LESSON NOTES

Steps involved in ISO-certification

 1. Develop your management system
 Identify your core or business processes.
 Document processes with the involvement of employees.
 Review, approve and distribute the documents to those who need access to the
information.
 2. Implement your system
 Ensure procedures are being performed as they are described in your
documentation.
 Ensure employees are trained properly for the tasks they are performing.
 Create effective reporting systems to cover inspection, testing, corrective actions,
preventive actions, management review meetings, monitoring of objectives,
statistical techniques and so on.
 Monitor the effectiveness of your processes through the use of measurable data,
where possible.
 Review and take action to improve in the areas required.
 3. Verify that your system is effective
 Conduct the audit and review the processes and system for compliance and
effectiveness. Observe, interview people and look at sample records.
 Identify and report strengths and weaknesses of the management system.
 Take corrective or preventive action as required.
 4. Register your system
 Select the appropriate auditing body for external registration.
 Submit your management system documentation for review to ensure it complies
with the applicable standard.
 Prepare for review by an external auditor to confirm that the system’s
requirements are being satisfied and that the management system is implemented
effectively.
 ISO 9001—Quality management
More than one million businesses around the world are certified to ISO 9001.
Obtaining this standard shows your commitment to providing the highest quality
products or services to your customers.
Getting ISO 9001 certified can help you:
 Reduce quality problems
 Increase cost savings and productivity
 Enhance customer satisfaction
 Create greater demand for your products and services
 Make your business more competitive
 Make better decisions and improve employee morale

1
The ISO 9001 norm is frequently updated. The latest revision to the ISO 9001:2015
version offered a number of improvements over the previous standard.
 There is now greater consistency between the ISO 9001 standard and other norms
in the ISO family.
 The new ISO 9001 standard requires businesses to use “risk-based thinking” to
identify, consider and control the risks that are inherent in any system, process or
function.
 The standard is more flexible and requires less documentation than previous
versions.
 ISO 14000—Environmental management
ISO 14000 is an international standard for environmental management systems. ISO
14001 certification can help you:
 Enhance your environmental performance
 Fulfill compliance obligations
 Achieve environmental objectives
 Generate greater demand for your products and services and increase their
acceptance
 Reduce risk and liability while increasing efficiency and customer confidence
 ISO 22000—Food safety management
The ISO 22000 certification is an international food safety management system.
ISO 22000 certification can help you:
 Develop a food safety management system
 Demonstrate your compliance with government food safety requirements
 Gain customer confidence
 Develop new partnership and export opportunities
 Build employee awareness of hygiene and safety
 ISO 50001—energy management
The ISO 50001 certification works with the ISO 9001 and ISO 14001 standards to
integrate energy management into your company’s overall quality and
environmental improvement efforts.
ISO 50001 certification can help you:
 Develop a policy for energy efficiency
 Establish energy use targets
 Collect and use data to make decisions about energy use

Environment Management System, (EMS)

An Environmental Management System (EMS) is a set of processes and practices
that enable an organization to reduce its environmental impacts and increase its
operating efficiency. This site provides information and resources related to an EMS
for small businesses and private industry, as well as local, state and federal agencies.
2
The EPA continues with its progress in developing and maintaining an environmental
management system at each of its offices, labs, and other facility operations, focusing
on the reduction of the agency's environmental footprint.
An Environmental Management System (EMS) is a framework that helps an
organization achieve its environmental goals through consistent review, evaluation,
and improvement of its environmental performance. The assumption is that this
consistent review and evaluation will identify opportunities for improving and
implementing the environmental performance of the organization. The EMS itself
does not dictate a level of environmental performance that must be achieved; each
organization's EMS is tailored to its own individual objectives and targets.
 Basic EMS
An EMS helps an organization address its regulatory demands in a systematic and
cost-effective manner. This proactive approach can help reduce the risk of non-
compliance and improve health and safety practices for employees and the public.
An EMS can also help address non-regulated issues, such as energy conservation,
and can promote stronger operational control and employee stewardship. Basic
Elements of an EMS include the following:
 Reviewing the organization's environmental goals;
 Analyzing its environmental impacts and legal requirements (or compliance
obligations);
 Setting environmental objectives and targets to reduce environmental impacts
and comply with legal requirements (or compliance obligations);
 Establishing programs to meet these objectives and targets;
 Monitoring and measuring progress in achieving the objectives;
 Ensuring employees' environmental awareness and competence; and,
 Reviewing progress of the EMS and making improvements.
Costs and Benefits of an EMS
Internal
 Staff/manager time (represents the bulk of EMS resources expended by most
organizations)
 Other employee time
External
 Potential consulting assistance
 Outside training of personnel
Potential Benefits
 Improved environmental performance
 Enhanced compliance
 Pollution prevention
 Resource conservation
 New customers/markets

