The document discusses quality management systems and practices. It provides background on the history and pioneers of quality management, including Frederick Taylor, Philip Crosby, Joseph Juran, and W. Edwards Deming. It describes the purpose and significance of quality management systems and procedures. It also provides an overview of the International Organization for Standardization (ISO) quality management standards, including ISO 9000, ISO 9001, and ISO 14000.
Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.
The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.
Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.
The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.
ISO 9001:2015 and how it can bring benefits to organisations in any sector and of any size. We take an overview based on some case studys from ISO.org.
Quality Management System PowerPoint Presentation Slides SlideTeam
Presenting this set of slides with name - Quality Management System PowerPoint Presentation Slides.The stages in this process are Quality Management System, Quality Assurance System, Qms.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
The Principles of Quality Management
Workshop on laboratory basics and fundamentals of ISO Quality Management Standards
March 21-22, 2018, Kyiv, Ukraine
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
ISO 9001:2015 and how it can bring benefits to organisations in any sector and of any size. We take an overview based on some case studys from ISO.org.
Quality Management System PowerPoint Presentation Slides SlideTeam
Presenting this set of slides with name - Quality Management System PowerPoint Presentation Slides.The stages in this process are Quality Management System, Quality Assurance System, Qms.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
The Principles of Quality Management
Workshop on laboratory basics and fundamentals of ISO Quality Management Standards
March 21-22, 2018, Kyiv, Ukraine
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
PDCA Cycle
PDCA is an iterative four-step management method used in business for the control and continual improvement of processes and products. It is also known as the Deming circle/cycle/wheel, Shewhart cycle, control circle/cycle, or plan–do–study–act (PDSA). Another version of this PDCA cycle is OPDCA.
This is complete research and study on the Six sigma and its methodology with case studies of Motorola and GE etc. This will help you a lot in understanding Six Sigma in Detail.
Explanation of the seven basic tools used to solve a variety of quality-related issues. They are suitable for people with little formal training in statistics.
ISO 14000 bears the potential to revolutionize the environmental industry, which historically operated on "command AND control," by proposing to now operate it on a "self-regulatory" basis.
A presentation was prepared on total quality management, general views and survey over the past 60 years. this was a collection of slides from some resources and any one can use it, under one condition, do not change the name of the presenter and the institution name,
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The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
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Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
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2. PREFACE
Primarily, this report has been written to incorporate syllabus requirement of the subject
“Operational Management”. Besides that, I wanted the content of this report to be
selected and prepared to achieve two objectives: to provide with the useful and relevant
information on Quality management practices in Pakistan and to give the reader an
understanding about the Quality management practices in relation with Operation
management.
Initially, I spent most of our time in gathering data and useful information about the
Quality Management practices.
When I started the project, I was very motivated & determined. Though I have put in
every effort not to leave out anything important, but at the same time, I have tried my
level best to compile this report.
3. ACKNOWLEDGEMENTS
Firstly I would thank Allah for giving us the opportunity and the
resources to be able to do something productive with our lives.
Without His blessings I would not have been able to come as far
as we have.
Then our sincere thanks to Miss, Qanita Imtiaz for helping us
throughout this report. Her guidelines have been very useful for
me in preparing this report. She helped us find new ways of
being innovative and creative.
This report would not have been possible without her
cooperation and continuous direction.
Last but not the least I would like to thank our families for their
incessant support and approval.
4. Quality Management System
Quality management is the single most important process in any organization, whether for profit,
nonprofit or an organization such as a health-care maintenance organization. It defines the
purpose of quality for the organization it represents. Quality management is often forgotten, but
it guarantees the quality in output from any organization and exists as an asset that always adds
value to it.
History
Quality management started to be introduced in the late 1800s with pioneers like Henry Ford and
Frederick Winslow Taylor, who realized what limitations existed in mass production. Quality
management started with the spot-checking of products as they rolled off the finish line. Fairly
soon, however, it was realized that this was not enough to guarantee quality with every single
item. As a profession, quality has grown considerably, and today it ranks as a recognized
profession among the other well-defined professions such as engineering, accounting and
medicine.
Pioneers of Quality Management
FREDERICK TAYLOR.
