Tool #31 Short Form

1. Tool #31 Short Form “ISO and QS 9000: Quality Launch Systems, Supplier Relationships Guiding Our Synchronous Future” • Topics 1. ISO/QS introduced and overviewed 2. ISO requirements, focus, foundations 3. General concerns, getting started 4. New product development relationships 5. Lean, six sigma, service relationships 6. Tool applications………..

2. ISO, international standards organization Focused on global marketplace, and at home QS, domestic customer/supplier, automotive How we do business, future, contract issues Consistent standards, level playing field ISO/QS Introduced And Overviewed 80% of ISO overlaps into QS standards • Automotive Industry Alliance Group (AIAG) • Key part of understanding, satisfying customers ISO is about Baldridge, broad framework, TQM • Baldridge is through Commerce Department • American “push” for quality

3. Baldridge basis, ISO, QS, relationships Leadership, how we do business Information and analysis Strategic quality planning Human resource development Management of process quality, operations Customer focus and satisfaction ISO/QS Introduced And Overviewed Standards do not measure quality……. • Organization identifies, defines, standards • Manages production per customer demands • Specifies, certifies quality, compliance • Organization certifies, contractually, customer

4. ISO/QS Introduced And Overviewed Registrar selected similar to any supplier • Registrar, body such as Underwriters Lab • Reviews documentation system, quality manual • Do pre-assessment, preparatory work internal • Must understand business, be customer focused • Objective, willing, to work your calendar Process design, documentation routinely updated • Describes what we do, who is responsible • Describes how all is done, records, practices Time to be registered generally 6-12 months ++ • Organization size, processes, preparedness • Startup costs, $15-25K, total easily twice this

5. Basic systems grew out of the 9000 framework 9000 was a five part series, basic guidebook 9001 was service, 9002 detailed production , and 9003 focused on inspection and testing 9001, 9002, 9003 was audited by third party ISO Requirements, Focus, Foundations Assessment, internal, external audit, certification • Internal is to comply, may not certify, correct • External certification, desired, third party More recent ISO developments are QS 9000 • 20 elements describe standard, areas to comply • Totality of elements provide quality system • Documented quality manual, increasingly online

6. 20 elements identified (cont.) Control of inspection, measuring, test equipment Inspection, test status Control, non-conforming product Corrective, preventive action Handle, storage, packaging, delivery preservation Control of quality records Internal quality audits Training Servicing Statistical techniques ISO Requirements, Focus, Foundations 20 elements identified • Management responsibility • Quality system • Contract review • Design control • Document, data control • Purchasing • Control of customer supplied product • Product identification, traceability • Process control • Inspection, testing

7. Quality Management Systems (QMS) International Standards Organization (ISO) Synchronous Tools, New Product Development Information Analysis, Communication Systems Enhanced Problem Solving, Decision Making Documentation Tools, Lean Project Team Professional Outcomes, Growth, Knowledge Technological Infrastructure Data Tools, Six Sigma Service, Tools Manufacturing, Non- Manufacturing Applied Research, Project Structure Internal, External, E-commerce Relationships Cultural Change And Continuous Improvement Industrial Technologists’ Toolkit For Technical Management ISO Requirements, Focus, Foundations

8. Four levels of quality documentation……. First level, quality manual, policies and objectives Second level is Process descriptions, flowcharts Third level, work instructions, step by step SOPs Fourth, lowest level, charting form and records ISO Requirements, Focus, Foundations Sector specific requirements, industry specific….. • Production part approval, verification: (PPAP or PVP) new product, supply chain, issues • Continuous improvement: all organization levels, functions defined, explained • Production capabilities: cross functions, issues organizationally, relationally, delivery ability

9. TS 16949 simplifies the previous 20 ISO elements to be more user friendly as five broad-based elements: Quality management system: relationships and sequences for all functions Management responsibility: demonstrable indications of top management commitment Resource management: assuring that resources are available to fulfill commitments Product realization: understanding quality objectives in product Measurement, analysis and improvement: data-based measures are used to improve ISO Requirements, Focus, Foundations

10. Environmental 14000 standard helps all to assess environmental performance in five areas: General requirements: requires establishment of a system compliant with 14000 Environmental policy: top management led environmental policy and commitment Planning: procedures put in place to assure appropriate environmental actions Implementation and operation: environmental management procedures, clearly documented Management review: management’s scheduled evaluations of systems, for improvement ISO Requirements, Focus, Foundations

11. General Concerns, Getting ISO Started • How we service,understand others, relationships • Managing organization, operating system • Paradigm shift in business accountability • Over 90 countries, workable, useful standards • Democratization, globalization • Contract language, how we communicate • Improved process linkages, efficiency • Teamwork, cooperation, flexibility, control • Improved ability of people to contribute • Decreased liability, increased reliability • Increased marketing abilities, advantages

12. General Concerns, Getting ISO Started • Involve all,broader purposes, not in a vacuum • Empower all, understand processes, use, improve • Determine how current systems do ISO/QS • If not doing something by standards--why? • Evaluate costs, implications of not implementing • Infrastructure, hardware, software, people • Persons who “champion” must handle change • Have broad expertise in processes, products • Evaluate, implement, standards, grow, together • Infrastructure must be satisfactorily in place • ISO increasingly becoming the base, umbrella…… • Managing organization, operating system • Lean, six sigma, general improvement……..

