Certified Quality Consultant/ Lead Implementer Course Certified Quality Consultant/ Lead Implementer Course دورة إستشاري الجودة وقائد فريق التطبيق Certified Quality Consultant / Lead Implementer ISO 9001:2015 Khartoum – Sudan 2020 Certified Quality Consultant/ Lead Implementer Course Eng. MOHAMMED YASSIN ABDALSALAM Aeronautical Engineer / QHSE/ISMS Professional Engineer & EFQM Excellence Specialist Email ID: Eng.M.Yassin@outlook.com Contact: +249-123171786 / + 249-999999669 www.themega llery.com ➢ ENG. DOCTORATE –(UTM ) University of Technology Malaysia (under study ) ➢ MSc. Master of science in mechanical engineering manufacturing technology ➢ MBA . Master in business administration - project management(PMP) ➢ BSc . Aviation mechanical engineering- Sudan university for science and technology (SUST) ➢ Diploma in Aeronautical Engineering – Avionics (SUST) ARICA Certified lead Auditor • ISO 9001:2015 • ISO 14001:2015 • ISO45001:2018 • ISO 27001:2013 • AS9100/9110 - Aerospace lead auditor • black belt lean six sigma –RICI CANADA + ISAC ISO 31000 – RISK management lead implementer+ Auditor • Lean manufacturing professional- RICI • QMS ISO 9001:2015 Lead Auditor From- ROBERE & ASSOCIATES – THAILAND LTD Certification No 897UND: 195616- IRCA, England • EMS ISO 14001:2015 Lead Auditor from ROBERE & ASSOCIATES – THAILAND LTD Certification No.941 – UND: 198883-IRCA , England • OHSMS ISO 45001:2018 Lead Auditor from ROBERE & ASSOCIATES – THAILAND LTD Certification No.938 -UND: 198883-IRCA , England • Information Security Management Systems (ISMS, ISO / IEC 2700:2013) Form HERMES INFOTECH CQI • UDN: 195616• Certificate ID oGrJfKcK4r- IRCA , England • Certified Risk Manager Based on The ISO 31000:2018 Form ASC-017, USA certificate No: 878239 • Aerospace Quality Management System Lead Auditor (AS9100)& IAQG From ASC-017 certification No (114702) , USA • Aerospace Quality Management System Lead Auditor (AS9110)& IAQG From ASC-017, • Certification No ( 710837) USA • EFQM –European Foundation for Quality Management Excellence Specialist - RICI CANADA • TOT train of trainer – approved from Hight level academy • Operation management professional • Quality management professional • TRIZ theory for inventive problem solving UTM UN. Malaysia • Design thinking strategy • AINA- Authorized Innovation Assessor Certified Quality Consultant/ Lead Implementer Course COURSE INSTRUCTOR: Eng. MOHAMMED YASSIN ABDALSALAM Aeronautical Engineer / QHSE/ISMS Professional Engineer & EFQM Excellence Specialist Email ID: Eng.M.Yassin@outlook.com You tube channel : DR Moe Yassin Contact: +249-123171786 + 249-999999669 Certified Quality Consultant/ Lead Implementer Course Introduce yourself • Name • Position – Job Title • Tell us about yourself • What do you know about this course • Why you attended this course • Your expectation Slide: 10 Certified Quality Consultant/ Lead Implementer Course QMS Awareness, Implementation and Internal Audit ISO 9001:2015 Online Course Time Table Session Start Course Submission 10:00 am Discussion session 02:00 pm Khartoum – Sudan – online course Certified Quality Consultant/ Lead Implementer Course ADMINISTRATIVE ARRANGEMENTS Timekeeper Breaks Certified Quality Consultant/ Lead Implementer Course Evaluation Criteria Type Video Attendance Discussion Class work Project presentation Required mark Success √ √ √ √ 70% Destination √ √ √ √ 90% Slide: 13 Certified Quality Consultant/ Lead Implementer Course Let’s get to work! Slide: 14 Certified Quality Consultant/ Lead Implementer Course Online Course Quality Management System ISO 9001:2015 Quality consultant 2020 TÜV SÜD Certified Quality Consultant/ Lead Implementer Course General Objective ❑ The objective of this course is to understand, develop, apply and audit the quality management processes in your organization, and have the ability to develop and implement good practices based on the recommendations and requirements of ISO guideline standards, ISO 9002 10001,2,3,4,5,6,7,8,12,13,14,15,17,18,19 in order to increase Product, service excellence and efficiency in all operations. CQC/Lead Implementer Course Introduction to QMS 17 Certified Quality Consultant/ Lead Implementer Course Section contents ❑What is quality ❑Quality costs ❑Quality management concepts ❑Quality management principals Slide: 18 Certified Quality Consultant/ Lead Implementer Course Session Plan Objectives: Understand the purpose of a quality management system Understand the historical evolution of approaches to quality management Understand basic concepts and associated vocabulary Understand and be able to explain the eight management system principles Understand and be able to explain the benefits of establishing the quality management system in accordance with ISO 9001:2015 Issue: Jan 2012 QMS Auditor/Lead Auditor Course Certified Quality Consultant/ Lead Implementer Course Session Plan Objectives: Understand the origins of the ISO 9000 series of standards Understand the purpose, contents and interrelationships of the ISO 9000 series as well as the supporting standards including ISO 19011 Understand the requirements of ISO 9001:2015 (up to section 3) and be able to explain and interpret those requirements Be able to use ISO 9000:2015 and ISO 9004:2009 to enhance the understanding of the ISO 9001:2015 requirements Recognise how the eight management system principles underpin the structure and requirements of ISO 9001:2015 Certified Quality Consultant/ Lead Implementer Course Introduction Into QMS System What is the Quality Management System? 21 Certified Quality Consultant/ Lead Implementer Course Quality You have the “official” definition, BUT… You tell me… what does quality mean to you? Issu e: Jan 2012 QMS Audit or/Le Certified Quality Consultant/ Lead Implementer Course Definition of Quality “degree to which a set of inherent characteristics fulfils requirements” Issu e: Jan 2012 QMS Audit or/Le Certified Quality Consultant/ Lead Implementer Course Differences in quality In that case, which is of a better quality? Issue: Jan 2012 QMS Auditor/Lead Auditor Course Certified Quality Consultant/ Lead Implementer Course 25 Certified Quality Consultant/ Lead Implementer Course 26 Certified Quality Consultant/ Lead Implementer Course 27 Certified Quality Consultant/ Lead Implementer Course Quality Dimensions (Garvin, 1998) Dimension Meaning Performance Primary product characteristics Features Secondary characteristics added features Conformance Meet specifications or industry standards, workmanship Reliability Consistency of performance overtime Durability Useful life Service Resolution of problems and complaints, ease of repair Response Human-to-human interface Aesthetics Sensory characteristics Reputation Past performance, ranking first • • Quality dimensions are independent focus on a few dimensions (e.g. Japanese cars – reliability, conformance, and aesthetics) Certified Quality Consultant/ Lead Implementer Course Historical Review ❑ Its start with the Industrial Revolution – Specialization of labor ❑ Decline in workmanship, product still not complicated – still 100% inspection ❑ 1924 – Walter Shewhart developed statistical chart (Book: Economic Control of Quality of Manufactured Product) ❑ Dodge & Romig developed acceptance sampling as a substitute for 100% inspection ❑ 1942 - US Managers failed to recognize value of SQC ❑ 1946 – ASQC (now ASQ) was formed Certified Quality Consultant/ Lead Implementer Course Historical Review ❑ 1950 – William Edwards Deming lectures CEOs in Japan on SQC ❑ 1954 – Joseph Juran went to Japan – Management’s responsibility for quality ❑ 1960 – Quality Control Circle (QCC) formed in Japan – quality improvement ❑ 1980’s – US Quality Movement, TQM Concepts published Certified Quality Consultant/ Lead Implementer Course Historical Review ❑ Late 1980’s – automotive industry emphasize SPC, suppliers required to use Malcolm Balridge Award established (to measure TQM implementation) Taguchi method, Design of Experiments (DOE) ❑ 1990’s – ISO 9000 series became Global QA std., QS 9000 introduced by automotive industry customer satisfaction ISO 14000 ❑ 2000 – New ISO 9000:2000 version, Six Sigma Program introduced information technology Certified Quality Consultant/ Lead Implementer Course Responsibility for Quality Customer Marketing Product Service Packing & Storage Quality Product / Service Inspection & Test Production Design Engineering ⚫Procurement (Purchasing) Process Design Certified Quality Consultant/ Lead Implementer Course Online Course Quality Management System ISO 9001:2015 Quality consultant 2020 TÜV SÜD Certified Quality Consultant/ Lead Implementer Course Introduction Into QMS System Cost of quality vs cost of poor quality 34 Certified Quality Consultant/ Lead Implementer Course Total cost of quality Armand V. ❑ Feigenbaum in a 1956 Harvard Business Review article COST of Quality IBM quality expert H. ❑ James Harrington in his 1987 book Poor Quality Costs Cost of poor quality 35 Total Quality Cost Certified Quality Consultant/ Lead Implementer Course I want my money back! Prevention Internal Failure Appraisal External Failure $ Cost of Quality (COQ) Cost of Poo r Qua Certified Quality Consultant/ Lead Implementer Course Cost of poor quality 37 Certified Quality Consultant/ Lead Implementer Course 38 Certified Quality Consultant/ Lead Implementer Course What is Cost of Poor Quality? • Direct Costs of Failures – Internal Failure • Costs associated with defects found BEFORE the customer receives a product or service – External Failure • Costs associated with defects found AFTER the customer receives a product or service • Costs to Control or Avoid Failures – Appraisal Cost • Costs associated with measuring, evaluating, or auditing products or services to assure conformance to quality requirements – Prevention Cost • Costs of activities specifically designed to prevent poor quality Certified Quality Consultant/ Lead Implementer Course Cost of Poor Quality Waste Testing Costs Rejects Rework Customer Returns Inspection Costs Recalls Certified Quality Consultant/ Lead Implementer Course Cost of PoorQuality As an organization gains a broader definition of poor quality, the hidden portion of the iceberg becomes apparent. Waste Customer Returns Rejects Testing Costs Inspection Costs Recalls Rework Excessive Overtime Late Paperwork Pricing or Billing Errors Excessive Field Services Expenses Excessive Employee Turnover Planning Delays Incorrectly Completed Lack of Follow-up Sales Order on Current Programs Customer Allowances Excess Inventory Unused Capacity Complaint Handling Premium Freight Costs Overdue Receivables Excessive System Costs Time with Dissatisfied Customer Development Cost of Failed Product COPQ ranges from 15-25% of Sales High Costs Hidden COPQ: The costs incurred to deal with these chronic problems Certified Quality Consultant/ Lead Implementer Course Challenges facing any organization ❑To do right things first time by right way ❑Without defects ❑Without injures or damage ❑Without waste or losses ❑With less cost ❑And satisfying all interesting parties Ultimate goals Certified Quality Consultant/ Lead Implementer Course “Cause and effect” Quality Management System Committed top management Effectiveness = “Ability to achieve planned results” Calibrated equipment Competent people Monitoring & measurement Work instructions etc Internal audits Management review Documented procedures Etc etc etc “CONSISTENT, CONFORMING PRODUCT” Efficiency = “Achieve planned results with minimum resources” (∑Outputs / ∑Inputs) 13 Certified Quality Consultant/ Lead Implementer Course Online Course Quality Management System ISO 9001:2015 2020 TÜV SÜD Certified Quality Consultant/ Lead Implementer Course Quality management system principles 45 Certified Quality Consultant/ Lead Implementer Course Quality management principles From ISO 9001:2015 Customer focus Leadership Engagement of people Process approach Improvement Evidence Base to decision making Relationship Management Issu e: Jan 2012 QMS Audit or/Le Certified Quality Consultant/ Lead Implementer Course CUSTOMER FOCUS Organization depend on Customer. Must understand current and feature customer needs. Must exceed customer expectations CUSTOMER “A customer is the most important visitor on our Premises. He is not dependent on us. We are dependent on him. He is not an interruption on work, he is the purpose of it. He is not an outsider on our business, but he is a part of it. We are not doing him a favour by serving him, he is doing a favour by giving us an opportunity to do so. - Mahatma Gandhi Issu e: Jan 2012 QMS Audit or/Le Certified Quality Consultant/ Lead Implementer Course Leadership Leaders provide: u Unity of purpose u Direction u Internal environment Issue: Jan 2012 QMS Auditor/Lead Auditor Course Certified Quality Consultant/ Lead Implementer Course Engagement of people People are the essence of the organisation Their full involvement enables using their abilities to the benefit of the organisation Issue: Jan 2012 QMS Auditor/Lead Auditor Course Certified Quality Consultant/ Lead Implementer Course Process approach PROCESS EFFECTIVENESS CONTROLS Extent to which planned activities are realised and planned results achieved PROCESS INPUT “set of interrelated or interacting activities which transforms inputs into outputs OUTPUT PRODUCT PROCESS EFFICIENCY RESOURCES Relationship between the result achieved and the resources used A desired result is achieved more efficiently when activities and related resources are managed as a process Issu e: Jan 2012 QMS Audit or/Le Certified Quality Consultant/ Lead Implementer Course Improvement The methodology known as “Plan-Do-Check-Act” can be applied to all processes of the QMS Act: take actions to Plan: establish continually improve process performance objectives and processes necessary to deliver results in accordance with customer requirements and the organisation’s policies Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results Do: implement the processes A permanent objective of the organisation Issue: Jan 2012 QMS Auditor/Lead Auditor Course Certified Quality Consultant/ Lead Implementer Course Evidence Base to decision making Effective decisions are based on the analysis of data and information Issue: Jan 2012 QMS Auditor/Lead Auditor Course Certified Quality Consultant/ Lead Implementer Course Relationships Managment An organisation and its suppliers are interdependent A mutual beneficial relationship enhances the ability of both to create value Issue: Jan 2012 QMS Auditor/Lead Auditor Course Certified Quality Consultant/ Lead Implementer Course ISO 9001:2015 How do you think that ISO 9001:2015 could help? Issue: Jan 2012 QMS Auditor/Lead Auditor Course Certified Quality Consultant/ Lead Implementer Course Quality management • we are always striving to do the right thing for the customer • but that the customer’s requirements are always changing • So we need to do is to have an approach which allows us to have the best opportunity of ‘knowing’ when these requirements have changed, and to be able to respond to that change Issu e: Jan 2012 QMS Audit or/Le Certified Quality Consultant/ Lead Implementer Course Why a quality management system? Organisation improvement Market positioning Customer requirement Legal requirement Supplier development Issu e: Jan 2012 QMS Audit or/Le Certified Quality Consultant/ Lead Implementer Course Benefits of a quality management system Increased profitability Improved internal transfer of know how Improved morale & motivation of staff Reduced quality costs Enhanced customer satisfaction and loyalty Increased competitiveness Issu e: Jan 2012 QMS Audit or/Le Certified Quality Consultant/ Lead Implementer Course Online Course Quality Management System ISO 9001:2015 2020 TÜV SÜD Certified Quality Consultant/ Lead Implementer Course 59 Certified Quality Consultant/ Lead Implementer Course ➢What is ISO ➢ISO standards ➢High level structure Slide: 60 ISO (International Organisation for Standardization) ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges. Iso Central Secretariat placed in Geneva, Switzerland History The organization today known as ISO began in 1926 as the International Federation of the National Standardizing Associations (ISA). It was suspended in 1942 during World War II, but after the war ISA was approached by the recently formed United Nations Standards Coordinating Committee (UNSCC) with a proposal to form a new global standards body. In October 1946, ISA and UNSCC delegates from 25 countries met in London and agreed to join forces to create the new International Organization for Standardization; the new organization officially began operations in February 1947 Since then, iso published over 22654 International Standards covering almost all aspects of technology and manufacturing. What are standards? International Standards make things work. They give world-class specifications for products, services and systems, to ensure quality, safety and efficiency. They are instrumental in facilitating international trade. ISO has published 22654 International Standards and related documents, covering almost every industry, from technology, to food safety, to agriculture and healthcare. ISO International Standards impact everyone, everywhere. Certified Quality Consultant/ Lead Implementer Course Overall Scenario of ISO/TC176 ⚫ Development of generic quality management system standards that have broad application: all market sectors ⚫ both private and public organizations ⚫ ⚫ Approx. 