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 equipments 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.
| S.No | Description | Document No | Verified By | Date |
| 1 | Installation, Operation and Maintenance Manual | |||
| 2 | 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 | Initials | Date | ||
| 1. | |||||||
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 | Initial / Date
mm/dd/yy |
- Conclusions / Comments:
- PASS FAIL
- Verified By: ________________________ Date: ______________
- Reviewed 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 | Initials | Date |
- 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 | Deviation Found | ||
| Pass | Fail | Yes | No | ||
| 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
- AMENDMENT RECORD
| S. No. | Item Name | Remarks | Signature & Date |
- Note: Any changes made in the system must be recorded in this sheet.
- CONCLUSION
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