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Standard
Observation Made By: Kranthi
Observation Date: Ongoing
Concept made by: Kranthi
Document made by: Kranthi
Document prepared date: 09AUG13
To Let any one and everyone perform an activity in the same way.
Before discussing about a standard, we will
work discuss on other interlinked issues....
What do you want to do in future?
What do you think you are doing now?
How do you want to see yourself?
Good Job!!!
Good job means???!!
Good salary!!!
How do you say a job is good????
When all our needs are fulfilled....
What are our needs to be fulfilled with job??
Before that ....
What is our role as human??
Performing any role of human, needs....
• Time
• Money
• Commitment
• Love
Pyramid Showing Human Needs.....
Ideal Time one shall spend to perform each role as human
IDEAL PERSONALITY Hours
Work
Need fulfillment
8Job satisfaction
Achievements
Goal attainment
Time for freshing up(Morning and Evening)
Freshness1.5
Hygenic appearance
Break fast,Lunch,DinnerHealth
1Stamina
SleepingPhysical Relaxation
6Peace of mind
General talk(with friends,neighbours etc in phone /directly )
Entertainment 0.75
Net surfing/TV watching/Study/Shopping/recreation/hobbies etc
Knowledge Gaining
1.75Satisfying Psychological needsTime pass
Time for spending with family
Responsibility Fulfilling
4Sharing and gaining Love Emotional relaxation
JourneyNeed
1Want
24
34%
6%
4%25%
3%
7%
17%
4%
Standard
work
Fresh up(M&E)
Break fast,Lunch,Dinner
Sleep
Talk(with friends,neighbours etc in phone /directly )
Net/TV/Study/Shopping/Hobbies/personal time etc
Family
Journey
Need in terms of time................
Money one needs to perform each role as human in general:
Thing Money (Per Month)
Shelter (House for Rent or loan) (If any person of the
family living separately in hostel), this may increase6000
Food Rice+ Daily groceries (8000)
Clothing
2000 (Yearly cost made it per month i.e. at least 5 major
occasions like festivals, Bday, Mday etc… each dress may
cost 1500/- on avg.)
Power, Gas, Milk, Paper, Mobile, Internet, Library etc... 8000/-
If any children or persons getting educated from institutes
(fees, books, tuition, hostel fee, food, uniform, shoes etc...)9000/- (on avg per month.)
Transport (Petrol or public vehicles) 1500/- - 2000/-
Savings (for next gen or for retirement or for health or
marriage)2000/-
Luxuries or other personal needs (boutique/ saloon,
restaurants, picnic, movie, gifts to family or friends, health
issues etc…)
4000/-
Total 41,000/-
Need in terms of Money................
Human Needs (Physiological): Family of 4 members
General Factors that employee expects
What is expected? Why?For the skill, knowledge, commitment given, employees
expect:
some recognition to their for being doneIndicates that the work being done is helpful in some way to the
organization.
Expectation from me i.e. what is expected out of me shall be
clearly known.For the growth of organization and self; together.
Should be treated fairly with respect That’s a need of every human.
Receive adequate training to perform their tasksTo be able to handle the tasks to be performed in the job. To be
less dependent.
Have rules, regulations and change in duties. For cordial atmosphere.
Should have a tolerable and peaceful working conditions For cordial atmosphere.
Have a reasonable work load
Excess free time indicates less important of the job role.
Excessive load causes stress. So balanced work load shall be
there.
Receive fair wages and benefits
The physiological needs of human shall be fulfilled, so fair
wages are needed. And that wage shall be based on the output I
give i.e. the return the organization gets out of the employee.
Have a reasonable amount of control over the work they doThis gives ownership and planning of the work an individual is
doing.
Should be given the opportunity to make suggestions and
have them considered.This gives a feeling of togetherness.
Have to provide a bright future by new learning’s in the
organization.
Gives confidence on self and the organization.
ఫలానా కంపెనీ ఉద్య ోగాలు మాత్రమె కాదు.. ఉజ్్జవలమైెన భవిష్ోత్తు నికూడా ఇసుు ంద్ి అనే నమమకం ఉండాలి.
They should be told of the output of their work that where it
fits into the overall scheme of the organization
Gives confidence that their work has some value in the
organization.
