Awareness session on iatf 16949 2016 standardAmit Mishra
This document provides an agenda for training on IATF 16949. The training will cover an overview of IATF 16949 and how it relates to ISO 9001:2015. It will discuss the key changes between ISO/TS 16949:2009 and IATF 16949, including 14 specific changes. It will also cover the IATF structure, goals of IATF 16949, high level structure, notable changes in terminology, and clause-wise additions and explanations. The training will identify 17 documented processes required by IATF 16949 and certain frequency requirements.
Design for maintainability (DFMaint) aims to make products easy and cost-effective to maintain and repair. It reduces downtime, maintenance costs, and inventory needs. DFMaint considers maintainability early in the design process through a closed-loop approach involving data analysis, maintenance issue prioritization, design incorporation, testing and improvement. Key features include easy component access and replacement using standard tools. Metrics like repair frequency and costs are used to measure DFMaint success. An example overhauled locomotive designs to meet emissions standards while improving maintainability.
This document summarizes sections 1, 2, and 3 of the AS9100C quality management system standard. Section 1 outlines the scope and applicability of the standard. Section 2 discusses exclusions from the standard's requirements. Section 3 defines key terms used in the standard, including special requirements, critical items, and key characteristics, and explains their interrelationships.
3.I Qualification of premises and air conditioning (HVAC) systems.docxSamehMostafa33
The document discusses the qualification of premises and HVAC systems in pharmaceutical facilities. It addresses the objectives of qualification, which are to systematically and documentedly prove that premises and systems are suitable for their intended use and compliant with GMP requirements. Qualification helps ensure products are manufactured safely and reproducibly. The document outlines regulatory requirements and discusses the different stages of qualification - design, installation, operational, and performance qualification. It emphasizes the importance of thorough design qualification to identify issues early on and control costs.
ADVANCED PRODUCT QUALITY PLANNING AND CONTROL PLAN Reference ManualLuisa Polanco
The document provides guidelines for Advanced Product Quality Planning (APQP) and Control Plans developed jointly by Chrysler, Ford, and General Motors. It aims to standardize quality planning processes for suppliers. The manual outlines the key phases of quality planning including planning and defining the program, product and process design, validation, feedback and assessment. It provides checklists and guidelines to ensure customer requirements are met through simultaneous engineering and defect prevention.
IRJET- Productivity Improvement Kaizen of XC-60 HousingIRJET Journal
1) The document discusses improvements made to the productivity and quality of an aluminum die casting process for an XC-60 housing component through the application of Kaizen methodology.
2) Major defects identified through analysis of 100 samples included dents, blackmarks, failures of M4 gauge tests and slider fits. Changes to dies, fixtures, and processes reduced rejection rates for these defects.
3) Additional changes such as a pneumatic slider cutting fixture and optimized sanding procedures increased productivity from 87 to 128 units and reduced cycle times from 71 to 48 minutes by addressing bottlenecks in machining and trimming operations.
This document provides an overview and requirements for conducting First Article Inspections according to AS9102 Rev B. It discusses:
- The purpose of an FAI is to validate that production processes can produce parts meeting requirements. An FAI must be performed on the first production run of a new part or when processes change.
- Key aspects of an FAI include verifying all design characteristics, material and special process certifications, manufacturing process capability, and resolving any non-conformances. FAI results are documented in a First Article Inspection Report.
- An FAI applies to assemblies, sub-assemblies, and parts but not prototypes, one-off parts, catalog items, or common hardware. An FAI must
This document provides guidelines for organizations to follow when implementing and maintaining a First Article Inspection process as required by the IRIS certification standard. It defines key terms related to FAIs and outlines the responsibilities, processes, and documentation involved in planning, executing, and documenting the results of FAIs for new or upgraded products. The guidelines recommend organizations define procedures, responsibilities, criteria for applicability, and processes for arranging, executing, and addressing nonconformities discovered during FAIs to help ensure proper validation of production methods and compliance with requirements.
Awareness session on iatf 16949 2016 standardAmit Mishra
This document provides an agenda for training on IATF 16949. The training will cover an overview of IATF 16949 and how it relates to ISO 9001:2015. It will discuss the key changes between ISO/TS 16949:2009 and IATF 16949, including 14 specific changes. It will also cover the IATF structure, goals of IATF 16949, high level structure, notable changes in terminology, and clause-wise additions and explanations. The training will identify 17 documented processes required by IATF 16949 and certain frequency requirements.
Design for maintainability (DFMaint) aims to make products easy and cost-effective to maintain and repair. It reduces downtime, maintenance costs, and inventory needs. DFMaint considers maintainability early in the design process through a closed-loop approach involving data analysis, maintenance issue prioritization, design incorporation, testing and improvement. Key features include easy component access and replacement using standard tools. Metrics like repair frequency and costs are used to measure DFMaint success. An example overhauled locomotive designs to meet emissions standards while improving maintainability.
This document summarizes sections 1, 2, and 3 of the AS9100C quality management system standard. Section 1 outlines the scope and applicability of the standard. Section 2 discusses exclusions from the standard's requirements. Section 3 defines key terms used in the standard, including special requirements, critical items, and key characteristics, and explains their interrelationships.
3.I Qualification of premises and air conditioning (HVAC) systems.docxSamehMostafa33
The document discusses the qualification of premises and HVAC systems in pharmaceutical facilities. It addresses the objectives of qualification, which are to systematically and documentedly prove that premises and systems are suitable for their intended use and compliant with GMP requirements. Qualification helps ensure products are manufactured safely and reproducibly. The document outlines regulatory requirements and discusses the different stages of qualification - design, installation, operational, and performance qualification. It emphasizes the importance of thorough design qualification to identify issues early on and control costs.
ADVANCED PRODUCT QUALITY PLANNING AND CONTROL PLAN Reference ManualLuisa Polanco
The document provides guidelines for Advanced Product Quality Planning (APQP) and Control Plans developed jointly by Chrysler, Ford, and General Motors. It aims to standardize quality planning processes for suppliers. The manual outlines the key phases of quality planning including planning and defining the program, product and process design, validation, feedback and assessment. It provides checklists and guidelines to ensure customer requirements are met through simultaneous engineering and defect prevention.
IRJET- Productivity Improvement Kaizen of XC-60 HousingIRJET Journal
1) The document discusses improvements made to the productivity and quality of an aluminum die casting process for an XC-60 housing component through the application of Kaizen methodology.
2) Major defects identified through analysis of 100 samples included dents, blackmarks, failures of M4 gauge tests and slider fits. Changes to dies, fixtures, and processes reduced rejection rates for these defects.
3) Additional changes such as a pneumatic slider cutting fixture and optimized sanding procedures increased productivity from 87 to 128 units and reduced cycle times from 71 to 48 minutes by addressing bottlenecks in machining and trimming operations.
This document provides an overview and requirements for conducting First Article Inspections according to AS9102 Rev B. It discusses:
- The purpose of an FAI is to validate that production processes can produce parts meeting requirements. An FAI must be performed on the first production run of a new part or when processes change.
- Key aspects of an FAI include verifying all design characteristics, material and special process certifications, manufacturing process capability, and resolving any non-conformances. FAI results are documented in a First Article Inspection Report.
- An FAI applies to assemblies, sub-assemblies, and parts but not prototypes, one-off parts, catalog items, or common hardware. An FAI must
This document provides guidelines for organizations to follow when implementing and maintaining a First Article Inspection process as required by the IRIS certification standard. It defines key terms related to FAIs and outlines the responsibilities, processes, and documentation involved in planning, executing, and documenting the results of FAIs for new or upgraded products. The guidelines recommend organizations define procedures, responsibilities, criteria for applicability, and processes for arranging, executing, and addressing nonconformities discovered during FAIs to help ensure proper validation of production methods and compliance with requirements.
AS 9100C is an internationally recognized quality management system standard for the aviation, space, and defense industries. It incorporates the requirements of ISO 9001:2008 and adds additional industry-specific requirements. Key differences from ISO 9001 include requirements for risk management, special requirements, critical items, and increased emphasis on process control and traceability. Compliance with AS 9100C can improve quality, reduce costs, and differentiate companies from competitors in the aviation/aerospace industry.
An Introduction to Technical Cleanliness InspectionOlympus IMS
Technical cleanliness is an increasingly important process that affects major industries including aerospace, automotive, heavy equipment, and electrical engineering. Even the smallest particle contamination occurring during the manufacturing process can have lasting effects on product lifespan, reliability, and function.
This guide will also answer the following questions:
- What are the basics of technical cleanliness?
- How does technical cleanliness affect a product's reliability?
- In what application areas is technical cleanliness most important?
- What is the technical cleanliness inspection process?
- What kind of system is required to conduct technical cleanliness inspection?
For more information, visit: https://www.olympus-ims.com/en/microscope/cix100/
Optimizing Product Realization Costs Across the Value ChainCognizant
The document discusses strategies for optimizing costs across the product realization lifecycle. It identifies factors that can lead to cost overruns at each stage, from requirements to post-market, and recommends best practices. These include adopting integrated requirements management, knowledge-based engineering to reduce design iterations, optimization tools for manufacturing planning, and an integrated quality management system to address issues early. Implementing cost analytics can provide visibility across the organization to analyze and communicate ROI of optimization efforts.
Project management assignment evaluating the process in car manufacturingTotal Assignment Help
In this Project Management Assignment it is identified that Lean manufacturing process is utilized in the engine design and manufacturing in car industry for increasing the work efficiency and reducing the negative impact on the environment.
The regulatory focus of facilities that manufacture therapeutic products for humans is centered on a product-process-facility attribute driven methodology where risk identification and mitigation are critical quality attributes. Under this methodology, the manufacturing process and the product requirements, not the building, become not only the main drivers for CD efforts, but must also provide a clear approach and understanding of how the building elements must be defined and operated in order to ensure patient safety in the manufacture of the product. This requires an enterprise approach to facility design focusing on:
Process-driven understanding around operational analysis
Regulatory philosophy
Business drivers
Management needs
Integrated hand-off to detailed design activities
1. The document provides an overview of core tool training for APQP, FMEA, and PPAP processes. It discusses the history and benefits of failure mode and effects analysis (FMEA) and outlines the FMEA process.
2. Key aspects of FMEA covered include potential failure modes, effects analysis, risk priority numbers, design controls, process controls, continuous improvement, and management responsibility.
3. Examples of potential failure modes, effects, and process steps from a sample PFMEA are also provided to demonstrate how to complete an FMEA.
