Section No. |
Description |
1 |
Title |
2 |
Objective |
3 |
Scope |
4 |
Re –
qualification criteria |
5 |
Overview of equipments / 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 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 |
- When there is change in location of the equipment.
- When there is major modification in the equipment.
- When there is major breakdown, which have direct impact on performance of the equipment.
- Installation Qualification: A documents verification of the installation in the selected user environment to comply with the approved design, the manufacturer’s recommendations and or user requirements.
- Operation Qualification: A documents demonstration that facilities and operation work to functional design specifications.
- Performance Qualification: A documents verification of the performance in the selected user environment to comply with the approved design, the manufacturer’s recommendations and or user requirements.
- 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.
- Review, monitoring and approval of the protocol.
- On going compliance of the quality system.
- Analysis of samples if any.
- Recording the QC raw data.
- Organization Preparation, approval and implementation of the protocol.
- Purchase order preparation.
- Co-ordination with vendor for related activities.
- Organizing the activities related to qualification in production area.
- SOP preparation for operation.
- Routine calibration and maintenance implementation.
- Report review and training of users.
- 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.
- Equipment shall be supplied and installed as per pre – determined specification Purchase Order.
- Material of construction and finish surface of equipment shall be as per pre – determined specification.
- All Utilities connected with the equipment shall be as per requirement.
- All components of the equipment shall work or function as defined.
- Equipment shall perform for its intended use as specified.
Equipment Name |
Dust Extractor Machine |
Equipment Type |
|
|
|
Location
(Floor) |
|
Designed
By |
|
Location
(Plant) |
|
|
|
Date
of Installation |
|
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 |
|
|
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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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 |
|
|
|
|
|
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 |
|
|
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 |
|
|
Name |
Designation |
Date of Training |
Trained by |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Area Representative |
Signature |
Date |
Production |
|
|
Engineering
Services |
|
|
Quality
Engineering |
|
|
Quality
Assurance |
|
|
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. |
|
Name of Tablet:
Performance Criteria
- Before Connecting This Machine:
1. Appearance:
2. Analysis
Performance
Criteria - After Connecting This
Machine:
|
1 |
2 |
3 |
Appearance |
|
|
|
Analysis |
|
|
|
Area Representative |
Signature |
Date |
Production |
|
|
Engineering
Services |
|
|
Quality
Engineering |
|
|
Quality
Assurance |
|
|
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 |
|
|
|
|
|
|
Area Representative |
Signature |
Date |
Production |
|
|
Engineering
Services |
|
|
Quality
Engineering |
|
|
Quality
Assurance |
|
|
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