- Table of Contents
- Pre-Approval
- Objective
- Scope of this Document
- Acceptance criteria
- Responsibility
- Protocol Executor
- Installation Qualification Test Plan
- List of Reference Drawings
- Material History Chart
- Bought-Out Components
- Safety feature Identification
- Instrument Details and Calibration Status
- Verification of safety
- Dimensional Measurement
- Operational Qualification test plan
- Machine Functional Test
- Power Supply Test
- Key functionality test
- Display Functionality Test
- Alarm Verification Test
- Equipment Trial Run
- Exception Report Log
- Exception Report Form
- List of Annex
- Reference
- List of Abbreviation
- Glossary
- FAT Report
- FAT Report Approval
Pre-Approval
This FAT protocol is prepared By:
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Functional Area |
Name |
Designation |
Signature |
Date |
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Validation |
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This FAT protocol is reviewed by the following functional areas:
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Functional Area |
Name |
Designation |
Signature |
Date |
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Technical Reviewer |
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User Department |
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Engineering |
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Quality Assurance |
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This FAT protocol is approved by:
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Functional Area |
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Date |
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Head Operation |
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Head Quality |
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- The fabrication and assembly of the equipment and any auxiliary support systems by physical inspection and testing conforms to the parameters as defined in the URS and Design Qualification.
- All design Documents, specifications and test certificates are approved, available and accurate.
- Physical Inspection of the electrical hardware.
- Functional testing (including safety tests) of the equipment, with printouts for tests that require supporting documentation.
Scope
Acceptance criteria
- The design documents specifications and test certificates shall be approved and accurate. The electrical hardware shall comply with the approved design specifications.
- The individual tests performed shall conform to the agreed acceptance criteria.
- Any tests not performed (due to limitations of resources, complexity of the complete assembly of the equipment and complexity of the tests) during the FAT shall be performed during the SAT or OQ of the equipment at site and shall clearly indicate these tests.
- If any deviations from the approved protocol occur or the user requests any changes, these deviations shall be reviewed by the SAT or OQ execution team, agreed upon and then hand marked in the original protocol with initials and date.
- The vendor shall agree upon an action plan on the corrective actions with mutually agreed time frame.
- The FAT may be repeated fully or in part (related to the deviation observed) depending upon the impact of the deviation.
Responsibility
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Department |
Responsibility |
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Supplier |
Execution
of FAT as per the protocol. Post
approval of the protocol. |
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Validation |
Preparation
and final review of the FAT protocol. Its
compliance to meet the acceptance criteria of the FAT protocol. Collection
and recording of data. Overall
co-ordination of the activity. Raise
of exception if required. |
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User Department |
Review
and approval of the FAT protocol. |
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Engineering |
Review
and approval of the FAT protocol. |
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Quality Assurance |
Review
and approval of the FAT protocol. |
Protocol Executor
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Name |
Department |
Designation |
Signature |
Initials |
Date |
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Reviewed By Name: Sign/Date:
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Section |
Test Description |
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1 |
List of Reference Drawings |
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2 |
Material History Chart |
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3 |
Bought-Out Components |
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4 |
Verification of Safety |
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5 |
Instrument Details and
Calibration Status |
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6 |
Safety Features Identification |
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7 |
Dimensional Measurement |
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8 |
Surface Finish
Report |
1. List of Reference Drawings
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Objective |
To
check reference drawing required for job against list mention below. |
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Requirements |
Approved
Drawings list |
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Test Procedure |
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Acceptance criteria |
The
drawings submitted shall be as specified in the list of reference drawing. |
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Sr. No. |
Title Of Drawing |
Submittal Stage |
Rev. |
Remarks |
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1. |
G. A. Drawing |
FAT |
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2. |
P & I Diagram |
FAT |
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3. |
Wiring Diagram |
FAT |
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4. |
Pneumatic diagram |
FAT |
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5. |
PLC Logic Diagram |
FAT |
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Remark:
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Performed by |
Checked by |
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Name |
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Signature |
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Company Name |
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Date |
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Objective |
To
prove that the materials used for construction of components are as per the
DR specification/ Approved drawing. |
