QMS MID SEM QMS MID SEMQMS MID SEMss.pptx

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1. MBA QM ZG 524 Quality management system Faculty: Mathew Paul Vizhalil 1st session Sem II 18-19

2. Today’s lecture is in the following parts: PART 1------Evolution of quality/Quality management/QMS PART 2 -----Evolution of ISO-the organization and QMS standards. ISO -9000 family of standards; Other such standards for other sectors.

3. PART 1 Objective Evolution of QUALITY, QUALITY MANAGEMENT & QMS

4. Evolution of Quality Quality Concepts Fitness of Standard Fitness to Use Fitness to Cost Fitness to Latest Requirement

5. 4 LEVELS OF QUALITY Level 1 Inspection Level 2 QA Level 3 Performance Level 4 Perfection Level 1 :- Quality by inspection :- Little quality Knowledge &culture Level 2 :- Improvement for process stability :- Start of worker involvement Level 3 :- Process capability :- Manufacturability at Development Stage :- Supplier Integration Level 4:- End customer orientation :- Superior product :- Cultural Alignmen t

6. THE JOURNEY

7. THE JOURNEY… Quality paths : TQM, EFQM, ISO. All the Quality Gurus gave their findings and learnings during 1960’s to 1980’s. Quality journey in INDIA- Annexure 1

8. Evolution of Management Earlier 3 Generations of Management 1 st Generation : Just do it yourself. 2 nd Generation : Telling others what and how to do it? 3 rd Generation : Management by objectives - Set Targets How people reacted to this change: a- Improve the system b- Distort the system c- Distort the figures 4 th Generation : Managers care greatly about results - They know that results can be attained only by fundamental improvements. They become champions of customer needs which are drivers of real improvement.

9. 3S 3P STRATEGY SYSTEMS STRUCTURE PURPOSE PROCESS PEOPLE We need to get clear understanding of how customer understands quality. To improve be able to talk the customers language. - We need to change the way we manage? - Question to be asked “Are we improving fast enough”? Attached -Annex 2 and 3 for reading

10. System development What is needed to develop a system? Issue Objective Strategy/procedure to meet the objective. Previous slide– this leads to INTERACTION of HARDWARE , SOFTWARE & PEOPLE End of part 1

11. MANAGEMENT SYSTEM Set of interrelated or interacting elements To Establish policy objectives and to achieve the objectives a b c a : Hard ware – Equipment b : Software – Methods c :Human ware – People

12. Summary so far We discussed the stages through which Quality, Quality Management & QMS have evolved…. 3S to 3P was an important paradigm change. WITH FOCUS ON PROCESSES & PEOPLE A management system is an interaction between hardware, software and human ware.

13. PART 2 Objective Evolution of International Organization for standardization and of QMS standards. ISO-9000 family of standards. Other Management System standards

14. international organization for standardization-1 1947 with 25 member countries. FUTURE of INTERNATIONAL STANDARDIZATION Acronym used is ISO -derived from the Greek isos meaning equal/harmony The International Organization for Standardization (ISO) is a Worldwide federation of the national standards organizations of member countries. provides diverse standards for industrial, commercial and public use. Standards for products & systems. Many guidelines, vocabulary are also called standards ( as we shall see for ISO-9000 and 9004 ) though these are not STANDARDS per se.

15. international organization for standardization-2 162 member bodies-(Geneva) About 22000 standards so far. Technical committees Sub committees and work groups Draft International Standards-- To member bodies for approval At least 75 % approval for acceptance by ISO council. Technical specification for 3 years (TS) Protocol for review every 5 years

16. STANDARDIZATION Formulation, publication, and implementation of guidelines, rules, and specifications for common and repeated use , aimed at achieving optimum degree of order or uniformity in a given context, discipline, or field-say product, process, system. --RESULTS in PRODUCT standards; Social standards. Process standards. System standards. Management system standards. First standard was developed by Fredrick Winslow Taylor for coal shoveling. He standardized eight types of shovels, each specific to a particular material e.g ash, different types of coals thereby almost quadrupling the productivity per person. (this was around the later part of the 19 th century). Industrial engineers continued to establish standards for methods and outputs.

17. Evolution of Management Systems Standards (ISO 9000 Family) 1987 First ISO 9000 Series published. Based on BS 5750 1994 Three Certification standards 20 Elemental approach focused on producing products at consistent quality level. 2000 ( ISO-9000,9001, 9004) +14010/11/12 ) Elemental to Process Approach( Deming-PDCA) Single Certification Standard.

18. Evolution of Management Systems Standards(continued) 2008 ( ( ISO-9000,9001, 9004) +19011:2002+ guidance documents ) No significant changes. Mostly clarifications 2015 ( (ISO-9000,9001, 9004) +19011:2011+ guidance documents )

19. HIGH LEVEL STRUCTURE HLS-high level structure is the name given to the harmonized structure of every management system standard document i.e - -identical sub clause titles, -identical text ; -common terms and -common core definitions:

20. High level structure Context of the organization Leadership Planning Support Operation Performance evaluation Improvement

21. Similar mgmt. system standards & guidance documents, ISO-14001-2015 Environment Management System ISO-21000- FDIS E ducational Management systems (2018) ISO 27010-2015 Information security management ISO 22000-2015 Food safety management. (2018) ISO-13485-2016 Medical devices — Quality management systems — Requirements for regulatory purposes. ISO-15378-2017 Primary packing for medicinal products . ISO 45001:2016 Occupational health and safety management systems ++ Many other standards are under revision to the new FORMAT—HLS. A note has already been uploaded on Taxila . ISO-9001 is the base for IATF 16949, and aerospace AS 9100 and TL 9000:2016.

22. ISO-9000 FAMILY ISO-9000:2015 Quality Management systems-Fundamentals & Vocabulary ISO-9001 : 2015 Quality Management Systems-Requirements ISO-9004: 2009 2018 Managing for the sustained success of an organization-a Quality Management approach NOW-Quality management-quality of an organization-guidance to achieve sustained success ISO-19011:2011 Guidelines for Auditing Quality Management Systems

23. ISO 9001-2015 UNDERLYING FUNDAMENTALS QMS Principles-7 no.s PROCESS APPROACH/MANAGEMENT RISK BASED MANAGEMENT PDCA

24. Quality Management System (4) ` Support & Operation (7.8) Leadership (5) Planning (6) Performance evaluation (9) Improvem -- ent (10) Ref: ISO 9001: 2015 Plan Do Act Check Plan-Do-Check- Act cycle Organization and its context (4) Customer requirement Needs and expectations of relevant interested parties (4) Customer Satisfaction Products and services Results of QMS Structure of this International standard in PDCA

25. ISO-9000:2015 Fundamentals & Vocabulary Topics covered

26. ISO-9004:2009 Topics covered

27. ISO-19011:2011 Guidelines for Auditing Management Systems. Generic standard for audits of ALL types of management systems the scope has been broadened from the auditing of quality and environmental management systems to the auditing of any management system ; remote audit methods, concept of risk and of confidentiality have been introduced; etc. End of part 2

28. Summary PART 2. Int. Org. for Standardization has evolved-----. QMS standard started in 1987 has undergone several revisions-latest in 2015. Many other parallel standards published for other sectors. Many standards made by other organizations for other sectors also aligned to ISO-9001- Automotive, aerospace, oil & petroleum, Telecommunications etc.. Now all revisions by the org. ISO are being standardized to the HIGH LEVEL STRUCTURE. 4 publications in the ISO-9000 family: ISO-9001 is the only standard for implementation & verification(audit). *****

29. Session 2 Overview of ISO 9001:2015 Objective : To get an overview of the standard. Recap --so far 1 Evolution of: 1.1 Quality, 1.2 Quality management and QMS i.e ISO-9001; 1.3 and many other sector standards. 2. Evolution of 2.1 International Organization for Standardization; 2.2. QMS standards, ISO -9000 family of standards; 2.3. Other standards for other sectors. MBA ZG524/QM ZG524 Quality management system

30. Session 2 Vocabulary/ Terminology OBJECTIVE: To get conversant with Important terminology and definitions related to Quality, Quality Management and QMS . Ref. ISO-9000:2015 Quality Management systems-Fundamentals & Vocabulary WILP Course MBA ZG524/QM ZG524 QMS session 2

31. While reading the standards   ‘Shall’ indicates a requirement. ‘Should’ indicates a recommendation. ‘May’ indicates a permission. ‘Can’ indicates a possibility. ‘a note’ is for guidance for understanding or clarification.

32. Customer Person or organization that could or does receive a product or a service that is intended for or required by this person or organization. EXAMPLE Consumer, client, end-user, retailer, receiver of product or service from an internal process beneficiary and purchaser. The boss/management/organization; family of the patient/student. The next process. Note : A customer can be internal or external to the organization. Question Who is/are your customer/s?

33. What is Quality “Fitness for use”- Of CUSTOMER

34. What is Quality- contd . Aesthetics/attractiveness; first impression. Capability to perform as required/expected. Durability/reliability –as required. Availability at the required time/place (and serviceability if applicable). Appropriate cost bracket.

35. Quality definition-1 degree to which a set of inherent characteristics of an object fulfils requirements . Terms to be understood: Requirements Characteristics Inherent degree

36. Quality definition- Terms to be understood. Requirements: Need or expectation that is stated , generally implied or obligatory. (3.6.4-ref ISO-9000) Characteristics: A distinguishing feature (3.10.1-ref ISO-9000) (various classes of characteristics-physical, functional, ergonomic etc ) Inherent: characteristics built into the product/service –as against assigned --. degree: Extent to which the requirements are fulfilled- e.g high, medium, low, bad etc.

37. Quality definition-2 Conformance to specified requirements Whose requirements?? Customers, statutory/regulatory bodies, society. Requirements are converted to characteristics to be built into the product/service through: - PO/DRAWING/SAMPLE -DESIGNER-DRAWING -STANDARDS-DATA SHEETS -CONTROL PLANS ETC - verbal INSTRUCTIONS Statutory/regulatory requirements are to be collected/compiled.

38. Characteristic distinguishing feature: can be inherent or assigned. can be qualitative or quantitative. various classes of characteristics: quality characteristic: inherent characteristic (3.10.1) of an object (3.6.1) related to a requirement (3.6.4).

39. Requirement v/s characteristic (Examples) Product/service REQUIREMENT Related characteristics Food processor Grinding of spices Motor HP & RPM; design & material of blades; Easy chair Seat, back, proper height. sizes, angles as per GRADE of chair. Strength Material of construction Data Timely and reliable, relevant. Systems, responsibility for collection and transmission, Handkerchief Handy, Different sizes for choice-separate range for ladies. Moisture absorbent, Specifications of cloth to be used. Aesthetic Designs on borders; prints etc.

40. Requirement v/s characteristic (Examples) contd. Product/service REQUIREMENT Related characteristics Software for the backend of the bank staff. No error in Calculations; Defect free code. S oft ware to support 24X7. 1.Regression testing of code. 2.Unit testing, peer review and superior review. 3.Made for MAINFRAM computers to keep it live 24X7. Etc. Anti-intrusion alarm system ( i ) Pr otection of the property . Low insurance cost. Proper police response. Easy to operate . 1. Feature of arming /disarming / integration of different type of sensors. 2. Embedding into the system adequate communication option to maintain stations. (Here adequate is as decided by the org.). 3. Visible/audible indicators. Door operating system -power or manual -to close gradually. -but not too slow. -fluid to be used, its further characteristics like viscosity; -time to close –within ----seconds; -Bearing –make, size etc. Etc.

41. Quality TYPES OF QUALITY Quality of design/grade decides the characteristics of the product in reference to customer requirements . Quality of conformance means satisfying the designed standard to ensure performance levels. QUALITY OF CONFORMANCE DESIGN/GRADE

42. From previous semester/s During the previous semester, there was lot of confusion over ‘quality of design’. True, quality of design is the quality designed by the organization. This itself will be the quality to be complied with during production/provision i.e quality of conformance. But there can be various qualities of design of the same product by same or different organizations. These are what are the qualities of grades. (Examples already given) For a specific quality of design, there can be no difference in the quality of design and of conformance.

43. Requirements (of customer) Characteristics (Requirements of the organization) Quality of design PRODUCT Quality of conformance Conforming -fulfilling requirements of organization. Non conforming (not fulfilling one or more requirements). DEFECT( Not fulfilling a requirement related to intended/specified use

44. ISO-9000:2015 Fundamentals & Vocabulary Terms have been systematically grouped as follows and defined as related to: Person/people Organization Activity Process System Requirement Result Data, information and document; Customer Characteristics Determination Action Audits.

45. QMS- Fundamentals and vocabulary-ISO 9000:2015 Fundamental Concepts : General: QMS enables the organization to meet challenges that are profoundly different from those encountered in recent post. Challenges: Accelerated change Globalization of market Knowledge as a principle resource Knowledge and demanding customers. The standard provides direction to organization’s approach to quality. All concepts of this standard should be seen as a whole and not in isolation.

46. Quality Management System: - QMS comprises of a set of interacting/interrelated activities by which the organisation: identifies its quality related objectives , determines the processes and Determines the resources needed to meet the objectives. QMS manages the interacting process and resources required to provide value to all interested parties. QMS enables the Top Management to optimize the use of resources considering the long term and short term goals and consequences of their Strategies and decisions. QMS also enables to identify actions to address intended and unintended consequences in providing products and services.

47. Terms of QMS-1 Quality Control- More commonly known as Inspection. It involves checking a product for acceptance or rejection based on whether it meets the specification criteria or not. This is a reactive approach based on quality of inspection. It has following steps:- Evaluate actual quality performance. Compare the actual to quality goals. Act on differences.

