Quality Magazine

March 2017 Issue-14

Husam Hazboun (Corporate Quality Director)

Ajai Srivastava (Corporate Quality Assurance Manager)
Hussein ElKersh (Senior Quality Assurance Engineer)
Olivia Osama (Quality Assurance Engineer)
Ragaee Azmy (Document Controller)
 Contents

1. Introduction ............................................................................................................... 4
2. Understanding the process approach ...................................................................... 4
3. Benefits of applying process approach .................................................................... 6
4. Factors to be considered in the process inputs/outputs.......................................... 6
5. Implementing the process approach .......................................................................... 7
5.1 Identification of the processes of the organization ............................................... 7
5.1.1 Defining the purpose of the organization ....................................................... 7
5.1.2 Defining the policies and objectives of the organization ............................... 7
5.1.3 Determining the processes in the organization .............................................. 8
5.1.4 Determining the sequence of the processes .................................................... 8
5.1.5 Defining process ownership ............................................................................. 8
5.1.6 Defining process documentation ..................................................................... 9
5.2 Planning the process ............................................................................................... 9
5.2.1 Defining the activities within the process ....................................................... 9
5.2.2 Defining the monitoring and measurement requirements .......................... 10
5.2.3 Defining the resources needed ....................................................................... 10
5.2.4 Verifying the process against its planned objectives ................................... 11
5.3 Implementation and measurement of the process .............................................. 11
5.4 Analysis of the process .......................................................................................... 11
5.5 Corrective action and improvement of the process............................................ 12
6. Conclusion ................................................................................................................ 12
7. Appendix ......................................................................................................................13

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1. Introduction
The process approach is one of the eight quality
management principles upon which the entire
ISO 9000 series of standards is based. The eight
management principles have already been
covered in the Quality Magazine Issue# 10
(October-2016), but more focus on the process
approach principle is needed in order to fully
understand and apply it.

This principle states that a desired result is achieved more efficiently when activities and
related resources are managed as a process. The word "process" is defined in ISO
9000:2005 as "set of interrelated or interacting activities which transforms inputs into
outputs". The systematic identification and management of the processes employed within
an organization and particularly the interactions between such processes is referred to as
the process approach.

2. Understanding the process approach

A process approach is a powerful way of organizing and managing activities to create
value for the customer and other interested parties. A process simply consists of a set of
inputs that are converted to outputs through activities as shown in the diagram.

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Purchasing Process Example

The Input is a requirement to purchase materials, components or services.

The Purchasing Activity involves selecting a supplier from our approved supplier list and
preparing a purchase order. We will interact with:

- Supplier: to place the order

- Warehouse: to notify them of the material ordered
- Engineering: if purchasing specifications are needed
- Quality Assurance/Quality Control: if receiving inspection is needed and to disposition
the product if it is non-conforming when received.

The Output is an approved purchase order released to the supplier.

Organizations are often structured into a hierarchy of functional units. Organizations are
usually managed vertically, with responsibility for the intended outputs being divided
among functional units. The end customer or other interested party is not always visible to
all the involved units. Consequently, problems that occur at the interface boundaries are
often given less priority than the short-term goals of the units. This leads to little or no
improvement to the interested party, as actions are usually focused on the functions, rather
than on the intended output. As in the following example the output from one process in
an organization is the input for another process within the same organization. As can be
seen in the diagram the output for activity one is the input for activity two and similarly
the output of activity two is the input for activity three.

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3. Benefits of applying process approach
The process approach introduces horizontal management, crossing the barriers between
different functional units and unifying their focus to the main goals of the organization. It
also improves the management of process interfaces.

Other benefits include:

Integration and alignment of processes to enable achievement of desired outcomes
Ability to focus effort on process effectiveness and efficiency
Provision of confidence to customers, and other interested parties, about the
consistent performance of the organization
Transparency of operations within the organization
Lower costs and creation of shorter cycle times, through the effective use of
resources
Improved, consistent and predictable results
Provision of opportunities for focused and prioritized improvement initiatives
Encouragement of the involvement of people and the clarification of their
responsibilities

4. Factors to be considered in the process inputs/outputs

Process Inputs
Does the process that supplies you with your input
know what you need from the input? If you are
constantly looking for further information, this may not
be the case. For instance, if your process uses a report
created by the purchasing department, but this report
does not include all of the purchasing information that
you need, you will need to look for this information
yourself. If it is easier for people in the purchasing
department to find this information, it would be an
improvement in efficiency for the report to include this
information rather than hunting for it later.