3
 Increased efficiency/reduced costs
 Enhanced employee morale
 Enhanced image with public, regulators, lenders, investors
 Employee awareness of environmental issues and responsibilities
EMS under ISO 14001

Figure 1: The continuous improvement cycle.

An EMS encourages an organization to continuously improve its environmental
performance. The system follows a repeating cycle (see figure 1). The organization
first commits to an environmental policy, then uses its policy as a basis for
establishing a plan, which sets objectives and targets for improving environmental
performance. The next step is implementation. After that, the organization evaluates
its environmental performance to see whether the objectives and targets are being
met. If targets are not being met, corrective action is taken. The results of this
evaluation are then reviewed by top management to see if the EMS is working.
Management revisits the environmental policy and sets new targets in a revised plan.
The company then implements the revised plan. The cycle repeats, and continuous
improvement occurs.
The most commonly used framework for an EMS is the one developed by
the International Organization for Standardization (ISO) for the ISO 14001
standard . Established in 1996, this framework is the official international standard
for an EMS which is based on the Plan-Do-Check-Act methodology. The five main
stages of an EMS, as defined by the ISO 14001 standard , are described below:

4
 1. Commitment and Policy - Top management commits to environmental
improvement and establishes the organization's environmental policy. The policy is
the foundation of the EMS.
2. Planning - An organization first identifies environmental aspects of its
operations. Environmental aspects are those items, such as air pollutants or
hazardous waste, that can have negative impacts on people and/or the
environment. An organization then determines which aspects are significant by
choosing criteria considered most important by the organization. For example, an
organization may choose worker health and safety, environmental compliance, and
cost as its criteria. Once significant environmental aspects are determined, an
organization sets objectives and targets. An objective is an overall environmental
goal (e.g., minimize use of chemical X). A target is a detailed, quantified
requirement that arises from the objectives (e.g., reduce use of chemical X by 25%
by September 2010). The final part of the planning stage is devising an action plan
for meeting the targets. This includes designating responsibilities, establishing a
schedule, and outlining clearly defined steps to meet the targets.
3. Implementation - A organization follows through with the action plan using the
necessary resources (human, financial, etc.). An important component is employee
training and awareness for all employees. Other steps in the implementation stage
include documentation, following operating procedures, and setting up internal and
external communication lines.
4. Evaluation - A company monitors its operations to evaluate whether targets are
being met. If not, the company takes corrective action.
5. Review - Top management reviews the results of the evaluation to see if the EMS
is working. Management determines whether the original environmental policy is
consistent with the organization's values. The plan is then revised to optimize the
effectiveness of the EMS. The review stage creates a loop of continuous
improvement for a company.

