Operational Qualification (OQ) Page1 / 26

Document No.: Version No.: Date of issue.:

Customer Ref. No.:
ESPL-OQ-08-0017 0.00

Model : Bin Blender 10L, 20L, 40 L

Batch No. : ESPL-120

Sr. No. : ESPL-08-0017

 Operational Qualification (OQ)

Change history

Version Reference Description, Ref. to Clauses or Chapters/Sections

Page No.

0.00 -- First official Issue, Dt.

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 Operational Qualification (OQ)

Index
1 Index ...................................................................................................................................... 3
2 Pre- Approval .......................................................................................................................... 4
3 Objective ................................................................................................................................. 5
4 Scope ....................................................................................................................................... 5
5 Responsibility ........................................................................................................................ 6
6 Machine Description .............................................................................................................. 7
7 Sequence Of Blender Operation ........................................................................................... 10
8 Verification Of Privileges ..................................................................................................... 11
9 Validation Requirement ........................................................................................................ 12
10 Operational Qualification Tests ............................................................................................ 13
10.1 Testing of Programmable Logic Controller’s Processor....................................................... 14
10.2 Verification of Human Machine Interface Screens – HMI ................................................... 15
10.3 Power & Communication Failure Recovery Verification..................................................... 17
10.4 Emergency Operation Verification ....................................................................................... 18
10.5 Verification of Alarms. .......................................................................................................... 19
11 Operational Qualification Tests Status ................................................................................. 21
12 Qualification Document report Approval .............................................................................. 22
13 Discrepancy and Corrective Action Report ........................................................................... 23
14 Remark If Any ....................................................................................................................... 24
15 Final Approval……………………………………………………………………………….25
16 Appendix ............................................................................................................................... 26

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 Operational Qualification (OQ)

3. Objective:
To design, engineer and supply the Bin Blender as per cGMP and GEP guidelines
and to provide assurance that the machine is manufactured as per the URS and it
complies with the Scope of Supply.

To prove that each operation proceeds as per the design specification and the tolerances
prescribed there in the document, are the same at utmost transparency. Validation
procedure is set for complete satisfaction of the customer & building confidence of the
user about the machine.

4. Scope:

The scope of this qualification document is limited to the Operational Qualification of

Bin Blender

In addition to an introduction to the machine functionality, this document provides a

detailed description for each identifiable separate function performed by the machine.
Qualification of support utilities is not within the scope of this qualification document.

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 Operational Qualification (OQ)

5. Responsibilities:

a) Client: -
1. To provide the URS for the Equipment.
2. To perform the Operational Qualification Test (OQ).

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 Operational Qualification (OQ)

6. Machine Description:

Equipment Description

1. Machine Housing:
Machine housing is made up of MS Powder coated & cladded with SS 304.3Interchangeable bowls
used in machine 10LTR, 20LTR& 40 LTR.
Rotating fork trolley assembly for bins, a fork is used to clamp the IBC bin. a fork consists of TC
clamp and locking mechanism to hold the bin.
2. Drive assembly:
Blending drive assembly consists of gearbox motor, bearing. Electric motor of 1HP is used for
rotation.
Maximum Rpm of blender is 20 & it is clockwise & anticlockwise both directions rotated.
3. Safety railing:
Safety railing provided in machine for human safety purpose.
4. HMI:
The HMI is the human machine interface; the functioning of the machine is done through the HMI.
The operator sends the signal to the PLC through the HMI and the PLC executes the same. HMI
makes functioning of the machine user-friendly. HMI also stores and records the required data.
5. Control Panel:
Control cum operating Panel consisting of VFD, Relay card, SMPS, MCB’s. It is Place in machine
housing.
6. VFD:
It is the variable frequency drive used to rotate the motors with variable speed.

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 Operational Qualification (OQ)

6.1 PLC Description

A programmable logic controller (PLC) executes the sequence of operation. The PLC is of Mitsubishi
making model FX5U series. The complete set of control system includes field sensors, PLC system,
HMI and printer interface.

