TABLE OF CONTENT
- Preapproval
- Objective
- Scope
- Responsibility
- Acceptance Criteria
- Installation Verification
- Operational Verification
- Deficiency and Corrective Action Taken
- Requalification Criteria
- Combined Installation/Operation Qualification Report
- List of Annexure
- Reference
- Post approval
PRE APPROVAL
- This protocol for Combined Installation/Operation Qualification (IOQ) of Weighing Balance (Equipment ID: ) to be used for weighing of material in warehouse department has been Prepared, checked, reviewed and approved in accordance with standards and adequately reflects the tasks and deliverables necessary for Installation/Operation Qualification of the equipment/Instrument / System.
- The signature by below mentioned persons indicates that the documentation and information contained herein complies with applicable regulatory, corporate, divisional/departmental requirements, and current Good Manufacturing Practices.
Prepared by : Quality Assurance | ||
Name | Designation | Sign/Date |
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Reviewed by : Engineering | ||
Name | Designation | Sign/Date |
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Reviewed by : Store | ||
Name | Designation | Sign/Date |
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Reviewed by : Quality Assurance | ||
Name | Designation | Sign/Date |
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Approved by : Quality Assurance | ||
Name | Designation | Sign/Date |
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OBJECTIVE
- The Instrument/equipment have been installed in accordance with the design and user requirements and meets the set acceptance criteria and cGMP requirements as stipulated in this document.
- Each installed component complies with the engineering design and equipment data sheets/specifications.
- All supporting utilities are properly connected & equipment operations are verified for its intended use.
- The Scope of this protocol is limited to the Combined Installation/Operation Qualification (IOQ) of Weighing Balance (Equipment ID: ) is safely installed in the warehouse department (Powder Dispensing Room) at XYZ Ltd.
Functions | Responsible |
Preparation of Protocol | Quality Assurance Officer/ Executive |
Review of The Protocol | Quality Assurance, Engineering & Store Department |
Approval of The Protocol | Head Quality Assurance |
Execution of Activity As Per Protocol | Quality Assurance, Engineering & Store Department |
Preparation of Report | Quality Assurance Officer/Executive |
Approval of The Executed Protocol And Report | Head Quality Assurance |
- The equipment shall be complying with the specification.
- All supporting utilities of specified capacities are to be near the place of installation.
- All the specified installation checks are to have complied.
- The equipment and its components shall be operated as per the specified operating instructions mentioned in the protocol.
- All SOPs for the equipment should be checked and verified.
- All the functionality of equipment components, safety features, and Utility requirements to be checked and verified.
INSTALLATION VERIFICATION
EQUIPMENT DESCRIPTION | ||
Equipment Name | : | Weighing Balance |
Equipment ID | : |
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Instruction of filling Checklist:
- For the Installation Checklist of the equipment and utilities use the word “yes’’ to show its presence and use ‘No’ to indicate the absence.
- For identification of the components of the equipment and utilities use the word ‘Comply’ otherwise use ‘Does not comply’ to indicate non-compliance along with the mode of verification.
- Give detailed information in the summary and conclusion part of the Installation Qualification report.
- Whichever column is blank or not used ‘NA’ shall be used.