Have a reasonable opportunity to use their skills, knowledge &
experiences in the suitable situations.
Gives a feeling of recognition, which is every human’s inherent
need.
So it is not only good salary that is needed for you to be happy in
a job.
It needs many things!!!!
• It shall be able to provide time to fulfil your other roles as a human.
• Provide money that you need to fulfil the responsibilities (needs and wishes
of dependants and self).
• Provide self-satisfaction of performing a duty that our output is helpful to the
society like so and so way. Because anything / activity that we do shall
effect the need of human to whom or product or service reaches.
What is a product?
Anything that solves the problem of a human or make some improvement in the existing life style.
What are the products we use in daily life??
Pen, book, watch, bike, key chains, chairs, water, soft drinks, cars, scale, geometry box, stickers, soaps, shampoo, perfumes, cosmetics, foot wear and many things..
What are their brands????
How many of them are Indian??
Why not Indian Products??
Why not Indian Products??
• They are not fulfilling our needs?
• Their existence is not known to us?
• As our family is using it, we are also using it, without a question?
Why?• If their existence is not known, that is the problem with the
marketing strategies being followed.
• If we are following it blindly what others are doing, we shall change
and get convinced with why we do that.
• If they are not fulfilling our needs, it means foreign designers/
developers are more successful. Being foreigners, they are able to
fulfil the needs of an Indian like us, it means they are more
observing and more sensitive for the problems we as a person face.
Also they are....
more passionate to acquire knowledge to find a solution for the problem we face,
– by gaining technical knowledge,
– people knowledge,
– process knowledge,
– needed knowledge and skills.
What is needed to provide a successful solution is....
• sensitivity towards problem,
• good observation,
• persistence and passion to acquire knowledge to
realize the thought,
• plan to make it known to everyone about the
solution so that people will buy.
This is what we as engineers shall do. This is
what is expected by our society from us.
ProductsProduct Indian Foreign
Soap
Cinthol & other godrej brands, santoor, wipro shikakai,
mysore sandal, margo, neem, evita, medimix, ganga ,
nirma bath & chandrika, Biotique, Lotus, VLCC, OJAS,
Khadi
Lux, lifeboy, rexona, liril, dove, pears,
hamam, lesancy, camay.
Shampoo Lakme, nirma, velvet, Biotique, Lotus, VLCCHalo, all clear, nyle, sunsilk, head and
shoulders, pantene
Tooth pasteNeem, babool, promise, vico vajradanti, prudent, dabur
products, miswakColgate, close up, pepsodent, cibaca
Tooth brush Prudent, promise, AjayColgate, close up, pepsodent, forhans, oral-
b
Mobile Micromax Motorola, Sony, Samsung, Apple
Laptop HCL All others like Dell, Sony etc.
Television Micromax All others we see regularly
Pen drive Kingston
Milk powder Indiana, amul, amulya Anikspray, milkana, everyday milk,
milkmaid.
Mobile
connectionsBsnl, Tata Hutch
bike TVS, Bajaj, Mahindra Honda
Watches Titan, Sonata Timex, Casio and others
Calculators Casio and others
Shaving Cream Godrej, emani Palmolive, old spice, gillete
Blade Supermax, topaz, lazer, ashoka Seven-o –clock, 365, gillette
Talcum PowderUse – santoor, gokul, cinthol, wipro baby powder,
boroplus
Ponds, old spice, Johnson baby powder,
shower to shower
Foot wear Bata, Paragon Inblu, Nike, Reebok
Bag Any local made, Bata, Fastrack Elvine, Reebok, Nike
Camera Nikon, FujiFilm, Canon, Sony
Wishing for India using many products designed, developed and manufactured in India.
This is not being against foreign products, but an encouragement for our young engineers to be passionate towards product development.
Observation Made By: Kranthi
Observation Date: Ongoing
Concept made by: Kranthi
Document made by: Kranthi
Document prepared date: 18SEP13
Entrepreneur
Organization
Problems in the society
Solution
Group of people
Functions
Employees
Solutions to the
Problems in the society
The distance between Entrepreneur and Employees shall be as less as possible i.e. thoughts of entrepreneur shall be realised by employees and those shall be
clearly known to them.
