KYAMBOGO UNIVERSITY

FACULTY OF ENGINEERING
DEPARTMENT OF MECHANICAL AND PRODUCTION ENGINEERING
BACHELOR OF ENGINEERING IN MECHANICAL AND
MANUFACTURING ENGINEERING
YEAR: IV SEMESTER: II
COURSE UNIT: RELIABILITY MAINTENANCE ENGINEERING

GROUP ASSIGNMENT

S/N NAME OF STUDENT REG NO

1. SESANGA HENRY 18/U/EME/17638/PE
2. LUBOWA SLIVEST 18/U/EME/17642/PE
3. WANYAMA DERRICK 18/U/EMD/17788/PD
4. KYALIGAMBA BRIAN 18/U/EME/17686/PE
5. KATO FALUKU 18/U/EME/17698/PE
6. SANGAALO LEONARD 17/U/8785/EME/PE

LECTURER: MR SEMPEBWA RONALD

10) Discuss the following term in relation to quality management systems requirements
a) Organization and its context
b) Leadership and commitment
c) Planning
d) Support
e) Operation
 f) Performance evaluation
g) Improvement

Definition of key terms

QUALITY MANAGEMENT SYSTEM

A quality management system (QMS) is a formalized system that documents processes,

procedures and responsibilities for achieving policies and objectives and it provides a basic cadre
to meet the customer requirements and legal requirements and improve the effectiveness and
efficiency on the continuous basis by not compromising on the productivity and loss of time.

A system comprised of quality planning and quality improvement activities, the establishment of
a set of quality policies and objectives that will act as guidelines within an organisation, and
quality assurance and quality control.

QUALITY MANAGEMENT (QC)

“A part of quality management focused on fulfilling quality requirements”. A corrective tool
focused on the quality of output.
Example: validation/software testing, inspection, peer review

An overview of ISO 9001-2015

The international organisation for standardization (ISO) is a nongovernmental organisation
whose role is to facilitate international coordination and the standardization of industrial
standard. These standards contribute to the development, manufacturing and delivery of products
and services that are more effective, safer and clearer. ISO performs systematic reviews every 3-
5 years to keep these standards up-to-date.

a) ORGANISATION AND ITS CONTEXT

When developing a quality management system (QMS). It is required to identify, analyse and
understand the business environment in which the organisation conducts. Its business and
realizes its product.
Any organisation is a combination of different business entities that relate and interact with each
other and exchange information and materials. The context of the organisation is an outline of
the interaction and integration of these business entities. It is the set of functions, factors,
processes, inputs and outputs, and conditions and limitations that create the business
environment of an organisation.

The organisation shall determine external and internal issues that are relevant to its purpose and
its strategic direction and that affect its ability to achieve the intended results of its QMS such as;

 Issues arising from technological competitive, market, culture, social and economic
environments;

 Issues related to values, culture, knowledge and performance of organisation.

 The identified needs and expectations of relevant interested parties.

 Applicable legal regulatory and other requirements to which the organisation subscribes.

Understanding and defining the organizational context

The following is the suggested process for an effective definition of the context of the
organisation.

Figure showing stages in understanding the organisation context.

PEST SWOT Identify interested

Identify internal & parties Define scope of
Analysis Analysis external issues the Q

The definition of the context of the organisation will begin with PEST (political, economic,
social, and technological factors) analysis, which will provide inputs for the strengths,
weaknesses opportunities and threats (SWOT) analysis.

SWOT analysis will define inputs for the determination of the internal and external issues will
help identifying relevant interested parties.

 Identifying interested parties will assist in defining scope of the QMs

 The scope of the QMS

PEST analysis
PEST stands for political, economic, social and technology and factors that may affect the
strategy of the organisation.

PEST analysis may be also extended to seven or even more factors, ecological (environmental),
legislative (legal) and industry analysis, which uses the name PESTELI analysis. But we will
concentrate on the four main factors.

Political factors
Political factors consists of government regulations and legal factors that can affect the business
environment issues such as political stability, trade regulations, manufacturing regulations, safety
regulations and employment laws are assessed for their influence on the QMS etc.

Economic factors
The economic factors evaluate issues that are bound on the cash flow, the business cycle, and
any critical decisions regarding the direction of the organisation for example economic growth,
unemployment rate, inflation, interest rates etc.

Economic factors
The economic factors evaluate issues that are bound on the cash flow, the business cycle and any
critical decisions regarding the direction of the organisation for example economic growth,
unemployment rate, inflation, interest rates among others.

Social factors
Social factors represent the socioeconomic environment of the markets in which the organisation
is active. For example life style trends, demographic trends, consumer attitudes and opinions
media views, image of the organisation, change in laws that affect social behaviours, ethical
issues, fashion and role models etc.