The main function of a PLC is to translate the instructions into the digital or analogue codes needed to
operate the device or machine. PLC system collects data from field instrumentation & displays the
information on the operator station. The instruments are connected to the system Equipment. The
collected data is utilized by the PLC for process control. The user interface, HMI, assists the operator to
supervise and control the process. Based on the displayed information, the operator, by means of the
user interface, provides commands to the PLC. The PLC then executes the operator instructions. A
Mitsubishi Family FX5U PLC is provided as the Central Processing Unit (CPU).

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 Operational Qualification (OQ)

The PLC system layout for the Bin Blender machine automation is as shown
below:

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 Operational Qualification (OQ)

7. Sequence of Operation:

Actual
Description Specified function
Observation
Ensure Availability of
Electrical Supply and 3 phase indication lamp will be ON the control panel.
Switch ON the main And HMI will be start up on the operating panel.
switch.
Login into the HMI. User access level, put user ID and Password.

Blending Operation Blending Operation  Start the Process

Ensure all the input status. Will be displayed on the Input status list in the HMI.

Select Operational Mode – HMI Menu  Mode Selection  Manual Mode  Start
Manual the process.

HMI Menu  Recipe  Create Recipe  Put necessary

Preparing Recipe
operational parameters  Save recipe  Load Recipe.

HMI Menu  Recipe Load  Load desired Recipe 

Select Operational Mode –
HMI Menu  Mode Selection  Auto Mode 
Auto
Operational parameters  Start the process.

Alarm Verification Will be displayed in Alarm History

Unlocking of Bin Manually unlock the bin from Shaft.

Cleaning Clean the blender as per standard sop.

Note:
Above explained sequence is a standard sequence of Operations, which can be altered
(if required) according to the requirements during commissioning & actual observations.

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 Operational Qualification (OQ)

8.0 Verification of Privileges:

Purpose:
To protect screen access by user levels

Test Equipment:
Not required.

Procedure:
1. Login by using user name & password allocated as per level.
2. Check the access as mentioned in table.
3. Verify that the specified user gets access/restrict as mentioned in table.

Acceptance Criteria:
1. Unauthorized person can’t access the system.

Access Operator Supervisor Manager Maintenance Admin

Auto Mode Yes Yes Yes No Yes

Manual Mode Yes Yes Yes No Yes

Recipe Edit/Save No Yes Yes No Yes

Recipe Load Yes Yes Yes No Yes

Recipe Delete No No Yes No Yes

Alarm Yes Yes Yes Yes Yes

Alarm Set-points No Yes Yes Yes Yes

Overview Yes Yes Yes Yes Yes

Manual Settings No Yes Yes No Yes

Maintenance No No No Yes Yes

Conclusions / Comments:

Result: - _______________________________________________________________

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

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 Operational Qualification (OQ)

9.0 Validation Requirement:

The following requirement / practices apply to OQ activities:

Verify that system is installed in accordance with approved engineering drawings and documents,
which shall include the following (as applicable).

G.A. Drawings, Layout Drawing & Electrical wiring drawings.

OEM / Bought out Components Drawings, Installation & operating Manuals.

Verify that the equipment and instrumentation are clearly described as per vendor, model, Capacity,
materials of construction and any critical criteria.

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 Operational Qualification (OQ)

10.0 Operational Qualification Tests:

Test Number Critical Feature

Testing of Programmable Logic Controller’s

10.1
Processor

10.2 Verification human machine interface Screens – HMI

Power & Communication Failure Recovery

10.3
Verification
10.4 Emergency Operation Verification

10.5 Verification of Alarms.

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10.1 Testing of Programmable Logic Controller’s Processor

Purpose:
To verify the normal operation of PLC Processor by observing the processor module’s LED status
indicator after turning on the PLC.
Test Equipment:
Not required.
Procedure:
1. Turn panel power to ON position.
2. Turn PLC power to ON position.
3. Check that PLC Processor is in RUN Mode.
4. Document the following indicators located on PLC front panel.

Acceptance Criteria:
The processor should function as specified in the verification table.

