Browse Topic: Traceability

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Customer Challenges Lead to Innovative SolutionsTBMG-3533610/1/2019
Contract manufacturers have an increasingly critical role in medical device manufacturing. For original equipment manufacturers (OEMs) that choose to outsource manufacturing operations, a successful contract manufacturing organization (CMO) partnership can help ensure that a new product will reach the market sooner, achieve financial success, and deliver high-quality innovation to end users.
Strategies for Low-Risk Sourcing of Components in a Constrained MarketTBMG-345626/1/2019
The medical device industry often looks to independent distributors to address chronic shortages in the availability of electronic components. Direct sourcing of electronic components for the medical device industry used to be pretty simple. An OEM would order direct from the manufacturer or through authorized distributors to obtain any required components. There was usually no need to look any further.
OBD Traceability MatrixJ1939-90_201902 (Historical)2/5/2019
This Information Report is intended to supplement the J1939 documents by offering the application of SAE RP J1939 to OBD data communications in a form that can be sorted and searched for easier use. It is NOT intended as a substitute for the actual regulations and standards documents, and any discrepancies between this document and the published documents must be resolved in favor of the published documents. This spreadsheet outlines elements in ARB OBD II and HD OBD requirements and identifies which J1939 SPNs and messages may be used to satisfy the datastream, readiness, in-use ratio, and test results requirements.
Truck Bus Control and Communications Network Committee
Feedback on Application of MBSE to an Avionics Subsystem2018-01-192210/30/2018
In avionics domain, currently most engineering efforts and costs come from integration, verification and validation activities. Each error found on requirements during product verification or validation requires a full engineering cycle to manage the change: impact analysis, design, realization, integration, verification and validation again. Hence, ensuring early and continuous validation of requirements in the engineering life cycle, becomes more and more crucial. In this paper, a Model-Based Systems Engineering (MBSE) approach is proposed. The proposed approach relies on SysML models and is composed of modelling tasks to capture requirements and to structure functional interfaces and functions. This approach has been applied in the frame of SAE ARP4754A aerospace recommended practices. This paper also provides feedback about the application of the proposed approach on an industrial avionic case study known as the Onboard Maintenance System by a team mainly used to document centric approach until recently. The feedback concerns the practical use of models to support functional part of the following processes: requirements capture, requirements validation, and top-level part of development of system architecture. After presenting the pilot case, results are given and discussed on several points: the lessons learned during and after application of the MBSE approach to identify use cases, to define black box scenarios, and to build the top-level functional architecture. Comments about the approach are given, e.g. use cases granularity, modelling stop criterion, communication between systems. Then, measured advantages and drawbacks of this modelling approach are discussed. The paper finally describes the challenges identified for wider adoption in the company and the remaining points of attention when extending the approach on a larger project.
Tang, Jian, Zhu, Shaofan, Faudou, Raphael, Gauthier, Jean-Marie
New Reference Material Ensures Validity of Test ResultsTBMG-276249/28/2017
A new reference material is primarily intended for use in calibrating procedures and devices for the determination of C-reactive protein (CRP) in human serum. It can also be used for value-assignment of in-house calibrator solutions and control materials.
Compliance Verification Matrix (VM) Slash Sheet for AS6174A, Counterfeit Materiel; Assuring Acquisition of Authentic and Conforming MaterielAS6174/1 (Current)4/11/2017
The verification matrix (VM) in this slash sheet is intended for use to establish compliance to AS6174A. This slash sheet is applicable to AS6174A. Nothing in this slash sheet, however, supersedes applicable laws and regulations, unless a specific exemption has been obtained through judicial/legal channels.
G-21 Counterfeit Materiel Committee
Handbook: The Program Managers' Guide to the Integrated Baseline Review ProcessGEIAHB748_1 (Current)10/1/2014
This guide clearly defines the purpose, goals, and objectives of an IBR. It also describes the attributes of an effective IBR and discusses a baseline review process that will lead to a better understanding of program risks. It provides a common definition and framework for the IBR Process. This process harmonizes, and to the extent possible, unifies the management objectives for all PMs. The IBR Process enables managers to effectively utilize the project Performance Measurement Baseline (PMB) to assess performance, and to better understand inherent risks. The IBR Process should continue throughout the life of a project.
