Back After a week......!!
Today i'll explain a little about operational qualification, for that you need to know what does OQ exactly mean...!!
What is Operational Qualification ( OQ ) ?
The Operational Qualification Protocol is a collection of test cases used to verify the proper functioning of a system. The operational qualification test requirements are defined in the Functional Requirements Specification. Operational Qualification is usually performed before the system is released for use.Depending on your needs and the complexity of the system, Operation Qualification can be combined with Installation Qualification or Performance Qualification.Operational Qualifications should be approved before protocol execution. A copy of the unexecuted protocol should be kept in the validation package. The unexecuted protocol should be approved by the System Owner and Quality Assurance. The executed protocol should be signed by the tester and reviewed by the system owner and Quality.
What are the Sequence of steps those needed to be executed for OQ Approval ?
This will be first initiated with
1) Instrument Calibrations,
2) Leak & Vibration Test,
3) Key Functions,
4) Deviation & Corrective Action Report,
5) Observations and Review of Documents,
6) Conclusion,
7) Approval.
Now, i gonna make you each step very clear,
INSTRUMENT CALIBRATIONS :
The instruments identified for calibration during Installation
Qualification Protocol, calibrated and the observations and or
results to be recorded. Certificates provided by Supplier, In house and
external calibration reports to be enclosed as attachment to this Qualification
report.
The Guages and all the sensors were tabulated and a calibrated frequency and last calibration date will be mentioned to ensure they all were in proper working condition, which is shown below.
LEAK & VIBRATION TEST :
After checking all possible test functions, leak & vibration test
will be carried out to demonstrate, that the equipment is installed without any
leakages.
KEY FUNCTIONS :
The key functions will
be classified in the specific headings. Each function test shall be recorded in a separate
test data sheet specifying each test function action, expected output/result,
actual output/result, and remarks.
UTILITIES:
To identify the
utility services those are connected to the equipment, and to check that the
connected utility is giving the rated performance as per the requirement.
SIMULATION CYCLE :
After checking all possible test functions, minimum three process
simulation cycles will be carried out to demonstrate, that the equipment as an
integrated system is capable of achieving the desired results when operated as
per the set parameters.
Similar two trials need to be taken for consistency, if found ok then the simulation cycle will be completed, or else 3 successive trails should be taken,
DEVIATION & CORRECTIVE ACTION REPORT : [ IF FOUND ANY ]
Description of Deviation & Date observed:
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Person Responsible for Corrective Action & Date Assigned :
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Corrective Action Taken & Date Conducted :
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OBSERVATION AND REVIEW OF DOCUMENT :
The following prepared document is checked for any loopholes or mistakes that were need to be solved before approval,
SUMMARY & CONCLUSION :
This includes the comments of the persons who gonna review and and the approver comments, and their conclusion.
OQ DOCUMENT APPROVAL :
Now Its Time for Document Approval, if everything done perfectly, then it will be approved.
That's it......!!! Its Done now.......!! Cheers.......!!!!
Any queries feel free to contact us..... We are always happie to help :)
Hi! I am Ajay Kumar Kalva, Currently serving as the CEO of this site, a tech geek by passion, and a chemical process engineer by profession, i'm interested in writing articles regarding technology, hacking and pharma technology.
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Follow Me on Twitter AjaySpectator & Computer Innovations
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