Risk Based Thinking & QMS Risk Management as per ISO

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Ada Mosley
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1 Risk Based Thinking & QMS Risk Management as per ISO PMI, PMP, PMBOK and the PMI Registered Education Provider logo are registered marks of the Project Management Institute, Inc.

2 At the end of the class, please fill the training feedback form! (Yellow paper in your notebook) Return the feedback form at the reception!

3 Learning Outcomes Introduction to ISO Terms & Definitions Introduction to QMS Risks, Opportunities and Risk based thinking Risk Management Principles Risk Management Framework Risk Management Process Actions to address the Risks QMS Risk Management Techniques Benefits & Success Factors Clarification / Discussion 01/09/2016 3

ISO 9001 2015 International Standard Applicable for any organization Fundamental system

4 ISO International Standard Applicable for any organization Fundamental system Auditable and certifiable standard Fundamental QMS Concepts Risk based approach 01/09/2016 4

QMS Risk Risk : Outcome of an uncertainty QMS Risk : Outcome of uncertainty to achieve QMS Objective Examples:- Compliance Violations, Penalties/Notices, No customers, Delays, Customer

5 QMS Risk Risk : Outcome of an uncertainty QMS Risk : Outcome of uncertainty to achieve QMS Objective Examples:- Compliance Violations, Penalties/Notices, No customers, Delays, Customer dissatisfaction, Customer Complaints, Rejections, Reworks, Product re-call, Bad reputation in the market, Incompetence, High Staff Turnover, Cost of Quality failures, etc. 01/09/2016 5

6 QMS OPPORTUNITIES Opportunity : Outcome of a favorable situation QMS Opportunity : Outcome of a favorable situation to achieve QMS Objectives. New Customers, New Markets, New Products / Services, New Scope, Customer Goodwill, Staff Goodwill, Employee Participation, Innovation & Creativity, Organizational Competence, Business Excellence, etc. 01/09/2016 6

7 What is risk-based thinking? Risk-based thinking is something we all do automatically and often subconsciously to get the best result The concept of risk has always been implicit in ISO 9001 this edition makes it more explicit and builds it into the whole management system Risk-based thinking ensures risk is considered from the beginning and throughout Risk-based thinking makes preventive action part of strategic and operational planning 7

8 Where is risk addressed in ISO 9001:2015? 8

9 Risk-based thinking is in: Introduction - the concept of risk-based thinking is explained Clause 4 - organization is required to determine its QMS processes and address its risks and opportunities Clause 5 top management is required to Promote awareness of risk-based thinking Determine and address risks and opportunities that can affect product /service conformity Clause 6 - organization is required to identify risks and opportunities related to QMS performance and take appropriate actions to address them 9

10 Risk-based thinking is in: Clause 7 organization is required to determine and provide necessary resources Clause 8 - organization is required to manage its operational processes Clause 9 - organization is required to monitor, measure, analyse and evaluate the effectiveness of actions taken to address risks and opportunities Clause 10 - organization is required to correct, prevent or reduce undesired effects and improve the QMS and update risks and opportunities Note, risk is implicit whenever suitable or appropriate is mentioned (clause 7 and 8) 10

11 Risk Management Principles Creates Value Integral part of business Enables decision making Explicitly addresses the Uncertainty Systematic, Structured & Timely Evidence based Tailored Considers human aspects Dynamic Transparent Continual Improvement 01/09/

12 Risk Management Framework Plan Act Leadership Context Do Check 01/09/

13 Risk Management Process 01/09/

14 Actions to Address the Risks Avoid : Change the Process, Upgrade the operations technology / Software, Go for Outsourcing Accept : KanBan Vs. Full Inventory Share/ Transfer : Insurance, Supplier Self Certification, Deviation Permit Exploit / Retain : New Product Development, (Proactive) Cost of Quality, Staff Turnover (Skillsets / Organization Knowledge) Treat / Mitigate : (Reactive) Cost of Quality, Customer Dissatisfaction 01/09/

15 Actions to Address the Risks Plan the actions to address the risk High level plan how to deal with Risks & Opportunities E.g. Risk Management Plan, Risk Treatment Plan, Risk Register,etc. Who will do what, when, where & How Implement the actions to address the risk 01/09/

16 QMS Risk Management Techniques QUANTITATIVE Risk Register Advanced Product Quality Planning(APQP) Failure Mode Effect Analysis(FMEA) QUALITATIVE Risk Workshops Project Quality Plan Fault Tree Flow Charts Check Sheets Control Plan SPC / SQC 01/09/

17 Benefits of QMS Risk Management Achieving the Quality Policy & Objectives Opportunities Capitalized (E.g. Customer Satisfaction, Market Share, Productivity, etc.) Threats Mitigated (Reduced Complaints/ Penalty / Cost of Quality / Variances) Assurance of Quality in Products and Services Confidence for the External & Internal Stakeholders Adds Values & Transparency to business model. 01/09/

18 Critical Success Factors Leadership Commitment and Support Empowerment for the Risk Owner No personal issues, only teamwork Individual & Organization Knowledge required Communication, Coordination & Follow up shall be effective 01/09/

19 Upcoming Batches for Lead Auditor ISO 9001:2015 QMS Lead Auditor Course ISO 14001:2015 EMS Lead Auditor Course Schedule: Jan 06, 2017 Feb 03, 2017 Days: 5 Fridays Time: 8 AM 2 PM Schedule: Jan 13, 2017 Feb 10, 2017 Days: 5 Fridays Time: 2 PM 8 PM

20 Clarification If any? 01/09/

21 Please return the feedback form at the reception! END OF THE SESSION

IMPORTANCE OF AUDITING ISO 9001: 2015

IMPORTANCE OF AUDITING ISO 9001: 2015 PMI, PMP, PMBOK and the PMI Registered Education Provider logo are registered marks of the Project Management Institute, Inc. At the end of the class, please fill