This document provides guidance for certification body auditors on conducting audits according to ISO/TS 16949. It outlines 31 required audit activities in a process flow chart and table. The table defines the knowledge and skills required of auditors for each activity, referencing source documents. It aims to ensure auditors are competent in areas that have been identified through IATF oversight of audits, such as having a process approach and knowledge of customer requirements and ISO/TS 16949.
Parag raj behura 190617006 designing effective urs and dqParag Behura
The document discusses user requirement specifications (URS) and design qualification (DQ) for pharmaceutical manufacturing processes. It provides guidelines for developing an effective URS, including ensuring requirements are clear, concise, testable, and understood by all parties. The URS should clarify technical and quality needs. DQ verifies the design meets functional specifications and can successfully perform its intended use in compliance with regulations. The steps of DQ include selecting equipment and verifying design achieves user specifications and good manufacturing practices.
In diesem Vortrag auf dem Vortrag auf dem YAVEON Kundentag 2014 stellt Rainer Elvermann, Geschäftsführer cbprocess GmbH & Co. KG, das "context based process management" vor. Anhand konkreter Beispiele aus komplexen Branchen (Luft- & Raumfahrt, Automotive, Forschungsschiffe, Bauwesen) spricht Herr Elvermann über aktuelle Erfahrungen mit Business Process Management im allgemeinen und dem verwendeten Tool, process4.biz, im besonderen.
This document has been prepared to provide a summary on the changes between ISO 13485:2003 and ISO 13485:2016. The documents contains the following:
a. Benefits of the new version of the standard.
b. Few key definitions
c. Mapping between the versions as per ISO.org.
d. Summary of key changes between the versions of the standard
The document discusses using operational and functional analysis techniques from systems engineering to effectively capture requirements prior to project bidding. It begins with an introduction on the importance of fully capturing requirements upfront.
It then provides an overview of the requirements capture process using these techniques, which involves analyzing operational scenarios, stakeholders, and functional requirements. A case study on developing a mission computer for an aircraft is presented to illustrate applying these techniques. Key activities in operational analysis like identifying scenarios, stakeholders, and requirements flow are described.
009 what are the systems validation protocol methods at atl 05 28-2015atlmarketing
If your product must meet the requirements of FDA cGMP, 21 CFR 210, 211, 820, ISO-9000, ISO-13485, or MDD/93/42/EEC (for the CE Mark), there are three very critical elements you must have to be in regulatory compliance. First, you must have a sound and strong Quality Management System (QMS). This is an expression of WHAT you do (your quality policies and structure). Second, you must have reliable Standard Operating Procedures (SOP’s). These are expressions of HOW YOU DO THINGS.
Missing in the above two items is an expression of HOW WELL YOU DO WHAT YOU DO? This is where you must establish your “Systems Validation Protocol” (SVP). Your SVP is an expression of how well your system is working (for example, this can be expressed in overall product conformance percentage or in defects per million for your various products). The SVP is a living and continuous document based on your quality records. The ATL White Paper “What Are The Systems Validation Protocol Methods At ATL?” is our attempt to share with you a sound approach to Systems Validation and the various protocols that you can use.
This document provides information on the Engine Management System course offered at the Ministry of Education, Malaysia Vocational College. The 3-credit, semester 2 course aims to teach students to detect defects in engine management systems and assess problems to assign required repairs. Key topics covered include setting up scan tools, performing fuel pressure tests, using scan tools for fuel system diagnosis, analyzing oscilloscope patterns, and checking engine management system components. The course is comprised of 5 hours per week of face-to-face instruction over various topics, with assessment based on competency in tasks like operating diagnostic tools according to specifications.
The document provides information on Advanced Product Quality Planning (APQP) and its 5 phases: 1) Plan and Define Program, 2) Product Design and Development, 3) Process Design and Development, 4) Product and Process Validation, and 5) Feedback, Assessment and Corrective Action. It describes the objectives and key activities that should be completed in each phase of the APQP process.
This document provides a summary of the industrial training completed by Ajay Kumar at Lumax Mannoh Allied Technologies from June 15th to July 15th, 2016. It includes an introduction to APQP (Advanced Product Quality Planning), the major elements and phases of APQP, examples of process outputs like an FFMEA (Failure Mode and Effects Analysis). It also summarizes key failure modes, effects, potential causes and controls as part of the FFMEA process for improving product quality.
This document summarizes the process control and quality assurance methods used by Filter Expert Co., Ltd. It discusses how they use statistical process control (SPC) and control plans to monitor key metrics like thread quality and gasket integrity. Thread quality and gasket quality are monitored through inspection checks, with data collected and presented in monthly reports. Notable numbers like failures per million produced are tracked to identify issues and drive down defects, such as a problem with edge sealing that was addressed through machine maintenance.
This document outlines the key phases of the electronics product design process: concept development, requirements gathering, specifications development, design and prototyping, testing, manufacturing, and disposal. It emphasizes that product development follows a systematic engineering approach involving thorough documentation at each phase, from initially defining customer needs to ensuring reliable, high-quality products that meet specifications. The goal is to deliver the best product at the lowest cost and time to market.
Join Joe Mansour, UL DQS Inc. Lead Auditor and ISO 9001:2015 Program Manager, as he gives an in-depth overview of the changes coming to ISO 9001:2015. Part 4 of the 5 part webinar concentrates on the review of questions received during part 3 and the review of sections 8, 9, and 10 of the standard.
ISO 9001-2015 IATF 16949-2016 Numeric Structure Ramona Kellner
ISO 9001:2015 IATF 16949; 2016
Numeric Structure Changes
Dear quality professionals, just in case you have not already done so for yourself, I am sharing a helpful sheet listing the new numeric structure for the emerging automotive standard. As I’m sure you are aware, there are differences between TS structure and IATF, something to keep in mind when auditing and addressing transition and corrective action. Applying IATF changes now, will confidently make it easier for all to save time effort and resources during this transition as well as current corrective actions as opposed to restarting in a year from now. Enjoy!
Este documento describe el método 8D para la resolución de problemas. El método 8D es un proceso en 8 etapas que incluye formar un equipo, definir el problema, implementar acciones provisionales, identificar la causa raíz, determinar acciones correctivas permanentes, verificar las acciones correctivas, prevenir problemas similares y reconocer el esfuerzo del equipo. El documento explica cada una de las 8 etapas del método y los beneficios de usar este enfoque sistemático para mejorar productos, procesos y prevenir futuros problemas
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AS 9100C is an internationally recognized quality management system standard for the aviation, space, and defense industries. It incorporates the requirements of ISO 9001:2008 and adds additional industry-specific requirements. Key differences from ISO 9001 include requirements for risk management, special requirements, critical items, and increased emphasis on process control and traceability. Compliance with AS 9100C can improve quality, reduce costs, and differentiate companies from competitors in the aviation/aerospace industry.
An Introduction to Technical Cleanliness InspectionOlympus IMS
Technical cleanliness is an increasingly important process that affects major industries including aerospace, automotive, heavy equipment, and electrical engineering. Even the smallest particle contamination occurring during the manufacturing process can have lasting effects on product lifespan, reliability, and function.
This guide will also answer the following questions:
- What are the basics of technical cleanliness?
- How does technical cleanliness affect a product's reliability?
- In what application areas is technical cleanliness most important?
- What is the technical cleanliness inspection process?
- What kind of system is required to conduct technical cleanliness inspection?
For more information, visit: https://www.olympus-ims.com/en/microscope/cix100/
Optimizing Product Realization Costs Across the Value ChainCognizant
The document discusses strategies for optimizing costs across the product realization lifecycle. It identifies factors that can lead to cost overruns at each stage, from requirements to post-market, and recommends best practices. These include adopting integrated requirements management, knowledge-based engineering to reduce design iterations, optimization tools for manufacturing planning, and an integrated quality management system to address issues early. Implementing cost analytics can provide visibility across the organization to analyze and communicate ROI of optimization efforts.
Project management assignment evaluating the process in car manufacturingTotal Assignment Help
In this Project Management Assignment it is identified that Lean manufacturing process is utilized in the engine design and manufacturing in car industry for increasing the work efficiency and reducing the negative impact on the environment.
The regulatory focus of facilities that manufacture therapeutic products for humans is centered on a product-process-facility attribute driven methodology where risk identification and mitigation are critical quality attributes. Under this methodology, the manufacturing process and the product requirements, not the building, become not only the main drivers for CD efforts, but must also provide a clear approach and understanding of how the building elements must be defined and operated in order to ensure patient safety in the manufacture of the product. This requires an enterprise approach to facility design focusing on:
Process-driven understanding around operational analysis
Regulatory philosophy
Business drivers
Management needs
Integrated hand-off to detailed design activities
1. The document provides an overview of core tool training for APQP, FMEA, and PPAP processes. It discusses the history and benefits of failure mode and effects analysis (FMEA) and outlines the FMEA process.
2. Key aspects of FMEA covered include potential failure modes, effects analysis, risk priority numbers, design controls, process controls, continuous improvement, and management responsibility.
3. Examples of potential failure modes, effects, and process steps from a sample PFMEA are also provided to demonstrate how to complete an FMEA.
This document provides guidance for certification body auditors on conducting audits according to ISO/TS 16949. It outlines 31 required audit activities in a process flow chart and table. The table defines the knowledge and skills required of auditors for each activity, referencing source documents. It aims to ensure auditors are competent in areas that have been identified through IATF oversight of audits, such as having a process approach and knowledge of customer requirements and ISO/TS 16949.
Parag raj behura 190617006 designing effective urs and dqParag Behura
The document discusses user requirement specifications (URS) and design qualification (DQ) for pharmaceutical manufacturing processes. It provides guidelines for developing an effective URS, including ensuring requirements are clear, concise, testable, and understood by all parties. The URS should clarify technical and quality needs. DQ verifies the design meets functional specifications and can successfully perform its intended use in compliance with regulations. The steps of DQ include selecting equipment and verifying design achieves user specifications and good manufacturing practices.
In diesem Vortrag auf dem Vortrag auf dem YAVEON Kundentag 2014 stellt Rainer Elvermann, Geschäftsführer cbprocess GmbH & Co. KG, das "context based process management" vor. Anhand konkreter Beispiele aus komplexen Branchen (Luft- & Raumfahrt, Automotive, Forschungsschiffe, Bauwesen) spricht Herr Elvermann über aktuelle Erfahrungen mit Business Process Management im allgemeinen und dem verwendeten Tool, process4.biz, im besonderen.
