Risk Based Thinking & QMS Risk Management as per ISO

Transcription

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

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

5 Process System Management System Quality Management System Organization Customer or Client External Providers Evidence based / Objective PDCA Cycle Risk Opportunity Risk Profile Risk Treatment Intrinsic & Residual Risk Control Measures Risk Owner Risk Criteria Risk Priority Number 01/09/2016 5

6 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 6

7 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 7

8 Risk Based Thinking A new approach. For the QMS to have the best benefits, all critical factors which might influence shall be identified and managed Consider the Risks & Opportunities prior to planning E.g. Context Analysis, Resource Provision, Design the Operations, Manage the Customers, Manage the Products, Manage the resources, Manage the Projects 01/09/2016 8

9

10 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/

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

12 Risk Management Process 01/09/

13 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/

14 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/

15 QMS Risk Management Techniques QUANTITATIVE Risk Register APQP FMEA Control Plan SPC / SQC QUALITATIVE Risk Workshops Project Quality Plan Fault Tree Flow Charts Check Sheets 01/09/

16 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/

17 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/

18 Clarification If any? 01/09/

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