WORKING OF PPMC (PRODUCTION PLANNING & MATERIAL CONTROLLLING) A PROJECT REPORT Under the guidance of MR. IMRAN SHERA Submitted by KAUSHAL BHARATKUMAR DAVE ROLL NO.: 1205017002 In partial fulfillment of the requirement For the award of the degree Of MBA IN [Operations Management] MARCH 2014
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WORKING OF PPMC
(PRODUCTION PLANNING & MATERIAL CONTROLLLING)
A PROJECT REPORT
Under the guidance of
MR. IMRAN SHERA
Submitted by
KAUSHAL BHARATKUMAR DAVE
ROLL NO.: 1205017002
In partial fulfillment of the requirement
For the award of the degree
Of
MBA
IN
[Operations Management]
MARCH 2014
Bona Fide Certificate:
BONAFIDE CERTIFICATE
Certified that this project report titled “Working of PPMC in companies across
Pharmaceutical Industries” is the bona fide work of “Kaushal Bharatkumar Dave” who
carried out the project work under my supervision.
SIGNATURE SIGNATURE
HEAD OF THE DEPARTMENT FACULTY IN CHARGE
Sr. No Chapter Name and Content Page No.
1 Preface
2 Acknowledgement
3 Executive Summery
4 List of tables
5 List of figures
6 List of abbreviations
7 Research Methodology
Chapter: I
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
PREFACE
It gives us great pleasure in placing in hand of our esteemed department, this report
that, we believe, will go through the documentation of this project work made by us.
Today business unit can exist when only work smarter than working harder. Man’s true
knowledge is the “Experience” and “Observation”. Hence it is a good thing that the
business school offers such training to the student in all the aspects of the
business. Looking at the today’s world or scenario, the students is focused into the world
of commerce and management, but less are in the world of practical
knowledge. Only the bookish knowledge is not sufficient. So, the SIKKIM MANIPAL UNIVERSITY has decided to include the program of
practical knowledge in the 4th Semester of MBA Program to hire some practical
knowledge about the Operation management like inventory levels, just in time
production, supply chain management, etc.
Acknowledgment
Through this acknowledgement, I express my sincere gratitude towards all those people
who aided me in the preparation of this project report which has been a learning
experience.
I would like to thank, Mr. Imran Shera, Manager- Production, Rajesh Gupta, Asst.
manager – Production, Jayesh Chaudhari, Executive Production & Purusharth Detroja,
Sr. officer Production for giving me the best opportunity of this practical work
experience.
Again I express m y thanks to the M r . N a v i n K . S i n g h , D G M – H R &
Mr. Manoj More, Asst. Manager-HR who had given me remarkable information
regarding Human Resource position of Famycare Pharmaceuticals Ltd.
Words are inadequate in offering my thanks to the Project Trainees, for their
encouragement and cooperation in carrying out the project work.
Finally, yet importantly, I would like to express my heartfelt thanks to my beloved
parents for their blessings, my friends for their help and wishes for the successful
completion of this project.
Executive Summary
Supply chain management focuses on the management of the transfer of materials and
information along the entire chain from the suppliers to the final consumer. This chain
will generally include the suppliers, producers, distributors, retailers and then the final
customer.
One of the major problem areas of supply chain management is Inventory management.
Inventory can be defined as the stock of any item or a resource that will help the firm in
generating revenue. The inventory can be the raw materials, the work in progress
inventory or the finished goods that have not been dispatched. They all have some costs
associated with them and these extra costs can affect the margins of the company.
The pharmaceutical industry was selected for the study because the industry is very fast
moving and requires dealing with huge amount of inventory, in all forms. The companies
selected for the study were the companies having the highest market capitalization in the
year 2013. The inventory data was collected for all the companies and a comparative
study was done.
The data required for analysis was taken from reliable databases like ACE Equity
Database.
The study was done on the basis of some parameters (ratios) that are used to measure the
inventory management of a company.
The study also revealed the trends that are prevailing in the pharmaceutical industry since
the last five years. The results also indicated that better inventory handling can provide
good results, as was visible from the data analysis.
The dissertation project helped me understand in detail the parameters of a supply chain
and inventory analysis in better detail.
List of Tables:
Table 1 - Major pharmaceutical industry in India
Table 2 - Top selling medicinal brands
Table 3 - countries where medicines are exported
Table 4 - Domestic planning vs. export planning
Table 5 - Products deliverance time based on dosage
Table 6 - Purchase requisition
Table 7 - Lead time chart
Table 8 - BMR & BPR requisition
Table 9 - Theory of constraints
List of figures
Figure 1 - Flow chart for supply chain management process of company
Figure 2 - Flow chart for monthly production planning activity
Famy Care was incorporated in India in 1990 with the vision of becoming a Competitive force to reckon with in Female Health Care with a focus On Hormonal &
Reproductive Health Care Products.