QMS implementing ISO standards,

How To Implement ISO 9001 (In 8 Steps)
1. Familiarize Yourself with ISO 9001.
2. Plan Everything out for Implementation.
3. Identify Responsibilities, Policies, and Objectives.
4. Develop Your Documentation.
5. Launch Your Quality Management System.
6. Review Your Performance.
7. Assess and Register for Certification.
8. Continual Improvement.
project auditing,
5
An ISO quality audit is a management tool companies use to evaluate, confirm, and
verify activities related to quality.
The ISO 9000 quality audit determines the effectiveness of an organization’s quality
management system (QMS). The results of the International Organization for
Standardization (ISO) audit assesses the quality management program. This ISO
audit scrutinizes objective evidence to determine the suitability, conformity, and
effectiveness of the elements of an organization’s Internal audits are audits that are
performed by your organization and are a self-examination of your
organization’s QMS, performed on-site. Internal audits have many benefits
including preparing your organization for external audits. The internal auditor must
be independent of the area being audited to ensure objective results. (It is
recommended to have more than one auditor to ensure no one is auditing his or her
area of responsibilities). Internal audits are an ISO 9001 requirement and they are
critical to the success of your QMS. (We offer internal audit training to ensure your
internal auditors are able to perform an effective internal audit as well as an audit
checklist to help guide your internal auditors on covering all areas of your QMS.)
Internal audits will be used to assess conformity, evaluate the effectiveness and
identify opportunities for improvement. When you perform an internal audit, you
will be able to compare your quality management system to the requirements and
understand if there are any non-conformances. This will allow you to correct your
QMS and ensure that your organization will meet the requirements for the external
auditor and allow for certification.
StandardStores offers several online training courses for Internal Auditors. Learn
more about the training options that are available here, or check out these products
available for download:
 ISO 9001:2015 Internal Auditor Training Options
 ISO 9001:2015 Online Internal Auditor Training
 ISO 9001:2015 Internal Auditor Training Material
External audits include customer, supplier, certification and surveillance. A
customer audit is where an existing, or potential customer, audits your organization
to verify you can or are meeting their requirements. If you are auditing an existing
or potential supplier, we consider this a supplier audit. Supplier audits can be one of
the methods used to meet the requirements around control of external providers (ISO
9001:2015 8.4).
A certification audit is an audit your selected registrar will conduct to verify
conformance against the ISO 9001 standard before they issue your official ISO 9001
certificate. Certification audits are most often broken into two stages. Stage one audit
is performed to determine an organization’s readiness for stage two of the audit.
Stage one is oftentimes conducted remotely in order to not spend additional costs on
travel. If the auditor determines you meet the minimum criteria for the stage one
6
audit, your organization will proceed with the stage two audit. Stage two audits will
always be on-site audits. This is where the auditor will interview your staff and
review your documented information (procedures, records, etc.) to verify you are
meeting all the ISO 9001 requirements. Certification audits are typically conducted
every three years.
After certification, your registrar will check-up on your periodically using
surveillance audits to verify you are still upholding your QMS and the ISO
requirements. Surveillance audits are very much like certification audits, with the
exception that they are not issuing or re-issuing a certificate. These are typically
conducted by your registrar annually.
 How did auditing change under the latest revision of ISO 9001?
The most significant changes between the ISO 9001:2008 and 2015 standard include
the concepts of risk-based thinking, context of the organization and new Leadership
requirements. You can expect that your auditor will be looking to see that you meet
these requirements just the same as they will be confirming you meet all the other
requirements. This is why it is important when you are beginning your journey
towards ISO 9001:2015 certification that you have a gap analysis performed to
identify any potential nonconformities you may have in these areas so that you can
address these gaps before your certification audit.
Key tools for audit implementation:

Training for project quality systems approach,

ISO 9001 has requirements for training which includes that all employees
understand how their role relates to the performance of the QMS and its relevance
to them.
 Train the ISO 9001 Project Manager & Team Leaders
Having your project manager trained on ISO 9001 and implementation will
result in a more effective and efficient system and implementation process.
 Train All Employees
Meet the requirements and train ALL employees on ISO 9001. Anxiety is
caused by not knowing what is going on. They need an awareness of:
 What is ISO 9001 and why is your organization doing this?
 How it impacts their job and how they can impact quality?
 What opportunities there are for them to help?
 Train your Teams
 Task team members will need to understand the standard in more detail to
do their job correctly.
 Train Internal Auditors
 Your team of Internal Auditors will need an understanding of ISO 9001 and
on ISO 9001 Internal Auditing.
7
Process based approach of quality assurance,
A process approach means an organization manages their business as a system of
processes – not departments or people or products. This works because if you have
a good process, you’ll have good results. Think about making cookies – if you
follow a proven recipe (series of processes), it will provide good cookies (output).
The interactions (the inputs and outputs that tie the processes together) between these
processes is important. If you look at the simplified diagram below, the output of
one process is the input of another process, which stresses the importance
of not treating each process as an individual silo (department, job, etc). Each process
needs to ensure it delivers (outputs) what the next process needs (inputs).