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Material |
Material
test certificates. |
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Method |
The
Vendor shall present certificates for the materials listed in the “Material History
Chart”. The
submitted certificates shall be checked for correct material usage against
the details submitted in the DR, by the vendor. |
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Acceptance criteria |
The
certificates shall prove that the materials used for construction of
components are as per the approved specifications. |
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Sr. No. |
Part Description & Size |
Acceptance Criteria |
Result |
Remarks |
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Material |
Certificate No. |
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2. |
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3. |
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4. |
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5. |
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6. |
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Performed by | Checked by | |
Name | ||
Signature | ||
Company Name | ||
Date |
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Objective |
To
prove that Bought Out components used for construction of the equipment are
as per the approved specifications. |
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Material |
Bought
Out component’s specification sheets (From the original manufacturer) |
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Method |
The
Vendor shall present previously approved specification sheets for the Bought-Out
components listed in the “Bought Out components list” for review at the start
of the FAT exercise. Inspect
the installed component. Compare Quality Certificate of the component the
make, Model No. and other specifications with the approved specifications. |
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The
verification shall prove that the Bought Out components used for construction of the equipment is as per
the approved specifications. |
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Sr. No. |
Component |
Make |
Certificate Type |
QTY. |
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MECHANICAL COMPONENTS |
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2. |
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3. |
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ELECTRICAL COMPONENTS |
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Performed by | Checked by | |
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Company Name | ||
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4. Safety feature Identification
To identify and list all Safety features for proper installation on the equipment.
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Sr. No. |
Safety feature description |
Properly Installed (Yes/No) |
Sign/Date |
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Remark:
Performed by | Checked by | |
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Company Name | ||
Date |
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Instrument Name |
Instrument ID |
Calibration Date |
Calibration
Due Date |
Pass/Fail |
Sign/Date |
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Objective |
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Requirements |
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Test Method / Instrument |
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Test Procedure |
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Acceptance criteria |
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Verification |
Specified Results |
Result |
Sign/Date |
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Pass |
Fail |
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Exception Report (If applicable) |
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Performed by | Checked by | |
Name | ||
Signature | ||
Company Name | ||
Date |
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Objective |
Dimension
check against Approved GA Drawings. |
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Instruments |
Measure
Tape 0-3000mm, Vernier Caliper 0- 300 mm, |
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Method |
Direct
measurement of Overall dimensions, Connection Points. Install the plant on
the suitable place. Measure
the indicated dimensions and fill in the dimension report. |
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Acceptance Criteria |
All
the measured dimensions shall be within the dimensional tolerances. |
Dimension checks
Overall dimension: height (h), length (l), width (w)
Utility connections checks
Check dimension against ga drawing. E.g. Feed water inlet, steam water inlet
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Sr. No. |
Parameter |
Value from G.A Drawing (mm) |
Actual Value (mm) |
Conclusion |
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1 |
Overall Height H |
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Overall Width W |
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3 |
Overall Depth D |
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Sr. No. |
Description |
Value from GA Drawing |
Actual Value |
Corresponding / Non corresponding |
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2. |
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3. |
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Performed by | Checked by | |
Name | ||
Signature | ||
Company Name | ||
Date |
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Objective |
To
check the surface finish of the surface of the plant and to verify against the
approved drawing requirement. |
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Instruments |
Surface
Finish Tester |
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Method |
Check
the Surface Finish of the product contact surfaces with the calibrated
Roughness Tester according to the instrument manual. Wipe
dry the surfaces using a moist cloth and check for any fibers getting caught
by the surface rubbed. Measure
the indicated surfaces at 3 different points. Results shall be recorded. |
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Acceptance Criteria |
All
the surfaces tested shall meet the requirements. |
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Surface |
Checking Point |
Accessibility limit (µm RA) |
No of measurements |
Actual Value (µm RA) |
Conclusion |
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1 |
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≤ 0.60 |
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2 |
1 |
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1 |
