Understanding Quality Management Systems
Understanding Quality Management Systems
A quality management system (QMS) is a formalized system that defines and documents an
organization’s processes, procedures, and responsibilities for achieving quality policies,
practices, and objectives. It helps an organization coordinate and direct its activities to meet
customer and regulatory requirements, as well as continuously improve its effectiveness and
efficiency.
WHAT ARE THE BENEFITS OF A QMS?
Meeting customer requirements, which helps instill confidence in the organization, in turn leading to more customers, sales,
and repeat business
Meeting the organization's requirements, which ensures compliance with applicable regulations and provides products and
services in the most cost and resource-efficient manner, creating room for expansion, growth, and profit
Each element of a QMS helps achieve the overall goal of meeting customer and
organizational requirements. A QMS should address an organization’s unique needs, but
many of the QMS systems have common expectations, including:
● Leadership
● Planning, commitment, and review
● The system spans the breadth of the organization
● Metrics and feedback
● Communication, education, and training
● Risk management
● Teamwork
● Compliance to requirements
● Continuous improvement
IMPLEMENTATION OF QMS
Every organization has its own culture, which influences which QMS methods are most efficient and effective.
Instead of developing a QMS by addressing each expectation described in a selected model, organizations should
outline the approaches currently in use for managing quality and meeting customer expectations.
A basic model for gathering customer expectations can be structured in the following four steps: plan your customer
data system, gather customer data, understand the data, and deploy (make use of) the data.
Next, map those approaches against the appropriate QMS framework or model. For each identified gap, the
organization should determine whether it would benefit from addressing the opportunity, and must clearly
understand the potential benefit before implementing any changes.
The QMS design should be influenced by the organization’s objectives, needs, products, and services. This structure
is based largely on the plan-do-check-act cycle and allows for continuous improvement to the product and QMS.
● Management review
● Document development and control
● Monitoring, analysis and review
● Internal audit
● Training
● Continual improvement (Corrective and Preventive Actions)
What is required to ensure effective integrated management systems?
To ensure effective systems, the following functions must be performed:
Risk Assessment- this should address customer perceptions, health & safety risks, environmental
concerns & impacts and process failure modes. By having a common approach it will be easier to
compare risks occurring in different parts of the business.
Norms & Regulations Management - to capture norms and regulations with respect to product
specifications, environment and health & safety and their impacts on the business.
Continual Improvement Management - this should focus on specific improvement programmes related
to quality, health & safety and environment.
Stakeholders Awareness - this should address needs of both customers, staff and general public with
respect to quality, health & safety and environment
What is the best approach to take?
Whether an organisation has an existing formal system or not, it is best to adopt the business process
approach to management system development. The benefits are that one coherent system can be
built which serves business needs and does not tie the organisation to a particular standard. The
standards are used to assist identify tasks and processes. This approach starts by looking at the
business as a whole and establishing its objectives, mission and core processes which deliver the
objectives and achieve this mission.
What types of systems can be integrated?
All systems relevant to the business, whether certifiable or otherwise, can be
included. These could include: Quality (ISO 9001); Environment (ISO 14001);
Occupational Health & Safety (ISO 45001 & BS 8800); Food Safety & Hazard
Analysis Critical Control Points (HACCP); Ethical Trading Practices (SA
8000); Social & Ethical Accounting, Auditing and Reporting (AA 1000);
Investor in People (IIP); Law Society Practice Management Standard
(LEXCEL), European Directives and CE Markings; Information Security (BS
7799); Quality System Requirements for Automotive Industry Suppliers
(ISO/TS 16949 & QS 9000); Quality System Requirements for
Telecommunications Industry Suppliers (TL 9000); and Business Excellence
Model (BEM).
Why should management systems be integrated?
Organizations that benchmark, adapt the process to best fit their own needs and culture.
Although the number of steps in the process may vary from organization to organization,
the following six steps contain the core techniques.
1. Decide what to benchmark.
2. Understand current performance.
3. Plan.
4. Study others.
5. Learn from the data.
6. Use the findings.
Pitfalls and Criticisms of Benchmarking
1. The most persistent criticism of benchmarking comes from the idea of copying
others. How can an organization be truly superior if it does not innovate to get
ahead of?
1. Strategic Benchmarking
2. Performance Benchmarking or Competitive Benchmarking
3. Process Benchmarking
4. Functional Benchmarking or Generic Benchmarking
5. Internal Benchmarking
6. External Benchmarking
7. International Benchmarking
Benefits of Benchmarking
● Step changes in performance and innovation;
● Improving quality and productivity; and
● Improving performance measurement.