This document has been prepared to provide a summary on the changes between ISO 13485:2003 and ISO 13485:2016. The documents contains the following:
a. Benefits of the new version of the standard.
b. Few key definitions
c. Mapping between the versions as per ISO.org.
d. Summary of key changes between the versions of the standard
The document discusses using operational and functional analysis techniques from systems engineering to effectively capture requirements prior to project bidding. It begins with an introduction on the importance of fully capturing requirements upfront.
It then provides an overview of the requirements capture process using these techniques, which involves analyzing operational scenarios, stakeholders, and functional requirements. A case study on developing a mission computer for an aircraft is presented to illustrate applying these techniques. Key activities in operational analysis like identifying scenarios, stakeholders, and requirements flow are described.
009 what are the systems validation protocol methods at atl 05 28-2015atlmarketing
If your product must meet the requirements of FDA cGMP, 21 CFR 210, 211, 820, ISO-9000, ISO-13485, or MDD/93/42/EEC (for the CE Mark), there are three very critical elements you must have to be in regulatory compliance. First, you must have a sound and strong Quality Management System (QMS). This is an expression of WHAT you do (your quality policies and structure). Second, you must have reliable Standard Operating Procedures (SOP’s). These are expressions of HOW YOU DO THINGS.
Missing in the above two items is an expression of HOW WELL YOU DO WHAT YOU DO? This is where you must establish your “Systems Validation Protocol” (SVP). Your SVP is an expression of how well your system is working (for example, this can be expressed in overall product conformance percentage or in defects per million for your various products). The SVP is a living and continuous document based on your quality records. The ATL White Paper “What Are The Systems Validation Protocol Methods At ATL?” is our attempt to share with you a sound approach to Systems Validation and the various protocols that you can use.
This document provides information on the Engine Management System course offered at the Ministry of Education, Malaysia Vocational College. The 3-credit, semester 2 course aims to teach students to detect defects in engine management systems and assess problems to assign required repairs. Key topics covered include setting up scan tools, performing fuel pressure tests, using scan tools for fuel system diagnosis, analyzing oscilloscope patterns, and checking engine management system components. The course is comprised of 5 hours per week of face-to-face instruction over various topics, with assessment based on competency in tasks like operating diagnostic tools according to specifications.
The document provides information on Advanced Product Quality Planning (APQP) and its 5 phases: 1) Plan and Define Program, 2) Product Design and Development, 3) Process Design and Development, 4) Product and Process Validation, and 5) Feedback, Assessment and Corrective Action. It describes the objectives and key activities that should be completed in each phase of the APQP process.
This document provides a summary of the industrial training completed by Ajay Kumar at Lumax Mannoh Allied Technologies from June 15th to July 15th, 2016. It includes an introduction to APQP (Advanced Product Quality Planning), the major elements and phases of APQP, examples of process outputs like an FFMEA (Failure Mode and Effects Analysis). It also summarizes key failure modes, effects, potential causes and controls as part of the FFMEA process for improving product quality.
This document summarizes the process control and quality assurance methods used by Filter Expert Co., Ltd. It discusses how they use statistical process control (SPC) and control plans to monitor key metrics like thread quality and gasket integrity. Thread quality and gasket quality are monitored through inspection checks, with data collected and presented in monthly reports. Notable numbers like failures per million produced are tracked to identify issues and drive down defects, such as a problem with edge sealing that was addressed through machine maintenance.
This document outlines the key phases of the electronics product design process: concept development, requirements gathering, specifications development, design and prototyping, testing, manufacturing, and disposal. It emphasizes that product development follows a systematic engineering approach involving thorough documentation at each phase, from initially defining customer needs to ensuring reliable, high-quality products that meet specifications. The goal is to deliver the best product at the lowest cost and time to market.
Join Joe Mansour, UL DQS Inc. Lead Auditor and ISO 9001:2015 Program Manager, as he gives an in-depth overview of the changes coming to ISO 9001:2015. Part 4 of the 5 part webinar concentrates on the review of questions received during part 3 and the review of sections 8, 9, and 10 of the standard.
ISO 9001-2015 IATF 16949-2016 Numeric Structure Ramona Kellner
ISO 9001:2015 IATF 16949; 2016
Numeric Structure Changes
Dear quality professionals, just in case you have not already done so for yourself, I am sharing a helpful sheet listing the new numeric structure for the emerging automotive standard. As I’m sure you are aware, there are differences between TS structure and IATF, something to keep in mind when auditing and addressing transition and corrective action. Applying IATF changes now, will confidently make it easier for all to save time effort and resources during this transition as well as current corrective actions as opposed to restarting in a year from now. Enjoy!
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Este documento describe el método 8D para la resolución de problemas. El método 8D es un proceso en 8 etapas que incluye formar un equipo, definir el problema, implementar acciones provisionales, identificar la causa raíz, determinar acciones correctivas permanentes, verificar las acciones correctivas, prevenir problemas similares y reconocer el esfuerzo del equipo. El documento explica cada una de las 8 etapas del método y los beneficios de usar este enfoque sistemático para mejorar productos, procesos y prevenir futuros problemas
Este documento proporciona 11 prompts o instrucciones para obtener resultados óptimos de ChatGPT. Estas instrucciones incluyen crear mapas mentales, analogías, planes de estudio, preguntas de práctica, tablas y más. Se recomienda proporcionar instrucciones detalladas y específicas a ChatGPT para obtener las respuestas deseadas, y corregir o ampliar las instrucciones si es necesario.
Este documento presenta una introducción a la tecnología RPA (Robotic Process Automation) y cómo puede ayudar a automatizar tareas monótonas y repetitivas. Explica brevemente qué es RPA, los tipos de robots que existen y algunas áreas comunes donde se puede implementar RPA, como finanzas, recursos humanos y contact centers. También ofrece consejos sobre cómo elegir los procesos adecuados para automatizar y evaluar su complejidad.
This document provides guidance on creating materials in the IMDS system, including:
- Recommendations for the minimum data needed to create a material, such as knowing at least 90% of substances and applicable standards.
- Instructions on whether to create a material or module based on intended reuse. Materials require filling out all three chapters while modules only require the ingredients chapter.
- Tips for searching for existing published or supplier materials before creating a new one, including filters for limiting searches.
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El documento describe los principales tipos de amenazas cibernéticas a las que se enfrentan las empresas, como ataques de ingeniería social (phishing, vishing y smishing), ataques a redes inalámbricas, ataques DDoS, malware (ransomware en particular) y fraude. También recomienda que las empresas protejan mediante la implementación de un sólido plan de ciberseguridad con medidas de prevención, detección y respuesta ante incidentes.
El documento habla sobre las tasas de apertura y clics en email marketing, que se calculan dividiendo el número de aperturas o clics entre el número de correos enviados. También discute cómo mejorar la efectividad de las campañas a través de tener una base de datos actualizada, el momento y personalización de los envíos, y el contenido y llamadas a la acción de los correos. Finalmente, recomienda formas de captar direcciones de correo electrónico como formularios en la web y eventos presenciales, pero no comprar bases de
This document provides an outline for a course on finance for non-financial managers. It covers key topics such as accounting information and statements, finance and corporate finance, and budgeting. Section A introduces accounting concepts like the basic accounting equation and key financial statements. It defines accounting and its role in providing financial information to internal and external users. Section B provides an introduction to corporate finance and the financial manager's role in serving shareholders and stakeholders. Section C covers the topic of budgeting. The document defines important financial terms and accounting concepts like the different types of costs and how they impact the financial statements.
El documento resume un libro sobre la importancia de desarrollar la capacidad de enfocarse y concentrarse. Explica que la atención es una habilidad que se puede entrenar y mejorar, y que requiere tomar decisiones conscientes sobre cómo invertir nuestro tiempo y esfuerzo. También describe algunas técnicas como imaginar eventos futuros como si estuvieran sucediendo en el presente para motivar la concentración en objetivos a largo plazo.
Este documento introduce el transporte de mercancías peligrosas por vía aérea. Explica que las mercancías peligrosas se transportan en equipaje de mano, equipaje facturado, correo aéreo y carga aérea. Las clasifica en 9 clases según su riesgo y describe las responsabilidades de los operadores aéreos y expedidores para identificar, embalar, etiquetar, clasificar, marcar y documentar las mercancías peligrosas de forma segura para su transporte.
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-VDA-Special-Characteristics Special characteristics.pdf
1. Contents Page
1 Preface 7
2 Objectives of the process covering special characteristics;
definitions and limitations 8
3 Categories of special characteristics 11
4 The process of applying special characteristics in the
product creation process 13
4.1 Description of the development process sequence 15
4.1.1 Requirements regarding the concept 16
4.1.2 Concept filter 16
4.1.3 Requirements regarding the design 17
4.1.4 Design filter 17
4.2 Description of the process sequence in production 18
4.2.1 Requirements regarding production planning 19
4.2.2 Production planning filter 19
4.2.3 Requirements regarding the production process filter 20
4.2.4 Production process filter 20
4.3 References to validation methods 21
4.4 Expanded details of the process description covering
significant and critical characteristics 22
4.5 Identification 23
4.6 Consequences 23
4.6.1 Recommended activities in product development 24
4.6.2 Recommended activities in process development 24
4.7 Documentation and archiving 25
5 Interaction with the FMEA 27
4 5
2. 28 Process description covering special characteristics
30 1 Preface
33
36 This VDA publication serves as a starting point for determining, specifying,
39 tracking, documenting and archiving special characteristics.
47
Throughout the supply chain, special characteristics
59 - are to be agreed between customer and supplier and
83 are to be identified within an organisation.
87
This publication is a recommendation for the practical use of significant and
critical characteristics, while complying with the framework conditions set out
in standards and in legislation.
As a process model the VDA publication "Maturity Level Assurance for new
Parts" has been taken by way of example. If preferred, a company's own in-
10 house product creation process can be used.
This 2nd edition updates the changes of the process description due to the
revisions of 4th edition of VDA Volume 1 "Documented Information and
Retention", the 1St edition of IATF 16949:2016-10 "Quality management
system requirements for automotive production and relevant service parts
organizations", and the 1st edition of "AIAG & VDA FMEA Handbook".
Additional changes of links to standards and VDA Volumes are updated.
12
13
15
18
A Appendix
A.1 Example: Fuel tank vent
A.2 Example: Light sensor
A.3 Example: Headlights
A.4 Example: Input shaft to steering system
A.5 Example: Steering wheel interlock
A.6 Example: Electric parking brake
A/ Example: Electronic control unit earthing cable
A.8 Example: Sliding roof drive motor
List of figures:
Figure 1: How robust design and robust processes influence special
characteristics
Figure 2: Lots of characteristics
Figure 3: Maturity level model from VDA Volume
"Maturity level assurance for new parts"
Figure 4: Development process sequence
Figure 5: Process sequence in production
The terms "major characteristics" and "critical characteristics" are replaced by
"special characteristics".
