“Risk-Base Thinking” (RBT)

ISO 9001:2015

……Rais_MR3 ( Bekasi, January 6, 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.

1987

1994 2000

2008

2015

Establish a

systematic approach to

risk 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

1 Overview

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.

2 What is RBT (Risk-base thinking)

•

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.

2

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)

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..

2 What is RBT (Risk-base thinking)

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

the context and risks.

2 What is RBT (Risk-base thinking)

Taking into account the overall

risk, organizations will:

3 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

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

3

Intuitively successful

company always uses a risk-

based approach

With the risk-based

thinking,:

Why Use RBT (Risk-Base Thinking)

DEFINITION

ISO 9001: 2015 defines risk as

the impact of uncertainty on the

expected results.

4 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 .

The emphasis of the risk-based

thinking in ISO 9001: 2015 as

follows:

4

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

Clause 10 (Improvement)

organizations are required to

improve the response to changes

in risk.

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.

Where is risk addressed in ISO 9001:2015

Using the approach of risk factors

in the process of your organization

5 How do I do it

1. Identification

Identify the risks and opportunities of each option will be taken

Consider things such as the

weather, surroundings and

other factors that could

interfere.

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.

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.

5

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.

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

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.

5

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

5

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

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.

5

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

Examples:

I cross the street, check

there are no barriers to

cross over and take a safe

place in the middle of moving

traffic.

5 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

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

7. Learning from experience

and continuous improvement.

5

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

context.

How do I do it

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

Risk-based thinking is not a

new thing and something that you

have done and continuously

6 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.