13. Good “mix” of products in cycle Some old, new launches, continuously improved New Product Development Relationships • Launch systems for quality • Class I, new platform: first time customer • Class II, derivatives: based on existing work • Class III, tailoring: custom tailored work • Basic principles in launch procedures, strategic • Cross functions, self managed, flexible, plan • Synchronous production data, documentation • Facilities to capacity, market share, competitive Product life cycle phases: Incubation, growth, maturity, saturation, decline……….

14. New Product Development Relationships • New product questions should include: • Are implementation costs offset by profits? • Product simplified? Improved? Safety impacted? • Should this be developed later, not now? • What is market, customer, long term strategy? • Compatibility with existing product, process? • Launch definitions, classifications, phases • Charter, vision, comparative advantage • Contract, management reviews • Customer led planning process (CLPP) • Program, leader, manager, sponsor defined • Design, development, prototyping phases • Managed introduction, 1st ship, stable

15. Lean, Six Sigma, Service Relationships • ISO/QS 9000, increasingly becoming base • As key management system, this has breadth and scope to embody various other quality tools • ISO/QS are umbrella for all quality systems • Based on systemic analysis, many other tools and quality methods can be pursued • If not used in this way, many duplicative systems and sub systems can result • Basis for improvement is ISO/QS, but the system must be designed for these purposes • Total quality system must facilitate kaizen, six sigma, lean—all based around ISO/QS

16. Lean, Six Sigma, Service Relationships • ISO/QS 9000, increasingly becoming base (cont.) • Each quality method requires data and documentation to do improvement • ISO/QS are umbrella for collecting data, documenting in ways to use for improvement • Cannot improve in absence of baseline data, well documented, designed for systematic applications • Many other quality methods will come and go, being brief buzz words…….. • ISO/QS systems have lasting value, mature base for total management, here to stay and enable many other quality methods

17. Lean, Six Sigma, Service Relationships

18. Lean, Six Sigma, Service Relationships • All organizations, units, provide service • Service internal, external, cannot exist without serving • All are customers, suppliers, upstream and downstream • All work areas must serve others well • Good service, tell one-two, bad, tell six-eight • All rely on one another--need each other • Manufactured product, discreet, measurable • Service not always physical, difficult to measure • General people functions, often ambiguous • Standards may not be readily established • Documentation required, synchronized, relates to QS/ISO

19. Lean, Six Sigma, Service Relationships • Service functions are people functions • May need to educate customer • Use SOP, instructions • Juggle, synchronize, multiple demands • Did we satisfy the customer? • Deliver service to customer, but does customer accept? • Will we get customer repeat business? • Good service, tell one-two, bad, tell six-eight • Did the product perform as stated? • How do we improve product via better service? • Did we correct or simply adjust, patch, band aid? • Communications, marketing, sales, quality, technical staff

20. Tool Applications……. • Toolkit applications are a key part of the courseware • Located in separate folder of the CD • Provides the template for team portfolio • Each application s part of team project, portfolio • Designed to be done by all, each team member • First read long form, then short review, applications • Total contribution in application form is compiled • Portfolio is gradually evolved around applications • Tool 31 applications are: • OPCP, introduced, continuously built, not just at start • FMEA also introduced, built gradually, evolved • Documentation System Design, Communication, DSDC • ISOQSAOPP, designed to help set a plan for team • LVAOCA, broad based launch system design • All follow through, do and post, independently

21. Tool Applications……. • Ongoing Process Control Plan (OPCP) • Continuously built over entire course • Gradually evolved based on team, project growth • Becomes key part of team project, portfolio • Key ISO technical document for improvement • Partial form shown below, gradually addressed……..

22. Tool Applications……. Failure Mode and Effects Analysis (FMEA) • Traditional FMEA, heavily oriented to manufacturing • Non-manufacturing failure-related issues apply as well • Ratings, analyses can lead to critical improvements • FMEA’s, built over entire course…….. • A “user-friendly” form may be something like……..

23. Tool Applications……. • ISO/QS Audit, Objective Prioritization Plan (ISOQSAOPP) • Preliminary plan, setup of assessments, work for team • Familiarize with ISO, auditing, all on same page, terms • Strategic planning, team level, change and improvement • Project 50% done when “problem” nailed down • “hot spots” focus, project objectives, gradually PPDPOA • Gantt from SDA form or template, for time, sequence • Partial form is shown……..

24. Tool Applications……. • Documentation System Design, Communication (DSDC) • Initial design, plan for how the team will work • Given that all work is about communications……. • Documentation is blackboard is critical • Must consider initially how this will happen, DSDC • DSDC provides opportunity to reflect on, discuss

25. Tool Applications……. • Launch Value Analysis, Open Agenda, Corrective Action • Design of a plan for how team will do launch • Agenda is open over course to do corrective actions • Value analysis of each part in product determined • Consider initially how this will happen, follow through • LVAOACA provides opportunity to reflect on, discuss • Partial format is shown below……..