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Installation/Operation Qualification Protocol of Weighing Balance

TABLE OF CONTENT
  1. Preapproval
  2. Objective
  3. Scope
  4. Responsibility
  5. Acceptance Criteria
  6. Installation Verification
  7. Operational Verification
  8. Deficiency and Corrective Action Taken
  9. Requalification Criteria
  10. Combined Installation/Operation Qualification Report
  11. List of Annexure
  12. Reference
  13. 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 attribute to verify that:
  1. The Instrument / equipment have been installed in accordance with the design and user requirements and meet the set acceptance criteria and cGMP requirements as stipulated in this document.
  2. Each installed components complies with the engineering design and equipment data sheets / specification.
  3. All supporting utilities are properly connected & equipment operations are verified for its intended use.

SCOPE
  • The Scope of this protocol is limited to the Combined Installation/Operation Qualification (IOQ) of Weighing Balance (Equipment ID:               ) is safely installed in 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
  1. The equipment shall be complying with the specification.
  2. All supporting utilities of specified capacities are to be near the place of installation.
  3. All the specified installation checks are to be complied.
  4. The equipment and its components shall be operated as per its specified operating instructions mentioned in the protocol.
  5. All SOPs for the equipment should be checked and verified.
  6. All the functionality of equipment components, safety features, Utility requirements to be checked and verified.

INSTALLATION VERIFICATION

EQUIPMENT DESCRIPTION

Equipment Name

:

Weighing Balance

Equipment ID

:

 


Instruction of filling Checklist:
  • For 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 mode of verification.
  • Give the detailed information in the summary and conclusion part of the Installation Qualification report.
  • Whichever column is blank or not used ‘NA’ shall be used.
Installation Checklist: 
  • Installation checklist is as follows:

Sr. No.

Statement

Yes / No

Checked By (Sign/Date)

Verified By (Sign/Date)

01

Verify that weighing balance is securely anchored and shock proof.

 

 

 

02

Verify that there is no observable physical damage.

 

 

 

03

Verify that all electrical connections are done properly

 

 

 

04

Safe electrical connections.

 

 

 

05

Equipment is Vibration Free and there is no any abnormal sound.

 

 

 


___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

                          Verified By (Sign/Date)

PEOPLE ALSO READ: Validation Protocol for Multi Mill (IQ/OQ/PQ)

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)

PEOPLE ALSO READ: Performance Qualification Protocol for Clean Room

Identification of Standard Operating Procedure:

The following Standard Operating Procedures were identified as important for 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 the checklist:
  • In case of the compliance of 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 the 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)

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) 


Verification of Standard Operating Procedure:

Sr. No.

SOP Title

Availability

(Yes/No)

Checked By (Sign/Date)

Verified By (Sign/Date)

1.

Operation & Cleaning of Weighing Balance

 

 

 


___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

                                              Verified By (Sign/Date) 


DEFICIENCY AND CORRECTIVE ACTION TAKEN
Following deficiency was identified and corrective actions 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 which 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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