individual suppliers. The AusCord coordinated system has provided significant benefits to the various stakeholders. The use of a standardized integrated approach to risk assessment and audit of suppliers and the consolidation of audits has resulted in increased surveillance of suppliers, improved supplier response rate, CBB access to a more comprehensive and concise summary of supplier performance and effective and efficient utilization of resources.