ISO
9001 promotes the process approach to managing an organization, and examines
over 20 processes in its scope, including the entire Quality Management System
(QMS) working as a process. Thus, you must document how you’re going to address
these processes and (procedures are a good way to do that). ISO 9001 introduces the
term process approach in the Introduction, and is again addressed in the
section Leadership, stating that managers need to promote the process approach.
1. What are processes, inputs and outputs?
Every organization is made up of a series of interacting processes. A process is a set
of activities that uses resources (people, machines, etc.) to transform inputs into
outputs.

8
As a process approach can often become a complex system with too many processes,
inputs and outputs we recommend using a diagram or flowchart to allow you to
better visualize the input-output relationship
The ISO 9001 Standard is designed to manage and improve processes.
2. First, you identify your key processes.
3. Second, you define standards for those processes.
4. Third, you decide how the process will be measured and evaluated.
5. Fourth, you document your approach to achieving the desired quality, as
determined by your measurements.
6. Fifth, you continuously improve.
Once these are identified, an organization can ensure its processes are effective (the
right process is followed the first time), and efficient (continually improved to ensure
processes use the least amount of resources).
The effectiveness of the entire system is determined by the effectiveness of each
process and the interactivity of these processes within the system. By
establishing quality objectives and auditing how effectively the processes fulfill
those objectives, an organization can determine whether the processes add value or
need to be improved. Using the Process Approach while designing and developing
a quality management system enables this to happen.
A QMS using the process approach (guided by standards) can meet their customers’
(internal or external) requirements and continual improvement in:
 The organization’s’ overall function- the series of processes
 Processes – the conversion of inputs into output
 Results – Products and services resulting from processes
 Quality – fulfilling requirements/objectives
 Environment – preventing pollution and waste to improve the new bottom-line
 Safety removing unacceptable risks for the people supporting the processes
The Process Approach approach enables the organization to meet customer
requirements and deliver continual improvement.
Role of project assurance teams,
Quality assurance and quality control ensure that your products or services meet
your customers' expectations. A quality assurance team conducts activities that
validate quality requirements. This typically involves planning, observation and
inspection. Building a reliable quality assurance team involves establishing
policies and procedures, defining job descriptions and recruiting talented team
members to perform tasks.
1. Planning Quality Assurance
Before you implement a quality assurance program, you need to create a plan. Your
plan should identify the standards, tools, acceptance criteria and outcomes
necessary to produce quality products and services. Your plan should also describe
9
 training programs that introduce the concepts to the rest of your organization and
create a sense of excitement and urgency around them. Otherwise, your employees
may not take quality assurance seriously and view it as just extra work.
2. Recruiting Team Members
Recruiting team members starts with writing clear, crisp job descriptions that
stipulate candidate characteristics and typical job tasks. First define the skills and
experience required. For example, according to the U.S. Bureau of Labor Statistics,
quality control inspectors usually require dexterity, math skills, mechanical skills,
physical stamina and strength, and technical skills. Quality assurance team
members typically have a high school diploma or equivalent.
Next, define the job tasks. Your job descriptions should also set expectations about
the roles of your team members. For example, depending on the intricacy of your
environment and product or service development operations, you may want to
develop a responsibility matrix to define who has accountability for each part of
your quality assurance process. If your quality control procedures involve
analyzing results from laboratory or technical data, you might also require that
team members possess superior analytical ability.
3. Documenting Processes
To monitor effectiveness, create a quality assurance framework that ensures you
meet requirements defined for a product or service. This typically involves
documenting standards and defining the nature and frequency of your reporting
mechanisms. Implementation of a quality assurance team allows your business to
analyze errors and improve them before these problems reach your customers and
hurt their satisfaction, loyalty and chance of repurchase. The quality assurance
framework should also be flexible enough adapt to changes in scope, constraints
and assumptions.
4. Monitoring Progress
Your quality assurance team’s success depends on monitoring outcomes
accurately. Large or complex projects may require special attention, such as expert
third-party consultants or additional policies and procedures. For example,
monitoring customer satisfaction with your products or services may involve
establishing a service-level agreement with clients before work is performed.
Afterward, it includes conducting surveys to get input on experiences, analyzing
results to identify problems and remedying issues as they occur. Quality assurance
functions shouldn’t be perceived as an extra task; they must be integral to your
business operations.
Principles of TQM,
 Customer focus. Central to all successful TQM systems is an understanding that
quality is determined by the customer. ...
 Employee involvement. ...
10
 Centred on process. ...
 Integrated system. ...
 Strategic & systematic approach. ...
 Decision-making based on facts. ...
 Communication. ...
 Continuous improvement.
PDCA cycle of improvement,
Variations: plan-do-study-act (PDSA) cycle, Deming cycle, Shewhart
cycle. Understand the evolution of these variations.
The Plan-do-check-act cycle (Figure 1) is a four-step model for carrying out change.
Just as a circle has no end, the PDCA cycle should be repeated again and again
for continuous improvement. The PDCA cycle is considered a project planning tool.