The distance between Entrepreneur and Society/ Customers shall be as less as possible i.e. problems of customers shall be understood and right
solution shall be given.
i.e.
By observing the problems in the society, someone (may not everyone) will
get a thought to solve/ improve.
That thought. If realized gives a solution.
If the solution is liked by many, it gives raise to an entrepreneur.
If the entrepreneur is passionate to continue finding solutions, he needs
support. Support of people, money, time.
“Out of interdependency raises the need of another persons.”
So people with similar thoughts will join.
How it moves from Problem – Solution!
May not everyone observe…
May not everyone who observe, identifies…
May not everyone who identifies, will think of a solution…
May not every one who think of solution, will have knowledge
to realize..
May not everyone who has knowledge has enough time or
money or courage to realize..
It takes time, knowledge, courage, passion, money
to give a solution for the identified problem.
• And once the solution is identified, individual cannot be able to make it in lot i.e. as per the
numbers needed for the people.
• So he needs the help of manufacturing team, where that team makes multiple copies of the
idea/ solution he has made. (Just like Xerox).
• Multiple ideas may be developed, where he needs the support engineers like him where
technical support can be obtained to realize the thought quickly. So R&D will be formed.
• As the team increases, space for organizing the people and infrastructure is needed, and to
handle people and communication among them support of a team like HR is needed to
maintain cordial atmosphere.
• When the products are selling good and they can be sold in international market also, need
of an international certification like ISO may arise, which gives raise to concept of testing and
QC/QA.
• After selling the solution, if there is any problem, someone shall resolve the problems at
customer site. So another group which we call as customer support may be needed.
Why organization gives jobs? Cntd.
Why organization gives jobs? Cntd.
• This is how based on the need, the teams will be added in the organization.
• Where CEO has objective to serve society and improve living conditions of
people using all the engineers in his team.
• A team is like human body. Brain is the objective we shall achieve and
departments are like the other parts of the body working towards achieving
the goal.
Organization has a need to search for people for jobs to support their objectives
Hope you understand what kind of a job you need!!
Also hope you understand what is your role as
engineer to perform the job.
Settle
• As one by one joins the team... It becomes tough to handle the team alone i.e. by
one person.
• So he/she selects the best person from the team whom he/ she can be in touch
with directly and asks him to handle the group.
• As the team size increases, the need of another person who can handle the group
rises... And so on. That‟s how with raise in business requirements, functional
areas will be formed i.e. teams will be named as functions. With further raise,
each function will have different teams.
• As the no. of people/ human resources increase, the need to take care of human
related issues will raise.
Single Entrepreneur to Group of Employees of functional departments....
Actually the expansion of the team is nothing but expansion of the mind, heart,
limbs of the entrepreneur (MD).
Because all the team that he accept to join with him is with a purpose that, as he can
not or not able to handle all the works to be done, inspite of him he has appointed
another group.
What is expansion of team?
• Marketing is like the legs, eyes, ears i.e. to move to different places of
this world, observe, listen; and mouth i.e. to communicate on the
products/ solutions we develop.
• R&D is like brain to think of a solution, hands to realize the thought
When the entrepreneur focuses on finding solutions....
• Marketing is like the legs, eyes, ears i.e. to move to different places of
this world, observe, listen; and mouth i.e. to communicate on the
products/ solutions we develop.
• Production is like hands to replicate the products developed based on the
customer requirements.
When the entrepreneur focuses on Business Development....
• HR is like extended heart of the entrepreneur/ MD.
– While selecting a person
– While training a person
– While parting from the person.
– While communicating with the person
As MD can not find enough time to handle those issues which he shall handle
with heart/ emotionally, those are to be handled by another team who is
called extended heart of MD, which is HR Team.
When the entrepreneur focuses communicating with ones own team....
HR is like extended heart of the entrepreneur/ MD.
• Quality is like the breath, which shall be in the
conscious and subconscious thoughts of every employee
of his team.
When the entrepreneur focuses improvement in the existing systems....
• And once the solution is identified, individual cannot be able to make it in lot i.e. as per the numbers needed
for the people.
• So he needs the help of manufacturing team, where that team makes multiple copies of the idea/ solution he
has made. (Just like Xerox).