Technological factors
Examples of technological factors are competing technology development, information and
communications, consumer buying mechanisms, innovation potential, technology access, global
communication, social media use, licensing, patents.
SWOT analysis
The principle of SWOT analysis is easy to understand;
 What is good in the present and in the past is strength?
 What is bad in present and in the past is a weakness?
 What is good in the future is an opportunity?
 What is bad in the future is a threat?

Strengths
These are internal attributes and resources that support the realization of the product and the
establishment, implementation, maintenance and improvement of QMS.

Weaknesses
Weaknesses are internal attributes that may interrupt the realization of the product and may
produce a non conformity in the QMS.

Opportunities
These are factors the organisation can draw advantages from the future.

Threats
Threats may be considered as the risks the organisation faces while managing the QMS and
realizing the products or services.

b) LEADERSHIP AND COMMITMENT

The success of implementing a quality management system (QMS) depends on the commitment
of the top management. This is no secret. The leadership in all organizational levels should
create an environment that will initiate and promote conditions in which employees feel the
commitment to achieving the objectives of the organisation.

Top management shall demonstrate leadership and commitment with respect to the quality
management system by;
 Taking accountability of the effectiveness of the quality management systems.
  Ensuring that the quality policy and quality objectives are compatible with the strategic
direction and the context of the organisation.
 Ensuring the integration of the QMS requirements into the organization’s business
processes.
 Promoting awareness of the process approach
 Ensuring that the resources needed for the QMS are available;
 Ensuring that the QMS achieves its intended results;
 Engaging, directing and supporting persons to contribute to the effectiveness of the QMS
 Promoting continual improvement
 Ensuring that customer requirement and applicable statutory and regulatory requirements
are determined and met.
 Ensuring that the risk and opportunities that can affect conformity of products and
sources and the ability to enhance customer satisfaction are determined and addressed.
 Establishing, reviewing and maintaining the quality policy.
 Ensuring that the responsibilities and authorities for relevant roles are assigned,
communicated and understood within the organisation.

Practicing and demonstrating leadership

Leadership initiates unity of purpose, while establishing the direction and strategy of the
organisation. This unity of purpose creates environment and conditions that support the QMS
and in which employees become completely involved in achieving the organization’s goals and
aims and assists employees in achieving quality objectives.

Thus, the leadership shall support relevant management roles in their areas of responsibility and
promote the empowerment of people at all levels of the organisation to take relevant decisions
regarding the QMs. How?

 Empowering people at all levels of the organisation, authorizing them and delegating
responsibilities of various areas of the QMS.

 Inspiring and motivating employees to take an active part in improving QMS.

  Providing trainings needed for the development of human resources for the operation of
the QMS.

 Promoting the concept of an effective QMS and the awareness of improving the QMS.

 Recognizing contribution of employees to the QMS.

Organizational structure
The organizational structure is the definition of hierarchy in the organisation and is the most
basic definition of you QMs. The structure defines who is superior to whom and who reports to
whom. The structure will relate to the working process and scope of the QMs.

Example of organizational structure

CEO

Marketing Production Finance Research

Production Human Lab

Sales manager manager resources

Production IT
Sales team Development
employee

QA Administration

c) PLANNING

Planning in the quality management system involve the organization to consider the issues
referred in understanding the organization and its context and the requirements referred to in
understanding the needs and expectations of interested parties and determine the risks and
opportunities that need to be addressed to give the that assurance that quality management
systems can achieve its intended results so as to prevent or reduce, undesired effects and to
achieve continued improvement.

ISO 9001 requirements

• The organization shall determine which risks and opportunities may affect its ability to achieve
the intended results.
• The objectives of this determination:

1. To ensure that the quality management system (QMS) can achieve its intended results
2. To enhance desirable effects
3. To prevent or reduce adverse effects
4. To achieve improvement

• The context of the organization and the needs and expectations of interested parties (as
specified in clauses 4.1 and 4.2) shall be taken into account when considering the risks that may
affect the ability of the organization to achieve the intended results.
• Actions to address risks and opportunities shall be planned and these actions shall be integrated
into the processes of the QMS.
• The effectiveness of these actions shall be evaluated.
• The actions shall be planned in proportion to the potential effects on conformity of goods and
services and customer satisfaction.
• Note—options to address risks may include actions that avoid risks, take risks in order to
pursue an opportunity, eliminate risk sources, change the likelihood or consequences, share risks,
or retain risks by informed decisions. 68 ISO 9001:2015—A Complete Guide to Quality
Management Systems
• Note—Opportunities can lead to planning and implementation of new practices, launching
new products, opening new markets, addressing new customers, building partnerships, and using
new technology and other desirable and viable possibilities to address the organization’s or its
customers’ needs
d) SUPPORT

Resources include: human resources (people), knowledge, processes environment, and

infrastructures according to ISO standard and are one of the foundation stones of the quality
management system (QMS) and, therefore, must be defined. Outsourced activities are regarded
as external resources that must be defined and, subsequently, controlled. The resources must be
competent and its done through evaluation through measuring the compatibility of your
resources to the expectations of the QMS.
ISO 9001 requires that;
• The organization shall identify, determine, and define the required resources needed for
establishing, designing, implementing, maintaining, and improving a QMS.
• The organization shall provide these resources.
• While doing so, the organization shall assess