● Raised awareness about performance and greater openness about relative strengths and
weaknesses;
● Learning from others and greater confidence in developing and applying new approaches;
● greater involvement and motivation of staff in change programmes;
● Increase in willingness to share solutions to common problems and build consensus about what is
needed to accommodate changes;
● Better understanding of the ëbig pictureí and gaining a broader perspective of the interplay of the
factors (or enablers) that facilitate the implementation of good practice; and
● Increasing collaboration and understanding of the interactions within and between organisations.
Quality Function Deployment
● Dr. Mizuno, professor emeritus of the Tokyo Institute of Technology, is credited with initiating the
quality function deployment (QFD) system.
● The first application of QFD was at Mitsubishi, Heavy Industries, Ltd., in the Kobe Shipyard, Japan,
in 1972.
● After four years of case study development, refinement, and training. QFD was successfully
implemented in the production of mini-vans by Toyota.
● Using 1977 as a base, a 20% reduction in startup costs was reported in the launch of the new van
in October 1979, a 38% reduction by November 1982, and a cumulative 61% reduction by April
1984.
● Quality function deployment was first introduced in the United States in 1984 by Dr. Clausing of
Xerox.
● QFD can be applied to practically any manufacturing or service industry. It has become a standard
practice by most leading organizations, who also require it of their suppliers.
Quality Function Deployment
Quality Function Deployment
# Food for thought
Imagine that two engineers are working on two different components of a car sunroof simultaneously but separately. The
‘insulation and sealing’ engineer develops a new seal that will keep out rain, even during a blinding rainstorm. The
‘handles, knobs and levers’ engineer is working on a simpler lever that will make the roof easier to open. The new lever is
tested and works well with the old seal. Neither engineer is aware of the activities of the other. As it turns out, the
combination of heavier roof (due to the increased insulation) and lighter lever means that the driver can no longer open the
sunroof with one hand, thereby violating a quality characteristic expected by the consumer. It is hoped that the problem will
be detected in prototype testing before the car is put into production. At that point, one or both component will need to be
redesigned. Otherwise, cars already produced will need to be reworked and cars already sold, will have to be recalled.
None of these alternatives is pleasant, they all involve considerable costs.
Shared Information: design project knows the design objectives and is aware of the inter-relationships of the
various parts of the design.
What is QFD and why is it used?
Definition of QFD
Quality Function Deployment may be defined as a system for translating consumer
requirements into appropriated company requirements at every stage, from research
through product design and development, to manufacture, distribution, installation and
marketing, sales and service.
In simpler terms……
It is a structured process is needed that will translate the ‘voice of the customer’ to
technical requirements at every stage of design and manufacture. Such a process is
called Quality Function Deployment (QFD).
Objective of QFD
To ensure that the voice of customer is common, continuous thread of information going
through all stages of the product lifecycle, from design concept, component, design, process
and manufacture through to the eventual user
Benefits of QFD
(i) Promotes better understanding of customer demands;
(ii) Promotes better understanding of design interactions;
(iii) Involves manufacturing in the design process;
(iv) Breaks down barriers between functions and departments;
(v) Focuses the design effort;
(vi) Fosters teamwork;
(vii) Improves documentation of the design and development process for product improvement
through technical benchmarking.
(viii) Increase customer satisfaction.
(ix) Reduces the number of engineering changes.
(x) Brings new design to the market faster.
(xi) Reduces the overall costs of design and manufacture.
House of Quality
Cost of Quality
Cost of quality is the amount of money a business loses because its product or service was
not done right in the first place.
A quality cost is considered to be any cost that the company would not have incurred
if the quality of the product or service were perfect.
Cost of Quality (COQ) has two main components:
1. Cost of Conformance and
2. Cost of Non-Conformance
The companies estimate quality costs for the following reasons:
a) To quantifying the size of the quality problem in the language of money improves
communication between middle managers and upper managers.
b) To identify major opportunities for cost reduction.
c) To identify the opportunities for reducing customer dissatisfaction and associated threats
to product salability.
Cost of Quality
Categories of Quality Cost
Many companies summarize quality costs into four broad categories. They are :
a) Internal failure costs - The cost associated with defects that are found prior to transfer of
the product to the customer.
b) External failure costs - The cost associated with defects that are found after product is
shipped to the customer.
c) Appraisal costs - The cost incurred in determining the degree of conformance to quality
requirement.
d) Prevention costs - The cost incurred in keeping failure and appraisal costs to a minimum.
Zero Defects
At this point it is important to define an improvement. There are five basic ways to improve: (1) reduce resources, (2) reduce errors, (3)
meet or exceed expectations of downstream customers, (4) make the process safer, and (5) make the process more satisfying to the
Kaizen
Kaizen relies heavily on a culture that
encourages suggestions by operators who
continually try to incrementally improve their job
or process.