6 7
3. 2 Objectives of the process covering
Special Characteristics; definitions and limitations
The objective of this process description is to describe a multidisciplinary
approach, to:
• to identify special characteristics,
• to classify special characteristics,
• to document special characteristics, and
• to establish safeguards (quality control loops) in the entire value
stream, in order to assure an efficient and effective production control.
The purpose of the method is:
• to promote pre-emptive functional and manufacturing robustness,
• to improve product quality in terms of safety, compliance with regulatory
as well as legal requirements and functional fulfilment,
• to create a common understanding of characteristics management in
the involved areas(e.g. product view vs. process view),
• to minimize manufacturing defects,
• to optimize inspection costs and
• to make sure that appropriate safeguards are defined for confirmed
special characteristics
Systems, components or parts with an immediate influence on:
• safety
• compliance with type approval relevant, legal and regulatory
requirements
• function
may require extra care and attention.
The following is understood by special care:
• design and assurance of the function or characteristics by means of
suitable design solutions (robust design).
• design and execution of manufacturing processes using suitable
process solutions (robust process)
• Identification of special characteristics
• safeguarding the special characteristics by means of suitable process
control measures, such as
1. compliance with process parameters (e.g.. process capabilities (Ppk),
failure rates (ppm))
2. failure detection inspections.
Among other matters, this care and attention refers to requirements which
extend over and above the general technical care required, where one or more
of the following aspects may be involved.
Development process
➢ Design of characteristics
➢ Ensuring the function required
➢ Calculations and simulation
➢ Tests and trials
➢ Monitoring during operation
➢ Validation of fail-safe features, robust operation)
➢ Emergency running concepts
➢ Acceptance checks and releases
➢ Documentation and archiving
Production process
➢ Process design
➢ Process, measurement and test/inspection equipment capability
➢ Process control covering manufacturing, test/inspection, maintenance,
handling, storage, packing, conservation, shipping, transport fixings and
transport
➢ Documentation and archiving
➢ Traceability
➢ Certification for customers
The extra work which may be involved with the heightened level of care and
attention is justified by the possible consequences of a failure of the function.
Characteristics of a product which do not have adequate robustness, which
are difficult to comply with in production and which, in the event of deviation,
lead directly to serious consequences can be identified as special
characteristics. Special characteristics are suitable to communicate and
safeguarded in the supply chain.
8 9
4. functional robust not functional robust
Design robust to fulfill the function?
Figure 1: How robust design and robust processes influence special characteristics
Special characteristics here are the result of a multidisciplinary decision-
making process. Taking into account the product and process development
results, a decision is made on the identification of special characteristics.
"As much as necessary; as little as possible" is the watchword in guaran-
teeing adequate security. These mean that, the more robust and validate the
design, the fewer special characteristics will be necessary.
Special characteristics are characteristics which require special care and are
not controlled by other processes.
The expression "other controlled processes" covers processes which (like the
special process) classify characteristics and, if appropriate, define any
requirements over and above the general technical level of care required.
Examples include:
ISO 26262 - Road vehicles — Functional safety,
ISO 14001 - Environmental management systems
ISO 45001 - Occupational health and safety management systems
2000/53/EG Vehicle end-of-life directive
VDA 4994 - Global Transport Label
3 Categories of Special Characteristics
Special characteristics are a subset of the total characteristics. Nature of
special characteristics, the non-fulfilment or non-compliance with which has
consequences/effects that can be categorised as follows:
cc/s cc = critical characteristics. Safety/security requirements/product
safety/safety-relevant consequences with immediate danger to life
and limb. The causal relationship between the characteristics and its
consequences must be predictable and must not be outside the
realm of probability.
Criteria may be:
➢ Protection for passengers in accidents
➢ Prevention of:
• momentary loss of sight of the road
• brake failure
• steering failure
• drive function failure
• sudden loss of power
• uncontrolled drive
• leakage of fuel / risk of fire
• insecure loads / trailers / parts
• injury when travelling or when using the vehicle in any way
cc/h cc = critical characteristics. Homologation relevant, legal and public
authority requirements at the time the product is introduced to the
market.
➢ Registration-related (e.g.., locking system, headlights)
➢ Homologation (e.g.., exhaust gases, vehicle emissions,
regulations issued by vehicle registration authorities)
➢ Legislation-related (recycling, warranty)
sc/f sc = significant characteristics. Functions and requirements
➢ Important functional requirements
(4 F (Form, Fit, Function and perFormance), tolerances, etc.).
10 11
5. Specifying Iha
supply 1.11,1111 Mid
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21 ktiVArra• 1 Pr duct .5.1 Process 51 PPA 51 PPA 71 Chow
rkirariapmtiori dev4k/94nOnt 44,o/okoroni (Prodikciitin (Production RILII*16.16
22 F4oXv74411.1411 3.2 Process
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54.00y OWN
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29 Process
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2.10 Change
rPnengerpnnt
4 The process of applying special characteristics in the
product creation process
all Characteristics
CheraclerislIcs
deslun concept not totItist
Characteristics
design nol roLuss
Characteristics (Geis, ccin, WI)
ManorecturIng process not rails(
= special charecteriste
As a process model the VDA publication "Maturity level assurance for new
parts" has been taken as an example. If preferred, a company's own in-house
product creation process can be used. The requirements relating to
significant and critical characteristics must be taken into account when car-
rying out maturity level assurance.
The considerations highlighted in the following illustration show areas with a
direct relationship to significant and critical characteristics.
Concept phase Production
* or via customer specifications
Figure 2: Lots of characteristics
oug....f4Airrono
D Note 1:
D Note 2:
D Note 3:
1 Vrolrul
management
12 Frocidemerd•
process
13 Product
development
14 Innovation/
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15 Supply dram/
Supply of
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16 Product
validation
17 Risk
man0#1
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reecpprorpeple
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ter 111P corilreLl
le be issued
Term related to characteristics see DIN EN ISO 9000:2015/3.10
Special characteristics see IATF 16949:2016-10/8.3.3.3.
The categories cc/s, cc/h and sc/f are neutral, informative
terms and are not prescriptive. They are put forward as
proposals to achieve desired uniformity.
111110,1.,
leloase fof lull
production
developmeel
0.1 Project
management
0,2 Innovation/
concept/
reliability
03 Procurement
process
04 Risk
management
Figure 3: Maturity level model from VDA Volume "Maturity level assurance for new parts"
The following sequential illustration is provided for clarity. The process model
is based on simultaneous engineering, in which process steps overlap in
terms of time.
The customer can request special characteristics.
The supplier negotiates
• the special characteristics requested by the customer,
• coordinates with the development and production department regarding
feasibility, testing concept and effort,
12 13
6. MLO
Innevollort WORN rye
lull plod.01E>m development
S c-
Mid
POMP
Mono-
rtesce
•System layout
Requirements specification
Risk analysis
Safety requirements
FungiInn, and !
Concept filter
Concept Yellcfated?
t
m
l:Clul
v
rtZ
s
rl
i.
lsn
t
:
charectsfishics
Concnpi chang '
Requirements mon For
the contract to be Issuocli
Concept
change
Relevant functions, requirements and
characteristics for
Safety, registration and function
Detailed description; performance
specification; experience from
previous projects; design layout; .-•
simulation; trials;
Spec
[Dad
special
thalat-
todstics
Prototype CP
Design filter
Design validated?
Design change
possible?
Design
change
Specifying the supply chain
and placing the order
ML3
Relearol Oflethrtkel
No special
characteristics as
validation by
robust design
is documented
Technical documentation Incl.
specified special characteristics
Concept, requirements & functions at vehicle level,
experience from previous projects,
safety requirements, homologation-relevant,
legal and public authority regulations,
customer requirements
• takes the additional expenditure into account in negotiations with the
customer, and
• makes a contractual agreement with the customer until the project starts.
If special characteristics specified by the supplier require measures to be
taken by the customer, the supplier agrees these measures with the cus-
tomer.
The multidisciplinary team must not filter out the agreed special character-
istics required by the customer.
14
4.1 Description of the development process sequence
Time Workflow Characteristics
neeciectlione
Figure 4: Development process sequence
15
7. Special characteristics which have already been specified must be included
directly in the technical documentation of the development, with no filtering.
In the design filter the first step is to determine whether the design is
validated and secure.
Methods for validation are set out
in Section 4.3 "References to
validation methods".
Relevant characteristics validated
by robust design (see Section 4.4)
or secured design are no Special
Detaileddescription,perk...Mance
iiPeCifIcallenioNkqUiles from
prouleIZ:Z.
tel
h
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assessment; verlikellOn
Design
change
No special
charecterietles se
validation try
mann design
II docurosniad
Characteristics and are not
any further.
Otherwise, a design modification must be considered.
The validation must be demonstrated and documented.
Itahnirsidotornernittorilmi.
seedbedspecial cliaractigestla
Prototype CP
.
;
Requirements mornt for
the contract la be issued
System layout
Requirements specification
Risk analysis
Safely requirements
C
oncept
hange
f runaoau.• I
s":2M11,1=2°'"
System layout
Requirements specification
Risk analysis
Safety requirements
Relevant functions, requirements and
charactedslies for
registration and function
4.1.1 Requirements regarding the concept
As a first step an examination is made (
rao
of the relevant functions and require- .
ments regarding the vehicle concept
and experience from previous projects.
System layout, requirements specifi-
cations and safety demands form the
basis for the risk analysis.
In addition, there are different types of failure and their consequences. These
results flow into the concept filter so that relevant functions, requirements and
characteristics can be determined.
4.1.2 Concept filter
The special characteristics agreed with the customer and specified by him
from functions, safety requirements or legal and public authority specifica-
tions are to be taken over directly without filtering. Special characteristics
from previous projects are passed through the filter and do not necessarily
have to be adopted.
In the concept filter the first step is to clarify if the concept is validated.
Methods of concept validation
are set out in Section 4.3:
"References to validation
methods".
In terms of the concept,
requirements can be validated
by, for example:
• error tolerances
• redundancies
• secure fall-back levels
Functions and requirements which have been validated in the concept are no
special characteristics and need not be tracked further.
The validation must be demonstrated and documented.
In the case of functions, requirements and characteristics not validated by the
existing concept, a change in the concept is considered.
16
If a change in the concept is not possible, or if the concept change does not
result in successful validation, these functions, requirements and
characteristics are considered further in the design.
