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Qms & iatf presentation1
This document provides an introduction to quality management systems (QMS), ISO 9001:2015, and IATF 16949:2016 standards. It discusses the basics of a QMS and highlights key changes between versions of the ISO 9001 and IATF 16949 standards. The document outlines the contents to be covered, including introductions to quality documentation, processes, risk analysis methods like PDCA and fishbone diagrams. It also introduces the key standards organizations IATF, IAOB, and AIAG and their purposes in developing consensus on automotive quality systems.
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Qms & iatf presentation1
- 1. 1 QMS, ISO 9001:2015& IATF 16949:2016 Introduction And Awareness Doing the right things in the right way
- 2. 2 Introduction toQuality Management System (QMS) Basics of Quality Management System (QMS) Introduction to ISO Organizations for Automotive Transition of ISO 9001:2015 Changes in ISO 9001:2015 Compared to ISO 9001:2008 Transition of IATF 16949:2016 Changes in IATF 16949:2016 Compared to ISO 9001:2008 PDCA Methodology – ISO/TS & IATF High Level Structure of ISO 9001:2015 Specific requirements of ISO 9001:2015 Specific requirements of IATF 16949: 2016 ISO 9001:2015 and IATF 16949:2016 Clauses and Requirements Contents
- 3. 3 What do youknow about QMS?
- 4. 4 What do youunderstand by QMS? Quality Management System: A Quality Management System is a collection of - Policies, Processes Procedures Plans Resources Practices Responsibilities Authorities To achieve product and services quality levels, customer satisfaction and company objectives.
- 5. 5 Quality Control Quality Assurance QualitySystem What do you understand by QMS?
- 6. 6 Quality Management Principles 1.Customer Focus 2. Leadership 3. People Involvement 4. Process Approach 5. Implement 6. Factual Approach to Decision Making 7. Mutually Beneficial Supplier Relationships
- 7. 7 What do youunderstand by QMS? Policy, Vision, Mission, QM Procedures Forms, Formats, Work Instructions, Guidelines, Standards, Specification, Checklists, Standards, Training Material, etc. All Filled up and Completed Documents Stored in Hard / Soft Format, etc. Level 1 (L1) Level 2 (L2) Level 3 (L3) Level 4 (L4) L1 L2 L3 L4
- 8. 8 Introduction of QualityDocumentation? 1. Quality Policy (Objectives of the Organization) 2. Vision / Mission (Where we want to see ourselves in future) 3. Quality Manual (Collection of Principles from Standards) 4. Quality Procedures (Set of requirements from functions) 5. Forms / Formats (Structured form if Information) 6. Checklist / Check Sheet (What is the difference?) 7. Standards (What something should be?) 8. Work Instructions (How to perform specific Task Correctly?) 9. Specifications (Statement of precise requirement)
- 9. 9 Why Industries needQMS? QMS affects every aspect of an organization's performance. To meet the customer’s requirements Counter meeting organization's requirements, which ensure compliance with regulations To utilize cost and resources efficiently Creating room for expansion, growth and profit Increasing Brand Value and Reputation of the Organization
- 10. 10 Process Map /InteractionMatrix Process Interaction Matrix • Scope of QMS • Interaction of Processes with each other • Categorization of processes into Management Oriented Processes (MOP), Customer Oriented Processes (COP) and Support Oriented Processes (SOP) • Flow of processes from Inputs by Customer to Out to the customer. Title: - Interaction of Processes Issue Date: 01.01.2019 Issue No. 01 Revision No & Date: 01/01.01.2019 #TopManagement * Customer Oriented Process ** Support Process #Management Process INTERACTION OF PROCESSES Marketing Purchase Store HR Quality NPD Production BusinessPlan ManagementReview StrategicPlanning ContingencyPlan Maintenance #Outsource Process #MR InternalAudit CorrectiveAction PreventiveAction OutsourceProcess
- 11. 11 Process Map /InteractionMatrix Process Interaction Matrix • Scope of QMS • Interaction of Processes with each other • Categorization of processes into Management Oriented Processes (MOP), Customer Oriented Processes (COP) and Support Oriented Processes (SOP) • Flow of processes from Inputs by Customer to Out to the customer.
