uality is one of the most important management principles for any organization regardless of industry. This is particularly true for the pharmaceutical sector: maintaining quality product standards is essential for the prevention and treatment of numerous medical disorders.
Although the pharmaceutical industry has been around for centuries, in recent years we have experienced an increase in the number of drugs being launched in the market. As a result of this increase, the need for quality assurance and quality control measures has risen. For instance, drug manufacturers must follow strict guidelines to get their drugs approved by the FDA (Food and Drug Administration) in the United States. Such guidelines include requirements for testing, manufacturing, labelling, packaging, storing and distributing pharmaceuticals.
Quality Management
Quality management is a crucial component of any successful organization as it ensures that products and services are produced and distributed consistently and effectively.
Good Manufacturing Practice (GMP) is the element of quality management that ensures goods are produced and controlled according to the quality standards of their intended use and that they meet the requirements specified by the marketing authorization or product specification. Additionally, it ensures that manufactured goods are safe, of high quality, and effective. For pharmaceutical companies, GMP entails the monitoring of procedures, apparatuses, employees, and environments.
Quality planning, quality control, and quality assurance are all important aspects of quality management too. We’ll look at what quality management is, why it’s important, and the main components and principles of quality management in this article.
Quality planning
Quality planning refers to the process of defining the quality requirements and standards of a product or service and identifying the resources needed to meet such requirements and standards. The planning phase is the first stage in establishing a good quality management system. It is in this phase that companies define their baseline quality objectives. Once goals have been set, organizations must determine what is required to achieve these objectives and what procedures should be implemented to ensure their success. During this stage of the quality management process, it is important to keep in mind the following considerations:
The organization’s definition of success
How often procedures and processes will be evaluated for improvement
If the stakeholders have any quality-related priorities, goals, or ambitions
If there are any legal procedures or standards that must be followed in order to achieve the desired quality level
Quality Control
Quality control is the next step in the quality management process. At this stage, companies assess through physical inspection and testing whether their plan is achievable.
7. IDENTIFICATION OF PROBLEMS
SELECTION OF PROBLEM
DEFINE THE PROBLEM
ANALYSE THE PROBLEM
FINDING ROOT CAUSE
DATA ANALYSIS
DEVELOPING SOLUTION
PROBABLE RESISTANCE
TRIAL IMPLEMENTATION
REGULAR IMPLEMENTATION
FOLLOW UP/ REVIEW
IDENTIFICATION OF CAUSES
APPROACH : 12 STEP METHODOLOGY & QC TOOLS
Developed by Dr. J. M. Juran
8. MEETING SCHEDULE :
EVERY MONDAY
TIME : 14:30 TO 15:30 HRS.
VENUE : TECHNICAL CENTRE ACADEMY
TILL 19TH SEPTEMBER 2020
NO OF MEETINGS HELD - 29
AVERAGE ATTENDANCE
PERCENTAGE - 90
9. STEP-1
IDENTIFICATION OF WORK-RELATED PROBLEMS
CUSTOMER
SATISFACTION
PDCA Cycle
Technique used : Brainstorming
1. Identification of work-
related problems
2. Selection of problems
3. Define the problem
Dr. EDWARDS DEMING
10. STEP #1: IDENTIFICATION OF WORK-RELATED
PROBLEMS BY BRAINSTORMING
TOTAL PROBLEMS IDENTIFIED : 52
PROBLEMS LISTED BY USING “A” “B” “C” ANALYSIS
“A”CATEGORY PROBLEM :- Minimum involvement of other departments in
solving the problem.
“B”CATEGORY PROBLEM :- Involvement of other departments is
necessity.
“C”CATEGORY PROBLEM :- Management sanction needed in
implementing the solution.
11. 1. Parison cutting Issue.
2. Leak Tester Issue.
3. Chiller Flow issue to Mould.
4. Frequent breakdown of Robo-packing machine
5. Oil temperature High.
6. Hydraulic Motor tripped.
7. Machine General and Preventive Maintenance.
8. Machine Safety Guard Problem.
9. Alpla maintenance Software requisition issue.
10.Wasting the Energy by turning ON the Motor during NO Plan.
