Sat Im

Download as docx, pdf, or txt
Download as docx, pdf, or txt
You are on page 1of 28

M/S: HMA MEDICAL

LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

SITE ACCEPTANCE TEST


PLASTIC INJECTION MOULDING PLANT

MODEL NO.: GS168V/HS and GS208V/HS


JOB NUMBER:
CLIENT: M/s. HMA MEDICAL LIMITED
PURCHASE ORDER NO.: ****
DATE: 30/10/2016

HMA/QA/SAT001-00 Page 1
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
CONTENT
Title Page
Table of Content
1.0 System Information
2.0 Document Details
3.0 Protocol Approval from Customer
4.0 Objective
5.0 Scope
6.0 Acceptance Criteria
7.0 Responsibilities
8.0 Checkpoints and Testing
List of Reference Documents
9.0 Installation Qualification
List of Reference Drawings
Bought Out Components
Dimension Measurements
Input Output Check (If applicable)
10.0 Operational Qualification
Cycle Operation (Running Trial)
Operation Sequence
11.0 SAT Report
12.0 SAT Report Approval
Abbreviations

HMA/QA/SAT001-00 Page 2
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
1.0 SYSTEM INFORMATION

M/s. SHANGHAI POYTON INDUSTRY CO. LTD.


Supplier
No. 888 Kungang Road, Song Jiang District, Shanghai, China 201616.
Customer M/s: HMA MEDICAL LTD
M/s: HMA MEDICAL LTD
Client
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
Proposed
M/s: HMA MEDICAL LTD
Installation
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
Location

2.0 DOCUMENT DETAILS

Document Generated By Name Sign Date Revision


Shanghai Poyton
Document Approved By Name Sign Date Revision

Shanghai Poyton

3.0 PROTOCOL APPROVAL FROM CUSTOMER

Department Name Sign Date

Production

Engineering

Quality Assurance

Administration

4.0 OBJECTIVE

HMA/QA/SAT001-00 Page 3
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

To confirm, by physical inspection and testing, that the fabrication and assembly of the
equipment and any auxiliary support systems, conforms to the Design parameters according
to the Design Review.

5.0 SCOPE

Verify the FAT documents for the tests carried out at Shanghai Poyton for the equipment.
The tests shall be carried out at the customer’s place.
The verification of compliance to specifications - according to DR documents and to GMP
requirements, shall be done by:
Confirmation that all design documents, specifications and tests certificates are
accurate, approved and available.
Physical inspection of the electrical hardware.
Mechanical inspection of the construction of the equipment.
Functional testing (safety tests) of the equipment with printouts for tests that require
supporting documentation.

6.0 ACCEPTANCE CRITERIA

The design documents specifications and test certificates shall be accurate and
approved.
The electrical hardware shall comply with the approved design specifications.
The individual tests performed shall conform to the agreed acceptance criteria.
Compliance of deviation recorded during FAT and acceptance of deviation of SAT by QA.

7.0 RESPONSIBILITIES

Approval of the Document


The heads of Engineering, Production and Quality Assurance shall approve the document and
the result of the evaluation.

Inspection
Customer or their authorised representatives are responsible for this SAT document.
All documents shall be checked and approved by Quality Assurance or their authorised
representatives.
Production personnel will perform this test.

8.0 CHECK POINTS AND TESTING

HMA/QA/SAT001-00 Page 4
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

8.1 Reference Documents

Objective To check the documents required for job as per checklist.


Material Documents list submitted in the FAT.
Verification of FAT document with actual material.
The submitted documents shall be checked for correct Documents No.,
Method
Version No., Date and Authorization details against the details submitted in the
FAT Test form by the vendor.
Acceptance The documents submitted shall be as specified in the list of reference
Criteria documents.

