How to implement risk management in ISO 9001:2015

How to implement risk management in ISO 9001:2015

Presenter: Carlos Pereira da Cruz

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What is risk-based thinking (RBT) and how do you apply it?

If you are planning a transition to, or just starting the implementation of ISO 9001:2015…

...you can save a lot of time if you approach RBT systematically.

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Risk-based thinking was always present; it just wasn’t called by

that name.


•Risk-based thinking process

•Risk definition and scope

•Choosing the best technique

• Intended outcomes, Products & services, and Processes

•Documenting and evidencing the RBT

•Main challenges

Agenda

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•Define the scope

•Adopt the methodology

•Conduct the risk assessment

•Mitigate the risks

•Follow up

•Watch the signs on the road!

Risk-based thinking process


•Risk = effect of uncertainty

•Note 1: An effect is a deviation from the expected - positive or negative

•4.4.1 f)

•5.1.2 b)

•6.1

•9.3.2 e)

•10.2.1 d)

Risk definition and scope

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•Context of the organization

•The type and range of risks being analyzed

•The availability of information and data

•Regulatory and contractual requirements

Choosing the best technique

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Intended outcomes

•Use the results of the SWOT analysis

Opportunities Threats Strengths Weaknesses

• Big competitor

closed

• Sustainability of

subcontractors

• Fast

sampling• Short

assembling

capacity

Expected result: Win more sales from new customers

Opportunity: Win new customers that were served by the now closed

competitor making use of our fast sampling skills

Risk: Economically weaker subcontractor could no longer be profitable and

close without orders from the now closed competitor. Our orders alone don’t sustain him

Risk: Winning orders that we cannot serve due to assembling capacity

shortage


•Complaints and devolutions

•Quality control nonconformities

•Lost customers

•Competitive advantages

Products and services

Expected result: Product density within specification limits

Risk: use of different sources of raw material A makes density variability much

wider

Opportunity: change the product recipe to make it much less prone to density

variability


•Use a flowchart

•Ask what can go wrong or be improved

• If needed or required use techniques like FMEA or HACCP

Processes

Receive

finished

product

Store

finished

product

Expected result: Correct package operation

Package

finished

product?

Wrong package

Wrong label

Wrong product

Improve label printing


•What the standard requires

•Should we document it?

•How to provide evidences of RBT

Documenting and evidencing the RBT

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•Defining the scope of the risk assessment

• Selecting a risk assessment technique

•Conducting a risk assessment

• Evidencing risk based thinking

Main challenges

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Conclusion

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Examine the context of your organization and choose the best

technique for you.

Risk-based thinking is continuous and ensures greater knowledge and

preparedness.

Q & A

Carlos Pereira da Cruz

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How to implement risk management in ISO 9001:2015

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