文件跟记录控制培训.ppt

Documents and Records - Module 16 Why do laboratories need to manage documents and records? To find information whenever it is needed! Hierarchy of Documents Avoid Drowning in Detail….. BAD EXAMPLE: “The purpose of this procedure is to document the aforementioned activities, herin after referred to as the prescribed tasks in terms that preclude their execution in an inconsistent manner, wherin such inconsistency may potentially result in the prescribed tasks delivering a result that is not repeatable or reproducible”… Job Aids Job Aids Document Control Document Control Elements system for organizing, such as numbering or coding system approval, distribution, and revision process master log that describes which documents are in circulation accessibility of documents at the point of use system for archiving Documents of External Origin Include in the laboratory document control system: instrument service manuals industry regulations ISO standards references used for documentation Why are records essential? Key Messages Information is our product. Documents are essential for assuring accuracy and consistency in the laboratory. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Do not rely solely on manufacturer product inserts Inserts do not provide specific information for test sites, such as: materials required, but not in kit specific safety requirements external quality control requirements Job Aids shortened version of SOPs hand written or printed visible location at testing site useful tool to assure all testing steps are correctly performed assures that the most current version is used ensures availability when needed organizational tool equipment service manuals SOPs texts, articles, reference books Controlled documents regulationsandstandards Numbering System need uniform numbering system do not change a current system that works one system: letter for the type of document and then an incremented number: B1, B2, B3 f