Reproductive Health Care Segment :
The company engaged in the anufacturing of a wide range of Reproductive
Healthcare Products, like Oral Contraceptives, Emergency Contraceptives, Intra Uterine
Devices and Tubal Ligation Rings for the quality conscious customers through quality
research and development.
It is the one of the largest suppliers of Intra Uterine Contraceptive Devices (IUD)
And Oral Contraceptive Pills (OCPs) to various Ministries of Health & Family Welfare
and Social organizations across the World.
Its products and services are distributed and maximized through all appropriate channels
in each geographic market.
Famy care is a global player in the Female Health Care Segment with a focus on
Hormonal & Reproductive Health Care Products. Famy care believes in the right of
women to be informed about their reproductive healthcare choices and to make good
health accessible to all. In a very short span of time we have become the largest
manufacturer of Hormonal Tablets. We have four world class plants at two locations
supported by strong R&D facility for development of Complex Hormonal &
Reproductive Health Care formulations.
(B) BUSINESS :
Its products of Hormonal formulations and Medical devices are available in more
than 40 countries worldwide. It is an approved supplier of UNFPA, PSI, and Crown
Agents-UK & PAHO. Its Products are supplied to projects run by DKT, World Bank,
IPPF and Ministry of Health in various parts of the world.
Foreseeing the rising demand of Hormonal and Reproductive Health Care
Products in Global Market, the facilities have been upgraded to meet the US and EU
regulatory requirements. Eventually, this will enable us to become a dominant Global
Player in the Hormonal and Reproductive Health Care Segment.
The company regularly participates in various trade fairs, seminars and
conference across the globe to meet likeminded people for carrying out business
alliances.
Milestones in OCP Business
Largest producer and exporter of Oral Contraceptive Pills.
Exporting over 150 Million cycles of Pills annually to various countries around
the world.
Famy Care has a wide range of product to meet all specific needs of the Pill
user.
The manufacturing plant not only has a WHO-GMP certification but also is the
only plant in India that has gone through a number of international GMP
compliance audits.
First company to start OCP‟s export from India
Milestones in IUD Business
One of the world's largest producers of Copper-T having the largest capacity to
produce IUD's.
First indigenous supplier of Copper- T to the Ministry of Health & Family
Welfare, Government of India, since 1991 with an Excellent track record of
accomplishment for 16 years.
Regular supplier of IUD's to various National Family Welfare Programs
around the world like UNFPA, World Bank, and large NGOs like DKT.
First company to start exports of lUD's from India to UNFP
(C) PRODUCT :
Its Product Range includes Oral Contraceptive pills, Emergency Contraceptive Pills,
Progestagen Only Pill, Intra Uterine Devices, Rings for Tubal Ligation and Cancer
Detection Kit.
Oral Contraceptive
Ranges from a combined combination of estrogen and progesterone, which
ranges from a vast range of Monophasic pills to Triphasic pills.
Monophasic
Monophasic pills contain constant combination ratio of estrogen and
progesterone in all of the active pills in a pack. Famycare brands of Monophasic
pills includes the molecules like Ethinylestradiol, Levonorgestrel, Norgestrel,
Desogestrel, Gestodene, Cypterone acetate etc.
Biphasic
Biphasic pills contain two different ratios of progesterone and estrogen. The
hormonal variations in the active pills changes twice during the cycle.
Triphasic
Triphasic pills contain three different doses of hormones in the active pills, the
hormonal variations in the active pills mimic the female natural menstrual
C & F (4 C&F in India hydrabad,delhi,culcata,gujrat)
Packaging
1. Packaging 2. Packaging and development & international regulatory affair
PACKAGING finish product packaging with batch manufacturing record
(BMR) &
batch packaging record (BPR)
2. Packaging and development & international regulatory affair - artwork code
(new & revised) generated by Packaging & development department
QA department
Review batch BPR &BMR, GMP documentation
Finish product storage goods department
Distribution department
For trade dispatch (domestic & export)
Tender (Gov.) dispatch (domestic & export)
C & F (4 C&F in India hydrabad,delhi,culcata,gujrat)
Distributors Retailers
(4) PROCEDURE FOLLOWED BY PPMC DEPARTMENT
4.1 PRODUCT AVAIBILITY REPORT FOR DOMESTIC PRODUCT
PAR is containing list of products which have pending orders.
Distribution department is giving PAR for TRADE and TENDER sale
list to the PPMC department and they also give Novagen PAR which
is separate division and Par for the third party division is given from
the supply chain management department and narcotic PAR is given
from excise department another four divisions are in Troikaa
A. Hospitroy division
PPMC department shall prepare separate sheet of the product list for
Thol, Dehradhun and third party and shall forward to Thol and
Dehradhun for filling purpose.
Procedure for filling of Par by plant in charge:
B. Plant in charge with coordinate with QC in charge and shall fill
up the expected quantity, batch number and expected date of
receipt. Only for those products which are work in process or
which plan in next week basis of following criteria.
1) For parenteral product 16 days should be provided and that is for finish
product.
