Quality Progress - October 2017 - 20

F E AT U R E

ISO 9001:2015
and prepare preventive actions
to mitigate those risks, including contingency plans, where
necessary."2
ISO 9000:2015-Quality management systems-fundamentals
and vocabulary, defines risk as
the effect of uncertainty. ISO
9001:2015 further explains the
concept of risk-based thinking.
Risk-based thinking enables
an organization to determine
the factors that could cause its
processes and its QMS to deviate
from the planned results, to put in
place preventive controls to minimize negative effects and to make
maximum use of opportunities as
they arise.
In fact, the word "risk" is
mentioned 50 times in the standard-which demonstrates the
significance and importance of
the term.
Embedded in the standard's
10 elements (Figure 1) are the
requirements to address, plan
and promote risk-based thinking
throughout the organization, as
well as to verify the effectiveness
of actions taken to address risks.

FIGURE 1

ISO 9001:2015-
10 elements
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement

20 QP

TA B L E 1

ISO 9001:2015 clauses specifically
addressing risk
Introduction 1.1 (c)

Address risks and opportunities associated with
organizational context and objectives.

Process approach 1.3.1

Management of the processes and the system as a whole
can be achieved using the plan-do-check-act cycle with an
overall focus on risk-based thinking.

Risk-based thinking 1.3.3

Risk-based thinking is essential for achieving an effective
quality management system.

Quality management system
and its processes 4.4.1 (f)

Address the risks and opportunities as determined in
accordance with the requirements.

Leadership and commitment
5.1.1 (d)

Promote the use of the process approach and risk-based
thinking.

Customer focus 5.1.2 (b)

Determine and address risks and opportunities that can
affect conformity of products and services and the ability
to enhance customer satisfaction.

Actions to address risks and
opportunities 6.1.1

When planning for the quality management system, the
organization shall consider the issues and determine the
risks and opportunities that need to be addressed.

Actions to address risks and
opportunities 6.1.2

Actions taken to address risks and opportunities shall be
proportionate to the potential impact on the conformity of
products and services.

Analysis and evaluation
9.1.3 (e)

Evaluate the effectiveness of actions taken to address risks
and opportunities.

Management review inputs
9.3.2 (e)

Management provides feedback on the effectiveness of
actions taken to address risks and opportunities.

Nonconformity and
corrective action 10.2.1 (e)

Update risks and opportunities determined during
planning, if necessary.

Table 1 lists the relevant clauses
specifically addressing risk in ISO
9001:2015.

Introducing FMEA

So, is there a risk management
approach that is known and proven
to be effective that many quality
practitioners are already aware of?
Yes-FMEA, which includes
evaluating potential failure modes
and their effect on outcomes. The
technique methodically breaks down
the analysis of complex products
and processes into manageable
steps. Risk reduction can be used to
eliminate, contain, reduce or control
failures and risks. This tool is one of
the fundamental tools used in the

October 2017 ❘ qualityprogress.com

practice of reliability and can be
applied readily to the QMS to identify and manage risk.
The potential areas of use for
FMEA are to prioritize risks and
monitor the effectiveness of risk
control activities. It can be applied
to user needs, products (design and
manufacture), processes (quality and
service), equipment and facilities. It
can even be used to analyze a manufacturing operation and its effect on
a product or process. FMEA identifies elements and operations in the
system that render it vulnerable to
risks. The output or results of FMEA
can be used as a basis for design or
further analysis, can guide resource
deployment and control plans.


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Table of Contents for the Digital Edition of Quality Progress - October 2017

Seen and Heard
Progress Report
Mr. Pareto Head
Expert Answers
Career Coach
In Focus
The Results Are In
Visual Aid
Experimental Learning
Statistics Spotlight
Standard Issues
Marketplace
Footnotes
Try This Today
STANDARDS AND AUDITING GUIDE
Quality Progress - October 2017 - intro
Quality Progress - October 2017 - cover1
Quality Progress - October 2017 - cover2
Quality Progress - October 2017 - 1
Quality Progress - October 2017 - 2
Quality Progress - October 2017 - 3
Quality Progress - October 2017 - 4
Quality Progress - October 2017 - 5
Quality Progress - October 2017 - Seen and Heard
Quality Progress - October 2017 - 7
Quality Progress - October 2017 - Progress Report
Quality Progress - October 2017 - Mr. Pareto Head
Quality Progress - October 2017 - 10
Quality Progress - October 2017 - 11
Quality Progress - October 2017 - Expert Answers
Quality Progress - October 2017 - 13
Quality Progress - October 2017 - Career Coach
Quality Progress - October 2017 - 15
Quality Progress - October 2017 - 16
Quality Progress - October 2017 - 17
Quality Progress - October 2017 - In Focus
Quality Progress - October 2017 - 19
Quality Progress - October 2017 - 20
Quality Progress - October 2017 - 21
Quality Progress - October 2017 - 22
Quality Progress - October 2017 - 23
Quality Progress - October 2017 - 24
Quality Progress - October 2017 - 25
Quality Progress - October 2017 - The Results Are In
Quality Progress - October 2017 - 27
Quality Progress - October 2017 - 28
Quality Progress - October 2017 - 29
Quality Progress - October 2017 - 30
Quality Progress - October 2017 - 31
Quality Progress - October 2017 - 32
Quality Progress - October 2017 - 33
Quality Progress - October 2017 - Visual Aid
Quality Progress - October 2017 - 35
Quality Progress - October 2017 - 36
Quality Progress - October 2017 - 37
Quality Progress - October 2017 - 38
Quality Progress - October 2017 - 39
Quality Progress - October 2017 - Experimental Learning
Quality Progress - October 2017 - 41
Quality Progress - October 2017 - 42
Quality Progress - October 2017 - 43
Quality Progress - October 2017 - 44
Quality Progress - October 2017 - 45
Quality Progress - October 2017 - 46
Quality Progress - October 2017 - 47
Quality Progress - October 2017 - Statistics Spotlight
Quality Progress - October 2017 - 49
Quality Progress - October 2017 - Standard Issues
Quality Progress - October 2017 - 51
Quality Progress - October 2017 - 52
Quality Progress - October 2017 - 53
Quality Progress - October 2017 - 54
Quality Progress - October 2017 - 55
Quality Progress - October 2017 - STANDARDS AND AUDITING GUIDE
Quality Progress - October 2017 - 57
Quality Progress - October 2017 - Marketplace
Quality Progress - October 2017 - 59
Quality Progress - October 2017 - Footnotes
Quality Progress - October 2017 - 61
Quality Progress - October 2017 - 62
Quality Progress - October 2017 - 63
Quality Progress - October 2017 - Try This Today
Quality Progress - October 2017 - cover3
Quality Progress - October 2017 - cover4
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