48. Quality Assurance – Set of processes which assure that the quality requirements shall be fulfilled. This is done by building quality during manufacturing process. Quality is manufactured and not inspected and aim is to eliminate inspection. - It assures processes by pro-active approach and is based on process root cause analysis, FMEA and SPC etc. It has following steps:- Identify the customers. Determine the needs of customers. Translate needs into your language. Develop product features that can be optimally respond to these needs. Develop a process that is optimally able to produce the product features. Transfer the process to operating people. Terms of QMS-2

49. Terms of QMS-3 MANAGEMENT SYSTEM Set of inter-related or interacting elements of an organization to establish policies/objectives , and processes to achieve those objectives. QUALITY MANAGEMENT Management with regard to QUALITY. QUALITY MANAGEMENT SYSTEM Part of a management system with regards to Quality. QUALITY MANAGEMENT SYSTEM REALIZATION Process of establishing, documenting, implementing, maintaining and continually improving a QMS.

50. Quality Objectives – Based on Company’s quality policy all functions decide the quality objectives. Those are measurable, within time frame and responsibility is defined. These cascade from Top to bottom to achieve Co’s overall goals. Examples are:- Product performance Competitive Performance Quality Improvement Cost of poor quality At the lowest level of Hierarchy the quality goals are based on Technological basis. Terms of QMS-4 Annexure -1 & 1A

51. From Google with thanks. Comments: The first three are not comparable v/s the previous level. Quality objectives Bosch - Maintain improving trend of Customer Satisfaction -Continual improvement in ‘on-time delivery’ of products as per customer requirements -Adherence to applicable statutory & regulatory requirements -Adherence to environment, health & safety (EHS) requirements at workplace& continuous improvement in house-keeping (5S). Constantly monitor suppliers’ quality and guide them in improvements. Your comments---????? From Google with thanks.

52. A bit difficult to read, but see the clarity in scale rules. From Google with thanks. Quality objectives (contd.)

53. Quality objectives (contd.) Annexure 1A Example of quality objectives in an Indian small scale engineering company.

54. Quality Policy – It is a guide to managerial action. It is a statement of Long term intentions/directions of the organization w.r.t QUALITY. Policy differs from a procedure which details how activities shall be done. eg . It is the policy of the company to provide products and services of a quality that meets the present and future expectations and needs of the customer by continual improvement. The Co wants to be the leader in the product quality reputation. -In order to progress towards this policy, the organization shall develop and implement many processes /procedures (in accordance with QMS) Terms of QMS-5 Pl see Annex-2

55. Terms of QMS-6 PROCESS (3.4.1) Set of interrelated or interacting activities that use inputs to deliver an intended result. OUTPUT (3.7.5) Result of a process. PRODUCT(3.7.6) Output of an organization that can be produced without any interaction taking place between the organization and the customer. SERVICE (3.7.7) Output of an organization with at least one activity necessarily performed between the organization and the customer. OBJECT (3.6.1) Entity, item, anything perceivable-e. g Product, service, process, person, organization, system, resource

56. Terms of QMS-7 TOP MANAGEMENT (3.1.1) Person or a group of persons who directs and controls an organization (3.2.1) at the highest level. CUSTOMER Person or organization(3.2.1) that could or does receive a product or a service that is intended for or required for this person or organization. IMPROVEMENT (3.3.1) Activity to enhance performance (3.7.8)- - - - - - (continual). NON CONFORMITY Non fulfillment of a requirement. DEFECT Non conformity related to an intended use or specific requirement.

57. Terms of QMS-8 Design & development Set of processes that transform requirements for an object (3.6.1) into more detailed requirements for that object. (characteristics) Review Determination of the suitability, adequacy or e ffectiveness of an object to achieve established objectives . (Applies to management review, design review, or any other e.g ‘contract’ review etc.) Verification Confirmation, through the provision of objective evidence , that specified requirements have been fulfilled. (Applies to design ; also to processes where it is called qualification process ) Validation Confirmation, through the provision of objective evidence (3.8.3), that the requirements (3.6.4) for a specific intended use or application have been fulfilled. (Applies to design, process , system, instrument/software etc.)

58. Terms of QMS-9 Competence Ability to apply knowledge and skills to achieve intended results. Capability Ability of an object to realize an output that will fulfil the requirements for that output. Qualification (non ISO) equivalent to verification i.e confirmation through objective evidence that a certain level of knowledge/skill has been acquired.

59. Organizations like human beings are adaptive and comprise of interacting systems. Each needs ability to change. QMS recognizes that all systems, processes and activities cannot, REPEAT cannot be predetermined and therefore need to be flexible and adaptable. System: Organizations seek to understand internal and external context to identify the needs and expectations of interested parties - The information is used to develop QMS to achieve organizational sustainability. - The input and output of each process are interlinked into the overall net work. - Every organisation is unique and has its own QMS. QMS

60. QMS (continues) Processes : Organisation has processes that can be measured, defined and improved. The processes interact to deliver results consistent with the objective and cross functional boundaries. Some processes are critical. Activity: People collaborate within a process to carry out daily activities. Some activities are prescribed and depend on understanding of the objectives. Some are not prescribed to enable them to react to external stimulae .

61. Summary-1 THE ISO-9001 REQUIRES THE ORGANISATION TO:- -DETERMINE THE NEEDS AND EXPECTATIONS OF CUSTOMERS AND OTHER INTERESTED PARTIES. -ESTABLISH POLICIES,OBJECTIVES AND ENVIORNMENT TO SATISFY THE ABOVE NEEDS. -DESIGN,DEPLOY AND MANAGE A SYSTEM OF INTERCONNECTED PROCESSES NECESSARY TO IMPLEMENT THE POLICY AND ATTAIN OBJECTIVES. -MEASURE, ANALYSE AND EVALUATE THE EFFECTIVENESS OF EACH PROCESS IN MEETING THE OBJECTIVE. -PURSUE CONTINUAL IMPROVEMENT.

62. Summary-2 -HOW -DETERMINE WHAT IS REQUIRED TO BE DONE. -CONVERT INTO CLEAR AND UNEQUIVOCAL INSTRUCTION. -CONFIRM IT IS FOLLOWED. -CHECK EVERYONE HAS KNOWLEDGE,ABILITY TO DO THE JOB AND TRAIN IF NECESSARY. -CHECK IF JOB HAS BEEN DONE CORECTLY. End

63. ISO-9000 FAMILY : (Recap) ISO-9000:2015 Quality Management systems-Fundamentals & Vocabulary ISO-9001 : 2015 Quality Management Systems-Requirements ISO-9004: 2009 2018 Managing for the sustained success of an organization-a Quality Management approach Guidance to achieve sustained success ISO-19011:2011 Guidelines for Auditing Quality Management Systems

64. OVERVIEW OF ISO-9001 INTRODUCTION (from standard) 0.1 General --- QMS can help the organization to: Improve its overall performance And Provide a sound basis for sustainable development initiatives. POTENTIAL BENEFITS (let us read from Standard-introduction) --a --b --c --d

65. Summary-1 Repeat from terminology THE ISO-9001 REQUIRES THE ORGANISATION TO:- -DETERMINE THE NEEDS AND EXPECTATIONS OF CUSTOMERS AND OTHER INTERESTED PARTIES. -ESTABLISH POLICIES,OBJECTIVES AND ENVIORNMENT TO SATISFY THE ABOVE NEEDS. -DESIGN,DEPLOY AND MANAGE A SYSTEM OF INTERCONNECTED PROCESSES NECESSARY TO IMPLEMENT THE POLICY AND ATTAIN OBJECTIVES. -MEASURE, ANALYSE AND EFFECTIVENESS OF EACH PROCESS IN MEETING THE OBJECTIVE. -PURSUE CONTINUAL IMPROVEMENT

66. Summary-1 Repeat from terminology THE ISO-9001 REQUIRES THE ORGANISATION TO:- -DETERMINE THE NEEDS AND EXPECTATIONS OF CUSTOMERS AND OTHER INTERESTED PARTIES. -ESTABLISH POLICIES,OBJECTIVES AND ENVIORNMENT TO SATISFY THE ABOVE NEEDS. -DESIGN,DEPLOY AND MANAGE A SYSTEM OF INTERCONNECTED PROCESSES NECESSARY TO IMPLEMENT THE POLICY AND ATTAIN OBJECTIVES. -MEASURE, ANALYSE AND EFFECTIVENESS OF EACH PROCESS IN MEETING THE OBJECTIVE. -PURSUE CONTINUAL IMPROVEMENT

67. Main Clauses of ISO 9001 Clause 4— Context of the organization + . Clause 5--- Leadership Clause 6- Planning . Clause 7- Support . Clause 8- Operation . Clause 9-- Performance evaluation. Clause 10- Improvement (SHALL) Each MAIN clause has sub clauses. You will find the same main clauses in all standards made/being made by ISO (the institution) in HLS i e the high level structure.

68. ISO 9001:2015 At A Glance ISO-9001:2015 Cl. 4 Context of the organization + Cl. 5 Leadership Cl. 6 Planning Cl. 7 Support Cl.8 Operation Cl.9 Performance evaluation Cl.10 Improvement 7 clauses, each representing a group of generic processes applicable to any type of organization.

69. Performance Evaluation Cl 9 Leadership & Planning cl 5 & 6 Support cl 7 Operations cl 8 Improvements Cl 10 Context & needs of interested parties cl 4 . Customer requirements Products & services as required Sequence and interaction of QMS processes at macro level

70. ISO-9001:2015 Focus on PDCA and the process approach is continued. RISK BASED THINKING The standard’s format-aligned to the HLS (High level structure). Context- Interested parties Organizational knowledge Explicit requirements from management/leadership. Increased focus on “roles/responsibilities/authority” and “Quality Objectives”. Management representative –not mandatory. Reorganization of clauses / subclauses . Flexibility. Etc. What is specific TO 2015 version –

71. ISO-9001:2015 Flexibility Provides flexibility to: Design your OWN structure of QMS. Prepare your OWN documentation except some mandated requirements. Adopt and follow your OWN terminology (and define the same). ( e.g purchase v/s externally supplied)

72. Summary of overview ISO-9001:2015 Overview of What does QMS want? How to do it. 7 inter-related and inter-dependent families of processes.

73. END OF SESSION 2

74. Session 3 Recap of Lecture 1 and 2 Evolution of Quality and ISO standards Terminology , vocabulary and ISO 9001:2015 overview MBA ZG524/QM ZG524 Quality management system

75. Session 3 Consists of 3a Quality management principles. 3b PDCA MBA ZG524/QM ZG524 Quality management system

76. QMP 3a Objective: What are the 7 QMP’s Significance of the QMP’s. Understanding the QMP’s. Role played by QMP’s in building the QMS of the organization. etc

77. ISO 9000: 2015 has defined QMP,s in clause 2.3 The Seven principles are:- Customer Focus. 2. Leadership 3. Engagement Of People 4. Process Approach Improvement 6. Evidence based Decision Making 7. Relationship Management These principles form the CONTEXT of how to interpret the SECTIONS of the Standard. Methods may change or evolve , but principles do not. QUALITY MANAGEMENT PRINCIPLES (QMP’s)

78. QMP 1 - CUSTOMER FOCUS:- What this means : Understand the needs of current and future customers Meet all customer requirements Strive to exceed customer expectations. How do I do it ? Recognize that survival is based on dependence upon the customer Align targets set in your planning to address customer changes Target customer perceptions, current and future Formally review contracts and be realistic in your capabilities Record and analyze complaints and returns to determine gaps from those commitments made Offer consumer value through preferred products and services - Key Benefits: Delighted customers and resulting in customer satisfaction and Loyalty Enhanced business share. Increased customer- base. Increased profitability.

79. QMP 2 - LEADERSHIP:- What this means : Establish unity of purpose and direction for your organization by going first through your Vision and Mission Set policy and objectives that inspire and challenge Establish your organization’s internal culture, in which employees are partners in achieving the organization’s objectives. How do I do it ? Set clear goals and objectives: have and organizational “compass” Share and Communicate Treat quality as strategic issue and identify the financial effects of failing to meet these goals Provide human and physical resources so your organization can achieve its objectives Coordinate lower-level objectives to align with top level so everyone is pulling in the same direction - Key Benefits: Increased effectiveness and efficiency due to co-ordination of actions at all levels Improved communication due to participative management Delivery of desired results due to development and participation of people

80. QMP 3 – ENGAGEMENT OF PEOPLE:- What this means : Fully develop the abilities and competencies of your people Give people the freedom to use their abilities to achieve maximum benefit How do I do it ? Maintain a high level of communication between leadership and employees Position your people in roles that match their abilities and competencies Integrate your human resources plan with your strategic business plan Conduct active and value-added training and process qualification activities Encourage employees to contribute to your organization’s improvement strategy Promote participation and empower people to take decision Align employees daily work tasks with the overall objectives of the organization - Key Benefits: Improved understanding of company objectives Enhanced motivation and involvement of people in meeting the objectives Enhanced personal development , initiatives and creativity Increased trust, satisfaction and collaboration throughout the organization

81. QMP 4. PROCESS APPROACH To be discussed separately Please recall 3S-3P; one of the P’s is PROCESSES .

82. QMP 5 – IMPROVEMENT:- What this means : Make improvement a permanent objective for the organization Focus on improvement will lead to maintaining current levels of performance, react to changes both internal and external and create new opportunities. How do I do it ? Focus on process improvement to achieve business results Identify critical items and strategically allocate resources to improve what matters Provide resources to ensure that targets are met Develop and operate mature corrective action loops. Set new realistic goals once the targeted level is achieved Strive to achieve stretch improvement goals Seek to prevent defects, and to reduce variation and waste in supply chain Key Benefits: Improved performance, customer satisfaction and meeting objectives Enhanced ability to react to internal and external risks and opportunities Innovative and learning organisation

83. QMP 6 – EVIDENCE BASED DECISION MAKING :- What this means : Base decisions on logical analysis of objective data and information Quantify the business case for the action How do I do it ? Focus on data such as audit results, performance reviews, corrective actions , and complaints to improve customer satisfaction , and focus on internal metrics for internal customer satisfaction Ensure data to be reliable, accurate and recent Make data to be available to all as per need (Need to know basis) Observe short- and long-term trends and indicators of performance to minimize immediate issues and to foresee risk Use data to continually improve your organization’s performance Key Benefits: Improved decision making Improved operational effectiveness and efficiency Improved assessment of process performance and ability to achieve objectives A very simple (but effective) case: one company drastically reduced the amount of uneaten food in their canteen simply by weighing and displaying everyday the weight of the uneaten food being wasted.