11.Mould Change Maintenance.
12.High level of noise observed while grinding.
13.Chiller Flow issue to Mould.
14.Cooling pipe near mould is damaged.
15.Injection Pressure transducer problem.
16.Raw Material Sucking Issue from Silo.
IDENTIFICATION OF WORK-RELATED PROBLEMS
BY BRAINSTORMING
“A” CATEGORY PROBLEMS :-
12. 17. Tonnage Build-up Issue.
18. Cavity Short Fill Issue.
19. Cavities blocked due to runner ejector pin function issue.
20. Calibration Drive Error.
21. Piovan dosing unit issue.
22. Double Shot due to ejector bolt Loose.
23. In Mold closing rod adjustment issue.
24. Oil leakage from ejector Cylinder.
25. Production stroke error on Blow Mold machines.
26. Frequent damage of cutting rings on Blow Mould machines.
27. Water leakages near drainpipe in AHU’s
IDENTIFICATION OF WORK-RELATED PROBLEMS
BY BRAINSTORMING
“A” CATEGORY PROBLEMS :-
A-Type 27
13. 1. Material Conveying Issue.
2. ISBM Pockets Damaged.
3. Sensor Issue.
4. Walkway Blocked due to pallets.
5. Regrinding Material Problem.
6. Power Fluctuations due to High/Low voltage.
7. Chiller water flow issue.
8. Air pressure fluctuation.
9. Strainer jam.
10. Water flow meter not working.
11. Oil level low alarm on the machines.
12. Cooling Towers inside dosing system with chemical is to be arranged.
13. Compressed air leakages on the machine and near joints of pipeline.
14. Mishandling of forklifts and hand trolleys.
15. RO unit rejection water is more compared to treated water.
“B” CATEGORY PROBLEMS :-
IDENTIFICATION OF WORK-RELATED PROBLEMS
BY BRAINSTORMING
B-Type 15
14. 1. Material Quality Issue( Damage wadding).
2. No availability of spare parts(Machine DT).
3. Dents on Pathway (Flooring).
4. Man Problem Issue.
5. Power fluctuation.
6. Wastage of hydraulic oil and lubrication oil due to leakages in various machines.
7. Lack of central water purifiers for drinking water.
8. Insulation worn-out on chiller water pipelines near machines.
9. Main bore connections to be linked up with Automatic On/Off remote system.
10. Material Conveying infrastructure modification.
“C” CATEGORY PROBLEMS :-
IDENTIFICATION OF WORK-RELATED PROBLEMS
BY BRAINSTORMING
C-Type 10
16. From above five problems, second problem is selected based on ranking method criteria used
for rank allotment.
1. UTILISATION OF AVAILABLE RESOURCES
2. PRODUCTIVITY
3. QUALITY
4. SAFETY
5. OPERATOR SATISFACTION
STEP #2 : SELECTION OF PROBLEMS
From identified 52 problems the following five problems are selected by our team members
based on priority.
17
S.No Problems S A P M Pr J B Total Rank
1 Mold General and Preventive
Maintenance
5 4 4 3 5 3 4 28 II
2
Frequent breakdown of Robo-
packing machine
5 5 5 5 4 4 4 31 I
3 Material Conveying Issue 4 3 4 3 3 3 3 24 V
4 Cold cutter Problems in EBM 3 3 3 4 5 4 5 28 III
5
Requisition raising Issue in Alpla
Maintenance Software
4 3 3 3 4 4 5 27 IV
17. 18
Hi machine down time
Low productivity
High rejection
SELECTED PROJECT
Frequent breakdown of Robo-packing machine
Reason for selection
18. PLANNING MILESTONE CHART
Quality Circle name : EKTHA
Dept. : PRODUCTION
Facilitator : SOUSHEEL
Project: Frequent breakdown of Robo-packing machine
Project: PRODUCTION LOSS DUE TO BREAKDOWN OF ROBO-PACKING MACHINE
Members: BRAHMAM (Leader), SWARA MADHURI (Dy.Leader)
Project No: 1 Project Start Date: 04.11.2019
Meeting day: Monday Time: 02:30PM-03:30PM No.of projects completed : 1
S.No
PDCA
Activity
1 2 3 4 5 6 7 8 9 10 11 12
Cycle WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK
1
P Defining the
problem 04.11 11.11
2
D
Analyzing the
problem 18.11
3
Identifying
the causes 25.11 02.12.
