Deviation List 11-Apr-16

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Signature Ted Dai Eric Shi Lu David
Date 11-Apr-16 11-Apr-16 11-Apr-16
Shanghai Zhongla QC & Trading Company
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Shanghai Zhongla QC & Trading Company
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Deviation Report e. Corrective photo 整改后照片
Deviation photo 不符合项照片
No.
3
Deviation description 问题描述 1. The belt is too long for the factory. 2. 3ml format of feeding screw is not suitable. 3. The seal gaskets and bearings need to be provided as spare parts. 4. There is rust on the main shaft. 5. There is abnormal sound at bearing and pressure rod of stations #2 and #3 6. #9 sealed vessel needs to be improved. 7. Send the 200 PCS unqualified samples for each format. 8. Bring the standard leakage tester during SAT.
Corrective action 纠正措施
Deviation photo 不符合项照片
Shanghai Zhongla QC & Trading Company
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Deviation Report
No.
Deviation description 问题描述 1. IM, OM and main components list need to be updated. 2. The material certificates for seal gasket need to be translated. 3. The FAT protocol needs to be updated. 4. PID drawing needs to be provided.
实际完成日期:指不符合项的实际关闭日期。
Date: 11.Apr.2016
No. Deviation description 问题描述 a. The program needs to be added the alarm for sensor invalid and inner pressure low alarm. b. The program needs to be added the unit on the graph. c. The program needs to be translated into English, such as alarm information, graph item, reject record and so. d. The program needs to be added the reject record. e. The program of CFR part 11, the changed data should be record. Corrective action/Comment 纠正措施或备注 NA e. The HMI needs to be changed. Program Stage 阶段 Due date 到期日 a.8-Apr-16 b.8-Apr-16 c.8-Apr-16 d.8-Apr-16 e.NA Complete date 完成日 a.8-Apr-16 b.8-Apr-16 c.11-Apr-16 d.8-Apr-16 e. can’t meet
Stage 阶段
Due date 到期日
FAT
1.3-Mar-16 2.8-Apr-16 3.20-Apr-16 4.20-Apr-16 5.20-Apr-16 6.20-Apr-16 7.Before packing 8.NA
Shanghai Zhongla QC & Trading Company
Deviation Report
Deviation Report 不符合报告
Customer 客户: Supplier 供应商: PO No. 订单号 (Project No. 项目 号): Equipment description 设备名称: Model No.型号:
Explanations 说明:
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Deviation Report Complete date 完成日 1.3-Mar-16 2.8-Apr-16 3. 4. Mechanical 5. 6. 7. 8.NA Corrective photo 整改后照片 Deviation Classi -fication 分类
ULSA TECH TOFFLON PO 1-560 Vial Pressure Decay Leak Detection Machine PDLD-4
1. Deviation classification includes: Mechanical, Hydraulic, Pneumatic, Electrical, Programming,
Deviation photo 不符合项照片
End of report
Shanghai Zhongla QC & Trading Company
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Deviation Report
Responsible person Supplier responsible: PE responsible: QA responsible: CIMA/Customer responsible:
Stage 阶段
Duer-16 b.2-Mar-16 c.20-Apr-16 d.20-Apr-16 e. 20-Apr-16
2
Deviation Classi -fication 分类 Electrical
Complete date 完成日 a. b. 2-Mar-16 c. d.
Finishing, Material, Documentation and others. 不符合项的分类包括: 机械、液压、气动、电气、程序、表面处理、材料、文件及其它。
2. Stage includes: Manufacturing, Pre-FAT, FAT, and Packing.
阶段分为:生产,预 FAT, FAT, 包装。
3. Due date: The planned date when the deviation is supposed to be closed.
到期日:指不符合项预计完成时间。
4. Complete date: The actual date when the deviation is closed.
FAT
1
Deviation Classi -fication 分类
Deviation photo 不符合项照片
Corrective photo 整改后照片
Shanghai Zhongla QC & Trading Company
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Deviation Report
No.
Deviation description 问题描述 a. The USB is damaged. b. The power 440V is required, needs a 440V to 380V transformer. c. The main motor needs to added independent cooling fan. d. Both transformers need to be added with protective cover. e. The compressed air and vacuum pipes should be distinguished by labels. Corrective action 纠正措施 NA
Stage 阶段
Due date 到期日 1.22-Apr-16 2.20-Apr-16 3.8-Apr-16 4.8-Apr-16
FAT
4 Corrective action 纠正措施 Complete date 完成日 1. 2.11-Apr-16 Document 3.8-Apr-16 4.8-Apr-16 Corrective photo 整改后照片 Deviation Classi -fication 分类