84. QMP 6 – RELATIONSHIP MANAGEMENT :- What this means : Create value through mutual, beneficial, interdependent relationships with interested parties How do I do it ? Determine relevant interested parties (such as suppliers, partners, customers, investors, employees, and society as a whole) and their relationship with the organization Determine and prioritize interested party relationships that need to be managed Establish relationships that balance short-term gains with long-term considerations; Define and document requirements to be met by relevant interested parties and show clear linkage to end-user requirements Evaluate interested parties ability to meet requirements and match the requirements according to risk Work with interested parties to develop mutual trust ,respect and commitment to customer satisfaction Integrate key elements of your organization’s QMS with interested parties’ quality improvement process.

85. QMP 6 – RELATIONSHIP MANAGEMENT :- continues Key Benefits: Enhanced overall company ‘s performance Capability to create value to customers Capability to manage risks and competition Stable supply chain resulting in consistent flow of products and services

86. 7 principles at a glance END

87. SESSION 3 b PDCA Objective: Learning what, why and how of PDCA; developing the ability to apply PDCA on improvement projects/problems. MBA ZG524/QM ZG524 Quality management system PDCA Must read notes on PDCA Ann 3b1 and 3b2.

88. PDCA (Plan-Do-Check-Act) Introduced by Walter Schewart in 1929 Popularized by W. Edwards Deming in the 1950s: as “a flow diagram for learning, and for improvement of a product and/or a process“ ( i.e for any improvement projects). PDCA

89. PDCA CYCLE Plan Determine goals , targets and methods Do Implement work plan Four Steps to PDCA Step 1 :- Define, analyze the problem, plan in details –reasons, causes, solutions/changes, resources etc…… Step 2 :- Implement the plan Step 3 :- Check/study the process and results of implementation, analyze & evaluate the results/findings. Step 4 :- Take necessary action as per evaluation. Check Examine results Act Take necessary follow up action starting with plan PDCA

90. PDCA CYCLE OF QMS BASIC PRINCIPLE * Concentrate on Processes not the Documents . “ Think Cause & Effect “ * Look at the Result - System Effectiveness - PDCA Approach Identification , Sequence , Interaction, criteria , Methods Implementation of Planning Implementation & Improvements Monitor , Measure the Process ACT PLAN DO CHECK PDCA

91. PDCA Spiral P A D C S A D P A C P Sr. No. what why where action who when 1 Modify the shaft design Shaft often breaks Workhead Design new shaft. Mr. A ?? b) Get new shaft Mr. B ?? c) Try new shaft. Mr. C ?? 5W -1H format PDCA D

92. PDCA (Summary of Reading matter) Salient points : PROBLEM CAUSE (???) SOLUTION IMPLEMENT REVIEW FOLLOW UP. Let us link the 7 points with the 4 PDCA stages. PDCA

93. Quality Management System (4) ` Support & Operation (7.8) Leadership (5) Planning (6) Performance evaluation (9) Improvem -- ent (10) Ref: ISO 9001: 2015 Plan Do Act Check Plan-Do-Check- Act cycle Organization and its context (4) Customer requirement Needs and expectations of relevant interested parties (4) Customer Satisfaction Products and services Results of QMS Structure of this International standard in PDCA

94. Summary QMP (Customer focus, Leadership, Engagement of People, Improvement, Evidence based decision making, Relationship Management) (Process approach will be covered in Lecture 4) PDCA

95. 4 ( PROCESS APPROACH) Objective: To understand the process approach and to learn to apply the approach to an organization. The module consists of: 4a) Process 4b) Process management 4c) Process approach 4d) Process mapping

96. PROCESS Definition- Set of interrelated or interacting activities that use inputs to deliver an intended result. Output of one process may be the input to the next process. interrelated or interacting processes/sub processes . All work gets done through processes only. No activity by itself can give a result and/or an output. An activity can contribute towards a result only along with other sequential, inter-related or interacting activities. Module 4a

97. PROCESS (contd.) INPUTS OUTPUTS SUPPLIERS INPUTS OUTPUTS CUSTOMERS PROCESS PROCESS Control ?? Module 4a

98. Add SIPOC/COPIS Schematic representation of a process Supplier Customer Characteristics Quantitative Qualitative Characteristics Module 4a

99. Let us break up this definition into smaller components. A process is a set of activities which: Are related to each other ; Have some interdependence, interaction, inter relationshiop between them; Are carried out in a specific sequence ; Convert specific inputs into planned outputs . Process –( contd ) Module 4a

100. SIPOC e.g A machining process Supplier ————Production supervisor or the previous operation/process. Input ——————Raw material –say M S rod as specified or semi finished part.. Process ————-The set of related and interdependent activities required to be carried out in a specific sequence for the purpose of processing on thjs station as planned- (effectively and efficiently ) (This time and every time for similar such repeated requirements.) Output —————As planned Customer ———next process. (More) More than one supplier/customer in the same process. Module 4a

101. Suppliers ----- Inputs------Process-----Outputs --- Customers Eg . For a purchasing process indenter indent-- ?? Material indenter Quantity at the Quality as required time required Simplistic SIPOC ?? Customers----- Outputs-------Process----------Inputs-------- Suppliers COPIS To be developed/ designed and described for improvements. Module 4a

102. SIPOC Process of appointing persons THE PROCESS INPUTS OUTPUTS CUSTOMERS SUPPLIERS Management, statutory & regulatory requirements, Policies etc. REQUIREMENT Job requirements, expectations, time period etc. Appointment of required persons with expected attributes and in the required time . Management and executives of the organization Providing human resources Module 4a

103. PROCESSES- SOME EXAMPLES Admitting students in a school/college. Budgeting Marketing Auditing A company/organization as a whole is also a NESTED PROCESS (The following were made by the students of previous sessions ): Repair/Overhaul of avionics at Rotable Overhaul Squadron. Creation of requirement specification for a software product. Shipment of finished product to customer as per the order. script review (verification of code quality) process. Etc. . Outputs ?? Module 4a

104. EXPECTATIONS FROM A PROCESS Has to be * Effective * Reliable * Efficient Effectiveness: The output as planned ( i.e as per customer requirement) Reliability: How often does the customer get what he wants. Efficient: How efficiently is the process carried out in terms of resources used, cycle time etc Repeatability Reproducibility Module 4a

105. ISO 5725-1 Repeatability : Precision under repeatability conditions independent test results the same test method identical test items the same laboratory the same operator the same equipment within short time interval Repeatability standard deviation : The standard deviation of test results obtained under repeatability conditions Repeatability limit (“r”) : the absolute difference between two test results obtained under repeatability conditions should be less than or equal to this value

106. ISO 5725-1 Reproducibility : Precision under reproducibility conditions independent test results the same test method identical test items different laboratories different operators different equipment longer time interval Reproducibility standard deviation : The standard deviation of test results obtained under reproducibility conditions Reproducibility limit (“R”) : the absolute difference between two test results obtained under reproducibility conditions should be less than or equal to this value

107. Process Monitoring & Measurement Control process:- Establish the required state/value (exit criteria). Assess the state after process ; Compare with the required state/value; Determine variance Take action to close variance if undesirable. Module 4a

108. In 4a: Process definition SIPOC with example; examples of processes; Expectations from processes etc PROCESS MANAGEMENT module 4b

109. Process management-WHAT An approach to organizational design that implies that activities performed within the company are organized, managed, controlled and improved as processes . Module 4b

110. The various levels are as under:- Level 1:- Processes are managed in an ad-hoc manner, there is no system. Level 2 :- Key processes for customer satisfaction and product realisation are defined and managed. Interactions between processes are defined and monitored. The effectiveness of system is systematically measured for improvements. Level 3:- Process planning is integral part of design and development. Customer needs are identified and used for process planning. Productivity improvements are measured. The quality performance is predictable/reliable. PDCA cycle for further improvement. Level 4:- Organisation is moving towards flexibility and reliability demands of customer. Conflicts of interactions between various functions resolved effectively. Innovation culture building Level 5:- The Organisation’s process performance levels compares with best in the industry as compared with Benchmark data of industry. PROCESS – MANAGEMENT Module 4b

111. PROCESS - MANAGEMENT Processes are specific to an organisation and depend on the complexity, size and maturity level of the organisation . Process management should lead to proactive management of all process including outsourced processes. It requires establishing processes, interdependence, resources etc.; the activities within each process should be determined The inter relationships between the processes should be reviewed continually for improvements. The process Management should be done by a system after understanding the network of sequence and interactions of processes. This can be shown on a Process map/Flowchart with relationships and interfaces. The organisations can be at various level of maturity from 1 to 5. After accessing the present level, we have to decide action plan. Module 4b

112. It is necessary that Process Management be done with a system. Guidance for such system: Determine the processes needed for QMS and their application through out the organisation: Name the processes including outsourced. Identify the Input & Output criteria. Define ownership of processes. Determine the sequence and interaction of these processes. Think of overall flow and Map the processes. Define the interfaces between processes. Develop documentation where necessary. Determine criteria and methods needed to ensure that operation and control of these processes are effective. Think about the characteristics of the intended and unintended outcomes of the process. Consider economical consideration. PROCESS - MANAGEMENT Module 4b

113. Ensure the availability of resources and information necessary to support the operation and monitoring of these processes. Allocate resources as needed Establish communication channels between the various functions involved. Obtain feed back and keep records as appropriate. Monitor, measure and analyze these processes Define the most appropriate method for monitoring and analysis of process performance. Analyze the information. Evaluate results. Attacking variance Challenge the variance after accepting it. Take correction or containment action. Find out the Root cause by analysis or Fault tree analysis as appropriate. Take suitable steps after having identified root cause as corrective action. Horizontal deployment for preventive action. PROCESS - MANAGEMENT Module 4b

114. Steps for process planning and control Organisation should determine and plan its process and define functions that are necessary to continually meet and improve customer and interested parties Expectations. Consideration in process planning should be given to- - Organizations environments and its analysis. - Short term and long term marketing forecasts and developments. - The needs of the customers are interested parties . - Objectives of the organisation . - Statutory and regulatory requirements. - Potential financial other risks. - Process inputs and outputs. - Interactions of the processes. - Resources and information. - Activities and methods. - Measurement, monitoring and analysis. - Documentation and records designed. Module 4b

115. PROCESS APPROACH Module 4c QMP 4 In 4b: Process management –what & levels; Details;

116. PROCESS APPROACH What this means: Manage resources as though they are processes Realize that the INPUTS for one process are actually the OUTPUTS of another , and the issue in a process can be the output from the process before Support processes that yield more effective and efficient results. How do I do it ? Carefully define and measure each process and all performance parameters and ensure that higher objectives are aligned with downstream requirements. Optimize the resources of each process Ensure that final products and services meet requirements Control each process itself , not just its output ,correlate measuresat pointsin the process using process output measures. Module 4c

117. PROCESS APPROACH (Continued) Product Process People Do the thing Right Process are fundamental concept within the arena of quality improvement. -Product : What is done -Process : How done -People : Use the process to produce quality -Process is a systematic series of actions directed towards achievement of goals. Do the Right thing Module 4c

118. BENEFITS Increased customer satisfaction Red. In rejection/rework etc. Improvement in inspection methods. Data based working Systematic working-more output Etc. Module 4c

119. PROCESS APPROACH Ref: ISO-9001:2015 The process approach involves: Systematic definition of processes; Management of processes; Management of interactions & inter relationships of the processes. ACHIEVE THE MANAGEMENT OF PROCESSES & SYSTEM AS A WHOLE USING THE PDCA CYCLE and OVERALL FOCUS ON RISK MANAGEMENT. Module 4c

120. PROCESS MAPPING Module 4d In 4c: Process approach- people realize product/service through processes

121. PROCESS MAP The purpose of process mapping is for organizations and businesses to improve efficiency. Process maps provide insight into a process, help teams brainstorm ideas for process improvement, increase communication and provide process documentation. Process mapping will identify bottlenecks, repetition and delays. They help to define process boundaries, process ownership, process responsibilities and effectiveness measures or process metrics A process map is also called a flowchart, process flowchart, process chart, functional process chart, functional flowchart, process model, workflow diagram, business flow diagram or process flow diagram. It shows who and what is involved in a process and can be used in any business or organization and can reveal areas where a process should be improved.