1. Its current process capabilities

2. • Its professional and organizational abilities and constraints
3. The conditions that limit the organization This assessment will indicate whether the
organization is able to provide these resources or not

• The organization shall decide which resources will be provided internally and which will be
provided by external providers

e) OPERATIONS

Operations is one of the major functions in an organization along with supply chain, marketing,
finance and human resources whose function requires management of both strategic and day- to-
day production of goods and services. Therefore, organizations must seek to constantly improve
its operations if it is to remain competitive and achieve its goals.
Operation is the process of transforming resources in order to create a result in form of product
or services having the requisite quality level.
Operational planning and control initiates the master planning for the realization of products or
services with the objectives of planning, realizing, controlling, leading, guiding, and instructing
all participants on the different functions and roles that are involved in the realization of a
product: how to manage design and development, how to prepare for the realization, how to
identify and locate the appropriate resources, which activities are needed, which controls are to
be applied, which documented information is necessary, how one verifies or validates the results,
and which evidences are expected.

f) PERFORMANCE EVALUATION

Performance evaluation is the critical check step in the Plan-Do-Check-Act (PDCA) cycle that
ISO 9001 is based on, and it’s only through this step that you can determine if your Quality
Management System (QMS) is functioning properly, or if changes are needed to meet the
requirements.
The Plan-Do-Check-Act (PDCA) is a concept (one of many) that drives continual improvement
in the organization.
Performance evaluation is defined as the formal and productive procedure to measure an
employees work and results based on their job responsibilities and it is used to gauge the amount
of value added by an employee in terms of increased business revenue in comparison to industry
standards and overall employee return on investment.

Performance evaluation comprises of measurement, monitoring, analysis, and evaluation

elements which are critical for the assessment of the performance of the quality management
system (QMS). The goal is to reflect the quantitative and qualitative performance of the QMS
and to report the degree to which processes meet their stated objectives.
The goal of monitoring, measurement, analysis, and evaluation is to provide the decision makers
an understanding through a situation report concerning the performance of processes.
The following principles (the ISO 9001 Standard requirements) should be applied when
carrying out performance evaluation.
• The organization shall determine which quality elements shall be monitored and measured.
• Methods for monitoring, measurement, analysis, and evaluation shall be determined. The
methods shall define which activities are needed to ensure valid results of monitoring and
measurements.
• The methods shall define the stages and the intervals in the process when activities of
monitoring and measurements must be performed.
• The methods shall define when results of monitoring and measuring shall be analyzed and
evaluated.
• The results shall enable the evaluation of the performance and the effectiveness of the QMS.
• Documented information on the results of the monitoring, measurements, analysis, and
evaluation shall be retained.
Advantages of performance evaluation.
• Implementing a systematic control of the realization processes
• Identifying deviations in time and submitting them to a controlled process for treatment
• Allowing users of the QMS to make decisions regarding results of processes
• Allowing the users of the QMS to prevent nonconformities by identifying gaps in a process
and preventing the transition of nonconforming outputs to the next process
• Determining the effectiveness and efficiency of processes
• Using the monitoring, measurement, analysis, and evaluation as means for continual
improvement
• Promoting the achievement of quality objectives through key process indicators related to the
objectives of the organization

Improvement
Improvement means finding the parameters that affect the attainment of goals and submitting
them to change. This concept drives the organization towards meeting customer requirements in
order to enhance the achievement of the quality objectives and customer satisfaction but the
challenge is identifying the specific processes that have the most effect on conformity of goods
to customer satisfaction. The ISO 9001 Standard requires the identification of those poor in
performance and effectiveness processes or process outputs (products or services) and the
implementation of controlled changes that will improve them.
Improvement enhances customer satisfaction and can be achieved through the following
ways as per ISO 9001 standards.
• Improvement of products and services in order to meet current as well as future expectations of
interested parties as well as enhancing customer satisfaction.
• Corrective actions
• Preventive actions
• Actions for reducing undesired effects
• Improvements of the performance of the QMS, certain indicators of processes and their
relevant criteria, which suggest how much processes achieve their objectives (or not). The
performance of the QMS is monitored, measured, and evaluated through many quality tools and
methods suggested in the standard. An analysis of process performance may result in
improvement, redesign, or reengineering of the QMS activities
• Improvements of the effectiveness of the QMS, Effectiveness of the QMS refers to which
extent objectives of processes were achieved and may indicate how much the QMS has
improved. This can be through Effectiveness of the planning of the QMS, Effectiveness of
processes and activities.

 Inputs for Continual Improvement

In order to be able to improve processes or products, you must first know what is needed to be
improved and need have the necessary inputs to indicate where improvements are needed. The
Standard defines two quality management tools for performance evaluation that may introduce
inputs to continual improvement.