1 day for washing of sterile and non-sterile product, 2day for
manufacturing of product in sterile tank, 3 day for filling in
ampoules and vials. And then next 13
days for sterility purpose including Q.C and packing purpose.
2) For the tablet/capsule products 11 days shall be provided from the
date of granulation to final product viability
1st day for Dispensing
2nd day for granulation
3rd and 4th day for compression
5th day for coating
And then tablet goes for finish goods Quara ntine.
After that another 6 days for testing of Q.C release including packing.
So total 11 days are taking for finish product availability
3) For Liquid-cap products 21 days shall be provided from the date of filling to
final date of finish product availability.
4) For Bifosa 35/70, 15 days shall be provided from the date of granulation to
final date of granulation to final date of finish product availability.
5) For Torero sachet 15 days shall be provided from the date of granulation to
final date of granulation to final date of finish product availability.
6) For Myonit SR 2.6/6.4,15 days shall be provided from the date of granulation
to final date of granulation to final date of finish product availability.
PPMC officer shall also observe the expected date of receipt of two consecutive
PARS given by the production department if any date is changed then PPMC
department ask reason for the same.
PPMC officer shall daily fill up PAR deviation report with reference to
manufacturing date of particular batch.
4.2 PROCEDURE FOR FILLING OF EXPORT ORDER STATUS REPORT AT PRELIMINARY STAGE BY PPMC DEPARTMENT: At the time of receipt of new order PPMC department shall fill up
indent for raw materials required in particular order and shall forward it to
purchase department. If proposed execution date (planned date) is longer
than shipment date then ppmc department shall inform to purchase department
for urgent procurement for the same.
If purchase department don’t conveys than it’s impossible to prepone
delivery dates due to shortage material in the market, than ppmc department shall
derive the ADC date and inform to export department to extend the last shipment
date.
Ppmc department shall mention the purposed ADC date and execution
date based on availability of RM/PM and production schedule.
Procedure of filling Non availability of product list before 23rd by ppmc
department
department shall mention product (domestic) if product is available in
the month after 23 rd in Non availability of product list before 23 rd of
month and forward the report to distribution department by every Monday
with PAR report.
Distribution department have to take following action
1) Inter branch transfer of Ppmc existing stock
2) Transfer the Guj stock to C&F
Procedure for filling order execution date based on product ion plan by
production department.
On receipt of export order status, production department shall mention
the ADC dates on the basis of actual weekly production plan and production
norms after filling the ADC dates the report shall be forwarded to Q.C head
Q.C head shall fill up the ADC date based on the actual release of the
batch, and shall forward the report to ppmc department
Ppmc department shall mention the ADC submission date in the export
order status.
FINAL EXECUTION DATE:
The final execution date shall be given by ppmc department. Execution date
shall be two days from the date of ADC submission date.
4.3 GUIDELINE TO FINALIZE EXPORT ORDER QUANTITY
OBJECTIVE
To lay down a procedure for finalizing the export order quantity to match with
standard batch size before confirming the export order to the agent/associate.
SCOPE
This guideline is applicable to all export orders of THOL /
DEHARADUN, except below categories of export order
Government /Tender supply
All ointments
Product promoted ethically in export market
Production planning and material control dept. must try to combine these
orders with domestic order if possible.
RESPONSIBILITY
Order finalization: Head – International Marketing
Production planning according to standard batch size-Head-
PPMC
ACCOUNTABILITY
Head –PPMC
Prior to finalization of order of Purchase indent, International Marketing shall
finalize the order Quantity, as per following.
PEXO sending from international marketing department
International marketing department shall send PEXO to PMC / QC / QA /
PLANT HEAD/BSR with remarks on PEXO as follows:
Government tender order. (Part shipment/part quantity not allowed)
Government tender order ( part shipment is allowed but total
quantity to be fulfilled)
Trade order (2% Minus quantities is allowed for closing of
the PO Quantities)/Part shipment allowed
PPMC dept. shall forward the same PEXO to production dept. for
information purpose.
Procedure of excess quantity to be packed
OPTION I
(product exclusively manufactured for export and domestic)
If the excess quantity found in export trade order, production head shall
intimate to ppmc officer /executive in well advance (before packing of the
product).ppmc shall take approval from international business to pack the
excess qty. in same order. Some time it is used for domestic supply.
OPTION II (Products are manufactured execlusively for export)
If order quantity manufactured is excess against the PEXO and cannot be
packed in present PEXO or in domestic supply, such quantity shall be
reflected as excess quantity in “excess unpacked quantity after export order
completed Report, which is prepared by production head and submit to
ppmc department every week.
PPMC officer shall forward this report to IB team with his
proposed remarks to accommodate the excess quantity in
pending PEXO.
IB team shall confirm their remarks and forwarded the same
report to ppmc department.
Ppmc officer shall take action in pending PEXO and forwarded
the same report to production department.