1.1 million certifications to ISO 9001 worldwide BUT ⚫ It’s about more than just “certification” ⚫ “Certification to ISO 9001” should be a result of a wellimplemented quality management system! 7 ISO/TC 176 ISO/TC 176 is Technical Committee 176 of the International Organization for Standardization (ISO), responsible for Quality management and quality assurance - the ISO 9000 family of standards Subcommittees The subcommittees usually have several working groups (WG). Large WGs can have task groups (TG). The Subcommittees are: •ISO/TC 176/SC 1: Concepts and terminology •ISO/TC 176/SC 2: Quality systems •ISO/TC 176/SC 3: Supporting technologies Certified Quality Consultant/ Lead Implementer Course Quality Systems (ISO 9001, ISO 9004 & others) Fundamentals & Vocabulary (ISO 9000) SC 1 WG 22 Interpretations ISO/TC 176 SC 2 WG 23 Communications & Product Support Supporting technologies (ISO 100xx) SC 3 WG 24 Revision of ISO 9001 8 Certified Quality Consultant/ Lead Implementer Course ISO 9000:2009 family Annexes A & B for information only Quality management systems Fundamentals & Measurement ISO 9000 Audits ISO ISO 10012 10012 ISO 19011 vocabulary Guidelines Quality management systems Guidelines for Implementation ISO 9002 ISO 9001 Quality management systems - Requirements Technical …as needed Reports (e.g. ISO/TR 10013) Certified Quality Consultant/ Lead Implementer Course ISO/TC176/SC2 Vision “SC2’s products* are recognized and respected worldwide, and used by organizations as an integral component of sustainable development” * ISO 9001, ISO 9004, and other guidance documents 9 Certified Quality Consultant/ Lead Implementer Course ISO/TC176/SC2 Mission To develop, maintain and support a portfolio of products that enable organizations to improve their performance and to benefit from the implementation of a robust quality management system. ⚫ To establish generic quality management system requirements that provide the foundations to build ⚫ confidence in goods and services delivered throughout the supply chain to organizations and people worldwide. ⚫ To provide guidance and support , where needed, to ensure the continued credibility of our products. 10 Certified Quality Consultant/ Lead Implementer Course 3 core concepts………… ⚫ Identify the processes needed to achieve the planned results ⚫ Continually monitor the risks (“Risk-based thinking”) ⚫ ⚫ Understanding “Cause and effect” Manage the processes and the system using “PDCA” 14 Certified Quality Consultant/ Lead Implementer Course Act • How to improve next time? Plan • What to do? • (“Objective”) • How to do it? • (“Procedure”) Check Do • Did things happen according to plan? • Do what was planned 15 Certified Quality Consultant/ Lead Implementer Course Generic Process How to carry out Process” – documented or not) Extent of planning depends on RISK INPUTS “Set of interrelated activities” DESIRED OUTPUTS “PRODUCT” CUSTOMER (Internal or external) Other Interested Parties • Effect on Product conformance • Environmental Aspects / Impacts UNDESIRED OUTPUTS • Health and Safety Risks (“WASTE” / “POLLUTION” etc.) • Social implications • Energy usage • Etc etc MONITOR/MEASURE 16 Certified Quality Consultant/ Lead Implementer Course Generic Process A How to carry out Process” – documented or not) Extent of planning depends on RISK INPUTS DESIRED OUTPUTS “Set of interrelated activities” D “PRODUCT” • Effect on Product conformance • Environmental Aspects / Impacts • Health and Safety Risks • Social implications • Energy usage • Etc etc C P MONITOR/MEASURE CUSTOMER (Internal or external) Other Interested Parties UNDESIRED OUTPUTS (“WASTE” / “POLLUTION” etc) 17 Certified Quality Consultant/ Lead Implementer Course Harmonization of management system standards Certified Quality Consultant/ Lead Implementer Course Positioning of some ISO (and other) Aerospace standards I.T. Supply chain ISO 27001 Service AS 9100 security ISO 20000 Telecomm TL 9000 Economic growth Automotive ISO/TS 16949 Environmental (Reqts) ISO 55000 ISO 14001 Environmental (Guidelines) Asset Mgt. Energy ISO 50001 ISO 9001 ISO 22000 ISO 31000 ISO 9004 integrity ISO 14064 ISO 20121 (OHSAS 18001) Future ISO Std Health & Safety (SA 8000) Social resp. Requirements Social responsibility ISO 37001 Greenhouse Gas Quality (Guidelines) Sustainable Purchasing ISO 18617 Environmental Food safety Risk management Sustainable Development ISO 14004 Quality (Reqts) ISO 28001 Information Security Anti- ISO 26000 bribery Social resp. Guidance ISO 39001 ISO 22301 ISO 14040 Life cycle Sustainable events Road safety Business continuity Certified Quality Consultant/ Lead Implementer Course High-Level Timing for ISO 9001:2015 Internal consensus (ISO/TC176 experts) Internal consensus (within ISO) First “public airing” June 2012 Nov 2012 Jun 2013 Apr2014 Nov 2014 Jan 2015 Sept2015 Draft Design Spec & “WD0”* Approved Design Spec & WD1* CD* for comment & ballot DIS* for ballot Draft FDIS* FDIS* for ballot Publication Verification and validation activities • SC2 Strategic Plan • Review of QMP’s • User Survey • TG Future Concept Papers • ISO Directives Annex SL Liaison with IAF & ISO/CASCO regarding transition Interactions with SC1 (ISO 9000) on terminology issues * WD = Working Draft CD = Committee Draft DIS = Draft International Standard FDIS = Final Draft International Standard Certified Quality Consultant/ Lead Implementer Course Need for Alignment of management system standards! ⚫ ISO Joint Technical Coordination Group (“JTCG”): Joint vision for management system standards ⚫ High level structure for all ISO management systems standards ⚫ Identical sub-clause titles under the high level structure ⚫ Generic core vocabulary for management system standards ⚫ ⚫ Aim is to make life easier for those who wish to have a “single management system” Certified Quality Consultant/ Lead Implementer Course ISO Directives Part 1:2012 “Annex SL” ⚫ Incorporates the recommendations of the JTCG work ⚫ Defines the common structure and format for all new ISO management system standards and revisions to existing standards ⚫ Common text (approx 30% or more of each standard will be identical text) ⚫ Significant impact on future revisions of ISO 9001 and ISO 14001 Certified Quality Consultant/ Lead Implementer Course “Annex SL” High Level Structure 1. Scope 2. Normative references 3. Terms and definitions 4. • Context of the organization Understanding the organization and its context Needs and expectations of • interested parties • • Determining the scope Management System 5. Leadership • • • Leadership and commitment Policy Roles, responsibility and authority 6. Planning • • Actions to address risks & opportunities Objectives and plans to achieve them 7. Support • Resources •• Competence Awareness • Communication Documented information 8. Operation • Operational planning and control 9. Performance evaluation • Monitoring, measurement, analysis & evaluation •• Internal audit Management review 10. Improvement • Non conformity and corrective action • Continual Improvement Certified Quality Consultant/ Lead Implementer Course Structure of Annex SL 7 common requirements: ❑Context of the organization ❑Leadership ❑Planning ❑Support ❑Operations ❑Performance Assessment ❑Improvement Certified Quality Consultant/ Lead Implementer Course Why certification of the QMS? Certification of quality system to ISO 9001 as a “bonus”: Tangible proof that the company’s quality system complies with internationally recognised standard Avoidance of multiple second party audits Marketing edge Certificate ISO 9001 Issu e: Jan 2012 QMS Audit or/Le Certified Quality Consultant/ Lead Implementer Course Why is a QMS necessary? Requirements of Society Sector requirements Market access Issue: Jan 2012 ISO 14000 OHSAS 45001 SA 8000 Environment Health & Safety Social Accountability TS 16949 TL 9000 EN 9100 Automobile ISO 9000 QMS Auditor/Lead Auditor Course Telecom Aeronautical Manufacturing Services Certified Quality Consultant/ Lead Implementer Course Online Course Quality Management System ISO 9001:2015 QMS Consultant 2020 TÜV SÜD Certified Quality Consultant/ Lead Implementer Course Organization and its context 84 Certified Quality Consultant/ Lead Implementer Course IMS Management System (4) Organization and its context (4) Support & Operation (7,8) Plan Customer requirements Planning (6) Do Leadership (5) Act Needs and expectations of relevant Intersted parties (4) Performanc e evaluation (9) Check Improvement (10) Customer satisfaction Results of the IMS Products and services Certified Quality Consultant/ Lead Implementer Course 86 Certified Quality Consultant/ Lead Implementer Course 87 Certified Quality Consultant/ Lead Implementer Course 88 Certified Quality Consultant/ Lead Implementer Course 89 Certified Quality Consultant/ Lead Implementer Course 90 Certified Quality Consultant/ Lead Implementer Course 91 Certified Quality Consultant/ Lead Implementer Course 92 Certified Quality Consultant/ Lead Implementer Course 93 Certified Quality Consultant/ Lead Implementer Course 1 Scope 1.1 General ➢ The standard specifies QMS requirements for use to: • demonstrate organisation’s ability to consistently provide product meeting customer & applicable regulatory requirements • enhance customer’s satisfaction through effective application of the system, including processes for its continual improvement and assurance of conformity to customer and applicable regulatory requirements NOTE: Product = only product intended for or required by customer Certified Quality Consultant/ Lead Implementer Course 1.2 Application ➢ Requirements are generic (common) ➢ Requirement may be excluded if cannot be applied due to the nature of organisation and its product ➢ Exclusions must: • Not affect ability or responsibility to provide conforming product • Be limited to requirements in clause 7 (Cl. 4.2.2: “details of & justification for any exclusion” to be included in the quality manual”) ➢ Conformity to ISO 9001 may not be stated if exclusions go beyond above Certified Quality Consultant/ Lead Implementer Course 2 Normative reference ➢ Users encouraged to use most recent revision ➢ ISO 9000 : 2015 Quality Management Systems Fundamentals and Vocabulary Certified Quality Consultant/ Lead Implementer Course 3 Terms and definitions ➢ ISO 9000 : 2015 applies ➢ New supply chain terminology ➢ Term “product” can also mean “service” …where Product = Result of process Note: four generic product categories: • hardware • software • services • processed materials (from ISO 9000:2009) Supplier Organisation Customer Certified Quality Consultant ISO 900I:2015 Requirements متطلبات المواصفة الوحدة الثانية Quality management system نظام إدارة الجودة 99 Quality management system نظام إدارة الجودة 4. Context of the organization ❑4.1 Understanding the organization and its context Slide: 100 ISO 9002:2016 Context of the organisation • To determine context means to identify the internal and external factors that can impact the organisations strategic objectives and the planning of the quality management system. • Focus on factors that can affect customer satisfaction and delivery of quality products and/or service. • The context will influence the type and complexity of the quality management system needed. ISO 9002:2016 External and internal issues information sources • internal documented information and meetings, in the national and international press, websites, • publications from national statistics offices and other government departments, • professional and technical publications, conferences and meetings with relevant agencies, • meetings with customers and relevant interested parties, and professional associations. ISO 9002:2016 Context of the Organisation External context: • Economic factors: such as money exchange rate, the general economic situation, inflation forecasts, credit availability • Social factors: such as local unemployment rates, safety perceptions, educational levels, public holidays and working days • Political factors: such as political stability, public investments, local infrastructure, international trade agreements • Technological factors: such as new sector technology, materials and equipment, patent expirations, professional codes of ethics • Market factors: such as competition, including the organization’s market share, similar or substitute products or services, market leader trends, customer growth trends, market stability, supply chain relationships • Statutory and regulatory factors: which affect the work environment such as trade union regulations, legal and statutory requirements (e.g. environmental legislation and codes) ISO 9002:2016 Context of the Organisation Internal context: • Performance factors: products and service offerings, financial results, regulatory requirements • Resource factors: including infrastructure, environment for the operation of the processes, organizational knowledge, assets, capabilities, information systems • Human factors: such as competence of personnel, organizational behaviour & culture, relationships with unions, suppliers & partners • Operational factors: such as process or production