UNIT-IV

Quality Improvement Tools and Continous Improvement

Q-7 Tools

What are the 7 basic quality tools?

Stratification

Histogram

Check sheet (tally sheet)

Cause and effect diagram (fishbone or Ishikawa diagram)

Pareto chart (80-20 rule)

Scatter diagram

Control chart (Shewhart chart)

The ability to identify and resolve quality-related issues quickly and efficiently is essential to
anyone working in quality assurance or process improvement. But statistical quality control can
quickly get complex and unwieldy for the average person, making training and quality assurance
more difficult to scale.

Thankfully, engineers have discovered that most quality control problems can be solved by
following a few key fundamentals. These fundamentals are called the seven basic tools of
quality.

With these basic quality tools in your arsenal, you can easily manage the quality of your product
or process, no matter what industry you serve.

Learn about these quality management tools and find templates to start using them quickly.

Where did the quality tools originate?

Kaoru Ishikawa, a Japanese professor of engineering, originally developed the seven quality
tools (sometimes called the 7 QC tools) in the 1950s to help workers of various technical
backgrounds implement effective quality control measures.

At the time, training programs in statistical quality control were complex and intimidating to
workers with non-technical backgrounds. This made it difficult to standardize effective quality
control across operations. Companies found that simplifying the training to user-friendly
fundamentals—or seven quality tools—ensured better performance at scale

Today, these quality management tools are still considered the gold standard for troubleshooting
a variety of quality issues. They’re frequently implemented in conjunction with today’s most
widely used process improvement methodologies, including various phases of Six Sigma, TQM,
continuous improvement processes, and Lean management.

7 quality tools

1. Stratification

Stratification analysis is a quality assurance tool used to sort data, objects, and people into
separate and distinct groups. Separating your data using stratification can help you determine its
meaning, revealing patterns that might not otherwise be visible when it’s been lumped together.

Whether you’re looking at equipment, products, shifts, materials, or even days of the week,
stratification analysis lets you make sense of your data before, during, and after its collection.

To get the most out of the stratification process, consider which information about your data’s
sources may affect the end results of your data analysis. Make sure to set up your data collection
so that that information is included.

2. Histogram

Quality professionals are often tasked with analyzing and interpreting the behavior of different
groups of data in an effort to manage quality. This is where quality control tools like the
histogram come into play.

The histogram represents frequency distribution of data clearly and concisely amongst different
groups of a sample, allowing you to quickly and easily identify areas of improvement within
your processes. With a structure similar to a bar graph, each bar within a histogram represents a
group, while the height of the bar represents the frequency of data within that group.

Histograms are particularly helpful when breaking down the frequency of your data into
categories such as age, days of the week, physical measurements, or any other category that can
be listed in chronological or numerical order.

Scenario of using a Histogram

A restaurant chain is committed to enhancing both food quality and customer satisfaction. They
believe that improving the efficiency of food delivery times can contribute significantly to
achieving these goals.
The restaurant collected data on food delivery times for the past month to evaluate their impact
on both food quality and customer satisfaction. They recorded the time it took for each order to
be prepared and delivered to the customer's table, measuring it in minutes.
Sample data includes
Order 1: 18 minutes
Order 2: 22 minutes
Order 3: 15 minutes
Order 4: 30 minutes
Order 5: 25 minutes
... (additional orders)
Inference
After analysing the histogram of food delivery times, the restaurant draws the following
conclusions.
 The histogram reveals a bimodal distribution, featuring two distinct peaks.
 One peak represents orders that were promptly delivered (around 15-20 minutes),
contributing to higher food quality and customer satisfaction.
 The other peak indicates orders with longer delivery times (around 25-30 minutes), which
can lead to lower customer satisfaction due to extended wait times.
Action taken based on Inference
 The kitchen workflow was reevaluated and streamlined. This included reorganizing
workstations, improving inventory management, and enhancing communication among
kitchen staff.
 The restaurant invested in additional staff training, focusing on efficiency and teamwork.
 An advanced order management system was introduced to prioritise and track orders
efficiently.
 A real-time performance monitoring system was implemented to track delivery times for
each order.
Results
After implementing these actions, the restaurant monitored the impact on food delivery times and
customer satisfaction over a three-month period.
 The frequency of orders in the longer delivery time peak (around 25-30 minutes)
significantly decreased. This reduction was attributed to improved kitchen processes and staff
efficiency.
 Delivery times became more consistent, with the majority of orders falling within the
prompt delivery peak (around 15-20 minutes).
 Customer satisfaction scores, as measured through surveys and feedback, showed a
noticeable increase.
 The restaurant observed a rise in repeat business and increased customer loyalty.

3. Check sheet (or tally sheet)

Check sheets can be used to collect quantitative or qualitative data. When used to collect
quantitative data, they can be called a tally sheet. A check sheet collects data in the form of
check or tally marks that indicate how many times a particular value has occurred, allowing you
to quickly zero in on defects or errors within your process or product, defect patterns, and even
causes of specific defects.

With its simple setup and easy-to-read graphics, check sheets make it easy to record preliminary
frequency distribution data when measuring out processes. This particular graphic can be used as
a preliminary data collection tool when creating histograms, bar graphs, and other quality tools.
check sheet example

4. Cause-and-effect diagram (also known as a fishbone or Ishikawa diagram)

Introduced by Kaoru Ishikawa, the fishbone diagram helps users identify the various factors (or
causes) leading to an effect, usually depicted as a problem to be solved. Named for its
resemblance to a fishbone, this quality management tool works by defining a quality-related
problem on the right-hand side of the diagram, with individual root causes and sub-causes
branching off to its left.

A fishbone diagram’s causes and subcauses are usually grouped into six main groups, including
measurements, materials, personnel, environment, methods, and machines. These categories can
help you identify the probable source of your problem while keeping your diagram structured
and orderly.

Scenario
A restaurant has experienced a decline in customer satisfaction scores over the past few months.
To identify and address the root causes of this problem, the restaurant management decided to
create a Cause-and-Effect Diagram.
Inference
After creating the Cause-and-Effect Diagram, the restaurant team drew the following
conclusions.
 The diagram revealed several major categories or factors that might contribute to the
problem of "Decreased Customer Satisfaction." These categories included People (staff and
customers), Process (service and kitchen operations), Equipment (kitchen appliances and POS
systems), Policies (service policies and menu), and Environment (restaurant ambience and
cleanliness).
 Under each major category, the team identified subcategories or specific causes. For
example, under "Process," they identified causes like Service Speed, Food Quality, and Order
Accuracy.
 During a team brainstorming session, potential causes or factors were discussed within
each subcategory. For instance, under "Service Speed," the team identified causes such as
Understaffing and Inefficient workflow.
 After analysing the potential causes, the team prioritized them based on their significance
and relevance to the problem. They found that "Understaffing" and "Inefficient workflow"
were the primary root causes contributing to decreased customer satisfaction.
Action taken based on Inference
Once the root causes were identified, the restaurant team took the following actions.
 Hiring additional staff to address the "Understaffing" issue.
 Optimising the workflow to reduce "Inefficient workflow" problems.
 Providing staff training to improve service efficiency and quality.
 Results
After implementing these actions, the restaurant monitored customer satisfaction scores over a
three-month period.
 The frequency of low customer satisfaction scores significantly decreased, especially
related to issues like long waiting times and service quality.
 Customer feedback indicated that service was more efficient, orders were more accurate,
and waiting times were reduced.
 The restaurant observed a noticeable increase in customer satisfaction scores and a rise in
repeat business, indicating improved customer loyalty.

5. Pareto chart (80-20 rule)

As a quality control tool, the Pareto chart operates according to the 80-20 rule. This rule assumes
that in any process, 80% of a process’s or system’s problems are caused by 20% of major
factors, often referred to as the “vital few.” The remaining 20% of problems are caused by 80%
of minor factors.