G-47 Systems Engineering
Five Strategies for Improving Aerospace Supply Chain Quality Management and Performance2014-01-22319/16/2014
Aerospace suppliers face the daunting task of constantly improving time-to-market, reducing cost of quality and turning compliance into a competitive advantage. Managing to these constraints while staying profitable is a challenge faced by the entire aerospace supply chain face today. The intent of this presentation is to share five lessons learned on how aerospace suppliers can optimize for these three constraints while growing their businesses. The first is electronically enabling traceability both within a multi-tier supply chains and throughout suppliers. Automating traceability at the shop floor improves quality management and accelerates compliance. Specific methodologies and metrics used to accomplish this will be provided. Second, lessons learned from implementing Manufacturing Execution Systems (MES) showing how shop floor visibility has a direct effect on supplier performance is illustrated with case studies and metrics. Third, lessons learned in making compliance pay by benchmarking performance to AS9100C, ISO9001, and ITAR standards is provided. Fourth, integrating engineering, program management, project management office, accounting and finance workflows together provides exceptional insight into the value of a project in real-time. Examples and metrics of performance will be provided illustrating this point as well. The final lesson learned is that having a single, unified system of record across a diverse aerospace supply chain leads to greater gains in collaboration and communication, leading to proven profitability gains.
Columbus, Louis
Integrated Technologies Take Medical Device Development to the Next LevelTBMG-200767/1/2014
According to the Journal of Patient Safety, a whopping 210,000 to 440,000 deaths attributable to medical errors occur in hospitals every year. Clearly, there is a desperate need for technology to take a leading role in medical device development in order to improve patient outcomes and save money. The two emerging technologies in the medical space are context-aware technology and multi-input technology.
Innovation in Product Data Management to Unlock the Efficiency Potential of the Company2013-01-21239/17/2013
From a past perspective, System Engineering was able to control the product data accuracy with respect to its requirements and towards product certification and delivery avoiding operational disruptions in the development lifecycle. But we usually do it by increasing the complexity of the product data management and administration what makes heavier the product integration. The trends indicate that the product complexity is intensifying and that the increasing load rate of changes will create serious efficiency disruptions if we persevere with today System Engineering approaches. New System Engineering paradigm is then proposed. It conducts to an innovative management of product identification and business integration. It is supported 4 key pillars: The Semantic Product Identification The Business Driven Intelligence The Product Life-Cycle Social Management The Data Management of Things It is highlighted the wide range of possibilities that could offer new product data aggregation laws based on correlating semantic context information. The other elements of the new PDM paradigm add an apparatus of synergy, management and lean architecture principles of the solutions. The benefits of a new integrated Systems Engineering will grant: 1) better data continuity and integration across domains, lifecycle & supply chain; 2) intensify data re-use; 3) create easy data access, consistency & transparency; 4) enable flexible interfaces between business processes; 5) Ease traceability of information and processes; and 6) Increase user acceptance on PLM solution approaches.
Martinez-Ablanedo, Moises
National Instruments13OFHD0613_016/13/2013
Keeping pace with increasingly intelligent machines Embedded systems are providing new levels of efficiency, performance, and safety to off-highway vehicles. Advances in fuel-efficiency through improved combustion techniques and hybrid powertrains are impacting the cost to operate while automatic GPS navigation and software-enabled implements are allowing equipment to accomplish more during operation. However, as embedded devices become more ubiquitous, engineers are facing significant challenges to ensuring the quality of these devices on time and on budget. To keep pace with this rapidly evolving complexity while also ensuring safe, high-quality vehicles, development teams must evolve the methods organizations use to design and validate embedded software.
Truchard, James
Continuity of a System Engineering Referential Repository Applied on an Aerospace Use Case2012-01-214210/22/2012
A major challenge of a System Engineering approach lies in its ability to promote an efficient Process/Method/Tools environment that leads to an efficient and accurate System Referential Repository. The key factor is the definition of a centralized system referential repository that is shared by the various stakeholders involved in the success of industrial projects, including customers, system architects, hardware and software development suppliers, validation and safety teams. This paper describes the development of a use case modeled with the most appropriate tool-chain that fulfills the above System Engineering expectations. Based on standard documents (INCOSE Handbook, ARP4754) and on experience achieved by the development of many System Engineering projects, a methodological approach is defined. This approach includes the complete process from textual requirements, to operational description, to functional breakdown, to technical architecture, and finally to certified software generated from models. An aerospace use case is selected that covers the main steps of this System Engineering approach. Based on an existing benchmark framework that includes cartography of tools, criteria, test means and use cases of several System Engineering tools, the SCADE® tool chain is selected because it offers an appropriate solution for the approach. The main tool that is used is SCADE System, which is suited for the System Engineering steps of the approach, including operational and functional analysis, architecture definition and allocation. Several graphical views of the Use Case, including subsystem parts, are developed for operations, functions, interfaces, components, all using a subset of the SysML standard (IBDs and BDDs diagrams) that is embedded into SCADE System. The SCADE Suite tool, for control logic and algorithm design, is also used for the modeling of some parts of the software behavior. The consistency checks and traceability links applied to the several layers of information embedded into the System Referential Repository are provided by the SCADE tool-chain. As demonstrated by the Use Case, SCADE System is tailored to the main requirements of the System Engineering process. SCADE System's graphical representation facilitates the communication among all of the teams. A System Referential Repository is built that is continuously used and enriched by all of the project stakeholders in the course of the development. Next step consists of improving some other System Engineering key tasks, such as modeling and simulation of a sequence of operations and functions, discrete modeling and simulation (state/event/transition) for the behavior of functions, continuous modeling and simulation for the behavior of the component of the product architecture, and support for the safety analysis based on FMEA generated from model.