- 12. 12 Customer needs & Expectations Customer SatisfactionProcess Quality Policies Quality Standards/ Specifications Quality Manual Document Forms/ Formats Records Quality Procedures Continuous Improvement Monitoring & Tracking Process Approach I N P U T O U T P U T
- 13. 13 Turtle Diagram With WhatResources? •Various resources as identified from actions. PROCESS OUTPUT •Received Customer feedback on satisfaction assessment. •Dissatisfaction evaluation. •Actions to enhance customer satisfaction •Implemented actions. •Effectiveness of implemented action PROCESS CUSTOMER SATISFACTION With Who? (Competence/ Skills /Training) •Skills to analyze data. PROCESS INPUT •Customer complaint/ returns •Customer Satisfaction assessment frequency. •Customer Satisfaction assessment Form. •Customer’s audit report. •Customer Ratings. •Risk Analysis & Opportunity •CSR With what Methods? •Send customer satisfaction assessment form to all major customers at least once in a year. •Obtaining of filled form with identified dissatisfaction. •Take actions against it. •Review of effectiveness for implemented actions. With what Key Criteria? •Customer satisfaction rating. Team Members •All functional Heads Process Owner HOD- MARKETING/M.R. INPUT OUTPUT
- 14. 14 Development of ISO9001: 2015
- 15. 15 What’s new inISO 9001: 2015?
- 16. 16 Process Approach &High Level Structure (HLS) P DC A 4 6 7 8 9 10 Context of the Organization 4 Leadership 5 Planning 6 Support 7 Operation 8 Performance Evaluation 9 Improvement 10 Leadership 5
- 17. 17 17 GALLAY INDIA PRIVATELIMITED GI/MR/FR/38 01/01.10.18 CONTEXT OF ORGANIZATION 1. INTERNAL ISSUES OF CONCERN 1.1. The following are issues of concern which have been, or may be raised by internal interested parties. Type Issue Bias Technological Organization has established adequate technological resources to consistently produce all products. Positive Employee base Availability of skilled workforce in the area remains high Positive Employee base Employee turnover is low Positive Supply Chain Quality issues pertaining to raw materials or critical services may not be addressed properly when using sole source or limited-source suppliers Negative Employee Safety Plant operation / maintenance activities are carried with following safety rules strictly. Positive Health Checkup Health checkup of all employees to be done annually. (Presently-NA) Positive Medical Services. Fully equipped Hospital is available for 24 hours near by company. Positive Employee Training Employees training were conducted for their development Positive Context of the Organization
- 18. 18 18 2. EXTERNAL ISSUESOF CONCERN 2.1. The following are issues of concern which have been, or may be raised by external interested parties. Type Issue Bias Competition More competitors for marketing may result in restriction in production. Neutral Society & Culture Organization provide Medical services , which makes good social relations Positive Labour Safety kits, PPE & annual health checkup ensured ( NA) Positive Statutory/Regulat ory All Statutory rule & regulation are followed & updates disseminated from time to time Positive Raw Material Ensured Availability of raw material Positive Technology Break down of machinery brought form foreign country may delay restart of plant due to unavailability of spares in time. Neutral Supply from Contractor Timely supply of products & services / contract manpower availability Positive Environment quality check Environmental quality checking by third party done regularly to run plant as per regulation laid down. Positive Context of the Organization
- 19. 19 19 Risk Analysis GALLAY INDIAPRIVATE LIMITED GI/MR/FR/40 00/ 01.01.2018 Process Name: NPD S. No. Risk Significant Non Significan t Mitigation Opportunity Action Responsibilit y Target Date Status(What we are doing to avoid the risk) 1 APQP activities not done (Part not made as per customer requirment) NPD procedure available Activities done as per procedure 1. Latest AIAG Manual to be arranged for APQP. 2. APQP time plan and APQP matrix to be matched with APQP procedure. 3. Customer requirement to be identified on regular intervals. NPD Head 2 ECN not recorded (Wrong product made) Timely documents updation and review prior to implementaion in production alongwith CFT . 1. Coherence Plan to be made for documents review. 