A combination of a bar and line graph, the Pareto chart depicts individual values in descending
order using bars, while the cumulative total is represented by the line.

The goal of the Pareto chart is to highlight the relative importance of a variety of parameters,
allowing you to identify and focus your efforts on the factors with the biggest impact on a
specific part of a process or system.
 Scenario
A manufacturing company specialises in producing electronic gadgets. They've recently become
concerned about the high number of defects in their products, which affect both product quality
and customer satisfaction. To address this issue, they decide to create a Pareto Diagram.
Inference
After creating the Pareto Diagram, the manufacturing team draws the following conclusions.
 The data collected includes information about the type of defect and the frequency of
each defect.
 They organised this data into a table or spreadsheet, listing defect types and their
respective frequencies.
Defect Type Frequency
Scratched Screen 50
Battery Issues 30
Missing Components 20
Connectivity Issues 15
Cosmetic Flaws 10
Others 5

 On the Pareto Diagram, they list the defect types on the x-axis (horizontal axis) in
descending order of frequency, from the most frequent to the least frequent. On the y-axis
(vertical axis), they plot the frequency of each defect type using bars.
 They include a line on the diagram that shows the cumulative percentage of defects. This
line helps determine the point at which the most significant issues (the "vital few") transition
into the less significant ones. For example, they might find that "Scratched Screen" and
"Battery Issues" together account for 80% of all defects. This means that these two defect
types should be prioritized for improvement efforts.
Action taken based on Inference
Based on their analysis, the manufacturing team takes the following actions.
 Initiates root cause analysis to understand why "Scratched Screen" and "Battery Issues"
are so prevalent.
 Implements corrective actions to address the root causes of these significant defects,
which may include changes in manufacturing processes or quality control procedures.
 Monitors the results of these actions closely to ensure that the defect rates for "Scratched
Screen" and "Battery Issues" decrease over time.
Results
After implementing these actions, the manufacturing company monitors the impact over a
three-month period.
 The defect rate for "Scratched Screen" and "Battery Issues" significantly decreases,
indicating improved product quality.
 The overall number of defects in electronic gadgets decreases, resulting in higher product
quality.
 Customer feedback and returns related to defects show a noticeable decrease, leading to
increased customer satisfaction.
By using the Pareto Diagram as a visual tool, the manufacturing company effectively identifies
and addresses the most critical defects, resulting in improved product quality and customer
satisfaction.

6. Scatter diagram

Out of the seven quality tools, the scatter diagram is most useful in depicting the relationship
between two variables, which is ideal for quality assurance professionals trying to identify cause
and effect relationships.

With dependent values on the diagram’s Y-axis and independent values on the X-axis, each dot
represents a common intersection point. When joined, these dots can highlight the relationship
between the two variables. The stronger the correlation in your diagram, the stronger the
relationship between variables.

Scatter diagrams can prove useful as a quality control tool when used to define relationships
between quality defects and possible causes such as environment, activity, personnel, and other
variables. Once the relationship between a particular defect and its cause has been established,
you can implement focused solutions with (hopefully) better outcomes.

Action taken based on Inference

Based on their analysis, the manufacturing team takes the following actions.
 Initiates root cause analysis to understand why "Scratched Screen" and "Battery Issues"
are so prevalent.
 Implements corrective actions to address the root causes of these significant defects,
which may include changes in manufacturing processes or quality control procedures.
 Monitors the results of these actions closely to ensure that the defect rates for "Scratched
Screen" and "Battery Issues" decrease over time.
Results
After implementing these actions, the manufacturing company monitors the impact over a
three-month period.
 The defect rate for "Scratched Screen" and "Battery Issues" significantly decreases,
indicating improved product quality.
 The overall number of defects in electronic gadgets decreases, resulting in higher product
quality.
 Customer feedback and returns related to defects show a noticeable decrease, leading to
increased customer satisfaction.
By using the Pareto Diagram as a visual tool, the manufacturing company effectively identifies
and addresses the most critical defects, resulting in improved product quality and customer
satisfaction.

7. Control chart (also called a Shewhart chart)

Named after Walter A. Shewhart, this quality improvement tool can help quality assurance
professionals determine whether or not a process is stable and predictable, making it easy for you
to identify factors that might lead to variations or defects.

Control charts use a central line to depict an average or mean, as well as an upper and lower line
to depict upper and lower control limits based on historical data. By comparing historical data to
data collected from your current process, you can determine whether your current process is
controlled or affected by specific variations.

Using a control chart can save your organization time and money by predicting process
performance, particularly in terms of what your customer or organization expects in your final
product.

Scenario
A manufacturing company produces electronic components and is committed to delivering
high-quality products to its customers. To ensure product quality, they decide to implement a
Control Chart to monitor the defect rate during the assembly process.
Inference
After implementing the Control Chart and regularly monitoring it, the company draws the
following conclusions.
 The Control Chart helps track the number of defects in each batch of components over
time.
 Control limits, set at ±3 standard deviations from the process mean, are used to identify
when the process goes out of control.
 When data points fall within the control limits, it indicates common-cause variation,
which is expected in any process and requires no immediate action.
 When a data point falls outside the control limits, it signals special-cause variation,
indicating a specific problem or anomaly in the process, such as machine malfunctions or
operator errors.
Action taken based on Inference
When a data point falls outside the control limits, the manufacturing team investigates the cause.
For example, if a batch of components shows an unusually high defect count, the team identifies
a specific machine malfunction as the cause.
Once the cause is identified, corrective actions are taken, such as repairing the malfunctioning
machine or providing additional training to operators to prevent similar issues in the future.
Results
After implementing the Control Chart and taking corrective actions, the company monitors the
defect rate over time.
 The Control Chart helps maintain consistent product quality by quickly identifying and
addressing special-cause variations.
 The defect rate decreases significantly as special-cause variations are minimised.
 The company's reputation for delivering high-quality products is enhanced, resulting in a
positive impact on their market share and customer base.

Bonus: Flowcharts

Some sources will swap out stratification to instead include flowcharts as one of the seven basic
QC tools. Flowcharts are most commonly used to document organizational structures and
process flows, making them ideal for identifying bottlenecks and unnecessary steps within your
process or system.

Mapping out your current process can help you to more effectively pinpoint which activities are
completed when and by whom, how processes flow from one department or task to another, and
which steps can be eliminated to streamline your process.

The 7 New Quality Tools

Gary Cox is a great Quality resource in addition to being very funny! [email protected]
The Seven New Management and Planning Tools

If you have had any formal training in Root Cause Analysis, Problem-solving, or any type of
Quality Improvement, then the seven basic QC tools have most likely been taught to you
rigorously . While the seven tools are sufficient for problem-solving, they are not ideal for
management and planning. The need for an expanded toolset was noticed and addressed in 1976
by the JUSE (Union of Japanese Scientists and Engineers) to promote innovation, communicate
information, and successfully plan major projects. A JUSE team presented 7 New Quality tools
(sometimes called the Seven Management and Planning -MP- tools): Affinity Diagram,
Relations Diagram, Tree Diagram, Matrix Diagram, Matrix Data Analysis, Arrow Diagram, and
Process Decision Program Chart (PDPC). Often in the modern world, the more complex Matrix
Data Analysis is replaced with the similar Prioritization Matrix, so I will cover the Prioritization
Matrix rather than the less commonly utilized Matrix Data Analysis tool.

The New Tools were exported to the United States in the mid-1980s and have become standard
project management tools in the U.S. and internationally. Not all of these tools were new by any
means, but the way they were presented was effective (Tague, 2005).