4.1.3 Requirements regarding the design
The non-validated functions
and requirements which have
been identified are taken into
account when drawing up the
performance specification and
deciding on the course of the
development.
The information gained from the detailed description, from the performance
specification, together with experience from previous projects and layouts, as
well as the results of simulations, trials, assessments and verifications are
also included in the design filter for further consideration.
If a prototype control plan (prototype CP) is required, the relevant character-
istics are included in this.
4.1.4 Design filter
The special characteristics which have been specified and have been
identified with the aid of the filters must be recorded in the technical
17
Concept, requirements & functions at vehicle
level, experience from previous projects,
safely requirements. hornologation-relevant,
legal and public authority regulations,
customer requirements
Relevant!unctions 1.1W(Irttonit thntl
Characteristics for
1....._lafety, registration and function_,
"710211,",:tdt' 'V
Detailed description; performance
specification. exponsoce from
prevlotrs
.
p=s
;
;
;
trlayout;
assessment; verification
I Prototype CP 1
8. Menulestuiln ratodbikty study
and lestablely enalyMs; risk
enalyett; productionphoning;
teat camp
Not sufficient secured
special characteristics
(Concept Phase, Robust
litHea.allechoylcel
some
Design) are to be analyzed
and documented within
the framework of the
manufacturing feasibility study and testability analysis, risk analysis,
production planning and the test/inspection concept. The results must be
documented in the pre-launch control plan (pre-launch CP).
documentation for the project and must be forwarded to the production
planning department and, if appropriate, also to the customer.
4.2 Description of the process sequence in production
Time Workflow Characteristics
Technical documentation incl
.
specified special characteristks
Manufacturing feasibility study
and Otstsefley analysis; task
altslyelE ptaductlonplanning;
fast concept
aae 011.lent
end...inns
Pnlatditilieh OP
V
Special characteristics to be
validated by process layout
Manufacturing feasibility study
and testability analysis; risk
analysis; production planning'
test concept
Production-
concept
change
Special
characteristics nor
tricked further es
validation is
documentedby
sibustpromise
Control Plan
Lessons
teamed
Validation of
production concept,
lest/Inspection planning
sloavoube soling
Comodmiled
nouts.
pro..
cep.
Product:an tool oar. and
1..11. ant etwiebte
Production process filter
Prodeatenproms vseldsiedi
-- Production proems
chomp possible?
Sewell
ebencieriellos not
incitedfurther as
validationle
documentedby
t robust amebae
Special characteristics
requiring
process control
Production process and
product approval (PPP)
Project closure
Responsibility transferred
le Production
Stert requallflcallon
Figure 5: Process sequence in production
18
4.2.1 Requirements regarding production planning
4.2.2 Production planning filter
Predefined special characteristics (Customer or own definition) must be
adopted directly in the next stage without filtering.
In the production planning
filter it must be clarified
whether the production
concept is validated and
therefore secured.
Production plennIng fillor
F
t
;
r:'
ecitZtorthe
bi" re]
dmsfritented
v,eldetionla
thaleasaint
Methods for validation are set
out in Section 4.3: "References
to validation methods".
Specinichat:amorist:Ls tobe
valideted by process layout
V
Production
contopl
change
hiaredaClerblitiealdbaay May
and testability outlets;risk
enelyels; productionplumage
aalcomp
Characteristics which have been
validated in the production concept are no special characteristics and are not
tracked any further.
Validation of the production concept must be demonstrated and documented.
If special characteristics cannot be validated by the production concept, the
first step is to consider a change to the product concept. If a change is not
possible of if the change does not result in successful validation, the
characteristics must be carried forward to the production process filter.
19
L
Technical documentation incl.
specified special characteristics
V
9. Spacial charactetislict to be
validated by process layout
s
Validation of
production concept,
test/Inspection planning
ML4
runt
da-oan
Validation of
production concept,
test/Inspection planning
Lessens
armed
Production rocess fi ter
pemtevrellet•OZ
pertibas?
A
Special characteristics
requiring
process control
SPeCtal
charealattailac 1101
backed further.
validationIs
documented
by robust process
Control Pion
Production-
process
change
'
ct
aral
br.pm, oal q.1•Al
4.2.3 Requirements regarding the production process filter
The validation of the production concept and
test/inspection planning can generate indicators
for further special characteristics in the process.
The special characteristics to be secured
are further considered.
4.2.4 Production process filter
Special characteristics may require special process control, if
• they are extremely sensitive to manufacturing conditions and/or the
slightest changes in material characteristics
• the manufacturing tolerances can be maintained only with considerable
effort.
Special characteristics already specified must be carried forward directly.
In the production process filter it is clarified whether the special characteristics
are validated and secured by the production process.
Methods for validation are
set out in Section 4.3:
"References to validation
methods".
The characteristics which
have been validated and
secured by a robust
production process are no
special characteristics and
are not tracked any further.
The robust production
process must be proven
and documented.
If special characteristics cannot be validated and secured by the production
process, the first step is to consider a change to the production process. If a
change is not possible of if the change does not result in successful
validation, the characteristics and the methods used to check and monitor
them are incorporated in the control plan (serial CP).
If special characteristics cannot be checked directly on the product, the
necessary associated process parameters must be monitored, and the
product must be checked on a random sample basis.
The results of the checks and monitoring must be recorded.
4.3 References to validation methods
Risk detection and actions to minimize risks, including verification and
validation of the implementation of these actions, are among the methods
used to validate and secure product and process.
Methods of risk analysis and risk assessment are described in VDA
publications, among others, such as:
>. Failure Mode and Effects Analysis (FMEA)
➢ Fault Tree Analysis (FTA)
The most important elements in all risk analyses are:
)=• Functions
)=. Characteristics
➢ Possible failure modes; deviations; non-conformances
➢ Possible effects of failure modes
➢ Risk assessment
➢ Specifying appropriate actions
Alternatively, the following activities can also be carried out:
)=. Design of Experiment (DoE)
➢ Hazard analysis and risk assessment (HARA)
)%. Event Tree Analysis (ETA )
➢ Value Analysis (VA) / Value Engineering (VE)
➢ List comparison
)=. Team of experts
Completion of
Production planning
nic000rtiorcheorett
israoruHossur thortacnon.
20 21
10. 4.4 Expanded details of the process description covering Proof of robust process is the obligation of the process planning department
responsible and can be provided, e.g.. by capability certification.
Control Plan (CP)
significant and critical characteristics
Premises
➢ The special characteristics must be determined on an inter-disciplinary
basis.
➢ Experience gained from previous projects is an input factor in determin-ing
significant and critical characteristics.
➢ Special characteristics must be determined without any consideration of
the work involved, within the framework of what is specified as legally
reasonable.
➢ Experience from product observation must be taken into account.
➢ If changes are made to product and/or process the exercise of deter-
mining special characteristics must be carried out again. This applies
particularly where production is transferred to another location.
➢ A proportion of safety-relevant critical characteristics and homologation-
related characteristics may be specified by the customer. However, as a
general principle, the supplier must also, on his own responsibility, identify
special characteristics.
Robust design
The term "robust design" describes a design which reacts without undue
sensitivity to fluctuations and interference factors (for example, if individual
features exceed tolerance limits), i.e.. it continues demonstrably to fulfil the
functions which are expected and required.
Proof of robust design is the obligation of the development function
responsible and can be provided, e.g.. by Design of Experiments (DoE).
Robust process
"Robust process" is understood as a process which reacts without undue
sensitivity to fluctuations and interference factors (e.g.., voltage fluctuations;
insulation defects on varnished wire, tool wear), i.e.. the manufactured product
traceable continues to perform as required, see the VDA publication: " Robust
production process".
The control plan describes the planned activities to validate and secure the
product and process characteristics. The control plan is defined in IATF
16949:2016-10/8.5.1.1 and in the appendix A.
4.5 Identification
To IATF 16949:2016-10/8.3.3.3 the special characteristics are to be marked
with symbols and documented in product production documents which
indicate the inquiry and introduction or measures control for these special
characteristics. This symbol provides a clear and simple identification.
Against this background the symbols should not contain too much specific
information.
It is recommended that the so-called "frame for check gauge" be used to
identify characteristics. This airship-shape symbol contains an identifying
letter for the category of the characteristics (s, h or f) and, for each category,
a sequential number to differentiate it in the release document.
Any further information associated with the characteristics (who what, how
and how many, with what documentation) can ideally be included in a table.
4.6 Consequences
The process used to determine special characteristics must be demon-
strated. Associate documents must be stored, Section 4.7: "Documentation
and retention".
The following activities regarding special characteristics must be agreed on
an inter-disciplinary basis:
➢ The special characteristics relating to technical documentation are
forwarded to the relevant production department
➢ Special characteristics which have been identified in the technical
documentation must be taken into account in all essential documents for
controlling the production process
➢ It must be specified how compliance with the special characteristics is to
be demonstrated
22 23
11. ➢ Monitoring of the special characteristics must be specified
➢ The organisation shall establish traceability plans based on the level of
risk and ensure that identification and traceability requirements are
implemented for products with special characteristics.
In the supply chain the customer must advise his suppliers of special
characteristics and agree on the way they are to be monitored.
The fact that the customer specifies special characteristics does not release
the supplier from his own responsibility to identify special characteristics and
to deliver conforming products.
4.6.1 Recommended activities in product development
➢ Product development — design layout (including, for example, emergency
running, redundancies, operating and display concept)
➢ Concept revision
➢ Manufacturing feasibility study — stimulus for carrying out a detailed
manufacturing feasibility study for this characteristics
➢ Design of Experiment (DoE)
➢ Special attention to special characteristics in test/inspection planning and
documentation as required in the prototype control plan (prototype CP)
4.6.2 Recommended activities in process development
➢ Process development — the need to carry out trial manufacturing on a large
scale must be checked and specified if required, together with
recommended quantities
➢ Manufacturing feasibility study/testability analysis — stimulus for carrying
out a detailed manufacturing feasibility study for this characteristics
➢ Provisional process capability study
➢ Particular consideration of special characteristics in the test/inspection
planning and documentation, in pre-launch and serial control plan
➢ Proof of full production capability/suitability for product launch; special
requirements covering long-term process capability
4.7 Documentation and retention
Documented information according ISO 9000:2015-11/3.8.5 encloses:
➢ Information (Documents) to operate the organization
Examples of Information (documents) with reference to the special
characteristics:
• Design documents and/or production documents (if demanded)
• Risk analyses (as Process-FMEA)
• Special procedure for products with special characteristics
• Regulations to the contact with safety-relevant bolt connections
• Control plans
▪ Provisions to the process qualification, e.g.. process capability, process
parameter, test process suitability
• Working instruction
➢ Evidence (Records) of results achieved Examples of evidence (records)
documents with reference to the special characteristics:
• Test results of products with special characteristics, incl. test results
• Verification of the gauge calibration
• Evidence of process capability, including quality charts
• Evidence of verification process
The retention period distinguishes between information (documents) and
evidence (records), which includes operating and archiving period.
