及医疗器械常用名词术语解释
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: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)
***Q: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__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
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