New Tools:

Affinity Diagram

Relations Diagram

Tree Diagram

Matrix Diagram

Prioritization Matrix

Arrow Diagram

Process Decision Program Chart (PDPC)

Affinity Diagram

Created in in 1960’s by Japanese anthropologist Jiro Kawakita, the Affinity Diagram is a method
that organizes a large number of ideas into logical and related groupings.When to use This tool is
one of pure abstract analysis, and therefore very useful at multiple points in the process.
Whenever your team is overwhelmed with a large number of facts or ideas presented in a chaotic
manner, this would be a good time to employ this tool. When the issue(s) seem too large and
complex for the team to understand what is usually needed is for the team to see the underlying
pattern. Once again, this is an excellent tool. When a team is trying to come to a consensus,
this tool helps the team work together to agree upon how the available facts relate to each other.

How to useThe most efficient methodology is to utilize a large work surface (wall or
whiteboard), sticky notes, and markers.

Each separate Idea is recorded on a separate note, and all notes are spread out randomly so that
everyone can see each note.

Relations Diagram

The original term was Relations Diagram, also called: Interrelationship diagram,
Interrelationship digraph, network diagram, or matrix relations diagram. This tool is designed
to show cause-and-effect relationships while helping a team evaluate the natural relationships
between the different nuances of a complex situation.

When to useWhile trying to understand relationships between Cause-and-Effects such as:Trying

to ID an area of greatest impact for improvement

During analysis of a complex issue for causes

During implementation of complex solutions.

Matrix Diagram

The Matrix Diagram helps to demonstrate relationships between multiple groups of information.
It can provide information about the relationship, including Strength, role played, measurements,
etc. There are six different Matrices possible: L-, T-, Y-, X-, C-, and roof-shaped, depending on
how many groups there are. This tool is very generic and may be adapted broadly.

Prioritization Matrix

The Prioritization Matrix is a L-Shaped matrix that compares a list of options/needs to a set of
criteria, in order to help choose the best options when too many options are available, or to set
the options in order of priority. This is an extremely rigorous method and can be quite time
consuming when performed properly as a cross-functional group.

Arrow Diagram

The Arrow Diagram is a very powerful project planning tool. The Arrow Diagram has evolved
over time and as project management has become more prominent. Some of the terms used to
describe an arrow diagram are: Activity Network Diagram, Network Diagram, Activity Chart,
node diagram, CPM -Critical Path Method- Chart, and PERT -Program Evaluation and Review
Technique- chart.

Process Decision Program Chart (PDPC)

This tool is a version of the tree diagram that is designed to identify all that might go wrong in a
plan being developed. Utilizing PDPC allows the team to create Countermeasures for those
possible failures, or the plan can be outright revised to eliminate those failure possibilities.

QFD-QUALITY FUNCTION DEPLOYMENT

Introduction:

 Quality Function Deployment (QFD) is a planning tool used to fulfill customer

expectations.
 It is a disciplined approach to product design, engineering and production and
provides in-depth evaluation of a product.
 QFD focuses on customer expectations or requirements often referred to as the voice of
the customer.
 It is employed to translate customer expectations in terms of specific requirements, in
two directions and actions, in terms of engineering or technical characteristics that can be
deployed through
 Product planning
 Part development
 Process Planning
 Production Planning
 Service Industries

QFD Team:

 When an organization decides to implement QFD, the project manager and team
members need to be able to commit a significant amount of time to it, especially in
the early stages.
 Teams compose of members from marketing, design, quality, finance and production.
 One of the most important tools in the QFD process is communication.
 Team meetings are very important in the QFD process.
 The team leader needs to ensure that the meetings run in the most efficient manner and
that the members are kept informed.
 The meeting format should have some way of measuring how well the QFD process
is working at each meeting and should be flexible depending on certain situations.

Voice of the Customer:

 Words used by the customer to describe their expectations are often referred
 to as the voice of the customer.
 Customer satisfaction like quality is defined as meeting or exceeding customer
expectations.
 QFD begins with marketing to determine what exactly the customer desires from a
product.
 During the collection of information, the QFD team must continually ask
and answer numerous questions such as
a) What does the customer really want?
b) What are the customers’ expectations?
c) Are the customers’ expectations used to drive the design process?
d) What can the design team to do achieve customer satisfaction?

House of Quality:

The primary planning tool used in QFD is the house of quality. The house of quality
translates the voice of the customer in to design requirements that meet specific target
values and matches those against how an organization will meet those requirements.
Many managers and engineers consider the house of quality to be primary chart in
quality planning.

Building a House of Quality:

Step1: List Customer Requirements (WHATs)

QFD starts with a list of goals and objectives.

 This list is often referred as the WHATs that a customer needs or expects in a particular
product.
  This list of primary customer requirements is usually vague and very general in nature.
 Further a most detailed list of secondary customer requirements is needed to
support the primary customer requirements.

Step 2: List Technical Descriptors (HOWs)

 The goal of the house of quality is to design or change the design of a product in
away that meets or exceeds the customer expectations.
 Here the customer needs and expectations are expressed in terms of customer
requirements; it is the duty of the QFD team to convert these requirements in to
engineering characteristics or technical descriptors.
 Implementation of the customer requirements is difficult until they are
translated in to counterpart characteristics.
 Counterpart characteristics are an expression of the voice of the customer in technical
language.
 The list of technical descriptors is divided in two primary, secondary and tertiary
technical descriptors.

 Determine their respective relationships.

 One way to reduce the confusion associated with determining the relationships
between customer requirements and technical descriptors is to use an L-Shaped
matrix.
 The L-Shaped matrix makes interpreting the complex relations very easy and
does not require a significant amount of experience.
 Step 3: Relationship Matrix

 The inside of the house of quality is called as the relationship matrix and it is usually
filled by the QFD team.
 It is common to use symbols to represent the relationship between the customer
requirements and descriptors.

Example:

A solid circle represents a strong relationship

A single circle represents a medium relationship
A triangle represents a weak relationship

An empty column indicates that a particular technical descriptor does not affect any of
the customer requirements and after careful scrutiny may be removed from the house of
quality.

Step 4: Develop an interrelationship Matrix between HOWs

 The roof of the house of the quality called the correlation matrix is used to identify any
interrelationships between each of the technical descriptors.

Symbols:

 A solid circle represents a strong positive relationship

 A circle represents a positive relationship
 An X represents a negative relationship
 An asterisk represents a strong negative relationship.
 Step 5: Competitive Assessments

 The competitive assessments are a pair of weighted tables that depict item for
item how competitive products are compared with current organization
products.
 The competitive assessment tables are separated in to two categories customer
assessment and technical assessment.
 The numbers 1 through 5 are listed in the competitive evaluation column to
indicate a rating of 1 for worst and 5 for best.
 The customer competitive assessment is a good way to determine is the customer
requirements has been met and identifies areas to concentrate in on the next design.

Technical Competitive Assessment:

 Customer requirements and technical descriptors that are strongly related should
also exhibit a strong relationship in their competitive assessments.
 If an organization technical assessment shows its products to be superior to the
competition, then the customer assessment should show a superior assessment.
 If the customer disagrees, then a mistake in engineering judgement has
occurred and should be corrected.

Step 6: Develop Prioritized customer requirements

 Importance to customer
 Target value
 Scale-up factor
 Sales point
 An absolute weight

Step 7: Develop Prioritized technical descriptors

 Degree of technical difficulty

 Target value
 Absolute weights
 Relative weights

Benefits of QFD

The quality function deployment is the task of design engineers; however, the efforts of all the
departments are required to implement it successfully.

Let us now understand the various advantages QFD has in an organization:Benefits of Quality
Function Deployment

Improves Product Quality: QFD is a tool used by the companies engaged in the manufacturing
and production of goods or services to continually enhance the quality of their products.