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 Process Outputs
Do you understand what the next process needs from your output? In the example above,
the purchasing department needs to better understand how their report is going to be
used. Further, is your output used by another process? If the output is a record that is
stored to demonstrate conformance, then it might not need to be an input to a subsequent
process in order to be useful. However, if you are creating a report that is not used
anywhere, then you need to question the effectiveness of this part of your process.
Wasting resources to create outputs that are not useful is inefficient.

5. Implementing the process approach

5.1 Identification of the processes of the organization

5.1.1 Defining the purpose of the organization

The organization should identify its customers

and other interested parties as well as their
requirements, needs and expectations, to define
the organizations intended outputs.

Guidance
Gather, analyze and determine customers and
other interested parties requirements, and
other needs and expectations. Communicate
frequently with customers and other interested
parties to ensure continual understanding of their requirements, needs and
expectations. Determine the requirements for quality management, environmental
management, occupational health and safety, management, business risk, social
responsibilities and other management system disciplines that will be applied
within the organization.

5.1.2 Defining the policies and objectives of the organization

Based on the analyses of the requirements, needs and

expectations, establish the organizations policies and
objectives.

Guidance
Top management should decide which markets the
organization should address and develop relevant policies.
Based on these policies, management should then establish
objectives for the desired outcome (e.g. products,
environmental performance, occupational health and
safety performance).

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5.1.3 Determining the processes in the organization

Determine all the processes needed to produce the intended outputs.

Guidance
Determine the processes needed for achieving the intended outputs. These
processes include Management, Resources, Realization and Measurement,
Analysis and Improvement. Identify all process inputs and outputs, along with the
suppliers, customers and other interested parties (who may be internal or external).

5.1.4 Determining the sequence of the processes

Determine how the processes flow in sequence and their interaction.

Guidance
Define and develop a description of the network of
processes and their interaction. Consider the
following:

The customer of each process

The inputs and outputs of each process
Which processes are interacting
Interfaces and their characteristics
Timing and sequence of the interacting processes
Effectiveness and efficiency of the sequence

Methods and tools such as block diagrams, matrix and flowcharts can be used to
support the development of process sequences and their interactions

5.1.5 Defining process ownership

Assign responsibility and authority for each process.

Guidance
Management should define individual roles and
responsibilities for ensuring the implementation,
maintenance and improvement of each process and its
interactions. Such an individual is usually referred to
as the "process owner. To manage process
interactions, it may be useful to establish a "process
management team", that has an overview across all the
processes, and which includes representatives from
each of the interacting processes.

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5.1.6 Defining process documentation

Determine those processes that are to be documented

and how they are to be documented.

Guidance
The main purpose of documentation is to enable the
consistent and stable operation of the processes. The
organization should determine which processes are to
be documented, on the basis of:

The complexity of the processes and their

interactions
The criticality of the processes
The availability of competent personnel

When it is necessary to document processes, a number of different methods can

be used such as graphical representations, written instructions, checklists, flow
charts, visual media, or electronic methods.

5.2 Planning the process

5.2.1 Defining the activities within the process

Determine the activities needed to achieve

the intended outputs of the process

Guidance
Define the required inputs and outputs of the
process
Determine the activities required to transform
the inputs into the desired outcomes
Determine and define the sequence and
interaction of the activities within the process
Determine how each activity will be
performed

In some cases, the customer may specify requirements not only for the
outputs but also for the realization of the process.

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5.2.2 Defining the monitoring and measurement requirements

Determine where and how monitoring and

measuring should be applied. This should be
both for control and improvement of the
processes and the intended process outputs.
Monitoring is always applicable but
measurement may not be practicable or even
possible. Nevertheless, measurement gives
more objective data on the performance of the
process and it is a powerful management and
improvement tool. The need for recording
results should also be determined.

Guidance
Identify the monitoring and measuring criteria for process control and process
performance, to determine the effectiveness and efficiency of the process, the
following factors need to considered:
Conformity with requirements
Customer satisfaction
Supplier performance
On time delivery
Lead times
Failure rates
Waste
Process costs
Incident frequency

5.2.3 Defining the resources needed

Determine the resources needed for the effective operation of each process.

