VALIDATION PROTOCOL
FOR
COMMINUTING MILL MACHINE
Purchase Order No.: HPP/170291 DATED 11-03-04
Cip Machineries Pvt. Ltd.
Registered Office :
10,11 Umiya Estate,
[Link] Party Plot, [Link].8,
Amraiwadi, Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-287 54 10
91-79-289 25 30
91-79-297 04 06-7-8
TeleFax: 91-79-289 14 10
Works :
Plot No.1903, Phase IV,
Opp. Maradia Steel Unit-3,
G.I.D.C., Vatva,
Ahmedabad 380 026.
Gujarat, INDIA.
Phone: 91-79-583 59 08
91-79-583 53 41-2-3
TeleFax: 91-79-583 58 53
E-Mail : cipmachad1@[Link]
sales@[Link]
Visit us on Internet at :
[Link] / [Link]
OUR VISION : TO ACHIEVE LEADERSHIP THROUGH QUALITY
Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
Table of Content
Section
No.
1.0
2.0
3.0
4.0
5.0
6.0
7.0
Description
7.1
7.2
7.3
7.4
7.5
7.6
8.0
9.0
10.0
11.0
12.0
13.0
14.0
15.0
16.0
Title
Objective
Scope
Re qualification criteria
Over view of equipments / description
Definition
Responsibilities
Quality Engineering
Quality Assurance
Quality Control
Purchase
Production
Engineering
Indented use of instrument
Acceptance Criteria
Reference
Installation Qualification
Standard Operating Procedure
Operation Qualification
Performance Qualification
Preventive Maintenance Schedule
Final Conduction and recommendations
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
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1.0 Title : Protocol for qualification of Comminuting Mill.
2.0 Objective : The objective of this protocol is to define the installation, operation and
performance Qualification requirement and qualifying criteria recommended from its Design
specification.
3.0 Scope : This qualification protocol is applicable to the Comminuting Mill.
4.0 Re qualification Criteria
Re qualification will be recommended in the following cases:
a. When there is change in location of the equipment.
b. When there is major modification in the equipment.
c. When there is major breakdown , which have direct impact on performance of the
equipment.
Re qualification shall be recommended by Quality Engineering.
5.0 Overview of Equipment / Description:
The equipment is a self-contained unit for the process of size reduction. The product is dropped from
the feed hopper in a chamber where it comes in the contact of high speed blades and reduces the size
of the product.
6.0 Definition
Qualification: The process of ensuring that equipment is appropriate for its intended use. It consists
of the following:
a. Installation Qualification: A documents verification of the installation in the selected user
environment to comply with the approved design, the manufacturers recommendations and or
user requirements.
b. Operation Qualification: A documents demonstration that facilities and operation work to
functional design specifications.
c. Performance Qualification: A documents verification of the performance in the selected user
environment to comply with the approved design, the manufacturers recommendations and or
user requirements.
Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
7.0 Responsibilities:
7.1 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.
7.2 Quality Assurance:
- Review, monitoring and approval of the protocol.
- On going compliance of the quality system.
7.3 Quality Control:
- Analysis of samples if any.
- Recording the QC raw data.
7.4 Purchase:
- Organization Preparation, approval and implementation of the protocol.
- Purchase order preparation.
- Co-ordination with vendor for related activites.
7.5 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.
7.6 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.
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
PAGE 5 of 16
8.0 Intended use of the Equipment: The Comminuting Mill shall be used for milling of the
product.
9.0 Acceptance Criteria:
a. Equipment shall be supplied and installed as per pre determined specification Purchase Order.
b. Material of construction and finish surface of equipment shall be as per pre determined
specification.
c. All Utilities connected with the equipment shall be as per requirement.
d. All components of the equipment shall work or function as defined.
e. Equipment shall perform for its intended use as specified.
10.0
a.
b.
c.
d.
Reference:
Technical specification / Operation Manual
GA drawing / Exploded drawing
Purchase order copy
FAT and SAT report recommendation.
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
11.0
PAGE 6 of 16
Installation Qualification:
11.1 Equipment Details:
Equipment Name
Comminuting Mill.
Designed By
Equipment Type
Location (Floor)
Location (Plant)
Date of Installation
11.2 Major Components & Material of Construction:
Sr.
No.
Description
Specification
Beaters
Rotor
Rotor Pin
Rotor Shaft
Perforated screen
Charging hopper
Discharge hopper
Gasket
Bearing Housing
Belt Guard
Pulley Guard
Legs
Wheel
Wheel Bracket
Motor
Handle for rack
SS 316
SS 316
SS 316
SS 316
SS 316
SS 316
SS 316
White silicon
SS 304
SS 304
SS 304
SS 304
White nylon
SS 304
7.5 Hp, 1440 RPM ,
SS 304
Actual
Remarks
Utility connected
with the
equipment
Remarks
11.3 Utility Details:
Sr.
No.
