“Risk-Base Thinking” (RBT) ISO 9001:2015
Started in 2015, one of the important leap in international standardization is to form a Risk-Base Thinking in ISO 9001: 2015. As a novelty, the more information in a variety of presentation would facilitate understanding of the principles of thinking based on risk. ……
Rais_MR3 ( Bekasi, January 6, 2015)
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Overview 1
2015 Revision Issue Establish
Revision each 5 until 8 years
a systematic approach to risk in the quality management system.
2015
Clause
2008
1987
7 on, preventive actions removed and replaced by incorporating risk into all standard. Risk-based
2000
1994
Plans to publish the ISO 2001: 2015, Sept. 2015
approach, making the organization proactively prevent or reduce undesirable effects and promote continuous improvement.
What is
RBT (Risk-base thinking)
2
Risk-based
thinking is something 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 there is a car in front of moving.
What is
RBT (Risk-base thinking)
2 Risk-based
thinking is taking into account the risk to the overall management system.
•
Risks are taken into account from the beginning for the entire standard, risk-based thinking is part of the process approach.
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.
What is
RBT (Risk-base thinking)
2 Risk
is generally understood as a negative thing. In a risk-based thinking, remain positive opportunities of each risk occurring. Example: Crossing the road in a straightforward manner, will provide an opportunity to reach across the road quickly, but the risk of injury is high because there is 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..
What is
RBT (Risk-base thinking)
2 Opportunity
does not always do with risk but is directly related to the purpose. Taking into account the situation is possible to identify the increasing opportunities. Example: This situation shows that there are opportunities to make further improvements: Prioritize
direct subway under way The traffic light pedestrian, or Divert the road so that the area to avoid traffic Impact
and feasibility should be considered in decision making. Whatever action is taken will change
Why Use RBT (Risk-Base Thinking) 3
Taking
into account the overall risk, organizations will:
Improving
achievement of defined objectives,
The
output would be more consistent Customers
increasingly assured of receiving a product or service that is expected.
Why Use RBT (Risk-Base Thinking) 3 With
the risk-based thinking,:
Will
build a strong knowledge base Nurture a culture of proactive towards improvement Ensure
consistency of quality of goods or services Increase customer confidence and satisfaction
Intuitively
successful company always uses a riskbased approach
Where is risk addressed in ISO 9001:2015 4 DEFINITION
ISO 9001: 2015 defines risk as the impact of uncertainty on the expected results.
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 .
Where is risk addressed in ISO 9001:2015 4
The emphasis of the risk-based thinking in ISO 9001: 2015 as follows: Clause
4 (Context) the organization is required to determine and give effect to the level of risk.
Clause
5 (Leadership) top management is required to commit to ensure Clause 4 followed.
Clause
6 (Planning) organization shall take action to identify risks and opportunities.
Where is risk addressed in ISO 9001:2015 4 Clause
8 (Operations) the organization is required to implement a process to address the risks and capitalize on opportunities. Clause
9 (Evaluation of the performance of) the organization is required to monitor, measure, analyze and evaluate the risks and opportunities.
Clause
10 (Improvement) organizations are required to improve the response to changes in risk.
How do I do it 5
Using the approach of risk factors in the process of your organization
1. Identification
Identify the risks and opportunities of each option will be taken Example Risk 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.
Consider
things such as the weather, surroundings and other factors that could interfere.
How do I do it 5
2. Create Priorities Analysis and set priorities for risk and what opportunities can be accepted, or not accepted? What are the advantages or disadvantages derived from the option taken. Example Objective: I have to safely cross the road to reach a meeting at a specific time. With the condition was not injured and was not too late. Opportunity
to get faster but with the possibility of injury.
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.
How do I do it 5
3. Case Analysis.
250-meter pedestrian bridge will add to the time of my trip. So if the weather is good, good visibility, deserted streets are not many cars passing.
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 5
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
can I reduce the risks that may be happening?
How do I do it 5
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. 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 5
5. Implement the plan and take action
Examples: I cross the street, check there are no barriers to cross over and take a safe place in the middle of moving traffic.
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 5
6. Check the effectiveness of the action and how it works?
Examples: I came across the street unharmed and timely. This plan is executed and undesirable results can be avoided.
How do I do it 5
7. Learning from experience and continuous improvement. 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 day is 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
How do I do it 5
8. Some considerations innovative opportunities:
Move
the meeting place so it does not have to cross the street.
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.
Conclusion 6 Risk-based
thinking is not a new thing and something that you have done and continuously 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.
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 –
