内部审计 - 实验室表现和声誉的关键
审计是系统,独立和记录的监控组织质量政策的工具。它有助于核实正在进行的实验室实践对监管指南的一致性。
审计通过简化运营,为实验室的盈利能力有助于增长和上升。实验室活动的文档和记录是成功审计的秘诀。
Audits mainly fall into two main categories:
- 内部审计
- 外部方审计
内部审计are periodic exercises conducted by the organization aimed at evaluation of laboratory operations using internal resources for review of efficiency, safety, and adherence to quality management systems whereas the objectives of audits by external parties are different. These are mainly concerned with recognition or accreditation by a regulatory body such as ISO, NABL, etc or evaluation of fitness by a customer or his deputed agent on the capabilities of the laboratory to provide reliable testing of its products.
内部审计计划
内部审计应遵守包括:
- 任命决定审计团队的团队负责人
- Definition of audit objectives, scope, and criteria
- 提前向Audite提供审计范围
- Review of documents and records
现场活动包括
- 与Auditiees开幕和沟通
- 检查有关部门
- 准备审计报告
- 审核后续后续行动包括完成纠正和预防措施计划的时间框架
- The quality manager decides re-audit if required
- 审计日期后,内部审计记录应至少保留五年
实验室中的典型不符合
- 继续使用未得知的SOP
- 未能适应和遵循SOP指南
- 对SOP和STP的未经授权更改
- 文件夹中的过时文档
- Non-maintenance of calibration schedules or use of un calibrated instruments
- Use of expired working standards
- Non-maintenance of calibration records
- Non-maintenance of instrument use logbooks
- 化学家未提供所需的任务培训
- 非操作安全装置,如灭火器安全淋浴等
- 不维护样品收据和处置记录
- Disposal of laboratory waste and in particular biological waste in non-conformance with existing guidelines
- 非维护仪器的服务和维护记录
在大多数组织中,内部审计被轻描淡写,而外部审计则是可怕的。在审计日期之前,您将发现化学家疯狂地更新他们的记录和质量保证人案,如兔子,确保在审计日期之前一切都在顺序。严格来说,这项活动和急速证明反复生成,因为在随后的匆忙中,几个漏洞仍然脱颖而出。此外,在外部审计之前,在外部审计之前将房屋置于遵守情况GLP.实践。这正是内部审计帮助为实验室的管理和工作人员提供士气推动。
它已正确地说:
“你越过于和平(内部审计),你将在战争中脱落的血液(外部审计)”
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I count myself privileged to be part of those who is impacted by your articles. It has boosted and improved my knowledge and skill in Laboratory techniques and management. Thank so very much sir