IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
Author(s) :
15.02.2023 PTT RiyanAtmandaSukma Staff, General Administration
15.02.2023 PTT Arya Sukma Staff, Electrical Design
HJ
Reviewed by :
16.02.2023 PTT Sutiknyo Manager, Assembly Department
16.02.2023 PTT Budianto Manager, Mechanical Design
16.02.2023 PTT Hasrul Manager, Electrical Design
HJ
Approved by :
16.02.2023 PTT Ika Andy Christiawan Operational Manager
HJ
HJ
HJ
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 Page |1
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
TABLE OF CONTENTS
Contents
Page
Revision Note………………………………………………………………………………………………………..………… 3
Socialization……………………………………………………………………………………………………………..…….. 3
I. Introduction…………………………………………………………………………………………..………. 4
A. Purpose……………………………………………………………………………………………..…….. 4
B. Scope……………………………………………………………………………………………..………… 4
C. Warning………………………………………………………………………………………..…………. 5
D. Note……………………………………………………………………………………………………..…. 5
E. Reference……………………………………………………………………………………………..…. 5
II. Procedure………………………………………………………………………………………………..……. 5
A. Pre-Requisities…………………………………………………………………………………………. 5
B. Installation Qualification……………………………………………………………………….... 5
C. Operational Qualification…………………………………………………………………………. 6
III. Conclusion ……………………………………………………………………………………………..……… 12
IV. Attachment……………………………………………………………………………………………..……. 13
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 Page |2
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
REVISION NOTE
Revision No Revision Effective Date
SOCIALIZATION
(Any personnel which involves in this execution must be socialized first regarding the steps of
qualification activity and write down the identity below)
Name Department Designation Sign Date
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 Page |3
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
I. INTRODUCTION
A. PURPOSE
To ensure and document evidence that every component of Automation on
Secondary Packaging Line 7 has been completely finish manufacture and
tested. So its capable to perform as per User Requirement Specification (HJ-
URS-PR-21-24-00)
B. SCOPE
This qualification will be performed for Automation on Secondary Packaging
Line 7 which start from manual loading material into feeder conveyor until
palletizer
C. WARNING
This protocol can not be changed during qualification process. Only trained
personnel can perform this qualification
D. NOTE
This Automation on Secondary Packaging Line 7 is used for pack the Strips
into Inner Box and Inner Box into Outer Box. Finished at Palletizer system
E. REFERENCE
User Requirement Specification, No. HJ-URS-PR-21-24-00
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 Page |4
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
II. PROCEDURE
A. PRE REQUISITES
A.1. Documentation Required For Tests
Documents that will be required and referred to during the execution :
No Document Number Date
1 User Requirement Specification HJ-URS-PR-21-24-00 03 Juni 2021
Deviation Yes No
*)mark through coloumn YES/NO which one decided
Performed by : sign: date:
Reviewed by : Sign: date:
B. INSTALLATION QUALIFICATION
B.1. Objective
To identify and verify the main components, parts and designs comply with
the User Specification Requirement of Automation on Secondary Packaging
Line 7
B.2. Drawing Verification
No Description Specification Result Conclusion