Details of Documents

HMA/QA/SAT001-00 Page 5
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

S/No Title of Document Submittal Stage Document No. Remarks

1. List of the reference drawings FAT/IQ

2. Bought-out components FAT/IQ


Components certification and
3. FAT/IQ
calibration (if applicable)
4. Dimensional report FAT/IQ

5. Operation Qualification Report FAT/IQ

Corrective Action in case of


Non Compliance

Conclusions

Performed by Checked by

Name

Signature

Date

9.0 INSTALLATION QUALIFICATION

HMA/QA/SAT001-00 Page 6
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

9.1 Content

Description

List of the reference drawings

Bought-out components

Components certification and calibration (if applicable)

Dimensional report

Operation Qualification Report

9.2 Reference Drawings

HMA/QA/SAT001-00 Page 7
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Objective To check reference drawings required for job against list mentioned below.
Material Approved drawings list submitted in the FAT/Final Documents.
Verification of FAT document with actual material.

The submitted documents shall be checked for correct Drawings No., Version
Method No., Date and Authorization details against the details submitted in the FAT
Test form by the vendor.

Record all the data on Form.


Acceptance
The drawings submitted shall be as specified in the list of reference drawings.
Criteria

HMA/QA/SAT001-00 Page 8
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Details of Reference Drawings

S/No Title of Document Submittal Stage Document No. Remarks

1. General Assembly drawings FAT/IQ

2. Hydraulic system drawings FAT/IQ

3. Electrical system drawings FAT/IQ

4. Mechanical system drawings FAT/IQ

Corrective Action in case of


Non Compliance

Conclusions

Performed by Checked by

Name

Signature

Date

HMA/QA/SAT001-00 Page 9
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

9.3 Bought-Out Components

To prove that the Bought Out components used for construction of the
Objective
equipment are as per the approved specifications.
Material Bought Out components specification sheets.
Verification of documents submitted during FAT.

Method Inspect the installed component. Compare Quality Certificate of the


component, the make, Model No. and other specifications with the approved
specifications.
Acceptance The verification shall prove that Bought Out components used for construction
Criteria of the equipment are as per the approved specifications.

HMA/QA/SAT001-00 Page 10
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Details of Bought-Out Components

Closed mould structure

No. Name Code or specification Quantity

1 O-ring φ82.5×3.55mm 2

2 DAS combined ring PCB0A0900-NCR0 1

3 O-ring φ48.7×3.55mm 1

4 U-ring ISI 55x65x6mm 1

6 Dust ring LBI 55x63x5x6.5mm 1

7 O-ring φ67×3.55mm 2

8 DAS combined ring PCB0A0750-NCR0 1

9 O-ring φ33.5×3.55mm 1

10 U-ring ISI 40x50x6mm 1

11 Dust ring LBI 40x48x5x6.5mm 1

HMA/QA/SAT001-00 Page 11
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Injection parts

No. Name Specification Quantity

1 Nozzle head GS258-01.01-06I 1

2 Dust ring LBI 30x38x5x6.5 2

3 U-ring ISI 30x40x6 2

4 O-ring φ48.7×3.55 4

5 O-ring φ25×3.55 2

6 DAS combined ring PCB1A0550-NCR0 2

7 O-ring φ118×3.55 4

8 O-ring PCB0A1250-NCR0 2

9 DAS combined ring φ54.5x3.55 2

10 U-ring ISI 60x70x6 2

11 O-ring φ60×3.55 2

12 Dust ring LBI 60x68x5x6.5 2

13 Oil seal TC 150x180x14 1

14 Thrust ball bearing 51320 1

15 Deep-groove ball bearing 61916 1

16 Taper roller bearing 30216 1

HMA/QA/SAT001-00 Page 12
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Hydraulic Component List


