Tools to Assist Risk Based Thinking

PMPA Quality Technical Committee Presentation

2018 – National Technical Conference Program
Foundation Tools to Assist Risked Based Thinking (RBT)

• Why and Where the ISO9001:2015 Quality Management System

Standard identifies the need for Risk Based Thinking
• Key Inputs and Risk Based Thinking Tools for your Transition to the
ISO9001:2015 or IATF 16949:2016 Quality Management Systems
• Use the Plan – Do – Check – Act Methodology when developing your
Risk Based Thinking Tool
• Provide Take Home Value for our Attendees

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 Why and Where the ISO9001:2015 Quality Management
System Standard identifies the need for Risk Based Thinking?

• Embedded in the ISO9001:2015 Quality Management Standard 10

Elements are the requirements to address, plan and promote Risk Based
Thinking (RBT) throughout the organization, as well as to verify the
effectiveness of actions taken to address risks
ISO9001:2015 – 10 Elements
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement

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 Why and Where the ISO9001:2015 Quality Management
System Standard identifies the need for Risk Based Thinking?

• Did you know the word “Risk” is mentioned 50 times in the standard
and demonstrates the significance and importance of the term.
• ISO9000:2015 QMS – fundamentals and vocabulary defines risks as
the effect of uncertainty
• ISO9001:2015 QMS - further explains RBT enables an organization to
determine the factors that could cause its processes and its QMS to
deviate from planned results, to put in place preventative measures
to minimize negative outcomes and to maximize opportunities as
they present themselves during RBT

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 Why and Where the ISO9001:2015 Quality Management System
Standard identifies the need for Risk Based Thinking?
• ISO9001:2015 Clauses specifically addressing risks

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 Why and Where the ISO9001:2015 Quality Management System
Standard identifies the need for Risk Based Thinking?
• 4.0 Context of the Organization.
• 4.1 Understanding the Organization and its Context
Have you determined the external and internal issues that are relevant to your
organization purpose and its strategic direction and those that affect your ability to
achieve the intended results of the QMS? (SWOT’s and/or Risk Assessment Tools)
• 4.2 Understanding the Needs and Expectation of Interested Parties
Have you determined the Needs and Expectations of interested parties that are
relevant to your QMS. (Interested Party List and Risk Assessment Tools)
• 4.3 Determine the Scope of the QMS
Has the scope of the QMS been determined taking into account the external and
internal issues, interested parties and your products and services (Risk Assessment
Tools
• 4.4 QMS and its Processes
Have you determined the inputs/outputs expected from the process? Have you
address the risks and opportunities as determined in accordance with the requirements
of 6.1 “Actions to address risks and opportunities” (Risk Assessment Tools
The above must be reviewed and monitored on a regular basis? (9.3.1 Management Review
Meeting to review 9.3.2 Management Review Inputs, and 9.3.3 Management Review Outputs).
Also include 9.1 Monitoring, Measurement, Analysis and Evaluation with regard to 9.1.3 Analysis
and Evaluation requirements to determine the effectiveness of actions taken to address risks and
opportunities
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 Why and Where the ISO9001:2015 Quality Management System
Standard identifies the need for Risk Based Thinking?

• 5.1 Leadership (Leadership from upper Management is critical) (ISO9004:2018)

Top Management shall demonstrate Leadership and Commitment
with respect to the QMS by promoting the use of the process approach and
risk based thinking, including 5.1.2 Customer Focus and ensuring “the risks
and opportunities that can affect conformity of products and services and
the ability to enhance customer satisfaction are determined and
addressed”

• 6.1 Actions to Address Risks and Opportunities

6.1.1 Determine the risks and opportunities that need to be
addressed (from 4.1 and 4.2).
6.1.2 Determine the actions to address these risks and opportunities,
integrate them into the QMS and evaluate the effectiveness of these
actions.

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Risk Based Thinking (RBT) Tools for your Transition
to the ISO9001:2015 Quality Management Systems

• SWOT Internal & External Analysis and Lists

• Internal and External Risk Register Reports
• Interested Parties Needs & Expectation List
• Interested Parties Risk Register Report
• Product Feasibility Studies
• Process - FMEA and Design - FMEA
• Internal Audit of your Processes
• Plant/Facility Wide Risk Aspect List
• Action Plans to Address Risks and Opportunities
(Preventive Actions)
• Management Review (Plan – Do – Check – Act)

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 SWOT Analysis Overview
• SWOT Analysis primary objective is to help organizations develop full
awareness of all factors involved in a decision
• Created in the 1960’s by Edmund P. Learned, C. Roland Christensen,
Kenneth Andrews & William D. Book in their book
• “Business Policy, Text and Cases” R.D. Irwin, 1969)

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Team Approach
• It is important to get the most out of your SWOT analysis by using a
team approach.
• It is important to have the CEO involved but also members from all
facets of your organization

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Internal Factors
• The first two letters in the acronym S (Strengths) and W (Weaknesses)
refer to internal factors.
• Financial resources
• Physical resources (location, facilities, equipment)
• Human resources
• Current processes

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 Strength
What advantages does your organization have?
What do you do better than everyone else?
What unique or lowest-cost resources can you draw
upon that others can't?
What do people in your market see as your strengths?
What factors mean you get the sale?
What is your organizations Unique Selling
Proposition?
S
W
O
T

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Strength

What advantages does your organization have?