4
Finding out
the root
causes 09.12
5 Data analysis 16.12
6
Developing
solutions 23.12 30.12
7
C
Foreseeing
probable
resistance 30.12
8
Trial &
Implementati
on 06.01.20
9
A
Regular
implementati
on 13.01.20
10 Follow up 20.01.20
19. 20
STEP-3
Tool & Technique used
High Level Flow Diagram
Detailed Flow Diagram
Brainstorming(Round Robbin method)
20. STEP # 3 : DEFINE THE PROBLEM
FREQUENT BREAKDOWN WHILE TRANSFER OF BOTTLES FROM
INJECTION STRETCH BLOW MOULDING MACHINE TO ROBO
PACKING MACHINE.
IMPACT OF THE PROBLEM:
INCREASE IN DOWNTIME
HIGH WASTAGE
LOSS OF PRODUCTION
21. HIGH LEVEL FLOW DIAGRAM
Incoming Raw
Material
Identification &
Inspection
Labelling on
Boxes
IPQC
Issue of
Materials to
Production
Processing
Packing of
FG/SFG
Palletization &
labelling
Loading/
Dispatch
Storage at
Warehouse
WORK AREA
22. DETAIL FLOW DIAGRAM
START
Loading Of RM
Drying 170°C
RM Feed To
Barrel
Injection
Processing
Preform
Conditioning Blowing Ejection Of
Bottles
Robot Taking
out
Conveyor
Pick Place
Dropping of
Bottles in
Shutter Cylinder
Packing In
Polybag
END
PROBLEMATIC
AREA
23. 24
Using Smart tools following is our objective & target
S:-Specific
M:-Measurable
A:-Achievable
R:-Relevant
T:-Time-Bound
OBJECTIVE: To reduce the breakdown time by 70%.
GOAL: Increase the machine efficiency by 80% to 90%.
Specific
Measurab
le
Realistic
Attainable
Time
Bound
S M A R T
25. What is the problem ? Frequent breakdown of Robo packing
machine
Where it is happening ? While bottle packing
When it is occurring ? While ejection and transfer of bottles.
Who is Effected ? Production and Customers
How it is analyzed ?
By studying the existing process
and suggesting suitable remedy
4W & 1H Analysis
STEP#4 ANALYSE THE PROBLEM
26. Packing machine break down data on monthly basis is collected
from May-2019 to October-2019
STEP#4 ANALYSE THE PROBLEM
Sl No. MONTH PROUCTION(qty) RUNNING (hrs) BREAK DOWN (hrs)
BREAKDOWN
COST/-
1
May-19
30,98,688 412 34.8 2,61,453.9
2
June-19
18,33,216 244 15.3 1,14,949.6
3
July-19
6,50,496 87 16.2 1,21,711.3
4
August-19
29,78,304 396 24.1 1,81,064.3
5
September-19
10,42,944 139 9.0 67,617.4
6
October-19
15,96,672 213 60.1 4,51,533.9
TOTAL 1,12,00,320 1,491 159.5 11,98,330.4
AERAGE/MONTH 18,66,720 248 27 1,99,722
27. STEP-4 ANALYSE THE PROBLEM
Pictorial presentation of data through Stratification
412
244
87
396
139
213
34.8
15.3 16.2 24.1
9.0
60.1
0
50
100
150
200
250
300
350
400
450
May-19 Jun-19 Jul-19 Aug-19 Sep-19 Oct-19
No
of
Hrs.
