食品理化实验室数据可靠性管理分析

Analysis of data integrity management in food analytical laboratories

数据可靠性成为了全球性的热门话题。近几年全球已有上百家企业因为FDA审查出数据管理问题而收到警告信,并停止出口产品,造成经济损失。对于食品理化分析实验室,保证数据可靠性是最基本的要求之一。然而由于食品多样性,基质复杂,分析仪器种类众多,样品处理繁多等原因,容易导致数据管理不当,无意或人为地造成数据不完整、不可信等问题。为保证数据可靠性,食品检验实验室可实行数据可靠性4层管理模型,包括基层的注重数据可靠性的集体文化和风气,一层的使用正确的分析仪器或系统,二层的正确的实验标准操作程序,及最后的正确分析正确的可报告结果。此4层管理模型有助于实验室更系统更明确地管理数据档案,可用于分析潜在问题点和控制关键点。此外,随着计算机系统的普及和不断更新换代,计算机系统验证成为了保证计算机系统安全性的重要一环,其能防止数据储存、转移和报告时的不正当行为。

Data integrity has become a global topic. In recent years, hundreds of companies around the world have received warning letters and stopped exporting products because of FDA audit trail of data management problems, which resulted in economic losses. For food physics and chemistry analytical laboratories, it is one of the basic requirements to ensure data integrity. However, due to the diversity of food, complexity of the matrix, variety of analytical instruments and complication of pre-preparation, etc., it easily leads to improper data management and incomplete and unreliable data inadvertently or artificially. In order to guarantee data integrity, the food analytical laboratories can implement four layers of data management model, which includes the foundation level of right culture and ethos for data integrity, level 1 of the use of correct analytical instruments or systems, level 2 of experimental standard operation procedure and the final level of correct analysis and correct right reportable result. This four-layers of management model helps the laboratories to manage data files more systematically and explicitly, and can be used to analyze potential problem points and control key points. In addition, with the popularity of computer systems and constantly upgrading, computer system verification has become a key part of ensuring the security of computer system, which can prevent data storage, transfer and reporting from doing improper behaviour.