No. Code Name Model Descriptions Comments
Y180M-4
1 MOTOR Electric motor Driving oil pump
(18.5KW) B35
Ratio variable A70-FR04HAS-A-
2 PUMP System motive power source HECKERT
plunger pump 60366
3 M1 Hydraulic motor PM4-600-D31 Driving screw mechanism DYNAMIC
Driving mould-adjust
4 M2 Hydraulic motor BMR-160P1A1Y1 EATON
mechanism
5 ACC.1 Oil filter TL1000A Oil liquid filtration
6 ACC.2 Liquidometer YWZ-150T Oil level display
7 ACC.3 Oil filter RF-70 Oil liquid filtration HECKERT
8 ACC.4 Air filter FSB-25BM Air filtration
9 ACC.5 Cooler XDEL-421 Oil temperature reduction
BG-03-32(0.1-
10 V2 Pilot Relief valve Back pressure pre-plasticization YUKEN
7MPa)
Electromagnetic DSG-01-3C2-D24-
11 V3 Injection site movement YUKEN
reversing valve N1-50
Electromagnetic DSHG-04-3C10-T- Control of injection, rubber
12 V4 YUKEN
reversing valve D24-N1-50 suction
Electromagnetic DSHG-04-2B2B-
13 V5 Pre-plasticization YUKEN
reversing valve D24-N1-50
Electromagnetic S-DSG-03-3C2-
14 V6 Ejector pin YUKEN
reversing valve D24-N1-50
Electromagnetic DSG-01-3C2-D24-
15 V7 Neutron A YUKEN
reversing valve N1-50
Electromagnetic DSG-01-3C2-D24-
16 V8 Neutron B YUKEN
reversing valve N1-50
Electromagnetic DSG-01-2B3-D24-
17 V9 Mould opening back pressure YUKEN
reversing valve N1-50
Cartridge inserted
18 V10 LCV-25-20-B(1:1) Mould opening back pressure HECKERT
valve
Electromagnetic DSHG-04-2B3-E-
19 V11 Mould closing differential YUKEN
reversing valve D24-N1-50-L
Electromagnetic DSHG-04-3C2-E-
20 V12 Mould opening/closing YUKEN
reversing valve D24-N1-50
Electromagnetic DSG-01-3C2-D24-
21 V13 Mould adjustment YUKEN
reversing valve N1-50
Stack-
Pressure maintenance of
22 V14 unidirectional MCP-01-2-10 YUKEN
injection site forward
valve
Cam directional
23 V15 DCG-01-2B2 Hydraulic security YUKEN
valve
25 G1 Pressure gauge 25VB4-P25 Display of system pressure
Display of pre-plasticization
26 G2 Pressure gauge 25VB4-P25
back pressure

HMA/QA/SAT001-00 Page 13
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Check list of Hydraulic components


