OPERATIONAL QUALIFICATION (OQ) FOR B.O.D. INCUBATOR INCUBATOR Model no.: ………….. Validation protocol no: ______________________________
Approval: Doc Prepared By : _____________________________________________Date:___________________ Approved By: ___________________________________Date: __________________
DJPL/7.5.2/F-5/R3
OPERATIONAL QUALIFICATION PROTOCOL OF B.O.D. Incubator, Model no.: ………………….
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TABLE OF CONTENT
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.
Objective Scope Responsibility Procedure List of measuring devices in the instrument requiring calibration List of standard apparatus and instruments required for performing calibration Calibration Record List of attachments List of documents (SOPs/manual) List of operators trained Acceptance Criteria For Operational Test a. Test in normal condition b. Test of worst case situation 12. Deviation Report 13. Operational Qualification Report Appendices
Performed by__________________________________________________ Date ____________________ Verified by ____________________________________________________ Date ____________________
DJPL/7.5.2/F-5/R3
OPERATIONAL QUALIFICATION PROTOCOL OF B.O.D. Incubator, Model no.: …………………. Name of equipment: B.O.D. Incubator
Date _______________ Date _______________ Date _______________ Date _______________
Objective: To determine that B.O. D. low temperature incubator, model no. …………….) operates according to its requirement, and to record all relevant information and data to demonstrate it functions as expected _____________________________________________________________________________________________ 1.
2. Scope: To be performed at time of operation, modification or relocation as per SOP. _____________________________________________________________________________________________ 3. Responsibility: 1. Approving body as listed above will be responsible for approving the protocol prior to the beginning of the qualification work. 2. Qualification performers: Officers from the Engineering Department, Production Department where the instrument is installed and QA Department. QA Assistant Officers can also be involved during machine qualification. 3. Qualification performers will observe the operation of instrument and collect and verify the test results. 4. One of the qualification performers will initial in “ performed by” and HOD QA shall initial in “verified by”. 5. Validation Manager will approve the OQ report.
Performed by__________________________________________________ Date ____________________ Verified by ____________________________________________________ Date ____________________
DJPL/7.5.2/F-5/R3
OPERATIONAL QUALIFICATION PROTOCOL OF B.O.D. Incubator, Model no.: …………………. 4.
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Procedure:
1.
Prepare a checklist for instrument functional test, its functional specification and critical operating parameters. 2. Prepare and approve SOPs for operation and cleaning of the instrument. 3. Provide training to the operators for the systems of instrument and record it. 4. Have OQ protocol approved by the approving body. 5. Test and Record the calibration data for calibrating apparatus and instruments. 6. Measure and record the results of specific challenge to the instruments in worst condition where appropriate. 7. Record any deviations to the instrument, its operation. 8. Prepare a Deviation Report including the justification of acceptance and impact on the function. 9. Prepare an OQ Report: This should include date of study initiated; completed; observations made; problems encountered; completeness of information collected; summary of deviation report; results of tests, location of original data other relevant information; and conclusions on the validity of the installation. 10. Submit the report for review and approval.
Performed by__________________________________________________
Date ____________________
Verified by ____________________________________________________ Date ____________________
DJPL/7.5.2/F-5/R3
OPERATIONAL QUALIFICATION PROTOCOL OF B.O.D. Incubator, Model no.: …………………. 5.
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List of measuring devices in the instrument requiring calibration.
Name of the monitoring devices 1.
Programmable Digital Temperature Controller
2. 3. 4. 5.
6.
List of standard apparatus and instruments required for performing calibration:
Name of the Apparatus/instruments
Code no:
1.
Digital Multi meter
-
2.
Ammeter
-
3.
Calibrated Thermometers
-
4.
Spirit Level
-
5.
7.
Calibration validity
-
Calibration Record
Name of the measuring devices Digital Multi meter
Calibrated date
Calibration method
Acceptable Value/Range
NA
Calibrated Thermometer Calibrated Thermometer
Observation (A/N) Acceptable
(-0 to 360)oC
Acceptable
(0 to 300)oC
Acceptable
Note: A- Acceptable and N- Not acceptable
Deviations if any:_______________________________________________________________________________ _____________________________________________________________________________________________ Performed by__________________________________________________
Date ____________________
Verified by ____________________________________________________ Date ____________________
DJPL/7.5.2/F-5/R3
OPERATIONAL QUALIFICATION PROTOCOL OF B.O.D. Incubator, Model no.: …………………. 8.
List of documents (SOPs and/ or manual required for operation)
QC Sop no
of B.O.D Incubator
10. List of operators trained
S. No.
Name
Sign
Date
Deviations if any:_______________________________________________________________________________ _____________________________________________________________________________________________ Performed by__________________________________________________
Date ____________________
Verified by ____________________________________________________ Date ____________________
DJPL/7.5.2/F-5/R3
OPERATIONAL QUALIFICATION PROTOCOL OF B.O.D. Incubator, Model no.: ………………….
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11. Acceptance Criteria For Operational Test Test in normal condition (if applicable): a.
Operating Criteria
S.NO.
1.
Acceptance Criteria
Pass/Fail
Sign
Date
Electrical Connection
Switch on the main toggle at Switch ON position. 2. Rotate main heat switch knob. 3.
Switch OFF the main toggle at off position
4.
Press push button of PLC controller.
5.
Switch ON the mains and load the tray with materials at a gap of 3 to 4 cm between two articles and the incubator wall. Set the temperature (SV) and record the temperature shown in (PV) display.
6.
Fluorescence lamp
Deviations if any:______________________________________________________________________________ _____________________________________________________________________________________________ Performed by__________________________________________________ Date ____________________ Verified by ___________________________________________________
Date ____________________
DJPL/7.5.2/F-5/R3
OPERATIONAL QUALIFICATION PROTOCOL OF B.O.D. Incubator, Model no.: ………………….
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b. Test of worst case situation (if applicable):
Tests
Results
Status Pass/Fail
Sign
Date
_________________________________________________________________________________________________ Deviations:____________________________________________________________________________________ _____________________________________________________________________________________________ _____________________________________________________________________________________________ Performed by: ______________________________________________________
OPERATIONAL QUALIFICATION PROTOCOL OF B.O.D. Incubator, Model no.: ………………….
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12. Deviation Report
Report written by: _____________________________________________________ Date ___________________ Verified by: __________________________________________________________ Date ___________________
DJPL/7.5.2/F-5/R3
OPERATIONAL QUALIFICATION PROTOCOL OF B.O.D. Incubator, Model no.: ………………….