and service provision capabilities, performance of the quality management system, monitoring customer satisfaction • Factors in the governance of the organization, such as its rules and procedures for decision making or organization’s structure ISO 9002:2016 Context of the Organisation • ISO 9001:2015 provides no suggested methods to analyse the context of an organisation, but there are many models that can help an organisation to understand the strategic nature of their industry and how they fit into that environment • Such as PESTLE analysis (political, economic, social technological, legal and environmental) this analysis determines which factors can influence how the organisation operates. • The PESTLE factors can be classified as opportunities and threats in a SWOT analysis (strengths, weaknesses, opportunities and threats) • another method is Porter’s five force model ISO 9002:2016 Context Analysis Process • Analyse and Evaluate Internal and External Issues. Use model of • SWOT analysis. Classify external factors into Strengths, Weaknesses, • Key Issues: From the SWOT, identify the key issues facing the • Create Policy. Document, communicate and make available a policy that • Set Objectives. Set objectives consistent with policy that are measurable, choice to identify compliance obligations, interested parties, environmental and market factors, (create a matrix of identification, evaluation and prioritization based on positive and negative impact (risk and opportunity)). Opportunities and Threats (Risks and Opportunities). organisation, i.e. the high priority issues that must be addressed in strategy, policy and objectives. addresses the key issues and commits the organization to continual improvement. monitored and communicated. SMART objectives, quality objectives, environmental objectives etc. ISO 9002:2016 PESTLE Analysis Template Political Factors Political Stability Economic Factors National economic policies and trends National & international: current Taxation issues & anticipated future Legislation Regulatory bodies Seasonal / weather issues Government policy’s Trade & monetary conditions Funding, grants, initiatives Specific sector conditions Market & political lobbying groups Interest & exchange rates Wars / conflicts International trade & monetary issues ISO 9002:2016 Social Factors Technology Factors Demographics & Lifestyle trends Competing technology development Attitudes & opinions Associated / dependent technologies Consumer attitudes, opinions, & buying patterns Replacement technology / solutions Media views, advertising, publicity Maturity of technology / organisations products/ services Law changes affecting social behaviour Information & communications, Social media use Image of the organisation Technology legislation Major events & influences Innovation potential Buying access & trends Technology access, licensing Ethnic / religious issues Intellectual property issues ISO 9002:2016 Legal Factors Environmental Factors Anti-trust law Weather Discrimination law Climate change Copyright, patents, intellectual property law Laws regarding environmental pollution Employment law Air and water pollution Consumer protection and e-commerce Attitudes towards and support for renewable energy Health and safety law Waste management Data Protection Attitudes towards green or ecological products Regional legislation Recycling Foreign trade Energy consumption ISO 9002:2016 Marketing Factors Total market size & market penetration Barriers to entry Trends & indicators State of maturity Knowledge of customers Competitors Channels of distribution Branding & packaging ISO 9002:2016 Context of the Organisation • SWOT analysis is a useful technique for understanding your strengths and weaknesses, and for identifying both the opportunities open to you and the threats you face ISO 9002:2016 SWOT Analysis Strategy Opportunities Threats Strength-Opportunity strategies Strength-Threats strategies Which of the company’s strengths can be used to maximise the opportunities you identifies? How can you use the company’s strengths to minimise the threats you identified? Weakness-Opportunity strategies Weakness-Threats strategies What actions can you take to minimise the company’s weaknesses using the opportunities you identified? How can you minimise the company’s weaknesses to avoid the threats you identified? (external, positive) Strengths (internal, positive) Weaknesses (internal, negative) (external, negative) ISO 9002:2016 SWOT Analysis Questions Strengths Weaknesses What advantage does your organisation have? What could you improve? What do you do better than anyone else? What should you avoid? What unique or lowest cost resources can you draw upon that others cant? What are people in your market likely to see as weaknesses? What do people in your market see as your strengths? What factors loose you sales? What factors mean that you get the sale? What do your competitors provide that you don't? ISO 9002:2016 SWOT Analysis Questions Opportunities Threats What good opportunities can you spot? What obstacles do you face? What interesting trends are you aware of? What are your competitors doing? Are there changes in government policy related to your field? Are quality standards or specifications for your products or services changing? Are there changes in technology or markets? Is changing technology threatening your position? Are there changes in social patterns, population profiles, lifestyle changes? Could any of your weaknesses seriously threaten your business? Local events? Do you have bad debt or cash flow problems? ISO 9002:2016 Porter Five Forces Model ISO 9002:2016 Context of the Organisation For example: • A small distribution business of imported goods could find out what external issues could affect the achievement of its quality management system’s intended results: its government policy for import-export activities, the type and quantity of its competitors, the culture of local consumers, or its credit availability. • internal issues that could affect its intended results include: its infrastructure, organizational knowledge, delivery capabilities and the competence of people working on its behalf. • Internal and external issues can change, and therefore its context should be monitored and reviewed on a regular basis. ISO 9002:2016 Consultant Activity No(1) 1. Name your organization 2. Design Organization structure 3. Design process map for main Company activity 4. Environmental Analysis ( internal & external issues ) Slide: 117 ISO 9002:2016 ABC Company ISO 9002:2016 ABC Company main process Information Work place Machineries H.R Information Server Computers software no Requerment / feed back Marketing & sales Engineering Design & development Procurement Manufacturing Q.C Check specification yes Customer no 3rd line maintenance Serial production Jigs & fixture Work place Requirement of DOA & POA yes C.VES STATIC & DAYNAMIC TEST MOCK DESGIN Testers Simulator ISO 9002:2016 ISO 9002:2016 (external & internal issues ) ISO 9002:2016 ISO 9002:2016 SWOT Analysis Quality management system نظام إدارة الجودة 4. Context of the organization ❑4.2 Understanding the needs and expectations of interested parties Slide: 124 ISO 9002:2016 Interested Parties • The definition of “interested party” states that it is a “person or organization that can affect, be affected by, or perceive itself to be affected by, a decision or activity”. • The intent of this requirement is to ensure that you consider the requirements of relevant interested parties, beyond just those of the customer and end user. However, you only need to focus on those relevant interested parties which can have an impact on your ability to provide products and services that meet requirements. • There will be those external interested parties that impose specific legal, regulatory or contractual requirements. • There may be also requirements specified by internal interested parties, such as : management, staff, shareholders, trade unions, etc. ISO 9002:2016 Identifying Interested Parties The list of relevant interested parties can be unique to your organisation. You can develop criteria for determining relevant interested parties by considering their: • possible influence or impact on the organisations performance or decisions • ability to create risks and opportunities • possible influences or impact on the market • ability to affect the organisation through their decisions or activities Need to understand the needs, expectations, and requirements of your interested parties / stakeholders. These are critical to ensuring that your products or services meet requirements which is the reason for having QMS. Don’t underestimate the importance of interested parties / stakeholder management to the success of the organisation. ISO 9002:2016 Methods of Understand the needs and expectations • reviewing orders received; • reviewing statutory and regulatory requirements with compliance or legal departments; • lobbying and networking; • participating in relevant associations; • benchmarking; • market surveillance; • reviewing supply chain relationships; • conducting customer or user surveys; • monitoring customer needs, expectations and satisfaction. ISO 9002:2016 Classifying Interested Parties Group interested parties based on their relationship with the organisation by their: • • • • • • Responsibility – investors, etc. Influence – pressure groups, etc. Proximity – neighbours, etc. Dependency – employees, etc. Representation – trade unions, etc. Authority – regulators, etc. Different groups may require a different management approach, relevance, needs and expectations ISO 9002:2016 Interested party QMS requires from Interested Parties Needs and expectations of Interested Parties Customers, Retailers, Distributors Specifications for design, manufacture, delivery, support Design, quality, price, quick response & on-time delivery of products and services Owners Share Holders Board Financial investment, Decisions & support Improvements Sustained profitability, Return on investment, Transparency, Legal compliance People in the organization Leadership, Motivation, Direction Involvement. Products & Services. Follow QMS requirements. Good work environment, Health & safety, Job security, Professional development, Recognition and reward, Training, Working relationships External Providers Partners Products, Services or Raw Materials. On-time delivery. Reliability. Mutual benefit and continuity, Prompt payment, Good working relationship Society Regulatory Authorities Legal & regulatory requirements. Certainty of law Environmental protection Ethical behaviour Compliance with statutory and regulatory requirements Conformity to industry codes & standards ISO 9002:2016 Interested QMS requires from party Interested Parties Needs and expectations of Interested Parties Local residents Workforce, Good relations Safe working conditions, environmentally friendly operations Bank / Finance Good Governance, Stability, Credit Financial performance Cash flow Trade Unions Realistic expectations Employment law compliance, Co-operation Good working relationship with management Insurers Guidance on risk, identification, treatment, avoidance No claims Risk management Prompt payment End Users Details of their needs, expectations and requirements Performance, ease of use, safety, reliability, maintainability, disposability ISO 9002:2016 Power and Interest Matrix Useful tool for helping you decide how to manage a particular Interested party How much interest do they have in your decisions and activities – interpreted as the strength of their relevance How much power or influence do they have over your decisions and activities – interpreted as their significance or risk Plotting helps to prioritise the effort required to meet their needs and expectations ISO 9002:2016 Interested Parties Interested Parties (IP) Board Customers Competitors Regulators Neighbours / Society Staff Financial Institutions Shareholders / Owners Suppliers QMS requires from IP IP Needs & Expectations Issues / Risks Objectives Risk Analysis Treatment Plan Priority ISO 9002:2016 Interested parties requirement • The information resulting from these activities should be considered in planning the quality management system (Clause 6) • Relevant requirements can be different for the different products and services provided, and can change due to unforeseen circumstances or intentional reactions to markets ISO 9002:2016 Monitor and review the relevant requirements • Monitoring and reviewing can be done by using the organization’s processes related to: • customer requirements, • design and development of products and services, • and (at a more strategic level) during management review. ISO 9002:2016 Consultant Activity No(2) 1. As QMS consultant how you will determine interested parties & their requirements? 2. How you will priorities them? Slide: 135 ISO 9002:2016 Interested parties & their needs & expectations ISO 9002:2016 ISO 9002:2016 Online Course Quality Management System ISO 9001:2015 QMS Consultant 2020 TÜV SÜD Quality management system نظام إدارة الجودة 4. Context of the organization ❑4.3 Determining the scope of the quality management system: ❑The organization shall determined ➢ Boundary ➢ Applicability of the QMS Slide: 139 ISO 9002:2016 Scope of the QMS • The scope is a vital part of the QMS as it defines how far the QMS extends within the company’s operations (boundaries), • The scope shall state the types of products and services covered, and provide justification for any requirement of ISO 9001:2015 that the organization determines is not applicable to the scope of its QMS. • The organization’s scope shall be maintained as documented information, e.g.:- quality manual; marketing materials; website; etc. ISO 9002:2016 Scope of the QMS The scope of the QMS, should be established based on the: • context-related external and internal issues • relevant requirements from relevant interested parties • products and services of the organization In determining the scope, you should also establish the boundaries of your QMS by considering such issues as: • infrastructure of the organisation • organisations different sites and activities • commercial policies and strategies • centralised or external provided activities, processes, products and services • organizational knowledge ISO 9002:2016 Scope of the QMS For example, in determining the scope for a small distribution business of imported goods, after analysing the collected information, it can find that: • the requirements in clauses 8.3 and 8.5.3 are not applicable because it does not carry out design and development, and does not have any property belonging to their customers or external providers • there is only one site for its operations that it needs to consider in the context-related issues, and sterilisation process is outsourced • The scope may be: Import and commercialization of glass bottles for cosmetics in the Technology Park facility for the European market, with the sterilisation process outsourced. • The outputs of the activities listed above should be available in a documented scope, including the justification of the non-applicable requirements, and any outsourced processes ISO 9002:2016 The scope of the QHSE management system is: ABC