No. Name Vickers model YUKEN model REXROTH or other models
1 Relief valve CG2V-6FW-10 HRF-G03-2-10
2 Relief valve CG2V-8BW-10 HRF-G06-1-E-31
3 Relief valve CG2V-8BM-10 HRF-G06-1-31
4 Relief valve CG2V-8FW-10 HRF-G06-2-10
Electromagnetic CG5V-6FW-D-MUHL5-20-
5 HRF-G03-1PN-2-L-D24-20
relief valve EN7
Electromagnetic CG5V-8FW-D-MUHL5-20-
6 HRF-G06-1PN-2-L-D24-20
relief valve EN7
7 Relief valve CG2V-6FW-10 DB10-2-5X/200-
8 Relief valve CG2V-8BW-10 DB20-1-5X/50Y
9 Relief valve CG2V-8BM-10 DB20-1-5X/50Y
10 Relief valve CG2V-8FW-10 DB20-2-5X/200-
Electromagnetic CG5V-6FW-D-MUHL5-20-
11 DBW10B-2-5X/200-6SG24K4
relief valve EN7
Electromagnetic CG5V-8BM-D-MUHL5-20-
12 DBW20B-2-5X/50-6SG24K4
relief valve EN7
Electromagnetic CG5V-8FW-D-MUHL5-20-
13 DBW20B-2-5X/200-6SG24K4
relief valve EN7
Hand-operated
14 DG17V-3-2C-60 4WMM6E5X
reversing valve
Electromagnetic
15 DG4V-5-0A-MUH6-20 DSG-03-2B3-D24-N1-50 4WE10C3X/CG24N9K4
reversing valve
Electromagnetic
16 DG4V-5-0AL-MUH6-20 DSG-03-2B2-D24-N1-50-L 4WE10Y113X/CG24N9K4
reversing valve
Electromagnetic
17 DG4V-5-2B-J-MUH6-20 DSG-03-2B2B-D24-N1-50 4WE10EA3X/CG24N9K4
reversing valve
Electromagnetic
18 DG4V-5-2C-J-MUH6-20 DSG-03-3C2-D24-N1-50 4WE10E3X/CG24N9K4
reversing valve
Electromagnetic
19 DG4V-5-31C-J-MUH6-20 DSG-03-3C10-D24-N1-50 4WE10U3X/CG24N9K4
reversing valve
Electromagnetic
20 DG4V-5-3C-J-MUH6-20 DSG-03-3C12-D24-N1-50 4WE10L3X/CG24N9K4
reversing valve
Electromagnetic
21 DG4V-5-6C-J-MUH6-20 DSG-03-3C4-D24-N1-50 4WE10J3X/CG24N9K4
reversing valve
Electromagnetic
22 DG4V-5-7C-J-MUH6-20 DSG-03-3C9-D24-N1-50 4WE10M3X/CG24N9K4
reversing valve
Electromagnetic
23 DG4V-5-2A-J-MUH6-20 DSG-03-3C5-D24-N1-50 4WE10F3X/CG24N9K4
reversing valve
Electromagnetic
24 DG4V-5-31B-J-MUH6-20 DSG-03-2B10-D24-N1-50-L 4WE10UA3X/CG24N9K4
reversing valve
Electromagnetic
25 DG4V-3-0AL-J-MUH5-60 DSG-01-2B2-D24-N1-50-L 4WE6Y116X/SG24N9K4
reversing valve
Electromagnetic
26 DG4V-3-0A-J-MUH5-60 DSG-01-2B3-D24-N1-50 4WE6C6X/SG24N9K4
reversing valve
Electromagnetic
27 DG4V-3-2AL-J-MUH5-60 DSG-01-2B2-D24-N1-50-L 4WE6Y6X/SG24N9K4
reversing valve
Electromagnetic
28 DG4V-3-2A-J-MUH5-60 DSG-01-2B2-D24-N1-50 4WE6D6X/SG24N9K4
reversing valve
Electromagnetic
29 DG4V-3-2C-J-MUH5-60 DSG-01-3C2-D24-N1-50 4WE6E6X/SG24N9K4
reversing valve
30 Electromagnetic DG4V-3-31C-J-MUH5-60 DSG-01-3C10-D24-N1-50 4WE6U6X/SG24N9K4