• Multiple ideas may be developed, where he needs the support engineers like him where technical support can
be obtained to realize the thought quickly. So R&D will be formed.
• As the team increases, space for organizing the people and infrastructure is needed, and to handle people and
communication among them support of a team like HR is needed to maintain cordial atmosphere.
• When the products are selling good and they can be sold in international market also, need of an international
certification like ISO may arise, which gives raise to concept of testing and QC/QA.
• After selling the solution, if there is any problem, someone shall resolve the problems at customer site. So
another group which we call as customer support may be needed.
Why organization gives jobs? Cntd.
Why organization gives jobs? Cntd.
• This is how based on the need, the teams will be added in the
organization.
• Where CEO has objective to serve society and improve living conditions of
people using all the engineers in his team.
• A team is like human body. Brain is the objective we shall achieve and
departments are like the other parts of the body working towards
achieving the goal.
Organization has a need to search for people for jobs to support their
objectives.
Dependence, Independence, Interdependence
Evolution of Concept of Quality, ISO
Observation Made By: -
Observation Date: -
Kaizen made by: -
Document made by: Kranthi
Document prepared date: 10SEP2013
Neolithic Revolution during 8000BC (8000 and 6000 BC)
• It was the wide-scale transition of many human
cultures from a lifestyle of hunting and
gathering to one of agriculture and settlement
which supported an increasingly large
population
Evolution of Money
With barter, an individual possessing any surplus of value, such as a measure of grain or a quantity of livestock could directly exchange that for something perceived to have similar or greater value or utility, such as a clay pot or a tool. The capacity to carry out barter transactions is limited in that it depends on a coincidence of wants. The seller of food grain has to find a buyer who wants to buy grain and who also could offer in return something the seller wants to buy. There is no agreed standard measure into which both seller and buyer could exchange commodities according to their relative value of all the various goods and services offered by other potential barter partners.
As it was difficult to carry such commodities for exchange, a common thing for business transactions was thought and so Money has come into existence.
Value of Money of a country i.e. Exchange rate; depends on Employment, GDP/ GNP.
Industrial Revolution during 1780s (i.e. 1760-1840)
• This transition included going from hand production methods to
machines, new chemical manufacturing and iron production
processes, improved efficiency of water power, the increasing use
of steam power and the development of machine tools. It also
included the change from wood and other bio-fuels to coal.
World War-II (1 September 1939 (1939-09-01) – 2 September 1945 (1945-09-02)
• During the second world war, a number of bombs exploded in factories during assembly. As a result, factories were required to document their procedures and to provide records to show that they were followed. They were then inspected to prove conformity to defined procedures.
Evolution of „Q‟
1875 Taylorism (inspect, detect defects)
1925 Shewhart (statistical process control)
1930s Dodge/Roming acceptance sampling methods
1950s Deming's approach to quality and productivity management
1950s Taguchi's robust design
1980s The U.S. organizations recognize Deming's approach
1990s Turkish organizations recognize Deming's approach
2000s Many Turkish organizations excel at TQM, but building quality upstream is not emphasized yet
Step-1:
• Quality management is a recent phenomenon. Advanced civilizations that
supported the arts and crafts allowed clients to choose goods meeting
higher quality standards than normal goods. In societies where arts and
crafts are the responsibility of a master craftsman or artist, they would
lead their studio and train and supervise others. The importance of
craftsmen diminished as mass production and repetitive work practices
were instituted. The aim was to produce large numbers of the same
goods.
• The first proponent in the US for this approach was Eli Whitney who
proposed (interchangeable) parts manufacture for muskets, hence
producing the identical components and creating a musket assembly line.
Two:
• The next step forward was promoted by several people including
Frederick Winslow Taylor a mechanical engineer who sought to
improve industrial efficiency. He is sometimes called "the father of
scientific management." He was one of the intellectual leaders of
the Efficiency Movement and part of his approach laid a further
foundation for quality management, including aspects like
standardization and adopting improved practices.
Three:
• Henry Ford was also important in bringing process and quality
management practices into operation in his assembly lines. In
Germany, Karl Friedrich Benz, often called the inventor of the
motor car, was pursuing similar assembly and production practices,
although real mass production was properly initiated in Volkswagen
after World War II. From this period onwards, North American
companies focused predominantly upon production against lower
cost with increased efficiency.
