Process Approach

• Father of Quality
• Understanding of the system
• Understanding variation
• Taught Japan after WWII and transformed quality
• In 1980 transformed American Quality revolution
• The foundations of Six Sigma

“If you can’t describe what are you doing as a

process, you don’t know what are you doing”

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Basis of ISO Management Systems
Appreciation of the system
• Systems are sets of components
that work together to accomplish
vision & goals
• Communication must exist
• Collaboration must exist
Theory of knowledge
• First understand problems then
solve them
• Make data driven decision
• Assess past performance
• Predict future performance
Knowledge of Variation
• Understanding variation is key to
improvement
• Variation exits in everything
• Variation causes waste
Psychology
• Understand people
• Understand interactions
• Need for relationships and
esteem; learning and contribution
• progress
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PDCA
• If the check shows the •Establish objectives and
plan that was processes necessary to
implemented in DO is an deliver results in
improvement, then it accordance with the
becomes the new target expected outcomes
(targets)

Act Plan

Check Do
• Study the actual results • Implement the plan,
and compare against the execute the process and
expected results to collect data for
ascertain any gaps measurement and
Analysis
Process Approach – Management System Standards

Many modern organizations are functional and hierarchical; they

suffer from isolated departments, poor coordination, and limited
lateral communication. All too often, work is fragmented and
compartmentalized, and managers find it difficult to get things
done.

• An organization exists to meet specific objectives.

• The organization’s objectives are derived from a balanced

consideration of the needs and expectations of its customers.
This is due to the fact that the customer needs and expectations
may not be the same but are interrelated
Process Approach – Management System Standards

Management Systems consist of interrelated processes.

Understanding how results are produced by this system enables an
organization to optimize the system and its performance.

Processes provide a likely solution. In the broadest sense, they can

be defined as collections of tasks and activities that together — and
only together — transform inputs into outputs. Within
organizations, these inputs and outputs can be as varied as
materials, equipment, measures and method.
Often the output from one process directly forms the input to the
next process. [internal customer]
The systematic identification and management of activities within a
process and particularly its interaction with other processes can be
considered as the process approach.
Management System
A management system is a set of interrelated or interacting elements of an
organization to establish policies and objectives and processes to achieve those
objectives
Process
• Set of interrelated or interacting activities which transforms inputs to outputs
Inputs
• Man, Machine, Material, Method & Measures, Working Conditions
Outputs
• Product and Service – Result of a process. Outputs of one process may be
inputs into another process
Outcomes
• Achieving the MS Objectives
Process Approach

The organization should be structured into processes that achieve the

desired objectives efficiently.
The process approach principle states that the objective is achieved
more efficiently when related resources and activities are managed as a
process.

Functional organizations are divided into various functional units of

which has their own internal agenda and culture.

Inherent processes do not recognize department or functional

boundaries.
Advantage
• Leads to control over linkage between processes, their combination
and interaction
• Process approach introduces horizontal management, crossing the
barriers between different functional units.
• Unifies their focus to the main goals of the organization.
• Improves management of process interfaces
 Determination of Processes

Organization balances the customers'’ needs and

Organizational Objectives – Desired Results

expectations and develops organizations objectives
Needs & Expectations of Customers

POLICY AND OBJECTIVES

Organizations develops structures (processes) to

achieve the declared objectives

PLANNING OF PROCESSES

A
C E F
B D

Realization of Intended outputs/outcomes

Process

A process is a set of inter-related or interacting activities which transforms

inputs into outputs.