122. PROCESS MAP (continues) A flowchart is a visual /diagrammatical representation of a workflow or process, showing the different type of steps as specific boxes/symbols for each type of step; connecting them with arrows to show their sequence and inter-relationships. Process maps are broad flow charts of processes and may have many parallel processes. Process maps can represent a complete procedure by giving the additional information on the map itself. Module 4 d

123. Symbols for operation steps Activity Brief description symbol Operation   Value adding activity which moves a process forward. Inspection Review/inspection /approval/authorization Transportation/movement Of product / associate / information/document/equipment for processing. Storage/delay (planned) Scheduled delay of material, product. Storage/delay –unplanned Unscheduled delay of material/product, human waiting time. Rework   Reworking/reprocessing a bad work to correct and make it usable again. Flow charts/Process Flow Diagrams were introduced by Industrial engineers with the following 6 notations: Module 4 d

124. A Physical Movement Storage Flow of Control Annotation Report Transmission ANSI STANDARD FLOWCHART SYMBOLS Delay Physical movement Start/ end Operation /activity Decision Inspection Module 4 d

125. Simple flow diagram-1 Issuing material from stores Need for an item/material Go to Supervisor Fill up requisition & get it authorized Walk to store (about 20 meters) Give slip at the window Wait Receive material and sign slip for receipt Verify for item and quantity carry material to dept. Keep at the required place Start End Module 4 d

126. Simple Flow diagram 2 Examination process (Examinee) Take seat wait Receive Question Paper Read Through Is everything clear Clarify from Staff And Proceed Write Answers Ask for additional Sheets Leave the room Yes Submit paper Review Answers Start End No Module 4 d

127. Suppliers ----- Inputs------Process-----Outputs --- Customers Eg . For a purchasing process indentor indent-- ?? Material indentor Quantity at the Quality as required time required Simplistic REPEAT SIPOC ?? Customers----- Outputs-------Process----------Inputs-------- Suppliers To be opened or described Module 4d also

128. Example of process mapping Process selected ‘Appointing persons as required.’ Module 4 d

129. Describing the process (The process box) ‘for appointing persons’ 1 Receive requirement, verify that it is approved. 2 Contact the outsourced service supplier to send suitable resumes. 3 Review and shortlist resumes. 4 Send resumes to the requisitioner to scrutinize the resumes and fix a tentative date for interviews. 5 Inform the outsourced service supplier to call for interviews. 6 Make arrangements for guiding the candidates to the place of interview. 7 Interview the candidates (along with other members of the interview panel). 8 etc. ????? Sequence, ----- DOES THIS MEET OUR NEED TO DESCRIBE ALL ASPECTS OF THE PROCESS??? Module 4 d

130. Process mapping ‘Appointing persons’ Module 4 d The map can be continued to next page through a connector.

131. ‘Appointing persons’ Related and dependent on other processes. Contd. Support /resources related processes People related processes Processes related to other resources Appointing persons Other processes related to people resources Module 4 d These are all from the PROCESS GROUP “support”

132. Performance Evaluation Leadership & Planning Support Operations Improvements Products & services as required Support group of processes are part of the QMS of the Co. Requirements of customers & interested parties. Module 4 d

133. MORE OF PROCESS MAPS Procurement process in Army SIPOC Supplier Input Process Output Customer Demand Raising Department Demand Note ???? Receipt of item(s) as required. Demand Raising Department Procurement section Head of Establishment Finance Section Technical Evaluation Committee Price Negotiation Committee Store Department Vendor / supplier Module 4 d Example 1 By a former student page 1 of 3

134. Procurement Process Defense Institute of Quality Assurance Process Flow Diagram Department Raising Demand Procurement Section Head of Establishment Finance Section Technical Evaluation Committee Price Negotiation Committee Store Department Vendors / Suppliers Start Demand Note Vetting of Demand OK Return for Resubmission Approval Formulation of Specifications Allocations of Fund Publication of Tender BIDS ` Submission of Bids Module 4 d Example 1 By a former student page 2 of 3 Only the last column ??

135. Procurement Process Defense Institute of Quality Assurance Process Flow Diagram Department Raising Demand Procurement Section Head of Establishment Finance Section Technical Evaluation Committee Price Negotiation Committee Store Department Vendor / Supplier Technical Evaluation Financial Evaluation Declaration of L1 Issue of SO Supply of items Receipt of item Inspection & Receipt of stores END Module 4 d Example 1 By a former student page 3 of 3

136. Commissioning of Machines CUSTOMER MARKETING SERVICING Q.A/WORKS REF.DOC REMARKS For Delhi & around, Engr. Is sent from Q,A WI-7B01 FM-7B07 FM-7B07 Keep in touch with customer for m/c delivery Intimate service to send Engr. to site Delivery of machine- inform Reach Site Provide power supply to machine Install Machine Check & make ready for trials Trials Move to office Installation report Follow up action If any Receive Installation voucher Take action if any required Trials & CA’s if any Verify Provide installation voucher File Module 4 d Example 2

137. Repairing Pg.1 of 3               Send defective product for repair   1           Receive product, record reception and customer comments and send to quotes and invoices       1       Is the product under warranty?       1       Out of warranty: Prepare repair quote and send to customer. Does the customer accept the quote?     1         No: Send the product to packing to return it to the customer without repair   1         Pack and return unrepaired product to customer     1         Create repair order and send product to repair           1   Repair identified defect         1     Functional test: Does it pass all tests OK?         1     Burn-in test: Does it pass all tests OK?   1         Pack and return to customer     1         Close repair order     1       Repaired out of warranty: Prepare and send invoice to customer Y N Y N Y N Y N Coordinator Rec. Packing & Shipping Quotation & invoicing customer Tes ting Repai ring Activity Module 4 d Example 3 Page 1 of 3

138. Send defective product for repair Receive product for repair, record reception and customer comments and send to quotes and invoices Prepare repair quote and send to customer for acceptance. . Receive acceptance. Create repair order and send product to repair Repair identified defect Functional test: Does it pass all tests OK? Burn-in test: Does it pass all tests OK? Send to packing & info to invoicing Pack & return to customer   Prepare and send invoice to customer   Coordinator Rec. Packing & Shipping Quotation & invoicing customer Tes ting Repai ring Activity Y N Y N Module 4 d Pl notice the changes made to eliminate the two N Y clusters around the top. Example 3 Page 2 of 3 Repairing Pg.2 of 3

139. Customer Receiving, Packing and Shipping Coordinator Quotes and Invoices Test Repair   ACTIVITY                 1           Receive product for repair, record reception and customer comments.     1         Create repair order and send product for repair           1   Repair identified defect, record parts changed.         1     Functional test: Does it pass all tests OK?         1     Burn-in test: Does it pass all tests OK?   1         Send to packing. Send repair order & parts cost incurred to             Pack & return to customer     1       Prepare and send invoice to customer, Close repair order.                 Module 4 d Pl notice the changes made to eliminate the two N Y clusters toward the end. Example 3 Page 3 of 3 Repairing Pg. 3 of 3

140. END OF MODULE 4 PROCESS PROCESS APPROACH PROCESS MANAGEMENT PROCESS MAPPING.

141. SESSION 5 Recap on Lecture 4 Session 5 Objectives. Correction/Corrective Action/Preventive Action Root Cause Analysis PFMEA Cost of Quality

142. A NON-CONFORMITY (3.6.9) non-fulfilment of a requirement (3.6.4) requirement need or expectation that is stated, generally implied or obligatory. quality requirement (3.6.4) related to quality (3.6.2)

143. Containment , Correction To take immediate steps to prevent or arrest damage after a problem has been reported/detected. Corrective action- Action to eliminate the CAUSE of a non conformity and to PREVENT recurrence. Preventive action - Action to eliminate the CAUSE of a POTENTIAL non conformity or other potential undesirable situation. A ction/s on a non conformity.

144. Corrective Action A reactive approach to problem solving: Need to attack cause and not act on symptoms; Such actions are carried out after root cause analysis ; Objective being –Eliminate/avoid recurrence of non conformity. Preventive action A proactive approach to RISK management: Objective being— Avoid/eliminate occurrence of a risk/problem. Based on learning and actions from: - corrective actions ; - Risk identification and mitigation ( FMEA or any other tool) A ction/s on a non conformity.

145. CAUSE ROOT CAUSE ROOT CAUSE ANALYSIS Objective: What and why of ROOT CAUSE. What is ROOT CAUSE ANALYSIS. Methods of the same. One of the MOST IMPORTANT ACTIVITY to provide QUANTUM RESULTS.

146. causes EFFECT ROOT CAUSE ANALYSIS CAUSE AND EFFECT DIAGRAM (FISH BONE/Ishikawa DIAGRAM) FOR ANALYSING CAUSES All effects ---from---some causes. Cause category Cause category Cause category Cause category

147. Cause and Effect Diagram Main categories Machinery / Equipment Man / People Materials Methods / Procedures Effect प्रभाव

148. C & E diagram –an example. Quality Prod. Dept No awareness of status Lack of supervision identification Status of rejects not maintained No Accountability No process 100 % inspection not proper control Non conforming material Not stopped from Further processing QA not a priority Belief in 100 % inspection No system of identification Management Q System

149. WHY-WHY ANALYSIS WHY & What , When &where Who & How.

150. Format for why-why analysis PROBLEM--- Dept./SECTION/LOCATION Problem observed on -------------at --------- Problem resolved on -------------at--------- Team members _____________ ______________ _________ Final action Are you satisfied with the solution yes/no if no—what next_______________ WHY ANSWER/RESPONSE ACTION IF ANY

151. Example1 of why-why analysis PROBLEM--- Machine trips repeatedly Dept./SECTION/LOCATION M/C shop GD-06 Problem observed on 22-12-2015 at 11AM (earlier also) Problem resolved on -28-12-15 at--------- Team members Ramesh ; Sanjay ; D ivyesh Final action –install a flow control switch & establish a schedule for cleaning. Are you satisfied with the solution yes/ no if no—what next_______________ WHY ANSWER/RESPONSE ACTION IF ANY Why is m/c tripping repeatedly PCB card fails Restarts after some time.- about 6 minutes wasted every time Why is the PCB card failing. One thyristor gets overheated. Why does the thyristor get overheated. Cooling water not adequate. Why -Cooling water not adequate The water pipeline is not clean. Cleaned-lot of choking found. Why is the water pipe line not clean. Ther e is no system/schedule for this cleaning. Schedule to be made & implemented.

152. WHY WHY - Example 2 Case #1: Freemake 
 Freemake  is a multimedia startup. Their apps stream YouTube videos. But in February 2015, YouTube went down and Freemake displayed an error instead of streaming. So, they went through a 5 Why session:  1.  Q: Why did Freemake software show an error? A: Because YouTube content wasn’t available.   2.  Q: Why wasn’t YouTube streaming available? A: Because YouTube went down and we had nothing to display.   3.  Q: Why did Freemake have nothing to display? A: Because we were not aware of the YouTube disaster, we were not ready for such an event and we showed a default message. 4.  Q: Why didn’t we know of YouTube's disaster? A: Because we don’t have an alarm notification system 5.  Q: Why didn’t we have an alarm notification about streaming? A: Because we don’t have quality assurance testing for emergency situations.   Risk analysis - FMEA

153. WHY WHY-Example 3 Case #2: Buffer Now let’s look at Buffer, a social media management service company. In 2014 the service had a brief system-wide outage. Here’s how they ran the 5 Whys  1.  Q: Why did we go down? A: Because the database became locked.   2.  Q: Why did it become locked? A: Because there were too many database writes/operations-more than the capacity..  3.  Q: Why were we doing too many database writes? A: Because this wasn't foreseen and it wasn't tested & just happened.  4.  Q: Why wasn't the change tested? A: Because we don't have a development process set up for when we should test changes.  5. Q: Why don't we have a dev. process for when to do a load test? A: We've never done too much load testing and are hitting new levels of scale.   Risk analysis - FMEA MODULE 6

154. FAILURE MODE EFFECTS ANALYSIS FMEA DESIGN PROCESS SYSTEM FOR ADDRESSING POTENTIAL PROBLEMS EVALUATION, ANALYSIS & MITIGATION OF RISKS DURING PROCESSES OF DESIGN & PRODUCT SERVICE REALIZATION BEFORE THE ‘EVENT ’ TEAM ACTIVITY CRITICAL EXAMINATION OF EACH STEP TO IDENTIFY POTENTIAL PROBLEMS (RISKS) THE RISKS ARE EVALUATED ON THREE CRITERIA SEVERITY OF POTENTIAL RISKS PROBABLITY OF OCCURRENCE OF RISKS/EVENTS DETECTABILITY OF THE OCCURRENCE/EFFECT BEFORE RELEASE/DELIVERY RPN = S*O*D A NUMERICAL NUMBER – CAN BE COMPARED & PRIORITIZED Risk mngmt

155. FAILURE MODE EFFECTS ANALYSIS Define the Scope Define the Customer Identify Functions, Requirements and Specifications Identify Potential Failure Modes Identify Potential Effects Identify Potential Causes Identify Controls Identifying and Assessing Risk Recommended Actions and Results Risk mngmt

156. Module 7

157. --------------------process   System/ subsystem  N A     Potential Failure Mode and Effects Analysis Component  N A.         Despatch process   Process owner  AAAA       Key Date         Core Team   ------------               Sl. No./ Op No. Operation name/ functions Requirement/s Potential failure mode Potential effects of failure severity (of effects of failure) S Potential cause(s) of failure Current process controls Risk priority no. RPN =S*O*D Preventive Occurrence O Detective detectability D                                                                                                                                         PFMEA format upto current status Let us review every term –next slide

158. PFMEA terms 1 . Sl. No./Op no. 2. FUNCTION--- REQUIREMENTS. P. FAILURE MODE- F P. EFFECTS OF THIS FAILURE-FE ON ----- SEVERITY S P causes of this failure FC --- Current process controls: PREVENTIVE DETECTIVE. OCCURRENCE O DETECTABILITY D RPN-Risk Priority Number

159. PFMEA for induction hardening operation The columns for proposed changes can be similarly filled up as applicable.

160. Module 7

161. DFMEA terms Same as those for PFMEA except that Sl. No. 7 changes to current design controls.

162. General steps for conducting an FMEA: Identify the steps of a process, or parts of a product. Identify possible failures modes. (In what way can the product or process fail? What can go wrong?) Identify the failure effects. (What is the impact on key process measures or product specifications?) Assess the severity of the potential failure. (How severe is the problem to the customer? 1 = least severe, 10 = most severe) Identify the potential causes of the failure. Assess the occurrence. (How frequently is this failure likely to occur? 1 = low occurrence, 10 = high occurrence) Identify the current detection modes. (What are the existing controls that either prevent the failure from occurring or detect it should it occur? Assess the detection of the failure. (How easy is this failure to detect?) Calculate the risk priority number, or RPN. ( RPN = severity * occurrence * detection ) For the potential failures with the highest RPN, create mitigation plans. Once the actions have been taken, recalculate the RPN to confirm the failure risk has been reduced.

