Tool #25 Short Form “ISO and QS 9000 Maturing:

1. Tool #25 Short Form “ISO and QS 9000 Maturing: Foundations For Quality Services, Auditing And Lean Improvements” • Topics 1. ISO/QS introduced and overviewed 2. ISO requirements, focus, foundations 3. TS 16949 2002, environmental 14000 4. Auditing quality systems 5. General concerns, getting started 6. Kaizen, six sigma, lean relationships 7. Tool applications………

2. ISO, international standards organization Focused on global marketplace, and at home QS, domestic customer/supplier issues 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 customers • QS standard is mostly American ISO • Understanding, satisfying customers

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 ISO is about Baldridge, broad framework, TQM • Baldridge is through Commerce Department • American “push” for quality

4. Standards do not measure quality……. Organization identifies, defines, standards Manages production per customer demands Specifies, certifies quality, compliance Organization certifies, contractually, customer 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

5. Assessment, internal, external audit, certification Internal is to comply, may not certify, correct External certification, desired, third party 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

6. 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/QS Introduced And Overviewed

7. 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 More recent ISO developments are QS 9000 • 20 elements which describe the standard • Elements detail specific areas for compliance • Totality of elements provide quality system • Documented quality manual, increasingly online

8. 20 elements identified Management responsibility Quality system Contract review Design control Document and data control Purchasing Control of customer supplied product Product identification and traceability Process control Inspection and testing ISO Requirements, Focus, Foundations

9. 20 elements identified (cont.) Control of inspection, measuring, test equipment Inspection and test status Control of non-conforming product Corrective and preventive action Handling, storage, packaging, delivery preservation Control of quality records Internal quality audits Training Servicing Statistical techniques ISO Requirements, Focus, Foundations

10. Most complex, first tier is quality manual Overall guide to organization Policies and objectives Second level of complexity, procedural tier Process descriptions Flowcharts of the system ISO Requirements, Focus, Foundations Third level, work instructions, step by step • Standard operating procedures (SOPs) Fourth tier, lowest level, form and record • Detailed charts, records, systems’ elements

11. Sector specific requirements……..those requirements specific to your industry Production part approval, verification: PPAP or PVP each focus on new product development platforms in supply chain Continuous improvement: how this philosophy is addressed throughout the organization must be defined, explained Manufacturing capabilities: cross functionalities impacting manufacturing issues must be accounted for, addressed ISO Requirements, Focus, Foundations

12. Seamless, integrated quality management systems Based on ISO 9000 systems, traditions, three broad areas of concern for TS 16949 Product development: one of the keys, how to manage customers and suppliers in the chain Production processes: a second area focused on adding value in the stream of processes Support processes: documenting technical functions required to facilitate production These give an over-arching framework for TS 16949 systems, main processes for adding value TS 16949 2002, Environmental 14000

13. 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 TS 16949 2002, Environmental 14000

14. 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 TS 16949 2002, Environmental 14000

15. A key method for improvement is the audit…….. Audit is essentially a evaluative survey of system conducted for improvement Commonly a review of documentation derived from quality system Generally an independent review by someone outside the group or function being audited Seeking to identify and resolve non-conformities Usually done as external, internal or third party Types of audits include financial, system, product and process Auditing Quality Systems

16. A key method for improvement is the audit…….. Financial audit focuses on accounting issues Systemic audits look at broad policy, procedures Product review, quality characteristic compliance Process audits review total process, sub systems Auditing Quality Systems There are several reasons for doing the audit…….. • To assure compliance to standard • Monitor personnel improvement • Improve financial performance • Measure management effectiveness

17. Auditing Quality Systems …….reasons for doing the audit……..(cont.) • Improve internal operations • Helps all stay focused, centered • Roles, responsibilities are flushed out • Firms up the best practices • Provides internal benchmarking systems Audit connects to long and short term improvement • Strategic planning • Based in facts, objectivity • Non-judgemental, non-punitive

18. Auditing Quality Systems Several key steps for doing the audit • Initiation: someone, circumstance necessitates the audit, requests or requires • Planning: persons charged with doing audit put a plan together which facilitates process • Conduct of audit: organized and systematic acquisition and analysis of all information • Reporting: findings from the audit are documented and shared with appropriate groups • Closing: group being audited has the opportunity to correct any misunderstandings

19. General Concerns, Getting 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

20. General Concerns, Getting 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

21. Kaizen, Six Sigma, Lean 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

22. Kaizen, Six Sigma, Lean 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

23. 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 25 applications are: • OPCP, introduced, continuously built, not just at start • PASPC also introduced, built gradually, evolved • Documentation System Design, Communication, DSDC • ISOQSAOPP, designed to help set a plan for team • GOTA, vacabulary, glossary of terms • All follow through, do and post, independently

24. Tool Applications……. • P-Attribute Statistical Process Control (PASPC) • First logical step for SPC, based on attributes • Interactive with GSIC, integrated systems • Inspect, track attributes as key characteristics • Do key statistical analysis, charting around on this • Analysis tool for improvement, leads to variable data • Partial table below is start for collection, calculation

25. 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……..

26. Tool Applications……. • Glossary Of Terms, Applications (GOTA) • Continuously added to over entire course, by all • Helps enhance vocabulary, get all on same page • Terms are in toolkit, various parts, not just this course • A sampling of the form (partial) is shown……..

27. 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……..

28. 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