A Brief outline for a typical PLC/SCADA system Qualification of Process Equipment

(Example: FBP)
Installation Qualification(IQ) Tests:

S.No IQ Check Point Remarks

1. Control System Architecture Layout This defines the architecture of the entire
Software (it includes flow starting from PLC, I/O
Module, Network switch, Communication
Adapter, Power Module, IPC connections and
HMI Monitor
2. Verification of Control System Hardware This Includes the following, but not limited to:
and Software (Make, Model, Quantities)
 PLC
 Communication Adapter
 Digital Input Module
 Digital Output Module
 Analog Input Module
 RTD Module
 Power Module
 Network Switch
 IPC
 HMI/Monitor
 Others
3. Verification of IPC Hardware & This Includes the following, but not limited to:
Software configurations and Back up (Record the ‘Observed Value’ w.r.t ‘Specified
details Value):
1) IPC Specifications:
 Operating System (name/version)
 Processor
 RAM
 System Type
 Hard Disk
2) SCADA Specifications:
 Application software name (e.g. Zenon)
 Application software version (e.g. 7.60
pro)
3) Back Up:
 Data backup path
 Auto backup path
4. Verification of Communication Cables This Includes the following, but not limited to:
(Record the ‘Observed Value’ w.r.t ‘Specified
Value):
 PLC to IPC (e.g. RJ 45 Ethernet)
 IPC to Monitor
 PLC to Remote Modules

Raktim Dey
Dy. Manager-Validations & Qualifications
Granules India Limited, Place: Hyderabad
 A Brief outline for a typical PLC/SCADA system Qualification of Process Equipment
(Example: FBP)
S.No IQ Check Point Remarks

5. Verification of Electrical Utilities of the This Includes the following, but not limited to:
Control System. (Record the ‘Observed Value’ w.r.t ‘Specified
Value):
 PLC Voltage Range (e.g. 24V ±10%)
 IPC Voltage Range
 Monitor Voltage Range
6. Verification of Access groups/ levels This includes, PLC logical security access levels
available in the system w.r.t the following Levels:
 Operator
 Supervisor
 Maintenance
 Administrator
7. Verification of Environmental This includes the desired environmental
conditions: conditions for the system hardwares w.r.t
Temperature and % RH
(Record the ‘Observed Value’ w.r.t ‘Specified
Value):
 PLC (e.g.: Temp: 0-40ºC, %RH: 5- 95%)
 IPC
 Monitor
8. Verification of Control Panel: Record the ‘Observed Value’ w.r.t ‘Specified
Value for the following:
1) Control Panel Box:
Control panel should be clean and dust free
2) Wires and cables:
Wires or Cables should not be terminated or
Broken
3) Components:
Exhaust Fans, Service lights, Cables Ferruling,
tags etc. should be available
4) Earthing:
Control system must be Earthed properly

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~END OF IQ TESTS~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Raktim Dey
Dy. Manager-Validations & Qualifications
Granules India Limited, Place: Hyderabad
 A Brief outline for a typical PLC/SCADA system Qualification of Process Equipment
(Example: FBP)
Operational Qualification(OQ) Tests:

S.No OQ Tests Remarks

1. Verification of Functional Keys and In this section, each of the functional keys from HMI
GUI (Graphical User Interface) shall be tested to verify; what is ‘Specified’ is what
Screens is ‘Observed’. Few of the examples are, but not
limited to:
1. Verification of Welcome Window
2. Verification of Log in Screens (Verify the
Login, Logout, Create/Deactivate user
and Close the Log in screen)
3. Verification of User Management Function
(Verify the New, Change and Delete user
functionality)
4. Verification of New/Change functionality
(Verify the creation of New user, Change
password, Authorization Levels etc.)
5. Verification of Home Functionality
(Verify the functionality w.r.t: Auto Mode,
Manual Mode, Charging Function, Spray
Check, Maintenance Function, WIP Function,
Bag Up/Down Functions, Events Function
for Audit trail screen, Recipe Function,
Parameter Function, Input/output function,
Trends function, Alarms Function to see
details of Alarms generated, Reports function,
Acknowledge Function to acknowledge
alarms, Reset function to reset alarms,
SCADA exit function to close the
Application Software)
6. Verification of Bag Up/Down:
(Verify the functionality w.r.t: Filter Selection,
Finger Bag, UP- to move bag upward, Down-
to bring bag down, Lock-to lock the bag in
position, Unlock-to unlock the bag, Seal-to
Seal the bag, Unseal-to unseal the bag, Open-
Open the inlet damper, Close-to close the inlet
damper.)
7. Verification of Modes:
(Verify the modes of operation:
Auto- to select Auto mode of operation,
Manual-to select Manual mode of operation,
Charging-to select charging mode, Spray
Check-to select spray check mode,
Maintenance-to select maintenance mode,
WIP- to select WIP spray mode, Top Spray- to
select Top spray functions, Bottom Spray- to
select bottom spray function)