163. Criteria Description Low Number High Number Severity Severity ranking encompasses what is important to the industry, company or customers (e.g., safety standards, environment, legal, production continuity, scrap, loss of business, damaged reputation) Low impact High impact Occurrence Rank the probability of a failure occuring during the expected lifetime of the product or service Not likely to occur Inevitable Detection Rank the probability of the problem being detected and acted upon before it has happened Very likely to be detected Not likely to be detected Assessment of S, O and D

164. EVALUATION OF SEVERITY “S”. No effect, no danger 1 Very minor – usually noticed only by discriminating or very observant users 2 Minor – only minor part of the system affected; noticed by average users 3 Moderate – most users are inconvenienced and/or annoyed 4-6 High – loss of primary function; users are dissatisfied 7-8 Very high – hazardous. Product becomes inoperative, customers very unhappy. Failure constitutes a safety hazard and can cause injury or death.   9-10 EVALUATION OF OCCURRENCE “O”. No documented failures on similar products/processes 1 Low – relatively few failures 2-3 Moderate – some occasional failures 4-6 High – repeated failures 7-8 Very high – failure is almost certain 9-10 EVALUATION OF DETECTABILITY “D”. Fault is certain to be caught by testing   1 Fault almost certain to be caught by testing   2 High probability that tests will catch fault   3 Moderate probability that tests will catch fault   4-6 Low probability that tests will catch fault   7-8 Fault will be passed undetected to user/customer   10

165. FMEA examples in day to day life

166. Quality TYPES OF QUALITY Quality of design decides the characteristics of the product in reference to customer requirements . Quality of conformance means satisfying the designed standard to ensure performance levels. QUALITY OF CONFORMANCE DESIGN/GRADE

167. COST of QUALITY Cost of quality Prevention Appraisal Failure External Internal

168. Why Use Cost of Quality? To provide a benchmark against which improvement can be measured over time. To measure RESULTS of the quality management system (QMS) rather than its activities To provide a link between business objectives and the QMS To provide a money-based report card on quality improvement efforts To provide an effective tool to identify, prioritize and select quality improvement projects

169. Categories of Cost of Quality Prevention costs -Build it right the first time Appraisal Costs -Inspection and testing Internal failure costs -Scrap and rework External failure costs -Warranty claims, recalls, lost business

170. Four Categories of Quality Costs Category 1: Prevention Costs These costs are incurred in the process of trying to prevent defects and errors from occurring. Planning the quality control process Training Education Designing the product for quality Designing the production system for quality Preventive maintenance

171. Four Categories of Quality Costs Category 2: Appraisal Costs These are the costs of determining the current quality of the production system. Measuring and testing parts and materials Running test labs Acquiring testing equipment Conducting statistical process control Receiving inspection Reporting on quality

172. Four Categories of Quality Costs Category 3: Internal failure costs These costs are incurred when defects and errors are found before shipment or delivery to the customer. Labor and materials that are scrapped Engineering change notices Reworking and retesting to correct defects Lost profits on downgraded products Lost yield Expediting

173. Four Categories of Quality Costs Category 4: External failure costs These are the costs of trying correct defects and errors after receipt by the customer. Quick response to complaints Adjustments to correct the problem Lost goodwill Recalls to correct for other customers Warranties and insurance Settlements of lawsuits

174. BENEFIT OF COQ MEASUREMENT Management focus Project focus Measurement focus

175. PROBLEMS IN QUALITY COST MEASUREMENT The difficulty in measurement an quantifying certain quality parameters such as the customer loyalty, staff commitment etc There is apparently subjective nature of classification of quality costs. The technical-accounting problems of a cost measurement system which by definition is in complete. The difficulty in apportioning overheads across the quality cost categories

176. RATIOS for COSTS OF QUALITY Sales Ratio = Total quality cost/Net sales Cost Ratio = Total quality cost/Costs of operations Unit Ratio = Total quality cost /Units produced Labor Ratio = Total quality cost /Direct labor cost

177. RATIOS for COSTS OF QUALITY Prevention Ratio = Prevention cost/Total cost of quality Appraisal Ratio: = Appraisal cost /Total cost of quality Failure Ratio: = Failure cost /Total cost of quality

178. Total Quality Cost graph

179. END OF SESSION 5 Correction/Corrective Action/Preventive Action Root Cause Analysis PFMEA Cost of Quality

180. SESSION 6 6 a : Risk Management 6 b : Self Assessment (ISO 9004)

181. SESSION 6a RISK MANAGEMENT OBJECTIVE : Risk management has been given lot of focus by the standard to PREVENT unfavorable incidents (risks) and to UTILIZE any opportunities as these arise. In this module, we shall learn about: Risk, Risk management; An example; Tools for risk management Risk Based Thinking Reading material From ISO site ISO-9001 and Risk Based thinking and Note on Risk management—have been uploaded for your study. Risk mngmt .

182. RISK MANAGEMENT Part of all processes at all levels . The word “risk” now appears 46 times in ISO 9001:2015. Concerns every manager. So establish a methodology to: -Identify risks; -Evaluate and prioritize the risks identified ; -manage (plan & implement actions) as prioritized; -verify the actions and the results; -standardize the changed procedure. (As per need of the organization and the s ituation) . Risk mngmt

183. RISK MANAGEMENT ISO 31000 - Risk management Risks affecting organizations can have consequences in terms of economic performance and professional reputation, as well as environmental, safety and societal outcomes. Therefore, managing risk effectively helps organizations to perform well in an environment full of uncertainty.

184. RISK MANAGEMENT (contd.) IS-31000:2009 DEFINITION --the “effect of uncertainty on objectives” . Effect is a deviation from the expected — positive and/or negative. Uncertainty is the state, even partial, of: deficiency of information related to,: understanding of an event or knowledge of the event, consequences of the event or likelihood of the event. Example: Say –in the cooking process- events like: getting burnt, spilling the material, causing fire/explosion, are some possible events with negative consequences. In this case, we understand the first two events , can be said to have knowledge of the event; but not fully of the consequences/likelihood of the events. Risk mngmt

185. Whereas for the third ‘possible’ event, we have partial/deficient information of all the four parameters. These are (some) risks in the process of cooking and are addressed, and managed in each cooking unit. (still the explosions happen ----) Risks are mostly identified with a potential event , its consequences and the likelihood of its happening. RISK MANAGEMENT (contd.) Risk mngmt

186. Risk mngmt RISK MANAGEMENT PROCESS

187. Overall risks in an organization w r t the QMS Context Organization’s QMS Objectives Enhancement of customer satisfaction. Demonstrate the ability to consistently provide products meeting all requirements. 3. What might happen. Delayed Delivery/ ies . 4. Likely effects on Customer satisfaction shall not get objectives. enhanced. ------- When/how often. Every delivery. How 1 Production capacity not adequate. 2 No scheduling systems. 3 --- Why 1 Funds shortage. 2 ------- 3 ---- How to deal 1 Priortize —prod capacity 2 Likely Action/s 1. Outsource 2. Plan for expansion. Risk mngmt AN EXAMPLE

188. 6.1 Actions to address risks & opportunities. TOOLS – many as listed in the attached note. An example of PDPC TO Identify risks and to find alternatives. Risk mngmt

189. S N N N N G A C A C A C A C Structure of Process Decision Program Chart PDPC we have a branch on the side or all the other representing adverse abnormal occurrence (A). After each such Occurrence, we have a countermeasure steps (C) representing the action that would enable to reach the goal in spite of the Risk mngmt

190. PROCESS DECISION PROGRAM CHARTS – PDPC Processes do not always proceed exactly as planned unexpected problems frequently occur in complex systems, some time leading to serious consequences. PDPC is a tool for preventing this and achieving desired objectives. It is used to plan for the various contingencies. Advantages of PDPC Facilitate forecasting and enable past experience to forestall potential problems. This helps in pinpointing the portable locations of problems. This helps in understanding the decision makers intentions. This is flexible planning tool and allow to modify easily by gathering various opinions. Structure of PDPC It resembles a flowchart . The difference is that here one considers events other than the normal expected events and thus branching out of chart. In the diagram, S is starting point, G is the goal, N represent the normal flow, A the abnormal flow and C the counter measure. Procedure for making PDPC Prepare a Normal (N) flow of all expected events. Consider the possibility of variance and A occurring against the plan. Show these a branching from N- flow chart. Consider consequences C, connecting to the corresponding A. Connect to the flow after C to meet the goal (G). Risk mngmt

191. S N N N N G A C A C A C A C Structure of Process Decision Program Chart PDPC we have a branch on the side or all the other representing adverse abnormal occurrence (A). After each such Occurrence, we have a countermeasure steps (C) representing the action that would enable to reach the goal in spite of the Risk mngmt

192. Get a steady job Start saving early Invest in housing Invest for long-term Manage Investments Provide secure future Loss of property Householder Insurance Savings lost to illness Medical Insurance Losses due to bad inv. Get advice on portfolio May lose job Develop alt. skills PDPC – Providing secure future for dependents Early Demise Life Insurance Risk mngmt

193. ISO 31000 :2018 ISO 31000:2018 supersedes ISO 31000:2009. The risks organizations face have changed significantly the last 9 years. Risks such as terrorism and cyber-attacks were not as prevalent a decade ago.  To adapt to these new realities and to facilitate risk management, the standard Risk Management standard ISO 31000 has been revised, and the latest version has just been released.

194. ISO 31000:2018 ISO 31000:2018,  Risk management – Guidelines , provides principles, framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector. Using ISO 31000 can help organizations increase the likelihood of achieving objectives, improve the identification of opportunities and threats and effectively allocate and use resources for risk treatment. However, ISO 31000 cannot be used for certification purposes, but does provide guidance for internal or external audit programmes. Organizations using it can compare their risk management practices with an internationally recognised benchmark, providing sound principles for effective management and corporate governance.

195. ISO 31000 :2018 Simple is the best way to describe the new ISO 31000:2018 standard. It is clear and concise while giving enough detail to be applicable to organization anywhere in the world and applied to different processes from finance to production. It has been presented with a simple language where risk management fundamentals can be understood by everyone. To make the standard accessible and easy to understand, its terminology has been revised and certain terms used in risk management have been moved to ISO Guide 73,  Risk Management – Vocabulary.

196. ISO 31000 :2018 Changes in this new Risk management standards are to provide Value Creation and Protection to every organization. These principles make risk management: Integrated Structured and comprehensive Customized Inclusive Dynamic Based on best available information Aware of human and cultural factors Focused on continual improvement

197. Risk Based Thinking Reading Material “Note on ISO 9001 and Risk Based Thinking” Discussion

198. END OF MODULE on RISK MANAGEMENT Definition of risk (ISO-31000:2009) The risk management process. Tools Risk Based Thinking Reading Material Discussion

199. SESSION 6b SELF ASSESSMENT PROCESS MATURITY MODELS In ISO-9004 –self assessment –an important part. What--- Why— Why are we taking it up??---

200. Self - assessment Self - assessment  can be defined as “a systematic, and regular review of an organization's activities and results against a model of business excellence culminating in planned improvement actions”. Our context is PROCESSES .

201. Assessment-general ASSESSMENT--- SELF ASSESSMENT--- Each of these has to be against a CRITERIA. INTERNAL AUDITS /AUDITS are also assessments of the QMS against the criteria of the standard and company’s QMS-(documented or not).

202. Assessment-general… BUT ---Only yes or no- Any finding above the basic requirement is given an 'yes'-thereby not knowing whether a further improvement is possible /required / warranted. This can be done by assessing the point / process on a continuing scale –may be 1 to 5, 1 to 7 ,1 to 10 etc.

203. Assessment-general… The SELF ASSESSMENT MODELS (ISO-9004 being one of these) and THE PROCESS MATURITY MODELS P rovide (normally) five* levels of performance. If you are at one , you know, you need to go to two and then to three and so on.  Maturity of processes will lead to company excellence.

204. (SELF) ASSESSMENT to determine the maturity levels of different processes; to obtain a status of these processes vis a vis the ‘world class’/ a higher benchmarked standard. Thereby identifying opportunities for improvement and innovation. What, why. asq

205. (SELF) ASSESSMENT MODELS ISO-9004 BPMM- Business process maturity models. CMMI ---Capability Maturity Model Integration. CII-Exim EFQM--European Foundation for Quality Management. Many organization’s own models (e g telstra ). . .

