1. Short Form Tool 31 ITTTM 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. Short Form Tool 31 ITTTM ISO/QS Introduced And Overviewed 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 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. Short Form Tool 31 ITTTM 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. Short Form Tool 31 ITTTM 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 ISO/QS Introduced And Overviewed 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. Short Form Tool 31 ITTTM ISO Requirements, Focus, Foundations 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 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 Assessment, internal, external audit, certification Internal is to comply, may not certify, correct External certification, desired, third party

6. Short Form Tool 31 ITTTM 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. Short Form Tool 31 ITTTM Documentation Tools, Lean Data Tools, Six Sigma Service, Tools Manufacturing, Non- Manufacturing Synchronous Tools, New Product Development Project Team Cultural Change And Continuous Improvement Information Analysis, Communication Systems Applied Research, Project Structure Enhanced Problem Solving, Decision Making Internal, External, E- commerce Relationships Quality Management Systems (QMS) International Standards Organization (ISO) Professional Outcomes, Growth, Knowledge Technological Infrastructure Industrial Technologists’ Toolkit For Technical Management ISO Requirements, Focus, Foundations

8. Short Form Tool 31 ITTTM 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. Short Form Tool 31 ITTTM 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. Short Form Tool 31 ITTTM 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. Short Form Tool 31 ITTTM 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 General Concerns, Getting ISO Started

12. Short Form Tool 31 ITTTM 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 General Concerns, Getting ISO Started 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. Short Form Tool 31 ITTTM 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 New Product Development Relationships Good “mix” of products in cycle Some old, new launches, continuously improved Product life cycle phases: Incubation, growth, maturity, saturation, decline……….

14. Short Form Tool 31 ITTTM 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 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?

15. Short Form Tool 31 ITTTM 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 Lean, Six Sigma, Service Relationships

16. Short Form Tool 31 ITTTM 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 Lean, Six Sigma, Service Relationships

17. Short Form Tool 31 ITTTM Lean, Six Sigma, Service Relationships

18. Short Form Tool 31 ITTTM 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 Lean, Six Sigma, Service Relationships

19. Short Form Tool 31 ITTTM 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 Lean, Six Sigma, Service Relationships

20. Short Form Tool 31 ITTTM Tool 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 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

21. Short Form Tool 31 ITTTM Tool Applications……. Part Name:Process Location:OPCP Form Of Supplier:Revision: Other Pertinent General Information: Process Description. Provide a written description of process in text format and a process flow chart depicting the same: Tools For Manufacture/Production. Describe equipment required to produce the product, consistent with the flow chart above: Process Parameters. Describe unique elements involved in processing the product which require additional explanation: Product Characteristics. Describe all characteristics of the product, primarily as attributes or variables which are critical: Class. Describe any codes or other unique identifiers per the specific industry or organization to help further distinguish the product: Product/Process Specification. Provide specific measurable definitions for each product characteristic identified above: Evaluation Method. Describe how specifications of characteristics are evaluated, what the measurement systems are: Sample Size, Frequency of Inspection. Describe the sample, how it is derived, including devices used to inspect in a step by step manner: Analysis Methods. Describe the methods and systems used to analyze the sampled data, such as statistical, experimental, and so on: Reaction Program. Describe steps to be taken when product or process is found to be functioning inappropriately: 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. Short Form Tool 31 ITTTM 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…….. Part Name/Service:Process/Service Location:FMEA Form Of Supplier:Product, Process or Design FMEA, and Why?Revision: Other Pertinent General Information, Particularly Oriented To Other Supportive Documentation And Data Attached: Process Description. Provide a general written text description of the process, and detailed flow chart of same: Product Description. Provide a general written text description of the product, and detailed step by step functioning of same: Potential Failure Mode. Describe the general failure which has occurred or may occur, giving appropriate details to help all improve on same: Key Characteristics. Describe key characteristics in product or process to be addressed to decrease likelihood of failure (rank order according to level of criticality, 1 being low and 10 being high): Characteristic Ranking 1-10: Potential Effects of Failure. Describe the general failure effects, particularly focused on implications for damage to surrounding environment (provide a rating of severity where 1 is low and 10 is high): Severity Rating 1-10: Potential Causes of Failure. Describe general failure cause, particularly focused on process or product design which are implicated, with sufficient details to enable improvement. Also provide a occurrence of failure rating (1 = low and 10 = high): Occurrence Failure 1-10: Current Detection Control. Describe systems or methods of detecting failure which can lead to control of failure, including methods for same. Also provide a rating from 1-10 to indicate likelihood of occurrence ( where 1 = high and 10 = low): Detection Control 1-10: Risk Priority Number (RPN). Provide a RPN based on multiplying severity X occurrence X detection.RPN Calculated: Recommended Action. Describe appropriate actions to be taken in process or product to alleviate failure, including area to take action and when (if multiple actions are needed, add rows): Responsible Area:When: Tool Applications…….

23. Short Form Tool 31 ITTTM 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…….. Organization Under Discussion:Current Operation:Location: General Description Of Operations/Production Functions/Systems Being Assessed As An Internal Audit: ISO/QS Element (TS 16949 2002—Others)Technical Function DescriptionAudit Preliminary InformationActions, Recommendations For Change (list each element separately for analysis/audit)(describe technical function being audited)(How does function compare to standard)(explain anticipated necessary actions, changes) Planning Statement Or Issue, Particularly As Associated With The Service Environment:Criticality Level: HML (H = 5; M = 3; L = 1) Fac = Facility issues; Cost = Cost issues; Time = Time issues; Pers = Personnel issues Objectives Prioritized, 5 Being Highest:Criticality HML FacCostTimePers 5, 4, 3, 2, 1 Problem Background:Resources? (Budget/Other Concerns)? Task/Deliverable/Objective:Who Will Do?How Measured?

24. Short Form Tool 31 ITTTM 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 ResearcherCommunication Method, Internal And External Customers: Toolkit/Blackboard Design Element, How Does It Work? How To Improve Professional Relationships, Communication? 1. Identify How The Systems’ Design You Are Advocating Can Assist IN Tieing Together PPDPOA, TPMSS, FACR, TRIRPA And Other Elements Of Team Problem Solving And Improvement: Explain ISO/QS Characteristics And Other Necessary Entities To Be Possessed By Documentation And Communication Systems, Categorically, Particularly Focused On Service Functions: Using The Template At The End Of The Applications Complete A Cause And Effect Diagram Indicating Issues And Opportunities For Systemic Documentation Relationships/Improvements, Particularly Focused On Service Functions: Identify And Explain Why Your Organization Is Well Suited To The Documentation And Communication System Being Developed, Particularly Focused On Service Functions:

25. Short Form Tool 31 ITTTM 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…….. Identified Nature Of Product To Be Supplied, Specific Details: Explain ISO/QS Characteristics (And Other Necessary Definitions) To Be Possessed By Launch Systems, Categorically: Explain Potential Opportunities For improvement In Supplier Chain Systems: Identify And Explain Why Your Organization Is Well Suited To Supply The Product Being Contracted: Develop A Flow Chart, With Explanation, Of The Overall Launch System: Current Product Cost:Target Production Cost:Current Sales Cost:Target Sales Cost:Other Costs or Functions: Part/ComponentFunction/PurposeValue Rating (VR) (1-10) Part Cost (PC) % Of Cost Total (TC%) Value Added Weight (VAW) Alternatives to Add Value Column Totals: Value Analysis Summary Statement: Open Agenda Topic/Issue/ActivityWhen Started/Done/By Who?Follow Up Details/Actions?