If excess quantity found very minor quantity like 600 ampls
and vials and 3500 tabs and if it cannot be packed than
withdrawing the sample for RA if required and rest of the
quantity should be destroyed.
For products listed in Annex I : (slow moving & exclusively export
product list)
International Marketing dept. shall review the qty mentioned
Order quantity shall be considered as combined quantity of
sale as well as free scheme samples, which should match the
same qty.
If order quantity matching as per Annex-I qty, international
marketing department shall raise PEXO with highlight the order value
of each product with US $ for the further decision.
GMP aspects of the product
Order value of the order
Impact of not supplying the product in to the international market.
For the products listed in annex II (fast moving products):
If order quantity matching with specified qty in annex II,
international marketing department shall raise the purchase
indent and release the PEXO.
PPMC shall review planning of such product for domestic
purpose & shall club export quantities with domestic
quantity to have standardize batch size as per annex II.
PPMC department shall inform the export department for
the execution of such order which shall be approx .55 days
from the date of the receipt of the order.
4.4 Domestic planning Vs Export Planning
Domestic Planning Export Planning
Domestic production planning is
done based on Demand
forecast data given by
marketing department.
Make To Stock: MTS is a
usually technique, where in
anticipation of demand vast
quantities of goods are Produced
and stocked in warehouses.
Push Based Supply Chain : In
this type of supply chain,
Products are manufactured in
advanced of customer’s order,
stored into warehouse and then
pushes distribution chain to sell the
products.
Inventory
Less inventory keeping stock
compared export product
stock.
Domestic PPMC Planning
It is not a critical process compared to
International planning.
Export production planning is
done based on Export Sales
Orders.
Make To Order :
MTO is a production approach
where once a confirmed order for
products is received, and then
products are built.
Pull Based Supply
Chain : In this type of
supply chain,
Customer’s orders act as pull
factor and according to that
products are manufactured.
Inventory
High inventory stock compared
to domestic product.
International PPMC Planning
It is very critical and time taking process
Compared to domestic planning.
8 FINDINGS
Major Finding 1
F1 WORKING OF PPMC (PRODUCTION PLANNING AND
MATERIAL CONTROLLING)
F1.1 Step: 1 Demand forecasting of domestic and export product
Demand forecasting is used for estimating future demand of
product for domestic market and international market. Most of
companies are used time series method for estimating future
demand .However some large companies both domestic and
multinational employees Business economists or outsource
it from business consulting or market research firms.
Here some of the methods are given which are generally used by the
company:
OPTION II (Products are manufactured execlusively for export) If order quantity manufactured is excess against the PEXO and
cannot be packed in present PEXO or in domestic supply, such
quantity shall be reflected as excess quantity in “excess unpacked
quantity after export order completed Report, which is prepared
by production head and submit to ppmc department every week.
PPMC officer shall forward this report to IB team with his
proposed remarks to accommodate the excess quantity in
pending PEXO.
IB team shall confirm their remarks and forwarded the same
report to ppmc department.
Ppmc officer shall take action in pending PEXO and forwarded
the same report to production department.
If excess quantity found very minor quantity like 600 ampls
and vials and 3500 tabs and if it cannot be packed than
withdrawing the sample for RA if required and rest of the
quantity should be destroyed.
For products listed in Annex I : (slow moving & exclusively export
product list)
International Marketing dept. shall review the qty mentioned
Order quantity shall be considered as combined quantity of
sale as well as free scheme samples, which should match the
same qty.
If order quantity matching as per Annex-I qty, international
marketing department shall raise PEXO with highlight the order value of
each product with US $ for the further decision.
GMP aspects of the product
Order value of the order
Impact of not supplying the product in to the international market.
For the products listed in annex II (fast moving products):
If order quantity matching with specified qty in annex II,
international marketing department shall raise the purchase
indent and release the PEXO.
PPMC shall review planning of such product for domestic
purpose & shall club export quantities with domestic quantity
to have standardize batch size as per annex II.
PPMC department shall inform the export department for the
execution of such order which shall be approx .55 days from the
date of the receipt of the order.
4.4 Domestic planning Vs Export Planning
Domestic Planning Export Planning
Domestic production planning is
done based on Demand
forecast data given by
marketing department.
Make To Stock: MTS is a
usuallytechnique, where in
anticipation of demand vast
quantities of goods are Produced
and stocked in warehouses.
Push Based Supply Chain :
In this type of supply chain,
Products are manufactured in
advanced of customer’s order,
stored into warehouse and then
pushes distribution chain to sell the
products.
Inventory
Less inventory keeping stock
compared export product
stock.
Export production planning is
done based on Export Sales
Orders.
Make To Order :
MTO is a production approach
where once a confirmed order for
products is received, and then
products are built.
Pull Based Supply Chain : In
this type of supply chain,
Customer’s orders act as pull
factor and according to that
products are manufactured.
Inventory
High inventory stock compared
to domestic product.