Systematic Information: Designing the house of quality for a particular product enables the
organization to arrange the data obtained, in an orderly manner.

Competitive Quality Analysis: It also determines the competitiveness of the firm through quality
analysis on the grounds of customer reviews and preference.

Reduces Wastage: QFD directs the efforts of the organization’s personnel in the right direction
and thus reduces the chances of wastage of time, efforts and resources.

Increases Customer Satisfaction: It ensures better quality products by analyzing consumer

preference, thus enhancing the level of customer satisfaction.

Shortens Product Development Cycle: With the help of continual research and improvement of
product quality, the product development cycle becomes abridged and leads to the sustainability
of the organization in the market.

Unanimous Decision: QFD is a team-oriented activity; therefore, the product-related decisions so

are taken have the consent of all the members involved in the process.

Decreases Startup Cost: It reduces a startup’s expenses tremendously since it is a cost-efficient

means of product design and marketing research.

Promotes Team Work: It is a complex process and cannot be performed single-handedly. Thus, it
requires the efforts of the whole team, including the personnel from different departments such
as marketing, production, research and finance departments.

Disadvantages of QFD

Though QFD is an essential tool for product design and quality analysis, it has certain
drawbacks, which makes it ineffective for some organizations. Following are some of these
shortcomings:

Disadvantages of QFD

The ambiguity of Categories: The customer requirement categories are based on qualitative
aspects and therefore appears to be vague and not very clear at times.
Complex Matrix: The house of quality is compiled of a matrix, and in the condition of multiple
categories and technical elements, this matrix becomes convoluted and difficult to analyze.

The difference of Opinion: Different team members can have varying opinions, which may lead
to arguments and indecisiveness.

Not Universally Applicable: The QFD technique cannot be applied in the case of customized
products and valuables like antique items. Also, the products which have a limited number of
consumers cannot be analyzed through this tool.

Labour-Intensive Process: It requires team building, i.e., the involvement of various personnel of
the organization, which ultimately increases the non-productive time.

Comprehensive and Extensive Method: QFD involves making of a matrix which is elaborated
holistically. Compiling all this information in a single house of quality makes the diagram quite
lengthy and broad, which may lead to confusion and misunderstanding.

Time Consuming: The process of data collection and its presentation on a house of quality
consumes a lot of time and efforts of the personnel.

Based on Qualitative Data: The results so obtained cannot be termed as accurate since they are
based on the qualitative input rather than quantitative information.

Conclusion

Quality function deployment is a six sigma strategy which considers quality as the primary
parameter for customer satisfaction.

Planning is the base for building up a strong brand and brand image. Therefore, QFD is an
inevitable part of the manufacturing and production organizations.

Kaizen
Kaizen is a system of continuous improvement in quality, technology, processes, company
culture, productivity, safety and leadership. The concept of Kaizen was born in Japan following
World War II. The word Kaizen means “continuous improvement.” It comes from the Japanese
words 改 (kai), which means “change” or “to correct” and 善 (zen) which means “good.”
Kaizen is a company-wide philosophy oriented toward continuous improvement. The literal defi
nition extends to one’s personal and social lives. In business, it applies to continuing
improvement applicable to everyone, both managers and employees. The main idea is to
maintain and improve work standards with the responsibility delegated to the worker.
The Kaizen strategy is one of the most important concepts in Japanese management and is
credited with being the key to Japanese competitive success. One important aspect of Kaizen is
its emphasis on process, complemented with management acknowledgement. This contrasts with
Kaizen—Continuous Improvement results-oriented management, which is ingrained in western
thinking. Kaizen, mostly, focuses on implementation.
Kaizen is a system that involves every employee from the upper management to the cleaning
crew.
Everyone in an organization is encouraged to come up with small improvement suggestions on a
regular
basis. This is not a random activity undertaken once a month or once a year. It is continuous. In
Japanese companies such as Toyota and Canon, a total of 60 to 70 suggestions per employee per
year are written down, shared and implemented.
In most cases these are not ideas for major changes. Kaizen is based on making small changes on
a regular basis. Kaizen focuses on improving productivity, safety and eff ectiveness while
reducing waste.
The suggestions are not limited to a specifi c domain such as production or marketing. Kaizen
focuses on making changes in any area where there is a scope for improvement.
In business, Kaizen encompasses many components of Japanese businesses that have been seen
as a part of their success. Quality circles, automation, suggestion systems, just-in-time delivery,
Kanban and 5 S are all included within the Kaizen system of running a business.
Kaizen involves setting standards and then continually improving those standards. Kaizen also
involves providing the training, materials and supervision that is needed for employees to
achieve
higher standards and maintain their ability to meet those standards on an on-going basis.
CONCEPTS OF KAIZEN
The essence of most “uniquely Japanese” management practices—productivity improvement,
TQC activities, QC (Quality Control) circles, or labour relations—can be reduced to one word,
Kaizen.
Using the term Kaizen in place of such words as productivity, TQC, ZD (zero defects) Kanban,
and the suggestion system paints a far clearer picture of what has been happening in Japanese
industry.
Kaizen is regarded as a conceptual “umbrella” consisting of a collection of Japanese practices
and includes customer orientation, total quality control, robotics, QC circles, suggestion systems,
automation, discipline in the workplace, total productive maintenance, Kanban, just-in-time, zero
defects, new product development, small group activities, productivity improvement, statistical
quality control and cooperative labour/management relations.
Getting Started with Kaizen
Kaizen is about taking action to generate suggestions and then implementing these immediately.
Some of the micro-level techniques for implementing Kaizen are mentioned below. Some of the
techniques have been discussed in detail in the chapter.
• Involved and committed employees who use commonsense and creativity.
• Various types of check sheets or checklists.
• Active use of the seven quality control tools—Pareto chart, cause-and-eff ect diagram,
histograms, control charts, scatter diagram, check sheets, graphs, etc.
• Systematic questioning techniques like 5W1H (What, When, Where, Whom, Why and How).
• Concept of the Deming Wheel (PDCA) and poka-yoke methods.
• Use of the Simply, Combine, Add and Automate, Re-arrange, Eliminate (SCARE) principle.
• Elimination of muda, mura and muri along with 5 S.
• Group dynamics.
• Principles of standardization and visual management.
• Some inputs on organizational behaviour topics such as team building, inter- and intra-group
behaviour.
Gemba Kaizen
Masaaki Imai, the chairman of the Kaizen Institute, propounded the concept of Gemba Kaizen.
Gemba in Japanese means “real place,” or the place where real action occurs. The problem with
most managers is that they prefer their desk to be their workplace, and wish to distance
themselves from the events taking place in the gemba. Most managers come in contact with
reality only through their daily, weekly or even
monthly reports or other meetings. The report from the gemba is merely secondary information.
The manager’s first priority should be to go to the gemba and observe the situation. When
managers go to the gemba, what they see is the real data.
The five gemba principles are shown below:
1. Go to the gemba: Many managers learn about the problems that occurred in the gemba from a
report that reaches them several days or weeks later. When there is a problem (abnormality), it is
the
manager’s responsibility to go to the gemba fi rst. This helps the managers get fi rst-hand
information
about the problems.
2. Check the gembutsu: Gembutsu, another Japanese term, refers to tangible items that one can
hold or feel. These may be machines, tools, rejects and customer complaints. If a machine is
down
(the machine itself is the gembutsu), go to the gemba and have a look at the machine. By looking
at the machine and asking the question “why” several times, you can probably fi nd out the
reason
for the breakdown on the spot.
3. Take temporary measures or countermeasures on the spot: To begin with, take temporary
countermeasures
on the spot to solve the problem. For instance, if a customer is angry, you will need to
apologize or even give some gift s to appease him. However, these are only temporary measures
and do
not address the real issue that lead us to the next point.
4. Find the root cause: If any problem occurs, go to the root cause by repeating the question
“why”
several times. This will enable one to fi nd out the root cause of the problem.
5. Standardize to prevent recurrence: Once you identify the root cause and come up with
appropriate
measures, you should standardize such a measure so that the same problem will not recur.
Major Tools of Gemba Kaizen
One major tool of gemba Kaizen is waste elimination. There are three types of wastes—muda,
muri and mura. Gemba Kaizen is the process of identifying, reducing and eliminating muda,
muri and mura from the gemba.
Muda in Japanese means work without a product or eff ort wasted. Muda is any wasteful activity
or any obstruction to the smooth flow of an activity.
Activity = Work + Muda
Expenditure = Cost + Waste
Kaizen—Continuous Improvement 275
Each activity is associated with a cost. Any expenditure on the muda is a waste. Therefore, less
muda equals happier clients (as it impacts quality, cost and delivery of products and services).
The various types of muda are as follows:
1. Muda of overproduction: This is regarded as the worst type of muda. If you produce more
than your customer needs, you have extra pieces that need to be taken care of and expenses for
handling and keeping in stock.
2. Muda of inventory: This is the result of overproduction. If you process only those products
that the next process needs, you can eliminate the muda of inventory altogether.
3. Muda of waiting: How often do you see operators just waiting for the materials to arrive or
the machine to start? No value is added when there is a long waiting period.
4. Muda of motion: No value addition takes place when operators simply move around looking
for tools or going to get the work pieces.
5. Muda of transportation: No value addition is made when materials are moving on the trucks,
forklift s or on the conveyor.
6. Muda of producing rejects: Producing rejects leads to rework, or else rejects must be thrown
away and this is indicative of a big muda.
7. Muda of processing: By rearranging the working sequence, you can oft en eliminate a
particular process.
The concept of muda elimination is central to Kaizen since elimination does not cost any money.
Muri in Japanese refers to an overburdened system. This leads to physical strain at the workplace
such as bending to work, pushing hard, lifting weight, repeating tiring action and wasteful walk.
Mura in Japanese refers to the unevenness in the flow of work. Mura relates to the
inconsistencies
in the system.