Core business Processes

An organization’s operations are conducted (conscious or unconsciously) by business
processes. A core business process is that which adds more value to a product or
service. Core business processes are normally linked to the business strategy, and are
thus paramount for the sustainability of the organization.
Support Processes
The processes supporting operational activities are those processes that do not
contribute directly to production or service, but which are necessary for its proper
conduct, or are imposed by regulatory constraints or requirements of good corporate
governance.
Management System Process
The processes to effectively manage and continually improve a management system are
called management system processes. These processes are usually required to be
established by an ISO standard.
Process

Typical Processes within an Organization

System Processes Core Business Processes Support Processes

Documentation
Contracts review Purchasing
Processes

Risks & Opportunities Production Planning Storage

Objectives and their

Engineering Process IT
achievement

Internal Audit Execution HR

Corrective Actions
Management Inspections & Testing HSE
Processes

Delivery
Phase
Establishing the process – Planning

Objectives & Targets

• define objectives of the system and processes necessary to
achieve them

Governance Structure
• establish authority, responsibility and accountability for managing
processes
• understand the organization’s capabilities and determine resource
constraints prior to action
Establishing the process – Planning

Determine the Processes

• Determine the sequences of activities
• Determine the resources required (inputs)
• Determine the method and Criteria
• Determine process interdependencies and analyze the effect of
modifications to individual processes on the system as a whole
• Ensure the necessary information is available to operate and
improve the processes and to monitor, analyze and evaluate the
performance of the overall system
Process inputs and outputs

Process inputs can be tangible or intangible. Inputs may come in the form of
people, equipment, materials, parts, assemblies, components, information,
money, and so on (see Figure below). The process transforms, changes, or
converts the inputs into an output. Inputs are the thing(s) that will be
transformed and the transformation mechanisms.

An output may be a product or service. Outputs can include: parts,

assemblies, materials, information, energy, money, machines, devices,
equipment, completed treatment, performance of a skill, and so on. The
output product is a result of the process.
Process Approach - Planning

Objectives
Machine, Material Objectives, targets and Plan
Equipment, software, hardware,
tools, materials and substances

With
what
Location/Infrastructure
Access, working
conditions,
Weather Process
Conforming
Input
(Sequence of activities) Output Product/
Service
Method & Criteria
Procedures, Standards,
Method Statement

Man Monitoring
Training, Competency , skills,
Inspections, testing, analysis
experience, knowledge
and evaluation
Interacting activities

Some activities, within a process, take place outside a function or

department, this scenario is known as interaction of
activities/processes. This interaction may result in conflict between
the two interacting activities/processes if the measures, or
methods are not aligned.

This part is usually not covered in the procedures, that how and
what will be done in case of conflicting activities. However, review
of procedure by interested parties/stakeholders prior to
implementation and meetings among the process owners can be
considered as measures to resolve these conflicts and these
conflicts may pose risk to the management system.
Transformation
Processes are responsible for the changes that take place within a system. Some call this
changing or a transformation. A process is developed solely to transforms inputs into
outputs, this transformation or change takes place as a series of activities or steps that
lead to a desired result (intended outcome).

The balancing and equilibrium of inputs and outputs is called the Law of Conservation.
The Law of Conservation requires that the sum of the inputs equal the sum of the
outputs for a given process. For example, the uncut metal plate input equals the
fabricated bracket, plus scrap and metal filings. The third principle is that the Law of
Conservation applies to a defined process. For processes to work, inputs and outputs
must be in balance. If process elements are out of balance, the objectives would not be
achieved and the process would not be effective. The output objective demands certain
inputs and if you don’t have sufficient inputs, the outputs will never be achieved.

Processes can be operated at a set of optimum conditions for best utilization of

resources and achievement of objectives. Economics is an important consideration of
design and process operation. Every process has a set of optimum operating conditions
for achieving both economic and performance objectives.
Internal and External Issues

Product/Service & Internal Interested Parties External Interested

operations Parties

Issues & Relationship & Customers

Consideration Interdependencies with
Needs & Internal Departments
Expectations Suppliers
Internal Issues IT
of Interested
Operations
Parties Regulatory Bodies
External Issues Maintenance
Procurement
Other Interested
Logistics Parties
Human Resource

Scope of Management System

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Needs & Expectations of Interested Parties

Expectations of Interested Parties may not be the same

1) Customers who want products that meet their expectations.
2) Suppliers who want commercially viable and stable
relationships.
3) Employees who want satisfying employment.
4) Shareholders who want a good return on their investment.
5) Society, which want the organization to operate responsibly,
lawfully and ethically.
What are Inter-related activities?