HMA/QA/SAT001-00 Page 14
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
reversing valve
Electromagnetic
31 DG4V-3-3C-J-MUH5-60 DSG-01-3C12-D24-N1-50 4WE6L6X/SG24N9K4
reversing valve
Electromagnetic
32 DG4V-3-6C-J-MUH5-60 DSG-01-3C4-D24-N1-50 4WE6J6X/SG24N9K4
reversing valve
Electromagnetic
33 DG4V-3-7C-J-MUH5-60 DSG-01-3C9-D24-N1-50 4WE6M6X/SG24N9K4
reversing valve
Electro-hydraulic
34 DG5S4-042A-J-MUH5-60 DSHG-04-2B2-E-D24-N1-50 4WEH16D6X/6SG24N9K4
reversing valve
Electro-hydraulic DSHG-04-2B2B-ET-D24-N1-
35 DG5S4-042BL-J-MUH5-60 4WEH16EB6X/6SG24N9TK4
reversing valve 50-L
Electro-hydraulic
36 DG5S4-042C-MUH5-60 DSHG-04-3C2-E-D24-N1-50 4WEH16E6X/6SG24N9K4/B10
reversing valve
Electro-hydraulic
37 DG5S4-042C-MUH5-60 DSHG-04-3C2-E-D24-N1-50 4WEH16E6X/6SG24N9K4/B10P4.5
reversing valve
Electro-hydraulic DSHG-04-2B2B-ET-D24-N1-
38 DG5S4-042C-T-MUH5-60 4WEH16EB6X/6SG24N9TK4/B10
reversing valve 50-L
Electro-hydraulic
39 DG5S4-043C-T-MUH5-60 DSHG-04-3C12-ET-D24-N1-50 4EH16L6X/6SG24N9TK4
reversing valve
Electro-hydraulic
40 DG5S4-046AL-E-MUH5-60 DSHG-04-2B2-E-D24-N1-50-L 4WEH16Y316X/6SG24N9K4
reversing valve
Electro-hydraulic
41 DG5S4-046C-T-MUH5-60 DSHG-04-3C4-ET-D24-N1-50 4WEH16J6X/6SG24N9TK4
reversing valve
Electro-hydraulic
42 DG5S4-042B-T-MUH5-60 DSHG-04-2B2B-E-D24-N1-50 4WEH16EA6X/6SG24N9K4
reversing valve
Electro-hydraulic
43 DG5S4-0431C-T-MUH5-60 DSHG-04-3C10-ET-D24-N1-50 4WEH16U6X/6SG24N9TK4
reversing valve
Electro-hydraulic
44 DG5S4-H8-0A-MUH5-60 DSHG-06-2B3-E-D24-N1-51 4WEH22C6X/6SG24N9K4
reversing valve
Electro-hydraulic
45 DG5S4-H8-2C-MUH5-60 DSHG-06-3C2-E-D24-N1-51 4WEH22E6X/6SG24N9K4
reversing valve
Electro-hydraulic
46 DG5S4-H8-2C-T-MUH5-60 DSHG-06-3C2-ET-D24-N1-51 4WEH22E6X/6SG24N9TK4
reversing valve
Electro-hydraulic
47 DG5S4-H8-3C-T-MUH5-60 DSHG-06-3C12-ET-D24-N1-51 4WEH22L6X/6SG24N9TK4
reversing valve
Electro-hydraulic
48 DG5S4-H8-6AL-E-MUH5-60 DSHG-06-2B2-E-D24-N1-51-L 4WEH22Y316X/6SG24N9K4
reversing valve
Electro-hydraulic
49 DG5S4-H8-6C-T-MUH5-60 DSHG-06-3C4-ET-D24-N1-51 4WEH22J6X/SG24N9TK4
reversing valve
Electro-hydraulic
50 DG4V-3-2C-MUH5-60 DSG-01-3C2-D24-N1-50 4WE6E6X/EG24N9K4
reversing valve
Electromagnetic
51 DG4V-3-31C-MUH5-60 DSG-01-3C10-D24-N1-50 4WE6U6X/EG24N9K4
reversing valve
Electromagnetic
52 DG4V-3-2B-MUH5-60 DSG-01-2B2B-D24-N1-50 4WE6EA6X/EG24N9K4
reversing valve

HMA/QA/SAT001-00 Page 15
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Corrective Action in case of


Non Compliance

Conclusions

Performed by Checked by

Name

Signature

Date

HMA/QA/SAT001-00 Page 16
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

9.4 Components Certification and Calibration

To verify the Test Certificates and Calibration Certificates of designated


Objective
components.
Test Certificates and Calibration Certificates of designated components (From
Material
original manufacturer or supplier or from a certified laboratory).
Verification of documents submitted during FAT.

Check whether the certificates correspond to the installed components.


Method
Compare the make, Model No. and other features from the certificates with the
specifications of the components and in the table.
Acceptance The verification shall prove that the designated components used for
Criteria construction of the equipment are properly tested and or calibrated.

