19例次医院灭菌制剂生产偏差分析研究

Deviation of 19 cases in sterilized preparations production

目的提高医院制剂生产质量水平,最大程度地保障临床用药安全。方法回顾性分析2016年1—12月联勤保障部队第909医院19例次灭菌制剂生产偏差的原因,参考PDCA循环模式,通过人、机、料、法、环五个方面探讨偏差原因,拟定并落实12条纠正和预防措施。结果 2017年上半年与2016年上半年同期对比,产生偏差例次减少了55.56%。结论加强医院制剂质量风险管理,结合适当的管理方法及时分析偏差原因,积极落实纠正和预防措施,有助于提升生产质量管理水平,保证临床用药安全。

Objective To improve the production quality of hospital preparations,and to ensure the safety of clinical medication to the greatest degree.Methods The data of 19 cases deviation in sterilized preparations production in The 909th Hospital of Joint Logistis Support Fore from January 2016 to December 2016 were retrospectively analyzed.With reference to PDCA cycle mode,the five aspects of deviation including human,machine,material,method and environment were discussed,and 12 corrective and preventive measures were drafted and implemented.Results Compared with the same period in the first half of 2016,the deviation decreased by 55.56%in the first half of 2017.Conclusions Strengthening the risk management of hospital preparation quality,and analyzing the causes of deviation in a time combined with appropriate management practices,implementing the corrective and preventive measures are helpful to improve the quality of production management and to ensure the safety of clinical medication.