Activities are inter-related i.e. take place in a sequential manner,

thus are dependent on each other, completion of a successive
activity is dependent on timely and accurate completion of a
predecessor activity. adoption of a correct method that is,
sequence and use of suitable equipment, competent person,
correct material, selection of accurate measure, including the
tolerance limits will help in process success.

Working conditions will have an impact on the selection of

sequence, equipment, competency, material and measure.

Non-availability or deviation in material, equipment, required

competency, critical measure or sequence will result in
nonconformity as well as will be a risk to the management system.
Process Roles, Responsibilities and Authorities

The related roles i.e. who performs, who inspects, who approve
and who deliver etc. should be determined for each activity,
according to the assigned role responsibilities are determined e.g.
what is required for performing, inspecting and approving an
activity or set of activities. If the person performing, inspecting or
approving an activity or set of activities can take certain decisions
to ensure conformity of the process, it is called authority related to
the activities.

These parts of the process are usually covered within the

procedures, checklists, Inspection and Test Plans etc.
Change in Process
Any change in the sequence, material, equipment, measure or
working conditions to be evaluated and managed prior to
implementation.

- The critical sequence,

- measure of material,
- time taken for completing an activity

(criteria) should be monitored, measured, analyzed. The results of

analysis are then evaluated against the set criteria to ensure if the
planned arrangements are capable of meeting the needs and
expectations of the customer (be it internal or external) or
achieving the desired results.
At these identified critical points, process performance is verified
against the criteria
Process inputs and outputs & Outcomes

There are many other inputs to a process (other than the object of the
transformation) that make it possible to complete the transformation. It is
convenient to categorize these inputs as Process Elements. The process
elements can be divided into six groups that contain all the factors that make up
a process.
The six groups are people, equipment, environment, materials, measures, and
methods.

Process outcomes

Output of a process may or may not be acceptable or meeting the process

objectives (intended results), hence, outcome of a process would be non-
conforming product/services or conforming product/service. The desired results
of every process are that the transformed product meets the needs and
expectations of the customer, be it internal or external, as well as conform to
the method and criteria.
Implementation of the Process

The organization shall develop a project for

implementation that includes, but is not limited to;

• Management involvement
• Implementing the monitoring & measurement activities
• Communication & Awareness
• Training
• Change management.
Control of Process
In most cases, it is desirable to control processes to avoid negative
consequences. The amount or level of control varies depending on
the risk and acceptability of undesirable outcomes.
The control on process is established by:

1. Determining the method; and

2. Determining the criteria

Method
For management to control a process or activity, it must establish a
predetermined method. Without it, there is no basis to adjust or
improve the process. Predetermined methods can include:
International Standards, plans, procedures, work instructions,
checklists, outlines, diagrams, flow charts, step-by-step software
program code, process maps, and so on.
Process Control
Criteria
The essential requirement for any control system is that there is a feedback information
loop from the process output. The feedback information is used to adjust the process or
make decisions about the output (before the next process or before the customer
receives it).

- Feedback information may be in the form of temperature, pressure, dimension,

weight, volume, count, color, condition, or portion.
- The function of the control feedback loop is to achieve output targets and objectives.
- Feedback information should relate to the process performance criteria and/ or
objectives.

Feedback can be in the form of a quality characteristic such as activity level or

dimensions, and feedback can be a performance measure such as yield, cost, waste,
delays, utilization, error rate, field failures, and satisfaction and so on. Sometimes it is
easier to monitor a process parameter such as temperature or pressure that is a function
or indicator of the performance of the process. For example, we can monitor the
temperature of a process because we know that if it goes above 107 degrees centigrade,
the product will darken and fail the color test. Without a feedback loop objective cannot
be assured
Process Control

To control a process, it is essential to determine the critical points

where deviation to method and criteria would render a product or
service non-conforming.