Breakdown analysis of Robo-packing machine
RUNNING (hrs) BREAK DOWN (hrs)
OBJECTIVE: To reduce the breakdown time by 70%.
GOAL: Increase the machine efficiency by 80% to 90%.
29. Through brainstorming method all possible causes identified by the members and potential
members
S.NO CAUSE SUGGESTED BY
1 Index pockets failure Sousheel
2 Bottle conveying issue Bramham
3 Bag sealing issue Praveen
4 Bottle pick and place issue Swara Madhuri
5 Operator negligence Pavan
6 Delay in resolving breakdown Jyothi
7 Out dated preventive Maintenance checklist Ajay
8 Wrong operation of machine Swara Madhuri
9 Lack of spares Sousheel
10 Machine Programming issue Jyothi
11 Poor quality of index pockets Praveen
12 Sensor failure Bramham
IDENTIFICATION OF CAUSES
30. CAUSE & EFFECT DIAGRAM
Frequent breakdown of
Robo-packing machine
METHOD MATERIAL
MACHINE
MAN
Lack of knowledge
Not trained
Operator negligence
Index pockets failure
Maintenance person busy
Delay in procuring
spares
Poor quality of index
pockets
Due to bottles getting jammed
Machine Programming issue
Lack of spares
Homing done incorrectly
Manufacturing defect
Bag sensor issue
Delay in resolving breakdown
Wrong operation
Of machine
Out dated preventive
Maintenance checklist
Sensor failure
Incorrect adjustment
Bag sealing issue
Bottle conveying issue
Failure of conveyor
Conveyor belt alignment issue
Bottle pick and
place issue
Motor and
shaft coupling
failure
take out operation
Bearing failure
31. STEP-6
FINDING OUT ROOT CAUSES
Tool & Technique used :
Validation of causes through 3W & 1H Analysis
32. ALL PRABABLE CAUSES CATEGORISED FOR FURTHER VALIDATION
33
MAIN CAUSE SUB CAUSE SUB-SUB CAUSE
Index Pockets Failure
Due To Failure Of Take Out
Operation
Due To Failure Of Take Out Operation
Bottle Conveying Issue Failure Of Conveyor Conveyor Belt Alignment Issue
Bag Sealing Issue Bag Cutting Sensor Problem
Operator Negligence Lack Of Knowledge
Delay In Resolving Breakdown Maintenance Person Busy
Poor Quality Of Index Pockets Manufacturing Defects
Sensor Failure Incorrect Adjustment
Out Dated Preventive
Maintenance Check List
Lack Of Spares Dealy In Procuring Spares
Machine Programming Issue Homing Done Incorrectly
Wrong Operation Of Mahicne
Machine Side
Issues
Material Side
Issues
Method Side
Issues
Manpower
Side Issues
33. Frequent breakdown of
Robo-packing machine
MACHINE
Index pockets failure
Due to bottles getting jammed
Bag sensor issue
Bag sealing issue
Bottle conveying issue
Failure of conveyor
Conveyor belt alignment issue
Bottle pick and
place issue
Motor and
shaft coupling
failure
Due to failure of take out operation
Bearing failure
Sl.no What Where Why How Validation
1
Motor and shaft coupling
failure
Machine High load
Slipping of grub
screws
Valid
2 Index pockets failure Machine
Due to bottles getting
jammed
Due to failure of
take out operation
Valid
3 Bottle Conveying Issue Machine
Conveyor belt alignment
issue
Bearing failure Not Valid
4 Bag Sealing Issue Machine Bag Sensor issue sensor failure Valid
VALIDATION OF CAUSES THROUGH 3W&1H
34. Frequent breakdown of
Robo-packing machine
MAN
Lack of knowledge
Not trained
Operator negligence
Maintenance person busy
Delay in resolving breakdown
Sl.no What Where Why How Validation
1 Operator negligence During working
Lack of
knowledge
Not trained Not Valid
2
Delay in resolving
breakdown
Machine
Maintenance
person busy
Maintenance person is
attending other
breakdown
Not valid
VALIDATION OF CAUSES THROUGH 3W&1H
35. Frequent breakdown of
Robo-packing machine
METHOD
Delay in procuring
spares
Machine Programming issue
Lack of spares
Homing done incorrectly
Wrong operation
Of machine
Out dated preventive
Maintenance checklist
Sl.no What Where Why How Validation
1 Lack of spares Machine Imported
Delay in procuring
spares
Not Valid
2
Machine Programming
Issue
Machine Program error
Homing Done
incorrectly
Not Valid
3
Out dated Preventive
Maintenance Checklist
Machine
Delay in Preventive
Maintenance
Maintenance of
machine is not done on
regular basis.