5 FINDINGS
Major Finding 1 WORKING OF PPMC (PRODUCTION PLANNING
AND MATERIAL CONTROLLING)
F1.1 Step: 1 Demand forecasting of domestic and export product
Demand forecasting is used for estimating future demand of product for
domestic market and international market. Most of companies are used
time series method for estimating future demand .However some large
companies both domestic and multinational employees Business
economists or outsource it from business
consulting or market research firms.
Here some of the methods are given which are generally used by the
company:
Composite of sales fore opinions: company is deciding sales forecast
for particular product.By ask its sales representatives to estimates their
future sales.
Expert opinion: company will obtain forecasts from experts including
dealers, distributors,Suppliers, marketing consultants and trade
associations. Occasionallycompany will invite group of experts to prepare
a forecast
Past sale analysis: sales forecasts can be developed on the basis of
past sales.
1)Time series analysis: breaking down past time series in to four
components. Trend, cycle, seasonal and erratic and projecting these
components in the future.
2) Exponential smoothing method: projecting next period sales by
combining the Average of past sales and most recent sales
3) Statistical demand analysis Consists of measuring the impact level of
each of a set of causal factor: income, marketing expenditures ,price on the
sales level
4) Market-Test method: used for forecasting new- product sales.
After that, calculate net following formula:
production quantities based on sales forecasting by using
Production plan of next month = Sales forecast of
current month + Inventory
norms - Opening stock–
Production plan of current month
Convert production quantities into multiple of batches as per standard
batch size.
Export Sales Orders:
For international market, production is done based on specific Export Sales
order.
Regulatory
Finance
Pack F&D
PRODUCT EXPORT OREDR
It is internal communication document which is prepared by business co-
ordination team and executed by Supply Chain Management Team, describes
customer’s orders and their requirements.
Product export order involves following information:
Consignee’s Name & Address
country
Delivery terms
Payment terms
Mode of shipment like by Air or Sea
Product information ( code, pack, quantity, value)
Special Instructions if any
Last date of submission of ADC
Name of the manufacturer and Location
Name of the buyer
Trade or Tender
After approval of international business team, planning concerned compile the
Product export order for following elements viz.
Batch size
Production feasibility
Process time
Additional specific remarks, if any in product export order.
Products deliverance time based on dosage viz. after receipt of approved
product export order.
Product export order
Shelf life Total Qty Remark value
($ or euro)
Product, strength, brand
Freshly 30000 tabs
Shelf life and pack size Manufactured
1. ATORVASTATIN TABLET
10 MG (Lesstrol 10)
Shelf life: 2 years
3x10 TAB BLISTER
F1.2 STEP-II: Next step is MRP (Material Requirement Planning).
Material Requirement Planning is a production planning and inventory
control system used to manage manufacturing processes.
To run MRP on PHARMASUITE, first of all we have to enter
inputs into PHARMASUITE system.
MRP Inputs:
Bill of Material
Material master
Export order & forecast data
Inventory status file
Bill of Material:
For material requirement planning first get enter in to the
PHARMASUITE and then select location like THOL or DEHARADUN.
Then select Production than go for purchasing than material
requirement planning, we have to select.
n a
c P c
a
e
Whatever Raw material and packaging material is required are
to be planned for EXPORTING (TENDER OR TRADE),
DOMESTIC ORDER (TENDER OR TRADE) Order is come
by export order status and by check list for domestic and PAR
from distribution which are pending orders which have to
provide by production department.
Whatever material is required for manufacturing product and its
material availability status can be known by go into the production
than production planning and then select Material availability status and
then select RM or PM.
MRP (Material Requirements Planning)" is a concept of creating material
plan and production schedules based on the lead times of a supply chain
However, even if you create an MRP-based plan based on an ideal factory
model, problems may still actually occur.
Traditional MRP (or MRP II: Manufacturing Resource Planning) and DRP-based
planning are both techniques of supply chain management. If we collectively call
those methods MR -based supply chain planning, what are the haracteristics
and what are the differences between MRP-based supply chain constraint-
based supply chain planning?
In MRP-based planning, demand plans i.e. sales plans, are created
independently from constraints on created based on the production and
material plans, and production plans are lead times of the supply chain.
If a schedule is created by determining the "product remix", i.e. products to
manufacture and their BOM (Bill of Materials) then exploding processes
and imposing loads on each operation will result in a schedule that
exceeds operation capacity because capacity constraints are not reflected on the
M
m
s
a
p
schedule. If the operation capacity is sufficient then the MRP-based schedule will
be an optimal just-in-time schedule in which the lead time is minimized and
throughput is maximized.
However, in reality, it's often the case that materials are input and production
schedules are carried out exceeding production capacity. This results in in-
process inventory that waits for resources. Even with schedules created for an
ideal factory, there will be in-process inventory that waits for resources, a
build up of excess inventory occur and some operations that are susended due to
insufficient raw materials.
