RISK-BASED THINKING IN ISO 9001:2015
Purpose of this paper
- to explain risk-based thinking in ISO 9001
- to address perceptions and concerns that risk-based thinking replaces the process approach
- to address the concern that preventive action has been removed from ISO 9001
- to explain in simple terms each component of risk-based thinking
What is risk-based thinking?
One of the key changes in
the 2015 revision of ISO 9001 is to establish a systematic approach to
considering risk, rather than treating “prevention†as a separate component of
a quality management system.
Risk is inherent in all
aspects of a quality management system. There are risks in all systems,
processes and functions. Risk-based thinking ensures these risks are
identified, considered and controlled throughout the design and use of the
quality management system.
In previous editions of
ISO 9001, a clause on preventive action was separated from the whole. By using
risk-based thinking the consideration of risk is integral. It becomes proactive
rather than reactive in preventing or reducing undesired effects through early
identification and action. Preventive action is built-in when a management
system is risk-based.
Risk-based thinking is
something we all do automatically in everyday life.
Example: If I wish to
cross a road I look for traffic before I begin. I will not step in front of a
moving car.
Risk-based thinking has
always been in ISO 9001 – this revision builds it into the whole management
system.
In ISO 9001:2015
risk-based thinking needs to be considered from the beginning and throughout
the system, making preventive action inherent to planning, operation, analysis and evaluation activities.
Risk-based thinking is
already part of the process approach.
Not
all the processes of a quality management system represent the same level of
risk in terms of the organization’s ability to meet its objectives. Some need
more careful and formal planning and controls than others.
Example: To cross the
road I may go directly or I may use a nearby footbridge. Which process I choose
will be determined by considering the risks.
Risk is commonly
understood to have only negative consequences; however the effects of risk can
be either negative or positive.
In ISO 9001:2015 risks
and opportunities are often cited together. Opportunity is not the positive
side of risk. An opportunity is a set of circumstances which makes it possible
to do something. Taking or not taking an opportunity then presents different
levels of risk.
Example:
Crossing the road
directly gives me an opportunity to reach the other side quickly, but if I take
that opportunity there is an increased risk of injury from moving cars.
Risk-based thinking considers both the current situation and the possibilities for change.
Analysis of this situation shows opportunities for improvement:
- a subway leading directly under the road
- pedestrian traffic lights, or
- diverting the road so that the area has no traffic
Where is risk addressed in ISO 9001:2015?
The concept of risk-based
thinking is explained in the introduction of ISO 9001:2015 as an integral part
of the process approach.
ISO 9001:2015 uses
risk-based thinking in the following way:
Introduction - the
concept of risk-based thinking is explained
Clause 4 – the organization
is required to determine its QMS processes and to address its risks and
opportunities
Clause 5 – top management
is required to
- Promote awareness of risk-based thinking
- Determine and address risks and opportunities that can affect product /service conformity
Clause 6 – the organization
is required to identify risks and opportunities related to QMS performance and
take appropriate actions to address them
Clause 7 – the organization is required to
determine and provide necessary resources (risk is implicit whenever “suitableâ€
or “appropriate†is mentioned)
Clause 8 – the organization is required to
manage its operational processes (risk is implicit whenever “suitable†or
“appropriate†is mentioned)
Clause 9 – the organization is required to
monitor, measure, analyse and evaluate effectiveness of actions taken to
address the risks and opportunities
Clause 10 – the organization is required to
correct, prevent or reduce undesired effects and improve the QMS and update
risks and opportunities
Why use risk-based thinking?
By considering risk
throughout the system and all processes the likelihood of achieving stated
objectives is improved, output is more consistent and customers can be
confident that they will receive the expected product or service.
Risk-based thinking:
- improves governance
- establishes a proactive culture of improvement
- assists with statutory and regulatory compliance
- assures consistency of quality of products and services
- improves customer confidence and satisfaction
- Successful companies intuitively incorporate risk-based thinking.
How do I do it?
Use risk-based thinking
in building your management system and processes.
Identify what your risks
are – it depends on
context
Example:
If I cross a busy road
with many fast-moving cars the risks are not the same as if the road is small
with very few moving cars. It is also necessary to consider such things as
weather, visibility, personal mobility and specific personal objectives.
Understand your risks
What is acceptable, what
is unacceptable? What advantages or disadvantages are there to one process over
another?
Example:
Objective: I need to safely cross a road to reach a
meeting at a given time.
It is UNACCEPTABLE to be
injured.
It is UNACCEPTABLE to be
late.
Reaching my goal more
quickly must be balanced against the likelihood of injury. It is more important
that I reach my meeting uninjured than it is for me to reach my meeting on
time.
It may be ACCEPTABLE to
delay arriving at the other side of the road by using a footbridge if the
likelihood of being injured by crossing the road directly is high.
I analyse the situation.
The footbridge is 200 metres away and will add time to my journey. The weather
is good, the visibility is good and I can see that the road does not have many
cars at this time.
I decide that walking
directly across the road carries an acceptably low level of risk of injury and
will help me reach my meeting on time.
Plan actions to address the risks
How can I avoid or
eliminate the risk? How can I mitigate risks?
Example: I could
eliminate risk of injury caused by being hit by a vehicle if I use the
footbridge but I have already decided that the risk involved in crossing the
road is acceptable.
Now I plan how to reduce
either the likelihood or the impact of injury. I cannot reasonably expect to
control the impact of a car hitting me. I can reduce the probability of being
hit by a car.
I plan to cross at a time
when there are no cars moving near me and so reduce the likelihood of an
accident. I also plan to cross the road at a place where I have good
visibility.
Implement the plan – take
action
Example:
I move to the side of the road, check there
are no barriers to crossing. I check there are no cars coming. I continue to look for cars whilst crossing
the road.
Check the effectiveness
of the action – does it work?
Example:
I arrive at the other side of the road
unharmed and on time: this plan worked
and undesired effects have been avoided.
Learn from experience – improve
Example:
I repeat the plan over
several days, at different times and in different weather conditions.
This gives me data to
understand that changing context (time, weather, quantity of cars) directly
affects the effectiveness of the plan and increases the probability that I will
not achieve my objectives (being on time and avoiding injury).
Experience teaches me
that crossing the road at certain times of day is very difficult because there
are too many cars. To limit the risk I revise and improve my process by using
the footbridge at these times.
- I continue to analyse the effectiveness of the processes and revise them when the context changes.
- I also continue to consider innovative opportunities:
- can I move the meeting place so that the road does not have to be crossed?
- can I change the time of the meeting so that I cross the road when it is quiet?
- can we meet electronically?
Conclusion
- Risk-based thinking:
- is not new
- is something you do already
- is on-going
- ensures greater knowledge of risks and improves preparedness
- increases the probability of reaching objectives
- reduces the probability of negative results
- makes prevention a habit
Other useful documents
- ISO 31000:2009 Risk Management – Principles and guidelines
- PD ISO/TR 31004:2013 Risk management - Guidance for the implementation of ISO 31000
- ISO 9001:2015 Risk-based thinking - power point presentation
- ISO 31010:2010 Risk management - Risk assessment techniques
User questions & answers