1 Assembly Drawing The Drawing OK/NOK
reflect as installed
condition
2 Electric Wiring Diagram The wiring diagram OK/NOK
reflect as installed
condition
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 Page |5
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
Tape Applicator type M1000
Camera IV2
pendeteksi ada/tidak
isolasi
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 Page |6
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 Page |7
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
B.3. Main Component Verification
No Description Type/Model Result Conclusion
1 PLC Keyence – KV-7500 OK/NOK
2 HMI Weintek – 10 inchiColour OK/NOK
3 Robot Picker Epson – LS20, 4 axis OK/NOK
4 Robot Filling Epson – VT6, 6 axis OK/NOK
5 Robot case Packer Epson – VT6, 6 axis OK/NOK
6 Robot Palletizer Borunte – 2550, 6 axis OK/NOK
7 Cartoning Machine PTT – pocketed belt conveyor OK/NOK
8 Tape Applicator PTT – M1000, Belt conveyor OK/NOK
9 Camera Sensor Keyence type IV2 OK/NOK
Selotip
10 Camera Check Cognex type IS2001 (mono) OK/NG
Coding
9 Stacking System PTT – Belt & Pneumatic OK/NOK
10 Seal Case PTT/Hualian – 500Wx500Hx600L OK/NOK
mm max carton size
11 Label Printer Toshiba OK/NOK
Deviation Yes No
*)mark through coloumn YES/NO which one decided
Performed by : sign: date:
Reviewed by : Sign: date:
C. OPERATIONAL QUALIFICATION
C.1. OBJECTIVE
The Operational Qualification tests are designed to verify functionality of the
system including robots and other installed hardware
C.2. System Function Verification Test
No Description Specification Result Conclusion
1 Turn on the main breaker System turn ON OK/NOK
and the power will supply to correctly
all system components
2 Verify all sensors placed in The system designated OK/NOK
the system by blocking the will be confirmed and or
sensors with any obstacle alarm will appear
3 Turn on and off all electric The motors will on and OK/NG
motors off accordingly
4 Set Robots to its HOME Every robots will move OK/NG
POSITION into its HOME POSITION
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 Page |8
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
5 Press Emergency button System will stop OK/NOK
while machine running immediatelly
6 Turn OFF the main Breaker Machine will turn OFF OK/NOK
C.3. Alarm Verification
No Condition Alarm Machine Conclusion
1 PB EMG HMI CLEAN ROOM MR5001 #PB EMG Stop OK/NOK
DITEKAN HMI DITEKAN
2 SERVO SAMPLING TERJADI ERROR MR5002 #ALARM Stop OK/NOK
ERROR SERVO
SAMPLING
3 SERVO CONVEYOR BELT TERJADI MR5003 #ALARM Stop OK/NOK
ERROR ERROR SERVO
CONV BELT
4 SERVO STRETCH TERJADI ERROR MR5004 #ALARM Stop OK/NOK
ERROR SERVO
STRETCH
5 SERVO TRANSFER TERJADI ERROR MR5005 #ALARM Stop OK/NOK
ERROR SERVO
TRANSFER
6 SERVO UNLOADING TERJADI MR5006 #ALARM Stop OK/NOK
ERROR ERROR SERVO
UNLOADING
7 SERVO EA TERJADI ERROR MR5007 #ALARM Stop OK/NOK
ERROR SERVO EA
8 SERVO LOADING TERJADI ERROR MR5008 #ALARM Stop OK/NOK
ERROR SERVO
LOADING
9 PERGERAKAN CYLINDER SAMPLING MR5009 #CYL Stop OK/NOK
ABNORMAL SAMPLING
ABNORMAL
10 PERGERAKAN CYLINDER UPPER MR5010 #CYL Stop OK/NOK
GATE ABNORMAL UPPER GATE
ABNORMAL
11 PERGERAKAN CYLINDER LOWER MR5011 #CYL Stop OK/NOK
GATE ABNORMAL LOWER GATE
ABNORMAL
12 PB EMERGENCY STOP CONTROL MR6001 Stop OK/NOK
PANEL DITEKAN #EMERGENCY STOP
DITEKAN
13 AIR PRESSURE LOW MR6002 #ALARM Stop OK/NOK
AIR PRESSURE LOW
14 SERVO ROTATOR TERJADI ERROR MR6003 #ALARM Stop OK/NOK
