Process Approach of ISO

Process Approach to Quality Management Systems

New ISO-9000:2000 standards promote the adoption of a ‘process approach’ when developing, implementing and improving quality management system (QMS). Process approach and its application in quality management system is explained in the following slides:

What is a Process?

“Any activity, or set of activities, that uses resources to transform inputs to outputs can be considered as a process.”

Outputs from one process are typically inputs into other processes Overall aim is to add value by planning and controlling processes

What is a process approach?

Any organization would have many processes depending upon complexity of its business and nature of its activities. To function effectively organizations have to identify and manage numerous interrelated and interacting processes. Often the output from one process will directly form the input into the next process. The systematic identification and management of the processes employed within an organization and particularly the interactions between such processes is referred to as the “Processes Approach”.

What is a process approach….

At the heart of quality management system are the product realization processes which add value. In addition to these processes, which transform inputs to outputs, they need auxiliary processes to facilitate efficient performance of activities or operations.

This integrated process approach is schematically shown in figure 1.

Support Processes

Customers/Inte rested parties

Figure 1

Schematic Representation of Process Approach

inputs outputs

•Top management processes include, for example, planning, allocation of resources, management review, etc.

•Realization processes include, for example, customer related processes, design and development, product realization, etc.

•Support processes include, for example, training, maintenance, etc.

Customers/Inte rested parties

Top Management Process

REALISATION PROCESSES

A B C

Management control through process approach

Process approach enables effective control over the individual processes within the system of processes as well as their combination and interaction.

When used within a quality management system such an approach emphasizes the importance of:

a. Understanding and meeting requirements. b. The need to consider processes in terms of added value. c. Obtaining results of process performance and effectiveness and d. Continual improvement of processes based on objective

measurement. The model of process based quality management system is shown in

figure 2 on the next slide.

Figure 2Complete Model of Process based Quality Management System

Continual Improvement of the quality management system

ProductProduct

realization

Managementresponsibility

Resourcemanagement

Measurement, analysis &

improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Process based Quality Management System

The model of process based quality management systems illustrates the process linkages presented in clauses 4-8 of ISO 9001: 2000. The interrelationship of these clauses is explained in the following slides.

Customer Driven

The model assumes that quality starts and ends with the customer, as such it is customer driven. In the diagram customer is shown on both left and right. Generally it will be the same customer, but on occasions it could be different one. The system starts with understanding customers requirements which become input to the quality system. Delivery of product or service to the customer is the output of the quality system.The model gives importance to obtaining information on customer feedback shown by dotted arrows on the right.


Product

Productrealization


Resourcemanagement


improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Product Realization

The input in the form of customer requirements is fed into product or service planning the first process in the series of product realization processes. This box contains various activities which your organization needs to do to make your product or service. After transformation by various processes the final product or service is realized which is delivered as output to the customer


ProductProduct

realization


Resourcemanagement


improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Measurement, analysis and improvement

The next box covers activities such as measurement of various parameters in different processes with reference to the specified standards and generates data about deviations. These measurements not only include internal measurements, but also external inputs like field failures, customer feedback, etc. This data is required to be analyzed to determine corrective and preventive measures as well as improvements in the processes or products.


ProductProduct

realization


Resourcemanagement


improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Management Responsibility

The results of analysis and customer feedback information is passed on to the management to take appropriate decisions for overall improvement of organizations performance. Management responsibility also covers defining of quality policy, setting of measurable objectives and necessary planning and documentation of standard instructions for important processes for guidance of concerned people.


ProductProduct

realization


Resourcemanagement


improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Resource Management

Management also needs to determine and provide resources, which is addressed in the forth box (resource management) in the quality management system. Resources include work space; equipment and people. The management needs to ensure that people are trained and competent for the tasks assigned to them.


ProductProduct

realization


Resourcemanagement


improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Continual Improvement

The data analysis activities shown in the box titled ‘Measurement Analysis and improvement’ may identify opportunities for improvements to the quality management system. This is indicated as the arrow pointing to the box at the top titled ‘Continual Improvement of the Quality Management System’. In addition, top management as a result of management review may suggest investigation of potential improvements.


ProductProduct

realization


Resourcemanagement


improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Mechanism for Continual Improvement

There could be two mechanisms for effecting improvement.

A As a part of quality management processes (depicted by arrows of inner loop). This could cover rectification, corrective action and preventive action.

B As a result of management review, which look critically at the whole quality management system and make improvements.

A Step Towards TQM

It will be seen that figure 2 ties together concepts of quality assurance to continual improvement and TQM. In fact, ISO-9004 is specially designed to help companies to go beyond quality system certification and move towards TQM.

Application of PDCA Cycle

Process model of QMS shown in figure 2 also represents application of Deming’s PDCA concept for continual improvement. Top and left boxes signify PLAN activity. Product realization box indicates DO activity. Measurement and analysis is the CHECK activity, and the top box showing improvement measures approved by the management shows ACT phase of PDCA cycle.


ProductProduct

realization


Resourcemanagement


improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Application of PDCA Cycle

The ultimate aim of any management system is continual improvement of its performance. To achieve this, Deming’s PDCA cycle of improvement is interwoven in the structure of the new standard. Very first operating clause 4.1 of ISO-9000:2000 dealing with General Requirements contain all the four elements of PDCA cycle as illustrated in figure 3 on the next slide.

ACTImplementation of

improvement( Clause 4.1f )

PLANIdentification of

sequence, interactioncriteria & methods( Clause 4.1 a,b,c )

CHECKMonitoring,

Measurement& Analysis

( Clause 4.1e)

DOImplementation of

the planning( Clause 4.1.d)

Figure 3PDCA Cycle applied to ISO 9001:2000 clause 4.1

Documents

Process Approach of ISO