Verification results:

Complies Remarks
Indicator Specified Actual
Yes / No/ NA

LED on when PLC power

Power LED
applied
LED on when PLC is in
RUN LED
RUN Mode
If actual result is not like that of, expected result. Turn power
to panel “OFF” and notify to engineer. Document any
discrepancies on the operational qualification deviation report.

Conclusions / Comments:

Result: - _______________________________________________________________

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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10.2 Verification of Industrial PC Screens – HMI

Purpose:
To verify that the screens displayed by the HMI according to the system requirements.
Test Equipment:
Not required.
Procedure:
1. Access the HMI and verify that all of the functions on each of the screens listed below confirm to the
Manual.
2. Record the results of verification on test data sheets.

Acceptance Criteria:
1. The system shall operate as per design specification.

Results of HMI screen verification:

Stimulate Complies Remarks

Procedure Expected Result
Yes / No/ NA

Start Up This screen will display whenever Operator station will

Screen the operating terminal starts. display the Start Up
screen at the startup.
Selection Press the MENU button on the Operator station will
Screen startup screen and check whether display the Selection
that Selection screen opens screen.
Enter respective user ID and
Auto Mode password, then Press the AUTO Operator station will
Screen MODE key on the Mode Selection display the Auto Mode
screen and check whether that Auto screen.
Mode screen opens.
Press the
Manual MANUAL MODE key on the Operator station will
Mode screen Mode Selection screen and check display the Manual Mode
whether that Manual Mode screen screen.
opens.

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 Operational Qualification (OQ)

Stimulate Complies
Procedure Expected Result Yes / No/ NA Remarks
Press the Alarm Log key on
Operator station will
Alarm the Selection screen and check
display the Alarm
history whether that Alarm History
Log screen.
Screen screen opens.
Input / Press the IO Status key on the
Operator station will
Output Status Selection screen and check
display the Input &
Screen whether that IO Status screen
Output screen.
opens.
Batch Report Press the Reports key on the Operator station will
and Audit Selection screen and check display the reports
Trail whether that Manual Mode generated on the
screen opens. screen

Note: - Screens are accessible only for authorized person, means operator should enter the password
via LOG IN key before operate the specific password level of HMI.

Conclusions / Comments:

Result: - _______________________________________________________________

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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 Operational Qualification (OQ)

10.3 Power & Communication Failure Recovery Verification

Purpose:
To verify that in the event of a power failure, the equipment will stop in safe condition and
the operating parameter will not be lost or corrupted.

Test Equipment:
Not required.

Sr. Procedure Checked Observed

No. Value Value
1 Operate the equipment in automatic mode or Manual mode.

2 Start the operation and set dummy parameters of the process.

3 While the blender is in operation, shut down the main power

switch.
4 Record if the equipment stops in a safe and secure condition.

5 Wait for 5 minutes then restore power to the equipment.

6 Restart the equipment. Record whether the equipment starts

normally, and note any adverse condition.
7 Verify that the parameters recorded in the step 2 are unchanged
after the power failure. And are retentive.
8 Record the displayed date and time after the power failure.

Conclusions / Comments:

Result: - _______________________________________________________________

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

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10.4 Emergency Operation Verification

Purpose:
To deactivate the equipment in the event of an emergency stop.

Test Equipment:
Not required.
Procedure:
1. With the emergency stop pressed in, try to cause movement of an operating function.
2. With the equipment in operation, activate (press in) the emergency stop.

Acceptance Criteria:
1. The equipment will be inoperative.
2. The operation will ramp to a complete stop in four seconds or less.

Failsafe Results:
Emergency Stop
Complies
Test Acceptance Criteria Yes / No/ NA Remarks
With the emergency stop The equipment will be
pressed in, try to perform an inoperative.
operation of machine
With the equipment in The process will stop in 4
operation, press the emergency seconds or less.
stop button.

Conclusions / Comments:

Result: -
_______________________________________________________________

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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10.5 Verification of Alarms

Purpose:
To verify alarm’s function and respond according to the system design.