If there is leeway in operation capacity, the MRP can be used as an initial plan
and the difference between the schedule and the actual capacity can be solved by
the schedule controlled by the shop floor. However, if you try to match MRP
directly with actual production then demand should be adjusted so as not to
exceed the actual capacity and you should repeatedly execute the MRP over
and over again. Therefore, an extremely high-speed MRP system will be
required.
Historically, MRP was not as widely spread in Japan as it was in Europe and the
United States. This may have been because there was a gap between the ideal
factory and the actual factory and that lead to the development of "KKD" ("kan"
meaning sense, "keiken" meaning experience, and "dokyo" meaning courage)
to respond to the reality of the shop floor
The planning system of supply chain management emerged as a form of
planning that replaced the "KDD" part with information technology that
furthered scientific planning. JIT (Just-in-Time) is a constraint-based process
management system. If we replace the word "constraint" with "reality", most
Japanese companies will respond that it makes sense.
0s However, in Europe and the U.S., since the planning system was developed
from an MRP-based ideal factory model, the concept of "constraints" is
regarded as a fresh and new concept. TOC (Theory of Constraints) is a
methodology that caused, together with Japan's TQC (Total Quality Control), a
paradigm shift for production management in the U.S. in the 1980s.
CREATION OF MASTER FORMULA RECORD & ARTWORK IN
PHARMASUITE:
First of all Master formula record has been prepared by F & D department.
MFR involves all detailed work instructions. After that F & D shall forward the
duly approved original MFR to Quality Assurance documentation cell for
issuance and distribution to the Technology Transfer department.
Based on MFR, Technology Transfer department shall prepare MMR
(Master Manufacturing RECORD) I,II and forward the duly approved original
MMR-I,II to Quality Assurance department for issuance and distribution to
SCM department for purpose of creating ARTWORK and Material Master on
pharmasuite. After receiving approved MMR-I & II, authorized executive of
supply chain will create Material Master Code and ARTWORK CODE in
PHARMASUITE.
MMR-I: (for Raw Materials)
MMR-II: (for Packaging Materials)
MFC (Master Formula Card)
MMR-I and II (Master Manufacturing Record)
Artwork code, Material Master (PHARMASUITE)
ARTWORK GENERATION BY P&D (PACKAGING AND DEVELOPMENT).
Packaging and development department create ARTWORK which is NEW or
REVISED for different products for different countries and whatever raw material
and packaging material required for that is also indented and revised artwork
is there than code is changed from previous one.Like from 01 to 02.
F 1.4 Step-3: (Raw material / Packaging Material) indenting:-
As we run MRP on PHARMASUITE system, Based on the Purchase
requisition memo, forecast data or orders and current inventory stock
of materials PHARMASUITE system itself raise RM/PM indent
list.RM/PM indent list involves only that RM/PM with their quantities
which have to purchase from vendors.
The main objective of RM/PM indenting is in view of “Optimization of Raw
and Packing materials Inventory”, to determine the net requirement of raw
material and packing material to be procured to deliver the current month (if any
revision) and sub sequent next two month of domestic and export products.
There are five types of scenario, wherein Indents gets generated in
P HARMASUITE system viz.
1) System automated collective generation of Indents
In this type of scenario, PHARMASUITE system automatically generate
RM/PM indent on collective basis after seeing all order and forecast data.
2) New products, RM/PM based on supply chain head approvals
For new product RM/PM, indent shall be raised after approval of supply chain
head approval. And for New product launch proposal
3) Export RM/PM, that is imported from foreign supplier or from domestic
supplier.And all information regarding indenting to material receipt register
can be get from PHARMASUITE.
Indent Details
1) Indent No:
2) Date:
3) Description Code:
4) UOM:
5) Sch qty:
6) Req.Qty:
P.O. Details
1) P.O No:
2) DATE:
3) Name of Supplier:
4) Rate:
5) Delivery due date:
6) G.R.N. No
4) Subjective, as advised by Purchase head, to take price benefit from market
Sometimes purchase head advised to SCM dept to raise indent of
particular RM/PM to get price benefit from market.
After checking of MRP end results, net requirement of Raw and Packing
materials line by line is being checked by material planner. If any correction
in current month and subsequent next two productions plan, appropriate call is
taken for addition and deletion of RM/PM requirement.
F 1.5 Step: 4 Purchase Requisition
After that Purchase department make Purchase Order and it will place the
Purchase order to the approved vendor and send the copy of order to the vendor.
If there is new product, purchase department will approach for 3 quotations
from approved vendors and after that negotiate with vendors and approved one of
them after getting confirmation from Finance department and receiving the
materials on the credit basis.
LEAD TIME CHART
PARAMETERS PRODUCT NORMS
Finish product
process time
Tablet
General
Categary
11 days
Parentals 16 days
Manufacturing
week
Tablets Last day of
asssigned week
Parenterals Last day of
asssigned week
QC release time Sterile 15 days
Non sterile 10 days
Buffer time For all products 7 days
Procurement Packing material 20 days
Raw material 20 days
Imported material
(By air)
15 days
Imported material
(By sea)
30 days
Lead time is the time from the moment the customer places an order (the
moment you learn of the requirement) to the moment it is received by the
customer.
