GB Project Template

To reduce the extreneous matter complaints

[Project Sponsor: Mr. K K Rana]

[Project leader: Mr. Ashok Gavate]

Team member – Sandeep Kanwar
Yadwinder Singh

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GB Project Template
Step 1: Generate Project Ideas

D Step 2: Select Project

Step 3: Finalize Project Charter and High Level Map

Step 4: Finalize Project Y, Performance Standards for Y

M Step 5: Validate Measurement System for Y

Step 6: Measure Current Performance and Gap

Step 7: List All Probable X’s

A Step 8: Identify Critical X’s

Step 9: Verify sufficiency of Critical X’s for the project

Step 10: Generate and Evaluate Alternative Solutions

I Step 11: Select and Optimize best solution.

Step 12: Pilot, Implement and Validate the solution

Step 13: Implement Control System for Critical X’s

C Step 14: Document Solution and Benefits

Step 15: Transfer to Process Owner, Project Closure

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 Why this project was selected?
 Voice of Business:
To identify source of extraneous matter contamination and to improve customer satisfaction and credit rating by increasing
demand of supply of good quality products.
 Voice of Customer:
Voice of the Customer (VoC) - customer’s feedback and their expectations for our products would be bad for receiving of
repeated complaints w.r.t Extraneous matter. It focuses on customer needs, expectations, understandings, for improvement of
product quality.
 Critical to Quality (CTQ):
A Critical to Quality- To identify gaps and take action to avoid the cross contamination of extraneous matter in product quality to
fulfill the needs of the customer requirement. It helps to improve customer trust and supply good quality products.

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Why was this project selected?
Elaborate the logic or scenarios (examples) that support selection of this project by linking the
project objective to the organization’s objective and also highlighting that would happen if this
project was not selected?

Last year we have received 12 complaints related to extraneous material and because of which
clear gaps in practices followed at IOL end are evident. Even though we have robust quality system
still such complaints reported by customer. Therefore, it is very important to identify the root cause
and fill the gap to bring down these complaints to improve the system and to avoid risk of
customer dissatisfaction/ loss and strengthen the quality system compliance.
To reduce the customer complaint as well as cost w.r.t extraneous matter from 34% to 5% incurring
the addition cost for further reprocessing around Rs 50 Rs/Kg. This has implication on compliance
level and pose risk of customer loss.

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Scope Justification
Show drill down using appropriate method to explain inclusion and exclusion
of elements from the scope of the project.

Provide other Stakeholder’s inputs used to finalize/ modify the scope.

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 Complaint Customer
Product Date Dispatch qty Dispatch qty
no. name
2500
22.02.23 5 GIL 880
2000 2000 2000
14.04.23 8 Mylan 2000 2000

20.06.23 15 Tigaka 1000 1500 1500

1500
28.06.23 16 Zentiva 2000
1000 1000 1000 1000
28.07.23 20 Mylan 1000 1000 880
600
31.07.23 22 Tigaka 2000 500 500
Ibuprofen 500
250
28.08.23 24 Dresden 1000
0
27.09.23 27 Tigaka 250 IL n a a n a n a a le d is d d
G yl
a
g ak ntiv yla gak da gak gak su leo Er ovi leo
01.12.23 30 Tigaka 1000
M Ti Ze M Ti
re
s Ti Ti a n
a c H a c
D Sp M M

18.12.23 33 Spansule 500

Total Qty 11630 kg
20.05.23 2 Macleod 1500
22.06.23 3 Eris 600
Metformin 11.10.23 8 Hovid 1500

Total Qty 3600 kg

Pantoprazo
20.05.23 1 Macleod 500
le
500 kg
Total Qty

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 COST CALCULATION FOR COMPLAINT BATCHES
Product Customer name Dispatch qty Product cost Freight Cost Total cost
Ibuprofen GIL 880 704000 10824 714824

