School of Mechanical and Materials Engineering

CHEN 40480
Lean Sigma Biopharma Process

Assignment-1

Student Name

Shriram Sridhar

Student Number

14201505

Submission Date

31/10/2014

I/We declare that the material contained in this project is

the end result of my/our own work and that due
acknowledgement has been given in the bibliography to
ALL Sources, be they printed, electronic or personal
Shriram Sridhar

.................................
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Lean Sigma Assignment

Lean:
Lean is the process of maximizing customer value by reducing /minimizing wastes. In simple terms, it is the
process of making more values to the customers with the lesser resources.
Waste:
The process or Work that does not add value to the product is called waste in lean.
Types:
The easy way to remember the waste as TIM WOODS

TIM WOODS

Transp
ort

Invent
ory

Moti
on

Waitin
g

Over
Product
ion

Over
Process
ing

Defect
s

Skills(Lab
ours)

Among the above eight wastes, Skills (Human Resources) will influence greatly in Lean Sigma. There is a
relationship between Skills and the Organizational Growth. So, it will greatly impact the Organizational growth.
Effective Utilization of resources must be done to avoid the Skills waste.
Consider the following activities, identify whether they add value or are waste. If you consider an activity as
waste classify it using the official waste categories:
A) Asking a customer what they want in a product?
Even though, business is mainly focussed with customers but we cannot modify our products as per wings and
fancies of them. Because, the expectations differ from person to person so lot of modifications cannot done. It
will be considered as a waste if we do like that.
So, it is considered as a waste if at all lot of modifications done for the customers.
B) Checking data entered on a batch record?
This activity comes under Over Processing. Due to the recent development in the technology, batch records are
created and maintained by the systems. So, even a small deviation or a mistake can be easily tracked not with
the help of man power. The machines/ systems are more accurate and if at all any deviation occurs, the
particular in charge person will be informed automatically so that we can prevent it.
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Moreover, the time consumption for checking the data on a batch record is more. There are more chances for
humans to do errors on checking the data once gain entered on a batch record. So, it is preferable to use the
system for batch record creation and maintenance rather than deploying humans for doing it.
c) A production line is operating at record levels of efficiency; it is currently producing a popular product
with a target output of 100,000 units so theres no harm in carrying on to produce an additional 20% as
theyll sell anyway?
This comes under Over Producing. The effects of over producing are
1.
2.
3.
4.
5.

Low profit
High Risk
Increased warehouse stocks need lot of money for storing it.
Product expiration
Impacts transportation & Inventory costs

According to Marx, in capitalism improvements in technology and rising levels of productivity increase the
amount of material wealth in society while simultaneously diminishing the economics of this wealth, thereby
lowering the rate of profita tendency that leads to the paradox, characteristic of crises in capitalism, of
"reserve army of labour and of poverty in the midst of plenty, or more precisely, crises of overproduction in
the midst of under consumption.
D) QA activities to check whether product can be released?
This is not at all a waste and it is the most valued activity in the entire processes. Since, Validation and testing
of the products is getting done at this stage to analyse if there is any defect in the products or not. It only should
give the approval of the products getting into the market.
E) Moving dispensed material to a staging area prior to a production campaign?
It is for ordering or arranging/grouping the materials upon their usage. It is done for eg: naming the product,
serial number and expiry date when moving on a conveyor belt. This is also not a waste and it is of course a
good practice followed in almost in all companies.
F) Working with a supplier to specify certificates of analysis?
As mentioned earlier, it also carries the equal weightage as that of Quality Assurance. It is nothing but the
certificate signed and given by the manufacturer for delivering the goods with standard quality in terms of its
requirements. It bears the manufacturer name, Expiration date etc. So, it is a better practice and plays a pivot
role in supply chain of the products in terms of delivery.
G) The process produces 2% waste but the bills of material have a 5% allowance?
It is the good sign for process improvement and efficiency when it comes to Lean Sigma. It is a Good Practice
by having the minimal wastages so that the customers will automatically come for the products. The
manufacturer can also try to reduce the wastage level
H) Recycling product from rejected material?
It is also better practice and it should be followed across all the companies in the world. It leads

Saving the money

Protecting the environment in terms of Corporate Social Responsibility(CSR)
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Improving the Efficiency

Effective Reutilization of Resources.

I) Using templates during a machine set-up?

It is also a Good Practice and should be carried out in a company instead of having documents for all the
processes. It is the clear representation of the process for the machine set-up so that even lay man can easily
understand the process by having a look over it.
J) Training operators to identify quality issues?
It is another Better activity to look into any defects in the products which will lead to the constant and
consistent improvement of the product. It is an important activity for each and every operator to know about the
quality testing. So, Training has to be given to all the operators.

2. Please only select one answer per question, a, b, c, d or e.

2.1 For a normal distribution, two standard deviations on each side of the mean would include what percentage
of the total population?
a. 95%
b. 68%
c. 47%
d. 34%
Ans: [A]
2.2 Which of the following is the key objective of a six sigma project?
a. Developing detailed control charts for critical processes
b. Developing a matrix to understand the hows and whats of a problem process
c. Reducing variation in critical processes
d. Reducing investment costs while improving output quality
Ans: [C]
2.3 What is a defect?
a.
b.
c.
d.

Something that the customer is willing to pay for

A feeling that the process is causing a problem
Something we should ignore if possible
A measurable characteristic not conforming to a customer requirement

Ans: [D]
2.4 Achieving Six Sigma quality means your business is what?
a. Producing 500,000 defects per million opportunities (DPMO)
b. Producing 100,000 DPMO
c. Producing 25,000 DPMO
d. Producing 3.4 DPMO
Ans: [D]
2.5 What is a standard deviation
a. A measure of variation
b. A normal perversion
c. A behavioural aberration that is considered typical
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d. An acceptable modification of a process

Ans: [A]
2.6 What is the standard model for Lean and Six Sigma methodologies?
a. BACI
b. CIADF
c. DPMO
d. DMAIC
Ans: [D]
2.7 What is the midpoint in a range of data?
a.
b.
c.
d.

Median
Mode
Discrete data
Mean

Ans: [A]
2.8 Process mapping is
a. A one-time event
b. A tool used for statistical validation
c. A tool used at the end of the DMAIC process
d. An ongoing living document used throughout the DMAIC process
Ans: [D]
2.9 Which plot describes the many distributions in one graph in quartiles?
a. Interval plot
b. Capability plot
c. Probability plot
d. Median plot
e. Box plot
Ans: [E]
2.10 Choose the best statement about the difference between internal and external customers
a. Internal customers are within an organization and external customers receive a product or service
from the organization
b. Internal customers are suppliers and external customers are employees
c. External customers are the purchaser and internal customers are merchants
d. Both internal and external customers are within the organization
Ans: [A]

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