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Risk-Base Thinking (RBT)
ISO 9001:2015
Rais_MR3 ( Bekasi, January 6, 2015)
Started in 2015, one of the important leap ininternational standardization is to form a Risk-BaseThinking in ISO 9001: 2015. As a novelty, the moreinformation in a variety of presentation wouldfacilitate understanding of the principles of thinkingbased on risk.
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1987
19942000
2008
2015
Establish a
systematic approach torisk in the quality
management system.
Clause 7 on,
preventive actions
removed and replaced by
incorporating risk into
all standard.
Risk-based approach,
making the organization
proactively prevent or
reduce undesirable
effects and promote
continuous improvement.
Revision each 5 until 8 years
2015 Revision Issue
Plans to publish the ISO 2001: 2015, Sept. 2015
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Overview
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Risk-based thinking issomething that we've all done
automatically.
Example: If I want to
cross the road I will
ensure safe conditions
before my street. I
would not move if thereis a car in front of
moving.
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What is RBT (Risk-base thinking)
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Risk-based thinking is taking
into account the risk to the
overall management system.
Example:
To cross the road I may directly or use the
pedestrian bridge nearby. I select a process that
will be determined by consideration of risk.
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Risks are taken into
account from the
beginning for the entire
standard, risk-based
thinking is part of the
process approach.
What is RBT (Risk-base thinking)
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Risk is generally understood as
a negative thing. In a risk-based
thinking, remain positiveopportunities of each risk
occurring.
Example:
Crossing the road in astraightforward manner, will
provide an opportunity to
reach across the road
quickly, but the risk of
injury is high because thereis a car moving.
The risk of using the pedestrian bridge is that
I might be too late. But the chances of getting
hit by a car is very small..
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What is RBT (Risk-base thinking)
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Opportunity does not always do with
risk but is directly related to the
purpose. Taking into account thesituation is possible to identify the
increasing opportunities.
Example:
This situation shows that there areopportunities to make further
improvements:
Prioritize direct subway under way
The traffic light pedestrian, orDivert the road so that the area
to avoid traffic
Impact and feasibility should be considered in
decision making. Whatever action is taken will changethe context and risks.
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What is RBT (Risk-base thinking)
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Taking into account the overall
risk, organizations will:
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Why Use RBT (Risk-Base Thinking)
Improving achievement
of defined objectives,
Customers increasingly assured of receiving a
product or service that is expected.
The output would be
more consistent
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Will build a strong knowledge base
Nurture a culture of proactive towards improvement
Ensure consistency of quality of goods or servicesIncrease customer confidence and satisfaction
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Intuitively successfulcompany always uses a risk-
based approach
With the risk-based
thinking,:
Why Use RBT (Risk-Base Thinking)
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DEFINITION
ISO 9001: 2015 defines risk asthe impact of uncertainty on the
expected results.
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Where is risk addressed in ISO 9001:2015
Effect is a deviation from the
expected can be positive or
negative.
The risk is about what could happen
and whether this effect might occur.
The risk is also considering the possibility of
achieving the target of the management system .
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The emphasis of the risk-based
thinking in ISO 9001: 2015 as
follows:
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Clause 5 (Leadership) top
management is required to
commit to ensure Clause 4
followed.
Clause 4 (Context) the organization is required to
determine and give effect to the level of risk.
Clause 6 (Planning) organization shall take action
to identify risks and opportunities.
Where is risk addressed in ISO 9001:2015
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Using the approach of risk factors
in the process of your organization
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How do I do it
1. Identification
Identify the risks and opportunities ofeach option will be taken
Consider things such as the
weather, surroundings and
other factors that could
interfere.
ExampleRisk crossing the road at a busy time with a lot of
fast moving cars, not the same if the cross on a
deserted road with a bit of a moving car.
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Analysis and set priorities for risk and whatopportunities can be accepted, or not accepted? What
are the advantages or disadvantages derived from the
option taken.
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Example
Objective: I have to safely cross the road to reach ameeting at a specific time. With the condition was not
injured and was not too late.
Might be acceptable, if late arriving across the
street because it uses a bridge rather than the
possibility of injury due to the direct cross.
Opportunity to get faster but
with the possibility of injury.
2. Create Priorities
How do I do it
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250-meter pedestrian bridge will
add to the time of my trip. Soif the weather is good, good
visibility, deserted streets are
not many cars passing.
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3. Case Analysis.
So I decided to directly cross the street with a low
level of risk of injury and had a chance to reach
the meeting on time.
How do I do it
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How can I reduce the risks that may be
happening?
4. Create a Plan
Plan of action to address
the risks that may occur
are:
How can I avoid or eliminate
the risk when crossing?
How do I do it
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Sample Case:I could eliminate the risk of
injury by using the bridge but
I've decided that any risks that
occur when crossing the road is
acceptable.
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Plans and considerations:Reduce the possibility of injury
and injury or effect, the cross
when no cars are moving at close
to me.
Crossing the road in a place that has good visibility
and can stop in the middle to look back on the number
of cars that move.
How do I do it
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Examples:
I cross the street, checkthere are no barriers to
cross over and take a safe
place in the middle of moving
traffic.
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5. Implement the plan and
take action
I check there are no cars coming. I crossed half
way and stopped in the middle in a safe place. I
check again later to continue crossing the street
situation.
How do I do it
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5
6. Check the effectiveness
of the action and how itworks?
Examples:
I came across the street
unharmed and timely. This plan
is executed and undesirable
results can be avoided.
How do I do it
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7. Learning from experience
and continuous improvement.
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Example
I repeat the plan for a few days, at different times
and in different weather conditions.? Experience
teaches, that cross the road at a certain time of dayis very difficult because there are too many cars.
To limit the risk of me
revise and improve the process
by using a bridge on the
condition.
I continue to analyze the effectiveness of the
process and revise them if there is a change of
context.
How do I do it
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5
Move the meeting place so it
does not have to cross the
street.
8. Some considerations
innovative opportunities:
Change the meeting time so I cross the
street when the quiet of the vehicle.
I can have a meeting with the use of
equipment electronic.
How do I do it
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Risk-based thinking is not a
new thing and something that you
have done and continuously
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Conclusion
Source readings:
....
ISO 31000: 2009 Risk Management Principles and
guidelines
PD ISO / TR 31 004: 2013, Guidelines for the
implementation of risk management - ISO 31000
Risk-based thinking:
Ensure greater knowledge and readiness.
Increase the likelihood of achieving the goal. Make a habit of prevention
Reduce the possibility of a bad outcome.