Guidance
Examples of resources include:
Human resources
Infrastructure
Work environment
Information
Natural resources
Materials
Financial resources

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5.2.4 Verifying the process against its planned objectives

Confirm that the characteristics of the processes are

consistent with the purpose of the organization which has
been already defined in 5.1.1

Guidance
Verify that all the requirements identified in 5.1.1 are
satisfied. If not, consider what additional process activities
are required and return to 5.2.1 to improve the
process.

5.3 Implementation and measurement of the process

The processes and their activities to be implemented as planned in 5.2 The

organization may develop a plan for implementation that includes, but is not limited
to:

Communication
Awareness
Training
Change management
Management involvement
Applicable review activities

Controls to be applied, and the monitoring and measurements to be performed as

planned.

5.4 Analysis of the process

The process information obtained from monitoring

and measuring data to be analyzed and evaluated, in
order to quantify process performance. Where
appropriate, statistical methods can be used.
The results of process performance to be compared
with the defined requirements of the process, to
confirm process effectiveness and efficiency and to
identify any need for corrective action.
Process improvement opportunities based on the
results of the analysis of process information to be
identified.
Top management, and other relevant people in the
organization to be notified of the performance of the
process, as appropriate.

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5.5 Corrective action and improvement of the process

Whenever corrective actions are needed,

the method for implementing them should
be defined. This should include the
identification and elimination of the root
causes of the problems (e.g. errors, defects,
lack of adequate process controls). The
effectiveness of the actions taken should
be reviewed and their effectiveness
verified.

When planned process outcomes are being achieved and requirements fulfilled, the
organization should focus its efforts on actions to improve process performance to
higher levels, on a continual basis. The method for improvement should be defined and
implemented (examples of improvements include: process simplification, enhancement
of efficiency, improvement of effectiveness, reduction of process cycle time).

Risk analysis tools may be employed to identify potential problems. The root cause(s)
of these potential problems should also be identified and eliminated to prevent
occurrence in all processes with similarly identified risks. Lessons learned need to be
recorded and communicated as part of the process improvement.

6. Conclusion
The process approach is a powerful tool to any organization. Understanding and
applying this approach result in many benefits. Five main steps should be adopted in
order to properly apply the process approach and accomplish the benefits associated
with it.

The appendix includes a diagram showing the interaction between various processes in
our organization. The diagram also shows the departments included in these processes
and references from ISO 9001:2008 as well as our procedures. Can you produce a
simple diagram for one of the processes that you are involved in, and forward it to:
Corporate.Quality@orascom.com

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 Interaction between processes

C. 5.3
Quality
IMM QMP-002
Policy
C. 5.4 Management
Strategic Customer Satisfaction committee
Review
Plan C. 5.6
C. 5.4.1
Quality
Objectives
PRO-TPD-01 Customer feedback
Technical & Complaints
Procurement Procurement C. 8.2.1
Dept

PRO-TPD-02 PRO-TPD-02
Commercial Projects Project QC
Dept Control Suppliers Subcontractor Dept
Evaluation Evaluation C. 7.4
Engineering C. 7.4
Procedure PRO-QUA-01
COP-001 PCP-000 PRO-TPD-01 PRO-TPD-01 QCP-40-014
PQP
Determine &
Project Project Inprocess & final Initial/final
Review Customer Design Subcontracting Project Execution
Planning Procurement Inspection Handing Over
Requirements C. 7.3 C. 7.4 C. 7.5 C. 8.2
Requirements

C. 7.2 C. 7.1 C. 7.4 C. 8.2

Satisfaction
Customer

Customer
PQP
Oracle system Customer Surveying
Property works Corrective and
Inventory Accounting C. 7.5.4 C. 7.6
preventive action
PQP
C. 7.5.5 C. 8.5
C. 7.1 QMP-006
CHRP-001 Identification & Planning
PRO_EQM-02 tracability PCP-000 Cost
Training & Awareness
Equipment PQP C. 7.5.3 Control
Provision PCP-001
Staff Requisition
C. 6.3 C. 6.2

CHRP-003
QMP-005
QMP-004 PRO-QUA-04

Equipment Control of non Quality Statistical

Human Resources conformance Audit Reporting
Dept. C. 8.3
C. 8.2.2 C. 8.4

QMP-001 QMP-001

Documents Continual Improvement

QA Records Control
Control committee
C. 4.2.3 C. 4.2.4

Procedure
Department
ISO Clause