2. Review frequency to be freezed for documents. Coherence plan Prepared for documents review after ECN and revise the documents accordingly. NPD Head 01.01.18 Done. 3 PPAP not done (Did not understand the customer requiement) PPAP done according to customer requirement. Latest AIAG Manual to be arranged for PPAP NPD Head 4 Initial Suppply activities not done (Defect increased) Initial Supply activities done as per procedure 1. Inspection frequency to be increased. 2. Process capability to be introduced to identify the process variation. 3. Separate recording to be done for internal issues and action to be taken to eleminate the issues. Safe launch activity introduced after final inspection to avoid defect part flow at customer end. NPD Head 01.01.18 Cont. 5 FMEA not done (Defect increased) FMEA done for every new part 1. Latest AIAG manual to be arranged for FMEA. 2. FMEA review frequency to be defined. 3. Risk to be addresed prior to review FMEA. 4. Action to be taken to reduce high RPN's. NPD Head
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- 21. 21 Three Key Organizations 1.IATF – International Automotive Task Force 2. IAOB - International Automotive Oversight Bureau 3. AIAG – Automotive Industries Action Group Publishing standards and offering educational conferences and training. IATF AIAG Auditing Bodies Industry-2 Industry-3 IAOB
- 22. 22 Purpose of theIATF Organization • Develop consensus for international quality system requirements (automotive) • Develop policy & procedure for registration • Provide appropriate training • Serve as formal liaison
- 23. 23 IATF Members Vehicle manufacturers: 8Subscribers- • BMW, • Daimler Chrysler, • FIAT, • Ford Motor, • GM, • PSA (French Car Mfg.), • Renault, • Volkswagen Industry trade organizations: AIAG – Automotive Industry Action Group ANFIA (Italy)- National Association of the Automobile Industry (Associazione Nazionale Fra Industrie Automobilistiche) FIEV (France)- French Vehicle Equipment Industries Association (Fédération des Industries des Equipements pour Véhicules) SMMT (UK), VDA (Germany), ZF (Germany) Guest members: JAMA - Japan Automobile Manufacturers Association
- 24. 24 Goal of IATF16949:2016 Goal of the IATF 16949 standard is the development of strong QMS that; 1. Provides for continual improvements 2. Emphasizes defect prevention 3. Promotes reduction of variation and waste throughout the supply chain. 4. Includes specific requirements and tools from the automotive industry (Development of Quality Management System)
- 25. 25 Comparison Between ISO9001 :2015 & ISO 9001 :2008
- 26. 26 Differences in Terminologies ISO9001:2008 ISO 9001:2015 Products Products and services Exclusions Not used (See Clause A.5 for clarification of applicability) Management representative Process Owners Documentation, quality manual, documented procedures, records Documented information Work environment Environment for the operation of processes Monitoring and measuring equipment Monitoring and measuring resources Purchased product Externally provided products and services Supplier External provider
- 27. 27 Comparison in Clausesand Sub-clauses ISO 9001:2008 ISO 9001:2015 Changes/Remarks 0. Introduction 0. Introduction No Change 1. Scope 1. Scope No Change 2. Normative references 2. Normative references No Change 3. Terms and definitions 3. Terms and definitions New Definitions are added such as Aftermarket Part, Accessory Part, DFA, DFM, DFMA, Escalation, FTA, etc. 4. Quality Management System 4. Context of the organization Added Communication to External Parties and Risk Assessment 4.1 General Requirements 4.1 Understanding the organization and its context 4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual - 4.2.3 Control of Documents 7.5 Documented Information Records and Documents are now "Documented Information" 4.2.4 Control of Records 7.5 Documented Information Records and Documents are now "Documented Information"
- 28. 28 Changes in Index ISO9001:2008 ISO 9001:2015 Changes/Remarks 5. Management Responsibility 5. Leadership 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 6. Planning 5.4.1 Quality Objectives 5.4.2 Quality Management System Planning 5.5 Responsibility, Authority, and Communication 5.5.1 Responsibility and Authority 5.5.2 Management Representative MR not required. Process Owners are the MRs of their respective functions. 5.5.3 Internal Communications 5.6 Management Review 9.3 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output
