risk based thinking & qms risk management as per iso 9001...

Risk Based Thinking & QMS RiskManagement as per ISO 9001 - 2015

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Learning Outcomes• Introduction to ISO 9001 2015• 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 / Discussion01/09/2016 3




ISO 9001 2015

• International Standard• Applicable for any organization• Fundamental system• Auditable and certifiable standard• Fundamental QMS Concepts• Risk based approach

01/09/2016 4© 2016 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD



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.




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.




What is risk-based thinking?Risk-based thinking is something we all do automatically and often sub-

consciously 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

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Where is risk addressed in

ISO 9001:2015?

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Introduction - the concept of risk-based thinking is explainedClause 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 thinkingDetermine 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

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Risk-based thinking is in:

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

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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



Risk Management Framework

LeadershipContext


Plan

Do

Check

Act



Risk Management

Process




Actions to Address the Risks


Avoid : Change the Process, Upgrade the operationstechnology / Software, Go for OutsourcingAccept : KanBan Vs. Full InventoryShare/ Transfer : Insurance, Supplier Self Certification, Deviation PermitExploit / Retain : New Product Development, (Proactive) Cost of Quality, Staff Turnover (Skillsets / Organization Knowledge)Treat / Mitigate : (Reactive) Cost of Quality, CustomerDissatisfaction



Actions to Address the Risks


• Plan the actions to address the riskHigh 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



QMS Risk Management Techniques


QUANTITATIVE• Risk Register• Advanced Product

Quality Planning(APQP)• Failure Mode Effect

Analysis(FMEA)• Control Plan• SPC / SQC

QUALITATIVE• Risk Workshops• Project Quality Plan• Fault Tree• Flow Charts• Check Sheets



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.




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




Upcoming Batches for Lead Auditor

ISO 9001:2015 QMS Lead Auditor Course

Schedule: Jan 06, 2017 – Feb 03, 2017Days: 5 FridaysTime: 8 AM – 2 PM

ISO 14001:2015 EMS Lead Auditor Course

Schedule: Jan 13, 2017 – Feb 10, 2017Days: 5 FridaysTime: 2 PM – 8 PM

Clarification… If any?




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risk based thinking & qms risk management as per iso 9001...

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