1. Create and Publish aims of purposes of organisation: Long term goals, innovation
against obsleteness, ever evolving, family feeling
2. Learn new Philosophy: Priority, Non conformance refusal, Prevention than
Detection, all Levels involvement
3. Understand the purpose of Inspection: Mass inspection= Managing Failure, Defect
Prevention = Managing Success, Use of Statistical evidence for self and supplier
4. Stop Awarding Business Based on Price Alone: L1 without quality has no meaning,
Single Supplier, Relationships of trust and loyalty, PLM feedback to supplier
5. Improve Constantly and Forever the system:Continual Strive using Control Charts,
Responsibility to teams to remove causes
6. Institute Training:Statistical Methods Training
7. Teach and Institute Leadership: Clear Communication and Pride of workmanship
Deming's 14 Points
8. Drive out fear, so that everyone may work effectively for the company.
9. Break down barriers between departments. People in research, design, sales, and production must work as a team, to foresee
problems of production and in use that may be encountered with the product or service.
10. Eliminate slogans, exhortations, and targets for the work force asking for zero defects and new levels of productivity. Such
exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system
and thus lie beyond the power of the work force.
11a. Eliminate work standards (quotas) on the factory floor. Substitute leadership.
11b. Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute leadership.
12a. Remove barriers that rob the hourly worker of his right to pride of workmanship. The responsibility of supervisors must be
changed from sheer numbers to quality.
12b. Remove barriers that rob people in management and in engineering of their right to pride of workmanship. This means, inter alia,
abolishment of the annual or merit rating and of management by objective.
14. Put everybody in the company to work to accomplish the transformation. The transformation is everybody's job.
TPS: Decoding the DNA of the Toyota Production System
Toyota Production System (TPS), originally called “Just-in-Time production”
Its basic concept is the reduction of cost through elimination of waste and optimization of machine and human capabilities.
Only the necessary products, at the necessary time, in necessary quantities are manufactured.
Toyota has built up a system of respect for people ingrained in the TPS concept. It puts emphasis on the points as follows:
Just-in-Time and Jidoka are the main pillars of the Toyota Production System.
The main objectives of the TPS are to design out overload and inconsistency and to eliminate waste.
The most significant effects on process value delivery are achieved by designing a process capable of delivering the required
results smoothly, by minimizing inconsistency.
It is also crucial to ensure that the process is as flexible as necessary without stress or overburden since this generates waste
(e.g. waste of overproduction, waste of transportation, waste of making defective products etc.).
Pillars of TPS
● The basic philosophy of the Toyota Production System is based on two pillars. The first pillar is jidoka―which can be
loosely translated as "automation with a human touch"―based on the concepts of stopping immediately when
abnormalities are detected to prevent defective products from being produced and improving productivity to eliminate
the need for people to be simply watching over machines.
● The second pillar is Just-in-Time, based on the concept of synchronizing production processes―linking all plants and
their production processes in a continuous flow―by making only what is needed, when it is needed, and in the
amount needed.
● The term Jidoka means to make the equipment or operation stop whenever an abnormal or defective condition arises.
In short, its distinctive feature lies in the fact that when an equipment problem or machine defect happens, the
equipment or entire line stops, and any line with workers can be stopped by them.
● Just-in-Time and Jidoka are the main pillars of the Toyota Production System. The main objectives of the TPS are to
design out overload and inconsistency and to eliminate waste.
● The most significant effects on process value delivery are achieved by designing a process capable of delivering the
required results smoothly, by minimizing inconsistency. It is also crucial to ensure that the process is as flexible as
necessary without stress or overburden since this generates waste (e.g. waste of overproduction, waste of
transportation, waste of making defective products etc.).
Poka Yoke
Error Proofing
The Poka yoke devices are developed based on the answers to the following questions pertaining to a defect on a
product/part What is the defect? When is the defect discovered? What are the standard elements involved in making the
part or assembly? What mistakes or errors are made? Why are the mistakes made?
2. It is simple to install which means that it is not requiring continuous attention from the operator and it is not burdensome
for the operator. It should work even if the operator is not aware of the necessity of its action to prevent defects.
5. If a component is not having the correct shape or form, then the production process should detect it before performing
any operation on it.
Poka Yoke
Traditional kanban boards are separated into three columns named something like:
To do
Doing
Done
2. Muda, which refers to the seven classes of waste—over-production, delay, transportation, processing, inventory, wasted motion,
and defective parts.
6. The five S’s for workplace organization, which are five Japanese words that mean proper arrangement (seiko), orderliness
(seiton), personal cleanliness (seiketso), cleanup (seiso), and discipline (shitsuke).
7. Visual management by means of visual displays that everyone in the plant can use for better communications.
8. Just-in-time principles to produce only the units in the right quantities, at the right time, and with the right resources.
10. Team dynamics, which include problem solving, communication skills, and conflict resolution.
Lean Management
Six Sigma