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1 1 “Quality has to be caused, not controlled.” Philip B. Crosby Mohd Nizam Ab Rahman Pusat Jaminan Kualiti UKM FOR TRAINING PURPOSE ONLY

“Quality has to be Mohd Nizam Ab caused, not Rahman · 1 “Quality has to be caused, not controlled.” Philip B. Crosby Mohd Nizam Ab Rahman Pusat Jaminan Kualiti UKM FOR TRAINING

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Page 1: “Quality has to be Mohd Nizam Ab caused, not Rahman · 1 “Quality has to be caused, not controlled.” Philip B. Crosby Mohd Nizam Ab Rahman Pusat Jaminan Kualiti UKM FOR TRAINING

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“Quality has to be caused, not controlled.”

Philip B. Crosby

Mohd Nizam Ab Rahman

Pusat Jaminan Kualiti

UKM

FOR TRAINING PURPOSE ONLY

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2

Introduction to ISO 9001:2015

Risk-Based Quality Management

System: Risk-Based Thinking

Model

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By the end of this workshop, participants

will be able to:

1. Understand the concepts of changes in ISO

9001:2015 standards

2. Develop Risk-Based Thinking

3. Integrate Risk-Based Thinking with the Process

Approach as required by ISO 9001:2015

4. Understand the audit approach

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Overview of ISO 9001

Standard

1

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About ISO

Non-governmental organization (NGO) established in

1947, based in Geneva, Switzerland

Has a membership of 160 national standards institutes

from countries in all regions of the world

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About ISO

Developed various standards for all dimensions of

sustainable development: economic, environmental and

societal

• Examples :

ISO 9001 – Quality Management Systems (QMS)

ISO 14001 – Environmental Management Systems (EMS)

ISO 27001 – Information Security Management Systems (ISMS)

ISO 31000 – Risk Management (Principles and Guidelines)

SIRIM and STANDARD Malaysia are major

representative to ISO

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What is ISO 9001?

ISO 9001 is the world’s most popular and most

commonly used standard for Quality Management

Systems (QMS)

International consensus on good management practice

Focuses on meeting customer requirements and other

interested parties

Covers any organization – whatever the size, industry or

culture

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Advantages of Certification

Compliance with customer requirements

specifying certification

Independent check of conformity

Indicates an effective Quality System

National/International recognition

Provides competitive advantage

Improves company image

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Why Was ISO 9001 Revised?

Adapt to a changing world

Enhance an organization’s ability to satisfy customers

Maintain relevance, provide integrated approach to

organizational management, and integrate with other

management systems

Reflect needs of all user groups and increasingly

complex operating environments

Set a consistent foundation for the next 10 years

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Key Improvements to ISO 9001:2015

Increased emphasis on achieving value for the

organization and its customers

A greater emphasis on leadership and organizational

context

The focus on risk-based thinking

Emphasis on objectives, measurements and change

Stakeholder-focused communication and awareness

Decreased emphasis on documentation

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ISO 9001 – Key Differences

ISO 9001:2008 ISO 9001:2015

0 Introduction 0 Introduction

1 Scope 1 Scope

2 Normative references 2 Normative references

3 Terms and definitions 3 Terms and definitions

4 Quality management system 4 Context of the organization

5 Management responsibility

5 Leadership

6 Planning

6 Resource management 7 Support

7 Product realization 8 Operation

8 Measurement, analysis and

improvement

9 Performance evaluation

10 Improvement

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ISO 9001 – Different Terminology

ISO 9001:2008 ISO 9001:2015

Products Products and services

Documentation, quality manual,

documented procedures, records,

instructions

Documented information

Work environment Environment for the operation of processes

Monitoring and measuring equipment Monitoring and measuring resources

Purchased product Externally provided products and services

Supplier External provider

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Term: “Documented Information”

“Retaining” Doc. Info. = Records “Maintain” Doc. Info. applies to…

Quality Objectives Quality Policy

Fitness for purpose of monitoring and measuring resources Quality Objectives

Evidence of Competence Scope of the QMS

Conformity of Products/Services

Review of Customer Requirements

Design and Development Process

Design and Development Changes

Evaluation/Performance of External Providers

Product/Service ID and Traceability

Pre and Post Delivery Change Authorizations

Conformity with Acceptance Criteria

Authorized Release of Products/Services

Non-conformances and C/A

Internal Audits

Management Reviews

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Benefits of the New ISO 9001:2015