Probably the most famous management pioneer of all is Frederick W. Taylor (1856–1915), the
father of scientific management. Taylor rose from common laborer to chief engineer in six years,
and completed a home study course to earn a degree in mechanical engineering in 1883.
In trying to overcome soldiering by the workers, Taylor began a scientific study of what workers
ought to be able to produce. This study led to the beginnings of scientific management. Taylor
used time studies to break tasks down into elementary movements, and designed complementary
piece-rate incentive systems.
Taylor believed management's responsibility was in knowing what you want workers to do and
then seeing that they do it in the best and cheapest way. He developed many new concepts such
as functional authority. In other words, Taylor proposed that all authority was based on
knowledge, not position. He wrote Shop Management in 1903, became the president of the
American Society of Mechanical Engineers in 1906, and was a widely traveled lecturer, lecturing
at Harvard from 1909 to 1914.
Philip B. Crosby
Philip B. Crosby was responsible for noting that it makes sense to get things right the first time.
He calls this the zero defects principle. What Crosby was saying is that costs will increase when
quality planning isn’t performed up front. I’m sure we’ve all seen this in our own work where
late changes cause rework and may have knock on affects to other areas, causing more rework in
those areas. And all of this costs money!
5. Prevention of this rework was the key to Crosby’s zero defects principle. If the defect never
happened, then costs are lower and requirements are more easily met. In Crosby’s work the
measurement for quality was thus the cost of non-conformance rather than the cost of rework.
Joseph M. Juran
Joseph M. Juran is notable for his fitness for use work. This fitness for use principle goes beyond
just thinking of quality in terms of defect levels, instead, it asks, was the output of the project
what we set out to produce at the outset? Fitness for use is very customer focused, reflecting the
customer’s and stakeholder’s view of quality.
Given Juran’s broad view of quality under fitness for use, it’s not difficult to see why he
introduced two terms, grade and quality.
Grade: compares your product or service with those of a similar type but with different
technical characteristics
Quality: describes how well the product meets its requirements (number of know
defects)
W. Edwards Deming
W. Edwards Deming was all about process, not people. Deming suggested at up to 85% of the
total cost of quality was a management problem. By this he meant that once quality issues get to
the worker level, the workers have little control. As an example, let’s say you’re building a TV
as a worker and the sourcing team has supplied you with inferior grade plastic, then of course
you’ll have little control over quality. In addition to this, Deming also believed that for workers
to perform their best, they need to be shown what acceptable quality is. They also need to
understand that quality and continuous improvement are essential in any organisation.
Purpose of QMS
A QMS is implemented to promote quality and efficiency within a company. QMSs rely on
creating procedures for the processes used in producing a product or service. The motivation
behind QMS is customer satisfaction.
Significance
Quality has become much more significant since the world's demand for products has grown
exponentially. Along with more demand, the demand for specialist products and quality in
production have grown together. Competition has been a strong factor in this and so has
something known as "the global village" (where companies are competing on a global level).
Probably the most significant change has been the change in society, which has driven a demand
that never existed before. And this global sea-change has made a significant difference to any
quality considerations.
6. ISO Quality Management System
What is ISO?
Understand the International Organization for Standardization (ISO) guidelines is where the
TQM process can become a bit overwhelming. These standards are guidelines on how to
document the processes in specific industries. The goal is consistency and a set of complete, easy
to follow instructions. While TQM is focused on employee involvement and product
improvement, achieving a particular ISO certification shows that an organization is following
well-established industry standards.
What is ISO 9000-and9001?
Times they are a-changing, and with the world becoming so much smaller and businesses “doing
their business” globally, it is important that there are some sort of regulatory standards so that the
consumer knows just what to expect about the quality of goods they are receiving.
ISO 9000 is designed to do just that. It is a family of standards regarding quality management
systems. Maintained by the ISO (International Organization for Standardization) they regularly
update their rules to keep up with the times, and go about advocating these basic standard
requirements for trade. As an example, some of the ISO 9001/2008 (one of the standards within
the ISO family) including the following:
a set of procedures which aim to cover and include all key processes of the business
making sure that these processes are effective by constant monitoring
keeping adequate and up to date records at all times
quality control on output for possible defects, with appropriate corrective actions where
needed
regular reviews of the effectiveness of the processes and quality systems in place
continual improvement
What is ISO 14000?