Ibuprofen Mylan 2000 1600000 32360 1632360

Ibuprofen Tigaka 1000 800000 21260 821260

Ibuprofen Zentiva 2000 1600000 21900 1621900

Ibuprofen Mylan 1000 800000 21260 821260

Ibuprofen Tigaka 2000 1600000 32360 1632360

Ibuprofen Dresdan 1000 800000 32220 832220

Ibuprofen Tigaka 250 200000 13232.5 213232.5

Ibuprofen Tigaka 1000 800000 21260 821260

Ibuprofen Spansule 500 400000 15630 415630

Metformin Macleod 1500 375000 24570 399570

Metformin Eris 600 150000 4584 154584

Metformin Hovid 1500 375000 25830 400830

Pantoprazole Macleod 500 2000000 8205 2008205

Total 12204000 285496 12489496

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 Project Charter
Business Case Opportunity Statement

• In 2023, total 16 customer complaints/ rejections
due to extraneous matter which cost around 50
Rs/kg of Product reprocessing cost of Ibuprofen &
Metformin. This has implication on customer trust
as well as regulatory compliance.
To reduce customer complaints w.r.t. extraneous matter
contamination in all APIs and enhancing customer
satisfaction 2. To reduce risk of Business/ Customer.

Goal Statement Project Scope

To achieve zero repeated complaint w.r.t. extraneous • As major complaints are received in Ibuprofen and
matter in all APIs out of 32 % received in Year 2023 Metformin .Hence only related plants are
o Currently level –% Target Level –% considered in scope for time being

Project Team Project Timeline

1. Mr. Ashok Gavate (QA) Date: 21/06/24 Date: 25/01/24

2. Mr. Yadwinder Singh (QA) & Mr. Sandeep Kanwar

(QA) Problem

3. Mr. Mandeep Kamboj & Mr. Harpal (Production) Date: 25/05/24 Date: 24/02/24
4. Mr. Karan (Utility)
5. Dr. Uttam Singh & Mr. Khushendra Singh (QC)
Date: 21/03/24

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 SIPOC
Supplier INPUTS Process Output Customer

• Vendor/ Supplier for • Raw material Approved vendor

Vendor approval process • • Production
RM/ PM • Packing material • Reject Vendor

• Sampling of Rm/PM • Approved stock for • Approved then issue

• Raw material received • Approved or reject • Receiving of material issuance to production
from Supplier the quality of Material • Sampling plan • Reject material then • Rejected then send
send back to vendor back to vendor

• After approval then

material transfer to
• Using fork lifter for • Material issued to
Approved area for Raw material issuance
transfer of material to production for batch • Production
issuance to Procedure
batch charging
production

• Equipment usage
• Production start the • Raw materials • Manufacturing of
Batch Charging • Production
batch • Manpower Intermediate/ API
• Accessories

• Qualification of Qualified equipment

Production Personnels • Gowning equipment •
• Good quality/
Procurement of PM schedule •
• • • Purchasing of suitable accessory Supply of good quality
Equipments Cleaning of Accessories •
• Use of cleaned of Customer
Purchasing of equipment •
• • Cleaning procedure equipment before
Accessories • Use of Accessories
use

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 SIPOC
Supplier INPUTS Process Output Customer
• Use of Raw material/
Intermediate for
manufacturing of
Finished product • BPCR Good quality of Batch
Production •
• Use of Sampling tools • Sampling procedure • Customer
•
• Use of Master BPCRs
for manufacturing of
Batch

• Approved then
• Sampling of Rm/PM Approved stock for issuance
issue to
•
Production Cleaning aids • Receiving of material Reject material then send
production
• • •
• Sampling plan back to vendor • Rejected then
send back to
vendor

• Issuance of Packing • Customer / market

• Production Packing of product • Material packed
material for packing dispatch

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SIPOC for vendor approval, material receiving upto Issuance
Supplier Input Process Output Customer
a) Test report
a) Raw material
b) Qualification result
a) Vendor b) Packaging material a) QMS
c) Selective sampling
b) Warehouse c) Sampling plan Receiving QC b)
result
c) QMS d) Sampling procedure Production
d) Vendor approval
e) Vendor approval
status
procedure
a) Admin a)Material movement
b)QMS equipment
c) Warehouse b) Procedure for transfer Material transfer a) Material receipt at
manpower of material from warehouse production end as per Production
(Contractual) c) Manpower to plant procedure
d) Production
manpower
AHU breakdown Batch process
Material filling
Sampling process
Final Packing