company services & products : • Engineering, Construction and Upgrade of : • Control & Drive Systems and Panels. • Power Generation and High Voltage Substations. • Production of automation devices • Highly automation product • we are committed to produce our product in compliance with requirement of ISO 9001- 2015,iso 14001:2015 and iso 45001:2018 Requirements. • all clauses of the IMS standards are applicable except some exclusion in iso 9001:2015: • 7.1.5 Monitoring and measuring resources • 7.1.5.2 Measurement traceability • The justification that we as company don’t have a workshop for calibration and we calibrate our measurement system in outsource party. ISO 9002:2016 Online Course Quality Management System ISO 9001:2015 QMS Consultant 2020 TÜV SÜD Quality management system نظام إدارة الجودة 4. Context of the organization ➢ Process approach • Organization shall determined: • Processes needed, Input , output , resources , control for identified processes • Processes interactions • Risks to conformity (goods, services and in-effective interaction) • Key performance indicator • Responsibility and authority • Improvement Slide: 145 ISO 9002:2016 Process approach All organisations use processes to achieve their objectives • is a set of interrelated or interacting activities that uses inputs to deliver an intended result • has built-in controls and checks of performance and promotes improvement. • The inputs and outputs may be tangible (e.g. materials, components or equipment) or intangible (e.g. data, information or knowledge) The process approach includes establishing the organisations processes needed to operate as an integrated and complete system • The management system integrates processes and measures to meet objectives • Processes define interrelated activities and checks, to deliver intended outputs • Details planning and controls can be defined and documented as needed, depending on the organisations context ISO 9002:2016 Process approach In order to determine the processes you need, you should consider the following: • the defined scope of the quality management system • list of products and services • list of sites and production lines processes • capabilities • resources • performance indicators such as: - service response time; service outage trends,throughput rates, defect rates; re-work costs; warranty costs - risks and opportunities identified (see 6.1) ISO 9002:2016 Risk-based thinking, PDCA & the process approach • The process approach enables an organisation to plan its processes and their interactions. • The PDCA cycle enables an organisation to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted upon. • Risk-based thinking enables an organisation to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimise negative effects and to make maximum use of opportunities as they arise. ISO 9002:2016 Risk-based thinking, PDCA & the process approach These three concepts together form an integral part of ISO 9001:2015 standard. Risks that may impact on objectives and results must be addressed by the management system. Riskbased thinking is used throughout the process approach to: • Decide how risk is addressed in establishing the processes to improve process outputs and prevent undesirable results. • Define the extent of process planning and controls needed (based on risk). • Improve the effectiveness of the quality management system • Maintain and manage a system that inherently addresses risk and meets objectives. ISO 9002:2016 Process approach For example: The processes needed for a small distribution business of import goods may be: • Strategic planning process • Commercial process • Procurement and import process • Distribution process • Administration process • IT support process • QMS process ISO 9002:2016 Process approach ISO 9002:2016 Application and Quotation Process Application Application and Quotation Process Suppliers Inputs Client Phone Call / Email Marketing Process Quotation Outputs Customers 1. Client Inquiry Send SendRFQ RFQ Marketing Client Request 2. Send out RFQ ▪▪Email Email ▪Client Client Completed RFQ 3. Review RFQ (not offered) ▪▪Decision - No Decision - No ▪Client /Marketing Client Completed RFQ 3.2 Review RFQ (offered) ▪▪Decision - Yes Decision - Yes ▪Marketing Client Completed RFQ 4 Log Data ▪Update Goldmine Marketing Client Completed RFQ 5. RFQ Complete (no) ▪Return RFQ to ▪ Client Client Client Completed RFQ 6. RFQ Complete (yes) RFQ to Manager Operation Manager Operation Manager Complete RFQ 7. Complete Quote + Manday Sheet ▪Quote / Manday ▪Marketing Sheet ISO 9002:2016 Process Interaction Feedback 13. Analysis of Data, Continuous improvement 11. Resource Management 10. Management Responsibility 12. Internal Audits, CAR’s Document/Record Control Communication Channel Communication Channel 1. New Product Introduction 2. Purchasing 3. Order Review & Scheduling Customer Service 4. Warehouse/ Material control Delivery Notes & Invoices Finished Goods 1. Product Engineering 5. Assembly 8. Material Control RMA Products Products 7. Rework and Repair Production Schedules & Previsions Lists 9 Shipping Non Conforming 15. RMA Material Control 6. QA Test & Verification Non Conforming Products Customer Related Processes Material Control Processes Manufacturing Processes Material Control Process CUSTOMER CUSTOMER Realisation Processes Quality management system نظام إدارة الجودة 154 نظام إدارة الجودة Quality management system Online Course Quality Management System ISO 9001:2015 QMS Consultant 2020 TÜV SÜD نظام إدارة الجودة Quality management system 5.1 Leadership and commitment- 5.1.1 accountability Integration of the QMS effectiveness of QMS commitment Communicated, understood & applied Policies & objectives QMS achieves its intended outcome(s); ensuring Leadership supporting other relevant management roles Supporting promoting of process approach 540 Resources availability promoting continual improvement engaging, directing Communication & supporting persons ISO 9002:2016 Leadership and commitment • Top management is defined in ISO 9001:2015 as the “person or group of people who directs and controls an organization at the highest level”. In a small organization this may include the owner or partners and a few key people who report directly to them. • The intent of this requirement is to ensure that top management, demonstrate leadership and commitment by taking an active role in engaging, promoting, and ensuring, communicating and monitoring the performance and effectiveness of the quality management system. • If you want your quality management systems to be successful you need management support. Without this support the QMS will be overtaken by other priorities and the benefits from using continual improvement to focus on customer needs will be lost. • The role of top management is to inspire by leading by example. • Top management is expected to be “hands on” and to ensure that the quality policy and quality objectives are consistent with the overall strategy and context. ISO 9002:2016 How to show commitment • • • • • • QMS effectiveness is measured, & management is involved in assessing this, (Management Reviews). The Quality Policy and objectives are in place per management direction, communicated in the organization, and tracked for progress. Ensuring the integration of the quality management system requirements into the business processes (not a side project). Resource needs are reviewed and addressed by management. Continual improvement is promoted and supported by management. Ensuring that recommendations from audits, corrective actions, management reviews, etc. are implemented. ISO 9002:2016 How to show commitment • • • • There is a way to ensure customer, statutory and regulatory requirements are understood and met, and people understand why this is important. Management focus on customer satisfaction. Organizational roles, responsibilities, and authorities are assigned, understood by the person who is assigned, and known to all employees. Top management will be expected to not only ensure that its commitment is well known throughout your organization, but also to keep appropriate records to show how this was achieved, reports of management meetings can be used to provide such evidence. ISO 9002:2016 5.1.2 Customer focus • Top management needs to ensure that effective processes are in place to determine customer requirements and statutory and regulatory requirements related to the organization’s products and services, and that these requirements are understood. • Top management can focus on enhancing customer satisfaction by using the results of analysis and evaluation of customer satisfaction data نظام إدارة الجودة Quality management system 5.2. Policies Communicated understod 551 Upplied Quality management system نظام إدارة الجودة QHSE COMPANY POLICY SAMPLE The top management of ABC Company has a commitment in the following fields. 1) Integrated solutions for manufacturing automation products & systems. 2) Substations Construction installation. 3) Testing, commissioning and start up for electrical equipment and aim to commit to the following: • Commitment to apply the requirements of Quality Management System ISO 9001:2015 , Environment Management System ISO 14001:2015 , Occupational Health & Safety Management System ISO 45001:2018 and keep with the latest manufacturing technology and use the academic expertise in the field of Control& Instrumentation Systems tech. and continuous improvement and development. • Achieve customer satisfaction &orientation, successful collaboration with external customer by manufacturing a high quality, and assuring its conformity to the customer specifications Applying of related international standards, codes, and regulatory & statutory requirements & requirements and complies with the legal requirements of government agencies that deals with the company. • Commitment to compliance with any legal requirements and other requirements that are related to occupational health & safety risks & environment impacts arising from activities & product. نظام إدارة الجودة Quality management system • includes a commitment to consultation and participation of workers, and, where they exist, workers’ representatives • Understanding of the quality, environmental & occupational health & safety objectives throughout the company and provide all ways to achieve these objectives. • Provide training & awareness programs for employees which concern about quality, environmental, health and safety systems. • Provide safe and healthy working conditions for the prevention of work- related injury and ill health that can be exposed employees depending on their work places also commitment to eliminate hazards and reduce OH&S risks. • Commitment of preventing contamination and maintain the environmental effects that results from activities and products and sustainable resource use. • Activate maintenance program for all equipment and facilities of the company. • Periodic review of the company policy and communicate it for all the employees & relevant interested parties Approved \ Chairman Signature نظام إدارة الجودة Quality management system 5.3 RESPONSIBILITY AND AUTHORITY assigned and 562 communicated shall assign the responsibility and authority for: a) ensuring that the QMS conforms to the requirements b) reporting on the performance of the QMS c) Reporting on opportunities for improvement and on the need for change or innovation d) ensuring the promotion of customer focus e) ensuring the integrity of the QMS is maintained when changes to the QMS are planned and ISO 9002:2016 Organizational roles, responsibilities and authorities • • • can be assigned to one or more persons. responsibility and accountability for the QMS remains with top management. could be through the use of relevant documented information, e.g. • job descriptions, • work instructions, • duty statements, • organization charts, • manuals, procedures. ISO 9002:2016 QHSE Role & Responsibilities • QHSE Manager Job Description: Performs reporting, risk assessments and auditing and observes all QHSE related activities and policies within a location. Ensures operations are conducted in a safe and efficient manner and in conformance to federal, provincial and company safety regulations by integrating and implementing company and third-party QHSE policies and procedures. Performs post-incident investigations and communicates with the QHSE Manager and others until all action items have been closed. Files QHSE documents and participates in job risk analysis and continual improvement. Likely to be either a specialist within a particular focus area for QHSE, e.g., environmental, manufacturing , production ,training etc., or is based at a specific location in a generalized role. Typically has completed required safety/environmental training. Typically, intermediate level positions perform more complex duties requiring some skills and judgment. Some decision making may be made independently; may work under supervision. This level is developing knowledge and problem-solving skills. Possesses 3-6 years of experience. ISO 9002:2016 Production manager job description sample Responsibilities of the job include: • planning and organizing production schedules • assessing project and resource requirements • estimating, negotiating and agreeing budgets and timescales with clients and managers • ensuring that health and safety regulations are met • determining quality control standards • overseeing production processes • re-negotiating timescales or schedules as necessary • selecting, ordering and purchasing materials • organizing the repair and routine maintenance of production equipment • liaising with buyers and marketing and sales staff • supervising the work of junior staff • organizing relevant training sessions ISO 9002:2016 Consultant Activity 1.QMS POLICY Sample for your company. 