The ISO 14000 environmental management standards exist to help organizations ensure that
their operations do not have a negative impact on the environment, that they comply with
applicable laws, regulations, and other environmental requirements, and that they continually
improve on these. ISO 14000 is similar to the ISO 9000 quality management in that it also
concerns itself with how the product is produced, in other words the process, rather than the
product itself. It was revised in May 2004 with the updated standard called ISO 14000:2004.
ISO 14001:2004 is the requirement standard of the ISO 14000 series. It specifies a
framework for an Environmental Management System against which an organization can be
certified by a third party.
7. The standard applies to all types and sizes of organizations and while it does not establish
absolute requirements for environmental performance, it does require a commitment to continual
improvement and compliance with applicable legislation and regulations.
A Simple Guide to Understanding ISOStandards
ISO standards are really a Quality Management System with very specific rules on
documentation and record-keeping. ISO is not a replacement for Total Quality Management. In
fact, they can co-exist quite peacefully, since ISO is focused on consistency and record-keeping,
while TQM is focused on employee involvement and product improvement. Both claim to be
customer satisfaction and continuous-improvement oriented, but Total Quality Management is
really the better forum for this. In fact, it is the goal of the TQM process.
ISO requires that the same things be done the same way all the time, and it is hard to squeeze
customer satisfaction out of that process.
ISO Requirements
ISO is methodical and rigorous. It requires a company to take its production process and break it
down into key steps. Each process is then analyzed to determine what the quality standards
should be. Next, the company decides how it will measure each process to determine if it meets
the quality standard they defined. Then, the approach to achieving that quality is documented (in
the form of a Standard Operating Procedure), and finally, the company performs audits, internal
and external, to ensure that the procedures are being followed. For each key process, you must
look at 21 elements and decide which ones apply to that step, and then come up with a detailed
plan to carry out and enforce the elements that do apply. Some of these elements include:
Employee training, documentation, written standard operating procedures, training, management
buy-in, tool calibrations and records, internal auditing, external auditing, document control, input
material quality verification, and plans for handling non-conforming product.
The process sounds complicated, and it can be, depending on the level of quality control at a
facility. The unusual thing is, ISO doesn’t care if your process is complicated or even whether it
produces a quality product. All it cares about is that the company making the product follows
the procedures they established, and that the end product is consistently like the last one and the
next one. They “assume” that your product is already acceptable to the public, and that their
mission is to ensure that product is consistent. The company makes it own rules, decides what to
measure, how to track it, how to record it, and how to manage the records to be in ISO
compliance.
8. ISO Standards Example
To try and make sense of all of this, let’s make a cake following (within reason) the standards
that ISO requires: The Overall Process is: Making a Cake.
It has three sub-processes: Mixing, Baking, and Frosting.
Process One: Mixing.
The inputs are: Precisely measured quantities of milk, flour,
eggs, vanilla, baking powder, baking soda, and sugar. The
output is batter. The process is: Mix for 0:45 seconds or until
there are no lumps larger than 1/16” in diameter.
Process Two: Baking.
The inputs are: Batter (poured to the proper height in the pan so
it doesn’t overflow), and heat (an oven), pre-set to the correct
temperature for baking. The process is: Bake for 40.0 minutes,
or until a knife inserted in the center of the cake can be
removed without any visual particles sticking to it. The output
is a completed cake.
Process Three: Frosting.
The inputs are: Cake and icing, and the output is a finished cake. The process is: Frosting, using
a 2” wide stainless steel spatula and distributing evenly until the entire visible portion of the cake
has been covered.
That was the ISO process. Now, here are the ISO compliance steps:
You have followed a written recipe for making the cake that has been documented, and
kept in a controlled location (perhaps a locked recipe box) so that no one can change the
recipe.
In Process One, the ingredients would have been measured using a specific measuring
device (Pyrex cup) that was calibrated annually.
The device would have a sticker on it showing the last time it was checked for accuracy
(calibrated to a known standard).