Figure 1: Plan-do-check-act cycle

QFD,
 Introduction to Quality Function Deployment (QFD)
The average consumer today has a multitude of options available to select from for
similar products and services. Most consumers make their selection based upon a
general perception of quality or value. Consumers typically want “the most bang for
their buck”. In order to remain competitive, organizations must determine what is
driving the consumer’s perception of value or quality in a product or service. They must
define which characteristics of the products such as reliability, styling or performance
form the customer’s perception of quality and value. Many successful organizations
gather and integrate the Voice of the Customer (VOC) into the design and manufacture
of their products. They actively design quality and customer perceived value into their
products and services. These companies are utilizing a structured process to define their
customer’s wants and needs and transforming them into specific product designs and
process plans to produce products that satisfy the customer’s needs. The process or tool
they are using is called Quality Function Deployment (QFD).
 What is Quality Function Deployment (QFD)
Quality Function Deployment (QFD) is a process and set of tools used to effectively
define customer requirements and convert them into detailed engineering specifications

11
and plans to produce the products that fulfill those requirements. QFD is used to
translate customer requirements (or VOC) into measureable design targets and drive
them from the assembly level down through the sub-assembly, component and
production process levels. QFD methodology provides a defined set of matrices utilized
to facilitate this progression.
QFD was first developed in Japan by Yoji Akao in the late 1960s while working for
Mitsubishi’s shipyard. It was later adopted by other companies including Toyota and its
supply chain. In the early 1980s, QFD was introduced in the United States mainly by
the big three automotive companies and a few electronics manufacturers. Acceptance
and growth of the use of QFD in the US was initially rather slow but has since gained
popularity and is currently being used in manufacturing, healthcare and service
organizations.
 Why Implement Quality Function Deployment (QFD)
Effective communication is one of the most important and impactful aspects of any
organization’s success. QFD methodology effectively communicates customer needs to
multiple business operations throughout the organization including design, quality,
manufacturing, production, marketing and sales. This effective communication of the
Voice of the Customer allows the entire organization to work together and produce
products with high levels of customer perceived value. There are several additional
benefits to using Quality Function Deployment:
 Customer Focused: QFD methodology places the emphasis on the wants and needs
of the customer, not on what the company may believe the customer wants. The
Voice of the Customer is translated into technical design specifications. During
the QFD process, design specifications are driven down from machine level to
system, sub-system and component level requirements. Finally, the design
specifications are controlled throughout the production and assembly processes to
assure the customer needs are met.
 VOC Competitor Analysis: The QFD “House of Quality” tool allows for direct
comparison of how your design or product stacks up to the competition in meeting
the VOC. This quick analysis can be beneficial in making design decisions that
could place you ahead of the pack.
 Shorter Development Time and Lower Cost: QFD reduces the likelihood of late
design changes by focusing on product features and improvements based on
customer requirements. Effective QFD methodology prevents valuable project
time and resources from being wasted on development of non-value added features
or functions.
 Structure and Documentation: QFD provides a structured method and tools for
recording decisions made and lessons learned during the product development
process. This knowledge base can serve as a historical record that can be utilized
to aid future projects.
12
Companies must bring new and improved products to market that meet the customer’s
actual wants and needs while reducing development time. QFD methodology is for
organizations committed to listening to the Voice of the Customer and meeting their
needs.
 How to Implement Quality Function Deployment (QFD)
The Quality Function Deployment methodology is a 4-phase process that encompasses
activities throughout the product development cycle. A series of matrices are utilized
at each phase to translate the Voice of the Customer to design requirements for each
system, sub-system and component. The four phases of QFD are:
1. Product Definition: The Product Definition Phase begins with collection of VOC
and translating the customer wants and needs into product specifications. It may
also involve a competitive analysis to evaluate how effectively the competitor’s
product fulfills the customer wants and needs. The initial design concept is based
on the particular product performance requirements and specifications.
2. Product Development: During the Product Development Phase, the critical parts
and assemblies are identified. The critical product characteristics are cascaded
down and translated to critical or key part and assembly characteristics or
specifications. The functional requirements or specifications are then defined for
each functional level.
3. Process Development: During the Process Development Phase, the manufacturing
and assembly processes are designed based on product and component
specifications. The process flow is developed and the critical process
characteristics are identified.
4. Process Quality Control: Prior to production launch, the QFD process identifies
critical part and process characteristics. Process parameters are determined and
appropriate process controls are developed and implemented. In addition, any
inspection and test specifications are developed. Full production begins upon
completion of process capability studies during the pilot build.
Effective use of QFD requires team participation and discipline inherent in the practice
of QFD, which has proven to be an excellent team-building experience.
 Level 1 QFD
The House of Quality is an effective tool used to translate the customer wants and needs
into product or service design characteristics utilizing a relationship matrix. It is usually
the first matrix used in the QFD process. The House of Quality demonstrates the
relationship between the customer wants or “Whats” and the design parameters or
“Hows”. The matrix is data intensive and allows the team to capture a large amount of
information in one place. The matrix earned the name “House of Quality” due to its
structure resembling that of a house. A cross-functional team possessing thorough
knowledge of the product, the Voice of the Customer and the company’s capabilities,

