Professional Documents
Culture Documents
INSTALLATION / OPERATIONAL
QUALIFICATION PROTOCOL
Document Author
Name Position Signature Date
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Approval
Name Position Signature Date
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IOQ Centre logo can be inserted here
1. APPROVALS
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Comments
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Comments
TABLE OF CONTENTS
Section Page
1. APPROVALS..............................................................................................................................................................2
2. DOCUMENT CONTROL..........................................................................................................................................3
3. INTRODUCTION & SCOPE.....................................................................................................................................4
4. DATA COLLECTION................................................................................................................................................5
5. NON-CONFORMANCES..........................................................................................................................................6
6. PERSONS PERFORMING IOQ................................................................................................................................6
7. PRE-REQUISITES TO COMMENCE IQ SECTION................................................................................................7
8. INSTALLATION CHECK (IQ)..................................................................................................................................8
9. COMMISSIONING CHECK (IQ)...........................................................................................................................10
10. PRE-REQUISITES TO COMMENCE OQ SECTION............................................................................................12
11. FUNCTION & ALARM CHECKS (OQ).................................................................................................................13
12. TEMPERATURE MAPPING STUDY (OQ)...........................................................................................................15
13. INTERNAL SOP AND TRAINING REVIEW (OQ)...............................................................................................20
14. SUMMARY OF TESTS PERFORMED..................................................................................................................22
15. list of Appendices......................................................................................................................................................23
2. DOCUMENT CONTROL
3.1 Introduction
The purpose of this IOQ is to qualify the refrigerator (detailed below) to confirm that it has been installed according to
the design intent and operates in accordance with the manufacturers specifications, drawings and other relevant design
documents.
The IOQ will cover the following refrigerator:
Equipment Name Make & Model Identification No. Location
Refrigerator
4. DATA COLLECTION
All written data will be entered using a blue or black indelible pen in clear handwriting at the time of testing or
completion.
All dates will be entered in the International Standard format, i.e. 01 Jun 2008. American format (MMM DD YY) must
not be used.
Mistakes and errors will be crossed out using a single line and correction made in blue or black pen. Correction fluid
must not be used.
The person responsible for the correction must initial and date any corrections, with any appropriate explanation, at the
time of change.
Ticks, crosses and dittos must not be used. The checker should indicate the appropriate response by his/her
initials.
Deviations from approved test procedures or acceptance criteria will be made by crossing out and a suitable explanation
for the change given. The change will be signed and dated by the person instigating the change. If there is a significant
change this may require a higher level of approval.
All empty or incomplete boxes will be scored through. They should be annotated as non applicable with N/A, and
initialled and dated.
All attachments and appendices will be cross-referenced in the protocol and signed and dated.
All drawings/schedules/quotations etc. will be marked up in accordance with the relevant protocol test instructions to
indicate compliance, non-compliance and deviations from the expected result.
The following highlighter pens will be used for marking up documents and drawings: -
Yellow indicates compliance with the drawing/schedule etc.
Blue indicates non-compliance with the drawing/schedule etc.
Green indicates areas that were unable to be checked and should be accompanied by a simple explanation
Where the documentation is to be stored electronically, any raw data or supporting documents must be scanned in.
If the protocol is to be completed electronically, the document must have adequate security to avoid amendment and
alteration to the completed protocol.
5. NON-CONFORMANCES
Where there are failures or deviations in meeting some or all of the agreed approved acceptance criteria during the
execution of protocols, the impact of the failure is assessed and categorised and formally documented on a non-
conformance form for control and close out.
The non-conformance solution must be approved by a responsible person before the protocol can reflect closure.
Comments on corrective action taken to resolve the non conformance are documented on the form and the form is held
with the appropriate protocol for traceability and reference
Non conformances are encountered when the equipment/system/process does not agree with or operate to the specified
design criteria.
A non-conformance also arises when the specification, test method or acceptance criteria has been incorrectly defined in
the protocol.
Categorising of non-conformance is as per the table below:
Category Description Required Action
Non-conformances which have either no The process of qualification may continue, only
Low impact or a negligible impact on gametes or following review of the non-conformance and
embryos with signed acceptance
All personnel entering information in this protocol must be identified in the table below by name, affiliation, full
signature and initials.