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≤ 0.60 |
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1 |
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Performed by | Checked by | |
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Signature | ||
Company Name | ||
Date |
Operational Qualification test plan
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Section |
Test Description |
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1 |
Machine Functional
Test |
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2 |
Power Supply Test |
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3 |
Key functionality
test |
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4 |
Display functionality
test |
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5 |
Alarm Verification
test |
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Objective |
To
check the power supply on/off. |
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Requirements |
Utilities
as required |
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Test Method / Instrument |
Operational |
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Test Procedure |
Turn
on the mains. Check
the machine for power supply. Turn
off the mains, the power to machine shall be OFF. |
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Acceptance criteria |
System
gets start only after keeping mains ON and get OFF after keeping mains OFF. |
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Verification |
Specified
Results Visually
check that system gets switched ON after keeping mains ON. Visually check
that system gets OFF after keeping mains OFF. |
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Exception Report (If applicable) |
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Performed by | Checked by | |
Name | ||
Signature | ||
Company Name | ||
Date |
- Check that all the displays on the panel are properly Labeled / Identified.
- Turn on the power from the electrical panel.
- Set the control (s) on the panel.
- Verify functionality of each component on the panel against its Specified functions.
- Observe and record the responses of the control panel.
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Sr. No. |
Key / switch Description |
Specified Function |
Results Satisfied (Yes / No) |
Checked By (Sign/Date) |
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2. |
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3. |
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4. |
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5. |
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Performed by | Checked by | |
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Signature | ||
Company Name | ||
Date |
3. Display Functionality Test
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Sr. No. |
Key Indicator |
Specified Function |
Results Satisfied (Yes / No) |
Checked By (Sign/Date) |
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1. |
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2. |
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3. |
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4. |
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5. |
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Performed by | Checked by | |
Name | ||
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Company Name | ||
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Objective |
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Requirements |
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Test
Method / Instrument |
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Test
Procedure |
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Acceptance criteria |
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Verification |
Specified Results |
Result |
Sign/Date |
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Pass |
Fail |
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Exception
Report (If
applicable) |
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Performed by | Checked by | |
Name | ||
Signature | ||
Company Name | ||
Date |
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Objective |
To
carry out equipment trial run for observing performance/operation of all the items
installed on the equipment. |
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Method |
Perform
the operations as per Instruction given in the manual. |
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Acceptance Criteria |
Equipment
shall run as per the procedure given in the manual. |
Performed by | Checked by | |
Name | ||
Signature | ||
Company Name | ||
Date |
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Exception Report No. |
Description |
Status Open/Closed |
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Validation Exception
Report Number: |
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1. Identification
of Exception |
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Test Affected |
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Date of Occurrence |
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Date of Observation |
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Date QA Notified |
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QA Initial Date |
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2. Nature of Exception |
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3. Root Cause Investigation |
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4. Impact of Exception |
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5. Corrective Actions |
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Prepared By Name:
Signature: Date: |
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6. Approval to Proceed Signatures
below indicate the relevant department managers and QA Validation Compliance
concur with root cause analysis and approve the implementation of proposed
corrective actions. Where
no corrective actions are required or implementation of actions was required prior
to preparation of this report, these signatory boxes may be lined out and
Section 8. Signatures shall represent Approval to proceed. |
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Validation Manager or
Delegate |
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Validation Exception
Report Number: |
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Name: |
Signature: |
Date: |
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Responsible Area Manager
or Delegate Area: Name: Signature: |
Date: |
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QA Manager or Delegate Name: |
Signature: |
Date: |
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7. Corrective Action
