The value to blood establishments of supplier quality audit and of adopting a European Blood Alliance collaborative approach.

Abstract

The assessment of suppliers of critical goods and services to European blood establishments is a regulatory requirement proving difficult to resource. This study was to establish whether European Blood Alliance member blood services could collaborate to reduce the cost of auditing suppliers without diminishing standards. Five blood services took part, each contributing a maximum of one qualified auditor per audit (rather than the usual two). Four audits were completed involving eight auditors in total to a European Blood Alliance agreed policy and process using an audit scope agreed with suppliers. Audits produced a total of 22 observations, the majority relating to good manufacturing practice and highlighted deficiencies in processes, procedures and quality records including complaints' handling, product recall, equipment calibration, management of change, facilities' maintenance and monitoring and business continuity. Auditors reported that audits had been useful to their service and all audits prompted a positive response from suppliers with satisfactory corrective action plans where applicable. Audit costs totalled € 3,438 (average € 860 per audit) which is no more than equivalent traditional audits. The four audit reports have been shared amongst the five participating blood establishments and benefitted 13 recipient departments in total. Previously, 13 separate audits would have been required by the five blood services. Collaborative supplier audit has proven an effective and efficient initiative that can reduce the resource requirements of both suppliers and individual blood service's auditing costs. Collaborative supplier audit has since been established within routine European Blood Alliance management practice.