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过程能力指数在临床生化实验室中的运用 被引量:4

Application of Process Capability Indices in the Clinical Biochemistry Laboratories
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摘要 目的 通过调查临床生化实验室11个检测项目的过程能力指数,将已在工业生产、公共服务等多个领域广泛应用的过程能力指数(Cp及Cpk)引入临床实验室.方法 运用过程能力指数公式,结合Minitab软件计算11个生化检查项目两个质控浓度从2014年8月~2015年2月连续7个月的Cp及Cpk.结果 低浓度质控血清中77个Cp中有16个Cp≤1.33,61个Cp> 1.33;高浓度质控血清中77个Cp有9个Cp≤1.33,68个Cp>1.33.结论 过程能力分析是一种以数据和事实为决策依据的管理方法,是一种更为客观、全面、科学的管理方法. Objective To introduce process capability indices (Cp and Cpk) ,which have widely used in the industrial produc-tion, public services,and other fields,into the clinical laboratory by investigating the process capability indices (Cp, Cpk) of the 11 test items of clinical biochemical. Methods Daily quality control data of the Second Xiangya Hospital of Central South University from August in 2014 to February in 2015 were analyzed, Cp and Cpk values were calculated for low and high levels by using the process capability index formulas and Minitab software. Results There were 77 Cp in the low level including 16 Cp ≤1.33 and 61 Cp〉1. 33. In the other side. There were 77 Cp in the high level including 9 Cp≤1. 33 and 68 Cp〉1. 33. Conclusion Process capability analysis is a management method based on data and facts for decision making. It is a more objective,comprehensive and scientific management method.
出处 《现代检验医学杂志》 CAS 2015年第5期169-172,共4页 Journal of Modern Laboratory Medicine
关键词 过程能力指数 质量控制 Minitab软件 process capability indices (Cp and Cpk) quality control minitab software
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参考文献11

  • 1Juran JM, Gryna FM. Juran's quality control hand- book[M]. 4th Ed. New York: McGraw-Hill Profes- sional, 1988 .. 1-59.
  • 2Dejaegher B, J imidar M,De Smet M, et al. Improving method capability of a drug substance HPLC assay [J]. J Pharm Biomed Anal,2006,42(2) :155-170.
  • 3Kamberia M, Garciab H, Feder DP, et al. Setting ac- ceptance criteria for validation of analytical methods of drug eluting stents Minimum requirements for analytical variability[J]. Eur J Pharm Sci, 2011,42 (3) :230-237.
  • 4Raska CS,Bennett TS, Goodberlet SA. Risk-based an- alytical method transfer: application to large multi- product transfers[J]. Anal Chem,2010,82(14) 5932- 5936.
  • 5GitlowaHS,OppenheimAJ,OppenheimR,等.质量管理[M].张杰,译.北京:机械工业出版社.2008:95-111.
  • 6Chesher D, Burnett L. Equivalence of critical error calculations and process capability index Cpk[J]. Clin Chem,1997,43(6pt 1) :1100-1101.
  • 7黄亨建,周君,宋昊岚.质量控制过程能力指数在临床生化中的应用[J].华西医学,2006,21(1):96-97. 被引量:1
  • 8Westgard JO, Burnett RW. Precision requirements for cost-effective operation of analytical processes [J]. Clin Chem, 1990,36(9) : 1629-1632.
  • 9Beckman N, Nightingale MJ, Pamphilon D. Practical guidelines for applying statistical process control to blood component production [J]. Transfus Med, 2009,19(6) 329-339.
  • 10Chen MS, Wu MS, Lin CM. Application of indices Cp and Cpk to improve quality control capability in clinical biochemistry laboratories[J]. Chin J Physiol, 2014,57(2) :63-68.

二级参考文献4

  • 1刘小娟,黄亨建,李萍,徐克和,余霆,胥劲,叶艾竹,吴士吉.罗氏生化试剂用于奥林巴斯全自动生化分析仪的溯源性分析[J].华西医学,2004,19(3):401-402. 被引量:16
  • 2Westgard JO,Barry PL.Cost-effective quality control:managing the quality and producttivity of analytical processes[M].Washingto,DC:AACC Press,1986.
  • 3Quality assurance for the chemical and process industries:a manual of good practices[M].Milwaukee Wi:Amsoc for Quality control,1987,37.
  • 4Westgard JO,Burnett RW.Precision requirements for cost-effective operation of analytical processes[J].Clin Chem,1990,36:1629-32.

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