IV.

PROCESS APPROACH

1. Statement:

“Consistent and predictable results are achieved more effectively and efficiently when
activities are understood and managed as interrelated processes that function as a coherent
system.”
2. Rationale

Rationale for this quality management principle further explains that “The quality
management system consists of interrelated processes. Understanding how results are produced
by this system enables an organization to optimize the system and its performance.”

3. Explain:
Process approach is one of ISO 9001's seven principles for quality management and
incorporates people into processes in order to obtain consistent outcomes. Organizations must
identify and manage a number of interconnected processes in order to perform effectively
(particularly the interactions between these processes). A process approach should be defined and
used while creating a quality management system. To begin, you must first define your most
main business operations. Then you should establish standards for those processes and decide
how you will assess them. Next, your approach to quality should be documented. It offers a
framework that allows you to develop continually when you record your approach.
The process approach or system approach refers to the act of using a method or rules for
analyzing, identifying, managing and measuring an organization's processes. These processes are
necessary for the operation of the quality management system and the realization of the product.
The fundamental purpose is to standardize the process within the business and to guarantee that
individuals or different organizational units within the company operate in unison. The process
approach's goals are as follows:

 Creating awareness and understanding in the organization regarding responsibility

for managing activities
 Implementing a method for the identification and planning of activities needed for
the operation of the quality management system
 Defining the sequences between processes
  Identifying and ensuring the interactions between processes, that is, activities in
the organization
 Ensuring accurate delivery of inputs to processes
 Monitoring and controlling activities of the quality management system
 Ensuring delivery of the right process outputs
 Ensuring achievement of intended results or process objectives
 Enhancing satisfaction of process customers
 Creating basis and environment for addressing risks and preventing errors
 Creating basis and environment for the planning, implementation, and analysis of
improvements (PDCA cycle).
Processes in the quality management system must interact with each other. ‘A process is an
integrated set of activities that uses resources to transform inputs into outputs’ and ‘it is quite
normal for processes to be interconnected because the output from one process frequently
becomes the input for another process’. Processes of a system exchange many types of
information, data, material, goods, or services through activities. In order to make the system
effective, the interactions between the processes in the system must be planned, divide the big
process into the small processes makes it easy to control and manage. So, consistent and
predictable results are recorded more effectively and efficiently when activities are explained and
managed as interrelated process functioning as a single coherent system. Understanding
processes will enable the organisation to optimise its performances.
Defining Inputs to the Processes

Inputs of a process are defined as specified requirements needed for the operation of a
process. Inputs are the fuel that drives the process: man, method, machine, material and
measurement. Explicitly speaking such as people, resources, materials, data or information,
technology, or knowledge. Inputs may be tangible (raw material for production process) or
intangible (information or data, e.g., results of a customer satisfaction survey or knowledge). In
order to effectively analyze and identify the inputs, one must first know which activities a process
includes.

Defining Outputs to the Processes

An output is a deliverable result of an operational process aimed to address the expectations

of the customer of the process. Outputs are finished goods to meet customer's requirements or
benefit specifications or meet the standard on purchase order. An output may be tangible
(finished products) or intangible (services provided to a customer or information such as results
of a calculation) such as : material, equipment, information,...

Defining the Sequence of Processes

 Defining the sequence of processes entails determining the sequence of various activities of
various elements engaged in the process and building the workflow in the organization. The
objective is to ensure that processes achieve quality goals, deliver desired outputs and ensure
product or service conformity. The sequence should provide an overview of your workflow and
show how you work and work in your enterprise. A correct process sequence will allow
information to flow effectively throughout the workflow, supply the required inputs to the
processes, and offer the appropriate outputs.

Measurement, and Monitoring of Processes

Measuring and evaluating these interrelated processes helps you also find opportunities for
improvement. More information is supplied to help you comprehend monitoring and measuring.
In most cases, the requirements are monitored and measured at the same time. Monitoring and
measuring requirements are used for process control, obtaining intended process outputs
(ensuring process effectiveness), and enhancing process efficiency.

Addressing Risks

During the analysis of its processes an organization is required to address risks related to
products and services that may occur when processes deliver unintended outputs or when the
interaction between the processes is ineffective. Applying the process approach, determining the
processes included in the QMS, and identifying their owners, inputs, and outputs should put you
in a position to understand what the intended results are for each process. The next step will be to
understand what is the relation between the conformed products or services and the intended
outcomes of the processes that realize them. The risks may occur throughout the supply chain, the
realization of the product, or the provision of a service. After understand- ing which risks are
potential, you must define the actions to handle and control these risks.

Continuous improvement will adapt to the rising needs and expectations of customers and
ensure a dynamic evolution of the organization's quality management system. The use of the
PDCA paradigm ensures continuous improvement. Each process takes place under the PDCA
cycle (Deming cycle) to complete the actions as a plan - do - check – act, focusing entirely on
"risk-based thought" to prevent unwanted results. This is a very simple four-step management
method used in business for the control and continuous improvement of processes. The steps are:

Plan – determine what needs to be done, when, how, and by whom;

Do – carry out the plan, on a small scale first;
Check – analyse the results of carrying out the plan;
Act – take appropriate steps to close the gap between planned and actual results.

When used within a quality management system, process approach provides numerous
different benefits such as understanding requests and consistency in their accomplishing,
analysing processes in terms of value added, optimizing performance through effective process
management, efficient use of resources and reduced cross-functional barriers, establishing
effective performances and improving processes on the basis of valuing data and information.

For example, proposal writing is an area where many businesses should use a process
approach. By using a proposal template, you simplify your business process. You create a
document that you can reference to throughout the entire project. This is useful for the client’s
understanding of the proposal. But it is also useful to you. It keeps you on track and helps you
ensure that each task in the project adds value to your client. When you do so, your business will
be able to use resources more efficiently. Many businesses have also found that a process
approach helps to keep things consistent across departments. In the end, processes are just a way
to make your results more predictable. When you clarify actions in your business, everyone reaps
the benefits.