Installation/Operational Qualification Protocol of Weighing Balance

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

Reviewed by : Engineering
Name	Designation	Sign/Date

Reviewed by : Store
Name	Designation	Sign/Date

Reviewed by : Quality Assurance
Name	Designation	Sign/Date

Approved by : Quality Assurance
Name	Designation	Sign/Date

OBJECTIVE

The objective of this document is to provide a written guideline for the execution of the Combined Installation/Operation Qualification (IOQ) of Weighing Balance for static attributes to verify that:

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.

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SCOPE

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.

RESPONSIBILITY

Responsibilities of different department/personnel involved in different activities related to the Combined Installation/Operation Qualification of the Weighing Balance are defined below:

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

ACCEPTANCE CRITERIA

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	:

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.

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Installation Checklist:

The installation checklist is as follows:

Sr. No.	Statement	Yes / No	Checked By (Sign/Date)	Verified By (Sign/Date)
01	Verify that the weighing balance is securely anchored and shockproof.
02	Verify that there is no observable physical damage.
03	Verify that all electrical connections are done properly
04	Safe electrical connections.
05	The equipment is Vibration Free and there is no any abnormal sound.

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Verified By (Sign/Date)

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Verification of Equipment Description

Equipment	:	Weighing Balance
Equipment ID	:
Location	:

Sr. No.	Equipment/ Components	Specification	Actual Observation	Checked By (Sign/Date)	Verified By (Sign/Date)
1	Manufacturer
2	Model
3	Serial No.
4	Capacity
5	Location
6	Platform Size
7	Accuracy
8	Working Range

Verified By (Sign/Date)

Identification of supporting utility:

UTILITY	Properly Identified & Connected (Yes/No)	Checked By (Sign/Date)	Verified By (Sign/Date)
Electricity: Single phase, 220 - 240 V

Verified By (Sign/Date)

Identification of Safety Features

Sr. No.	Safety Features Description	Function	Checked By (Sign/Date)	Verified By (Sign/Date)
1	Earthing	To avoid electrical shocks

Verified By (Sign/Date)

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Identification of Standard Operating Procedure:

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.

Verified By (Sign/Date)

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.

Operational Qualification Test:

Sr. No.	Functions/ Parameter	Acceptance Criteria	Comply / Not Comply	Checked By (Sign)	Date
1.	On switching Main Switch to On position	Main Power supply to machine should on
2.	Off switching Main Switch to off position	Main Power supply to machine should off
3.	Vibration during operation	Should be free from vibration

Verified By (Sign/Date)

Verification of supporting utility:

UTILITY	Observation	Checked By (Sign/Date)	Verified By (Sign/Date)
Electricity: Single phase, 220V-240V

Verified By (Sign/Date)

ALSO READ: SOP for Operation of Analytical Balance (PRECISA XB 220 A)

Verification of Safety Features

Sr. No.	Safety Features Description	Function	Checked By (Sign/Date)	Verified By (Sign/Date)
1.	Earthing	To avoid electrical shocks
2.	Connect the Power Cord to the mains outlet and switch on the mains power	Power of weighing balance shall be ON.
3.	Self-test and subsequently display weight after ON the machine.	The instrument goes through the self-test and subsequently displays weight.

Verified By (Sign/Date)

Operational Test:

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.
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.
3	Accuracy Test	Different masses ranging from minimum load to maximum load area weighed for accuracy.	Result should be consistent.
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.

Checked By (Sign/Date) Verified By (Sign/Date)

ALSO READ: Checklist for Supplier Qualification

Verification of Standard Operating Procedure:

Sr. No.

SOP Title

Availability

(Yes/No)

Checked By (Sign/Date)

Verified By (Sign/Date)

Operation & Cleaning of Weighing Balance

Verified By (Sign/Date)

DEFICIENCY AND CORRECTIVE ACTION TAKEN

The following deficiency was identified and corrective actions were taken in consultation with the Engineering Department.

Description of deficiency:

Corrective Action(s) Taken:

REQUALIFICATION CRITERIA

The Weighing Balance has to be Requalified if:

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.

COMBINED INSTALLATION/OPERATION QUALIFICATION REPORT

Summary:

Conclusion:

Compiled By: Checked By:
(Sign & Date) (Sign & Date)

LIST OF ANNEXURES:

Sr. No.	Details of Annexures

POST-APPROVAL

This report for Weighing Balance Combined Installation/Operation Qualification has been Prepared, reviewed and Approved by the following persons. The reviewer’s & approver’s signature indicates that this document has been reviewed, approved and it accurately and completely reflects the tasks and deliverables necessary for installation & operation Qualification of the equipment / Instrument / System, and the documentation and information contained herein complies with applicable regulatory, corporate, divisional/departmental requirements and current Good Manufacturing Practices.

Reviewed by : Engineering
Name	Designation	Sign/Date

Reviewed by : Store
Name	Designation	Sign/Date

Reviewed by : Quality Assurance
Name	Designation	Sign/Date

Approved by : Quality Assurance
Name	Designation	Sign/Date

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Installation/Operational Qualification Protocol of Weighing Balance

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