Puts greater emphasis on leadership engagement

Helps address organizational risks and opportunities in a

structured manner

Uses simplified language and a common structure and

terms

Addresses supply chain management more effectively

Is more user-friendly for service and knowledge-based

organizations

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ISO 9001 and Risk

Structure

2

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Emphasis on Process Approach

Understanding and meeting

customer requirements

How do processes value add

Measure process

performance and

effectiveness

Continual improvement of

processes based on

measurement

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Risk-based Management

To improve customer

confidence and satisfaction

To assure consistency of

quality of products and

services

To establish a proactive

culture of prevention and

improvement

Successful companies

intuitively take a risk-based

approach

Improve governance

Risks Opportunities

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ISO 9001 Approach is Based on the

Plan-Do-Check-Act (PDCA) Cycle

Organization and

its context (4)

Customer

Requirements

Customer

Satisfaction

Products

and services

Results of

the QMS

Needs and expectations

of relevant interested

parties (4)

Leadership(5)

Performance evaluation

(9)

Support & Operation

(7,8)

Planning(6)

Improvement(10)

Plan Do

CheckAct

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PDCA and ISO 9001 Clause Structure

ACT PLAN

DOCHECK

9. Performance

Evaluation

4. Context of the

Organization

5. Leadership

6. Planning

7. Support

8. Operations

10. Improvement

0. Introduction

1. Scope

2. Normative References

3. Terms & Definitions

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ISO 9001 Clause Structure (4-10)

PLAN DO CHECK ACT

4. Context of the

organization

5. Leadership 6. Planning for

the QMS

7. Support 8. Operation 9. Performance

evaluation

10. Improvement

4.1 Understanding the

organization and its

context

5.1 Leadership and

commitment

6.1 Actions to address

risks and

opportunities

7.1 Resources 8.1 Operational

planning and control

9.1 Monitoring,

measurement,

analysis and

evaluation

10.1 General

4.2 Understanding the

needs and

expectations of

interested parties

5.2 Quality policy 6.2 Quality objectives

and planning to

achieve them

7.2 Competence 8.2 Determination of

requirements for

products and services

9.2 Internal audit 10.2 Nonconformity

and corrective action

4.3 Determining the

scope of the QMS

5.3 Organizational

roles, responsibilities

and authorities

6.3 Planning of

changes

7.3 Awareness 8.3 Design and

development of

products and services

9.3 Management

review

10.3Continual

improvement

4.4 QMS and its

processes

7.4 Communication 8.4 Control of

externally provided

products and services

7.5 Documented

information

8.5 Production and

service provision

8.6 Release of

products and services

8.7 Control of

nonconforming

process outputs,

products and services

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Risk-Based Practices

3

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Risk Management

I have never known a battle plan to survive after a first contact

with the enemy.

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Context of the Organization

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• Risk Based Thinking

• Is not new

• Make prevention a habit and reduces the probability

of negative results

• No “Preventive Action sub-clause”. PA is expressed

through a Risk-Based Approach to formulating QMS

requirements

• Risk-based approach has facilitated some reduction in

prescriptive requirements and their replacement by

performance-based requirements

• Actions taken to address Risks and Opportunities

shall be proportionate to the potential impact on the

conformity of products and services

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Decision making and ISO-9001:2015

The first is a quality principle quoted from ISO 9000:2015, namely “evidence-based decision making.” It is not hard to understand that better decisions are made when they are based on evidence rather than by conjecture.

Clause 4.1, “Addressing external and internal issues (risks and opportunities) associated with its context and objectives.”Addressing risks means proactively managing uncertainties. The simple meaning of “managing uncertainties” is that decisions should be made with consideration of the possible positive and negative consequences that the uncertain future may bring.

Clause 5.1, entitled Leadership and Commitment, there is a requirement for top management: “Ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization.” Top management’s most basic role is strategic decision-making for the organization.

