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1 QC Training Services, Inc American Blvd West, Suite 1500 Minneapolis, MN (952) qctraininginc.com

2 Understand the significance of Dimensional Metrology and associated standards and its impact on the manufacturing industry Be able to value stream map an organization s standards needs Understand the standards traceability and framework as it applies to global manufacturing supply chain Gain an understanding of what NIST, ASME, ISO and other organizations are doing to promote standards adoption and sustained use Get a head start for business strategies that minimize risks in the supplier-customer relationship

3 Standards A brief history and today Quality and Standards A synergy Framework A key business success tool Supply Chain Risk Mitigation Partnerships

4 Metrology the science that deals with measurement. Measure to determine the dimension, quantity, or capacity of something Method A procedure for completing a calibration or a measurement. Consistently followed, well documented methods are vital! Hopefully decisions come from data. Most data comes from a measurement. Improper measurements can mean wrong decisions.

5 What comes to your mind? Harmonization Artifacts Competition ERP (Enterprise Resource Planning) E(Quality) Risk Other?

6 What are standards? Generally speaking, an accepted method of defining what is right; a systematic means for achieving quality results. Common: Keyboards Paper size Electronics Legal: Driving on the right side of the road in the USA Electrical and construction codes

7 To assure Consistency From the beginning, everyone did their own thing when it came to quality standards Significant variability; country-to-country, industry-toindustry Nations and industries often took different approaches: Formal vs. informal methods and approaches Enforceable vs. suggested requirements Specific vs. generic Lack of agreement often led to trade barriers nations, industries, and special interest groups

8 Many of the bridges the Romans built 3000 years ago still stand today, with traffic driving over them The U.S. standardized the size and width of railroad tracks in the 1800 s allowing trains to travel anywhere in the country Best Practices were often driven crafts or guilds, and these evolved into standards still in use today.

9 International Organization for Standardization Largest developer of internationally accepted standards in the world. A world-wide federation of national standards bodies Over 160 countries participate in ISO which publishes over 22,000 standards of all types. Today, ISO standards provide a common language for use in defining preventive practices to enable verification through the auditing process. Management Systems Standards and their defined processes and feedback mechanisms formally imbed preventive activities.

10 From the Greek word isos, meaning equal. Often used with the International Organization of Standards reference. Indicates adherence to the world-wide ISO standards and quality management systems certified a 3 rd party registered organization, and thus equal in terms of required processes around the globe.

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16 In 1880 many industrialists and innovators felt that there was an opportunity to better serve the needs of engineers and managers of the machine shops providing them with a forum for discussion and collaboration. Engineering standards, the founders agreed, would ensure safety, reliability and operational efficiency in machine design and mechanical production. In 1887, ASME issued, Standard for the Diameter and Overall Dimensions of Pipe and Its Threaded Ends, which addressed mass production and standardization issues with the manufacturing of pipe.

17 The totality of features and characteristics of a product or service that bears on its ability to satisfy stated or implied needs. The processes which an organization creates value to meet the ongoing needs and expectations of their customers, employees, owners and community. Organization Creating value Meeting ongoing needs and expectations Customers, and other stakeholders

18 transcendent & product-based Customer products and services needs user-based Marketing Design value-based Distribution Manufacturing manufacturingbased Information flow Product flow

19 User-based consistent, long term, on target performance of products and services in the hands of the customer Manufacturing-based conformance to standards, making it right the first time Product-based specific and measurable attributes of the product; features

20 Quality Assurance (big Q, Quality ) All those planned and systematic activities implemented to provide adequate confidence, or assurance, that an entity will fulfill requirements for quality. Quality Control (little q, quality ) The operational techniques and activities that are used to fulfill requirements for quality.

21 Quality Assurance Risk assessment Root Cause CAPA Quality Management Systems Auditing Process Approach Document Control Process Capability FMEA Total Quality Management Customer Focus Quality Control Check Sheets Specs Drawings Inspection Measurement/lab GR&R Material Review Board Rework/Non-conformance Calibration SPC / Control Plan

22 To achieve quality results Need for universally accepted standards in international trade Enhance the free movement of goods and services Provide a set of standards applicable for contractual purposes between suppliers and their customers Provide for independent verification of the organization s quality management system leading to confidence on the part of customers and stakeholders Provide an agreed-upon structure for the growing international emphasis on quality

23 Taking Things For Granted Organization is Certified/Accredited so they have access to and use all relevant published guidelines and standards to deliver their product/service Quality Management Representative is the person in-charge/responsible The product specification sheets lists/references the standards The laboratory scope lists/references the standards

24 Standards Initiatives can run into COGNITIVE : What do you mean, exactly? MOTIVATIONAL : Do I really need to change? RESOURCES : We don t have the resources. POLITICAL : Our leaders aren t onboard.