Four:
• Walter A. Shewhart made a major step in the evolution
towards quality management by creating a method for
quality control for production, using statistical
methods, first proposed in 1924. This became the
foundation for his on-going work on statistical quality
control.
Five:
• W. Edwards Deming later applied statistical
process control methods in the United States
during World War II, thereby successfully
improving quality in the manufacture of
munitions and other strategically important
products.
• Quality leadership from a national perspective has changed over the past
five to six decades. After the second world war, Japan decided to make
quality improvement a national imperative as part of rebuilding their
economy, and sought the help of Shewhart, Deming and Juran, amongst
others. W. Edwards Deming championed Shewhart's ideas in Japan from
1950 onwards. He is probably best known for his management philosophy
establishing quality, productivity, and competitive position. He has
formulated 14 points of attention for managers, which are a high level
abstraction of many of his deep insights. They should be interpreted by
learning and understanding the deeper insights.
• In the 1950s and 1960s, Japanese goods were synonymous with cheapness and low
quality, but over time their quality initiatives began to be successful, with Japan
achieving very high levels of quality in products from the 1970s onward. For
example, Japanese cars regularly top the J.D. Power customer satisfaction ratings.
In the 1980s Deming was asked by Ford Motor Company to start a quality initiative
after they realized that they were falling behind Japanese manufacturers. A
number of highly successful quality initiatives have been invented by the Japanese
(see for example on this page: Genichi Taguchi, QFD, Toyota Production System.
Many of the methods not only provide techniques but also have associated quality
culture (i.e. people factors). These methods are now adopted by the same western
countries that decades earlier derided Japanese methods.
• Customers recognize that quality is an important attribute in products and
services. Suppliers recognize that quality can be an important
differentiator between their own offerings and those of competitors
(quality differentiation is also called the quality gap). In the past two
decades this quality gap has been greatly reduced between competitive
products and services. This is partly due to the contracting (also called
outsourcing) of manufacture to countries like India and China, as well
internationalization of trade and competition. These countries amongst
many others have raised their own standards of quality in order to
meet International standards and customer demands.
• To have their own standards, every country has developed their own
standards which are developed by NSI (National Standards Institutes)
To meet the global standards,
• We need international standards that are
accepted by every country, then was ISO
formed. For globalization and unification of
standards.
Quality Improvement:There are many methods for quality improvement. These cover product improvement, process improvement and people based improvement. In the
following list are methods of quality management and techniques that incorporate and drive quality improvement:
• ISO 9004:2008 — guidelines for performance improvement.
• ISO 15504-4: 2005 — information technology — process assessment — Part 4: Guidance on use for process improvement and process capability
determination.
• QFD — quality function deployment, also known as the house of quality approach.
• Kaizen — 改善, Japanese for change for the better; the common English term is continuous improvement.
• Zero Defect Program — created by NEC Corporation of Japan, based upon statistical process control and one of the inputs for the inventors of Six
Sigma.
• Six Sigma — 6σ, Six Sigma combines established methods such as statistical process control, design of experiments and failure mode and effects
analysis (FMEA) in an overall framework.
• PDCA — plan, do, check, act cycle for quality control purposes. (Six Sigma's DMAIC method (define, measure, analyse, improve, control) may be
viewed as a particular implementation of this.)
• Quality circle — a group (people oriented) approach to improvement.
• Taguchi methods — statistical oriented methods including quality robustness, quality loss function, and target specifications.
• The Toyota Production System — reworked in the west into lean manufacturing.
• Kansei Engineering — an approach that focuses on capturing customer emotional feedback about products to drive improvement.
• TQM — total quality management is a management strategy aimed at embedding awareness of quality in all organizational processes. First promoted
in Japan with the Deming prize which was adopted and adapted in USA as the Malcolm Baldrige National Quality Award and in Europe as the
European Foundation for Quality Management award (each with their own variations).
• TRIZ — meaning "theory of inventive problem solving"
• BPR — business process reengineering, a management approach aiming at optimizing the workflows and processes within an organisation.
