Qualification Protocol for Dust Extractor Machine

Table of Content

Section No.	Description
1	Title
2	Objective
3	Scope
4	Re – qualification criteria
5	Overview of equipment's / Description
6	Definition
7	Responsibilities
7.1	Quality Engineering
7.2	Quality Assurance
7.3	Quality Control
7.4	Purchase
7.5	Production
7.6	Engineering
8	Indented use of the instrument
9	Acceptance Criteria
10	Reference
11	Installation Qualification
12	Standard Operating Procedure
13	Operation Qualification
14	Performance Qualification
15	Preventive Maintenance Schedule
16	Final Conduction and recommendations

Title:

Protocol for qualification of Dust Extractor Machine.

Objective: 

The objective of this protocol is to define the installation, operation and performance Qualification requirement and qualifying criteria recommended from its Design specification.

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Scope: 

This qualification protocol is applicable to the Dust Extractor Machine.

Re–qualification Criteria:

Re – qualification will be recommended in the following cases:

1. When there is the change in the location of the equipment.
2. When there is major modification in the equipment.
3. When there is major breakdown, which have direct impact on the performance of the equipment.

Re – qualification shall be recommended by Quality Engineering.

Overview of Equipment / Description:

The equipment is a self-contained unit for collection of dust from the tableting etc. machine.

Definition:

Qualification: The process of ensuring that equipment is appropriate for its intended use. It consists of the following:

1. Installation Qualification: A document verification of the installation in the selected user environment to comply with the approved design, the manufacturer’s recommendations and or user requirements.
2. Operation Qualification: A document demonstrating that facilities and operations work to functional design specifications.
3. Performance Qualification: A document verification of the performance in the selected user environment to comply with the approved design, the manufacturer’s recommendations and or user requirements.

Responsibilities:

Quality Engineering:

• Preparation, approval and implementation of the protocol.
• On going compliance of the system.
• Organizing the activities related to qualification.
• Co – ordination with production, engineering purchase department.
• Qualification reports preparation.

Quality Assurance:

• Review, monitoring and approval of the protocol.
• On going compliance of the quality system.

Quality Control:

• Analysis of samples if any.
• Recording the QC raw data.

Purchase:

• Organization Preparation, approval and implementation of the protocol.
• Purchase order preparation.
• Co-ordination with vendor for related activities.

Production:

• Organizing the activities related to qualification in production area.
• SOP preparation for operation.
• Routine calibration and maintenance implementation.
• Report review and training of users.

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Engineering:

• Providing the design specification.
• Inspection at vendor site.
• Utilities arrangement for equipment.
• Organize the calibration of parts of equipments & instruments as a whole.
• Organizing the activities related to qualification.

Intended use of the Equipment: 

The Dust Extractor Machine shall be used for suction of dust.

Acceptance Criteria:

1. Equipment shall be supplied and installed as per pre – determined specification Purchase Order.
2. Material of construction and finish surface of equipment shall be as per pre – determined specification.
3. All Utilities connected with the equipment shall be as per requirement.
4. All components of the equipment shall work or function as defined.
5. Equipment shall perform for its intended use as specified.

Reference:

Technical specification / Operation Manual

GA drawing / Exploded drawing

Purchase order copy

FAT and SAT report recommendation.

Installation Qualification:

Equipment Details:

Equipment Name	Dust Extractor Machine	Equipment Type
		Location (Floor)
Designed By		Location (Plant)
		Date of Installation

Major Components & Material of Construction:

Sr. No.	Description	Specification	Actual	Remarks
1	Chamber	SS 316
2	Impeller	CIP MAKE
3	Cotton Bag	CIP MAKE
4	Motor	1 Hp
5	Wheel	Pu

Utility Details:

Sr. No.	Utilities recommended by the vendor	Specification	Utility connected with the equipment	Remarks
1	Electrical	1 Hp, 3 phase
2	Chilled water	NA
3	Cooling water	NA
4	Hot water	NA
5	Compressed air	NA
6	Steam pressure	NA

Installation Checks:

Sr. No.	Test	Test Procedure	Observation
1	Position as per GA drawing	Ensure that position of equipment is as per the GA drawing
2	Electrical connection	Check 3 phase supply to starter through a proper isolator with suitable backup MCBs.
3	Direction of Motor	Check direction of motor depending upon suction
4	Earthing	Check the earthing of machine

Installation Done By:                                                  Verified By:

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Final Report:

Summary:

The equipment shall be procured as per specification. Installation is carried out as per manufacturers recommendations and user applicability. Supporting utilities will be connected.

