Template for Installation Qualification Protocol
PURPOSE
To describe the Installation Qualification procedure to be used during qualification of Name of Equipment machine to define the Specification of the system in order to
Ensure that the equipment meets the specification as per Design Qualification (Doc Number).
Aid verification of the installation as per equipment general arrangement drawing
Ensure that the system installation meets acceptance criteria
Ensure that the equipment’s will be installed in accordance with current Good manufacturing Practices (cGMP).
SCOPE
This procedure applies to the installation qualification of Name of Equipment.
RESPONSIBILITIES
It is the responsibility of the manufacturer to prepare the installation qualification protocol as per Design Qualification
It is the responsibility of the client to check and approve the installation qualification protocol.
It is the responsibility of the manufacturer to perform all the specifications verification checks and tests with respect to installation qualification and compiling data in co-ordination with client.
PROCEDURE
The following requirement / practices apply to Name of Equipment, Installation Qualification activities:
Verify that major components are tagged or labelled with a unique ID number.
Verify that the equipment and instrumentation are clearly described as per vendor, model, capacity, materials of construction and any critical criteria.
Verify that systems are installed in accordance with approved engineering drawings and documents, which shall include the following
- General arrangement drawing.
- Installation specification; and
- Equipment manuals
INSTALLATION QUALIFICATION TESTS
The table below lists the tests to be performed as part of the Installation Qualification phase.
CRITICAL FEATURE
- Documents & Drawings Verification
- Verification of Technical Specification for
- In-House & sub-components / bought out items
- Utilities Verification
- Material of construction verification
Documents & Drawings Verification
Rationale – To verify that the documentation provides complete and correct technical references and permits servicing of the units.
Test equipment – None Required.
Procedure :
Verify that the required documents and drawings
Review the documents and drawings for completeness and exactness with the installed units.
Attach the copies of the drawings or reference the location from where they can be easily retrieved.
Any items in the installation, which are not conforming to the corresponding drawings, must be commented on in the appropriate space. List the non-conformances and the reasons for them in an attachment if necessary.
Acceptance Criteria :
The documents must be accurate and complete.
The drawing information must correspond to the physical installation.
Documentation Verification Results.
| Description | Document No |
| Installation, Operation and Maintenance Manual | |
| General arrangement drawing |
Conclusions / Comments:
PASS / FAIL
Verified By: _______________________ Date: ______________
Checked By: ________________________ Date: ______________
Verification of Technical Specification for In-House & sub-components / Bought out items
Purpose
To verify that each major component of the Name of Equipment, is present and identified.
Test Equipment
None Required
Note any deviations or discrepancies and recommend follow up action if required.
Confirm that the various components of Name of Equipment, is present and tagged as per specifications and drawings, in the proper number and configuration.
- Model Number
- Manufacturer
- Identification (Tag)
- Type
Confirm that identification name plates have been applied to the units and that these indicate the following (where applicable).
Procedure
Acceptance Criteria
All units and parts specified in design qualification and on latest revision of drawings must be present, documented and tagged.
Components Result (The rows shall be increased/ decreased as per requirement.)
| Description | Specification | Meets Spec. (Yes/No) | Verification Source |
Utilities Verification
Rationale – To verify that all necessary utilities are correctly installed.
Procedure :
- Confirm that utilities connections are configured as per specification and in compliance with local codes.
- Record the results in the table below. Note any deviations or discrepancies.
Acceptance Criteria
- All services and connections must be installed and documented.
- Utilities Specification Results (The rows shall be increased/ decreased as per requirement.)
| Description | Specified | Observation |
PASS / FAIL
Verified By: _______________________ Date: ______________
Checked By: ________________________ Date: ______________
Material of Construction Verification
Rationale – To verify that all assembly of Name of Equipment, has been manufactured as per the specification provided by the customer.
Test equipment – Moly testing unit (To identify 304 or 316 materials)
Procedure :
Put a drop of Molybdenum solution on the material to be tested.
Take battery & keep anode at one end of the material and cathode at Moly drop.
If the solution turns pink and stays for around one minute, then it is SS316 & if the solution turns pink and immediately vanishes, then it is SS304.
Acceptance Criteria
All material of construction for the Name of Equipment, shall meet the MOC provided in Design Qualification.
Material other than SS316 and SS304 are verified based on their material testing certificates provided by the Manufacturer.
Material of Construction verification Results (The rows shall be increased/ decreased as per )
| Description | Specification | Meets Spec. (Yes/No) | Verification Source |
Reviewed By: ________________________ Date: ______________
Verified By: ________________________ Date: ______________
PASS FAIL
Conclusions / Comments
Installation Qualification Tests Status
The table below lists the tests performed and related results.
| Test Number
|
Critical Feature
|
Pass / Fail | |
| Pass | Fail | ||
| Documents & Drawings Verification | |||
| Verification of Technical Specification for In-House & Sub-contract / bought out items. | |||
| Utilities Verification | |||
| Material of Construction Verification | |||
Data Analysis, Summary of IQ & Recommendations
Note: Any changes made in the system must be recorded in this sheet.
CONCLUSION