2.Sample for roles and responsibility for QMS Personal: • Quality personal • Production manager Slide: 168 ISO 9002:2016 Online Course Quality Management System ISO 9001:2015 QMS Consultant 2020 TÜV SÜD Quality management system نظام إدارة الجودة 170 نظام إدارة الجودة Quality management system 6.1 Actions to address risks and opportunities Organization shall consider 4.1 and 4.2 when planning intend outcome, conformity of goods and services and customer satisfaction Prevent and reduce undesired effect Achieve improvement actions to address these risks and opportunities evaluate the effectiveness of these actions Actions taken shall be appropriate for the effect can include: avoiding risk, taking risk , eliminating the risk source, changing the likelihood or 500 consequences, sharing the risk, or retaining risk ISO 9002:2016 Risk-based thinking • Its purpose is to • prevent nonconformities, including nonconforming outputs, • and to determine opportunities that might enhance customer satisfaction • or achieve an organization’s quality objectives. ISO 9002:2016 Risk-based thinking • Examples of the risks that: the quality management system will not achieve its objectives • include the failure of processes, products and services to meet their requirements, • or the organization not achieving customer satisfaction. • ISO 9002:2016 Risk-based thinking • Examples of opportunities include: • the potential to identify new customers, • to determine the need for new products or services • And to bring them to market, • or to determine the need for revising or replacing a process by the introduction of new technology in order for it to become more efficient. ISO 9002:2016 Risk Assessment Techniques • There is no requirement in ISO 9001:2015 to use formal risk management in the identification of risks and opportunities. You can choose the methods that suit your needs. • ISO 31000 Risk Management – more formal approach, not obligatory • The standard IEC 31010 Risk management – Risk assessment techniques provides a long list of risk assessment methodologies, some of which may be appropriate, depending on what your organization does and its context. ISO 9002:2016 Risk Assessment Techniques • Tools such as Strengths, Weaknesses, Opportunities and Threats analysis (SWOT); Political, Economic, Social, Technological, Legal, Environmental analysis (PESTLE); and Porter’s 5 Forces industrial analysis, can be used. A simple approach can include asking "what if" questions. Application of Brainstorming techniques can be used as one of the effective tools for application of risk based thinking. • Some techniques can be more popular in certain sectors, e.g. Failure, Mode and Effects Analysis (FMEA) in the automotive sector; Failure, Mode, Effects and Criticality Analysis (FMECA) in for the medical devices sector; Hazard, Analysis and Critical Control Points (HACCP) for the food sector. It is for you to decide which methods or tools to use. ISO 9002:2016 Risk Management Process ISO 9002:2016 Risk-based thinking Actions to address risk include developing appropriate process controls, for example: • the inspection, monitoring and measuring of processes, products and services; • calibration; • product and process design; • corrective actions, and in particular making sure that these are extended to other relevant areas of the organization; • specified methods and work instructions; • the training and use of competent persons. ISO 9002:2016 Risk treatment Implement the plan – take action • Avoidance: Eliminate causes, changing plans, discontinuing activities, etc. • Mitigation: Reduce event probability, limiting exposure, reducing impacts, etc. • Acceptance: Taking no action and accepting consequences • Transference: Removing impact / consequences by reassigning responsibility • Exploitation: Increasing probability while maximising possible effects Example: • I move to the side of the road, check there are no barriers to crossing. I check there are no cars coming. I continue to look for cars whilst crossing the road. ISO 9002:2016 SWOT Analysis Strategy Opportunities Threats Strength-Opportunity strategies Strength-Threats strategies Which of the company’s strengths can be used to maximise the opportunities you identifies? How can you use the company’s strengths to minimise the threats you identified? Weakness-Opportunity strategies Weakness-Threats strategies What actions can you take to minimise the company’s weaknesses using the opportunities you identified? How can you minimise the company’s weaknesses to avoid the threats you identified? (external, positive) Strengths (internal, positive) Weaknesses (internal, negative) (external, negative) ISO 9002:2016 SWOT Analysis for computer store Strengths Weaknesses Knowledge: our competitors are pushing Price & Volume: The major stores are pushing Relationship selling: we get to know our Brand power: We cant match the competitors History: we've been in our town forever. We Service: We are not open the same hours as the Opportunities Threats Training: The major stores don’t provide The larger price-oriented store: When they Service: As our target market needs more The computer as appliance: Volume buying of boxes, but we know systems, networks, programming, and data management customers, one by one have the loyalty of customers and vendors training, but as systems become more complex, training is in greater demand service, our competitors are less likely than ever to provide it. boxes and can afford to sell for less. full-page advertising in the Sunday papers. We don’t have the national brand name. major stores. advertise low prices in the newspaper, our customers think we are not giving them good value. computers as products in boxes. People think they need our services less. ISO 9002:2016 Likelihood (Probability) Consequence (Severity) Rare 1 Unlikely 2 Possible 3 Likely 4 Minimal 1 1 2 3 Minor 2 2 4 6 8 10 Moderate 3 3 6 9 12 15 Major 4 4 8 12 16 20 Severe 5 5 10 15 20 25 High Significant Medium Low 4 Very likely 5 5 ISO 9002:2016 20 2 Supply Supplier failing to deliver service as per the SAL Telecom Co. CD - Formal contract in place - Clear communications channels established - contract subject to Formal regular review 4 4 16 3 Environme nt Loss of a key facility through fire IL - Smoking is not allowed in the building - Work on electrical installation is subject to a Work permit - Flammable liquids and combustible materials are strictly controlled - Fire protection is installed throughout the building - building and contents are insured 3 4 12 4 People Lack of expertise of employees EF - All employees receive induction training - Structured training program in place 3 3 9 Due Date Level 5 Actions Consequences 4 Owner - Clear policy on access control in place - Data in transit is always encrypted - Audit logs record access to sensitive information Objectives AB Risks Technology Confidential information being disclosed to unauthorised parties Category 1 No. Likelihood Risk Treatment in place Risk Register ISO 9002:2016 Risk Profile ISO 9002:2016 • various situations where risks and opportunities should be considered, for example: • strategy meetings, • management reviews, • internal audits, • different kinds of meetings on quality, • meetings to set quality objectives, • the planning stages for the design and development of new products and services, • and the planning stages for production processes. ISO 9002:2016 Consultant Activity Business risk register Slide: 186 ISO 9002:2016 Online Course Quality Management System ISO 9001:2015 QMS Consultant 2020 TÜV SÜD ISO 9002:2016 188 نظام إدارة الجودة Quality management system 6.2 Quality Objectives and planning Planing shall covers : SMART communicated Updated as appropriate OBJECTIVEs Monitored , Documented information 552 Responsiblities Resource Planning needed Time ISO 9002:2016 Quality Objectives • Establishing objectives and planning how to achieve them can help your organization to accomplish its business goals. • The quality objectives take the goal(s) stated in the quality policy and turn these into statements for improvement against which plans can be made • Quality objectives may be established to measure the performance of products, processes, customer satisfaction, suppliers, use of resources, and the overall performance and effectiveness of the quality management system • If you state in your policy that you will “meet customer requirements”, then you might set customer focused objectives for: product defects, customer complaints and returns, on-time delivery, etc. ISO 9002:2016 Quality Objectives Examples of quality objectives: • Product: reduction in defect rates, PPM, scrap rates, ontime delivery • Process: improving productivity, reduction of waste, set-up times or rework, improved cycle times • Customer: product returns, reduction in complaints, improvement in customer satisfaction scores, improved ontime delivery. • Suppliers: reduction of complaints or defects, improved ontime delivery • Resources: availability, capability, personnel, competency, efficiency, absenteeism ISO 9002:2016 Quality Objectives • The objectives should be designed to be SMART (setting objectives that are Specific, Measurable, Achievable, Realistic and Time-based). • Specific: Clear and concise • Measurable: If you cant measure, how do you know it has been achieved. • Achievable: personnel need to agree that the objective is achievable • Realistic: do not set unrealistic goals • Time-based: Need to set a due by date to focus attention and to monitor achievement to your goals ISO 9002:2016 Quality Objectives Quality objectives shall:• Consistent with quality policy • Relevant to products & services and enhance customer satisfaction • Measurable • Monitored • Updated Organisation shall determine:• What will be done • Resources required • Responsibility • Timeframe • How results will be evaluated 6.2 Quality objectives and planning to achieve them We are going to show how QMS operates on strategic and operational level using PDCA approach. Each management level is using its’ own PDCA loop. Both loops are connected and synchronized by information exchange. Top management P D C A QMS Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers' requirements and the organization's policies; Process owners Top management P D C A QMS Do: implement what was planned; Process owners Top management P D C A QMS Process owners Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requirements and report the results; Top management QMS P D C A Act: take actions to improve performance, as necessary. Process owners Top management QMS Process owners 5.2 Quality policy P 8.1 Target values 6.1 and 6.2 Business plan with quality objectives 8.1 6.1 Actions FMEA, SWOT D C A Top management shall establish, implement and maintain a quality policy and establish quality objectives at relevant functions, levels and processes needed for the quality management system. Action plan Quality plan Top management QMS Process owners 5.2 Quality policy P 8.1 Target values 6.1 and 6.2 Business plan with quality objectives 8.1 6.1 Actions FMEA, SWOT D C A The organization shall plan actions to address these risks and opportunities. Action plan Quality plan Top management QMS Process owners 5.2 Quality policy P 8.1 Target values 6.1 and 6.2 Business plan with quality objectives 8.1 6.1 Actions D C A Managing organization according to Quality policy and objectives The organization shall plan, implement and control the processes needed to meet the requirements for the provision of products and services FMEA, SWOT Action plan Quality plan 8.2 to 8.5 Operations as planned Top management QMS Process owners 5.2 Quality policy 8.1 Target values and 6.2 P The organization shall6.1 implement D C A Business plan planned arrangements, at with appropriatequality stages,objectives to verify that the product and service requirements have been met and Managing organization control nonconforming output. according to Quality policy and objectives Check Corrective 10.2 actions 6.1 Actions 9.1.3 FMEA, Analyzing SWOT data 8.7 Control of nonconformities Action plan Quality plan 8.2 to 8.5 Operations as planned Nonconformance 9.2 8.1 8.6 Check Internal audits Customers QMS Top management Process owners 5.2 Quality policy P D C 8.1 Target values 6.1 and 6.2 Business plan with quality objectives Corrective 10.2 actions 6.1 6.1 Top management shall Actions review the organization's 9.1.3 Managing organization FMEA, at planned Analyzing according to QualityQMS, policy SWOT data Intervals. and objectives 8.7 Control of nonconformities Check A 8.2 to 8.5 8.6 9.2 Management review Analyzing results and action 9.3.3 taking Action plan Quality plan Operations as planned Nonconformance 9.3 8.1 Check Internal audits 9.1.2 Customers QMS Top management Process owners 5.2 Quality policy P D C 8.1 Target values 6.1 and 6.2 Business plan with quality objectives Managing organization according to Quality policy and objectives Check 8.7 Control of nonconformities Action plan Quality plan 8.2 to 8.5 8.6 9.2 Management review Analyzing results and action 9.3.3 taking 8.1 Operations as planned Nonconformance 9.3 A Corrective 10.2 actions 6.1 Actions 9.1.3 FMEA, Analyzing SWOT data Check Internal audits 9.1.2 Customers Company owners Practical example Top management Process owners Project manager and experts Corrective & preventive actions Quality policy C Business plan with quality objectives A NOT OK Targets Analysis of NC Appr oval DO OK Approved business plan Process plan Action plan Work according to plan Work according to plan Work according to plan Non conformance CHECK Checking Checking Quarterly Audit report Checking monthly Prototype production (vendor) Auditing Non conformance A C Checking Analyzing results Monthly ACT Annual report Customer Quarterly Non conformance Annual management review Checking Analysis of customer perception of quality Customer satisfaction feedback Quality management system نظام إدارة الجودة 6.3 Planning of changes ❑Organization shall determined the needs and opportunity to maintain and improve the QMS ❑Organization shall undertake changes ➢ Planned systematic manner Simply , evaluate before ➢ Identify risks implementation ➢ Opportunity ➢ Reviewing the potential consequence of change 206 ISO 9002:2016 6.3 Planning of changes • The need for a change to the quality management system can be determined in: • as part of management review, • from audit results, • reviews of nonconformities, • complaints • analysis, • analysis of process performance, • changes in context or • from the changing needs of customers • and other relevant interested parties 207 ISO 9002:2016 6.3 Planning of changes • To help plan the change, examples of actions the organization can take include: • plan performance tests and validation, • run both the old and new systems concurrently for a limited time • apply formal project management techniques. ISO 9002:2016 Quality Objectives sample QMS Smart Objectives : • Improve company productivity by 70 % in 2020 • Improve staff competency by 50% each in their fields (HR) • Apply control measure to improve product quality in all production lines by 100% in 2020(Production) • Define 5 other qualified supplier and develop potential supply list by the end of June 2020 (procurement ) • Exceed customer expectation and decrease the complains by 50 % in 6 months (marketing) ISO 9002:2016 Plane to achieve the Quality Objectives sample OPJECTIVES No (1) Improve company productivity by 70 % in 2020 OPERATION PLANE DETAILS ACTIVITIES Apply quality control inspection in production lines Apply iso 9001:2015 system Eliminate all type of waste in the factories by apply lean methodologies Use new technology Responsibility Start date End date 12/ 3/2020 12/12/2020 3/1/2020 9/8/2020 Quality manager Iso knowledge & expertise Obtain iso9001:2015 certification Production team Lean tools 11/4/2020 2/10/2020 Decrease waste by 50% Quality + production team Resource s needed Inspection tools & equipment's Performance measure (Ob. KPI) Increase productivity by 70% in 2020 ISO 9002:2016 Consultant Activity • Quality Objectives (SMART) • plan to achieve the mentioned objectives Slide: 211 ISO 9002:2016 Online Course Quality Management System ISO 9001:2015 QMS Consultant 2020 TÜV SÜD Quality management system نظام إدارة الجودة 213 نظام إدارة الجودة Quality management system 7. Support Competence الكفاءة 7.2 Resources الموارد 7.1 7.3 Awareness التوعية 7. Support المساندة Documented Information المعلومات الموثقة 7.5 7.4 Communication التواصل ISO 9002:2016 7.1 Resources “determine”, “provide” and “maintain” • For example, those responsible for a particular process might determine specific infrastructure requirements, • the