• OQRM — Object-oriented Quality and Risk Management, a model for quality and risk management.
• EcoMobility SHIFT, a tool to assess, audit and label urban transport performance in cities.
Quality SoftwareQuality software
• Quality Management Software is a category of technologies used by organizations to manage the delivery of high quality products.
Solutions range in functionality, however, with the use of automation capabilities they typically have components for managing
internal and external risk, compliance, and the quality of processes and products. Pre-configured and industry-specific solutions are
available and generally require integration with existing IT architecture applications such as ERP, SCM, CRM, and PLM.
Quality Management Software Functionalities
• Non-Conformances/Corrective and Preventive Action
• Compliance/Audit Management
• Supplier Quality Management
• Risk Management
• Statistical Process Control
• Failure Mode and Effects Analysis
• Complaint Handling
• Advanced Product Quality Planning
• Environment, Health, and Safety
• Hazard Analysis & Critical Control Points
• Production Part Approval Process
Enterprise Quality Management Software
The intersection of technology and quality management software prompted the emergence of a new software category: Enterprise Quality
Management Software (EQMS). EQMS is a platform for cross-functional communication and collaboration that centralizes, standardizes, and
streamlines quality management data from across the value chain. The software breaks down functional silos created by traditionally
implemented standalone and targeted solutions. Supporting the proliferation and accessibility of information across supply chain activities,
design, production, distribution, and service, it provides a holistic viewpoint for managing the quality of products and processes.
Quality Certifications
• Product
• System/ Process
• Please check Page 61 of this file. (Please click here)
As said earlier....
When Barter system was gradually stopped and system of value of
exchange has come, the need for a certification has come i.e.
irrespective of who does it, it is assured that the product we get for
the value we pay is a good one. And that was through NSIs National
Standards Institutes.
Later when the Imports and Exports have started, this local standards
defined with in the country are not accepted globally.
So, the NSIs have together have formed ISO.
Basic Need of Any Standard is....
Irrespective of who, When, How, Where, Why it was
made, the thing we obtain for the value we pay shall
fulfill its needs.
And the certification is an assurance that the standard is
met.
How do we implement a standard?
By understanding its requirements....
What are the different standards
available?
• ISO
• IEC
• IPC
• ANSI
• CENELEC &
Many are there..... Depending on the need we use any of
the standard.
Please click here for the standards available.
Each Standards Body speaks about different
issues.....
ISO has released 18000 standards until now... On different subjects...
Please click here for the standards released
What are we certified with?
ISO 9001:2008
73
ISO 9001
A world benchmark system for good management
practices
A generic system standard
Gives ‘What’ an organization should do & leaves ‘How’
to be decided by organization
74
What does ISO 9001:2008 talk about?
It speaks about QMS
QMS- Quality Management System.
75
What is Quality Management System?
Before going into detail of it.... Let‟s take
an example....
• If we are fresher's to this office and to the job too.... We did not
know anything about any job.
• Because of heavy work in production, if we were allotted to
complete the work of soldering. What would happen? What is the
chance that we give same kind of output?
The question that may arise is why same output is needed!?
Let‟s take an example....
Favorite mobile....!You have bought your favorite mobile... And trying to dial to your favorite
person... But when trying, you see that the keypad “9” isn‟t working.
What do you do?
Return to the shop and get a new one of similar piece?
Would change the brand?
Would complain to customer care and buy the same mobile?
This is our experience as a customer.....
Now let‟s see what happens at the manufacturer end...!
Favorite mobile....!To see that customer do not face such problems again in future, he shall find
the reason for problem and see that it wont repeat.
And when the reason was found, it was one of the persons in manufacturing
unit, who could not do the soldering properly.
The reasons for she not being able to do properly are many..... i.e.
She might not be trained
Her tool isn‟t working properly
Material might be faulty etc.
And it was observed that the person who did the mistake
there in that manufacturing company is our relative!
I mentioned the person is our relative just to increase the attachment with the issue there.
We faced different experiences as a customer, as a
relative of the person in manufacturing unit....
But as a customer, the experience was difficult and
unacceptable.
Who ever does the work, if same kind of output was
obtained, such difficult experience would not have
occurred.
What to do? To obtain same output?