25 IMAGINE IF YOU TOOK THE THINGS YOU ALREADY DO WELL AND MADE THEM BETTER?

26 A problem solving approach that tries to identify the specific cause of problems, not just addressing symptoms. Keep in mind: One problem may have more than one root cause One root cause may be contributing to many different problems When the root cause is not addressed, expect the problem to reoccur Prevention is the key!

27 Ask Why? five times Stop when the corrective actions do not change Stop when the answers become less important Stop when the root cause condition is isolated

28 Identify Problem Relevant standards are not being utilized Determine Team Members: Team Leader Metrologist Machinist Manufacturing Eng Quality Eng Design Eng Immediate Action!! Identify what published standards are available for use Identify resources that provide expertise on those standards

29 Part measured at incorrect temperature why? Worker not sure of correct environment why? Work Instruction did not identify that why? Engineering did not reference the requirement why? Not aware there was a published standard ROOT CAUSE!

30 Corrective Required use of temperature probe during measurement and noting that down along with the measured result Preventive Provided a TEMPERTUARE CONTROLLED ENVIRONMENT for inspection

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32 QA personnel Line inspectors, Metrologists Mfg personnel Machinists, Manufacturing Technicians

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34 Standards Service Providers ( e.g. IHS Markit, ANSI, ASME, ISO, ASTM, ASQ, NCSLI, SAE, FDA, etc.) are limited to offering PAID subscription services for the most part. Efforts to promote interoperability No specific guidance for within a particular industry (e.g. power tools, automotive, medical device, etc.) EPR modules related to QUALITY function are limited to Inspection Data management and CAPA. PLM modules are limited to equipment and software

35 Standards Adoption and Implementation is being considered more and more as Certification/Accreditation requirement ONLY! ISO has Standards Catalogued per ICS ( International Classification for Standards) or TC (Technical Committee)

36 I found your contact information on NIST's website - Question - Does your group have access to a detailed list of standards that are practiced/used the industry? Can you share that with me, if possible? Also could you share findings from the NIST Standards Services Curricula Development Cooperative Agreement Program? Answer - I am afraid that we have nothing like what you are looking for. Our work was done with local industry partners for a very specific purpose and did not include a detailed list of standards as you have described.

37 Everett Community College Center of Excellence for Aerospace and Advanced Manufacturing Measurement Science Curricula Development for Advanced Manufacturing Working with industry subject matter experts, Everett Community College will develop a course curriculum on measurement science that will be imbedded in their advanced manufacturing and aerospace programs that produce skilled workers for the U.S. aviation and aerospace industry. A short term course certificate will also be introduced. Module Standards One Framework Quality Fundamentals for Effective Implementation

38 University of Hartford College of Engineering, Technology, and Architecture, Mechanical Engineering Program Impact of Documentary and Measurement Standards and Standardization on Product Realization To develop case studies in product design to introduce documentary and measurement standards and standardization into several course modules in the mechanical engineering curriculum.

39 Texas A&M University Kingsville Frank H. Dotterweich College of Engineering, Department of Mechanical and Industrial Engineering Curriculum Innovation Through the Integration of Manufacturing Related Materials and Quality Control Standards for Different Level Engineering Students from Freshmen to Graduates To create a systematic framework for engineering students at multiple levels including course modules for undergraduate and graduate students and a graduate certificate program. Webinars and an annual e-conference will also be offered.