Utilities recommended by
the vendor
Specification
01
02
03
04
05
Electrical
Chilled water
Cooling water
Hot water
Compressed air
3 Hp, 3 phase
NA
NA
NA
NA
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
06
Steam pressure
PAGE 7 of 16
NA
11.4 Installation Checks:
Sr.
No.
01
Test
Position as per GA drawing
02
Leveling and equipment
alignment
03
Electrical connection
04
Direction of Motor
05
Earthing
06
Checks for Lubrication
07
Screen fixing
08
Discharge Hopper
Installation done by:
Test Procedure
Observation
Ensure that position
of equipment is as per
the GA drawing
Ensure the uniform
alignment of
equipment using level
indicator
Check 3 phase supply
to the reversible
starter through a
proper isolator with
suitable backup
MCBs.
Check direction of
motor, forward should
give clockwise
rotation seen from top
and reverse to give
anticlockwise rotation
Check the earthing of
machine
Ensure that the grease
cup on bearing
housing is filled with
lubricants
Mount desired screen
on the screen holding
plate and between
two studs. Lock by
rotating and with
wing nuts.
Mount discharge
hopper and clamp
with 4 nos. wing nut
Verified by:
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
11.5
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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
Production
Engineering Services
Quality Engineering
Signature
Date
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
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Quality Assurance
12.0
Standard Operating Procedure:
Draft SOP of the equipment shall be available
SOP No.
Title
Location
Effective
Date
Revision
No.
Remarks
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
13.0
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Operational Qualification:
13.1 Procedure: The equipment (Comminuting Mill) shall be checked for the following parameters:
13.2 Operational Checks:
Sr.
No.
01
Activity
Specification
On / Off Test
Machine should be
ON and OFF with
operating buttons
02
04
Test for Speed
Minimum Speed
Moderate Speed
Maximum Speed
Start Machine with forward
Start Machine with reverse
Test for vibration
05
Test for noise
06
Stooping of the Machine
03
Observation
Remarks
750
1500
3000
Smooth running
Smooth running
No abnormal
vibration
No abnormal Noise
should be there.
Machine should
STOP
13.3 Safety Features:
Sr.
No.
01
02
Safety features
provided with
the equipment
Proper earthing to
the machine
Safety interlocks
if any
Method of
Verification
Target
Ensure that there is
no loose earthing
Should work as
designed
Complete
earthing
No deviation
Actual
Remarks
13.4 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
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
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13.5 FINAL REPORT
Summary
The operation of the equipment COMMINUTING MILL MACHINE is carried out
standard operating procedure.
as per
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: COMMINUTING MILL MACHINE
Location
Purpose
:
: Use for milling of the powder.
Frequency of Validation : Validation due on
or the event of any change in
critical component of the machine.
"THE EQUIPMENT COMMINUTING MILL MACHINE VALIDATED AND RELEASED
FOR USE.
Approval:
Area Representative
Production
Engineering Services
Quality Engineering
Quality Assurance
Signature
Date
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
PAGE 12 of 16
14.0 PERFORMANCE QUALIFICATION
14.1
EQUIPMENT VALIDATION
The simulation of the process was carried out by milling of the powder from the machine.
Simulation of the process consist of the following:
[Link]. Activity
01
Proper assembly of hopper.
02
Position of Sieve
03
Pouring of Powder
04
Powder collection
Functional Acceptance
Criteria
As per the details given with
the operating manual
It should be properly fixed
with the wings nut.
It should from the feed
hopper.
It should be from the
discharge chute.
Status / Observation
14.2 PERFORMANCE QUALIFICAION EVALUATION:
NAME OF MATERIAL:
PERFORMANCE CRITERIA - BEFORE MILLING:
1. APPERANCE :
2. SIEVE ANAYALSIS
PERFORMANCE CRITERIA - AFTER MILLING:
1
APPERANCE
SIEVE ANAYALSIS
14.3
DATA EVALUATION AND CONCLUSION:
Based on the quality control results generated by simulating the process and its review, it
said that machine performs satisfactory and confirming to the acceptance criteria.
Inspected by: _____________________Date :
can be
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
PAGE 13 of 16
14.4 FINAL REPORT
Summary
The performance of the equipment COMMINUTING MILL MACHINE was carried out as
standard operating procedure.
per
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: COMMINUTING MILL MACHINE
Location
Purpose
:
: Use for milling of the powder.
"THE EQUIPMENT COMMINUTING MILL MACHINEVALIDATED AND RELEASED
FOR USE.
Approval:
Area Representative
Production
Engineering Services
Quality Engineering
Quality Assurance
Signature
Date
Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
PAGE 14 of 16
15.0 On going Activities
15.1 Preventive Maintenance Schedule:
Sr.
No.
Preventive maintenance
details
Any major
change
Performed by
Remarks
15.2 Change in the History card:
New equipment installed on: Date Sr. Change
No recommended
by
Reason for
change
Modification Details
15.3 Modification with recommendation for re qualification:
Re-qualification Remark
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VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
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16.0 Final Conclusion and Recommendation:
Approval:
Area Representative
Production
Engineering Services
Quality Engineering
Signature
Date
Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE
Quality Assurance
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