206. THE MODEL-ISO-9004 As per ISO-9004 Table A.1 Key element Level 1 Level 2 Level 3 Level 4 Level 5 1 Criteria Base level Criteria –best practice 2 3 Key element can be equated to the ‘item’ or, in our case, THE PROCESS to be assessed e.g problem handling (as above) or say competency development.

207. Example from Crossby’s QM Maturity Grid Level Process Level/stage 1 uncertainty Level/stage 2-Awakening Level/stage 3- Enlightenment Level/stage 4 -Wisdom Level/stage 5-Certainty Problem handling Problems are fought as they occur; inadequate definition; no resolution; Teams set up for major problems; long range solutions not solicited; say fire fighting. Problems are faced openly and resolved in a systematic manner. Problems identified early during development; all open to suggestions and improvements. Problems mostly prevented. Quality improvement No organized activity. Motivational short range method. 14 step program with thorough understanding. Continue the 14 step program with certainty. Quality improvement is a normal and continued activity.

208. The various levels are as under:- Level 1:- Processes are managed in an ad-hoc manner, there is no system. Level 2 :- Key processes for customer satisfaction and product realisation are defined and managed. Interactions between processes are defined and monitored. The effectiveness of system is systematically measured for improvements. Level 3:- Process planning is integral part of design and development. Customer needs are identified and used for process planning. Productivity improvements are measured. The quality performance is predictable/reliable. PDCA cycle for further improvement . Level 4:- Organisation is moving towards flexibility and reliability demands of customer. Conflicts of interactions between various functions resolved effectively. Innovation culture building Level 5:- The Organisation’s process performance levels compares with best in the industry as compared with Benchmark data of industry. PROCESS – MANAGEMENT Module 4b

209. Level no. Crossby’s QM Maturity Grid CMMI Process as per session 4 1 Uncertainty Initial-unpredictable and reactive. Work is often delayed and over budget. Adhoc. –processes are managed in ad-hoc manner without any system. 2 Awakening Managed—on project level. Projects are planned, performed, measured and controlled. -Key processes for customer satisfaction and product realization and interaction between them are defined and managed. -The effectiveness of system is measured for improvements. 3 Enlightenment Defined-proactive rather than reactive. Organization wide standards provide guidance across projects, programs and portfolios.   All processes are planned on the basis of customer needs/requirements. -The quality performance is predictable/reliable. -PDCA cycle for further improvement. -Improvements are measured. --- 4 Wisdom Quantitatively managed-Measured and controlled. –data driven; with predictable and quantitative performance improvement objectives; aligned to meet the needs of all stakeholders. -Organisation is moving towards flexibility and reliability demands of customer. - Conflicts of interactions between various functions resolved effectively. -Innovation culture building   5 Certainty Optimizing-stable and flexible. Organization is focused on continuous improvement; org is built to respond to opportunity and change; the organization’s stability provides a platform for agility and innovation. The Organisation’s process performance levels compares with best in the industry as compared with Benchmark data of industry.   Comparison of criteria of three maturity levels. ISO-9004

210. “ Organisational Project Maturity model ”

211. WHAT NEEDS TO BE DONE The process of self assessment Management decision, broad plan and assigning responsibility. Establish the model; Prepare team Develop/modify criteria; organize trainings and awareness . Conduct assessment & prepare report including maturity level of each process assessed . Identify improvement opportunities Process owners to plan and act for improvements Review progress Standardize START END

212. Example 1- People/competency development LEVEL Criteria Summary of observations To next level-y/n Uncertainty 1 Trainings are adhoc and/or crisis based. There are no processes for competency reviews. Awakening 2 Processes are established and implemented for competency review. Competencies are developed as part of an overall plan linked to the organization’s strategy. Enlightenment 3 A skills qualification system is established with mentoring and coaching. Wisdom 4 Training is provided to develop skills for creativity and improvement. Certainty 5 External networking involves people throughout the organization. People participate in development of processes and products. Best practices are sought and implemented using PDCA approach.

213. Assessment Process-Competency Development Alternatively, 1 Competent, engaged, empowered and motivated People are considered to be resource in an informal or ad hoc manner. Competence development is provided in an informal or hoc manner. 2 Processes to attract competent, engaged, empowered and motivated people are implemented. Processes to determining, developing, evaluating and improving resources are evident in some cases.  Some competence reviews have been implemented. 3 A planned, transparent, ethical and socially responsible approach is applied at all levels throughout the organization.  Reviews and evaluations of the effectiveness of actions taken ensure the personal competences (in both the short and long term) are in accordance with the mission, vision and objectives.

214. Example 2-Improvement process LEVEL Criteria Summary of observations To next level-y/n Uncertainty 1 Improvement Activities are done in an informal or ad-hoc manner. Necessary resources to achieve improvement are provided. Awakening 2 Processes for corrective and preventive actions have been established and implemented. Process to train persons in tools of quality, SPC etc are in place but not implemented fully. Enlightenment 3 The focus of improvement processes is aligned with the strategy and objectives, and top management is visibly involved in improvement activities. Schemes are in place to train and empower teams and individuals in improvement and innovation. Wisdom 4 The improvement/innovation culture in the company is obvious through results. Certainty 5 The improvement/innovation culture in the company is obvious through results.

215. Assessment Process-Determining objectives Level 1 1.1 processes for ------are informal and ad hoc. 1.2 only the short term objectives are defined. Assessment (self)…. 1.1.1. Do we establish objectives for processes? i) Yes for delivery, production and quality by the Works manager……. OR ii) Yes for all processes in a meeting with all process owners. 1.1.2 Is it done regularly? i) No, whenever there is a problem. OR ii) Yes, every month Etc. Now, can the level of this process be assessed? If the answers are the ones shown in i)’s, the process is surely at level 1, whereas if the answers are ii)’s, the assessor has to continue further to see whether the process falls in level 2 or higher.

216. FROM TELSTRA (Australian telecom giant) It is not that every organization’s criteria ALWAYS starts from ADHOC. continuous improvement matrix of Telstra –(Google) People management process.(There are more processes) 1. Joint problem solving is the basis for creatively involving people . We develop plans for doing so. 2. We share a common problem solving methodology throughout the organization. We address cross functional issues . 3. Continuous improvement is built upon collaboration and valid information . Feeling are expressible as valid information. 4. The organization values learning . Ideas for improvement are sought and acknowledged. 5. Policies and procedures are aligned to maximize opportunities for individual and team contributions. 6. The questioning and challenging of core values and assumptions is a core part of organizational life. 7. Our people are active advocates of our learning organization .  

217. END OF SESSION 6 Risk Management Self Assessment (ISO 9004)

218. Lecture 6b and Lecture 7 Recap on Lecture 5 and 6a

219. SESSION 6b SELF ASSESSMENT PROCESS MATURITY MODELS In ISO-9004 –self assessment –an important part. What--- Why— Why are we taking it up??---

220. Self - assessment Self - assessment  can be defined as “a systematic, and regular review of an organization's activities and results against a model of business excellence culminating in planned improvement actions”. Our context is PROCESSES .

221. Assessment-general ASSESSMENT--- SELF ASSESSMENT--- Each of these has to be against a CRITERIA. INTERNAL AUDITS /AUDITS are also assessments of the QMS against the criteria of the standard and company’s QMS-(documented or not).

222. Assessment-general… BUT ---Only yes or no- Any finding above the basic requirement is given an 'yes'-thereby not knowing whether a further improvement is possible /required / warranted. This can be done by assessing the point / process on a continuing scale –may be 1 to 5, 1 to 7 ,1 to 10 etc.

223. Assessment-general… The SELF ASSESSMENT MODELS (ISO-9004 being one of these) and THE PROCESS MATURITY MODELS P rovide (normally) five* levels of performance. If you are at one , you know, you need to go to two and then to three and so on.  Maturity of processes will lead to company excellence.

224. (SELF) ASSESSMENT to determine the maturity levels of different processes; to obtain a status of these processes vis a vis the ‘world class’/ a higher benchmarked standard. Thereby identifying opportunities for improvement and innovation. What, why. asq

225. (SELF) ASSESSMENT MODELS ISO-9004 BPMM- Business process maturity models. CMMI ---Capability Maturity Model Integration. CII-Exim EFQM--European Foundation for Quality Management. Many organization’s own models (e g telstra ). . .

226. THE MODEL-ISO-9004 As per ISO-9004 Table A.1 Key element Level 1 Level 2 Level 3 Level 4 Level 5 1 Criteria Base level Criteria –best practice 2 3 Key element can be equated to the ‘item’ or, in our case, THE PROCESS to be assessed e.g problem handling (as above) or say competency development.

227. Example from Crossby’s QM Maturity Grid Level Process Level/stage 1 uncertainty Level/stage 2-Awakening Level/stage 3- Enlightenment Level/stage 4 -Wisdom Level/stage 5-Certainty Problem handling Problems are fought as they occur; inadequate definition; no resolution; Teams set up for major problems; long range solutions not solicited; say fire fighting. Problems are faced openly and resolved in a systematic manner. Problems identified early during development; all open to suggestions and improvements. Problems mostly prevented. Quality improvement No organized activity. Motivational short range method. 14 step program with thorough understanding. Continue the 14 step program with certainty. Quality improvement is a normal and continued activity.

228. The various levels are as under:- Level 1:- Processes are managed in an ad-hoc manner, there is no system. Level 2 :- Key processes for customer satisfaction and product realisation are defined and managed. Interactions between processes are defined and monitored. The effectiveness of system is systematically measured for improvements. Level 3:- Process planning is integral part of design and development. Customer needs are identified and used for process planning. Productivity improvements are measured. The quality performance is predictable/reliable. PDCA cycle for further improvement . Level 4:- Organisation is moving towards flexibility and reliability demands of customer. Conflicts of interactions between various functions resolved effectively. Innovation culture building Level 5:- The Organisation’s process performance levels compares with best in the industry as compared with Benchmark data of industry. PROCESS – MANAGEMENT Module 4b

229. Level no. Crossby’s QM Maturity Grid CMMI Process as per session 4 1 Uncertainty Initial-unpredictable and reactive. Work is often delayed and over budget. Adhoc. –processes are managed in ad-hoc manner without any system. 2 Awakening Managed—on project level. Projects are planned, performed, measured and controlled. -Key processes for customer satisfaction and product realization and interaction between them are defined and managed. -The effectiveness of system is measured for improvements. 3 Enlightenment Defined-proactive rather than reactive. Organization wide standards provide guidance across projects, programs and portfolios.   All processes are planned on the basis of customer needs/requirements. -The quality performance is predictable/reliable. -PDCA cycle for further improvement. -Improvements are measured. --- 4 Wisdom Quantitatively managed-Measured and controlled. –data driven; with predictable and quantitative performance improvement objectives; aligned to meet the needs of all stakeholders. -Organisation is moving towards flexibility and reliability demands of customer. - Conflicts of interactions between various functions resolved effectively. -Innovation culture building   5 Certainty Optimizing-stable and flexible. Organization is focused on continuous improvement; org is built to respond to opportunity and change; the organization’s stability provides a platform for agility and innovation. The Organisation’s process performance levels compares with best in the industry as compared with Benchmark data of industry.   Comparison of criteria of three maturity levels. ISO-9004

230. “ Organisational Project Maturity model ”

231. WHAT NEEDS TO BE DONE The process of self assessment Management decision, broad plan and assigning responsibility. Establish the model; Prepare team Develop/modify criteria; organize trainings and awareness . Conduct assessment & prepare report including maturity level of each process assessed . Identify improvement opportunities Process owners to plan and act for improvements Review progress Standardize START END

232. Example 1- People/competency development LEVEL Criteria Summary of observations To next level-y/n Uncertainty 1 Trainings are adhoc and/or crisis based. There are no processes for competency reviews. Awakening 2 Processes are established and implemented for competency review. Competencies are developed as part of an overall plan linked to the organization’s strategy. Enlightenment 3 A skills qualification system is established with mentoring and coaching. Wisdom 4 Training is provided to develop skills for creativity and improvement. Certainty 5 External networking involves people throughout the organization. People participate in development of processes and products. Best practices are sought and implemented using PDCA approach.

233. Assessment Process-Competency Development Alternatively, 1 Competent, engaged, empowered and motivated People are considered to be resource in an informal or ad hoc manner. Competence development is provided in an informal or hoc manner. 2 Processes to attract competent, engaged, empowered and motivated people are implemented. Processes to determining, developing, evaluating and improving resources are evident in some cases.  Some competence reviews have been implemented. 3 A planned, transparent, ethical and socially responsible approach is applied at all levels throughout the organization.  Reviews and evaluations of the effectiveness of actions taken ensure the personal competences (in both the short and long term) are in accordance with the mission, vision and objectives.

234. Example 2-Improvement process LEVEL Criteria Summary of observations To next level-y/n Uncertainty 1 Improvement Activities are done in an informal or ad-hoc manner. Necessary resources to achieve improvement are provided. Awakening 2 Processes for corrective and preventive actions have been established and implemented. Process to train persons in tools of quality, SPC etc are in place but not implemented fully. Enlightenment 3 The focus of improvement processes is aligned with the strategy and objectives, and top management is visibly involved in improvement activities. Schemes are in place to train and empower teams and individuals in improvement and innovation. Wisdom 4 The improvement/innovation culture in the company is obvious through results. Certainty 5 The improvement/innovation culture in the company is obvious through results.