6.1 When planning for QMS, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed.

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What is Risk

The concept of RISK in the context of the

ISO Standard relates to the uncertainty in

achieving objectives

Risk is the possibility of events or activities

impeding the achievement of an

organization’s strategic and operational

objectives

Page 28: “Quality has to be Mohd Nizam Ab caused, not Rahman · 1 “Quality has to be caused, not controlled.” Philip B. Crosby Mohd Nizam Ab Rahman Pusat Jaminan Kualiti UKM FOR TRAINING

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Risk Based Thinking Examples and Ideas

Purchasing

Design and Development

Process

The concept of RISK in the context of the

ISO Standard relates to the uncertainty in

achieving objectives

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What should you do?

Identify what the risks and opportunities are in your organization – it depends on context

Analyze and prioritize the risks and opportunities in your organization

• what is acceptable?

• what is unacceptable?

Plan actions to address the risks

• how can I avoid or eliminate the risk?

• how can I mitigate the risk?

Implement the plan – take action

Check the effectiveness of the actions – does it work?

Learn from experience – continual improvement

Page 30: “Quality has to be Mohd Nizam Ab caused, not Rahman · 1 “Quality has to be caused, not controlled.” Philip B. Crosby Mohd Nizam Ab Rahman Pusat Jaminan Kualiti UKM FOR TRAINING

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Failure Mode and Effects Analysis (FMEA)

Risk Based Thinking Tool

Page 31: “Quality has to be Mohd Nizam Ab caused, not Rahman · 1 “Quality has to be caused, not controlled.” Philip B. Crosby Mohd Nizam Ab Rahman Pusat Jaminan Kualiti UKM FOR TRAINING

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Jay Stahan January 12, 2016

Risk Based Thinking Tool

PROBABILITY

S

E

R

I

O

U

S

N

E

S

S

RISK MATRIX

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Risk Based Approach Tool

Probability

Severity

Risk Register Ranking Matrix

Page 33: “Quality has to be Mohd Nizam Ab caused, not Rahman · 1 “Quality has to be caused, not controlled.” Philip B. Crosby Mohd Nizam Ab Rahman Pusat Jaminan Kualiti UKM FOR TRAINING

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Risk Based Thinking Tool

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Audit Approach

4

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What is a Quality Audit?

Systematic, independent and

documented process for

obtaining audit evidence and

evaluating it objectively to

determine the extent to which

audit criteria are fulfilled

Audit criteria

• Processes or procedures

• Standards

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What Are Audits Used For?

Looking at the overall process

Auditing conformity

Auditing effectiveness

Approving external service providers

Assessing for certification

Investigating problems

Way of improving

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Types of Quality Audits

First party audit

• Internal audit (by your organization’s Quality department)

Second party audit

• Your customer auditing your organization

Third party audit

• A certification body auditing your organization

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Internal Audit

To ensure the whole Quality

System is audited to check:

• The system is being followed

• The system meets ISO 9001

requirements

• The system is effectively

implemented and maintained

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Audit Approach

Focuses on employees’ understanding of the

organization’s processes and verifies that these

processes are:

• complied with

• under control

• achieving the desired results

Provide evidence, e.g. records, meeting minutes, reports,

data and emails

Page 41: “Quality has to be Mohd Nizam Ab caused, not Rahman · 1 “Quality has to be caused, not controlled.” Philip B. Crosby Mohd Nizam Ab Rahman Pusat Jaminan Kualiti UKM FOR TRAINING

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Audit Findings

Minor Non-conformity

Observation

Major Non-conformity

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Audit Findings

A major non-conformity relates to the absence or total

breakdown of a required process or a number of minor

non-conformities listed against similar areas

A major non-conformity at the Registration Audit would

defer recommendation for registration until that major

has been closed

Major Non-conformity

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Audit Findings

A minor non-conformity is an observed lapse in your

systems ability to meet the requirements of the standard

or your internal systems, while the overall process

remains intact

Minor Non-conformity

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Audit Findings

An observation or opportunity for improvement relates to

a matter about which the Auditor is concerned but which

cannot be clearly stated as a non-conformity

Observations also indicate trends which may result in a

future non-conformity

Observation

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Messages to take home…

RBT likely to increase organizational resilience and

success and element in Process Approach

RBT is an input to Management Review

Risk attitudes and cultures influence organizational

behavior

People resources can be trained in methods and tools

RBT is an element in PDCA process and focused on

prevention

Effective leaders listen and learn (PDCA)

We only scratched the surface here….

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Q & A

Group Activity

Thank You Very Much

[email protected]