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SIPOC for the receipt of Materials at Site
Supplier Input Process output Customer
a) Vendor Material Material reciept at Site Gate entry Security/Admin
Material list verified and approved
Security/Admin Intimation to material entered in SAP
Warehouse
Dedusting done and verification of
NA Material unloaded any wear and tear of material
Material unloaded and kept packaging Warehouse
in
NA Material weighing warehouse area Material moved to quarantine area
done
Label print from Pasted on consigment
SAP
Warehouse Request given for QC to perform sampling QC
sampling to QC
QC sampling
QC person perform sampling as per
plan . At this point material is exposed QC
QC sampling procedure for short duration to environment
followed
Quality comply
Result information to warehouse
Forklift to regular storage area if complies Warehouse
Material movement from
else transferred to reject room with
Quarantine area
help of forklift
Request for
material
Material transfer to
Warehouse Material receipt in raw material area Production
Material Movement production
through tractor

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SIPOC for Material Issuance upto Release
SIPOC for the receipt of Materials conversion in intermediate area
Supplier Input Process output Customer
arehouse Material request Material recived and kept
Material receipt at Production for Production (intermediate
in RM-INT storage
processing area)
Material transfer by warehouse to area/production area
plant (via trolley/forklift)
NA Material weigh verification by Material weighed verified
production
NA Material consumption Production (intermediate
area)
Intermediate
Material charged to the reactor as
Auxiliary used in Intermediate area,
per BPCRS
nitrogen line during Centrifugation Intermediate manufactured
Production
Drying operation either in
RTD/VTD/TDS QC
Sample offered for testing
QC Results Production
Either consume in next stage QC person perform
sampling as per plan . At
Used in process this point material is Production
Production exposed for short duration
to environment
Surplus transferred to warehouse
Stock transfer
Warehouse Warehouse
Forklift/Trolleys Material movement from
intermediate area
Final stage- formation and transfer
of reaction mass
Final stage Material after filtration
Production Material Movement after filtration dissolution/Charcoalization stage in received in clean reactors Production
through Hyflo followed by micron INT area of PP area
(0.2 to 5 micron)

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High End Process Map

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 Start

mate ri al found
Se nd back to damage Mate ri al procure d and
ve ndor re ce i ve at mai n gate

Mate ri al found ok

Mate ri al unl oad, te ste d

and shi ft e d to approved
are a

Fai l
Se nd back to Mate ri al
ve ndor Re sul t

Pass
Mate ri al shi ft e d to Batch producti on
approve d are a and i ssue start
to pl ant for batch

Batch mai ntai n the Mate ri al Inproce ss sampl e

re acti on and se nd agai n Re sul t te sti ng
Fai l

Pass
Futhe r proce e d for
Inte rme di ate Mfg.

Mate ri al se nd for
Fai l Mate ri al
re proce ssi ng or di spose (i f
Re sul t
re proce ssi ng proce dure not
the re

Pass

Batch proce e d for

Fi nal proce ssi ng

Batch manufacture d

Mate ri al se nd for Fai l Mate ri al

re proce ssi ng or di spose (i f
Re sul t
re proce ssi ng proce dure not
the re

Pass
Batch proce e d for
fi nal packi ng and
se al i ng and di spatch

End
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CTQ Characteristics
Identify the Primary and Secondary Metrics

CTQ Performance Standards

CTQ Characteristics
CTQ
Measure Data Type Operational Definition Target USL LSL

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Past Performance Trends
Use appropriate graphs (like bar chart, pie chart, trend line etc.) or use data in tabular format to
show the past performance of Primary Metrics (if applicable)

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Measurement System Analysis
 Is MSA needed?
 If yes, show the measurement system analysis results
 If no, please explain why is it not needed.

