Operational Qualification is the next step after installation qualification in an equipment validation activity. This test is performed after the equipment is satisfactorily installed, and the buyer and manufacturer verify its installation. This article discusses what is an operational qualification, its template and some common checklist.
What is operational Qualification?
In operational Qualification, the equipment’s operation is validated against the designed parameters agreed upon during the design qualification phase. The equipment is run with the actual product and actual process parameters.
Operational Qualification’s main aim is to ensure that the equipment can operate with the desired process parameters, agreed upon during the design qualification. It also helps detect deviations in equipment operation, enabling both parties to put forward an action plan for resolving the issue.
Additionally, regulatory bodies such as the United States Food and Drug Administration critically review the Operational Qualification documents during their routine inspection. These regulatory bodies can issue warning if quality personnel do not perform and maintain Operational Qualification documentation.
Operational Qualification template
There is no fixed template for operational qualification. The only requirement is that every piece of information and test should be included in the OQ test.
The common format for the OQ test includes a tabular form with columns indicating desired test, its acceptance criteria, and the result, as shown below.
| S.No. | Test | Acceptance
Criteria |
Result | Pass / Fail |
In the above format, the following is the explanation of each column
- Test: It is the equipment’s process which is under investigation
- Acceptance Criteria: The desired response, making the test satisfactory
- Result : Actual output of the test
- Pass / Fall: Whether the result is according to the acceptance criteria or not. If it is according to the acceptance criteria, the test is marked Pass. Otherwise, fail.
Operational Qualification Checklist
Operational Qualification includes a series of tests to verify equipment operation against standard parameters. Before conducting OQ, tests are prepared in advance. The manufacturer and buyer both review and comment on it, and after approval of both parties, Operational Qualification is executed.
Common tests in Operational Qualification include the following.
Process Parameters
In this test, the equipment’s process parameters are checked. The process parameters should meet the specifications agreed upon during the design phase.
Qualification of process parameters is necessary because they impact the production process and final product. Any deviation in these process parameters drifts the final product away from standard specifications.
Some process parameters and their acceptance criteria can be as follows.
| S.No | Test | Acceptance Criteria | Result | PASS / FAIL |
| 1 | Pressure
(chamber pressure) (vessel pressure)
Vacuum Pressure
Pressure variation
|
The chamber / vessel pressure must be at __ bar
The vacuum pressure must be ___bar
The pressure variation should remain within ____ bar
|
___ bar
___ bar
___ bar |
|
| 2 | Temperature
(chamber) (forming, heating, sealing) (Fluid Bed Dryer)
Temperature variation
|
The temperature must be ___ ⁰C
The temperature must remain in the range of ___ ⁰C |
___⁰C
___⁰C |
|
| 3 | Time
(sterilization) (Mixing, Granulation) |
The time must be within ____ sec of external calibrated timer | ___ secs | |
| 4 | Machine Speed
Run the machine at ____ / sec or /min, and verify it with external calibrated speedometer
|
Variation in machine speed must be within ___ min / secs | min / secs |
Safety System
In this stage, safety systems are verified.
The main aim of this test is to check whether the manufacturer has included all the safety mechanisms as agreed during the design phase. Additionally, whether these are active and perform according to the agreed specifications.
Some safety system check, common in operational qualification include the following
| S.No | Test | Acceptance Criteria | Result | PASS / FAIL |
| 1 | Emergency switch
Emergency switch working
|
Emergency switch should be installed at
· Front panel · Rear side · Discharge / end
Machine should immediately stop, without completing the cycle
|
||
| 2 | Temperature safety system
Alarm indication |
When temperature exceeds ___⁰C, it immediately aborts the process
Alarm indication on the front panel / HMI / front display
|
||
| 3 | Pressure safety system
Safety valve
Alarm indication |
When pressure exceeds ___ bar, it immediately aborts the process
Safety valve should open and immediately releases the pressure until pressure becomes normal
Alarm indication on the front panel / HMI / front display |
||
| 4 | Machine guarding | All the moving parts should be cover by suitable covering, to eliminate human contact during its motion
Machine should not start, when these guards are not in place
Machine should stop, if these guards are removed in running machine. |
||
| 5 | Human safety sensors | All the moving parts should include sensor, that detects the human presence
These sensors should stop machine operation with alarm indication when any human enters its vicinity
|
Main Control Panel
In this test, all control elements on the main panel are verified according to the specifications agreed upon during the design qualification stage.
Some common tests in this stage include the following
| S.No | Test | Acceptance Criteria | Result | PASS / FAIL |
| 1 | Power Button
Press the Power – ON button
Press the Power – OFF button
Human Machine Interface / Graphical display
|
Machine should start with · HMI powered-up · Power indication on
Machine should powered – OFF disabling all Electronic, Electrical and Mechanical systems
HMI should display company logo with welcome screen |
||
| 2 | Start button
Press the start button |
Machine process should start | ||
| 3 | Stop button
After process is started, press the stop button |
Machine should stop process | ||
| 4 | Reset button | All alarm should reset | ||
| 5 | Emergency button
Press the emergency button |
Machine should immediately stop without completing the cycle | ||
| 6 | Printer | Printer should print all parameters when this button is pressed | ||
| 7 | Indications
· Start
· Stop
· Machine Running
· Emergency |
When start button is pressed,, indication should powered – up
When stop button is pressed,, indication should powered – up
When machine is normally running, this indication should ON
Emergency indication should ON, when Emergency button is pressed
|
Software System
This test verifies software systems according to the specifications agreed upon during the design qualification phase.
This test ensures that the manufacturer has provided all the software requirements.
Some common tests in this stage include the following.
| S.No | Test | Acceptance Criteria | Result | PASS / FAIL |
| 1 | Operating Software | The operating software must be of _____ make with ________ model and ______version | ||
| 2 | HMI software and version | The HMI software must be ________ with _____ version | ||
| 3 | Batch Record | The software must be able to record details of previous batches up to ___ days / months / year | ||
| 4 | The software must print all the batch parameters of a process | |||
| 5 | Audit Trail
· Click the audit trail button
· Click show data |
Audit trail screen should appear Screen should appear indicating each process of software amendments with time date, and User ID |
Login Credentials
Login ID and Password levels are verified in this test according to the specifications agreed upon during the design qualification phase.
Common tests in this stage include the following.
| S.No | Test | Acceptance Criteria | Result | PASS / FAIL |
| 1 | Press the Login button | Login screen should appear | ||
| 2 | Enter User ID and its relevant Password | HMI should show screen with relevant user level | ||
| 3 | Enter Incorrect Login ID and Password | Login ID and Password should fail and restricts access. |