ALSO READ: SOP for Verification/Calibration of Balances by External Team
Installation Checklist:
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Sr. No. |
Statement |
Yes / No |
Checked By
(Sign/Date) |
Verified
By (Sign/Date) |
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01 |
Verify
that the weighing balance is securely anchored and shockproof. |
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02 |
Verify that there is no observable physical
damage. |
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03 |
Verify that all electrical connections are done
properly |
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04 |
Safe electrical connections. |
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05 |
The equipment is Vibration Free and there is no
any abnormal sound. |
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ALSO READ: Qualification of Walking Type Stability Chamber
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Equipment |
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Weighing Balance |
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Equipment ID |
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Location |
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Sr. No. | Equipment/ Components | Specification | Actual Observation | Checked By (Sign/Date) | Verified By (Sign/Date) |
1 | Manufacturer |
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2 | Model |
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3 | Serial No. |
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4 | Capacity |
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5 | Location |
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6 | Platform Size |
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7 | Accuracy |
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8 | Working Range |
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________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Identification of supporting utility:
UTILITY | Properly Identified & Connected (Yes/No) | Checked By (Sign/Date) | Verified By (Sign/Date) |
Electricity: Single phase, 220 - 240 V |
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________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Identification of Safety Features
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Sr. No. |
Safety Features
Description |
Function |
Checked By (Sign/Date) |
Verified By
(Sign/Date) |
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1 |
Earthing |
To avoid electrical shocks |
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ALSO READ: SOP for Calculation of Weighing Range of Analytical Balance
The following Standard Operating Procedures were identified as important for the effective Operation & performance of Weighing Balance.
Sr. No. | SOP Title | Identified By (Sign/Date) | Verified By (Sign/Date) |
1. | Operation & Cleaning of Weighing Balance. |
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________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
OPERATIONAL VERIFICATION
Instruction for filling out the checklist:
- In case of compliance with the Operational test, use either ‘comply or actual function/operation/value to show its presence/completion and use ‘Not comply to indicate the absence of the identity or Non-conformance.
- Give detailed information in the summary and conclusion part of the Operational qualification report.
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Sr. No. |
Functions/ Parameter |
Acceptance Criteria |
Comply / Not
Comply |
Checked By (Sign) |
Date |
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1. |
On switching Main
Switch to On position |
Main Power supply to
machine should on |
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2. |
Off switching Main
Switch to off position |
Main Power supply to
machine should off |
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3. |
Vibration during
operation |
Should be free from
vibration |
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Verification of supporting utility:
UTILITY | Observation | Checked By (Sign/Date) | Verified By (Sign/Date) |
Electricity: Single phase, 220V-240V |
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________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
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Sr. No. |
Safety Features
Description |
Function |
Checked By (Sign/Date) |
Verified By
(Sign/Date) |
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1. |
Earthing |
To avoid electrical
shocks |
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2. |
Connect the Power Cord
to the mains outlet and switch on the mains power |
Power of weighing
balance shall be ON. |
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3. |
Self-test and
subsequently display weight after ON the machine. |
The instrument goes
through the self-test and subsequently displays weight. |
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Sr. No. | System description | Test | Acceptance Criteria | Actual Observations |
1 | Repeatability Test | A mass at least 50% of the maximum load is weighed repeatedly and checked for consistency. | Result should be consistent. |
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2 | Corner Load Test | A mass at least 30% of the maximum load is weighed on all 4 sides of the weighing pan area. | Result should be consistent. |
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3 | Accuracy Test | Different masses ranging from minimum load to maximum load area weighed for accuracy. | Result should be consistent. |
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4 | Linearity Test | This test involves the use of 2 masses of 50% of the maximum capacity for checking the non-linearity of the instrument. | A mass should weigh same at all regions within the capacity of the instrument. |
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Sr. No. |
SOP Title |
Availability (Yes/No) |
Checked By (Sign/Date) |
Verified By
(Sign/Date) |
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1. |
Operation &
Cleaning of Weighing Balance |
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- There are any major changes that affect the operation of the equipment.
- After major breakdown maintenance is carried out.
- As per Requalification Frequency.
- Transfer/Shifting of Equipment.
Compiled By: Checked By:
(Sign & Date) (Sign & Date)
LIST OF ANNEXURES:
Sr. No. | Details of Annexures |
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Reviewed by : Engineering | ||
Name | Designation | Sign/Date |
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Reviewed by : Store | ||
Name | Designation | Sign/Date |
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Reviewed by : Quality Assurance | ||
Name | Designation | Sign/Date |
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Approved by : Quality Assurance | ||
Name | Designation | Sign/Date |
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