The dimensions of the eggs would have to fall within a certain range, and the milk would
have to be at a precise temperature before measuring (you might also state in your
procedure – recipe – whether the milk is 2% or whole).
The individual ingredients would be verified to be fresh (by comparing and documenting
their expiration dates).
The date used and the expiration date would be documented on the “assembly” sheet.
9. The mixer’s beater speed would have to be checked on some frequency to ensure the
mixing speed was the same every time, and the setting on the mixer would have to be
documented (and another calibration sticker on the mixer).
The baker would have had documented training in reading a recipe, proper measurement
techniques, and mixer operator training.
All of this information would be stored in a binder in a particular location for easy
access.
Plus, every so often, a certified baker would have to come to your house to inspect your
calibration records, your process procedures, and your training credentials to ensure you
were complaint with the rules you set up.
And that’s just to make the batter!
Keep in mind that, once the cake is done, it must taste and look like every other cake that was
made before using that same recipe. ISO doesn’t assure quality, it assures consistency. If your
recipe called for McCormick vanilla, and you used Kroger-brand, you would have just produced
a non-compliant cake, which would have to put into an isolation area until a determination could
be made as to what to do with it (rework, scrap, release with exceptions noted).
Note also that in the ISO process, the cake doesn’t have to taste good. This is where a
complementary Total Quality Management system would work well. If the family thought your
cake was lousy (negative customer feedback), you would have to modify the recipe
(documenting each change for the ISO records), until your family liked it (customer satisfaction).
ISO is a rigorous method of ensuring a business has a Quality Management System. ISO
certification tells other businesses and customers that they take great care to control the quality
of their product, and can prove it. This can be of particular importance, especially to other
businesses, who want to use this product as an input to their process, and need it to be exactly the
same every time to ensure consistency.
Eight Principles of ISO Quality Management
System
The International Organization for Standardization (ISO) outlines eight quality management
principles called the ISO 9000 series of standards. These principles are guidelines used by many
companies for quality discipline purposes. They aid companies in achieving long-term quality
performance.
1. Customer Focus
Organizations should understand their customer's current and future needs. The customer focus
principle states that organizations should strive to surpass the expectations of customers. This
principle involves understanding the customer's needs and expectations, communicating the
needs throughout the organization and managing customer relationships.
10. 2. Leadership
This quality principle describes the responsibility of leaders within an organization. Leaders
should lead by example, understand and respond to changes and consider all stakeholders' needs.
Leadership also includes establishing a clear vision for the company's future and encouraging
and inspiring people to reach goals.
3. Involvement of People
This principle holds that all people within the organization are beneficial for the company.
"People at all levels are the essence of an organization and their full involvement enables their
abilities to be used for the organization's benefit," the ISO states.
4. Process Approach
This principle states that a company runs more efficiently when all activities are viewed as a
process. Desired results are defined as well as risk evaluations. The managing process is
established clearly, and a business process flow is created and maintained.
5. System Approach to Management
Efficiency and effectiveness come from identifying, understanding and managing a process
system. The system is defined and continuously improved through measurements and
evaluations.
6. Continual Improvement
Continual improvement to systems, products and processes is a vital part of every quality system.
It should be a permanent objective within the company. It includes making periodic assessments
for improvements and improving the efficiency in every aspect of the business process.
7. Factual Approach to DecisionMaking
The analysis of information leads to effective decisions. This principle involves collecting data
and information and ensuring that it is accurate and reliable. It also includes evaluating the
information with an effective method and making decisions based on the evaluations.
8. Mutually Beneficial Supplier Relationships
This principle involves identifying and selecting key suppliers. Companies should build long-
term relationships with suppliers, sharing a joint understanding of customer needs and sharing
future plans with each other.
11. ISO Quality Management System Document
Types
A quality management system (QMS) requires documentation which provides the company a
plan for constant improvements in the future. A QMS is designed as a way of increasing
customer loyalty and understanding that all aspects of a business contribute to the quality of the
company's products and services. The document types in a QMS manual vary, but they typically
include authority, quality policies, audits and design control.