- 29. 29 Changes in Index ISO9001:2008 ISO 9001:2015 Changes/Remarks 6. Resource Management 7. Support 6.1 Provision of Resources 7.1 Resources 6.2 Human Resources 7.2 Competence 6.2.1 General 6.2.2 Competence, Training, and Awareness 7.2 Competence 6.3 Infrastructure 6.4 Work Environment 7. Product Realization 8. Operation 7.1 Planning of Product Realization 7.2 Customer-Related Processes 7.2.1 Determination of Requirements Related to the Product 7.2.2 Review of Requirements Related to the Product 7.2.3 Customer Communication
- 30. 30 Changes in Index ISO9001:2008 ISO 9001:2015 Changes/Remarks 7.3 Design and Development 7.3.1 Design and Development Planning 7.3.2 Design and Development Inputs 7.3.3 Design and Development Outputs 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation 7.3.7 Control of Design and Development Changes 7.4 Purchasing 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product
- 31. 31 Changes in Index ISO9001:2008 ISO 9001:2015 Changes/Remarks 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision 7.5.2 Validation of Processes for Production and Service Provision 7.5.3 Identification and Traceability 8.5.2 Identification and traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 8.5.4 Preservation Production and service 7.6 Control of Monitoring and Measuring Equipment 8. Measurement, Analysis, and Improvement 9. Performance evaluation 8.1 General 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 9.2 Internal Audit 8.2.3 Monitoring and Measurement of Processes 8.2.4 Monitoring and Measurement of Product
- 32. 32 Changes in Index ISO9001:2008 ISO 9001:2015 Changes/Remarks 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement 10 Improvement 8.5.1 Continual Improvement 10.3 Continual improvement 8.5.2 Corrective Action 10.2 Nonconformity and corrective action 8.5.3 Preventive Action -Replaced by Risk Based Thinking and Risk Assessments
- 33. 33 What is newin IATF 16949?
- 34. 34 What is newin IATF 16949?
- 35. 35 September 2015: ISO 9001:2015 StandardReleased April 2016: IATF Standard conference to review draft 16949 standard October 2016: Expected publication of IATF 16949 October 2017: No further audit to ISO/TS 16949:2009 September 2018: Full conformance with new IATF 16949 2015 2016 2017 March 2017: 2018 Kick off development Transition of IATF
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- 37. 37 Why Transition toIATF 16949 : 2016? Why transition to new automotive Standard? 1. Increased expectation from stake holders (OEMs, Regulatory bodies…) 2. Development in and emergence of new Manufacturing Technologies 3. Raising the bar
- 38. 38 ROADMAP FOR TRANSITIONTO IATF 16949:2016 We are currently certified to ISO/TS 16949:2009 What should I do?
- 39. 39 Timeframe for transitionaudit to IATF 16949?
- 40. 40 ISO 9001 CertificationProcess
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- 42. 42 To minimizethe likelihood of failure during new program development To maximize the potential realization of planned activities. To ensure risk-based thinking is pervasive throughout the organization Top management needs to be actively engaged. Risk-based is essential for achieving an effective quality management system. Carrying out preventive action to eliminate potential nonconformities To conform to the requirements of International Standard, an organization needs to plan and implement actions to address risks and opportunities. Risk Based Thinking
- 43. 43 Our Experience Our Experience •A QMS involves more that HARD measures of quality • SOFT Measures - Teamwork - Empowerment - Management Approach - Working environment - Mindset
- 44. 44 Our Experience Lessons Learnt 1.Shift in Management Philosophy 2. Culture of Continuous Improvement 3. Training is Key 4. Effective Communications 5. Recognition of Achievements / Motivation 6. Results in Improved Productivity
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- 46. 46 I need moreinformation…. Where should I contact? 1.Certification Bodies 2.Local QMS Coordinator 3.Search through Internet and Media 4.Training Providing Agencies (Omnex, TUV SUD, etc.
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