Not Valid
VALIDATION OF CAUSES THROUGH 3W&1H
36. Frequent breakdown of
Robo-packing machine
MATERIAL
Poor quality of index
pockets
Manufacturing defect
Sensor failure
Incorrect adjustment
Sl.no What Where Why How Validation
1 Sensor failure Machine Incorrect adjustment
It is not transmitting
signal to the electronic
control module.
Valid
2
Poor Quality of Index
pockets
Machine
Manufacturing
defect
Thickness of the pockets
is less
Valid
VALIDATION OF CAUSES THROUGH 3W&1H
37. IMAGES OF MAIN PROBABLE ROOT CAUSES
Failure Of Take Out Operation Bottle conveying issue
Motor and shaft
coupling failure
39. PARETO DIAGRAM
STEP # 7 : DATA ANALYSIS
S.No Root cause (hrs.) Cum. % To total Cum.%
1 Take out unit bottle dropping
125 125 78.37 78.37
2
Bottle counting sensor not
working 20.5 145.5 12.85 91.22
3 Bag sensor
11 156.5 6.90 98.12
4 Bottle conveying problem
3 159.5 1.88 100.00
Total 159.5
Data collected on possible root causes from 9th to 16th December-2019
41. Tool & Technique used : Brain storming ( Round Robin Method )
We have involved potential members for developing solutions along
with our QC Members
STEP NO.8
42. Possible Solution-1: Sensors
DEVELOPING SOLUTIONS
Root Cause
Possible
Solution-1
Advantage Disadvantage Validation
Take Out unit Bottle
Dropping
Sensor Placed On
Shutter Cylinder
Minimize the
breakdown, Double Shot
Issue is erased.
Nil Accepted
All our Ektha Quality Circle members through brainstorming
developed solutions
Without Sensors Sensors Placed On Shutter Cylinder
43. Possible Solution-2: Installation Of Vibrators
DEVELOPING SOLUTIONS
Root Cause Possible Solution-2 Advantage Disadvantage Validation
Take Out unit
Bottle
Dropping Issue
Installation of Vibrator
Minimize the Double
Shot Issue, No damage
of bottle, reduces the
rejection.
Nil Accepted
BEFORE AFTER
45. Possible Solution-3: Rack And Pinion Mechanism
DEVELOPING SOLUTIONS
Root Cause Possible Solution-3 Advantage Disadvantage Validation
Take Out unit
Bottle Dropping
Issue
Replaced belt
conveyor with rack and
pinion mechanism
Reduces breakdown
for slippage of belt.
Nil Accepted
BEFORE-Timer belt pulley
mechanism
AFTER-Rack and pinion mechanism
47. STEP#9 FORESEEING PROBABLE RESISTANCE
After developing solutions we explained about our project to our HOD & Colleagues.
We got some resistance from below mentioned departments
Root
Cause
Possible
Solution
Department Resistance Step To Overcome
Take Out
unit Bottle
Dropping
Issue.
Sensor Placed On
Shutter Cylinder
Maintenance Involved high project cost
Breakdown cost is higher than
project cost.