Verification |
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Prepared By Name: |
Signature: |
Date: |
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8. Exception Report
Approval Signatures
below verify that: The
stated actions have been implemented and are deemed appropriate to resolve the
exception. Where
actions were completed prior to preparation of the report, justifications
provided in Section 5. Adequately explain why actions were required in
advance. Where
actions have not been implemented, the ongoing actions are assigned to XXX quality
systems. The ongoing actions are appropriately referenced in the report and
are traceable to conclusion. The
exception report number is listed on the deviation log associated with the
protocol document and will be included in the final validation package. |
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Validation Manager or
Delegate Name: Signature: |
Date: |
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Responsible Area Manager
or Delegate Area: Name: Signature: |
Date: |
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QA Name: |
Signature: |
Date: |
List of Annexures
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Sr. No. |
Details of Annex. |
Annex. Number |
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1 |
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2 |
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3 |
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4 |
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5 |
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Abbreviations |
Full Form |
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Glossary
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Qualification terms |
Definition |
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User Requirement Specification (URS) |
User
Requirement Specifications (URS) are prepared for each critical utility or
piece of equipment prior to the manufacturing stage. The specification provides
a list of requirements for the planned system. The User Requirements
Specification specifies the needs of the end user as well as any regulatory requirements. |
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Design
Qualification (DQ) |
Detailed
Design Specifications (DDS) are prepared for each critical utility or price of
equipment prior to the manufacturing stage. The specification provides a
detailed description of the utility or piece of equipment design based on the
Functional Requirement Specification (FRS) document. |
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Factory
Acceptance Test (FAT) |
The
Factory Acceptance Test protocol provides documented evidence that a piece of
equipment, system or integrated process has been adequately tested at the manufacturer’s
facility and performed to the end user’s expectations prior to the piece of
equipment, system, or integrated process being delivered to the end user. |
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Site
Acceptance Test (SAT) |
A
Site Acceptance Test protocol provides documented evidence that a piece of
equipment, system, or integrated process that has been delivered to the end user
has not been affected in the transportation and has been adequately tested at
the end user’s facility and performed to the end user’s expectations after Operational. |
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Installation Qualification
(OQ) |
The
documented verification that the facilities, systems and equipment, as installed
or modified, comply with approved design and manufacturer’s recommendations. |
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Operational
Qualification (OQ) |
The
documented verification that the facilities, systems and equipment as installed
or modified, perform as intended throughout the anticipated operating ranges. |
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Performance
Qualification (PQ) |
The
documented verification that the facilities, systems and equipment, as
connected together, can perform effectively and reproducibly, based on the approved
process method and product specification. |
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Standard
Operating Procedure (SOP) |
Standard
Operating Procedures (SOP) are prepared for each critical utility or piece of
equipment to provide all personnel working with the equipment information and
instructions on what is required in order to maintain, operate and clean the utility
or piece of equipment. |
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Critical
Equipment / Parameter |
Describes
a process step, process condition, test requirements, or other relevant parameter
or item that must be controlled within predetermined criteria to ensure that the
product meets the specification. Non-Compliance to which would impact the product
or patient safety, stability or efficacy. |
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Amendment |
Additional
data to an approved protocol and summary report that further substantiate and
clarify the original acceptance criteria. |
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Validation / Qualification |
The
documented act of proving that any procedure, process equipment, material activity,
or system actually leads to the expected results. |
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Re-qualification |
Re-qualification
is the repetition of the prospective qualification study or a specific
portion of the study to demonstrate that the system under investigation
operates as expected. |
Summary of the results obtained:
Significant
deviations observed:
FAT Report Approval
Supplier Signature
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Functional Area |
Name |
Designation |
Signature with stamp |
Date |
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Supplier |
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This FAT protocol is compiled by following functional areas:
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Functional Area |
Name |
Designation |
Signature |
Date |
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Validation |
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Functional Area |
Name |
Designation |
Signature |
Date |
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User Department |
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Engineering |
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Quality Assurance |
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Functional Area |
Name |
Signature |
Date |
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Head Operation |
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Head Quality |
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