13
should complete the matrix. The different sections of the matrix and a brief description
of each are listed below:
 “Whats”: This is usually the first section to be completed. This column is where
the VOC, or the wants and needs, of the customer are listed.
 Importance Factor: The team should rate each of the functions based on their level
of importance to the customer. In many cases, a scale of 1 to 5 is used with 5
representing the highest level of importance.
 “Hows” or Ceiling: Contains the design features and technical requirements the
product will need to align with the VOC.
 Body or Main Room: Within the main body or room of the house of quality the
“Hows” are ranked according to their correlation or effectiveness of fulfilling each
of the “Whats”. The ranking system used is a set of symbols indicating either a
strong, moderate or a weak correlation. A blank box would represent no
correlation or influence on meeting the “What”, or customer requirement. Each of
the symbols represents a numerical value of 0, 1, 3 or 9.
 Roof: This matrix is used to indicate how the design requirements interact with
each other. The interrelationships are ratings that range from a strong positive
interaction (++) to a strong negative interaction (–) with a blank box indicating no
interrelationship.
 Competitor Comparison: This section visualizes a comparison of the competitor’s
product in regards to fulfilling the “Whats”. In many cases, a scale of 1 to 5 is used
for the ranking, with 5 representing the highest level of customer satisfaction. This
section should be completed using direct feedback from customer surveys or other
means of data collection.
 Relative Importance: This section contains the results of calculating the total of
the sums of each column when multiplied by the importance factor. The numerical
values are represented as discrete numbers or percentages of the total. The data is
useful for ranking each of the “Hows” and determining where to allocate the most
resources.
 Lower Level / Foundation: This section lists more specific target values for
technical specifications relating to the “Hows” used to satisfy VOC.
Upon completion of the House of Quality, the technical requirements derived from the
VOC can then be deployed to the appropriate teams within the organization and
populated into the Level 2 QFDs for more detailed analysis. This is the first step in
driving the VOC throughout the product or process design process.
 Level 2 QFD
The Level 2 QFD matrix is a used during the Design Development Phase. Using the
Level 2 QFD, the team can discover which of the assemblies, systems, sub-systems and
components have the most impact on meeting the product design requirements and
identify key design characteristics. The information produced from performing a Level
14
2 QFD is often used as a direct input to the Design Failure Mode and Effects Analysis
(DFMEA) process. Level 2 QFDs may be developed at the following levels:
 System Level: The technical specifications and functional requirements or “Hows”
identified and prioritized within The House of Quality become the “Whats” for the
system level QFD. They are then evaluated according to which of the systems or
assemblies they impact. Any systems deemed critical would then progress to a
sub-system QFD.
 Sub-system Level: The requirements cascaded down from the system level are re-
defined to align with how the sub-system contributes to the system meeting its
functional requirements. This information then becomes the “Whats” for the QFD
and the components and other possible “Hows” are listed and ranked to determine
the critical components. The components deemed critical would then require
progression to a component level QFD.
 Component Level: The component level QFD is extremely helpful in identifying
the key and critical characteristics or features that can be detailed on the drawings.
The key or critical characteristics then flow down into the Level 3 QFD activities
for use in designing the process. For purchased components, this information is
valuable for communicating key and critical characteristics to suppliers during
sourcing negotiations and as an input to the Production Part Approval Process
(PPAP) submission.
 Level 3 QFD
The Level 3 QFD is used during the Process Development Phase where we examine
which of the processes or process steps have any correlation to meeting the component
or part specifications. In the Level 3 QFD matrix, the “Whats” are the component part
technical specifications and the “Hows” are the manufacturing processes or process
steps involved in producing the part. The matrix highlights which of the processes or
process steps have the most impact on meeting the part specifications. This information
allows the production and quality teams to focus on the Critical to Quality (CTQ)
processes, which flow down into the Level 4 QFD for further examination.
 Level 4 QFD
The Level 4 QFD is not utilized as often as the previous three. Within the Level 4 QFD
matrix, the team should list all the critical processes or process characteristics in the
“Whats” column on the left and then determine the “Hows” for assuring quality parts
are produced and list them across the top of the matrix. Through ranking of the
interactions of the “Whats” and the “Hows”, the team can determine which controls
could be most useful and develop quality targets for each. This information may also be
used for creating Work Instructions, Inspection Sheets or as an input to Control Plans.
The purpose of Quality Function Deployment is not to replace an organization’s existing
design process but rather support and improve an organization’s design process. QFD
methodology is a systemic, proven means of embedding the Voice of the Customer into
15
both the design and production process. QFD is a method of ensuring customer
requirements are accurately translated into relevant technical specifications from
product definition to product design, process development and implementation. The fact
is that every business, organization and industry has customers. Meeting the customer’s
needs is critical to success. Implementing QFD methodology can enable you to drive
the voice of your customers throughout your processes to increase your ability to satisfy
or even excite your customers.