What are the problems that may occur if we do soldering?
(as we were given the work because of heavy production orders?)
• Wrong placement of components
• Less skilled soldering
• Reverse soldering
and few other.....
How to solve those problems?
• Provide awareness on components, placement of it.
• Provide training on activities involved
• Provide wok instructions for them.
• Define Specific people for specific activity instead of giving it to
all available people.
To conclude on it,
what are the different activities we do to
get common output?
• Training
• Work Instructions
• Defined role and responsibilities
A quality management system (QMS) can be expressed as the
organizational structure, procedures, processes and resources
needed to implement quality management.
Quality Management System:
Collective policies, plans, practices, and the supporting infrastructure
by which an organization aims to reduce and eventually eliminate
non-conformance to specifications, standards, and customer
expectations in the most cost effective and efficient manner.
85
QMS
Quality management can be considered to have three main components:
quality control, quality assurance and quality improvement. Quality
management is focused not only on product/service quality, but also the
means to achieve it. Quality management therefore uses quality assurance
and control of processes as well as products to achieve more consistent
quality.
Quality Management:
All management activities and functions involved in determination of quality
policy and its implementation through means such as quality planning and
quality assurance (including quality control).
86
Elements of QMS
• Organizational Structure
• Responsibilities
• Methods
• Processes
• Resources
• Customer Satisfaction
• Continuous Improvement
87
Principles of QMS
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships
13-Aug-16 Knowledge Sharing session on QMS & ISO 88
Process, Procedure, Resources, Organizational Structure
Process: An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.
Resource: Some thing that can be used for support or help.
An available supply that can be drawn on when needed.
An organizational structure is a mainly hierarchical concept of subordination of entities that collaborate and contribute to serve one common aim. An organization can be structured in many different ways and styles, depending on their objectives and ambience.
13-Aug-16 Knowledge Sharing session on QMS & ISO 89
Stake holders of an organization
• Stake holder: Person, group, or organization that has direct or indirect
stake in an organization because it can affect or be affected by the
organization's actions, objectives, and policies.
• Key stakeholders in a business organization include creditors,
customers, directors, employees, government (and its agencies), owners
(shareholders), suppliers, unions, and the community from which the
business draws its resources.
• Stake: The amount of a security either owned (a long position) or owed (a
short position) by an investor or dealer.
13-Aug-16 Knowledge Sharing session on QMS & ISO 90
Contd…
13-Aug-16 Knowledge Sharing session on QMS & ISO 91
Over All process
Linking Product to Person to Organization to Job to
Employee to Product to Country Development
Pain
Gain
Product Person Organization Job Person/
Employee
Sales
Country
GDP/GNP
Value of
Currency
Improvement
in living of
people
Overall Process
Identification of a problem
Define the
product or
service
Need-Want
analysis
Analysis on our strengt
hs
Competitor
Analysis
Market Analysis
Product SWOT
analysis
Product Realiza
tion
Customer
Opinion
Improvements in the
product
Marketing plan
salesManufacturing
Testing QC, QA
Third party
inspectionDispatch
Installation/
Comissioning
Customer Suppot
Customer Feedback
Enhancement/Maint
enanceDisposal
What are the different processes in an
organization??
• Research and Development
• Production
• Customer Support
• Quality Management (QC+QA of processes and product)
• Business Development (MAR+ SAL)
• Administration
13-Aug-16 Knowledge Sharing session on QMS & ISO 94
“Every process that is next to you is your process customer.
Every process who provides input to you is your process supplier.”
• It is necessary that your process output is of good quality, on time;
as desired by the succeeding process. So that no. of defects are
less. This may be the information we provide, semi-finished good,
training.
Now:
• Step-1: Identify your customers and suppliers; internally and
externally.
• Step-2: If you want to improve, try to collect feedback from your
customers and provide feedback to your suppliers, because there
are times where you feel dissatisfied with the inputs and your
customers feel the same with yours.
Quality Policy and Objectives
Quality Policy: Top management's expression of its intentions, direction, and aims regarding quality of its products and processes.
Quality Objective (specific to product): Specified level of quality that must be met by a product to be deemed acceptable.