ERROR SERVO
ROTATOR
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 Page |9
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
15 ROBOT 3 TERJADI ERROR MR6004 #ALARM Stop OK/NOK
ROBOT 3 ERROR
16 ROBOT 3 MASIH DALAM KONDISI MR6005 #ALARM Stop OK/NOK
BELUM HOME SAAT AKAN JALAN ROBOT 3 NOT
AUTO HOME
17 PROGRAM ROBOT 3 MASIH DALAM MR6006 #ALARM Stop OK/NOK
KONDISI BELUM RUN SAAT AKAN ROBOT 3 NOT RUN
JALAN AUTO
18 PERGERAKAN CYLINDER COVER MR6007 #ALARM Stop OK/NOK
ROTATOR ABNORMAL CYL COVER
ROTATOR ABN
19 PERGERAKAN CYLINDER GUIDE MR6008 #ALARM Stop OK/NOK
ROTATOR ABNORMAL CYL GUIDE
ROTATOR ABN
20 PERGERAKAN CYLINDER DOOS MR6009 #ALARM Stop OK/NOK
CLAMP ABNORMAL CYL DOOS CLAMP
ABN
21 PERGERAKAN CYLINDER SWING MR6010 #ALARM Stop OK/NOK
PUSHER ABNORMAL CYL SWING PUSHER
ABN
22 PERGERAKAN CYLINDER PUSHER MR6011 #ALARM Stop OK/NOK
TAPE BANORMAL CYL PUSHER TAPE
ABN
23 PERGERAKAN CYLINDER CUTTING MR6012 #ALARM Stop OK/NOK
TAPE ABNORMAL CYL CUTTING TAPE
ABN
24 ROBOT 1 TERJADI ERROR MR6013 #ALARM Stop OK/NOK
ROBOT 1 ERROR
25 ROBOT 1 MASIH DALAM KONDISI MR6014 #ALARM Stop OK/NOK
BELUM HOME SAAT AKAN JALAN ROBOT 1 NOT
AUTO HOME
26 PROGRAM ROBOT 1 MASIH DALAM MR6015 #ALARM Stop OK/NOK
KONDISI BELUM RUN SAAT AKAN ROBOT 1 NOT RUN
JALAN AUTO
27 TERJADI KEGAGALAN VACUUM MR6100 #ALARM Stop OK/NOK
PADA ROBOT 1 ROBOT 1 VACUUM
FAILED
28 PERGERAKAN CYLINDER DOOS MR6101 #ALARM Stop OK/NOK
PUSHER ABNORMAL CYL DOOS PUSHER
ABN
29 PERGERAKAN CYLINDER MBOX MR6102 #ALARM Stop OK/NOK
UNLOADING ABNORMAL CYL MBOX
UNLOADING ABN
30 PERGERAKAN CYLINDER MBOX MR6103 #ALARM Stop OK/NOK
PUSHER ABNORMAL CYL MBOX PUSHER
ABN
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 10
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
31 PERGERAKAN CYLINDER MBOX MR6104 #ALARM Stop OK/NOK
FLAP CLOSER ABNORMAL CYL MBOX FLAP
CLOSER ABN
32 PERGERAKAN CYLINDER MBOX MR6105 #ALARM Stop OK/NOK
CLAMP ABNORMAL CYL MBOX CLAMP
ABN
33 ROBOT 2 TERJADI ERROR MR6106 #ALARM Stop OK/NOK
ROBOT 2 ERROR
34 ROBOT 2 MASIH DALAM KONDISI MR6107 #ALARM Stop OK/NOK
BELUM HOME SAAT AKAN JALAN ROBOT 2 NOT
AUTO HOME
35 PROGRAM ROBOT 2 MASIH DALAM MR6108 #ALARM Stop OK/NOK
KONDISI BELUM RUN SAAT AKAN ROBOT 2 NOT RUN
JALAN AUTO
36 TERJADI ERROR PADA INVERTER MR6109 #ALARM Stop OK/NOK
VACUUM PUMP ERROR INVERTER
VACUUM
37 ISOLASI TIDAK TERDETEKSI OLEH MR6110 #ALARM IB Rejected OK/NOK
KAMERA NO ISOLASI
C.4. Operation Panel Components and Its Description
No Component Function
1 PB EMERGENCY STOP Tombol untuk menghentikan semua proses mesin
dalam kondisi emergency
2 PB MASTER ON Tombol untuk mengaktifkan mesin agar siap
digunakan
3 PB SERVO ROBOT ON Tombol untuk mengaktifkan semua servo robot
4 SS MODE AUTO MAN Select switch untuk memilih mode operasi yang
diinginkan secara auto atau manual
5 PB RETURN Tombol untuk mengembalikan ke posisi home
6 PB RESET Tombol untuk mereset alarm
7 PB AUTO ON Tombol untuk menjalankan mesin secara auto
8 PB AUTO OFF Tombol untuk menghentikan proses auto
9 BUZZER Menyala/Berbunyi sebagai tanda bahwa mesin
terjadi abnormal
10 HMI Touch panel untuk menjalankan mesin dalam
kondisi manual dan untuk display informasi mesin
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 11
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
C4.1 Additional Controller on Tape Applicator
C4.2 Camera Check Absence-Presence Selotip
Additional Camera installed at the area of Conveyor after Coding IJP.