Personnel must be fully aware of all the procedures to follow, specifically procedures for data collection and recording
discrepancies.
Name Company Signature Initials Date
8.1 Objective
To verify that the refrigerator has been installed to a satisfactory standard and is safe to use.
To confirm there is adequate documentation to support the on-going operation and maintenance of the refrigerator.
8.2 Pre-Requisites
Pre-Requisite Description Initials Comments
Table 2
Check Comment
8.6 Conclusion
This section of the protocol has been completed and is deemed to (initial appropriate box below):
Comments Non-conformance
9.1 Objective
To verify that the refrigerator has been satisfactorily commissioned and a commissioning report has been provided by
the supplier.
9.2 Pre Requisites
Pre-Requisite Description Initials Comments
Table 2
Check Comment
The commissioning report has been adequately
completed and is signed and dated
9.6 Conclusion
This section of the protocol has been completed and is deemed to (initial appropriate box below):
Comments Non-conformance
11.1 Objective
To verify that all refrigerator components function correctly as specified for normal operation.
To verify that all alarms function as specified.
11.2 Pre Requisites
Pre-Requisite Description Initials Comments
Adjustments to environmental parameter operational set points must result in a corresponding response from the
refrigerator control system.
Environmental parameter alarms must trigger in accordance with the set points above.
11.5 Results
Table 1
Check Comment
Record temperature set points (for both operating level Operating Set Point:
and the alarm limits) and also confirm these meet the Low Alarm Set Point:
acceptance criteria High Alarm Set Point:
Hold door open to confirm the alarm activates and record
the delay time. Close door and confirm alarm de-
activates
Increase the temperature set point by 3oC. Confirm that
the refrigerator system responds to increase the
temperature and the alarm activates (visual and audible)
when temperature exceeds alarm high limit
Ensure temperature set point is returned to the original
value on completion and confirm alarm de-activates
Table 1
Check Comment
Decrease the temperature set point by 3oC. Confirm
that the refrigerator system responds to decrease the
temperature and the alarm activates (visual and audible)
when temperature exceeds alarm low limit
Ensure temperature set point is returned to the original
value on completion and confirm alarm de-activates
11.6 Conclusion
This section of the protocol has been completed and is deemed to (initial appropriate box below):
Comments Non-conformance
12.1 Objective
To verify that the refrigerator functions correctly in maintaining the correct temperature conditions throughout.
To determine how quickly temperature limits are exceeded when the door is opened or when there is a significant loss
of power, and how quickly temperature returns to within operating limits once the door is closed or and/or power
restored.
Note: By simulating a loaded refrigerator, this will provide data to support Performance Qualification requirements.
12.2 Pre Requisites
Pre-Requisite Description Initials Comments
Refrigerator is filled with simulated product to represent
a typical full load
12.8 Results
12.9 Conclusion
This section of the protocol has been completed and is deemed to (initial appropriate box below):
Comments Non-conformance
13.1 Objective
To verify that appropriate Standard Operating Procedures (SOPs) have been identified to operate, clean and maintain
the refrigerator and these should be at least in draft format.
To confirm that a suitable level of training to operate, clean and maintain the refrigerator has been identified.
13.2 Pre Requisites
Pre-Requisite Description Initials Comments
A system is in place to formally issue and control
operating procedures and instructions
There is a system for identifying and documenting
training
Table 2
Date
Personnel Identified Description Pass / Fail
Performed/Planned
13.6 Conclusion
This section of the protocol has been completed and is deemed to (initial appropriate box below):
Comments Non-conformance
The following provides an outline summary of the test sections in this protocol.
Non
Check Pass / Pass with Comment / Fail
Conformance
No Details
IV Additional Data
APPENDIX I
NON CONFORMANCE FORMS
APPENDIX II
TEST INSTRUMENTATION CALIBRATION
CERTIFICATES & CALIBRATION DATA
APPENDIX III
TEMPERATURE MAPPING RESULT DATA
APPENDIX IV
ADDITIONAL DATA