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设施能力评估

Facility capability assessment.

作者信息

McCandless J

机构信息

Apogee Strategic Services, Sandy, Utah 84093.

出版信息

Qual Assur. 1994 Jun;3(2):156-66.

PMID:7804631
Abstract

An inspection and evaluation procedure has been developed to assess the capabilities of contract toxicology laboratories. This procedure has been used for the inspection of 18 different contract toxicology laboratories. There are 10 areas inspected: 1. Facility 2. Personnel 3. Operations 4. Animals/Animal Care 5. Standard Operating Procedures 6. Quality Assurance 7. Equipment 8. Test Article 9. Data 10. Archives. Each of these areas is divided into categories with each category divided further into specific topics. Points are assigned to each topic. The points earned by the laboratory reflect the inspector's assessment of the laboratory's quality in each area. Area scores are added and a percentage score for the facility is calculated. This approach provides a clear distinction among the laboratories evaluated. The facility inspection and rating system played an important role in screening laboratories when the author worked for the Atlantic Richfield Company (ARCO) corporate toxicology department. It highlighted strengths and weaknesses of individual laboratories.

摘要

已制定了一项检查和评估程序,以评估合同毒理学实验室的能力。该程序已用于对18个不同的合同毒理学实验室进行检查。检查的领域有10个:1.设施;2.人员;3.操作;4.动物/动物护理;5.标准操作规程;6.质量保证;7.设备;8.试验物品;9.数据;10.档案。这些领域中的每一个都分为若干类别,每个类别又进一步细分为具体主题。为每个主题分配分数。实验室所得分数反映了检查员对实验室在每个领域质量的评估。将各领域分数相加,并计算该设施的百分比分数。这种方法在被评估的实验室之间提供了清晰的区分。当作者在大西洋富田公司(ARCO)企业毒理学部门工作时,设施检查和评级系统在筛选实验室方面发挥了重要作用。它突出了各个实验室的优势和劣势。

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