Tools to Assist Risk Based Thinking PMPA Quality Technical Committee Presentation 2018 National Technical Conference Program

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Carol Ferguson
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1 Tools to Assist Risk Based Thinking PMPA Quality Technical Committee Presentation 2018 National Technical Conference Program

2 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 Page 2 of 35

3 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: 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 Page 3 of 35

4 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 Page 4 of 35

5 Why and Where the ISO9001:2015 Quality Management System Standard identifies the need for Risk Based Thinking? ISO9001:2015 Clauses specifically addressing risks Page 5 of 35

6 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 Management Review Inputs, and Management Review Outputs). Also include 9.1 Monitoring, Measurement, Analysis and Evaluation with regard to Analysis and Evaluation requirements to determine the effectiveness of actions taken to address risks and opportunities Page 6 of 35

7 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 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 Determine the risks and opportunities that need to be addressed (from 4.1 and 4.2) Determine the actions to address these risks and opportunities, integrate them into the QMS and evaluate the effectiveness of these actions. Page 7 of 35

8 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) Page 8 of 35

9 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) Page 9 of 35

10 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 Page 10 of 35

11 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 Page 11 of 35

12 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? O S T W Page 12 of 35

13 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 O S T W What could you improve? What should you avoid? What are people in your market likely to see as a weakness? What factors lose you sales Consider from an Internal & External perspective Page 13 of 35

14 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 Page 14 of 35

15 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 Opportunities What good opportunities can you spot? O S T W What could you improve? What should you avoid? What are people in your market likely to see as a weakness? What factors lose you sales Consider from an Internal & External perspective 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 Page 15 of 35

16 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 Opportunities What good opportunities can you spot? 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 aske yourself whether these open up any opportunities O S T W Threats What could you improve? What should you avoid? What are people in your market likely to see as a weakness? What factors lose you sales Consider from an Internal & External perspective 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? Page 16 of 35

17 SWOT Internal Analysis Page 17 of 35

18 SWOT External Analysis Page 18 of 35

19 Page 19 of 35

20 Page 20 of 35

21 Interested Parties List Page 21 of 35

22 Page 22 of 35

23 Product Feasibility Studies to Determine Risks Page 23 of 35

24 Product P-FMEA and Design FMEA to Determine Risk Page 24 of 35

25 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) Page 25 of 35

26 Internal Audit of your Processes Page 26 of 35

27 Internal Audit of your Processes Page 27 of 35

28 Plant/Facility Risk Aspect List Page 28 of 35

29 Plant/Facility Risk Aspect List Page 29 of 35

30 Management Review (Plan Do Check Act) Page 30 of 35

31 Management Review (Plan Do Check Act) Page 31 of 35

32 Action Plans to Address Risks and Opportunities (Preventive Actions) Page 32 of 35

33 The ISO9001:2015 Standard Structure is built around the Plan, Do, Check, Act Cycle Dan Wilson 11/1/2017 Plan Do Check Act 4.0 Context of the Organization 5.0 Leadership 6.0 Planning 7.0 Support 8.0 Operations 9.0 Performance Evaluation 10.0 Improvement 4.1 Understanding of the Organization and its context 5.1 Leadership and its Commitment 6.1 Actions to Address Risks & Opportunities 7.1 Resources 8.1 Operational Planning & Control 9.1 Monitoring, Measurement, Analysis and Evaluation 10.1 General, Org shall determine & Select Opportunities for Improvement 4.2 Understanding the Needs and Expectations of Interested Parties 5.2 Quality Policy 6.2 Quality Objectives and Planning to Achieve Them 7.2 Competence 8.2 Requirements for Products and Services 9.2 Internal Audit 10.2 Nonconformity & Corrective Action 4.3 Understanding the Scope of the QMS 5.3 Organizational Roles, Responsibilities & Authorities 6.3 Planning of Changes 7.3 Awareness 8.3 Design and Developments of Products and Services 9.3 Management Review 10.3 Continual Improvement 4.4 Undertsanding the QMS and its Processess 7.4 Communication 8.4 Control of Externally provided processes, products and Services 7.5 Documented Information 8.5 Production and Service Provision 8.6 Release of products and services Page 33 of Control of Nonconforming Outputs