HMA/QA/SAT001-00 Page 17
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Components Certification and Calibration

S. No. Component Make S. No./I.D. No. Cert. No.

Corrective Action in case of


Non Compliance

Conclusions

Performed by Checked by

Name

Signature

Date

HMA/QA/SAT001-00 Page 18
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

9.5 Dimensional Measurements

Objective To verify dimensions against approved drawings


Material Tape rule 0-7500mm, Vernier Calipers 0-300mm
Direct measurement of Overall dimensions and Connection Points.

Method Install the plant on the suitable place.

Measure the indicated dimensions and fill in the dimension report.


Acceptance
All the measured dimensions shall be within the dimensional tolerances.
Criteria

HMA/QA/SAT001-00 Page 19
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Dimensional Measurements

Value from Value from Value from Value from


Approved Approved As Built - As Built -
S.
Parameter Drawing Drawing Actual Actual Conclusion
No.
(mm) (mm) (mm) (mm)
GS208V GS168V GS208V GS168V
1. Length (L) 5.35 4.92 5.35 4.92
2. Width (W) 1.59 1.35 1.59 1.35
3. Height (H) 2.03 1.93 2.03 1.93

Utility Connection Points Checks

Value from
Value from As
Approved
S. No. Description Built - Actual Conclusion
Drawing
(mm)
(mm)

Corrective Action in case of


Non Compliance

Conclusions

Performed by Checked by

Name

Signature

Date

HMA/QA/SAT001-00 Page 20
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

9.6 PLC Input-Output Check (If applicable)

To check the Input-Output and to verify against the electrical drawing


Objective
requirements.
Check the input output against electrical drawing visually, during operation.
Method
Results shall be recorded.
Acceptance
All the Input and output shall meet the requirements.
Criteria

HMA/QA/SAT001-00 Page 21
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Input-Output Checks

Test to be Carried Out and Results (Pass/Fail)


Acceptance Criterion
Procedure with Sign
Check the Input-Output
All the Input-Output shall meet the
against electrical drawing
requirements.
visually during operation.
Remarks: PLC Input / Output checked & verified during cycle operation (Running Trial)

Corrective Action in case of


Non Compliance

Conclusions

Performed by Checked by

Name

Signature

Date

HMA/QA/SAT001-00 Page 22
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

10.0 OPERATIONAL QUALIFICATION

10.1 Cycle Operation (Running Trial)

To carry out plant running trial for observing performance/operation of all


Objective
items installed on the plant.
Method Perform the operations as indicated in form.
Acceptance 1. (Refer attached Form).
Criteria 2. The nuts, bolts shall be tightened.

HMA/QA/SAT001-00 Page 23
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Cycle Operation (Running Trial)

S. No. Results
Test to be Carried Out and
Acceptance Criterion (Pass/Fail) with
Procedure
Sign

Corrective Action in case of


Non Compliance

Conclusions

Performed by Checked by

Name

Signature

Date

HMA/QA/SAT001-00 Page 24
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

11.0 OPERATION SEQUENCE TEST REPORT

To carry out plant Operation sequence for observing performance/operation of


Objective
all the items installed on the plant.
Method Perform the operations sequence as indicated in form.
Acceptance
(Refer attached Form)
Criteria

Operation Sequence Test Report


S. No. Results
Test to be Carried Out and
Acceptance Criterion (Pass/Fail) with
Procedure
Sign
1. Check operation sequence
according to procedure given in As specified in Operations
operation and maintenance manual.
manual.

Corrective Action in case of


Non Compliance

Conclusions

Performed by Checked by

Name

Signature

Date

HMA/QA/SAT001-00 Page 25
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

11.0 SAT REPORT

Summary of Results obtained:

Significant deviations observed:

HMA/QA/SAT001-00 Page 26
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:

Conclusions:

HMA/QA/SAT001-00 Page 27
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
12. SAT REPORT APPROVAL

Remarks: Approved / Not Approved

Department Name Signature Date

For M/s HMA MEDICAL LIMITED

Production

Engineering

Quality Assurance

Administration

For M/s Shanghai Poyton Industry Company Limited

Service

HMA/QA/SAT001-00 Page 28

You might also like