Lead time is made of:
Preprocessing Lead Time: It represents the time required to release a purchase
order (if you buy an item) or create a job (if you manufacture an item) from the
time you learn of the requirement.
Processing Lead Time: It is the time required to procure or manufacture
an item.
Post processing Lead Time: It represents the time to make a purchased item
available in inventory from the time you receive it (including quarantine,
inspection, etc.)
Generally for all the RM/PM, lead time is 30 days at Famycare ltd.
After receiving materials, purchase department send the GR (Goods Receipt) to
SCM and sampling department send the sample to QC for Specification as per the
SOP of Raw material specification.
Purchase Requisition
Purchase order
Goods Receipt
Then QC people test the sample and prepare the ROA and decide the lot number
(BMR& BPR). Head of the QC send this ROA to the purchase dept and SCM.
As per the ROA, prepare the production schedule consulting with the production
dept.
BPR/ BMR form containing the manufacturing and expiry date of the product. As
per the order from the country, lot is divided into the batch depends on the
machine capacity. After this materials are transferred to production dept for
convert into the tablets.
F 1.6 Step-5: Production Scheduling:-
Production scheduling is done with the coordination of production dept,
considering product requirement, material availability, capacity availability and
uniform loading is given by Production department. Production plan of next
month is given to production for scheduling by 6th of every month.
The main objective of production scheduling is to determine the delivery dates
of next month’s production plan.
By taking expected delivery date of RM/PM from purchase department,
production scheduler shall prepared granulation plan for next month and every
day “Granulation plan Vs Actual” shall be generated by production
scheduler. If any deviation in granulation shall be discussed on daily basis as to
meet current month plan.
Scheduling is done in such a manner, that it fulfills market requirement for
domestic products and meet dispatch deadline in case of export orders. Production
schedule should show uniform loading on each machine and effective capacity
utilization.
Products required for next month’s sale are scheduled before 23th so that
product can reach the C&F in time. Priority is given for the products, which are
having higher value and volume to be loaded first and then product with lower
value and volume to be loaded next in scheduling.
Projected capacity utilization report shall be generated (Dosage-wise) for next
month plan by every 5th of succeeding month. After the month end,
“Projected capacity Vs Actual utilization” shall be prepared to show previous
month performance.
Production schedule show all details like which machine are working and
which resources are working and which one is free. How much time require to
produce the listed lot, it show the starting and ending time. Also show the
sequence of the products and total number of batches.
F1.7 Step-6: Production Order:-
To create production order on the basis of planed production and
packaging requirements and advance scheduling, SC will convert planned
production order into production orders, after evaluating the ground situation and
consulting production executive.
As per the production order, SCM will continue check and in contact with the
production department and get the daily report from the production office.
Production dept try to deliver the goods in the bond room or warehouse.
Semi finished goods i.e. sample of tablets (before labeling) are again transfer to
QC. QC will test the all tests as per the SOP prepare the report and send to
packaging department. QC will perform the various test like Dissolution test,
HPLC test, Friability test, GC test, Weight variation etc. and the entire test have
their limit. Semi finished goods must pass all test within the prescribed limit.
Packaging department will pack the semi finished goods as per the order and
use the packing materials which are prescribed in the list of PM. First pack into
primary packing as per the PO i.e. 28 Tablets in one strip. In secondary packing
number of strips in one box i.e. 1×28 T.In Final packing, as per total weight of the
carton - number of box are put into one carton.
On every carton, stick the slip which containing the weight, product name, batch
no, mfg date and expiry date. After all this steps goods are store in bond room.
F2 ISSUES IN PRODUCTION PLANNING AND MATERIAL
CONTROLLING (INBOUND LOGISTIC MANAGEMENT)
1. Inappropriate Material Management
In Famycare pharma company lead time for Raw material and packaging material
is fixed whether it is imported or from domestic.
Lead time for Raw material which is imported is 30 days
Lead time for Raw material which is from domestic company is 20 days
Lead time for packaging material which is from domestic (printed or non-
printed) 20 days
Whenever lead time is increase from vendor due to many reasons whole
production schedule is delayed because of non availability of material and if
company can’t fulfill order of TENDER SALE for domestic and export then
company have to pay fine for that.
Many reasons are there for delaying in packaging and raw material:
1) Inappropriate transportation system that is by sea, railway and road it will take
more time due to many reasons.
2) No response of vendor because of not comfortable of business with company and
less profit.
3) Delay in payment by the company so vendor may not respond next time.
4) There is not matching of quality of material criteria between company and
vendor.
5) If there is excess material sent by vendor to store department.
6) In appropriate material quality given by vendor.