Test Equipment:
Not required.

Procedure:
1. Place the equipment into normal operation mode.
2. Trigger each alarm outline in the table below.
3. Verify that the specified alarm response is obtained and the correct alarm is displayed on the HMI
Screen.
4. Once the alarm has been activated, resolve the problem and reset.
5. Verify that the equipment returns to normal operation mode.

Acceptance Criteria:
1. The alarms function and respond according to the system design.

Results of Verification of Alarms:

Alarm Verification

Sr. No Alarm Actual Occurrence Simulation Impact Remark

Press the
If emergency stop button is
Emergency Emergency Stop Process
1. pressed then this alarm will be
Stop Pressed on the control Will Stop
generated.
panel.
Utility 3 If Electrical Supply Monitoring
Switch off the Only
2. Phase Power input is not detected, then this
3-phase supply Alarm
Failed alarm will be generated.
Safety If safety railing not close Open safety Process
3. Railing Open properly or open railing will stop
If VFD amperage increases than
Blender Trip the VFD Process
4. rated current for more time VFD
VFD trip MPCB manually will stop
will overload.
If Motor Circuit Breaker trip
Blender
because of overload or short Trip the Blender Process
5. VFD MCB
circuit or it is kept off, then this VFD MCB. will stop
Trip
alarm will be generated.
When the blending process is
Remove the home
over os stop is pressed, then the
Home position sensor,
blender goes in the homing speed
Position start the blender Process
6. and searches for the sensor and if
Sensor and then press Will Stop
this sensor is not found for 60
Failed stop and wait for
seconds, then this alarm will
60 secsonds.
occur.

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Conclusions / Comments:

Result: - _______________________________________________________________

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: _____________

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11.0 Operational Qualification Tests Status

The table below lists the tests performed and related results.

Critical Feature Complies Remarks

Yes / No/ NA

Testing of Programmable Logic

Controller’s Processor
Verification of human machine interface
Screens – HMI
Power & Emergency Failure Recovery
Verification
Emergency Operation Verification

Verification of Alarms

Description Complies Remarks

Yes / No

All critical test/verification have been

performed and acceptance criteria were
met and/or major deviation completed.

Conclusions / Comments:

Result: -
_______________________________________________________________

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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12.0 Qualification Document report Approval

12.1Summary:

12.2 Certification:

Checked By: _______________________ Date: ______________

Verified By: ________________________Date: ______________

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13.0 Discrepancy and Corrective Action Report

13.1 Description of discrepancy:

13.2 Person, responsible for corrective action and date assigned:

13.3 Corrective action taken:

13.4 Any other (Please specify):

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14.0 Final Approval

Manufacturer -

Prepared By Name & Designation Signature & Date

Commissioning Engineer

Reviewed By Name & Designation Signature & Date

Commissioning Engineer

Customer: -

Reviewed By Name & Designation Signature & Date

Approved By Name & Designation Signature & Date

Quality Assurance

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15. Remark If Any

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15. Appendix
List Of Abbreviations
Sr. No. Short Form Full Form

1 cGMP Current Good Manufacturing Practices

2 GEP Current Good Engineering practices

3 AISI American Iron & Steel Institute

4 WIP Wash In Place

5 MS Mild steel

6 FLP Flame Proof

7 SS Stainless Steel

8 CFM Cubic Feet Per Minute

9 kW Kilo Watt

10 DQ Design Qualification

11 HEPA High Efficiency Particulate Air Filter

12 HMI Human Machine Interface

13 FAT Factory acceptance test

14 DP Differential Pressure

15 PLC Programmable Logic Controller

16 Controller- Algorithm for control loops with Proportional

PID
(P), Integral (I), and Differential (D) factor.

17 IQ Installation Qualification

18 OQ Operational Qualification

19 PIC/S Pharmaceutical Inspection Convention Scheme

21 PQ Performance Qualification

22 URS User Requirement Specification

23 MOC Material of construction

24 RPM Revolutions per minute

25 V Volts

26 Hz Hertz

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