Raktim Dey
Dy. Manager-Validations & Qualifications
Granules India Limited, Place: Hyderabad
 A Brief outline for a typical PLC/SCADA system Qualification of Process Equipment
(Example: FBP)
S.No OQ Tests Remarks

8. Verification of functionalities in ‘Auto’ mode

(Verify the following: Machine Lamp ON/Off,
Scrubber Bypass-to bypass Scrubber, Batch
Start/Stop-to start/stop a batch, Seal- to seal the
container, Unseal-to unseal the container, Start-
to start auto mode, Stop-to stop auto mode,
Auto reset-to reset auto mode, Drain ON- to
turn on steam drain, Drain OFF-to turn off
steam drain.
9. Verification of functionalities in ‘Manual’
mode
(Repeat all the tests as per Auto Mode, in
Manual mode)
10.Verification of functionalities in
Maintenance mode
(Verify the following: Digital Cards- click to
select Digital Input/Output cards, Analog
Cards-click to select Analog Input/Output
cards, Digital Outputs- click to enable digital
output.
11.Verification of functionalities in
‘Charging’ mode
(Verify the following: Seal-to seal the container,
Unseal- to unseal the container, ON-to turn on a
particular function, OFF-to turn off a particular
function.
12.Verification of functionalities in “Spray
check” mode
(Verify the following: On-to on the spray
function, OFF-to off the spray function.
13. Verification of ‘Events’ functionality
(Verify the following: Filter- click to select
ranges to view events (Audit trails), Print-clock
to print Event report, Arrow Keys- click each
arrow keys to move to Left, Right, Next line,
previous line etc.)
14. Verification of ‘Recipe’ functionality
(Upload/Download recipe- to open recipe
management screen, Stop coating-to stop
spraying/coating, ALL DPT-to view all DP
transmitter parameters, Alarm tolerance- click to
view alarm tolerance parameters, Bag Shaking-
click to view bag shaking parameters, Back-click
to close the open screen.
15. Verification of “Recipe Management”
(Verify the following: New recipe-click to create
new recipe, Delete recipe-click to delete selected
recipe, Save Recipe-click to save a recipe,

Raktim Dey
Dy. Manager-Validations & Qualifications
Granules India Limited, Place: Hyderabad
 A Brief outline for a typical PLC/SCADA system Qualification of Process Equipment
(Example: FBP)
S.No OQ Tests Remarks

Upload-click to upload recipe, Download-click to

download a recipe)
16. Verification of Input/Output functionality:
(Verify the following: Digital Cards-click to
select Digital input /output cards, Analog
cards-click to select analog input/output
cards.
17. Verification of ‘Trends’
(Verify the following trends: Atom. Pressure-
click to view atomization pressure trend, CFM
trend- click to view CFM trend, Dew Point trend-
click to view Dew point temperature trends, Inlet
temperature trend-click to view inlet temperature
trends, Product Bed temp. trend-click to view
product bed temperature trend, Exhaust temp.
trend-click to view exhaust temp. trend, Inlet
humidity trend-click to view humidity trend,
History trend-click to view history trend, Real
time trend-click to view real time trend, Print-
click to print trends.
18. Verification of ‘Alarms’
(Verify the following: History-click to view
alarm history, Alarms-click to view active
alarms)
19. Verification of ‘Reports’ generation
Verify the following: Batch start-click to start
batch, Batch stop-click to stop batch, Parameters
report-click to view parameters report,
Production-click to view batch reports, Alarms-
click to view batch wise alarm reports, Audit trial
batch wise-click to view batch wise audit report,
Audit trial timewise-click to view timewise audit
report.

2. Verification of Security Policies In this section we need to verify the Security

policies and privileges test procedure:
(Record the ‘Observed Value’ w.r.t ‘Specified
Value):
 Create new user ID and assign Operator group –
Software will allow creation.
 New user Creation with existing ID- software
should not allow new ID creation.
 Log in with newly created user ID- Software
ask user to change initial password.
 Change the Password by entering the character
less than minimum password length- Software
should not accept less password length.

Raktim Dey
Dy. Manager-Validations & Qualifications
Granules India Limited, Place: Hyderabad
 A Brief outline for a typical PLC/SCADA system Qualification of Process Equipment
(Example: FBP)
S.No OQ Tests Remarks

 Change the password without password

complexity- Software should not accept
 Change the password by entering the same
Password-Software should not allow
 Change the password by entering the characters
above minimum length- software allows.
 Verification of user Lock out- User ID should
be locked after specified wrong attempts.