Analysis / Evaluation:

The machine shall be installed at the location. Supporting utilities shall be connected and Used for Functioning properly. Standard operating procedure shall be identified and listed. History card shall be prepared for the equipment. The user shall verify all relevant critical document and drawing.

Reviewed & Inspected by: ___________________         Date :

Approval:

Area Representative	Signature	Date
Production
Engineering Services
Quality Engineering
Quality Assurance

Standard Operating Procedure:
Draft SOP of the equipment shall be available

SOP No.	Title	Location	Effective Date	Revision No.	Remarks
1
2
3

Operational Qualification:

Procedure:

The equipment (Dust Extractor Machine) shall be checked for the following parameters:

Operational Checks:

Sr. No.	Activity	Specification	Observation	Remarks
1	On / Off Test	Machine should be ON and OFF with operating buttons
3	Start Machine with proper suction direction	Smooth running
4	Test for vibration	No abnormal vibration
5	Test for noise	No abnormal Noise should be there.
6	Stopping of the Machine	Machine should STOP

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Safety Features:

Sr. No.	Safety features provided with the equipment	Method of Verification	Target	Actual	Remarks
1	Proper earthing to the machine	Ensure that there is no loose earthing	Complete earthing
2	Safety interlocks if any	Should work as designed	No deviation

Training:

Following operating / maintenance personnel were trained by the vendor and authorized to operate or carryout routine maintenance of the equipment.

Name	Designation	Date of Training	Trained by

Final Report:

Summary

The operation of the equipment DUST EXTRACTOR MACHINE is carried out as per standard operating procedure.

The equipment performs within the assigned limits when operated as per approved standard operating procedure.

Operating parameters that have a significant impact on the equipment ability to operate and achieve the process are satisfactory and confirms to the acceptance criteria.

Equipment: DUST EXTRACTOR MACHINE

Location :

Purpose : Use for suction of the dust.

Frequency of Validation: Validation due on or the event of any change in critical component of the machine.

"THE EQUIPMENT "DUST EXTRACTOR MACHINE” VALIDATED AND RELEASED FOR USE.

Approval:

Area Representative	Signature	Date
Production
Engineering Services
Quality Engineering
Quality Assurance

Performance Qualification:

Equipment Validation

The simulation of the process was carried out by connection with the specific machine.

Simulation of the process consist of the following:

Sr. No.	Activity	Functional Acceptance Criteria	Status / Observation
1	Proper assembly of cotton bags	As per the details given with the operating manual
2	Position of chamber	It should be properly fixed with machine and fixed with knobs.
3	Powder suction	It should be from the specific machine with this machine to be attached.

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Performance Qualification Evaluation

Name of Tablet:

 

Performance Criteria - Before Connecting This Machine:

 

1. Appearance:

2. Analysis

 

Performance Criteria  - After Connecting This Machine:

	1	2	3
Appearance
Analysis

Data Evaluation and Conclusion:

Based on the quality control results generated by simulating the process and its review, it can be said that machine performs satisfactorily and confirming to the acceptance criteria.

Inspected by: _____________________           Date :

Final Report:

Summary

The performance of the equipment DUST EXTRACTOR MACHINE was carried out as per standard operating procedure.

The equipment performs within the assigned limits when operated as per approved standard operating procedure.

Performance parameters that have a significant impact on the equipment ability to operate and achieve the process are satisfactory and confirms to the acceptance criteria.

Equipment: DUST EXTRACTOR MACHINE

Location :

Purpose : Use for suction of the dust.

"THE EQUIPMENT "DUST EXTRACTOR MACHINE VALIDATED AND RELEASED FOR

USE.

Approval:

Area Representative	Signature	Date
Production
Engineering Services
Quality Engineering
Quality Assurance

On – going Activities:

Preventive Maintenance Schedule:

Sr. No.	Preventive maintenance details	Any major change	Performed by	Remarks

Change in the History card:

New equipment installed on: Date - 

Sr. No	Change recommended by	Reason for change	Modification Details	Re-qualification	Remark

Modification with recommendation for re – qualification:

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Final Conclusion and Recommendation:

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Approval:

Area Representative	Signature	Date
Production
Engineering Services
Quality Engineering
Quality Assurance

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