QFD + House of Quality Example

 Learn More About Quality Function Deployment (QFD)
Quality-One offers Quality and Reliability Support for Product and Process
Development through Consulting, Training and Project Support. Quality-One provides
Knowledge, Guidance and Direction in Quality and Reliability activities, tailored to
your unique wants, needs and desires. Let us help you Discover the Value of QFD
Consulting, QFD Training or QFD Project Support
Deming wheel.
Definition of Deming Cycle, PDCA:

16
 Never-ending improvement is the heart of any continuous improvement effort. The
Deming Cycle, or PDCA, is one of the first formalized approaches to utilize an
iterative approach to improving processes, and it still serves as a fundamental tool
today for continuous improvement.
This article will describe the stages of the Deming Cycle, the benefits of using the
PDCA approach to improvement, an example of how it can be applied, and some
best practices for successful use of the method for improving your processes.
 Overview: What is the Deming Cycle (or PDCA)?
The Deming Cycle (or Plan-Do-Check-Act (PDCA)) is a four-step iterative
technique used to solve problems and to improve organizational processes. Dr.
Walter A. Shewhart, the renowned physicist and statistician from Western Electric
and Bell Labs, developed the original concept during the 1920s. His approach was a
three-step linear problem-solving method.
Dr. W. Edwards Deming, the famous quality-control pioneer and author
of Deming’s 14 Points, popularized the technique in the 1950s and took Shewhart’s
linear three-step process and revised it to be the iterative four-step circle and cycle
we know today. This then became known as the Deming Cycle.
So, what is PDCA and the Deming Cycle?
 Plan: In this step, you investigate the current situation in order to fully understand
the nature of the problem being solved. Be sure that you develop a plan and a
framework to work from, and specify the desired outcomes and results.
 Do: To identify the real problem by analyzing the data and defining and
implementing a solution plan. The PDCA cycle focuses on smaller, incremental
changes that help improve processes with minimal disruption. You should start with
a small-scale pilot so as not to disrupt the organization should the solution not work
as expected.
 Check: To monitor the effect of the implementation plan and find countermeasures
if necessary to further improve the solution. You should do a check during
implementation to make sure that the project’s objectives are being met. Do a second
check upon completion to allow for successes and failures to be addressed, and for
future adjustments to be made based on lessons learned.
 Act: Implement your solutions and recommendations. Decide if the solution is
effective, and either integrate it into standard work practices or abandon it. If you
abandon it, you should ask what you’ve learned from the process and restart the
cycle.
 3 benefits of the Deming Cycle
PDCA has been used for many decades because of its many benefits. Some of those
are:
1. Facilitates continuous improvement: The fact that PDCA is an iterative cycle
encourages users to pursue ongoing and continuous improvement. The key is that it
17
 requires a commitment from leadership because the Deming Cycle is not a one-time
event.
2. Flexibility: The Deming Cycle can be used for a wide array of organizational
processes regardless of the function.
3. Simple yet powerful: The concept and the steps are easy to understand. The tools
needed are basic. Yet, the outcomes and solutions coming from PDCA can have a
significant impact on the organization.
 Why is the Deming Cycle important to understand?
Not only are the Deming Cycle and PDCA important to understand, they are also
important to implement and deploy in an organization.
