Вы находитесь на странице: 1из 16

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,
Nr.Bharat Party Plot, N.H.No.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@sancharnet.in

sales@cipmach.com
Visit us on Internet at :

www.cipmach.com / www.roll-compactor.com

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

PAGE 2 of 16

Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE

PAGE 3 of 16

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.

PAGE 4 of 16

Confidential
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.

Confidential
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

Confidential
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:

Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE

11.5

PAGE 8 of 16

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

Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE

PAGE 9 of 16

Quality Assurance
12.0

Standard Operating Procedure:

Draft SOP of the equipment shall be available


SOP No.

Title

Location

Effective
Date

Revision
No.

Remarks

Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE

13.0

PAGE 10 of 16

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

Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE

PAGE 11 of 16

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

Confidential
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:
Sr.No. 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

Confidential
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

Confidential
VALIDATION PROTOCOL FOR
COMMINUTING MILL MACHINE

PAGE 15 of 16

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

PAGE 16 of 16