Ault J A, Cassidy P S, Crawford C J, Jablonski J E, Kenyon R G
Ricerca, Inc., Painesville, Ohio 44077, USA.
Qual Assur. 1994 Dec;3(4):368-72.
Residue analysis frequently presents a challenge to the quality assurance (QA) auditor due to the sheer volume of data to be audited. In the face of multiple boxes of raw data, some process must be defined that assures the scientist and the QA auditor of the quality and integrity of the data. A program that ensures that complete and appropriate verification of data before it reaches the Quality Assurance Unit (QAU) is presented. The "Guidelines for Peer Review of Data" were formulated by the Residue Analysis Business Center at Ricerca, Inc. to accommodate efficient use of review time and to define any uncertainties concerning what are acceptable data. The core of this program centers around five elements: Study initiation (definitional) meetings, calculations, verification, approval, and the use of a verification checklist.
由于需要审核的数据量巨大,残留分析常常给质量保证(QA)审核员带来挑战。面对多箱原始数据,必须定义某种流程,以向科学家和QA审核员确保数据的质量和完整性。本文介绍了一个在数据到达质量保证部门(QAU)之前确保对其进行全面且适当验证的程序。残留分析业务中心在Ricerca公司制定了“数据同行评审指南”,以有效利用评审时间,并明确关于哪些数据可接受的任何不确定性。该程序的核心围绕五个要素:研究启动(定义性)会议、计算、验证、批准以及使用验证清单。