1. Organizations and leaders must understand that all processes can be improved.
PDCA is a great tool for starting on the journey to continuous improvement.
2. The Deming Cycle is a well documented and proven methodology. There is no need
to start from scratch and reinvent the wheel when an effective solution already exists.
3. With this method, change can be quick and solutions implemented in a timely
fashion so that your organization can see benefits right away.
 An industry example of the Deming Cycle
One of the benefits of the Deming Cycle is the versatility of the process. It can be
used in any number of functional areas. For example, a large manufacturing
company started to experience an increase in reported eye injuries by forklift
operators in their warehouse operation. They used PDCA to identify potential root
causes, and the obvious recommendations to wear appropriate eye protection were
the first implemented solutions.
Unfortunately, eye injuries continued despite better compliance. The company
completed a second round of PDCA with the conclusion that the standard eye
protection didn’t properly fit everyone. A third go at the Deming Cycle found that
debris was being dislodged from the racks when the forklift operators pulled off
pallets of product. It was recommended that plastic shields be placed on the top of
the forklift to catch the debris.
Finally, a fourth round of the Deming Cycle concluded that an ongoing cleaning
operation to remove and prevent debris from accumulating on the rack shelves was
the only way to remove the true root cause. The problem was solved, and eye injuries
disappeared.
 4 best practices when thinking about the Deming Cycle
Even though the use of the Deming Cycle seems simple at first glance, there are a
number of things you should be aware of to increase the probability of success of
your PDCA effort.
1. Be sure you have the support of not only senior leadership but the local leadership
and process owner. While PDCA can be used at the local level, the synergy of having

18
 participation and support across the entire organization will result in a more efficient
and effective process.
2. Identify and recruit the best members you can for participation in the project.
3. Stay focused and on task.
4. Try to gather as much data as is practical, and use the data to help drive your
recommendations rather than just pure subjective hunches.
 Frequently Asked Questions (FAQ) about the Deming Cycle
1. What is the Deming Cycle?
The Deming Cycle, otherwise known as PDCA, is a four-step iterative process for
solving problems and improving processes.
2. Who developed the PDCA methodology?
Dr. Walter A. Shewhart developed the original concept of an improvement process
based on Scientific Management. Dr. W. Edwards Deming popularized the concept
of an improvement method but added the all-important need for an iterative approach
and coined the term PDCA, which stands for Plan – Do – Check – Act
3. What is the difference between PDCA and PDSA?
Dr. W. Edwards Deming revised the original term PDCA to PDSA because he felt
that the use of Check was too closely aligned with the concept of inspection and
success/failure. He felt that using the letter S for Study would put more emphasis on
data and learning rather than just success and failure.
 Wrapping it up: Deming Cycle and PDCA
The Deming Cycle (or PDCA) is a simple, four-step iterative process that any
organization can use to solve problems and improve business processes. By
following the sequence of Plan – Do – Check – Act, your company can enjoy the
benefits of creating a continuous improvement mindset while producing better
products, delivering better service and providing a way for employees to engage and
participate in making the organization a better place to work.

19