Identifying Opportunities for Kaizen

Customer surveys: The suggestions for improvement of both internal and external customers
must be recorded.
Employee suggestions: Be receptive to your employees’ suggestions all the time, every time.
Empower your employees by giving them the freedom of voice and expression.
Brainstorming: Conduct brainstorming sessions on a process you want to improve. Make sure
that you involve all the employees regardless of their position in the organization.
Benchmarking: Identify the organization(s) you want to benchmark against. It can be other
operating units within the company, competitors or unrelated companies. However, they should
be a leader or
“best in class” in the area being benchmarked.
Guidelines for Preparing the Kaizen Proposal
The following guidelines need to be followed for a Kaizen proposal:
1. The Kaizen should be self-explanatory.
2. Sustenance of results must be clearly evident.
3. Ease of replication for other units/areas must be evident.
4. Clear impact on customer/quality/bottom line/intangible benefit must be presented.
5. Each team should have a maximum of five members including a coordinator.
6. The team must be a natural operating team.
7. The presentation must follow a systematic flow—methodology of theme/problem
identification, root cause/analytical analysis, usage of diff erent tools and techniques, problem
faced if any, team
working, actions taken, before/aft er condition through photograph/graphs/sketches/videos, etc.,
results achieved, replication and sustenance of results.

Kaizen Sheet
A Kaizen sheet is a useful way of depicting the information relating to the implementation of
Kaizen suggested by an individual or group of workers.3 The typical format of a Kaizen sheet is
shown in Figure 9.1.
Reward Success
The employees of an organization distinguish an average organization from a great one. The
difference
is not so much in the calibre of the personnel, as in the degree to which the personnel are used to
theirfull potential. Each person’s contribution should be valued. Employees should be motivated,
inspired, rewarded and recognized for their contributions however small they may be. Rewards
are not only in terms of monetary benefits. Rewards can also be in the form of displaying their
special achievements on bulletin boards, giving letters of appreciation to encourage them,
celebrating their success along with their teams by giving them a rolling trophy engraved with
their names on it, etc.
Benefi ts of Kaizen
Kaizen involves every employee in the change process. In most cases, these changes may be
small and incremental. It focuses on identifying problems at their source, solving them at their
source, and changing standards to ensure that the problem does not recur. It’s not unusual for
Kaizen to result in 25 to 30 suggestions per employee, per year, and to have over 90 per cent of
those implemented.
5S-Kaizen Approach:

The 5 S forms the foundation of Kaizen. A 5-S programme is usually a part of and the key
component in establishing a visual workplace. It is both a part of Kaizen and a component of
lean manufacturing. The 5-S programme focuses on implementing visual order, organization,
cleanliness and standardization. The results that can be expected from a 5-S programme are
improved profitability, efficiency, service and safety. The principles underlying a 5-S
programme at fi rst appear to be simple and obvious common sense. However, many businesses
ignored these basic principles until the advent of 5-S programmes. 5 S is the key to total quality
environment. Japanese factories are well known for their cleanliness and orderliness. Therefore,
the Japanese call their factories parlours. The 5-S practice is a technique used to establish and
maintain quality environment in an organization. The name stands for five Japanese
words—seiri, seiton, seiso, seiketsu and shitsuke. The Japanese 5-S practice is useful not just
for improving the physical environment, but also for improving thinking processes.
The 5-S Movement
The 5-S movement takes its name from the fi rst letter of the fi ve Japanese words—seiri, seiton,
seiso, seiketsu and shitsuke. As part of the visual management of an overall programme, signs
that repeat the steps are oft en posted in the workshop.
Step 1 Seiri (straighten up): It is about separating the things that are necessary for the job from
those that are not and keeping the number of the necessary items as low as possible and at a
convenient location. Differentiate between the necessary and the unnecessary and discard the
unnecessary in the areas such as work in process, unnecessary tools, unused machinery, defective
products and documents.
This can be achieved by:
• Stratification management: The key to good stratification management is the ability to make
decisions
about usage frequency and to ensure that the things are in their proper places. It involves
deciding how important something is and then reducing the non-essential inventory.
• Differentiate between need and want.
• Applying the theory of one-is-best, for example, by using one set of tools/one day processing.
Step 2 Seiton (put things in order): Things must be kept in order so that they are ready for use
when needed. An American mechanical engineer recalls that he used to spend hours searching
for tools and parts in his previous job at Cincinnati. He realised the value of “seiton” only aft er
he joined a Japanese organization and saw how easily the workers were able to find what they
needed. Seiton is all about neatness. Neatness is a study of efficiency. It is a question of how
quickly one can get the things needed and how quickly one can put them away. There are four
steps in achieving neatness:
1. Analyse the status quo
2. Decide where things belong
3. Decide how things should be put away
4. Obey the put-away rules (putting things back where they belong)
Step 3 Seiko (clean up): Keep the workplace clean. Everyone in the organization should put
leaning into practice, right from the managing director to the cleaner.
Step 4 Seiketsu (standardization): It means continually and repeatedly maintaining neatness and
cleanliness in the organization. As such, it embraces both personal cleanliness and the
cleanliness of the environment. The emphasis is on visual management (put up appropriate
labels) and standardization.
Step 5 Shitsuke (discipline): Discipline means instilling the ability of doing things the way they
are supposed to be done. Discipline is a process of repetition and practice. The emphasis here is
on creating a workplace with good habits. Everyone should follow the procedures in the
workshop.
The logic behind 5-S practices is that organization, neatness, cleanliness, standardization and
discipline
at the workplace are basic requirements for producing high quality products and services with
little or no waste and with high productivity. This is the reason why it is important to combine
the Japanese 5-S practice in TQM.
POKA-YOKE
In the early 1960s, quality guru Shigeo Shingo combined the concepts of “successive,”
“independent” and “source” inspections with Toyota’s in-house “fool proofing” techniques and
devised the famous production philosophy “poka-yoke” (poka means mistake or inadvertent
errors, while yoke means proofing. It is derived from the word “yokeru” meaning, to avoid).
The initial term was “baka-yoke,” which means “fool-proofing.” In 1963, a worker at Arakawa
Body Company refused to use the “baka-yoke” mechanisms in her work area because of the
term’s dishonourable and off ensive connotation. Hence, the term was changed to “poka-yoke”,
which means “mistake-proofing.”
It was designed as a tool to achieve and sustain “zero defects.” Poka-yoke refers to the absolute
elimination of defects in the production process. Defect free supplies are not just a desired goal,
but in many instances essential for suppliers. In many cases, a single defect has been found to be
the cause of outright rejection of the entire batch or 100 per cent manual reinspection of every
component in the batch at the expense of the supplier. It is simply a way to prevent the
occurrence of defects, injuries or losses of any kind at the workplace. It makes use of sensors and
instruments and devices that can identify disorders, abnormalities or mis-steps, without the
workers having to be extra sensitive to the smallest details.
Poka-yoke helps people and processes work right the first time. It can be thought of as an
extension of Failure Mode Effect Analysis. It can also be used to fi ne tune improvements and
process designs from Six Sigma Defi ne-Measure-Analyse-Improve-Control (DMAIC) projects.
The use of simple poka-yoke ideas and methods in product and process design can eliminate
both human and mechanical errors.
Poka-yoke does not need to be costly. For instance, Toyota has an average of 12
mistake-proofing devices
at each workstation and a goal of implementing each mistake-proofing device for under USD
150.
Poka-yoke works on five pillars as suggested by Shingo:
1. Use source inspection. The application of control functions at the stages where errors,
mistakes may
get converted into defects or accidents. Th at is, use control/warning function at the origin of the
defect.
2. Always use 100 per cent source inspection at least for attributes. It is better than sampling
inspection.
3. Minimize the time to carry out corrective actions when abnormalities appear or try to speed up
the
feedback corrective actions.
4. Set up mistake proofing devices (called poka-yokes), i.e. sensors, and transducers; limit
switches, metal detectors according to products and process requirements.
5. Respect workers and operators. T ey are human beings and not robots or programmable
machines.
Step-by-step Process in Applying Poka-yoke
1. Identify the operation or process based on a Pareto analysis.
2. Analyse the five whys and understand the ways a process can fail.
3. Decide on the right poka-yoke approach such as using a shut out type (preventing an error
from
being made) or an attention type (highlighting that an error has been made). Poka-yoke takes a
more comprehensive approach and should not be deemed limit switches or automatic shutoff s.
A poka-yoke can be electrical, mechanical, procedural, visual, human or any other form that
prevents incorrect execution of a process step.
4. Use the method of creating a checklist to ensure that all process steps have been completed
appropriately.
5. Try the method and see if it works.
6. Train the operator, review performance and measure success.

Poka-yoke is a Japanese lean manufacturing strategy that aims to eliminate mistakes and defects
during the manufacturing process – a simple yet effective quality control tool that can be used to
reduce errors in almost any industry.

Poka-Yoke devices consist of three effective methods to ensure detection and prevention of
mistakes: 1. Contact method 2. Fixed-Value method 3. Motion-step method; Each method can be
used in Control approach or Warning approach.
 UNIT-V

Quality Management Systems

Quality management systems

A quality management system is a management technique used to communicate to employees

what is required to produce the desired quality of products and services and to influence
employee actions to complete tasks according to the quality specifications. What Purpose Does a
Quality Management System Serve?

✔ Establishes a vision for the employees.

✔ Sets standards for employees.

✔ Builds motivation within the company.

✔ Sets goals for employees.

✔ Helps fight the resistance to change within organizations.

✔ Helps direct the corporate culture.

Benefits of Quality Management Systems


Compliance with quality standards: A quality management system helps you ensure
compliance with quality standards and regulations applicable to your organization.

Improved quality: By streamlining quality processes and promoting continuous improvement, a
QMS can help you improve the overall quality of your products or services.

Increased customer satisfaction: When customers are happy with the quality of your products
or services, they are more likely to continue doing business with you.

Improved efficiency: A quality management system can help you eliminate waste and
streamline quality processes, leading to increased efficiency and productivity.

 Reduced costs: By improving quality and compliance, a quality management system can help
you to reduce costs associated with rework, scrap, and customer complaints.

Improved communication and collaboration: A quality management system can help to
improve communication between departments and across the organization, as well as
collaboration between team members.
Recommended Reading: 10 Benefits of a Quality Management System for Life Sciences

Different Types of Quality Management Systems

There are different types of quality management systems. The right one for your organization
will depend on your industry, quality requirements, and other factors.
Some common types of quality management system requirements in the context of life science
industries include:
 ISO 9001:2015
 ISO 13485:2016
 FDA 21 CFR Part 820
 ISO 17025:2017
 ICH Q10
 GxP
 EU MDR & EU IVDR
Here is an illustration of the main regulatory requirements that could be applicable to medical
device and pharmaceutical companies.
Objectives of the internal audit
One of the main objectives of an internal audit is to keep stringent control over all the activities
of an organization. The management needs assurance of the authenticity of the financial records
and the efficiency of the operations of the firm. An internal audit helps establish both.
Introduction to ISO9000-TS16949
ISO 9000 is a series of international standards concerning quality management and assurance
developed to help organizations establish and maintain an effective quality management system
(QMS). The standards can help business entities fulfill regulatory requirements, improve
continuously, and ensure customer satisfaction.
 ISO 9000 meaning refers to a series of international standards describing the best quality
management practices. It helps to fulfill the requirements of customers and shareholders while
meeting regulatory needs.
 The series has seven principles. Leadership, relationship management, engagement, and
customer focus are some of them.
 Companies must clear a third-party audit to procure an ISO certificate. Also, they must
renew the certificate after the end of every three years.
 ISO 9000 benefits include reduction in manual work, improvement of brand image,
minimization of errors in recurring processes, etc.
Needs for ISO 9000
 ISO 9000 is a set of internationally recognized standards for quality assurance and
management. Published by the International Organization for Standardization, it aims
to encourage the production of goods and services that meet a globally-acceptable level of
quality
ISO 9000 Requirements

Let us look at the ISO 9000 series requirements.

1. Customer Focus

Organizations must understand the requirements of existing and future customers and aim to
exceed their expectations. They can ask for feedback from customers and monitor complaints.

2. Engagement

Everyone at every level of an organization should improve the business’s capability to create
customer value.

3. Leadership

A company’s leaders should establish a unity of direction throughout the organization to equip
and empower the employees to achieve quality-related objectives.

4. Process

Organizations must manage their activities as interrelated processes that work as a

well-organized system. Moreover, they must utilize process analysis tools to measure their
capability and spot relations between activities to improve the processes.

5. Evidence-based Decision Making

Companies must make all decisions after thoroughly analyzing and evaluating the necessary data
and information for the best results. One must remember to balance data analysis with qualitative
evidence and practical experience.
6. Relationship Management

For short-term and long-term success, business entities must manage their relationships with
related parties, such as vendors, partners, and contractors.

7. Continuous Improvement

Organizations must adopt an approach that focuses on continuous improvement; they should
empower workers to make improvements and celebrate the same. Moreover, they must measure
the improvements consistently.