These critical points should be monitored through visual

inspections, inspections through suitable measuring equipment,
taking samples and testing those samples.

Once the results of inspection and testing are obtained, process

owner or another suitably competent person should accept or
reject the results, this is known as approval process, the
product/service should not be delivered to the customer prior to
approval.
Process Control
Process Variation
Variation is inevitable. Everything varies. A key part of continual improvement is
understanding the information contained in variation. Many organizations look
at variation as only being within or out of specifications. We need to change our
paradigm of variation. Is the variation we see due to special causes of variation
or to common causes of variation, i.e., the way management designed the
process?

Common cause variation is the variation that exists because of the way the
process was designed (by management) and is managed. It refers to the many
sources of variation that are normally present within a process. For example,
consider how long it takes you to drive to work (assuming your process for doing
so is the same from day to day). Suppose, on average, it takes 20 minutes to get
to work. It doesn't take, however, 20 minutes each day. Suppose you know that,
in general, it will take between 15 minutes and 25 minutes to get to work. Some
days it may take 22 minutes; other days 18 minutes; others 24 minutes, etc.
Process Variation

The difference between each day's time and the average, most of
the time, will not be alarming to you. You realize that the
differences are due to the traffic, speed you drive, etc. All these
causes are called common cause variation. They represent the
normal variation in your process of getting to work.

In general, there are a large number of common causes present at

any time. Each cause has an effect that can't be measured. For
example, suppose one day you get to work in 17 minutes. You can't
relate that to driving at a certain speed, to traffic patterns, to the
way your car was running, etc. As long as you keep the process the
same, common cause variation is the same from day to day. Thus,
common cause variation is consistent over time. We can predict
the effect of common cause variation.
Process Variation

Special causes of variation are not part of the way the process is managed and
are considered abnormalities. This means that something that normally doesn't
occur has happened. Consider the driving to work example. If you get a flat tire
on the way to work, you will not arrive at work in the normal span of 15 to 25
minutes. This is a special cause. Its effect on the process is measurable.

For example, if you have a flat tire, it might take 60 minutes to get to work. This
is definitely out of the normal range of 15 to 25 minutes and is directly
attributable to having a flat tire. Other possible special causes for driving to work
would include adverse weather conditions and traffic congestion due to an
accident. Special causes are sporadic in nature and cannot be predicted.
However, they are usually easily discovered.
Process Variation
The approach to variation in this case is to look at what variation is due to
common causes and what variation is due to special causes. It is important to
distinguish between the two because the responsibility for process improvement
depends on what type of variation is present. In general, special causes are not
part of the process and can be discovered. It is usually the responsibility of the
front-line personnel to find and eliminate special causes.

Special causes are often related to one machine, one person, one type of raw
material, sudden change in environmental conditions, etc.

Common cause variation, on the other hand, is part of the system or process. To
decrease common cause variation, you must change the system. This is
management's responsibility. Only management, not the front-line personnel,
has the authority to change the system or process.
Monitoring, Measurement, Analysis & Evaluation
Measure the process performance against the determined:
-Sequence - International Standards, Procedures/ Process Maps
-Method – International Standards, Procedures, Process Maps
-And criteria – Inspection and Test Plans, Checklists, Inspection reports
-Objectives – Achievement of objectives

Process Monitoring Measurement Analysis Evaluation Evidence

Complaint No. of complaints Complaint analysis Complaints evaluation Results of evaluation

orders enquiry
Order to enquiry No. of orders received Target achievement Evaluation report
Marketing analysis

warranty cost
Warranty costs Cost incurred Actual vs target Warranty cost report
analysis

Qty. planned vs
Works done % of completion meeting the milestones Progress report
achieved
Production
number of hours
Rework hours % of rework Target Reworked hours report
reworked
Improvement

Monitor and Evaluate and take

1 2 Analyze the data 3
Measure the data decisions

Implement actions

5
Review & Analyze
Effectiveness of
actions taken