Authority
An important document within a QMS is the detail of authority within an organization. This
document lists all job titles and describes each title's responsibilities within the company. It
provides a summary of the job description and what is expected of each employee. Some of the
job descriptions include design control, training, management duties and purchasing
responsibilities.
Audits
The audit document in a QMS manual states audit procedures within the organization, including
internal and external procedures. It describes the frequency of audits, the staff responsible for
conducting or assisting with the audits and the objectives of the audits. Audits are designed to
assist in the quality control of a company and to give insight to problems of efficiency and
customer expectations. They are also designed to expose defects in the system and identify
changes that need to be made. Another aspect of an internal audit is dealing with customer
complaints, establishing new policies and developing audit reports.
Quality Policies
Another important document in a QMS is a statement of the policies regarding quality, along
with the policy objectives. This document lists important procedures employees must follow to
adhere to quality standards designed by the organization. It lists what is expected and the
requirements for meeting these goals. It also describes all objectives within the QMS. It often
includes process flow charts, organization charts, product specifications and inspection plans.
DesignControl
Design control begins with customer demand. All activities within design control are strictly
investigated and worked on. This document describes how products must meet the design input
and ensures all components are safe and effective. It describes the procedures for the
development of new designs and policies as to how the new designs are developed. New designs
must be tested and are subject to inspections as described in the QMS manual.
12. ISO Corrective and Preventive Actions
Corrective and Preventive Actions are key elements to a Quality Management System (QMS)
that is focused on Continual Improvement and Customer Satisfaction. Indeed, any ISO 9000 type
QMS should have this type of focus, unfortunately many do not.
It is important to properly use these two sub-systems when building a new QMS based on any
quality standard, or revising an existing QMS. In order to do this, one must understand the
difference between Corrective and Preventive Action.
Past Vs. Future
Simply put, Corrective Action is based on a nonconformance event that has happened in the past.
Preventive Action is based on preventing a nonconformance event in the future. Both are similar
procedurally, but with the focus as described. Together, Corrective and Preventive Actions—
typically referred to as CAPA (pronounced cap-uh)—are integral parts of a continuous
improvement program.
Both sub-systems should use some type of a log to record each event; a Corrective Action Log
and a Preventive Action Log. These logs are useful for performing trend analysis and to
determine if your actions are having the desired response.
Each Corrective and Preventive Action will typically have a form that is used to record the
details of the activity performed to satisfy the event; A Corrective Action Request (CAR,
pronounced car, as in an automobile) and a Preventive Action Request (PAR, pronounced like
the golf term, par).
Sometimes the situation is only a problem because it is looked at in a certain way. Looked at in
another way, the right course of action may be so obvious that the problem no longer exists.
Corrective Actions
Too often a company will fix a problem in their business process, say a customer complaint or
product return, after the problem has occurred. This is typically product or event focused. Then
the company will look at what they’ve done and say, “Well if we revise our shop router or
procedure, this will not happen again.” They will label this second phase as Preventive Action.
While it is a future thinking type of activity, it is still Corrective Action because it is based on
solving a problem that has already happened. A Corrective Action needs to focus on the Quality
System, so in this example the systemic action taken is the revision of the shop router or
procedure. This is Corrective Action.
13. Preventive Actions
Preventive Action activities should stand alone and not focus on past events. For example:
Company XYZ has a Preventive Maintenance management program that requires manual data
entry. It is working fine and there have not been any problems. However, it takes a lot of time to
manage and does have a high potential for error or lost records. XYZ decides to purchase
Preventive Maintenance software to manage this activity. Since the purchase is not based on
problems that have happened and is focused on process control or making an improvement to the
QMS, it is a Preventive Action.
A young functional Quality Management System should record and complete many more CAR’s
than PAR’s. On an annual basis, a company may record only a few Preventive Action activities,
while in the Corrective Action log many dozens of events are listed. Later has the quality system
matures, you should see more preventive actions than corrective actions.
For audit purposes, a handful of Preventive Action events will demonstrate that this important
part of the QMS is functional. A primary source of Preventive Action activities is the
Management Review process where discussions about quality strategy, quality budget requests,
and quality . Although the Management Representative, or Manager responsible for the CAPA
system, can also initiate and record Preventive Action activities.