What do you do better than anyone else?
What unique or lowest-cost resources can you draw upon that others can't?
What do people in your market see as your strengths?

Weakness
What factors mean you get the sale?
What is your organizations Unique Selling Proposition

What could you improve?

What should you avoid?
S What are people in your market
likely to see as a weakness?
W What factors lose you sales

Consider from an Internal &

External perspective
O
T

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External factors
• The second two letters in the acronym
O (Opportunities) and T (Threats) refer to external factors.
• Market trends
• Economic trends
• Relationships with suppliers and partners
• Political, environmental and economic regulations

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Strength

What advantages does your organization have?

What do you do better than anyone else?
What unique or lowest-cost resources can you draw upon that others can't?
What do people in your market see as your strengths?
What factors mean you get the sale?
What is your organizations Unique Selling Proposition Weakness

What could you improve?

What should you avoid?
What are people in your market likely to see as a
weakness?

S What factors lose you sales

W Consider from an Internal & External perspective

Opportunities
What good opportunities can you
O
spot? T
What interesting trends are you
aware of?

Use full opportunities can come

form such things as…
Changes in Technologies,
Government Policies, Social
patterns, population profiles
lifestyle changes

Look at your strengths and ask

yourself whether these open up any
opportunities

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Strength

What advantages does your organization have?

What do you do better than anyone else?
What unique or lowest-cost resources can you draw upon that others can't?
What do people in your market see as your strengths?
What factors mean you get the sale?
What is your organizations Unique Selling Proposition Weakness

What could you improve?

What should you avoid?
What are people in your market likely to see as a
weakness?

S What factors lose you sales

W Consider from an Internal & External perspective

Opportunities

What good opportunities can you spot? What

interesting trends are you aware of?
O
Use full opportunities can come form such things as
Changes in Technologies, Government Policies, Social
T
patterns, population profiles lifestyle changes

Look at your strengths and aske yourself whether these

open up any opportunities

Threats
What obstacles do you face?
What are your competitors doing?
Are quality Standards or Specifications for products or
services changing?
Is technology threating your business?
Bad Debt or Cash Flow problems?
Could any of your weaknesses seriously threaten your
business?

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SWOT – Internal Analysis

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SWOT – External Analysis

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Interested Parties List

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Product Feasibility Studies to Determine Risks

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Product – P-FMEA and Design – FMEA to Determine Risk

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P-FMEA Review. Determine Risk Rating (R.P.N) = Severity X Occurrence X Detection Rating.
Determine actions and responsibilities to mitigate or reduce the high risk ratings (R.P.N)

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Internal Audit of your Processes

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Internal Audit of your Processes

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Plant/Facility Risk Aspect List

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Plant/Facility Risk Aspect List

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Management Review (Plan – Do – Check – Act)

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Management Review (Plan – Do – Check – Act)

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Action Plans to Address Risks and Opportunities
(Preventive Actions)

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 Dan Wilson
The ISO9001:2015 Standard Structure is built around the Plan, Do, Check, Act Cycle 11/1/2017

Plan Do Check Act

4.0 Context of the 9.0 Performance 10.0

5.0 Leadership 6.0 Planning 7.0 Support 8.0 Operations
Organization Evaluation Improvement

4.1 9.1 Monitoring, 10.1 General, Org

5.1 Leadership 6.1 Actions to
Understanding of 8.1 Operational Measurement, shall determine &
and its Address Risks & 7.1 Resources
the Organization Planning & Control Analysis and Select Opportunities
Commitment Opportunities
and its context Evaluation for Improvement

4.2
6.2 Quality
Understanding 8.2 Requirements 10.2 Nonconformity
Objectives and
the Needs and 5.2 Quality Policy 7.2 Competence for Products and 9.2 Internal Audit & Corrective Action
Planning to
Expectations of Services
Achieve Them
Interested Parties

4.3 5.3 Organizational 8.3 Design and

Understanding Roles, 6.3 Planning of Developments of 9.3 Management 10.3 Continual
7.3 Awareness
the Scope of the Responsibilities & Changes Products and Review Improvement
QMS Authorities Services

4.4 8.4 Control of

Undertsanding 7.4 Externally provided
the QMS and its Communication processes, products
Processess and Services

8.5 Production and

Service Provision
7.5 Documented
Information
8.6 Release of
products and
services

8.7 Control of
Nonconforming
Outputs

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Questions and Answer Session

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Closing Comments

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