235. Assessment Process-Determining objectives Level 1 1.1 processes for ------are informal and ad hoc. 1.2 only the short term objectives are defined. Assessment (self)…. 1.1.1. Do we establish objectives for processes? i) Yes for delivery, production and quality by the Works manager……. OR ii) Yes for all processes in a meeting with all process owners. 1.1.2 Is it done regularly? i) No, whenever there is a problem. OR ii) Yes, every month Etc. Now, can the level of this process be assessed? If the answers are the ones shown in i)’s, the process is surely at level 1, whereas if the answers are ii)’s, the assessor has to continue further to see whether the process falls in level 2 or higher.

236. ISO-9004 Managing for sustained Success of an Organisation Thru QMS Think Cause and Effect Think & Work on enablers. Keep turning ‘PDCA’ Wheel for continual Improvement Improvement/Innovation/Learning ISO-9004

237. ISO-9004 The self-assessment tool. The tool has been designed to assist organizations in assessing the level of maturity of the various processes of the QMS. After assessing their processes, the quality improvement team can identify and prioritize potential areas for improvement.  

238. ISO-9004 Sustained Success Resource Management Leadership Strategy & Policy Development Process Management Monitoring, Measuring, Analysis Review ISO-9004

239. Managing QMS for sustained Success of Organisation This is based on ISO 9004-2009. All definition, terms and criteria are as for ISO- 9000-2015 and ISO- 9001-2015 . Introduction: The sustained success of an organisation is achieved by its ability to meet the needs and expectation of its customer and other interested parties. This standard promotes self assessment of review of the maturity level on parameters like Leadership, Strategy, management System, Resources and Processes. Maturity levels are on scale of 1- 5, where 1 denotes starting and 5 denoted World Class. Sustained success to be result of organisation to achieve and maintain its objective in long-term . ISO-9004

240. Managing QMS for sustained Success of Organisation A – Leadership The Top Management should apply the 7 quality management principles in QMS for sustained success. The QMS must be developed to ensure. Efficient use of resources. Customer focus for present and future needs. Decision making based on facts & figures. B - Sustained Success This can be achieved by achieving the needs and expectations of the various interested parties in a balanced way over the long term . The management should develop following to meet the challenges in long run in view of changing environment: ISO-9004

241. Managing QMS for sustained Success of Organisation B1 Long term planning - Must regularly monitor & review the organisations’ environment . -This includes identifying short-term and long-term risks and modify strategy accordingly. -To anticipate future needs. B2. Identifying all interested parties, assess their potential impact on organisation and determine how to meet the expectations in a balanced way. -Have open communication system with interested parties -Develop methods for ‘Win-Win’ situation for all parties even in conflicting needs. -Develop flexibility in partners to meet changing needs. ISO-9004

242. Managing QMS for sustained Success of Organisation B3 Develop Human Resource management Policies. Anticipate future needs of people & their competency . Create opportunities for learning & Innovations. C- Organizational Environment : Continual The environment should be monitored and timely decision for change be taken. D- Interested Parties, needs & expectation The needs and expectations of various parties may be different and conflicting also. The means to tackle this by collaborative approach by various forms like negotiation, collaboration, outsourcing or terminating some activities. ISO-9004

243. Strategy & Policy Formulation A- The Organisation should establish and maintain policies to: 1. Translate its strategy and policy into measurable objectives. 2. Establish responsibility, authority and resources for achieving objectives. 3. Identify risks and approach to counter these risks. B- The Organisation should identify action plan for: 1. Assessing the problems in current perspective and attack these by PDCA after root cause analysis. 2. Anticipate any future conflicts of interested parties due to different needs and expectations. 3. Keep all the interested parties informed, gain their confidence and getting feedback and idea for improvement. ISO-9004

244. Strategy & Policy Deployment contd. C -  The Co. Should develop Policy Deployment system to align all people for meeting the objectives. This can be done by: 1. Clearly identifying and showing interrelationship between various functions, systems, processes and organisation structure. 2. Identifying potential problems and taking preventive measures. 3. Cascading the objective by “Top down” approach for aligning, setting objectives and identifying the action plan as appropriate at each level. ISO-9004

245. Strategy & Policy communication contd D-   The Co. should have a processes for effective communication to all levels. For communication to be successful it should be: 1. Meaningful i.e understood at levels, timely and continual. There should be a feedback mechanism for effectiveness and review for improvement. 2. The communication should be horizontal and vertical and should be appropriate to the recipients eg. It can be conveyed differently to various levels, customers and other interested parties. 3. Create Visual Management for effectiveness. ISO-9004

246. Resource Management A: General The organisation should identify the internal and external resources that are needed for meeting the short term and long term objectives. It should have processes to monitor, provide, allocate, facilities, energy, people, knowledge, finance etc. The organisation should monitor current use of resources and use PDCA for improvement. It should also research on new resources, processes and technologies for future activities. B: Financial resources Financial resources such as Cash, Securities, loans or other financial instruments should be well planned for current and future requirements. There should be proper monitoring, controlling, reporting on effective utilization of resources related to the organizational objectives. ISO-9004

247. Resource Management contd. C: People Resources People are the main assets of an organisation, the leadership should orient the people towards the company objectives by Policy Deployment or other initiatives. D: Competence of People The competency mapping of people should be done to develop a “people skill development” plan. The following actions may be help in this- To identify competencies needed for future both short term and long term. Gap analysis to be done to identify the present status and future needs. Action should be taken to close the gaps and effectiveness of these actions should be monitored. Put in place system for retention of people. ISO-9004

248. Resource Management contd. E: Involvement and motivation The organisation must have activities and policies to motivate people for enhanced performance. These may include: Appropriate reward and recognition system Develop a learning organisation to share knowledge for improvement. Continual skill enhancement programmes keeping in view the carrier planning of employees. ISO-9004

249. Resource Management contd. F : Supplier and Partners The partnership is an interdependent relation for mutual growth and benefit. The suppliers can be part of growth where they can share profits and losses together. The system must take steps to Share information and knowledge as appropriate Improving the performance of partners ley technology, expertise, training etc. Take steps to continually improve then capabilities. Together with the suppliers the QCD performance of the organisation can be enhanced. ISO-9004

250. Resource Management contd. G: Infrastructure The infrastructure should be planned and managed effectively and efficiently. It should periodically asses the status of infrastructure to meet future goals and plan. The steps can include:- 1. Safety and security 2. Dependability of the infrastructure industry reliability, maintainability and support. 3. The efficiency, cost capacity. The organisation should assess risks and have contingency plans. ISO-9004

251. Resource Management contd. H- Work Environment A suitable work environment is essential as a combination of human and physical factors. This should include: Creative work methods and opportunities for greater involvement of people. Safety rules and protective equipment. Ergonomics, workload and stress, workplace location. Heat humidity, light, airflow. Various facilities like Canteen, Restroom, washrooms, hygiene, cleanness, noise, pollution etc. ISO-9004

252. Resource Management contd. I: Knowledge, Information and Technology: The organisation should have processes to identify, obtain, maintain, protect, use and evaluate need of these resources. I-1 Knowledge: Organisation should access the current knowledge base and acess how to meet the future needs by acquiring knowledge externally or internally. This can be done by: Learning from future Capturing knowledge from success stories in the organisation . Gathering knowledge from suppliers, vendors, customers. Capturing undocumented knowledge in the organisation . I-2 Information The organisation should establish a process for gathering reliable and useful data and convert it for decision making process. This should include storage security, protection, communication and distribution of data . ISO-9004

253. Resource Management contd. I: Knowledge, Information and Technology: contd. I-3 Technology: The organisation should continually enhance by improving technology. This should have a process for assessment of Current levels of technology and emerging trends. Economic analysis of technology Speed and ability to react to customers requirements- to remain competitive Evaluation of risks in view of emerging technology.  I-4 Natural Resources: The organisation should asses the risks by way of availability of natural resources in the short and long term. The organisation should give appropriate consideration to integration of environmental protection aspects in product and process design and development. Steps should be taken to minimize environmental Impacts over the full life cycle of the products from delivery to disposal. ** ** ISO-9004

254. Process Management ALREADY DISCUSSED MANY TIMES This should be done by “Process approach” and rotating PCDA cycle continually. ISO-9004

255. Monitoring, Measurement, analysis and review 1 : Monitoring : The organisation should establish process for monitoring environment and collecting information for Identifying and understanding the present and future needs and expectations of all interested parties. ‘SWOT’ Analysis be done and alternatives thought of Determining the emerging technologies, markets and customer expectations. Understanding the social, economic, ecological trends including expected changes in statutory and regulatory requirements.

256. Monitoring, Measurement, analysis and review contd. 2: Measurement: The management should measure and analyze the performance for effective decision making. The source of information gathering could include: Risk assessments and risk control. Gathering information and feedback on customers and interested parties through interviews, surveys etc. Benchmarking Monitoring process variables and product characteristics for analysis and improvement. ISO-9004

257. Monitoring, Measurement, analysis and review contd. 3 : Key Performance Indicators: Factors within control of organisation and critical to sustained success should be identified as KPI’s That should me measurable and should be cascaded top-down by policy deployment. The KPI’s should help Top Management in taking strategic decisions and also analyze for corrective preventive actions where needed The KPI’s could include: Information on needs and expectations of customers and other interested parties. Segment wise analysis of market for present and future trends. The effectiveness and optimize utilization of processes, natural resources, energy, manpower etc. The profitability, growth and financial ratios. ISO-9004

258. Monitoring, Measurement, analysis and review contd. 4 : Internal Audit: -This is best method for identifying gaps in actual vs desired state. -This should be carried out by competent people in areas which are directly under their control. The report should highlight opportunities for improvement of operators to meet all requirements of QMS. It should also highlight good practices for internal benchmarking. 5 : Benchmarking: This a tool to search best practice inside and outside the organisation with the aim for striving for higher and higher levels of performance. -The benchmarking is applied to areas such as: -Performance, Processes -Design Characteristics -Comparing strategic operations or processes only. ISO-9004

259. Monitoring, Measurement, analysis and review contd. Analysis: Top Management should analyze information gathered for identifying risks and opportunities and develop plans to manage them. The analysis based on factual data should enable decisions in areas such as Market/Product that provide maximum value to the organisation and potential changes in needs and expectations New competences and skills needed for future plans Potential changes in statutory / regulatory regulators and labour laws and availability. Emerging markets and technologies.   ISO-9004

260. Improvement, Innovation & learning . 1 : For sustaining the growth of the organization, improvement and innovation will be necessary These initiatives should apply to areas such as: - Products, Processes, human resources, infrastructure and environment and interest of related parties 2 : Improvement The culture of organisation should encourage improvement activities The improvement process should follow a structured process applicable to the initiative e.g Quality Circle, Small schemes etc. The activity can be encouraged by : 1. Empowerment of people and providing encouragement 2. Providing resources 3. Reward and recognition system ISO-9004

261. Improvement, Innovation & learning contd. 3 Innovation: The need to be Top Driver approach and requires following: Create awareness of innovation Establish process Provide resources Innovation can be applied to all levels and can relate to following areas Technology or product Processes Organisation Management System ISO-9004

262. Improvement, Innovation & learning contd. 4 : Learning The organisation should encourage learning to create a ‘ Learning Organisation ’ This requires following activities: Learning from success stories Learning from failures Collecting information from various internal and external resources Sharing of people knowledge Reward and Recognition ISO-9004

263. LATEST ON ISO-9004 ISO 9004 has been REVISED . The previous title of ISO 9004 was: " Managing for the sustained success of an organization – A quality management approach." It‘sl now be: "Quality of an organization – Gidance to achieve sustained success.“ "There are still questions as to what constitutes sustained success” . (An ISO copy can be purchased but the IS ( indian ) version is still not available). We have discussed the 2004 version only.

264. Session 8- Clause s 4 ,5 & 10 MBA ZG524/QM ZG524 Quality management system OBJECTIVES Read and understand each clause of the standard ISO-9001:2015. Understand the intent of requirements of each clause. Understand to apply the standard’s requirement in specific situations. Understand the need for documentation. Understand associated QMP’s. ETC.

265. CLAUSEWISE DISCUSSIONS Clause 4.

266. Clause 4 at a glance 4.1 Understanding the Organization & its context 4.3 Determining the Scope of QMS 4.2 Understanding the needs & expectations of interested parties 4.4 QMS & its processes 4. Context of organization + Cl. 4.1 ORGANIZATION & ITS CONTEXT Understanding CL. 4.2 NEEDS & EXPECTATIONS OF INTERESTED PARTIES. Understanding Cl. 4.3 SCOPE OF THE QMS Determining Cl. 4.4 QMS & ITS PROCESSES Summarizes the entire process of establishing, implementing, maintaining and improving the QMS

267. ISO-9001:2015 cl. 4-INTENT Intent of cl 4 The intent of this clause is to ensure that the organization: Decides the scope of the QMS only after UNDERSTANDING the two important issues of: UNDERSTANDING THE ORGANIZATION & ITS CONTEXT . NEEDS & EXPECTATIONS OF INTERESTED PARTIES . And only after this, proceeds to establish, implement, maintain and improve the QMS as per the clause 4.4. Define the steps for incorporating the PROCESS APPROACH.

268. Please refer to your copies of the ISO-9001, cl 4.1. CLAUSE 4.1 CONTEXT OF THE ORGANIZATION One example on this is given in the text book.

269. CL 4.2 Understanding the needs of interested parties Interested parties: The interested parties are those that provide significant risk to organizational sustainability if their needs and expectations are not met : Eg . - customers - employees - owners/ shareholders - society Read from the standard One example on this is given in the text book.