TS16949:2002

TS16949:2002 is a technical specification established by the International Automotive Task

Force (IATF) for quality management systems in the automotive industry. It was developed to
harmonize the various quality management system standards within the automotive sector
globally. TS16949:2002 was based on the ISO 9001 standard and included additional
automotive-specific requirements.

This specification aimed to enhance customer satisfaction by ensuring consistency in the quality
of automotive products and services throughout the supply chain. It emphasized continuous
improvement, defect prevention, and reduction of waste and variation in the manufacturing
process.
However, it's important to note that TS16949:2002 has been superseded by newer versions. In
particular, the latest version as of my last update in January 2022 was IATF 16949:2016. This
updated version aligns with the latest ISO 9001 standard and incorporates additional
automotive-specific requirements and expectations.

TS16949:2002, as well as its successor IATF 16949:2016, outlines several requirements that
organizations in the automotive industry must fulfill to achieve certification. Some of the key
requirements include:
1. Quality Management System (QMS):

 Establishing, documenting, implementing, maintaining, and continually

improving a quality management system.

 Ensuring the system complies with the standard's requirements.

2. Management Responsibility:

 Demonstrating commitment to the development and implementation of the QMS.

 Ensuring customer focus and satisfaction.

  Establishing quality policy and objectives.

 Conducting management reviews.

3. Resource Management:

 Providing adequate resources (human resources, infrastructure, etc.) to support the

QMS.

 Ensuring competency of personnel through training and awareness programs.

 Providing appropriate infrastructure and work environment.

4. Product Realization:

 Planning and designing processes suitable for achieving product requirements.

 Establishing and maintaining product realization processes.

 Ensuring product conformance through various stages of production.

 Controlling and monitoring production and service provision processes.

5. Measurement, Analysis, and Improvement:

 Establishing processes for monitoring, measuring, and analyzing product and

process characteristics.

 Implementing corrective and preventive actions to address nonconformities and

prevent their recurrence.

 Conducting internal audits to assess the effectiveness of the QMS.

 Implementing methods for continual improvement of the QMS.

These requirements are detailed within the standard and must be met by organizations seeking
certification. Compliance with TS16949/IATF 16949 demonstrates an organization's
commitment to producing high-quality automotive products and services, contributing to
customer satisfaction and competitiveness within the automotive industry.
 EMS14001 Certifications

ISO 14001 is an internationally agreed standard that sets out the requirements for an
environmental management system. It helps organizations improve their environmental
performance through more efficient use of resources and reduction of waste, gaining a
competitive advantage and the trust of stakeholder

list of benefits that ISO 14001 can bring to your organisation.

 Legal compliance. Getting ISO 14001 certified ensures you are keeping up to date with
legal regulation. ...
 Increased reputation with consumers. ...
 Competitive advantage. ...
 Reduce waste. ...
 Reduce costs. ...
 Reduced insurance costs.
Four elements for the checking & corrective action of ISO 14001
ISO14001 stipulates that an EMS must contain five main requirements:
(1) Environmental Policy: ISO 14001 provides requirements with guidance for use that relate to
environmental management systems. Other standards in the family focus on specific approaches
such as audits, communications, labelling and life cycle analysis, as well as environmental
challenges such as climate change.
(2) Planning: is ascertaining prior to what to do and how to do. It is one of the primary
managerial duties. Before doing something, the manager must form an opinion on how to work
on a specific job. Hence, planning is firmly correlated with discovery and creativ

3) Implementation: Implementation is the execution or practice of a plan, a method or any

design, idea, model, specification, standard or policy for doing something. As such,
implementation is the action that must follow any preliminary thinking for something to actually
happen.
(4) Checking and Corrective Action:

1. Monitoring and measurement.

2. Nonconformance and corrective and preventive action.
3. Records.
4. EMS Audits.
(5) Management Review
Management review is an essential process and is a review of the complete system to consider
possible improvements. Companies are required to carry out regular management reviews to
consider the effectiveness and adequacy of the current QMS and potential improvement
opportunities. . The objective of this section is to provide an overview of the five elements
seven elements for the implementation & operations of ISO 14001
Structure and responsibility Training, awareness and competency Communication EMS
documentation Documentation control Operational control Emergency preparedness and
response
Certification to ISO 14001 Environmental Management

ISO 14001 certification brands your business as environmentally responsible, winning you
recognition and new business opportunities. It helps you demonstrate how committed you are to
reducing your environmental impacts and to meet stakeholder expectations of sustainability.

How to get certified to ISO 14001

We make the certification process simple. After we have received your application we appoint a
client manager who will guide you and your business through the following steps.

1. Gap analysis -
This is an optional pre-assessment service where we take a closer look at your existing
environmental management system and compare it with ISO 14001 requirements. This helps
identify areas that need more work before we carry out a formal assessment, saving you time
and money.

2. Formal assessment -
This happens in two stages. First we review your organization’s preparedness for assessment
by checking if the necessary ISO 14001 procedures and controls have been developed. We
will share the details of our findings with you so that if we find gaps, you can close them. If
all the requirements are in place, we will then assess the implementation of the procedures
and controls within your organization to make sure that they are working effectively as
required for certification.
3. Certification and beyond -
When you have passed the formal assessment you will receive an ISO 14001 certificate,
which is valid for three years. Your client manager will stay in touch during this time, paying
you regular visits to make sure your system doesn’t just remain compliant, but that it
continually improve.

Requirements of ISO 14001

These requirements are divided into ten different sections (Section 1 to Section 10) and work
on Plan-Do-Check-Act (PDCA) approach. It is necessary to understand all the sections.
Section 1 to Section 6 is in the Plan stage. Section 7 and Section 8 are in the Do stage.

EMS Integration Look for opportunities to integrate the EMS into other organization
functions such as:

» quality

» engineering

» finance

» human resources

» maintenance

» purchasing

ISO 14001 Environmental Management Systems 6 ISO 14001 Structure and Responsibility
says:

Roles, responsibility, and authorities shall be defined, documented, and communicated to

facilitate effective environmental management ISO 14001 Environmental Management
Systems 7 What are Roles, Responsibilities, and Authority? ! Role is the position an
individual occupies with an organization (job title), and the relationship of that position to
others in the organization .
 Responsibilities are the assigned duties and obligations of an individual in a role ! Authority
is the power and influence an individual has to carry out responsibilities ISO 14001
Environmental Management Systems 8 Example ! Role:

Manager of Environment, Health, and Safety ! Responsibilities:

» Co-ordinate environmental management system activities

» Monitor compliance with laws and regulations

» Set performance standards » Report to senior management on environmental, health and

safety issues and performance ! Authority:

» Order cut-back in production if necessary to maintain compliance ISO 14001

Environmental Management Systems 9 What is Meant by “Defined, Documented, and
Communicated”?

Defined: the organization has identified the positions and responsibilities required to
effectively plan, implement, and maintain the EMS

Documented: roles, responsibilities and authority have been written down

» e.g., job descriptions, organization charts, operating procedures, memoranda ISO 14001
Environmental Management Systems 10 What is Meant by “Defined, Documented, and
Communicated”?