Information (Requirements documents)
The operating period begins with the release and ends when the document is
invalid, e.g.. because of a change (new version) or the expiry of a set period
(deviation permit), or the end of production of the product / process.
The archiving period begins when the document is invalid, in accordance with
the quality management system requirements for controlling documents and
data (e.g.., appropriate identification). The archiving period ends with the
specified point in time of deletion/destruction of the documentation.
24 25
12. Evidence (Quality records)
The operating period depends on the type of use and begins when the quality
record is created, e.g.. the documentation of a test result, a completed
process control chart, a process capability record, or an initial sample
inspection report. The records must not be modified once they
have been completed.
A further use of records is common, e.g.. for analysis purposes.
The archiving period begins after finalization of the record and ends with the
specified point in time of deletion/destruction. The VDA Volume 1
"Documented Information and Retention" includes an overview of terms and
definitions and also a classification system with examples, which show the
respective retention period.
The operating period begins with the day of the release and ends with the
specified point in time of the deletion/destruction of the documentation and
must comply with the valid legal and normative requirements.
Recommendation for retention period (operating and archiving period)
➢ 30 years for special characteristics cc/s and cc/h.
➢ 10 years for special characteristics sc/f.
In addition, consideration must be given to customer-specific requirements or
other stipulations.
5 Interaction with the FMEA
The special characteristics are identified with the described filters. The filters
can be applied by the FMEA team.
Special characteristics are documented in the Process-FMEA.
An assessment of the Severity (S) as S=10, S=9 or S=8 does not automat-
ically result in a cc/s or cc/h or sc/f.
For representation of the special characteristics in the FMEA see the
AIAG & VDA FMEA Handbook, appendix D1 "Special Characteristics".
26 27
13. A Appendix
Abbreviations used in this document
cc/h
cc/s
CP
DIN
EN
ETA
FMEA
FTA
IATF
ISO
ML
MLA
OEM
sc/f
SOP
VA
VE
Critical characteristics based on homologation relevant, legal
and public authority requirements at the time the product is
brought onto the market
Critical characteristics based on safety
Control Plan
Deutsche Industrie Norm (German industrial standard)
European standard
Event Tree Analysis
Failure Mode and Effects Analysis
Fault Tree Analysis
International Automotive Task Force
International Standardization Organization
Maturity level
Maturity level assurance
Original equipment manufacturer
Significant characteristics based on function or requirement
Start of Production
Value analysis
Value engineering
Examples
The following examples illustrate practical use in different degrees. The
methodical procedure is shown in each case.
The examples have been provided by various VDA member companies and
make no claim to comprehensiveness in terms of their contents. No
guarantee of any kind applies in any case.
A.1 Example: Fuel tank vent
A.2 Example: Light sensor
A.3 Example: Headlights
A.4 Example: Input shaft to steering system
A.5 Example: Steering wheel interlock
A.6 Example: Electric parking brake
A.7 Example: Electronic control unit earthing cable
A.8 Example: Sliding roof drive motor
Other abbreviations
DMR Diameter in Appendix A5
ECU Electronic control unit in Appendix A6
EPB Electronic parking brake in Appendix A6
28 29
19. Relevant functions, requirements and
characteristics for
specifying the supply chain ~Bg151lallOn an
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CIO
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pecification; experience from
previous projects; design layout;
covedng simulation; trials;
assessment; verification
Relevant for homologation are:
• the diameter of the
designed break point:
Dspec = 13.1 ± 0.1 mm
• the roughness of the
bearing peg: Rz = 6.3
Relevant for function is:
Design
mileage
Design filter
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specified characteristics
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eam
A.4.1 Description of the development process sequence
A.4.1.1 Requirements regarding the concept
The concepts and functions at vehicle
level, experience from previous projects ‘5140.
System layout
Requirements specification
Risk analysis
In the case of the input shaft to a steering gear, the customer has specified as
a critical safety characteristic (cc/s) the hardness of the bearing seat, which
must be 650HV +110HV1.
The system layout, requirements specification, risk analysis and safety
requirements reveal no further relevant requirements and functions relating to
safety, homologation and function.
A.4.1.2 Concept filter
The critical safety characteristic
(cc/s) specified by the customer,
that thehardness of the bearing „.„„,„„,„
seat must be 650HV+110HV1,
is taken forward as a relevant
safety characteristic without
passing through the concept filter.
The concept is examined.
Risks are detected for the
diameter of the designed
sPegc11,2S41,",:n.:;'d`e'r'''"
break point, the roughness
of the bearing peg and the roughness of the gearing. These cannot be
changed by a change in concept and are considered further as being
relevant. These fixed characteristics are allocated to the relevant
requirements and functions for safety, homologation and function. They then
go forward for further examination in terms of the design.
Other requirements and functions which have been secured by the concept
have been confirmed by trials and tests and are not considered further as
relevant regarding special and critical characteristics.
40
The trials and tests are described in instruction ref. V18/05. The results are
documented.
A change to the concept is considered, to take account of the requirements,
functions and characteristics not secured by the existing concept.
If the modified concept does not achieve the necessary level of assurance,
these requirements, functions and characteristics are examined further at the
design level.
A.4.1.3 Requirements regarding the design
The characteristics which have been identified are set out in detail.
• the gearing roughness level Rz = 12
These identified requirements, functions and characteristics are taken into
consideration when drawing up the performance specification and preparing
the layout in the development phase.
A.4.1.4 Design filter
The design layout of the
designed break point is
examined in Trial V18/09.
The trial confirms that the
diameter of the designed break
point Dspec = 13.1 ± 0.1 mm is a
robust design.
The results of the trial are filed
in the "NF9 steering gear" file.
The design diameter is secure and does not represent a special
characteristics.
41
ate heti
and relevant functions, together with IproductIondtelopment
requirements relating to safety, security,
homologation and function are examined
for possible special characteristics. Requirements rngrnt, for
the contract to be issued
Concept, requirements 8 functions al vehicle level,
experience from previous projects,
safety requirements, homologation-relevant,
legal and public authority regulations,
customer requirements
to b.Weed f
Relevant functions, requirements and
characteristics for
Safety, registration and function
System layout
Requirements specification
Risk analysis
Safety requirements
fuocuon.
nIt rp.
Z.
j [T•1•[1•11111,1
20. L
Technical documentadodIncl.
specified special characteristics
Manufacturing feasibility study
and testability analysis; risk
analysis; production planning;
test concept
MO
No further requirements, functions and characteristics representing special
characteristics are noted in the development.
In the technical documentation covering the development the following
special characteristics are specified and forwarded to the production planning
department.
Safety-relevant special characteristic:
• cc/s: Hardness of the bearing seat 650HV+110HV1.
Homologation-relevant special characteristic:
• cc/h: Surface roughness of the bearing peg Rz = 6,3
Function-relevant special characteristic:
• sc/f: Gearing roughness level Rz = 12
Once specified, these special characteristics are included in the prototype
control plan.
A.4.2 Description of the production process sequence
A.4.2.1 Requirements regarding production planning
The special characteristics
forwarded from the techni-
cal documentation in the
development phase and
specified for consideration
at the production planning
stage are processed further
and included in the control plan for the pre-production phase.
These special characteristics are:
Safety-relevant:
• cc/s: Hardness of the bearing seat 650HV+110HV1.
Homologation-relevant:
• cc/h: Surface roughness of the bearing peg Rz = 6,3
Function-relevant:
• SC/f: Gearing roughness level Rz = 12
These and all other special characteristics are verified within the framework of
the manufacturing feasibility analysis and testability, risk analysis, production
planning, test/inspection concept and the design review. Checks must also be
made to determine whether test/inspection specifications contain product
characteristics and any requirements regarding process parameters.
42 43
21. Spacial characteristics to be
validated by process layout
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validated by process layout
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production concept,
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A.4.2.2 Production planning filter A.4.2.3 Requirements regarding the production process filter
The special cc/s safety charac-
teristic specified by the customer
for the hardness of the bearing
seat (650HV+110HV1) does not
pass through the production
planning filter. Instead, it is for-
warded as a special safety
characteristic.
The actions taken to validate the
production planning and test/
inspection planning do not reveal
any further special characteristics.
The relevant requirements, functions
and characteristics which have been
identified are set out in more detail.
A.4.2.4 Production process filter
The other information gained flows into the production planning filter in order
to identify the special characteristics.
The purpose of the production planning filter is to clarify whether the produc-
tion concept is secure. The homologation-related special characteristic cc/h
(the surface roughness of the bearing peg Rz = 6,3) is secured by the design
of the tool. This characteristic is therefore no longer included as a special
characteristic in the production process.
Proof of security is demonstrated and is documented in the production
planning papers.
The function-relevant special characteristic sc/f (gearing roughness level Rz =
12) cannot be secured by the production concept.
A change to the production concept does not result in a secure product. This
special characteristic is therefore included in the production process filter and
in the control plan for pre-production.
44
The special cc/s safety
characteristic specified
by the customer for the
hardness of the bearing
seat (650HV+110HV1)
does not pass through
the production process
filter. Instead, it is for-
warded as a special
safety characteristic.
The function-relevant
special characteristic
sc/f (gearing roughness
level Rz = 12) can be
secured in the process, based on lessons learned from a previous project.
This robust process is documented in the production description, with proof of
capable production. No consideration is given to a change in the production
process. The special characteristic is secured by the production process.
Because it is now secure, the special characteristic is not incorporated in the
control plan for full production.
45
22. Concept, requirements & functions at vehicle level,
experience from previous projects,
safety requirements, homologation-relevant, legal
and public authority regulations,
customer requirements
Innovation release for lull
production development
System layout
Requirements specification
Risk analysis
Safety requirements
A.4.3 Result A.5 Example: Special characteristics for a steering wheel interlock
The safety-relevant special characteristic cc/s specified by the customer
(hardness of the bearing seat 650HV+110HV1) by-passes all the filters
and is carried forward to the control plan for full production. It must be taken
into account in the manufacturing process and covered by documentation.