The rejection equipment uses same methode as IJP rejection, which use air blow
Identification of absence – presence selotip by green and read lamp located at the camera.
Note : To set up and calibrate the Camera shall use PC/Laptop with appropriate software
GREEN LIGHTED
RED LIGHTED
AIR BLOW
REJECTION
SELOTIP PRESENCE SELOTIP ABSENCE
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 12
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
C4.3 Camera Check Coding Ink Jet Printer (IJP)
Additional Camera to Check Coding IJP purpose is installed just after the IJP applied.
The Checking Result can be seen at IJP display (see image below).
The rejection system uses Air Blow, same as rejection for Selotip absence presence.
Sample of NG written CODING Sample of OK written CODING
If Coding written OK, then all character is colour GREEN, included the line
If Coding written NG, then the line will be colour RED
Note : To set up and calibrate the Camera shall use PC/Laptop with appropriate software
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 13
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
C.5. HMI Screen Display And Its Function
C.5.1. HMI CASE PACKER
- MENU
- MANUAL ROTATOR
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 14
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
- MANUAL TAPE APLIKATOR
- MANUAL MBOX ERECTOR
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 15
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
- MANUAL CASE PACKER
- AUTO
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 16
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
- I/O MONITOR
- ALARM HISTORY
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 17
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
C.5.2. HMI CARTONING
- MENU
- MANUAL
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 18
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
- AUTO
- SETTING
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 19
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
- MONITOR
- ALARM HISTORY
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 20
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
5.1.3. HMI CLEAN ROOM
- MANUAL CYLINDER SAMPLING
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 21
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
- MANUAL SERVO SAMPLING & CONV BELT
- MANUAL CONV FEEDING & SERVO LOADING
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 22
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
- MANUAL SERVO STRETCH & SERVO TRANSFER
- MANUAL SERVO EA & SERVO UNLOADING
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 23
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
- AUTO
- I/O STATUS
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 24
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
- HOME POST CHECK
- ALARM HISTORY
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 25
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
D. PERFORMANCE QUALIFICATION
Trial No Quantity Products Time Tested Result Conclusion
OK/NOK
OK/NOK
OK/NOK
OK/NOK
Note :
Performed by : sign: date:
Reviewed by : Sign: date:
III. CONCLUSION
After all test done as described above, we Accept / Not Accept this Automation
on Secondary Packaging Line 7, and ready to deliver to PT Hexpharm Jaya
Deviation Yes No
*)mark through coloumn YES/NO which one decided
Performed by : sign: date:
Reviewed by : Sign: date:
IV. ATTACHMENT
No attachment required
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 26
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 27
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 28
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 29
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 30
IQ-OQ Test Protocol of Automation on Secondary Packaging Line 7
Effective Date :Feb 2023 Document No : PTT/HJ-IQOQ01/23 P a g e | 31
