药品质量管理相关术语

一.QA术语词汇 

1.QA：品质保证（Quality Assurance） 

2.IQC：进料检验(InComing Quality Control))    

3.FQC：最终品质检验 (Final Quality control)  

4.OQC：出货检验(Outgoing Quality Control)  

5.IPQC：制程检验(In process Quality Control) 

6.QCC：品管圈 (Quality Control Circle)  

7.TQM：全面品质经营（Total Quality Manage）或者TQC（Total Quality Control） 

8.SPC：统计制程管制（Statistics Process  Control） 

9.COQ：品质成本（Cost Of Quality）   

10.AQL：允收品质水准（Accept Quality Control） 

11.QRA :Quality & Reliability Assurance质量与可靠性保证  

12.MQA :Manufacturing Quality Assurance 制造质量保证  

13.DQA: Design Quality Assurance 设计质量保证  

14.VQC: Vendor Quality Control__售货质量控制  

15.IPQC: In Process Quality Control 制程质量控制  

16.OQA: Out going Quality Control 出货质量控制

17.QM Quality Manual 品质手册 

18.DPPM: Defective Pieces Per Million units 百万件中有损件数  

19.PPM: Pieces Per Million 百万分之一  

20.RMA: Return Material Authorization(RMA)_ 退货授权(RMA)  

21.ISO: International Standard Organization__国际标准化组织  

22.VMI: Visual Mechanical Inspection__外观机构检验  

23.AVL: Approval Vendor List__合格厂商  

24.FQC: Final Quality Control__最终质量控制  

25.OBA: Open Box Audit__成品检验  

26.FAI: First Article Inspection__首件检验  

27.CAR: Corrective Action Request__改进对策要求 

28.4M: Man; Machine; Material; Method 人,机,物料,方法  

29.ESD: Electrical Static Discharge 静电释放  

30.BOM: Bill OF Material__材料清单  

31.ECR: Engineering Change Request__工程变更申请  

32.ECO: Engineering Change order__工程变更指令  

33.EVT: engineer Verification Test__工程验证测试  

34.DVT:__Design Verification Test__ 设计验证测试  

35.VQA Vendor Quality Assurance 供应商品质保证 

36.CQA Customer Quality Assurance 客户品质保证 

37.FPY First Pass Yield Rate 直通率(一次成功率) 

38.MRB Material Review Board 物料评审委员会 

39.X-R Chart 平均值与全距管制图 

40.X-Rm Chart 个别值与全距管制图 

41.P Chart 不良率管制图 

42.U Chart 单位缺点管制图 

43.C Chart 缺点数管制图 

44.Ca Capability of Accuracy 精确度

45.CP Capability of Precision 准确度 

46.CPK 制程能力分析 

47.ESD Electro-Static Discharge 静电释放(放电) 

48.ISO International Standard Organization 国际标准组织 

49.RMA Procedure RMA程序 

50.FIFO First In First Out 先进先出 

51.AC/RE （Accept/Reject） 接收/拒收

52.CR （Critical） Defect 严重缺陷 

53.MA Major Defect严重缺陷 

54.MI Minor Defect次要缺陷 

55.TQM Total Quality Management 全面品质管理 

56.PDCA Plan Do Check Action 计划`实施`检查`行动 

57.MTBF Mean Time Between Failures 平均失效间隔时间 

58.FMEA Failure Mode Effective Analysis 失效模式分析 

59.ORT On-going Reliability Test 持续可靠度实验 

60.SCAR Supplier Corrective Action Report 供应商改善措施报告 

61.GR&R Gauge Reproducibility and Repeatability 量测系统重复性与再现性 

62.DOE Design of Experiment 实验设计法 

63.Reliability Test Report 可靠度测试报告 

TUV 德国认证公司 

UL 美国优力安全检验 

CE 欧盟认证公司 

SGS 英国远东公证 

MIL Military(U.S) 美国军事标准