The homologation-relevant special characteristic cc/h (roughness of the
bearing peg Rz = 6,3) was secured by the production concept and is not
included as a special characteristic in the manufacturing process. The fact
that it has been secured by the production concept is documented.
The function-relevant special characteristic sc/f (gearing roughness level Rz =
12) is secured in the production process by a robust process. Experience
from previous projects is available here.
In total, on safety-relevant special characteristic is carried over into the
control plan for full production. The special characteristics relating to homo-
logation and function have been secured and are not included in the control
plan.
Requirements mgmt for the
contract to be issued
A.5.1 Process steps for the OEM: MLO and ML1
A.5.1.1 Determining the functions at vehicle level
Vehicle
Transport the passengers from A to B under the control of the driver
Protect the passengers from injury
Protect all persons involved from serious injury in an accident situation
Protect passengers from environmental influences
Protect the vehicle against theft
Comply with noise requirements
Minimize vehicle operating costs
A.5.1.2 Identifying and describing functions relevant to
special characteristics, based on external and
internal requirements at vehicle level
Vehicle
Transport the passengers from A to B under the control of the driver
*s__ Protect the passengers from injury
No►s_ Protect all persons involved from serious injury in an accident situation
Protect passengers from environmental influences
mlh_ Protect the vehicle against theft
Comply with noise requirements
*f_ Minimize vehicle operating costs
46 47
23. Vehicle
Transport the passengers from A to B under the control of the driver
s_Protect the passengers from injury
s_Protect all persons involved from serious injury in an
accident situation
Protect passengers from environmental influences
h_Protect vehicle against theft
Comply with noise requirements
f_Minimize vehicle operating costs
Warnii SYgern
ir.o.note
Enable the vehicle to be steered
h_Prevera steering movement with key removed
[_Minimize repair costs (insurance classification)
Comply with noise requirements for the steering function
h_Public authority requirement: steering system must he
uniquely identified for traceability
Brake system
Slaw the vehicle as desired by the driver
_Slaw the vehicle as desired by the system
with noise requirements for the brake system
A.5.1.3 Breakdown of identifications for part-functions and
part-systems
A.5.1.4 Identifying and classifying functions relevant to special
Vehicle Steering system Steering wheel interlock characteristics, based on a risk analysis
h_Protect vehicle against
theft
h_Prevent steering wheel movement h_Engage steering column in locked
with key removed key position Vehicle
Transport the passengers from A to B
Controllability of vehicle performance Impossible to steer the vehicle
significantly restricted
under the control of the driver — Enable the vehicle to be steered
Steering system
— in the "open" position
Steering wheel interlock
Steering column blocked with key in the
"open" position
Release the steering column with the key
Identification of requirements relating to homologation at part-system level:
The steering system must be uniquely identified for traceability The chain of defects is assessed as safety-relevant and this causes the function
"Transport the passengers from A to B under the control of the driver" to be classified at
vehicle level with S_ as a function for which a special characteristic is relevant.
The classification is then broken down into part-functions and part-systems.
A.5.1.5 Deriving special characteristics by the OEM
em
Brake 061ein
s Stow the vehicle as desired by the driver
s Stow the vehicle as desired by the system
(;empty with noise requirements for the brake system
tearing system
h_steering system must be uniquely identified for traceability
Steering wheel interlock
h_Engage steering column in locked
Steering column in key position release openly and safely
Comply with noise requirements for the steering wheel interlock
Steering column protect against damage from misuse
Steering gear
Special characteristics relating to the steering wheel interlock:
Hardness of the interlock component: sc/f_material hardness 268HB
Steering system
Enable the vehicle to be steered
h_Prevent steering movement with key removed
f_Minimize repair costs (insurance classification)
Comply with noise requirements for the steering function
h_Public authority requirement: steering system must be uniquely identified for traceability
r
H
skip
i
teedng
we1
o
h;
n
Itee
Steering wheel inrt
H_Steeri
Steering i
Noise req
Steering c
Steering gear
A characteristic can be specified on the basis of a homologation requirement
at part-system level:
*The steering system must be uniquely identified for traceability => cc/h
If the steering wheel interlock is subjected to misuse forces, a "hard" interlock
(a latching peg, for example) can damage the steering column, perhaps
resulting in high repair costs. For this reason, the *hardness of the interlock
component is determined as sc/f.
filly
A.5.1.6 Transferring the information from the OEM to the steering
system supplier (for example, in the development requirements
specification)
Steering wheel interlock functions for which special characteristics are
relevant:
h_lock the steering column with the key in the "closed" position
s_guarantee release of the steering column with the key in the
"open" position
f_protect the steering column from damage in the event of misuse
Special characteristics relating to the steering column:
The steering column must be uniquely identified for traceability cc/h
48 49
24. System layout
Requirements specification
Risk analysis
11111t
ik
Safety reetaramantf.
'Mk
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ROI•VAIV function. ternMelhafilt and
characteristics for
Sandy.registration and function
A.5.2 Process steps at Tier 1 level (ML1)
System structure of the steering wheel interlock:
Steering column tube
End-stop damper in
Latch
Latching unit
Latch spring
steering column tube
Steering column
tube cover Housing (left)
Steering wheel
Housing (right)
interlock
Drive unit Motor with pinion
Gear
Controller PCB
Setting unit
Steering wheel interlock
characteristics
A.5.2.1 Taking s, h and f characteristics to the part-functions
(concept level)
The steering wheel interlock concept:
50
Function network in the steering wheel interlock system:
Steering column tube
's provide rotating bearing point for latching unit
Steering column tube
s_ fix and position the drive unit
Latch
s_ release steering column in unlatched position
Housing (right)
s_ provide bearing for setting unit with housing (left)
Housing (right)
Steering wheel interlock rs_ provide bearing for bolt with adjustment in x-plane
s_ release steering column in key "open" Gear
position s_ transfer torque from motor to trigger with def. translation
Trigger
s_ convert torque from gear into axial movement of bolt
Bolt
s_ move latch in accordance with trigger movement
Housing (right)
s provide bearing for gear
Steering wheel interlock characteristics
s_ gap between released latch and steering column = 3 mm
51
25. Motor with
pinion
Controler
PCB
Controler
PCB
I Securing system Securing system
Steering column tube
Latch unit
Locking unit
Housing
Steering column tube
Latch unit
Locking unit
Housing
Gear
Release
V
Design filter
Deilen validated?
hasten chimps
- --
• Hoapticiat
chroxierIsi II
,11 validation by
I robust design
h documeaisd
Detailed description; performance
speclficalion; eve lance from previous
ofecle; design lay ut; simulation; trials
assessment; verification
Plisd
tothlto
---------)
Prototyp CP
-----
Design
change
Technical documentation incl.
specified special characteristics
Steering wheel interlock
h_ lock steering column with key in
"closed" position
Steering wheel interlock
f protect steering column from damage
in case of misuse
Steering column tube
s_h_ provide rotating bearing point for latching
esring column tube
s_h_fix and position the drive unit
Housing (right)
s_h_ provide bearing for setting unit with housing (left)
Housing (right)
s_h_ provide bearing for bolt with adjustment in x-plane
e
G ar
s_n_ transfer torque from motor to trigger with def. translation
1
Trigger
s_h_ convert torque from gear into axial movement of bolt
Set spring
h_provide tension between gear and trigger
Bolt
s_h_ move latch in accordance with trigger movement
Housing (right)
s_h_provide bearing for gear
Steering wheel interlock characteristics
h_Overlap between latched bolt and steering column >= 5 mm
Latch
f ensure definite shear without damage to steering column
in case of misuse
A.5.3 Process steps at Tier 1 level (ML2 and ML3)
A.5.2.2 Risk analysis at concept level
Steering wheel interlock
h_ lock the steering column with the
key in the "closed" position
Steering column not locked with key
in the "closed" position
Steering wheel interlock
s_ ensure steering column is released
with key in the "open" position
Steering column is blocked with the
key in the "open" position
Controller PCB
s_h_ provide current based on control
signals from vehicle ECU
Motor incorrectly supplied with current
Following recognition of the risk in the controller PCB (motor incorrectly
supplied with current) the concept was expanded by a function at system level,
which secures against the risk.
New: s_secure the latched positions.
This action removes the PCB functions from the concept filter and need not be
considered further with regard to special characteristics!
A.5.3.1 Taking s, h and f functions to the design characteristics level and
adopting the specified characteristic for the interlock characteristic
for the interlock component (latch):
Special characteristic f E_material hardness 268HB
52 53
27. A.5.4 Process steps at OEM and Tier 1 level (ML3)
Production-
concepl
I change
Manotactviing faealtablty study
and testability smartie,. risk
PiPPYstai ProdOctloriplanning;
cettcepi
Production s
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validated by process layout
V
Steering wheel interlock characteristics
s_gap between released latch and steering
column >=3 mm
Latch characteristic
s width= 24 mm ± 0.1
Bolt characteristics
s_h_length = 50 mm +0 1
Trigger characteristics
s_h_length= 12 mm ±0.1
Gear characteristics
s_h_length= 7 mm ±0.1
Characteristics of housing (left)
s_h_length= 80 mm ±0.2
Characteristics of housing (right)
s_h_length= 80 mm ±0.2
Characteristics of steering column tube
s_h_length of housing positioning= 80 mm ±0.2
Characteristics of steering column tube
s_h_gap between upper housing position and bearing
for latch = 13 mm ±0.05
s: Gap between released latch and steering column
[steering wheel interlock] >=3 mm
All other dimensions are identified as individual dimensions in the
component drawing:
s: control dimension for positioning peg = DMR 2.6 mm +0.1
[left-hand housing]
s: control dimension for positioning hole = DMR 2.6 mm -0.1
[right-hand housing]
s: coaxiality of bearing point diameter with housing = 0.08 [gear]
f E: Material hardness [barrier latch] = 268 HB
steering column in the vehicl- <
Fltstewing wheelMale*to the stowingcolumn
h_lock the steering column in 'key closed" position
jelienle steering column in 'key open" position
Sioanng colon.net releeend "kiny own'poulhon
deal noworwearemonni for %looms whorl inladeekt
Una**sleeking column IranUnmoor st once et
001411..lelteleiht pindbruyil
Lemma economicassembly
trili
alr
int;agesieving *halneatest( tern
ea
politicks
operators
s_h_postion slosatsp retool emetic),on amens *slum
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a h as aleanrio seheet Wort:ink ha togyercink
SiOlgillgWWIinuidock
1yeasas pegbeer be.'wen'Pate.