OHSAS 18001Quality Management System
OHSAS 18001, developed in 1999 and revised in 2007, is a comprehensive Occupational Health
and Safety (OH&S) management system specification, deigned to enable an organization to
control OH&S risks and improve its performance. OHSAS 18001 Certification demonstrates that
a safety oriented approach has been integrated into the company's processes, a company's
commitment to a safe working environment and to protecting employees against injury at work.
OHSAS 18001 has been developed to be compatible with ISO 9001 and ISO 14001 management
systems standards, in order to facilitate the integration of quality, environmental and OH&S
management systems by organizations. Legislative & regulatory commitment and continual
improvement are two important aspects of OHSAS 18001.
The standard is in two sections; OHSAS 18001 is the specification against which certification is
awarded. OHSAS 18002 provides guidance on implementing an occupational health and safety
management system and corresponds directly to the specification.
The elements of OHSAS 18001 include:
Policy and commitment
Hazard identification, risk assessment & risk controls
Legal requirements
14. Objectives & Programs
Organization & personnel
Training, Communication & Consultation
Documentation & records Operational Controls
Emergency Readiness
Measurement & monitoring
Accident & incident investigation, corrective & preventive action
Audit & Review
Quality Management System in Textile
Industry of Pakistan
The textile industry in Pakistan is mainly owned by number of big groups. Statistics shows that
about 75 percent of the textile plants in Pakistan are owned by 25 percent of the big group like
Sapphire group, Kohinoor Maple Leaf Group; Gulistan Group, Crescent Group, Ibrahim Group,
Master Group, Ilahi Group, Ayesha Group, Chakwal Textile etc.
Being export oriented Textile country, textiles organizations believe that Quality Management
system is critical parameter.
ISO 9000 Quality Management System (QMS) is a good starting point towards Total Quality
Management for the organization in less developed countries. It is also an advance management
tool for managing businesses effectively for 20th century and ensuring customers to deliver
consistent product & service quality particularly in global markets. Other management tools like
ISO 14000 Environment Management System (EMS), Occupational Health & Safety Standards,
Product Certification Standards, CE Marking have also joined the race of Quality Management.
It is of utmost important for the organization to adapt the best possible approach to meet the
future requirements in the field of Quality Management. Different approaches have been adopted
by the Pakistani organizations in textile segment for the quality management system
development in compliance with ISO 9001/2. It is very important for the Executive Management
to select the best possible approach for their organization. The poor judgement in this era may
lead the organization to develop an inefficient system and add cost to their product. Merits and
demerits of some of the approaches adopted by Pakistani textile organizations are highlighted
below:
APPROACH1: SYSTEM DEVELOPMENTBY A SELECTED EMPLOYEE
Initially textile groups adopted this approach. They selected one person from the organization
and start sending him on external training courses. The expectations from this person were not
only to develop Quality Management System himself but also to bring some sort of cultural
changes in the organization. In some cases the responsibility of this person was extended to deal
with number of plants at a time. Most of the textile groups later on changed their approach and
15. start running behind the consultants. The reason behind this change was poor judgement with the
intensity of issue and the textile culture.
APPROACH2: SYSTEM DEVELOPMENTTHROUGHCONSULTANTS
Many textile groups have taken this approach as a quick fit for quality management system
development. The most difficult part of this approach is the availability of industry specialized
consultants with strong technical knowledge and professional background. Very few consultancy
firms maintain this level. Therefore, selection of consultant organization is very important. Here,
not only the credibility and previous experience of consultant organization but also the
credibility and experience of system developer (junior consultant) deputed to your organization
is important (All that glitters is not gold). Otherwise you may get ISO 9000 certificate quickly
but may not bring any improvement in the organization.
To bring improvements is also heavily dependent on company’s perception towards quality
management system development. If the organization is only focusing on certification aspect
then how improvement can be achieved?
APPROACH3: SYSTEM DEVELOPMENTTHROUGHHUMAN
RESOURCE DEVELOPMENT
This is one of the best approaches particularly for textile industry of Pakistan.