40 ISO 9000 First Quality Management Standard AS 9100 Aerospace Standard ISO Medical Devices Standard ISO/TS Automotive Standard ISO Laboratory Standard FDA Government Standard EPA Government Standard

41 ISO Environmental Standard ISO Energy Management ISO Information Security ISO Auditing Principles ISO Social Responsibility ISO Anti-bribery ISO Customer Satisfaction

42 Document Number Document Title ISO Medical devices - Quality management systems - Requirements for regulatory purposes ASME B46.1 Surface Texture (Surface Roughness, Waviness, and Lay ASME Y14.5M Dimensioning and Tolerancing ASQ Zero Acceptance Number Sampling Plans ISO Cleanrooms and associated controlled environments - classification of air cleanliness ISO Cleanrooms and associated controlled environments - Specification for testing and monitoring ASTM A967A967M-13 Standard Specification for Chemical Passivation Treatments for Stainless steel Parts ASTM AF86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants ISO Guidelines for auditing management systems ANSI/ASME B1.16M Gages and Gaging for Metric M Screw Threads ANSI/ASME B1.22M Gages and Gaging for MJ Series Metric Screw Threads ANSI/ASME B1.2 Gages and Gaging for Unified Inch Screw Threads ISO 9000 Basic concepts and language ISO 9001 Quality Management System Requirements ISO 9004 Managing for the sustained success of an organization - A quality management approach ISO 10360, 1 to 9 Acceptance and reverification tests for coordinate measuring machines (CMM) ASME B5.54 Methods for Performance Evaluation of Computer Numerically Controlled Machining Centers ASME B5.57 Methods for Performance Evaluation of Computer Numerically Controlled Lathes and Turning Centers ISO/TR Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003 ISO Measurement management systems -- Requirements for measurement processes and measuring equipment ISO Medical devices -- Application of risk management to medical devices ISO/TR Medical devices -- Guidance on the application of ISO ASTM F86-13 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants ASTM A380 Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems AIAG APQP, PPAP, MSA, SPC, FMEA GHTF Several documents FDA/CDRH Several documents

43 Automotive Industry Action Group (AIAG) Started in 1982 as a non-for-profit association based in Michigan created to develop recommendations and framework for improvement of quality in the North American automotive industry. The Big Three (Ford, General Motors, Chrysler) were known to accept and drive the creation and acceptance of these standards throughout the supply chain. Evolved into an organization with a global mission focusing on standards and training.

44 Use the tools that are available to you currently More in-depth tools investigation, training and practice Daily Standards awareness and implementation

45 BEST PRACTICES QUICKLY BECAME THE OPTIMUM METHOD FOR ASSURING RESULTS Documentation control Corrective action Product measurements Calibrated instruments Process controls

46 COMPETITIVE Industry Leaders Top Performers with similar operating characteristics IDEAL SPOT Aggressive innovators Top Performers regardless of industry FUNCTIONAL Top departments within the company Top Performers within the company INTERNAL

47 Standards Initiatives can go your way, if OWN IT : Ownership, responsibility and accountability PROGRAM DEVELOPMENT : Design one that is in SYNC with company s challenges, mission, and competencies PROCESS : Make it a collaborative effort. SUSTAINABILITY : A shift in culture along with a cohort of internal SMEs that are committed to ongoing work.

48 Plan Do Check Act Are we applying this quality tool effectively when it comes to Standards Initiatives?

49 Cost Failure Appraisal Prevention Time Spent

50 (10.0%) Prevention Internal and External Failures (65.0%) (25.0%) Appraisal Reduce Quality Costs Increasing Prevention Efforts!

51 Supply Chain -- Need, least amount of cost and least amount of time Risk Management -- Reduce/Mitigate taking time to learn as much up front Industry need -- Safety and Efficacy Uncertainty -- Smaller is better

52 Dimensional Measurement Uncertainty Standards

53 Production Part Approval Process Part of APQP to establish confidence in component suppliers and their processes. Elements: A process owner. Definition of process. Documentation of process. Process is monitored, analyzed and improved. Records are maintained.

54 Effective and Timely Quality Planning Take the time up-front Standards Use Account for effective knowledge transfer Documents have HIGH Reusability Decision Making Come to mutual agreements based on known processes Estimate risks A successful relationship has mechanisms in place to monitor and measure the agreements Fuels Innovation Simultaneous Lift

55 FOR THE SUPPLIER Excellence Customer satisfaction Perceived Quality Value Availability Performance Features Reliability Conformance

56 FOR THE CUSTOMER Durability Aesthetics Perceived Quality Value Availability Performance Features Reliability Conformance Satisfaction Lower Cost

57 Hard work is required! Module Standards One Framework Qality Fundamentals for Effective Implementation

58 TAKE A MINUTE FINAL Q&A SESSION Module Standards One Framework Quality Fundamentals for Effective Implementation

59 Phone Office : Ext. 206 Mobile : Title Chief Standards Officer

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