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Sigma Level - Baseline Performance

Identify the baseline or current process performance using either of the following metrics

• Sigma Level (Z)

• DPMO
• DPU
• Yield

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Prioritized Requirements*

Show the prioritized requirements along with Examples and Scenarios

* For Tech Intervention Projects

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Define and Measure Tollgate
Step 1: Generate Project Ideas

D Step 2: Select Project

Step 3: Finalize Project Charter and High Level Map

Step 4: Finalize Project Y, Performance Standards for Y  Sponsor Sign Off

M Step 5: Validate Measurement System for Y

Step 6: Measure Current Performance and Gap
 Exec Sign Off

 Benchmark Sign Off

Step 7: List All Probable X’s

A Step 8: Identify Critical X’s

Step 9: Verify sufficiency of Critical X’s for the project

Step 10: Generate and Evaluate Alternative Solutions

I Step 11: Select and Optimize best solution.

Step 12: Pilot, Implement and Validate the solution

Step 13: Implement Control System for Critical X’s

C Step 14: Document Solution and Benefits

Step 15: Transfer to Process Owner, Project Closure

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List of methods used for finding Critical Xs

List the methods you will use for finding critical x’s/ focus areas/ root causes

Use separate slides for each method used. Examples are -

• VA/NVA Analysis
• Statistical Tests
• Pareto Charts
• FMEA
• Others like Arrays/ Simulations

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List of Critical X’s or Critical Requirements
 List all critical X’s or critical requirements (non-negotiables)

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Analyze Tollgate
Step 1: Generate Project Ideas

D Step 2: Select Project

Step 3: Finalize Project Charter and High Level Map

Step 4: Finalize Project Y, Performance Standards for Y

M Step 5: Validate Measurement System for Y

Step 6: Measure Current Performance and Gap

Step 7: List All Probable X’s  Sponsor Sign Off

A Step 8: Identify Critical X’s

Step 9: Verify sufficiency of Critical X’s for the project


Exec Sign Off

Benchmark Sign Off

Step 10: Generate and Evaluate Alternative Solutions

I Step 11: Select and Optimize best solution.

Step 12: Pilot, Implement and Validate the solution

Step 13: Implement Control System for Critical X’s

C Step 14: Document Solution and Benefits

Step 15: Transfer to Process Owner, Project Closure

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Solution creation or pilot execution plan
 Show the solution creation or execution plan along with responsibilities and dates.
 Show the progress and monitoring of the plan

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Trial implementation results (if relevant)
Pilot Strategy

 How many Days :

 On how many People :

 Requirements :

 Assumptions :

 Roles and Responsibilities :

 Timelines :

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Full Scale Implementation Plan (if relevant)

Improvement Baseline

On how many people

Requirements

Assumptions

Roles and Responsibilities

Start Date

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Pre vs Post
 Use graphs or tables to show the improvement
 Show improvement in the baseline metric

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Improve Tollgate
Step 1: Generate Project Ideas

D Step 2: Select Project

Step 3: Finalize Project Charter and High Level Map

Step 4: Finalize Project Y, Performance Standards for Y

M Step 5: Validate Measurement System for Y

Step 6: Measure Current Performance and Gap

Step 7: List All Probable X’s

A Step 8: Identify Critical X’s

Step 9: Verify sufficiency of Critical X’s for the project

Step 10: Generate and Evaluate Alternative Solutions  Sponsor Sign Off

I Step 11: Select and Optimize best solution.

Step 12: Pilot, Implement and Validate the solution


Exec Sign Off

Benchmark Sign Off

Step 13: Implement Control System for Critical X’s

C Step 14: Document Solution and Benefits

Step 15: Transfer to Process Owner, Project Closure

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Mistake Proofing (if relevant)
 Identify and list the mistake proofing techniques implemented to control the Xs

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Control Plan
 Show revised flow chart / modified procedure / control mechanism / modified dashboard
 Indicate how improved results will be sustained

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Control Plan
 Depict Control Charts to show that process is in control

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