Pep tositionnotopen
•
wowsscresdanal
lessenscolumn
A.5.3.2 Carrying out the design filter:
The characteristic cc/h is shown in the development stage to be
robust against process fluctuations (DoE trials).
Certification is described in the technical documentation covering
the development and the characteristic not be considered as
special characteristic.
A.5.3.3 Including the sc/cc in the technical documentation:
The characteristics of the chain of dimensions covering the
gap between the unlatched bolt and the steering column
are not considered as separate items. Instead, the complete
dimensional chain is considered as a single cc/s characteristic.
This is documented in the assembly drawing (s).
A.5.4.1 Deriving special characteristics on the basis of the
OEM's Process FMEA
The latch position "open" is not robust. Due to the high effect "steering
blocked while driving", a cc/s is identified and marked for this purpose.
Install:Merino system
s_enebre Widelobe Owed
ven?=Tibli
g'i
l'
de
r'
veiree
nrt'
l=key removed
alleirtai0 repair costs (Instal= dot. e:at
WMmeetMoulemeireskramailoalsowem
f_comply with delivery limes (JIT)
iYrdae steering gear In the vehicle <
The "latch position when received" is recorded in the assembly drawing as an
action from the Process FMEA (cc/s) and forwarded to the supplier.
cc/s: Latch position when received [steering wheel interlock] = open
A.5.4.2 Carrying out the production planning filter by the Tier 1 supplier
The characteristic cc/s: coaxiality of the bearing point diameter with the
housing = 0.08 [gear] is no special characteristic because the two diameters
are produced when gripped in a machine and therefore, as a concept, no
error can occur in terms of coaxiality. The machine capability is demonstrated
and documented.
56 57
28. Validation of
producilon concept,
teat/Inspection planning
Special characteristics
requiring
Mans control
Lesson*
to
''''''''
chareoleeletIce trot;
Itracked further**
validationIs
: documented by
tobtaitrocus
rroon ood
• ,11. ar• 4.1S.
Producioannroo.o.o ono,
prodon npoopirol iPOSI
ProrliKtkon o
reaneleee
Pliorhopqn
prooro.
CI
Manufacture of the controller PCB
(_Robust function over product life
Inadequate robustness over
product life
Assembly step xxxx
(
—8efiew cddering process
f Cdidudinglido between
components and PCB
Solder contacts not fully formed.
. Components on PCB are damaged
, Operator al fellow soldering machine
c
od.
f_eolder moll lenveralure = 230'C i10'
;olderClem - 220.0
Solder lanymmlivu ,..- 7.10'C
pasta
Assembly step yyyy
lectric
par
in
•
•ra
-
59
A6. Example: Electric parking brake
A.5.5 Process steps at Tier 1 and Tier "n" levels
Pnoi
roel emir*
lierpoontWir trrodonod
to Production.
PIA oporOrosoon
A.5.5.1 Deriving special characteristics on the basis of the
Process FMEA by the Tier 2 (n) supplier
Process-related variation of the process characteristic solder melt
temperature lead to a special characteristics sc/f.
A.5.5.2 Carrying out the production process filter at Tier 1 level
The production process filter at Tier 1 level does not identify further special
characteristics. The identified special characteristics are included in the Tier 1
supplier's control plan.
58
41. System layout
Requirements specification
Risk analysis
Safely requirements
Pagans ad
aqua,.eel
*OWNnatal p
durs,alla
Concept
change
Relevant functions, requirements and
characteristics for
Safety, registration and bamboo
"VZ.V4ravdvain
":)
butovation came ter full
production dexatopnmel
Concept, requirements 8 functions al vehicle level.
experience from previous projects.
safety requirements, homologaliondelevant,
legal end public authority regulations,
customer requirements
System layout
Requirements specification
Risk analysis
Safety reouirements
Requirements mgmt, for
the contract to be Issued
Relevant funreons, requirements and
cha-ncreristics for
,
Oat' legalalalland battalion
en piecing me Omer
Cala." answer.,performance
spatetun. a',amp ben
rucetats
Cvro.NulaNa; tlesx,ut laficaa-
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rrg;;;;;
c-p
PO.5.1110 Ofter
Detailed description; performance
specification; experience from previous
ojecta; design layout; simulation; trials;
assessment; verincalCon
-----
Prototype CP
---
lead
(
":g741="
1‘,
specified
documentation Incl.
specified special characteristics
Design
change
I No spaniel
Ichteselerlike as
vailtlettonby
I ,shoat dadan
a dOCOIlladdd
A.7.1 Description of the process sequence
a) The development process sequence
A.7.1.1 Requirements regarding the concept
Firstly, the relevant requirements
and functions regarding the vehicle
concept are examined, with experi-
ence from previous projects.
There are no customer requirements
regarding the ECU which give rise to
special characteristics.
The system layout, requirements specifications and safety requirements form
the basis for the risk analysis. This highlights out failure modes and their
consequences. These results flow into the concept filter to enable a determi-
nation of relevant requirements, functions and characteristics. One of the
important requirements is set out in the requirements specification and
demands compliance with EMC (electromagnetic compatibility) limits.
A.7.1.2 Concept filter
The concept is examined.
Compliance with the EMC
requirements is assessed
critically.
The requirement cannot
Be changed by a modi-
fication of the concept.
It is therefore regarded
as a relevant homologation
requirement and is carried
forward to the design
phase for further
examination.
Other functions and requirements which were secured at the concept phase
have been confirmed by tests and are not forwarded to the design phase as
relevant functions and requirements. The associated tests and their results
are documented in the development report EB14-2010.
A.7.1.3 Requirements regarding the design
The ECU is laid out in detail.
Appropriate actions are speci-
fied in the layout to ensure
compliance with homologation
requirements regarding out-
ward radiation and resistance
to inward radiation.
Experience regarding EMC
from previous projects is taken into account.
Following measurements in the EMC laboratory, the layout, components and
housing are optimized. The changes made are verified by further
measurements with the ECU (test report PB-E 07/2010).
Final confirmation that the EMC requirements are satisfied can be obtained
only by later measurements in the target vehicle.
A.7.1.4 Design filter
Measurements in the EMC building with the ECU installed in the target
vehicle indicate that all requirements can be met, provided there is a
satisfactory ground connection to the vehicle. However, tests with an
inadequate ground connection show that the limit figures are exceeded.
The ground connection
is therefore classified as
a critical characteristic
cc/h.
These tests also reveal
that an inadequate
ground connection also
leads to safety-relevant
functional failures of the
ECU. It is therefore also
classified as a critical
characteristic cc/s.
No further special characteristics were noted in the design phase.
84 85
42. The ECU and earthing cable are pre-assembled by the supplier and delivered
as a single unit to the customer. The earthing cable is installed by the OEM.
The customer must be informed of these special characteristics.
In the customer documentation (drawing issued for quotations, technical
customer documentation) the ground connection for the earthing cable is
identified and classified with s and h.
A.7.2 Consequences
In discussions between the customer and the production planning
department, as well as the customer's quality assurance department,
agreement is reached on the tightening torque and test/checking measures
(100% test/inspection).
The customer includes the special characteristics, the associated data and
the test/inspection measures in his control plan.
A.8 Example : Sliding roof drive motor
Design drawing (section)
86 87
43. System layout
Reek/in:moots specification
Rink anotysis
Safety roquiteMenis
sue et a Mrs
csinsem
strange
hiL2
sPITZ:17,
supply
Concept filter
- &
,ncspl Vallttatad?
Cern:opt change
noettipie?
B
Relevant functions, requirements and
characteristics for
Safely, registration and function
unmansma
inearnanarre not
rmelrinp warm
ansinceinnixa
( MLQ
J
Innotration release for full
pioductleet developmeet
Concept, requirements 8 functions at vehicle level,
experience from previous projects,
safety requirements, hornologationirelevani,
legal and public authority regulations,
customer requirements
System layout
Requirements specification
Risk analysis
Safety requirements
Requirements mgmt for
the contract to be Issued
Relevant ronitheins, requirements and
theracierislics far
palely, registration grid funratiot.,
"Vpiane
raigrZgm
Detailed description; performance
specification; experience from
previous projects; design layout;
covering simulation; teals:
assessment; verification
-------
-------------- Prototype CP
-
1
-------1
Detailed descrIprbon: perfOrmance
pecification; experience from previous
ognisi. design layout; simulation; trials
assessment; verification
L
Design filter
Daman validated?
Onoslump; --
possaget
3
LL
Technical documentation incl.
s special characteristics
Design
change
---
Prototype CP
.
I
.........
I No
ichatectertelles
validation by I
I robust dellan I
I.documented
1
A.8.1 Description of the process sequence
a) The development process sequence
A.8.1.1 Requirements regarding the concept
Firstly, the relevant requirements and
functions regarding the vehicle concept
are examined, with experience from
previous projects.
There are no customer requirements
regarding the sliding roof drive motor
which give rise to special characteristics.
The system layout, requirements specifications and safety requirements form
the basis for the risk analysis. This highlights failure modes and their conse-
quences. These results flow into the concept filter to enable a determination
of relevant requirements, functions and characteristics. One of the important
requirements is set out in the requirements specification and demands
compliance with the limit figures for the closing force of the sliding roof.
A.8.1.2 Concept filter
The concept is examined.
The requirements for the
closing force are analysed.
These requirements cannot
be changed by a modification
to the concept.
The closing force is examined
further as a safety-relevant and
homologation-relevant require-
ment and is carried forward to
the design phase for further
examination. Because of American FMVSS traffic homologation regulations
there is also an homologation relevance here.
Other functions and requirements which were secured at the concept phase
rheale
vevabnetefunnccotinofinrs d
m
a
e
n
db
r
y
eg
te
u
s
i
t
rrnnt
s
e
an
e
da
s
r
.
e not forwarded to the design phase as
Proof of compliance is documented in test report EV32/SC/2009.
A.8.1.3 Requirements regarding the design
The functions and requirements
Which have been identified are
taken into account when drawing
up the performance specification
and the design layout.
The position of the ring magnet
is identified as a safety-relevant characteristic because this has a crucial
influence on the closing force.
Closing force measurements on assembled samples are used to determine
the optimum position of the ring magnet.
A.8.1.4 Design filter
In design discussions it
determined that the position
of the ring magnet cannot
be secured by design
measures alone. The SE
team and the production
department therefore agree
that the position of the ring
magnet must be classified
as a cc/s to be handled as
a test dimension.
No further special characteristics are determined in the design phase.
The special characteristic is specified in the technical documentation of the
development phase (in particular in the drawing — see the illustration on the
first page of this example) and is forwarded to the technical documentation
department for production planning.
88 89