purchasing process will acquire and provide that infrastructure, • and activities will need to be established to maintain it (such as equipment maintenance, housekeeping, or information technology updates, periodic testing of information and communication systems, or periodic inspections of facilities and equipment). ISO 9002:2016 7.2 Competences • Competence requirements can be determined by different methods, such as • through defining job descriptions, • or by carrying out job evaluation exercises, • The competence of a person should be confirmed through • job interviews, • reviewing resumes, • observation, • documented information of training or diplomas. ISO 9002:2016 7.2 Competences • such actions to meets the competence requirements can include, but are not limited to, • mentoring the employee, • providing training, • simplifying the process so that the person can carry it out successfully, • Or reassigning the employee to another position ISO 9002:2016 7.2 Competences • evaluate the effectiveness of any actions taken by different means, including • direct observation of his/her performance • or by examining the results of tasks and projects. ISO 9002:2016 7.3 Awareness The organization can create awareness in many ways, such as: • a) clarifying what is expected (e.g. visual tools such as pictures of acceptable and unacceptable products and services); • b) communicating clear requirements for products and services; • c) designing processes to clearly segregate nonconforming outputs; • d) communicating clearly how to handle complaints and the internal escalation steps in the case of nonconforming outputs ISO 9002:2016 7.4 Communication ISO 9002:2016 7.5 Documented information ISO 10013 221 ISO 9002:2016 Scenario (Maintain & Retain) You have found all these papers lying on a desk. Which of these are documents and which are records? • testing algorithm • report of corrective actions • safety manual • • client test results temperature log (blank form) • standard operation procedures (SOPs) for an approved HIV rapid test • quality control record (blank form) • daily maintenance log (completed) • manufacturer test kit inserts • • summary of findings from on-site evaluation visit stock cards and stock book (completed) • EQA specimen transfer log (completed) 222 ISO 9002:2016 Good Documents are: • clear • concise • user-friendly • explicit • accurate • up-to-date 223 ISO 9002:2016 Documents for work processes should be accessible to staff at the work site : • instructions on handling incoming samples • SOPs for each test • quality control charts and trouble-shooting instructions • safety manuals and precautions 224 ISO 9002:2016 PURPOSE OF DOCUMENTATION ➢ Clearly written documentation prevents errors ➢ It provides assurance that quality related activities are carried out exactly the way they have been planned and approved ➢ Employees know what to do ➢ Responsibilities and authorities are identified ➢ Forms the basis for improvement 225 ISO 9002:2016 QUALITY SYSTEM DOCUMENTATION ➢ All the elements, requirements and provisions adopted by company for its quality system should be documented in a systematic, orderly and understandable manner in the form of policies and procedures. ➢ Documents should be developed, prepared, approved, reviewed and distributed in a controlled manner. ➢ It should be written in detail and in simple language that can be understood by the user. 226 ISO 9002:2016 TIERS OF DOCUMENTATION (1) Quality Manual Quality Procedures Supporting Documents or Work Instructions Quality Records Broadly, all documents relating to quality fall into the following categories should be controlled: Quality Manual Quality Procedures Supporting Documents or Work Instructions Quality Records All levels are integrated to form a comprehensive and cohesive 227 documentation network via a system of cross referencing ISO 9002:2016 QUALITY MANUAL The strategic document that outlines the organization’s system of providing quality assurance to achieve customer satisfaction. Quality Manual Quality Procedures Supporting Documents or Work Instructions Quality Records The Quality Manual could be in one document supported by several tiers of document, each becoming progressively more detailed. The Quality Manual should define the policy of the company, the organisational structure, functions, responsibilities, procedures, instructions, processes and resources for implementing the quality management. 228 ISO 9002:2016 QUALITY PROCEDURES The tactical document that outlines the process activities or operations of the organization in implementing the stated quality policies. Quality Manual Quality Procedures The quality procedures are needed to enable every employee to work individually and collectively to achieve the organization’s quality objectives. Supporting Documents or Work Instructions Quality Records 229 ISO 9002:2016 WORK INSTRUCTION The operational document containing instructions specifying how the activities are performed or products are accepted. Quality Manual Quality Procedures Supporting Documents or Work Instructions Quality Records The Working Instruction should describe step by step instruction specific to a task , activities and machine, specifying the tools, workmanship criteria, tolerance, and direction for the process. The working instructions is the easy guide for the operator to confirm each step in executing a task. The working instructions are needed to guide the staff in performing a specific function or task. 230 ISO 9002:2016 QUALITY RECORD Quality Records refer to results as well as charts and data pertaining to activities performed such inspection, testing, survey, audit, review, etc. They should be maintained as important evidence to demonstrate : Quality Manual Quality Procedures Supporting Documents or Work Instructions Quality Records conformance to specific requirements; the effective operation of the quality system All Quality Records should be : Legible and clear Dated Readily identifiable and retrievable Carry authorization status Retained for a designated period Protected from damage, light and 231 deterioration while storage ISO 9002:2016 Document Control assures that the most current version is used 232 ensures availability when needed organizational tool ISO 9002:2016 Document Control Elements • system for organizing, such as numbering or coding system • approval, distribution, and revision process • master log that describes which documents are in circulation • accessibility of documents at the point of use • system for archiving ISO 9002:2016 regulations and standards SOPs Controlled documents equipment service manuals 234 texts, articles, reference books ISO 9002:2016 Documents of External Origin • SUCH AS • instrument service manuals • industry regulations • ISO standards • references used for documentation ISO 9002:2016 Document Preparation and Control Process Preparation Issue Distribution Review Revision 236 Approval ISO 9002:2016 Why are records essential? Continuous monitoring of quality system Management tool Sample tracking throughout process Identify problems 237 ISO 9002:2016 Personnel records Critical communications Customer feedback Internal audits results Records User surveys Continuous improvement 238 External audits results ISO 9002:2016 Paper Systems ▪ Permanence • bind books • number pages • use permanent ink • control storage • Security • maintain confidentiality • keep safe from environmental hazards • Accessibility • Traceability • use system that will • allow for tracking of a allow ease of access specimen throughout all processes 239 ISO 9002:2016 240 ISO 9002:2016 Electronic Systems • permanence • computer system maintenance, backups • security • access • confidentiality • traceability 241 ISO 9002:2016 National legislation and regulation Testing process review Factors affecting retention times Time between assessments 242 -audits Research purposes Quality management system نظام إدارة الجودة 243 نظام إدارة الجودة Quality management system Defenses Product, project or Contract fail Production Purchasing Design & Develop Requirements Active Conditions Latent Conditions نظام إدارة الجودة Quality management system Defenses REASON’S MODEL Production Purchasing Design & Development Window of Opportunity Requirements Active Conditions Latent Conditions نظام إدارة الجودة Quality management system Defenses REASON’S MODEL Production Product, project or contract fail Purchasing Design & Development Window of Opportunity Requirements Active Conditions Latent Unsafe Conditions نظام إدارة الجودة Quality management system 8.5 Production 8.4 Purchasing 8.3 Design & Development 8.2 Requirements 8.1 Planning Others Product, project نظام إدارة الجودة Quality management system or contract fail 8.5 Production 8.4 Purchasing 8.3 Design & Development 8.2 Requirements 8.1 Planning Others نظام إدارة الجودة Quality management system 8.1 Operation Planning & Control 8. 1 Quality: The organization shall plan, implement and control the processes, (4.4), needed to meet requirements for the provision of products and services and to implement the actions determined in 6.1 - Process approach - Process and product control plan - Control of Outsourcing ISO 9002:2016 Effective controls are needed to: • a) confirm that the criteria are met; • b) ensure that the intended outputs are delivered; • c) determine where improvement is needed. ISO 9002:2016 0.3 Process approach Risk based thinking is part of the process approach! Process owner is responsible for planning and assuring results. P ISO 9002:2016 0.3 Process approach People in process are executing planed activities P D ISO 9002:2016 0.3 Process approach Results are checked before products and services are delivered to customer. P D C ISO 9002:2016 0.3 Process approach Customer internal or external If any nonconformities in products, services or process are detected, they are analyzed and corrective actions are performed to eliminate nonconformities. P D A C feedback ISO 9002:2016 0.3 Process approach We are monitoring customers’ perception of the degree to which their needs and expectations have been fulfilled, and acting upon the results in order to improve their satisfaction. P D A A Customer C Products and/or services feedback feedback Customer satisfaction ISO 9002:2016 0.3 Process approach First of all customer requirements, needs and expectations are gathered and analyzed. Customer A P D A A feed forward C Requirement s, needs and expectations Products and/or services feedback feedback Customers’ satisfaction ISO 9002:2016 0.3 Process approach Customer Business plan Requirement s, needs and expectations A P D C Products and/or services A Process owner shall align process goals to company goals … A Customers’ satisfaction ISO 9002:2016 0.3 Process approach Customer Business plan Statutory & Regulatory requirements Requirement s, needs and expectations A P D C Products and/or services A … process owner shall ensure process to meet applicable statutory and regulatory Requirements, … A Customers’ satisfaction ISO 9002:2016 0.3 Process approach Customer Business plan Statutory & Regulatory requirements Requirements of other processes … … and coordinating his/hers plans to plans of other processes. Requirement s, needs and expectations A P D C Products and/or services A A Customers’ satisfaction ISO 9002:2016 0.3 Process approach Measurements of process effectiveness Customer Business plan Statutory & Regulatory requirements Requirements of other processes Requirement s, needs and expectations A P D C Products and/or services A A Customers’ satisfaction 0.3 Process approach ISO 9002:2016 Measurements of process effectiveness Goals planned Business plan Measurement of process efficiency Resources planned Statutory & Regulatory requirements Requirements of other processes Goals achieved Customer Requirement s, needs and expectations A Resources used P D C Products and/or services A A Customers’ satisfaction 0.3 Process approach ISO 9002:2016 Measurements of process effectiveness Goals planned Business plan Measurement of process efficiency Resources planned Statutory & Regulatory requirements Requirements of other processes Goals achieved Customer Requirement s, needs and expectations A Resources used P Products and/or services C D NCR A CSI A Customers’ satisfaction Using TRIZ to detect N.C. ISO 9002:2016 Nonconformi Measurements of process effectiveness ng product is Goals planned Goals achieved produced here Measurement of process efficiency Business plan Resources planned Statutory & Regulatory requirements Requirements of other processes Improvin g features Improving speed and productivity Customer Requirement Nonconformi ng product s, is needs and not detected expectations here A Resources used P Worseni ng features Products and/or services C D NCR A CSI A Customers’ satisfaction Quality management system نظام إدارة الجودة 8.2 Requirements related to product (Marketing) 8.2.1Customer Communication: Communication channels for feedback, complaints, …… 8.2.2 Determine requirements: statutory and regulatory, Customer req, company req,… 8.2.3 review requirements: ensure that it has the ability to meet the requirements, 8.2.4 changes requirements: ensure that relevant documented information is amended and that relevant personnel are made aware of the changed requirements, Quality management system ISO 10001, 2, 3 & 4 نظام إدارة الجودة Quality management system 8.3 Design and development of products and 8.3.1 General: services 8.3.6 D&D changes: identify ,review and control changes نظام إدارة الجودة the organization shall establish, implement and maintain a design and development process 8.3.5 D&D outputs: • reference monitoring and measuring requirements, • acceptance criteria; 8.3.4 D&D • characteristics of control: the products and review, Verification and services validation 8.3.2 D&D Planning: determining the stages and controls for design and development 8.3.3 D&D Inputs: a) functional and performance requirements; b) information derived from previous similar design, c) statutory and regulatory requirements; d) standards or codes of practice,….. Quality management system 8.4 Control of externally provided products and 8.4.1 General: services (Purchasing) نظام إدارة الجودة Types of externally provided processes, products and services 8.4.2 type and extent of control: Determine the verification or other activities necessary to ensure the externally provided processes, products and services meet requirements 8.4.3 Information for external providers: All required information Quality management system 8.5 Production and service provision 8.5.6 Control of changes:: review and control unplanned changes نظام إدارة الجودة 8.5.1 Control of production and service provision 5Ms + E 8.5.2 Identification and traceability • use suitable means to identify process outputs • identify the status of process 8.5.4 Preservation outputs with respect to ensure preservation monitoring and of process outputs measurement requirements during production • Where traceability is a and service provision requirement, the organization shall control the 8.5.3 Property belonging to unique identification of the customers or external providers: process outputs identify, verify, protect and safeguard the customer's or external provider's property . 