Communicated: roles, responsibilities and authorities have been made known and are
understood by all personnel ISO 14001 Environmental Management Systems 11 Clearly Defined
Duties Need:

A clear ‘chain of command’ and reporting relationships .Well-defined areas of responsibility

with no overlaps, no gaps ,Effective communications between functions and levels in the
organization ISO 14001 Environmental Management Systems 12 ISO 14001 Structure and
Responsibility also says:
 Management shall provide resources essential to the implementation and control of the
environmental management system. Resources include human resources, and specialized skills,
technology, and financial resources ISO 14001 Environmental Management Systems 13
Management Responsibility

Ensure managers, supervisors, and workers have adequate:

» time

» training, know-how, experience

» equipment

» support

» i.e., RESOURCES to plan, implement, and maintain the EMS ISO 14001 Environmental
Management Systems 14 The Most Important Ingredient in an EMS ISO 14001 Environmental
Management Systems 15 EMS Costs and

De fine Quality Audits. Quality Audits examine the elements of a quality management system in
order to evaluate how well these elements comply with quality system requirements

Give the types of Organizational Evaluation Standards: Environmental Management System

Environmental Auditing Environmental Performance Evaluation


types of Product Evaluation Standards

Product quality refers to how well a product satisfies customer needs, serves its purpose and
meets industry standards. When evaluating product quality, businesses consider several key
factors, including whether a product solves a problem, works efficiently or suits customers'
purposes.
ISO 9000:2000 A tool for Customer Satisfaction

ISO 9000:2000 is a series of standards developed by (ISO) International Organization for standardization
main quality standards:

ISO 9000:2000 Quality Management Systems-Fundamentals and Vocabulary

ISO 9001:2000 Quality Management Systems -Requirements
ISO 9004:2000 Quality Management Systems -Guidelines for Performance Improvements
ISO 10005 Quality Management -Guidelines for Quality Plans
ISO 19011 Guidelines for Auditing Quality/or Environmental Management System Auditing

Although often referred to as quality standards, these are Quality Management System tools that
describe the critical ingredients to ensure customers are provided quality products and services.
The ISO 9001:2000 standard has 8 system elements describing the minimum requirements of
sound business practice. Examples of ISO 9001:2000 requirements include:

 Customer complaint resolution

 Formal design reviews

 Testing of all deliverables

 Reviews of requirements before accepting contracts

 Regular audits to verify compliance and the effectiveness of procedures

The purpose of ISO 9000:2000 Quality Management System Standards is to provide customers
with confidence that suppliers, contractors, subcontractors, and vendors have documented,
effective and independently verified Quality Management Systems.
Companies show customers that the service they provide is efficient and that all the processes in
their Quality Management System are:

 Monitored

 Verified

 Fit for purpose

 What the customer wants

 Represents a way of sharing best practices

 Promoting transparency and effectiveness

 Avoid the risk that innovative processes and changes confined to selected people and
get lost when these people leave the organization
THE NEW ISO 9000:2000 SERIES COMPRISES THESE MAIN STANDARDS:

 ISO 9000 Quality Management Systems – Fundamentals and vocabulary.

 ISO 9001 Quality Management Systems – Requirements.

 ISO 9004 Quality Management Systems – Guidelines for performance improvement.

SYSTEM ELEMENTS ISO 9000:2000

 1] SCOPE

 2] NORMATIVE REFERENCE

 3] TERMS & DEFINITIONS

 4] QUALITY MANAGEMENT SYSTEM

 5] MANAGEMENT RESPONSIBILITY

 6] RESOURCE MANAGEMENT

 7] PRODUCT REALIZATION

 8] MEASUREMENT ANALYSIS & IMPROVEMENT

 Key Revisions to ISO

 Management – Showing commitment to development and improvement of the quality

system.

 Responsibility – More customer focused.

 Resource Responsibility – Competency of staff, training, facilities, work environment.

 Product Realisation – Process oriented approach to defining the business operations all
parts of ISO

 Measurement Analysis – Includes need to monitor customer satisfaction-define

methodology. Includes audits. Improvement Analysis of data, nonconformity. corrective
action and preventative action.

Methods of actual audit:The audit process is not always an easy one and it can be difficult to
find time for, but the result of this type of testing will provide organizations with a ‘snapshot’
view of what is going on within the organization. Audits are carried out during different stages
in a company’s life cycle so that they might identify potential risks as well as opportunities
associated with any given stage or phase! In this blog post, we’ll cover what various types of
audit methods are available and which ones you should know about if your company does
regular internal or external audits!
1. Inquiry:
The most basic type of audit, which is asking questions. When an audit engagement begins,
the company and staff being audited agree to provide auditors with the right to obtain
information that is relevant to the preparation of the financial statements or the purpose of the
audit. Auditors are granted entry to individuals within the business who they feel will provide
them with evidence. This audit method mainly involves a series of interviews with staff who
can be asked about their job responsibilities and what they do on a day-to-day basis to see if
procedures are being followed correctly or not.
2. Observation:
Requires you to observe a process or activity. If internal auditors walk around with their eyes
open, they’ll be able to note any irregularities that may point towards some form of fraud. The
observer has no direct contact with the subject matter and must rely on his/her observations for
evidence, so this type of audit cannot typically produce conclusive results which means it should
not usually be used alone but instead combined with other types, like examination for example.
3. Examination:
Looks at whether work was performed following company policies and regulations set out by
an organization’s audit policy. It is a very broad audit method and can include any number of
audit techniques depending on the situation, such as interviewing staff or visiting different
departments to see if their procedures are being followed correctly or not.
4. Computer-Assisted Audit Technique:
Computer-assisted audit technique (or CAAT) combines manual review with
computer-generated analyses for improved efficiency in an audit procedure. The process
begins by generating test data which then goes through various types of testing before it’s
compared to what was expected when running the tests manually. A great tool for auditing
agencies that helps increase accuracy while also reducing human error at the same time!
5. Audit Analytical Procedure:
Looks at financial reports that have been produced using auditing standards, like GAAPs, for
example. When combined with analytical audit procedures, this audit method can be used to
look for fraud by reviewing the company’s financial statements and comparing them with what is
expected when audit standards are applied.
6. Inspection of Assets:
Examines whether work was performed following policies (in this case ones related to physical
property) or not but it relies on a thorough inspection of various types of assets which includes
looking at things like buildings/grounds, IT equipment, vehicles, etc. Inspecting these items
allows auditors to spot anything that doesn’t match up – such as missing data files on an
employee computer- resulting in the suspicious activity being found much earlier than if you
were using inquiry audit alone!
7. Recalculation:
Recalculating numbers is one audit technique that is used to audit financial statements. This
audit method can be used for both internal and external audits – the purpose of which is to
confirm numbers being reported on an audit statement are in line with what was done or not,
particularly when large amounts of money have been either gained or lost by a company.
8. Confirmations:
Used to confirm that the financial statements have been prepared following audit standards,
which includes examining whether they’re correct and accurate. The confirmation audit can be
either formal or informal; it’s usually a series of questions asked by the auditor to ensure he/she
has all the information needed for this type of audit.
9. Audit Procedures for Inventory:
Inspecting records and documents audit relies on a comprehensive inspection of the company’s
documentation, such as audit trails for example. This type of audit allows you to look at things
like computer logs to spot any inconsistencies with what was reported or not which would signal
fraud – it can be used alone but is usually combined with other types such as examination when
examining whether work was performed correctly or not.
VDA of Germany, AIAG of America, AVSQ of Italy and SMMT of UK
VDA stands for Verband der Automobilindustrie. VDA 6.3 defines a process-based audit
standard for evaluating and improving controls in a manufacturing organization's new product
introduction and manufacturing processes.
The Automotive Industry Action Group (AIAG) was established in 1982, AIAG is a
not-for-profit trade association where professionals from member companies – including
automakers, suppliers of all sizes, manufacturers, service providers, academia, and government –
work collaboratively to streamline industry processes via ..
French (EAQF) and Italian (AVSQ) automotive quality systems standards for the global
automotive industry. ISO 17025 outlines the general requirements for the competence of testing
and calibration laboratories.
What is SMMT? The Society of Motor Manufacturers and Traders (SMMT) exists to support
and promote the interests of the UK automotive industry at home and abroad. Working closely
with member companies, SMMT acts as the voice of the motor industry, promoting its position
to government, stakeholders and the media.