3. Verification of access control and
rights for different access levels
4. Verification of Boundaries of set
parameters
Verify the following privileges w.r.t Operator,
Supervisor, Maintenance and Administrator.
1. Login and Log out Verification:
For example,
Attempt to log in with Wrong User ID and
Incorrect password- Software should not allow
Operator, Supervisor, Maintenance and Admin to
log in.
Similarly,
Attempt to log in with Correct user ID and
correct password- Software should allow all
levels to log in.
2. User Privileges:
Al the functionalities shall be defined with user
privileges:
For example,
Bag Up and Down- The privilege of this
functionality is given to all levels. However, Delete
recipe-this privilege is given only to Admin.
Like this there are so many functionalities, for
which Privilege shall be defined and provided
accordingly in software. Few of the privileges are as
follows:
Modes, Events, Recipe, New recipe, delete recipe,
save recipe, upload recipe, download recipe,
parameters view, parameters set, change parameters,
Trends, Alarms, Reports, Audit trails, user
management etc.
In this section we need to verify the Range of
different parameters.
The system should Reject values below/above the
range but accepts value within the range
Few of the parameters are as follows:
Step time-1 (Range: 0- 999)
Set Blower Speed (Range: 0 -100)
Set Airflow (Range: 0-3000)
Set Atomization Pressure (Range: 0.1 – 10.0)
Etc.

Raktim Dey
Dy. Manager-Validations & Qualifications
Granules India Limited, Place: Hyderabad
 A Brief outline for a typical PLC/SCADA system Qualification of Process Equipment
(Example: FBP)
S.No OQ Tests Remarks

5. Verification of PLC inputs and In this section we need to verify the link between
Outputs field device, IPC display and respective PLC tags
for all Analog and Digital input/output points
associated with the control system.
Few of the I/O tests are as follows:
a) PLC TAG: D10 (For example)
Description: Emergency Stop
Specified: ON, Observed: ON
Specified: OFF, Observed: OFF

b) PLC TAG: D17 (For example)

Description: Blower VFD Fault
Specified: ON, Observed: ON
Specified: OFF, Observed: OFF
 Few other tests are,
 Bag Up/Down
 Bag Seal/Unseal
 Bag Lock/Unlock
 Bag Shaking
 Inlet filter Door Open
 Inlet Damper Open/Close
 Plenum chamber gasket Seal/Unseal
 Blower ON/OFF
 Machine Lamp ON/OFF
 Etc.

6 Verification of alarms & interlocks
Verify the functions of all alarms and interlocks.
Few of the Alarms that should generate are as
follows:
 Emergency Stop- Appropriate alarm should
be generated.
 Product Container-Earth fault.
 Finger Bag Broken
 RH Explosion Flap Open
 LH Explosion Flap Open
 Needle Air Pressure Low
 Dew point temperature low
 Dew point temperature high
 Spray Gun Choked
 Main air pressure low
 Etc.

Raktim Dey
Dy. Manager-Validations & Qualifications
Granules India Limited, Place: Hyderabad
 A Brief outline for a typical PLC/SCADA system Qualification of Process Equipment
(Example: FBP)
S.No OQ Tests Remarks

Few of the Interlocks are as follows:

 Container seal- appropriate interlock should
generate with alarm, if container not sealed
properly.
 Bag not sealed- appropriate interlock should
generate with alarm, if bag not sealed properly.
 Atomizing should be ON- appropriate interlock
should generate with alarm, if atomizing
pressure is not ON
 Etc.
7 Verification of Power failure Verify the Recipe parameters before and after power
condition failure- parameters should not change once power is
resumed after a power failure.

8 Verification of Communication Communication error should be displayed on IPC.

failure condition
9 Verification of Reports
Verify Recipe parameters before and after
communication failure- parameters should not
change once communication is re-established after a
communication failure.
Verify the following reports, but not limited to:
 Batch Report-Batch report shall be generated
with user name, report generated by, and with
time/date stamp in a non-editable format.
 Event Report-Event report shall be generated
with time/date stamp, operator, details of
events, details of changes made, runs and report
generated by, in a non-editable form.
 Alarm Report-Alarm report shall be generated
with Diagnosis name, report generated by with
time/date stamp, in a non-editable form.

10. Back up and Data restoration Verify the following:

Auto Back up- Auto back up of data shall be saved
in selected path as per the specified periodic
interval.
Data Restore Verification-Reports should not open
after data is moved to designated folder and shall
open only after data is restored to its desired
location.

Note: Remember to capture Screen Shots for each of the OQ tests

Raktim Dey
Dy. Manager-Validations & Qualifications
Granules India Limited, Place: Hyderabad