Book Description

Analytical Laboratory Quality Audits are designed to improve laboratory performance. The success of the audit, as for many activities, is based on adequate preparation, precise performance, well documented and insightful reporting, and productive follow-up. Adequate preparation starts with definition of the purpose, scope, and authority for the audit and the primary standards against which the laboratory quality program will be tested. The scope and technical processes involved lead to determining the needed audit team resources. Contact is made with the auditee and a formal audit plan is developed, approved and sent to the auditee laboratory management. Review of the auditee's quality manual, key procedures and historical information during preparation leads to better checklist development and more efficient and effective use of the limited time for data gathering during the audit itself. The audit begins with the opening meeting that sets the stage for the interactions between the audit team and the laboratory staff. Arrangements are worked out for the necessary interviews and examination of processes and records. The information developed during the audit is recorded on the checklists. Laboratory management is kept informed of issues during the audit so there are no surprises at the closing meeting. The audit report documents whether the management control systems are effective. In addition to findings of nonconformance, positive reinforcement of exemplary practices provides balance and fairness. Audit closure begins with receipt and evaluation of proposed corrective actions from the nonconformances identified in the audit report. After corrective actions are accepted, their implementation is verified. Upon closure of the corrective actions, the audit is officially closed.