8.5.5 Post-delivery activities: Implanted as per requirements Quality management system نظام إدارة الجودة 8.6 Release of productsQ.C and services Stages (Q.C) shall implement the planned arrangements at appropriate stages to verify that product and service requirements have been met. verification of conformity : The release of products and services to the customer shall not proceed until the planned arrangements for verification of conformity have been satisfactorily completed Unless??? authority: Documented information shall include a) Evidence of conformity with the acceptance criteria b) traceability to the person(s) authorizing the release , Quality management system نظام إدارة الجودة 8.7 Control of nonconforming process outputs, products and services a) correction; b) segregation, containment, return or suspension of provision of products and services; c) informing the customer; d) obtaining authorization . AND Corrective action Product, project Defenses Production Purchasing Design & Development Requirements Or contract fail Quality management system نظام إدارة الجودة 271 Quality management system How far would you drive without your gauges? نظام إدارة الجودة Quality management system نظام إدارة الجودة Quality management system نظام إدارة الجودة نظام إدارة الجودة Quality management system 9. Performance Evaluation Internal Audit MEASUREMENT, Monitoring, Analysis & Evaluation ETC MANAGEMENT REIVEW Slide: 275 نظام إدارة الجودة Quality management system 9. Performance Evaluation Customer performance Products Processes Providers Plans ……. MEASUREMENT, Monitoring, Analysis & Evaluation ETC CS = ISO 10004 P&P = ISO 10017 Internal Audit Pro = ISO 37500 MANAGEMENT REIVEW Slide: 276 ISO 9002:2016 277 نظام إدارة الجودة •At Planned Intervals •To Insure system Quality management system 9. Performance Evaluation • Confirmed • • • • ISO 19011 Documented Implemented Effective & continual improved Internal Audit MEASUREMENT, Monitoring, Analysis & Evaluation ETC MANAGEMENT REIVEW Slide: 278 نظام إدارة الجودة Quality management system 9. Performance Evaluation •At Planned Intervals Internal Audit Decisions & •Inputs Plans Management Review Meeting MEASUREMENT, Monitoring, Analysis & Evaluation ETC •Outputs MANAGEMENT REIVEW Slide: 279 Quality management system نظام إدارة الجودة 280 Quality management system نظام إدارة الجودة 10. Improvement 10.2 Nonconformity and corrective actions 10.3 Continual Improvement 281 ISO 9002:2016 types of nonconformities include • internal or external audit findings • monitoring and measuring results • nonconforming outputs (see ISO 9001:2015, 8.7[28]); • customer complaints; • noncompliance with statutory and regulatory requirements; • problems with external providers (e.g. on-time delivery, incoming inspection); 282 ISO 9002:2016 types of nonconformities include • employee identified problems (e.g. through suggestion boxes); • observations from a superior or responsible person or process patrols; • warranty claims. 283 ISO 9002:2016 • There are several methodologies and tools that the organization can consider to conduct continual improvement activities (kaizen). Examples can include, but are not limited to: Six Sigma methodologies; • “lean” initiatives; benchmarking and the use of self-assessment models. Quality management system نظام إدارة الجودة 285 استشاري الجودة ISO 9001:2015 Internal Auditor المراجعة الداخلية ISO 19011 4 Audit Management 3 Types of Audits First Party Audit • Self-audit (Client, auditor and auditees are Internal) Second Party Audit • Audit by an interested body (like a customer) Third Party Audit • Audit by independent body (certification/registration body) Issue: Jan 2006 QMS Auditor / Lead Auditor Training 287 4 Audit Management Accreditation Body Function Accreditation Body (e.g. ANAB, UKAS…) ISO Guide 62 and IAF Guidelines Certification/Registration Body ( (Link) (e.g. IQC, QA Technic) ISO 9001 Organization to be certified (i.e. Client) Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 288 4 Audit Management Certification Process Application Audit Stage 1 Contract Review: ▪ Scope ▪ Time-scale ▪ Audit team Audit Stage 2 Certification Issue: Jan 2012 Surveillance QMS Auditor / Lead Auditor Training Course 289 4 Audit Management Scope of Certificate – multiple or single site If you have a number of “similar” sites - you have a choice:Create one system with one certificate or many site systems with many certificates. The certification body and auditor must validate the scope of the QMS. Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 290 4 Audit Management ISO 19011 provides good guidelines for EMS and QMS auditing including: Section 4. Principals of auditing (ISO19011 pg 3) Section 5. Managing an audit programme Clauses 5.1 to 5.6 (ISO19011 pgs 4 to 9) Section 6. Audit activities Clauses 6.1 to 6.8 (ISO19011 pgs 9 to 21) Section 7. Competence and evaluation of auditors Clauses 7.1 to 7.6 (ISO19011 pgs 21 to 28) (see Chapter 15 of this course) Issue: Jan 2006 QMS Auditor / Lead Auditor Training 291 4 Audit Management Audit stages 1- Preparation 2- The Audit 3- Subsequent Action Slide: 292 292 4 Audit Management Initiating the Audit Define audit objectives, scope and criteria • Check the brief from the client and validate with auditee. Determine feasibility of the audit • Is information and estimates of time and resources adequate? Select the audit team • Need competence to fulfill audit objectives. Establish initial contact with the auditee • What do they do? • How big are they? • Complexity of operations • Degree of readiness Issue: Jan 2006 Reference ISO19011 6.2 QMS Auditor / Lead Auditor Training 293 4 Audit Management Conducting Document Review QMS certification, Stage 1 (Documentation) Audit fulfills document review (for details see Chapter 9 of this course) Assess readiness for full systems audit Focus on planning for Stage 2 (implementation) audit Establish personal contact and rapport with auditee Validates scope, purpose, methods Gather additional information Identify potential problems Reference ISO19011 6.3 Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 294 4 Audit Management Preparing for the On-site Audit Activities Determine amount of work Number of person-days Prepare plan Prepare working documents Keep Auditee advised, agree date and time Logistics Reference ISO19011 6.4 Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 295 4 Audit Management Audit Plan Scope Working Documents Checklists Criteria Dates & duration Forms Audit team Standard Detailed timetable Guidelines Matrix plan Audit team requirements Remember to cover shifts Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 296 4 Audit Management Notify the team: Notify the auditee •Dates & duration • Audit plan •Detailed plan • Timetable •Matrix plan • Matrix plan •Individual tasks • Checklists •Results of Stage 1 audit •Any special requirements Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 297 4 Audit Management Audit Check list Why Prepare a “Checklist” before an Audit? to assist memory to ensure covering all issues and control points to ensure depth & continuity of the audit help in time management organise note taking part of audit report Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 298 4 Audit Management Checklist Format Inquiries Leave space for notes Allow space for time control and recording Production Area (7.1) Reference the requirements of audit criteria ❑Observe equipment and settings Reference the control documents Reference verifying documents (records) Issue: Jan 2012 Evidence and Results ❑Interview Production Manager about production planning. Plan, results. Employee interviews (5.3, 6.2.2) ❑Are you aware of the quality policy? ❑How does the policy relate to what you do? ❑What type of training have you had on QM? QMS Auditor / Lead Auditor Training Course 299 4 Audit Management Conducting on-site Audit Activities Conducting the opening Meeting Communication during the audit Collecting and verifying information Preparing audit conclusions Conducting the closing meeting Reference ISO19011 6.5 Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 300 4 Audit Management Opening meeting agenda: Introduce the team Grading of NCR’s Reason, scope & criteria Confirm staff aware & available Review audit plan and methods Confirm logistics Explain about sampling Confirm guides Confidentiality Safety requirements Method of reporting Questions Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 301 4 Audit Management How do auditor find evidence ? • Reviewing documents • Looking at records • Interviewing people at all levels • Observing practices and physical environment NOTE: Can/should the auditor cover all people, documents and records during the audit? Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 302 4 Audit Management What documents should be reviewed for Document review? Quality manual Procedures Work instructions Other documents Records Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 303 4 Audit Management Observations Keep observing the physical evidence: • records • equipment, instruments • conditions, controls Observation – What to Look for ✓ Posted Procedures ✓ Structure & Organization ✓ Actual Operations ✓ Communications Postings ✓ Control Points ✓ Awareness Reminders ✓ Operating Logs ✓ Calibration Tags ✓ Instruments with Process Measurements ✓ Infrastructure ✓ Inspection Logs Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 304 4 Audit Management Observation. Auditor Proverb: “Seeing is believing” Visit the field! See the 'real world'!!! ✓ production line, controls, inspections; ✓ talk to people on the field - if you can hear them!; ✓ nonconforming product management; ✓ watch the processes as and where they happen; ✓ maintenance systems; ✓ check what is happening and verify the documented version of events… ✓ storage locations and conditions; ✓ product segregation; ✓ product handling, marking, packing; Issue: Jan 2012 ✓ ask what the dials and meters are indicating about process monitoring and measures. QMS Auditor / Lead Auditor Training Course 305 4 Audit Management Closing Meeting No surprises Don’t leave discussion of corrective actions for the closing meeting Be diplomatic Acknowledge achievements Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 306 4 Audit Management Closing Meeting Agenda Overall summary Thank the auditee and reintroduce the team Recap reason, scope & criteria Review audit plan and methods Report the observations, positive & negative Issue: Jan 2012 Questions & answers Corrective actions & timescale Recommendation Follow-up QMS Auditor / Lead Auditor Training Course 307 4 Audit Management Follow-up action Documentary Evidence • At agreed time • Records • Review of documentary • Training certificates evidence • Amended procedures • Re-audit on the site • Photographs • Only review of corrective actions • Videos • Don’t start it all over again Reference ISO19011 6.8 Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 308 4 Audit Management NCR, Corrective Actions & Reporting 309 4 Audit Management What is a Nonconformance? “Non-fulfillment of a requirement” Objective evidence exists showing that: • a requirement has not been addressed (intent) • practice differs from the defined system (implementation) • the practice is not effective (effectiveness) Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 310 4 Audit Management Nonconformity Report No set rules; however all have these two parts: • The requirement (what was supposed to be) • The evidence (what actually is) Different organizations have different formats • Use the format chosen by your client or firm Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 311 4 Audit Management A Nonconformance Must Also Be... Factual Precise Objective Traceable Concise (brief) Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 312 4 Audit Management Definition of a Major Nonconformance • A failure of the clients system to implement complete clause or requirement written within the company system. • A failure to achieve legal or statutory requirements. • Multiple minor nonconformities within the same requirement of the standard or company system. • A purposeful failure of the company to correct nonconformities. Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 313 4 Audit Management What is a Minor Nonconformance? • Minor indicates the issue is not significant • Sub clause • If it is not a MAJOR NC then it is a Minor NC. Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 314 4 Audit Management Scenario: Production - Lens Department W-4 Morning shift. 4 out of 18 operators seen not wearing nylon caps. Caps were available at the entrance area. WI4-01, clause 6, requires that all personnel entering W-4 must wear nylon caps. Instruction clearly displayed at the entrance. Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 315 4 Audit Management IRCA QUALITY AUDITS •Area •Problem Incident Number ….................... NONCONFORMITY REPORT Company under Audit: XYZ plc Area under review: ………………………………………. Note Number ............................. ISO 9001 Clause Number Production- Lens Div.W-4 …………………………………… 7.1.4 •Attribution Category MAJOR* MINOR* •Grading During the morning shift 4 out of 18 operators were not wearing nylon caps. WI4-01, cl. 6, requires that all staff entering W-4 must wear nylon caps. The standard requires that the organisation must determine and manage the work environment needed to achieve product conformity. •Reference to internal Requirement(s), if necessary •Sign Deficiency Auditor Issue: Jan 2012 * delete one A. U. Ditor QMS Auditor / Lead Auditor Training Course 316 4 Audit Management A word of Caution Don’t judge on face value! Make sure you have complete evidence! Make sure your evidence is objective! When in doubt, investigate! Identify the leads for further investigation. Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 317 4 Audit Management EXERCISE No:06 Nonconformity Reports Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 318 4 Audit Management Corrective Action Correction “Action to eliminate the cause of a detected nonconformity or other undesirable situation” Issue: Jan 2012 “Action to correct nonconformity” QMS Auditor / Lead Auditor Training Course 319 4 Audit Management Auditor Auditee Identify, note & communicate Agreement Prepare Prepare NCR NCR Acknowledge & investigate Agreement Explain Cause/Propose Corrective Action Review effectiveness Implement, verify & notify Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 320 4 Audit Management Corrective Action Request Company: Date: NCR Number: Example: Auditor: Non-conformance and Corrective Action Request Form Auditors Report: of non-conformance (requirement & evidence) Standard & Clause Auditee: Major: Minor Signed: Date: Cause & Proposed Corrective Action: Note area for corrective action review. What should be entered here? By who? Proposed Completion Date: Date: Corrective Action Review: Signature Signed: Date: Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 321 4 Audit Management EXERCISE 07 Reviewing Corrective Actions Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 322 4 Audit Management Reporting 323 4 Audit Management Written Reports are sent to persons designated by the Client and may include: Direct auditees Auditee management Internal auditors Management of the organisation on behalf of which you are auditing Your fellow auditors Accreditation body Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 324 4 Audit Management Quality characteristics of a report Contents Informative Factual Complete Accurate & precise Reality Test: Is the report easy to understand and useful? Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 325 4 Audit Management Tips on Writing Style Use simple words Precise wording Avoid passive voice Use reported speech Avoid abbreviations Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 326 4 Audit Management What are the Typical Contents of Final Audit Report? Audit scope & objectives Audit plan, identification of auditors & auditees Audit criteria Audit team judgement of QMS compliance with audit criteria Nonconformances System ability to achieve defined objectives Distribution list Attachments: Completed Notes & Checklists, Nonconformance Reports, Matrix Analysis Issue: Jan 2012 QMS Auditor / Lead Auditor Training Course 327 ISO 10017 SPC الوحدة الرابعة Certified Quality Consultant/ Lead Implementer Course 329 ISO 10019 : 2015 Guidelines for the selection of QMS consultants الوحدة الخامسة Certified Quality Consultant/ Lead Implementer Course -١المجـــــــال ❑ تعطى هذه المواصفة الدولية توجيها الختيار استشاريين نظام إدارة الجودة واستعمال خدماتهم. ❑ والمقصود من هذه المواصفة مساعدة المنظمات الختيار إستشارى نظام إدارة الجودة . ❑ وتعطى إرشادا لعملية تقييم قدرة إستشارى نظام إدارة الجودة وزيادة الثقة التي تحتاجها المنظمات والتوقعات للخدمات التي سوف يقدمها اإلستشارى. مالحظات: ❑ هذه المواصفة الدولية ليس المقصود منها أغراض استخدام الشهادة. 331 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة – 4.1مدخالت عملية االختيار – 4.1.1حاجات وتوقعات المنظمة ❑ عند اختيار إستشارى نظام الجود ِة ،يجب على المنظمة أ َ ْن تحدد حاجاتَها و ❑ توقّعاتها في استشاري نظام الجود ِة ،والمبنية على أهدافها لتحقيق نظام إدارة الجودة. َ نظام إدارة الجودة. التقييم واالختيار اإلستشارى تشرك في عملي ِة ب أ َ ْن اإلدارة العُليا يَ ِج ُ ِ ِ 332 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ – 4.1.2دور اإلستشارى نظام إدارة الجودة في دور إستشارى عملية االختيار يَ ِج ُ ِ ب أن تأخذ في االعتبار َ دور اإلستشارى ما يلي: تحقيق ِ نظام إدارة الجودة (أنظر الملحق أ ) .وعموما يَتض ّم ُن ُ .1مساعدة المنظمة للتأكد من أن تصميم وتنفيذ نظام إدارة الجودة يناسب ثقافة المنظمة وخصائصها ،ومستوى التعليم وبيئة األعمال الخاصة؛ .2توضيح المفاهيم المتعلقة بإدارة الجودة بطريقة واضحة ومفهومة في جميع أنحاء المنظمة ،مع إعطاء اهتمام خاص للتفاهم واعتماد مبادئ إدارة الجودة ؛ .3التواصل مع جميع األفراد المعنيين ،على جميع المستويات ،ومشاركتهم بفاعلية فى تحقيق نظام إدارة الجودة ؛ .4تقديم المشورة والدعم للمنظمة في تحديد العمليات المناسبة والالزمة لنظام إدارة الجودة الخاص بها وتحديد األهمية النسبية والتسلسل والتفاعل لهذه العمليات؛ 333 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ – 4.1.2تابع دور اإلستشارى .5مساعدة المنظمة في تحديد االحتياجات من الوثائق األساسية لضمان فعالية التخطيط والتشغيل والرقابة على عملياتها ؛ .6تقييم الفعالية والكفاءة لعمليات نظام إدارة الجودة لتحفيز المنظمة للبحث عن فرص التحسين ؛ .7المساعدة في الترويج لنهج العملية و التحسين المستمر لنظام إدارة الجودة داخل المنظمة؛ .8المساعدة في تحديد االحتياجات التدريبية لتمكين المنظمة من الحفاظ على نظام إدارة الجودة ؛ .9مساعدة المنظمة ،كلما كان ممكنا ،لتحديد العالقة بين نظام إدارة الجودة لديها وغيرها من أي نظم اإلدارة ذات الصلة ( مثل البيئة أو الصحة والسالمة المهنية ) وتيسير التكامل بين هذه النظم. 334 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ – 4.1.3تقييم الجدارة لالستشاري عند تقييم الجدارة والمالئمة لالستشاري يجب األخذ في االعتبار التالي: .1السمات الشخصية (انظر ، ) 4.2.2 .2التعليم ذات الصلة ( انظر ، ) 4.2.3 .3المعارف والمهارات الالزمة لتحقيق األهداف الكلية للمنظمة لنظام إدارة الجودة )انظر ، )4.2.5 ، 4.2.4 ،4.2.3 .4الخبرة في العمل ) أنظر ، ) 4.2.6 .5السلوك األخالقي ( أنظر . ) 4.3 335 Certified Quality Consultant/ Lead Implementer Course – اختيار إستشارى نظام اجلودة٤ 336 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ - .4.2.2السمات الشخصية السمات الشخصية المساهمة في األداء الناجح الستشاري نظام إدارة الجودة عامـــــة ,يجب أن تكون: .1األخالقية :النزاهة ،الصدق ،اإلخالص ،الرصانة. .2المالحظة :أن يكون على دراية تامة وفاعلة بثقافة وقيم المنظمة ،وأنشطتها والطبيعة المحيطة بها ؛ .3اإلدراك :الوعي والقدرة على فهم الحاجة إلى التغيير والتحسين ؛ .4التنوع :قادرا على التكيف مع المواقف المختلفة وتقديم الحلول البديلة واإلبداعية ؛ .5التركيز :الثبات والتركيز على تحقيق األهداف ، 337 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ - .4.2.2تابع السمات الشخصية .6حاسم :قادرا على التوصل إلى االستنتاجات في الوقت المناسب على أساس التفكير المنطقي والتحليل ؛ .7االعتماد على الذات :قادرا على العمل بشكل مستقل في حين التفاعل مع اآلخرين بشكل فعال ؛ .8التواصل :القدرة على االستماع إلى والمواجهة بفعالية مع جميع مستويات المنظمة ، بثقة وحساسية لثقافتهم ؛ .9عملي :الواقعية والمرونة مع إدارة الوقت بشكل جيد ، .10مسئول :قادر على تحمل المسئولية عن أفعاله ؛ .11مسهل :قادر على مساعدة إدارة المؤسسة والعاملين بها خالل تحقيق نظام إدارة الجودة. 338 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ – 4.2.3التعليم والمعرفة والمهارات استشاري نظام إدارة الجودة يجب أن يمتلك تعليم مناسب ليعينهم على اكتساب المعارف والمهارات ذات الصلة للخدمات االستشارية التي يقدمونها .وهناك مثال نموذجي في الملحق ب. مالحظة: ❑ في هذا السياق ،المعرفة والمهارات تكون ذات عالقة الدراسية العامة ،مثل القدرة اللغوية والمعارف األساسية من العلوم اإلنسانية. 339 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ - 4.2.4المعارف والمهارات المحددة إلدارة الجودة ❑ - 4.2.4.1المعايير ذات الصلة يجب على استشاريين نظام إدارة الجودة أن يكون لديهم القدرة على فهم وتطبيق المعايير الدولية ذات الصلة التي يمكن أن تؤثر على المنظمة ،مثل : .1أيزو 9000نظام إدارة الجودة -األسس والمفردات ، .2أيزو 9001نظام إدارة الجودة -المتطلبات ، .3أيزو 9004نظام إدارة الجودة -مبادئ توجيهية لتحسين األداء , .4أيزو - 19011المبادئ التوجيهية للجودة ( و ,أو ) مراجعة نظم اإلدارة البيئية , .5المعايير الدولية األخرى ذات الصلة على النحو الوارد في الفهرس . 340 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ - 4.2.4.1تابع المعايير ذات الصلة مالحظة :بعض األمثلة الموضحة: .1مواصفات قطاع محدد ، .2مواصفات نظم مراقبة اإلدارة، .3مواصفات االعتماد، .4مواصفات تقييم المطابقة، .5مواصفات المنتجات، .6معايير إدارة االعتمادية ، .7المواصفات المتصلة بجوانب السالمة. يجب على استشاريين نظام إدارة الجودة معرفة الوثائق اإلرشادية لأليزو والتي تعتبر كجزء من األيزو 9000والحزم الداعمة "." 16 341 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ - 4.2.4.2أنظمة االعتماد والمنح /الشهادات الوطنية والدولية يجب على استشاريين نظام إدارة الجودة أن يكون لديهم المعرفة العامة باألتي : .1التقييس ،ونظم المنح و االعتماد على الصعيدين الوطني والدولي ،ومتطلبات المنح لكل نظام ) مثل ISO / IECدليل ، )62 .2العمليات واإلجراءات للحصول على الشهادات الوطنية للمنتجات واألنظمة واألشخاص. 342 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ .1 .2 .3 .4 .5 343 - 4.2.4.3المبادئ العامة إلدارة الجودة ,المنهجيات والتقنيات يجب على استشاريين نظام إدارة الجودة أن يكون لديهم المعرفة والقدرة على تطبيق مبادئ الجودة المناسبة ،والمنهجيات والتقنيات .القائمة التالية تشير إلى هذه المجاالت حيث أنها قد تكون مفيدة لخبرة وقدرة االستشاري: مبادئ إدارة الجودة؛ أدوات وتقنيات التحسين المستمر؛ األساليب اإلحصائية المناسبة ؛ منهجيات وتقنيات التدقيق؛ مبادئ اقتصاديات الجودة ؛ Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة ❑ .1 .2 .3 .4 .5 .6 .7 344 – 4.2.4.3تابع المبادئ العامة إلدارة الجودة ,المنهجيات والتقنيات تقنيات العمل الجماعي؛ منهج ( PDCAخطط ،نفذ ،دقق ،راجع) ؛ طرق نشر السياسة؛ تقنيات رسم خرائط العملية ؛ أساليب حل المشكالت ؛ تقنيات لرصد رضا العميل /الموظف ؛ تقنيات العصف الذهني. Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة 4.2.5المعارف والمهارات الخاصة بالمنظمة - 4.2.5.1المتطلبات القانونية والتنظيمية ❑ معرفة المتطلبات القانونية والتنظيمية ذات الصلة ألنشطة المنظمة ونطاق عمل االستشاري ضروري الستشاري نظام إدارة الجودة .ومع ذلك ،ال يجب أن يتوقع أن يكون استشاريين نظام إدارة الجودة لديهم خبرة في تطبيق هذه المعرفة قبل بداية المشروع. ❑ ويجب أن تشتمل المعرفة ذات الصلة في هذا المجال عادة على المتطلبات القانونية والتنظيمية للمنتج في المنظمة على النحو المطلوب في المواصفة ،على سبيل المثال .9001 345 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة 4.2.5المعارف والمهارات الخاصة بالمنظمة – 4.2.5.2المتطلبات التنظيمية والعملية والمنتج يجب على استشاريين نظام إدارة الجودة أن يكون لديهم معرفة معقولة عن منتجات المنظمة والعمليات وتوقعات العمالء قبل الشروع في الخدمات االستشارية الخاصة بهم ،ويجب فهم العوامل الرئيسية ذات الصلة لقطاع المنتج في المنظمة التي يعمل بها. ويجب أن يكونوا قادرين على تطبيق هذه المعرفة على النحو التالي: .1لتحديد الخصائص األساسية لعمليات المنظمة والمنتجات ذات الصلة ؛ .2لفهم تسلسل و تفاعل عمليات المنظمة وتأثيرها على تلبية متطلبات المنتج ؛ .3لفهم طبيعة قطاع العمل الذي تعمل فيه المنظمة؛ .4لفهم طبيعة المهام والهيكل والعالقات داخل المنظمة ؛ .5لفهم الربط االستراتيجي بين أهداف العمل واالحتياجات من الموارد ذات الكفاءة . 346 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة 4.2.5المعارف والمهارات الخاصة بالمنظمة - 4.2.5.3ممارسات اإلدارة يجب على استشاريين نظام إدارة الجودة أن يكون لديهم معرفة بممارسات اإلدارة ذات الصلة لفهم كيف يمكن لنظام إدارة الجودة أن يتكامل ويتفاعل مع نظام اإلدارة العامة للمنظمة ،بما في ذلك الموارد البشرية ،وكيف سيتم نشرها لتأمين غايات وأهداف المنظمة. في بعض الحاالت ،يمكن أن تكون األهداف العامة مطلوبة لتلبية احتياجات إضافية للمنظمة والتوقعات لنظام إدارة الجودة الخاص بها ،مثل تخطيط األعمال واإلستراتيجية ،وإدارة المخاطر ،وأدوات وتقنيات تحسين األعمال (انظر الملحق B ). 347 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة - 4.2.6الخبرة العملية يجب على إستشارى نظام إدارة الجودة أن يكون على خبرة عملية باإلدارة ذات الصلة في الجوانب اإلدارية والمهنية والتقنية للخدمات االستشارية التي ستقدم . ويمكن أن تتضمن هذه الخبرة العملية على الممارسات والحكم على والحل للمشكالت، والتواصل مع جميع األطراف المهتمة (انظر الملحق . ) B يمكن عمل مراجع بالخبرات العملية واإلنجازات المهمة على أن تكون متاحة للمنظمة. 348 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة - 4.2.6الخبرة العملية ويمكن أن تشتمل الخبرة العملية لإلستشارى على بعض من أو مزيج من اإلجراءات التالية : .1خبرات عمل عملية، .2الخبرة باإلدارة ، .3الخبرة بإدارة الجودة ، .4الخبرة بمراجعة نظام إدارة الجودة ، .5الخبرة في تطبيق نظام إدارة الجودة ،في واحدة أو أكثر من المجاالت التالية : .6تقديم الخدمات االستشارية، .7كممثل إلدارة نظام إدارة الجودة؛ .8أداء وظيفة ذات صلة إلدارة الجودة. 349 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة – 4.2.7المحافظة والتحسين للجدارة يجب على إستشارى نظام إدارة الجودة المحافظة على الجدارة وتحسينها من خالل وسائل مثل خبرات اإلعمال المضافة ،والتدقيق والتدريب والتعليم المستمر ، والدراسة الذاتية ،والتدريب ،وحضور االجتماعات المهنية والندوات والمؤتمرات واألنشطة األخرى ذات الصلة . ويجب أن يكون التطوير االحترافي المستمر متوقف على احتياجات المنظمة ،وتوفير خدمات استشارية لنظام إدارة الجودة والمعايير وأي متطلبات أخرى ذات صلة . مالحظة: يمكن تحقيق ذلك من خالل العضوية في والمشاركة في الجهات المساعدة على التطوير المستمر على المستوى الشخصي والكيانات المحترفة ،المنظمات، المعاهد و الجهات التنظيمية والرقابية. 350 Certified Quality Consultant/ Lead Implementer Course – ٤اختيار إستشارى نظام اجلودة - 4.3االعتبارات األخالقية يجب على المنظمة أن تأخذ في االعتبار القضايا األخالقية التالية: .1تجنب أو تنحى أي تضارب في المصالح يؤثر على العمل الذي يتعين عليه القيام بها ، .2الحفاظ على سرية المعلومات المقدمة من قبل أو تم الحصول عليها من المنظمة، .3المحافظة على االستقالل عن جهات التسجيل أو المنح أو االعتماد لنظام إدارة الجودة، .4الحفاظ على الحياد في اختيار المنظمة إلصدار الشهادات /التسجيل للهيئات، .5تقديم تقديرات واقعية لتكلفة الخدمات االستشارية المقدمة، .6عدم إنشاء أي اعتمادات غير ضرورية للخدمات ، .7ال يقدم خدمات ال يملك الجدارة الالزمة لتنفيذها. 351 Certified Quality Consultant/ Lead Implementer Course - ٥استخدام خدمات إستشارى نظام إدارة اجلودة - 5.1خدمات اإلستشارى يجوز للمنظمة االستفادة من الخدمات االستشارية للمساعدة في واحد أو أكثر من األنشطة التالية ضمن نظام تحقيق إدارة الجودة ( أنظر . ) A.2 .1تحديد األهداف والمتطلبات، .2التقييم المبدئي، .3التخطيط، .4التصميم والتطوير، .5التطبيق، .6التقييم .7التدريب المستمر والصيانة، .8التحسين. 352 Certified Quality Consultant/ Lead Implementer Course - ٥استخدام خدمات إستشارى نظام إدارة اجلودة - 5.2عقد الخدمات االستشارية وينبغي للمنظمات ضمان أن لديهم عقد مع استشاري نظام إدارة الجودة على أن يحدد بوضوح مجال العمل (بما في ذلك المخرجات) ،ومعالم واقعية وفعالة من حيث ( أنظر ، ) A.1عند الدخول في العقد يجب األخذ التكلفة بالنسبة للمنظمة في االعتبارات ( أنظر ) A.2على النحو التالي : .1وضع أهداف تعاقدية متفق عليها وتكون محددة وقابلة للقياس ،يمكن تحقيقها ، واقعية ومحددة زمنيا ؛ .2وضع خطة مفصلة للتعاقد واالتفاق على مخرجاتها ومراحلها ؛ .3إبالغ الخطة لجميع األطراف المعنية ، .4تحديد االحتياجات التدريبية للموظفين المعنيين حتى يتمكنوا من األداء والتقييم المستمر ،وصيانة وتحسين نظام إدارة الجودة؛ 353 Certified Quality Consultant/ Lead Implementer Course - ٥استخدام خدمات إستشارى نظام إدارة اجلودة – 5.2تابع عقد الخدمات االستشارية .5تنفيذ الخطة، .6رصد وتقييم فعالية الخطة وتنفيذ اإلجراءات العرضية ،كلما كان ذلك ممكنا ؛ .7ضمان استيفاء المراحل المتفق عليها أو إعادة تحديدها ، .8تحديد عملية العتماد عائدات التعاقد. وينبغي أن تعقد اجتماعات لتقييم التقدم المحرز في تنفيذ النظام وأداء اإلستشارى . وفي كل هذه االجتماعات ،ينبغي استعراض التقدم المحرز في مجال الخطة والميزانية المخصصة ألنشطة أعمال نظام إدارة الجودة .وينبغي تقديم تقارير مرحلية موثقة لإلدارة العليا . 354 Certified Quality Consultant/ Lead Implementer Course - ٥استخدام خدمات إستشارى نظام إدارة اجلودة - 5.3اعتبارات مفيدة لخدمات االستشاري في عملية استخدام خدمات إستشارى نظام إدارة الجودة ،يجب على المنظمة األخذ في االعتبار ما يلي : .1النظام الناتج يجب أال ينشأ عنه إدارة أو وثائق غير ضرورية ، .2نجاح نظام إدارة الجودة يعتمد بشكل رئيسي على مشاركة والتزام اإلدارة العليا وليس على اإلستشارى وحده ؛ .3يجب للمنظمة تعيين موظف (عادة ما يكون الشخص الذي سيقوم في نهاية المطاف بضمان المحافظة على نظام إدارة الجودة ) لتنسيق ورصد أنشطة االستشاري؛ .4مشاركة الموظفين على جميع المستويات ،من أجل دمج نظام إدارة الجودة ضمن عمليات المنظمة عموما؛ 355 Certified Quality Consultant/ Lead Implementer Course - ٥استخدام خدمات إستشارى نظام إدارة اجلودة – 5.3تابع اعتبارات مفيدة لخدمات االستشاري .5 .6 .7 .8 356 يجب تمكين االستشاري للتفاعل مع إدارة المؤسسة والعاملين على جميع المستويات من أجل تقييم العمليات في المنظمة؛ حتى لو أن استشارة نظام إدارة الجودة كانت استجابة لمتطلبات السوق أو التعاقدية ،ستبقى هناك فرصة الستخدام نظام إدارة الجودة كأداة إدارة فعالة. هناك إمكانية لنظام إدارة الجودة لتوفير أساس ألداء التحسين المستمر المنظمة؛ يجب أن تكون الخدمات االستشارية متوافقة مع ثقافة المنظمة ،وجدارات موظفيها ،والعمليات الحالية ( و /أو ) التوثيق . Certified Quality Consultant/ Lead Implementer Course تقييم مراجع اإلستشارىB.2❑ .1 .2 .3 .4 .5 .6 .7 .8 .9 357 يجب أن يستند التقييم على فحص األدلة بموضوعية ويمكن أن تشمل ما يلي: مراجع من المهام السابقة ، نشر الكتب والمقاالت التي تتناول إدارة الجودة ؛ مراجع عن األخالقيات المهنية ؛ وثائق نظام إدارة الجودة التي وضعها االستشاري ؛ المقابالت التي أجريت مع المنظمات التي استخدمت خدمات اإلستشارى ؛ الفترة الزمنية التي تعين من خاللها وأكتسب خبرة اإلستشارى ، الخبرة والمعرفة مع المنظمات المتشابهة ، الشهادات والمؤهالت المهنية لإلستشارى ، مقابلة مع اإلستشارى لتقييم الجدارة . Certified Quality Consultant/ Lead Implementer Course سؤال؟؟؟؟ Certified Quality Consultant/ Lead Implementer Course Eng. MOHAMMED YASSIN ABDALSALAM Aeronautical Engineer / QHSE/ISMS Professional Engineer & EFQM Excellence Specialist Email ID: Eng.M.Yassin@outlook.com Contact: +249-123171786 / +249-999999669 www.themega llery.com
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