2. Issues Related to new product launching and product management:
When new product is launched by company at domestic level at all states there are
big challenges of supply chain for supplying drugs at all distributors. And it’s
challenge because company don’t know demand of their new product so
appropriate market research study have to carry out by company so at least
company can assume the demand of product otherwise stock out problem can be
occur which is create wrong implication. And whenever company wants to launch
their products, proper stock availability of raw material and packaging material
should be there. Otherwise delay in production schedule and disturbance in
production schedule.
3. Rejection of Raw material and packaging material
Whenever PPMC department had already planned regarding production and
material has already came to the store and it is tested by Q.C department and if
it is rejected then there will be delay in production. This type of problem
arises when there are no similarities in testing criteria of vendor and Q.C
department of company.
4. Machine break down
Some time when machine get breaks down due to many reasons wholly
production schedule has been disturbed because in Famycare pharma there
is no extra shift or machines for avoiding production delay so delay occur.
The causes for breakdown can be:
Failure to identify and replace worn-out parts.
Excessive work load
Inefficient or neglected cooling system.
Too low or too high voltage.
Lack of lubrication etc.
All machines deteriorate with use an exposure, fatigue, impact and
corrosion. Such deterioration indicated by:
Inability of the machine to take specified load.
Reduction in the speed of the machine.
Deterioration in quality of the output by any machine.
Reduction in operational life of the machine.
5. Fulfillment
Some time production order for domestic and export is rejected because it too
small or too big in which production capacity is not matching with the order or
STD batch is not matching. So order can’t not be fulfilled by production.
6. Rejection of contract manufacturing work of other company’s due to busy
production schedule and pending orders which have to complete fastly as
much as possible
Some time in contract manufacturing company (Famycare) has already taken
order but it cannot provide order on time because of busy production schedule and
company’s reputation gets spoiled. Some time whatever order is taken by company
in which finance, costing department are also involved and it is not matching
with standard batch size of production and actual transfer quantity.
7. Material availability status for urgent and additional production planning.
It’s difficult situation in the production for urgent planning or additional
production planning in material availability status have to prepare on urgent
planning bases in which list is prepared from software and have to give to the
Q.C department. So that time if Q.C department can’t release it on time than
Urgent production planning is delayed. So this is big issue.
8. Inappropriate man power in production department.
This is big issue in all companies because if there are not workers in
production department than lot of work is pending and production schedule gets
delayed.
9. Urgent ADC COA of products which are used for export purpose.
Some time export department intimate to the PPMC department and
distribution department for urgent ADC COA for export purpose so PPMC
department will intimate to the parenteral and tablet packing department and
Q.C department for urgent release so planning of packing and Q.C department
gets disturbed.
10. Daily Receipt Transfer stock statement
According to this statement actual product dispatch date for export product
and sale product for India like tender and trade, under release product can
be removed by checking daily release product COA and BMR and BPR status.
11. Bull whip effect
Some time due to continuously change in demand forecasting of particular
product and some time due to urgent production planning of particular product due
to urgent demand there is lot of problem in inventory management of that
materials which are required for that product manufacturing and some time supply
chain management department can’t provide product on time to distribution
department and due to this stock out problem is to be created and company image
is not good in front of customer and consumer.
Many factors are there for breaking of supply chain management.
In appropriate dealing with vendors.
Inappropriate transportation system of vendors or company.
Transportation delay due to many reasons.
Material rejection by Quality control department.
Rejection of contract manufacturing work of other company’s due to busy
production schedule and pending orders which have to complete fastly as much as
possible.
There is inappropriate manpower in production department and other department.
In appropriate documentation work by Quality assurance department.
Inappropriate artwork code generation by packaging and development department
and inappropriate labelling.
Inappropriate rules and regulations followed by regulatory affair department.
Inappropriate production schedule and inventory management which is done by
production planning and material management department.
12. Urgent testing of material which is given to the outside laboratory
For testing of material, and whatever date has given by them is not
correct or whatever date they have committed they are not following.
13. Transfer product
Some time due to urgent production order, production schedule is suddenly
changed, and whatever product is running in at any stage is stopped, and after
considering clearance time product which are on urgent basis is to be run on
production, so for this urgent indenting, continuously follow up with purchase
department, after completing production whatever product is removed from
schedule or transferred is carried out and another extra COA is required for
that.
F2.1 SUGGESTION
1. Inappropriate material management
This is big issue for PPMC and purchasing both because both are involved in this
process, here for avoiding material shortage proper buffer stock is keeping for
particular product for which demand is continuously grown day by day. Based
on demand forecasting data PPMC can know for supply of product and it’s
planning, if material is not receiving as per the company’s specification criteria
than it should be rejected by company. Proper vendor dealing should be there and
material is rejected by Q.C then urgent indenting is to be done by software.
2. Issues Related to new product launching and product management:
Co-operation: Collaborative planning, forecasting and replenishment (CPFR) is
longer term commitment, joint work on quality and support by the a buyer of
the suppliers, managerial, technological and capacity development. This
relationship allows a company to have access to current, reliable information,