Installation of
Vibrator
Production High noise level
Noise level is within tolerance
limit(<85db)
Replaced belt
conveyor with rack
and pinion
mechanism
Maintenance Involved high project cost
Implementing rack and pinion
for permanent solution
Need to replace
good quantity of
Index Pockets
Maintenance
Already procuring from
OEM
55. Month wise data trend
Regular implementation effected from 23.01.2020
SI No. MONTH RUNNING (hrs) BREAK DOWN (hrs) BREAK DOWN (%)
1 Jan-20 414 10.4 2.5
2 Feb-20 247 5.6 2.3
3 May-20 341 15.6 2.8
4 Jun-20 291 6.8 2.3
5 Jul-20 309 18.3 2.3
6 Aug-20 175 7.3 3.1
7 Sep-20 490 35.8 2.2
Data period from January to September-2020
Note: During lock down also we operate our operation due to our organization under
special category
56. Data period from January to September-2020
2.5
2.3
2.8
2.3 2.3
3.1
2.2
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
Jan-20 Feb-20 Mar-20 Apr-20 May-20 Jun-20 Jul-20 Aug-20 Sep-20
BREAK DOWN (%)
Note: During lock down also we operate our operation due to our organization under
special category
S No.
Average Breakdown before
modification(%)
Average breakdown after
modification (%)
Avg. reduction in breakdown (%)
1 12.4 4 8.4
57. STANDARDIZATION EFFECTED ON 01.02.2020 &
BELOW IS REVISED ON MAY-2020
All developed solution included in the Work instructions anf Check list and conducted
training for all our operators working in this process
59. Frequency of Review & Result
All the Members of EKTHA decided to share responsibilities for follow
up & review.
Review on 1st Monday every month
FOLLOW UP AND REVIEW
• Break Down Analysis
62. INVESTMENT FOR
TAKE OUT ERROR OF ROBO PACKING MACHINE
SI NO. INVESTMENT DESCRIPTION AMOUNT (RS.)
1 Photo electric sensors(x3) and reflectors(x3) Rs. 15,000/-
2 Vibrator(x2) Rs. 12,000/-
3 Rack And Pinion(x1) Rs. 18,000/-
Total Investment Rs. 45,000/-
Due to the modification done to Robo-packing machine for every 100 hours of production
Rs. 63109/- is saved by preventing production loss per month
Grand savings per year is 757308/-
TANGIBLE BENEFITS
64. PLANNING MILESTONE CHART
Quality Circle name : EKTHA
Dept. : PRODUCTION
Facilitator : SOUSHEEL
Project: PRODUCTION LOSS DUE TO BREAKDOWN OF ROBO-PACKING MACHINE
Project: PRODUCTION LOSS DUE TO BREAKDOWN OF ROBO-PACKING MACHINE
Members: BRAHMAM (Leader), SWARA MADHURI (Dy.Leader)
Project No: 1 Project Start Date: 04.11.2019 and Completed on 20.01.2020
Meeting day: Monday Time: 02:30PM-03:30PM No.of projects completed : 1
S.No
PDCA
Activity
1 2 3 4 5 6 7 8 9 10 11 12
Cycle WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK WEEK
1
P Defining the
problem
04.11 11.11
04.11 11.11
2
D
Analyzing the
problem
18.11
18.11
3
Identifying
the causes
25.11 02.12.
25.11 02.12.
4
Finding out
the root
causes
09.12
09.12
5 Data analysis
16.12
16.12
6
Developing
solutions
23.12 30.12
23.12 30.12
7
C
Foreseeing
probable
resistance
30.12
30.12
8
Trial &
Implementati
on
06.01.20
06.01.20 13.01.20
9 A
Regular
implementati
on
13.01.20
13.01.20
10 Follow up
20.01.20
20.01.20
Note: Trial Implementation take 16 days instead of 7 days but we have completed our project as per time line
65. PDCA Cycle
Graph
Cause and effect diagram
Brain storming
Flow Diagram
Pareto Diagram
Data collection
Stratification
66. Our senior management who has
encouraged Q.C. movement in our
organization which directly helped
us to develop our personality and
other department colleagues for
helping us to complete our case
study.
Feedback / Suggestions from the
Honorable Judges are very
valuable to us.
Our Special thanks to QCFI,
who is instrumental for QC
movement in our organization,
which is helping both self and
organization.