270. SCOPE Not a new requirement. Boundaries. Applicability or not. GIVES FOCUS TO YOUR QMS Read from standard. Applicability/exclusion to be discussed again after completion of all clauses.

271. SCOPE Example for an e-commerce company. The scope for QMS : Covers all operations related to buying, selling, stocking , shipping and electronic data processing. Merchandizing is not in scope of the QMS. The organization deals in off the shelf products only; therefore Design and Development (Clause 8.3) is not applicable. One more example of scope is given in the text book.

272. From ISO’s process approach-Relevant to 4.1 and 4.2 CLAUSE 4.1 CONTEXT OF THE ORGANIZATION Define the context of the organization The organization should identify ---its responsibilities towards: -the relevant interested parties and -their relevant requirements, needs and expectations to define the organization’s intended purpose . Gather, analyze and determine -external and internal responsibilities of the organization to: -satisfy the relevant requirements, needs and expectations of the relevant interested parties. ------Monitor or communicate frequently with these interested parties to: ensure continual understanding of their requirements, needs and expectations. Step of process approach What to do Guidance APPLYING THE PROCESS APPROACH

273. Scope from ISO’s Process Approach paper Relevant to cl. 4.3 Define the scope, objectives and policies of the organization Based on the analysis of the requirements, needs and expectations establish the scope, objectives and policies that are relevant for the organization’s quality management system. The organization shall determine the scope, boundaries and applicability of its management system taking into consideration the internal and external context and interested party requirements. Decide which markets the organization should address. Top management should then establish objectives and policies for the desired outcomes . Policies and objectives are covered in clauses 5.2 and 6.2 respectively. Step of process approachs What to do Guidance APPLYING THE PROCESS APPROACH

274. QMS & its processes (4.4) Note: The standard does not talk of production processes only. Rather production or product/service realization is a process which may have sub processes (as we shall see in each clauses). Processes/sub processes like establishing Quality Policy, monitoring & measurement; maintaining equipment, reviewing an order, maintaining documents etc are to be –First DETERMINED, ESTABLISHED, IMPLEMENTED, MAINTAINED and IMPROVED in accordance with the PROCESS APPROACH. 4.4.1 Read from the standard and compare with the PROCESS APPROACH discussed earlier.

275. QMS & its processes (4.4/4.4.1) From ISO’s process approach.  1 . Determine the processes in the organization Determine the processes needed to meet the objectives and policies and to produce the intended outputs . Management shall determine the processes needed for achieving the intended outputs. These processes include management, resources, operations, measurement, analysis and improvement. Step of process approach What to do Guidance

276. QMS & its processes (4.4/4.4.1) contd.  2. D etermine the sequence of the processes Determine how the processes flow in sequence and interaction. Define and describe the network of processes and their interaction. Consider the following: The inputs and outputs of each process (which may be internal or external). Process interaction and interfaces on which processes depend or enable. Optimum effectiveness and efficiency of the sequence. Risks to the effectiveness of process interaction. Note: As an example, realization processes (such as those needed to provide the products or services delivered to a customer) will interact with other processes (such as the management, measurement, procurement in the provision of resources). Process sequences and their interactions may be developed using tools such as modeling, diagrams, matrices and flowcharts. Step of process approach What to do Guidance

277. QMS & its processes (4.4/4.4.1) contd.  3. Define people or remits who take process ownership and accountability Assign responsibility and authority for each process. Top Management should organize and define ownership, accountability, individual roles, responsibilities, working groups, remits, authority and ensure the competence needed for the effective definition, implementation, maintenance and improvement of each process and its interactions. Such individuals or remits are usually referred to as the Process Owners.   To manage process interactions it may be useful to also establish a management system team that has a system overview across all the processes and may include representatives from the interacting processes and functions. Step of process approach What to do Guidance

278. QMS & its processes (4.4/4.4.1) contd. 4. Define the need for documented information Determine those processes that need to be formally defined and how they are to be documented. Processes exist within the organization. They may be formal or informal. There is no catalogue or list of processes that have to be formally defined. The organization should determine which processes need to be documented on the basis of risk-based thinking, including, for example: The size of the organization and its type of activities. The complexity of its processes and their interactions. The criticality of the processes. The need for formally accountability of performance.   Step of process approach What to do Guidance

279. QMS & its processes (4.4/4.4.1) contd. 4. Contd from prev slide. Contd.   Processes can be formally documented using a number of methods such as graphical representations, user stories, written instructions, checklists, flow charts, visual media or electronic methods including graphics and systemization. However, the method or the technology chosen are not the goals. They can be used to describe processes, which are the means to achieve the goals. Effective and organized processes can then deliver consistent and accountable operations and the desired objectives and results which can then be improved. Note: For more guidance see the ISO 9000 Introduction and Support Package module Guidance on the Documented Information Requirements of ISO 9001:20 15 Step of process approach What to do Guidance

280. QMS & its processes Read 4.4.1 from the standard.(IF)

281. Interaction cl 4.1 to 4.3 All the three processes i.e determining context, interested parties and scope are preparatory to QMS planning. QMS planning starts with the identification of salient/key processes.

282. Clause 4 Process owner/s Connected QMP’s Process approach Customer focus Improvement Relationship management

283. Sub clause 4.4.2 Documented information to be : Maintained and Retained.

284. Clause No. Documentation required by standard Likely document where this can be provided 4. TITLE ONLY - 4.1 Understanding the context--- None Though not specified in the standard, it is required to monitor and review the required information . This (monitoring and review) is not possible without documented information (as controlled standard documents) which can be revised as required. 4.2 Needs & expectations of int. parties None -do- 4.3 Scope Scope of the organization’s QMS. Quality manual, or a separate controlled document titled SCOPE 4.4.1 System & processes -- Requirements shall be discussed for each process. 4.4.2 TO THE EXTENT NECESSARY This is a requirement and is being explained as above and in each process. Documentation requirement Clause 4 only RETENTION

285. CLAUSE 5 LEADERSHIP Overall Intent of the clause: Explicit requirements from top management for: demonstrating leadership , commitment to QMS and to customer focus . Establishing & communicating QUALITY POLICY . Ensuring proper and clear allocation of roles and responsibilities of the team. OUTCOMES MBA ZG524/QM ZG524 Quality management system

286. Performance Evaluation CL. 9 Leadership CL 5 Planning CL 6 Support CL 7 Operations CL 8 Improvements Cl. 10 Context & needs of interested parties CL. 4 Customer requirements Products & services as required Sequence and interaction at macro level

287. LEADERSHIP & PLANNING Leadership & Planning 5 Leadership 6 Planning

288. Clause 5 at a glance 5.1 Leadership & commitment 5.1.2 Demonstrating Customer focus 5.2 Establishing Quality policy 5.3 Organizational roles; responsibilities & authorities, communicating & ensuring the understanding thereof Cl. 5 Leadership 5.1.1 Demonstrating leadership & committment Communicating the Quality Policy QMP-2 QMP-1 QMP’s 4 and 5 (process management and improvement are related to all clause.) QMP-3

289. LEADERSHIP 5.1.1 5.1.1 GENERAL Intent : Management to demonstrate its commitment to the development & implementation of QMS- Needs active involvement rather then simply signing Quality policy & delegating rest to others. How to ensure Personnel Involvement? Having basic understanding of QMS & how it works. Showing Knowledge of quality achievements, customer satisfaction and areas for improvement. Acting on quality related information. Ensuring quality objectives at various levels are defined and are in alignment with company objectives. Personal Compliance and involvement in QMS.

290. LEADERSHIP 5.1.2 5.1.2 CUSTOMER FOCUS QMP - to understand and focus on customer needs. Top management has the ultimate responsibility for ensuring that organization understands the needs/expectations of customers/Markets; Statutory/Regulatory requirements. Some Key Inputs : Voice of customer with data and information from Market research / positioning/ customer interviews, complaints, rejects; internal customer voice; Field service reports; Management comments & concerns; Benchmarking; Resource Constraints; Work environment; Product reliability; FMEA etc.

291. LEADERSHIP 5.2 5.2 QUALITY POLICY Intent: The overall intention & direction of an organization related to Quality as formally expressed by Top Management. It should be seen as organization’s conscience that should ride off other commercial, time or resources pressure. Must address needs and expectations of the organization’s customers consistent with business environment. Must commit for continual improvement. Should not be abstract must, reflect organization’s core values, vision & mission. Provide frame work for measurable quality objectives. Possible inputs Analysis of business environment & changes there of. Master business plan. Customer inputs. Action plans from management review. Etc.

292. LEADERSHIP 5.2.1, 5.2.2 Quality Policy (contd.) 5.2.1 TOP MANAGEMENT shall Establish, Implement, Maintain a quality policy- fulfilling the required characteristics of 5.2.1. 5.2.2 Be available as documented info. Communicated & understood –as appropriate: -At all levels of the organization and -to interested parties. Policy deployment

293. LEADERSHIP 5.3 5.3 ROLES & RESPONSIBILITIES Ensures QMS conforms to the requirements Ensures Processes to deliver Intended outputs Ensures Performance Management review Ensures promotion of Customer Focus Ensures the integrity of QMS.

294. LEADERSHIP SPECIFIC OUTPUTS OF CL. 5. LEADERSHIP ClAUSE 5 POLICY Roles, responsibilities, authorities Demonstrated leadership & commitment Leadership is all pervasive.

295. LEADERSHIP Enhancement of Performance & customer satisfaction

296. Clause No. Documentation required by standard Comments/explanation/remarks LEADERSHIP 5.1 Leadership & commitment TITLE ONLY ------- 5.1.1 GENERAL None Though not specified in the standard, it is required to demonstrate, ensure, promote etc . many parameters/performance metrics. Relevant data & records as evidence (and hence documented information ) shall be required. 5.1.2 customer focus None -------do-------- 5.2 Policy; establishing & communicating To be available and maintained as documented information. Quality manual, or a separate controlled document titled SCOPE. Communication can be addressed in he same document or separately as an SOP/work instruction. 5.3 Organizational roles, ------- None Assignment of responsibilities in any form –say an organization chart. Reporting formats and reports for cverification of requirements a) to e). Establish how the roles shall be communicated/displayed and verified. Documentation requirement Clause 5 only RETENTION

297. CLAUSE 10 - IMPROVEMENT Objective: To understand the improvement process and its various dimensions; to learn to establish and implement the process. (‘Improving’ is a process) MBA ZG524/QM ZG524 Quality management system

298. CL 10-IMPROVEMENT IMPROVEMENT Ref. Clause 1.b -Scope (of QMS –Requirements) Need of “ Enhancement of customer satisfaction through the effective application of the system including processes of improvement of the system---------” is one of the two main requirements from this QMS (the other being “the need to demonstrate consistent compliance to all requirements”. Intent of the clause To lay down the requirements of the process of improvement .

299. IMPROVEMENT-DEFINITIONS 1 3.3.1 improvement – activity to enhance performance (3.7.8) Note 1 to entry: The activity can be recurring or singular. 3.7.8 performance measurable result Note 1 to entry: Performance can relate either to quantitative or qualitative findings. Note 2 to entry: Performance can relate to the management (3.3.3) of activities (3.3.11), processes (3.4.1), products (3.7.6), services (3.7.7), systems (3.5.1) or organizations (3.2.1).

300. Correction – Containment, To take immediate steps to prevent or arrest damage after a problem has been reported/detected. Corrective action- A reactive approach to problem solving- needs to attack cause and not act on symptoms; Such actions are carried out after. root cause analysis; Objective being –avoidance/elimination of non- recurrence of non –conformity. IMPROVEMENT Definitions 2 (Repeat)

301. Preventive action - To avoid occurrence of problem - a proactive approach based on learning and actions from: - corrective actions ; - Risk identification and mitigation ( FMEA or any other tool) Continual improvement- Recurring activity to increase the ability to fulfill requirements. Should also concentrate on system results. EFFECTIVENESS Extent to which: Planned activities are realized and Planned results are achieved. IMPROVEMENT Definitions 3 (Repeat)

302. 1- Correcting things that went wrong. 2- Root cause analysis and corrective actions. 3- Analysis of process, risks and take preventive action. 4- Simply ask the question-is there a better way of doing this process. What to do for continual improvement

303. IMPROVEMENT-tools 1 PDCA 7 basic tools of quality Advanced tools of quality. Risk management. Voice of customer. DOE & many others like DMAIC, DFSS Etc. -Creativity/innovation and brain storming. -Organizational environment.

304. IMPROVEMENT-tools-2 7 basic tools of quality Check sheet Pareto Cause-and-effect diagrams Run charts Scatter diagrams Histogram Control chart (SPC) Stratification is also accepted as a basic quality tool.

305. IMPROVEMENT-tools 3 Advanced tools of quality: Relation Diagram Tree Diagram Arrow Diagram Affinity Diagram Matrix Diagram Matrix Data Analysis Diagram Process Decision Program Diagram

306. Clause No. Documentation required by standard Comments/explanation/remarks 10.1 None --- 10.2 To retain DOCUMENED INFORMATION as evidence of –(10.2.2 a and b). This may include 10.2.1 - d,e,f also. 10.3 None Salient improvement projects should be documented right from the planning stage. This can be done in the PDCA format. Effectiveness should be reviewed and hence documented. Salient learnings should be summarized, added to organizational knowledge and circulated in the organization as appropriate. Documentation requirement Clause 10 only RETENTION

307. 10 Improvements--summary Non conformities Actual Potential (FMEA) Corrective action Preventive action Containment, Correction Root cause & other tools Corrective action Preventive action Effectiveness RIGHT FIRST TIME AND EVERY TIME. records.

308. THANK YOU