Quality SystemsBackgroundQuestionReasons for a Quality SystemISO 9000 Series of StandardsToyota ManufacturingToyota AchievementsISO 14001How Toyota Does ItKaizens5 Standards in the SeriesISO 9000ISO 9001ISO 9002ISO 9003ISO 9004 - 1Other Quality SystemsQS 9000TE 9000AS 9000QuestionsImplementing a Quality Management SystemImplementation ContinuedSlide 24Slide 25Slide 26DocumentationDocumentation ContinuedElements of ISO/QS 9000ElementsSlide 31Slide 32Slide 33Slide 34Slide 35Slide 36Slide 37Slide 38Slide 39Results of Quality SystemsSuggestions for Writing DocumentationSlide 42For Every Task, IdentifyWriting Documentation Quality ManualSlide 45Outline Quality ManualOutline Quality ProcedureSlide 48Work / Job InstructionsInternal Audits Five ObjectivesInternal Audits How to do itInternal Audits How to do itRegistrationFour criteria’s for selecting a RegistrarSix Basic Steps of RegistrationThank you for your attentionQuality SystemsQuality SystemsInternational Standards for QualitybyRandy Gooden and David JurigaBackgroundBackgroundISO – International Organization for StandardizationFounded 1946 in Geneva, SwitzerlandPurpose – to promote international standards to facilitate the exchange of goods/services worldwideQuestionQuestionWhy do you think it is necessary to have ISO standards?Reasons for a Quality SystemReasons for a Quality SystemDemand for quality from the customerSnowball effect – requires subcontractors and suppliers to have built-in qualityHelps to maintain market shareISO 9000 Series of StandardsISO 9000 Series of StandardsDesigned to be generic and thus can be tailored to any organization’s needsSimply requires an organization to say what it is doing to ensure quality Documents what it says it is doingToyota ManufacturingToyota ManufacturingPerceived quality imageContinuous improvementEmployee participationWillingness to work in teams and share ideasContinue to changeToyota AchievementsToyota AchievementsCamry #1 selling car in U.S.TMMK’s assembly and powertrain ranked #1 in North America for productivity by Harbour ReportISO 14001 CertificationISO 14001ISO 14001Voluntary standard that deals with the company’s environmental management system. Verifies that each Toyota plant has a formal environmental policy as well as a management systemHow Toyota Does ItHow Toyota Does ItContinuous improvement conceptsTeam member participationUsing Kaizens (suggestion cards to improve process)Rely on Toyota Production SystemKaizensKaizensLast year had over 75,000 suggestions–7,000 team members–99.8% implementation of ideas5 Standards in the Series5 Standards in the SeriesISO 9000ISO 9001ISO 9002ISO 9003ISO 9004-1ISO 9000ISO 9000Quality Management & Quality Assurance Standard Guidelines for Selection and Use–Defines key terms–Provides guidelines for tailoring ISO 9001, ISO 9002, and ISO 9003 standards–Road map for entire seriesISO 9001ISO 9001Quality Systems – a model for quality assurance in design, development, production, installation, and servicing–Most comprehensive of standardsISO 9002ISO 9002Quality Systems – a model for quality assurance in production, installation, and servicing–Does not focus on design–Focuses on prevention, detection, and correction standardsISO 9003ISO 9003Quality Systems – a model for quality assurance in the final inspection and testing–Least comprehensive–Focuses on detection and control problemsISO 9004 - 1ISO 9004 - 1Quality Management and Quality System Elements – guidelines–Provides guidelines for developing and implementing a quality systemOther Quality SystemsOther Quality SystemsQS 9000 TE 9000AS 9000QS 9000QS 9000Characteristics–Developed by General Motors, Ford, Chrysler–Broader than ISO 9001–Adds automotive/heavy trucking requirements–Adds continuous improvement–Establishes customer requirements unique to Ford, General Motors, ChryslerTE 9000TE 9000Characteristics–Tooling and Equipment supplement–Interprets QS 9000 as it relates to tooling and equipmentAS 9000AS 9000Characteristics–Aerospace industry–Attempt to unify requirements of NASA, DoD, and FAA–Very similar to ISO 9000QuestionsQuestionsWhen implementing a quality management system, where do you first begin? What are some fundamental elements that are necessary for a successful implementation?Implementing a Quality Implementing a Quality Management SystemManagement System1. Senior Management Commitment •CEO support•Committing necessary resources2. Appointing Management Representative•Coordinates implementation•Contact person for everyoneImplementation ContinuedImplementation Continued3. Awareness•Everyone should understand the system•Training sessions 4. Appoint Implementation Team•Should be from all levels 5. Training•Should involve everyone (Teams, supervisors)Implementation ContinuedImplementation Continued6. Time Schedule•Schedule for implementation/registration•Should take less than 1.5 years7. Select Element Owners•Owners for each of system elements8. Review Present System•Should be first step in processImplementation ContinuedImplementation Continued9. Write Documents•Written quality policy and procedure manuals•Everyone should be involved10. Install New System•Integrate policies/procedures, work instructions11. Internal Audit•Conduct audit of system – working effectively?Implementation ContinuedImplementation Continued12. Management Review•To see if the system is achieving quality goals13. Registration•Submit application•Choose registrar•Registrar auditDocumentationDocumentation1. Policy •Defines what will be done and why•Should be clear and easy to understand2. Procedure•Describes methods that will be used to implement and perform stated policies•Who, When, WhereDocumentation ContinuedDocumentation Continued3. Work Instructions•Department, machine, task – spells out how to do job•Very detailed4. Records•Documents that policies, procedures, and work instructions have been followedElements of ISO/QS 9000Elements of ISO/QS 90001. Management Responsibility•Quality Policy – short/concise statement that defines organization’s objectives for quality•Responsibility & Authority – should be defined for all personnel affecting quality•Management Review – to remain effective (customer feedback, internal
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