13-Aug-16 Knowledge Sharing session on QMS & ISO 96
13-Aug-16 Title of the Presentation 97
Six Sigma concept
Cost of Quality Vs. DPMO (Defectives per million operations)
Sigma DPMO Cost of Quality Competitive Level
6 3.4 < 10% World class
5 233 10 – 15% World class
4 6,210 15 – 20% Industry average
3 66,807 20 – 30% Industry average
2 308,537 30 – 40% Non competitive
1 690,000 > 40% Non competitive
Cost of rectifying error
1x :
If process
owner
detects error
& rectifies
10x :
If error is
detected by
next
process &
rectified
100x
If error is
detected by
customer
(outside the
organization)
0x :
Producing
right first
time
‘x’ is cost of rectification of defect
‘A stitch in time saves nine’
Learning‘s
From the concept of process approach and all the above concepts discussed, what can be learnt????
99
Contd…
• We shall plan every thing we do
• We shall do what we plan
• We shall check if the plan is implemented and planned results are achieved.
• Revise the plan if necessary, to improve the results or to correct the plan.
i.e.
100
Say what you do, do what you say
PDCA Cycle
101
The Plan – Do – Check – Act (PDCA) cycle is the operating principle of ISO's management system standards.
Every process should implement PDCA.
And as a part of check for the entire organization, we shall do Audit
Audit
Audit is a tool to determine if the Quality Management System…
• conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
• is effectively implemented and maintained.
Simply.. Audit is to verify, if the execution of task is done as per the plan and verification is done to update the plan.
102
Types of Audit
• Internal
• External
Our Certifying body is UL.
103
Structure of ISO 9001:2008
104
Section 4 - Quality management system
Section 5 - Management Responsibility
Section 6 - Resource Management
Section 7 - Product realization
Section 8 - Measurement, analysis and improvement
Simplified Structure of QMS
105
Planning Processes
Support Processes
Business Processes
Improvement Processes
Process
If it is defined - It can be measured
If it is measured - It can be analyzed
If it is analyzed - It can be controlled
If it is controlled - It can be improved
106
Planning Processes
Establishing Quality Policy (5.3)
Establishing Quality Objectives (5.4.1)
Define responsibility & authority (5.5.1)
Appoint management representative (5.5.2)
Establish communication processes (5.5.3)
Support Processes
108
Human Resource (6.2.2)
Infrastructure (6.3)
Control of documents (4.2.3)
Control of records (4.2.4)
Business Processes
109
Customer Related Processes (7.2)
Design & development (7.3)
Purchasing Processes (7.4)
Production-related Processes (7.5)
Improvement related Processes
Customer satisfaction (8.2.1)
Internal Audit (8.2.2)
Process monitoring and measurement (8.2.3)
Control of nonconforming product (8.3)
Analysis of data (8.4)
Corrective action (8.5.2)
Preventive action (8.5.3)
Improvement (8.5.1)
Management Review (5.6)
110
Quality System
Documentation
111
QUALITY
MANUAL
PROCEDURES
WORK
INSTRUCTIONS
QUALITY
PLANS
COMPANY
POLICY
DEPLOYMENT OF POLICY
CONTRACTUAL OR
PRODUCT
SPECIFIC
REQUIREMENTS
Correction & Corrective Action
Correction
Action to eliminate a non conformity
Corrective Action
Action to eliminate the cause of a detected non
conformity or other undesirable situation
112
Corrective & Preventive Action
Corrective Action
Action to eliminate the cause of a detected non
conformity or other undesirable situation
Preventive Action
Action to eliminate the cause of a potential non
conformity or other undesirable situation
Corrective action is taken to prevent recurrence where as preventive action
is taken to prevent occurrence
113
Root Cause - Examples
Inadequate Training
Incapable Processes
Not following Procedures
Instruction / Information Unclear
Poor Maintenance
Poor Planning
Poor Work Environment
Supplier Quality Problem
Improper Process Steps
etc.,
114
Please click here for importance of RCA
Continual Improvement
Identify areas for improvement
Establish objective for improvement
Search possible solutions
Evaluate & select solution
Implement selected solution
Measure & analyse (if objective met)
Formalize change
115
Accreditation and Certification
International Accreditation Forum
Accreditation Body
Certification Body
Organization