In order to be cost effect and develop quality management system compatible with the
organizational goals & objectives it is highly beneficial to deal quality management era at group
level. It will enable the organization to:
Harmonize the horizontal communication with in the group
Highlight the operational strengths and weaknesses at different plants
Establish a consistent system at all plants
Be cost effective in the area of certification
Reduce the systems development cost
Make employees more comfortable to bring improvements
Both types of textile manufacturing set-ups (Composite units and individual units) have its own
advantages and disadvantages. It is easier for a composite unit to establish an independent
department headed by the selected person supported by a team. Who will guide and train the
technical team through formal or informal training sessions. The task will be harder but not
difficult.
On the other hand, it not feasible to set-up an independent department for each individual plant
to develop Quality Management System at individual spinning, weaving, knitting, dyeing plant.
Therefore, to deal the Quality Management era at group level, it is highly recommended to
establish Human Resource Development activity as a permanent part of the organization. It
might be very hard in the prevailing conditions of textile industry in Pakistan to delegate all the
responsibilities & authorities required to Human Resource Development Department.
Therefore, establishment of a Quality Systems and H.R. Development department at group level
and backed up with necessary resources can bring major cultural changes in the organization
16. through systems development and training. This department can be made responsible Human
Resource Development activities later on.
REASONS FOR ADOPTING ISO 9000
Most of the textile industry in Pakistan is in export business like Sapphire and covers all major
ports round the world. It is a matter of concern that very few textile companies are adopting ISO
9000 as a formal Quality Management System for improving their existing systems. Most of the
companies are taking ISO 9000 certification as to ad new equipment to their facilities not as a
quality management tool. Very few have realized that the certification alone can not attract the
customers if it is not supported by internal improvements. What it might do is to add cost to their
product and service in the form of certification and consultancy cost.
There may be different reasons for different companies to develop Quality Management
System in line with ISO 9000. However, at Sapphire reasons, for adopting ISO 9000 in order of
importance were as follows:
1. Improvement in existing Quality Management System
2. Improvement in production & servicing operations
3. Harmonizing Horizontal Communication at all levels in the group
4. Enhance competitive edge in global Market
5. Meeting customer’s implied needs in Quality Management era
CONCLUSIONS
Establish missing infrastructure in your group i.e. Quality Assurance & H.R
development
Install monitoring system to see results
Compare all the costs with recognition & improvements, it might be a negligible
amount
Build strong foundation to meet quality management requirements for 21th century.
Conclusion & Findings of the Report
The concept to described Quality management system gives good information on design,
development and delivery of a service, which complies with QMS. Quality management system
describe all activities in organization (way of working) including “Operations, Supply chain
marketing and Finance”.
In Pakistan 722 organizations adopt Quality management System.
In simply Quality management describe “All activity which are perform in organization are in
written form and should be implemented as it is as you write”.
17. Quality management system ensures product quality, the use of a quality management program,
the company can produce a product that performs according to its stated promises.
Quality management ensures customer satisfaction. Conduct customer satisfaction surveys to
understand the qualities of the product important to the customer.
Quality products and services give the company a spotless reputation in the industry. This
reputation allows the company to gain new customers and sell additional products and services to
existing customers. A quality management program also removes inefficient processes within the
system. By removing unnecessary processes, employee productivity increases. The employee is
spending less time on activities that do not contribute to the product's quality. As a result, the
employee is producing more work in less time.
A quality management program helps companies reduce waste. Companies that house inventory
are paying for the storage, management and tracking of the inventory. The costs of having the
inventory are built into the price of the product. Implementing a quality management program
reduces the amount of inventory that costs the company money and occupies valuable space.
Quality management means that there is a systematic approach to keeping inventories at
acceptable levels without incurring waste.
Quality management systems force company departments to work as a team. Different areas of
the company become reliant upon one another to produce a quality product that meets and
exceeds the customers' expectations. A quality system incorporates measures that affect sales,
finance, operations, customer service and marketing. The balanced scorecard is a one-stop-shop
for evaluating how various departments are operating against their performance expectations.
Use the balanced scorecard to show how close the company is to the financial, operational,
customer service and learning/growth targets.