LECNOTE 5

References: blog.capterra.com
leankit.com
asq.org

What is a Quality Management System?

A Quality Management System (QMS) is defined as a formalized system that documents processes, procedures, and
responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s
activities to meet customer and regulatory requirements and improve its effectiveness and its efficiency on a continuous
basis.
ISO 9001:2015, the international standard specifying requirements for quality management systems, is the most
prominent approach to quality management systems.
Quality Management Systems serve many purposes, including:
 Improving processes
 Reducing waste
 Lowering costs
 Facilitating and identifying training opportunities
 Engaging staff
 Setting organization-wide direction

Benefits of Quality Management Systems

Implementing quality management system affects every aspect of an organization’s performance. Benefits of
documented quality management system include:
 Meeting the customer’s requirements which help to instill confidence in the organization, in turn leading to
more customers, more sales, and more repeat business.
 Meeting the organization’s requirements which ensure compliance with regulations and provision of products
and services in the most cost-and resource-efficient manner, creating room for expansion, growth, and profit.

Elements and Requirements of a Quality Management System

Each element of a QMS helps achieve the overall goals of meeting the customers’ and organization’s requirements.
QMS should address an organization’s unique needs;
 The organization’s quality policy and quality objectives
 Quality manual
 Procedures, instructions, and records
 Data management
 Internal processes
 Customer satisfaction from product quality
 Improvement and opportunities
 Quality analysis

Establishing and Implementing a Quality Management System

Before establishing a QMS, the organization must identify and manage various connected multi-functional processes to
help ensure customer satisfaction. The QMS design should be influenced by the organization’s varying objectives,
needs, and products and service provided. This structure is based largely on the Plan-Do-Check-Act (PDCA Cycle) and
allow for a continuous improvement to both the product and the QMS. The basic steps to implementing a QMS are as
follows:
1. Design
2. Build
3. Deploy
4. Control
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 5. Measure
6. Review
7. Improve
Design and Build.
The design and build portions serve to develop the structure of a QMS, its processes, and plans for
implementation. Senior management should oversee this portion to ensure the needs of the organization and
the needs of its customers are a driving force behind the systems development.
Deploy
Deployment is best served in a granular fashion by breaking each process down into subprocesses and
educating staff on documentation, education, training tools, and metrics. Company intranets are increasingly
being used to assist in the deployment of QMS.
Control and Measure
Control and measurement are two areas of establishing a QMS that are largely accomplished through
routine, systematic audits of the QMS. The specifics vary greatly form organization to organization depending
on size, potential risk, and environmental impact.
Review and Improve
Review and improve detail how the results of an audit are handled. The goals are to determine the
effectiveness and efficiency of each processes toward its objectives, to communicate these findings to the
employees, and to develop new best practices and processes based on the data collected during the audit.

3 Popular TQM Processes

1. ISO 9000: Focuses on people
ISO 9000 – first published in 1987 by the International Organization for Standardization – encompasses an entire
family of quality management system standards.
ISO 9000 is based on seven quality management principles:
A. Customer Focus. Companies should focus first and foremost on meeting customer expectations.
B. Leadership. Good leaders are necessary to maintain the right internal environment and drive
companies toward their objectives.
C. Engagement of people. Employees must be empowered to take full advantage of their abilities.
D. Process-centric. All activities and resources should be managed as a system-wide process.
E. Improvement. Companies must continuously and actively seek improvement.
F. Evidence-based-decision-making. Decisions should be based on analyzed data.
G. Relationship management. Companies should maintain healthy and mutually beneficial relationships
with suppliers, contractors, and service providers.
*While ISO 9000 shares many of TQM’s principles, it focuses more on leadership in an organization and people
management. This process is used when the operation needs better leadership.
2. Lean Manufacturing: Focuses on waste
Lean manufacturing is a systematic method of eliminating waste and inefficiency within manufacturing while
continuing to produce products at the same (or even higher) level.
Lean manufacturing seeks to identify things that add value, as well as those that don’t, so the latter can be
eliminated.
Lean manufacturing focuses on seven types of waste:
A. Transport: Moving around things that aren’t necessary for production.
B. Inventory: Anything that isn’t involved in production.
C. Motion: People or equipment moving more than is required for production.
D. Waiting: Inactivity before the next production step.
E. Overproduction: Producing more than is required.

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 F. Overprocessing: Using more activity than is necessary to produce the end product.
G. Defects: Expending too much effort fixing problems with the finished product.
*Lean manufacturing focuses more on identifying inefficiencies in the manufacturing process, rather than promoting
an organization-wide focus on quality management. This process is used when the production inefficiencies are
decreasing the revenue.

7S Lean Workplace Methodology

1. SORT
Organization – keeping only what is necessary and discarding everything else – when in doubt, throw it out.
2. SET IN ORDER
Orderliness – arranging and label only necessary items for easy use and return by anyone.
3. SHINE
Cleanliness – keeping everything swept and clean for inspection – for safety and preventive maintenance.
4. STANDARDIZE
Standardized Cleanup – the state that exists when the first three pillars of “S’s” are properly maintained.
5. SUSTAIN
Sustaining the Discipline – making a habit of properly maintaining correct procedures.
6. SAFETY
Accident Prevention – awareness of all activities to identify and eliminate hazards for a zero accident and
injury-free workplace.
7. SPIRIT
Reliance on the people factor.

3. Six Sigma: Focuses on process.

Six Sigma developed in the 1980s at Motorola is a set of techniques for improving on processes in an
organization. This method aims to improve product quality by identifying and eliminating variability that can
cause defects.
The name Six Sigma is derived from the sigma rating system for the proportion of defects to total products
created, with six sigma being the very best possible.
Two Methodologies for Six Sigma
DMAIC
1. Define the system. Figure out what the customer wants.
2. Measure key aspects of the current process. Collect the data.
3. Analyze the data. Determine the cause of a defect.
4. Improve the current process. Create a new future state process.
5. Control the future state process. Put control systems in place and constantly monitor the process.
DMADV
1. Define design goals. Figure out what the customer wants.
2. Measure and identify characteristics that are critical to quality. Collect the data.
3. Analyze the data. Figure out how to develop and design alternatives.
4. Design and improve alternative. Fix the problem.
5. Verify the design. Implement the production process and then monitor it.

*Six Sigma focuses more on the manufacturing process rather than taking a holistic view of the organization.

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