Vuillemin, Bruno
Integration of Axiomatic Design into a Corporate Development Environment2005-01-15254/11/2005
Axiomatic Design is a powerful tool conceptualizing and analyzing a design at the earliest practical point. In addition to its analytic capabilities axiomatic design captures and preserves design intent and can provide a powerful traceability capability. As Axiomatic Design use expands to cover larger and more sophisticated development programs companies need to address specific changes in their internal design processes and in the integration of these processes into an overall product development environment.
Hamilton, Al
Developing solutionsOFHAPR05_074/1/2005
SAE 100 Future Look: The global automotive industry has faced considerable challenges over the last couple of years, to the extent that industry pundits have labeled the current environment as “The Perfect Storm.” The entire global mobility industry has faced considerable challenges over the last couple of years, to the extent that industry pundits have labeled the current environment as “The Perfect Storm.” The turmoil is a result of overcapacity, ultra-competitive environments, fluctuating commodity prices, high incentives, pension and health costs, and environmental and regulatory pressures. To compete in such an environment, the industry must leverage a strategy similar to that of many other industries: increase levels of innovation to provide unique customer features enabling a differentiated product. However, since the ability to extract a price premium for these innovative features is not very high, there is an added constraint of improving productivity to maintain profitability. This squeeze has been labeled as the “dreaded vice.”
Shepherd, Brian
Developing solutionsAUTOJAN05_121/1/2005
SAE100 Future look: The global automotive industry has faced considerable challenges over the last couple of years, to the extent that industry pundits have labeled the current environment as “The Perfect Storm.” The turmoil is a result of overcapacity, ultra-competitive environments, fluctuating commodity prices, high incentives, pension and health costs, and environmental and regulatory pressures. To compete in such an environment, the automotive industry must leverage a strategy similar to that of many other industries: increase levels of innovation to provide unique customer features enabling a differentiated product. However, since the ability to extract a price premium for these innovative features is not very high, there is an added constraint of improving productivity to maintain profitability. This squeeze has been labeled as the “dreaded vice.”
Shepherd, Brian
Reusable Software for Autonomous Diagnosis of Complex SystemsTBMG-30413/1/2002
A software system designed to provide a purely signal-based diagnosis of virtually any time-varying system has been developed. This software is part of an overall concept called “Beacon-based Exception Analysis for Multimissions,” or BEAM. This concept provides for real-time autonomous diagnostics and prognostics of virtually any complex system (e.g., intelligent spacecraft or advanced aircraft) by use of software executed on an embedded computer.
Configuration Management of Software for Designing HSCT4.0TBMG-3004310/1/1999
A report discusses the development of a highly complex system of distributed-computing, multidisciplinary design-optimization software, called "CJOpt," for use in research on model 4 of the High-Speed Civil Transport (HSCT) airplane (HSCT4.0). The emphasis in the report is on the application of formal software configuration management (SCM) to ensure the integrity of, and the traceability of changes in, the optimization software.
Vehicle Electronic Systems Integration92250111/1/1992
As power trains become more electronically complex, the process of vehicle requirements definition and electronics integration requires greater structure. Elements of the necessary structured process may be evolved from aerospace systems engineering processes, while specifically avoiding some of the inefficiencies associated with military development. The advantage of the structured process is that it facilitates needed decision making with regard to vehicle parameters which ultimately drive the bottom line transportation cost. Such a structured process is discussed, as well as the more classic integration functions such as standards, specifications, interface control, and integration and test.
Doskocil, D. C.
NATIONAL AEROSPACE AND DEFENSE CONTRACTORS ACCREDITATION PROGRAM (NADCAP)REQUIREMENTS FOR ACCREDITATION OF PASS-THRU DISTRIBUTORSAS7201 (Historical)10/1/1991
This aerospace standard outlines minimum quality assurance requirements common to commodities which must be met by a "PASS-THRU" distributor for third party accreditation.
Nadcap Management Council
Metrology: A Definition of Quality9109484/1/1991
Since defining quality so it will be accepted from company to company is a difficult task. This paper will discuss definitions of quality and how metrology can assist a company in defining its' quality. The title; Metrology:A Definition of Quality implies an explanation of how metrologists thinking has become important to companies committed to quality. This paper discusses the advantages quality programs derive from having metrology heavily involved in their processes and procedures. This paper also talks about the changing role of metrologists from strictly calibrating of the test equipment to applying process metrology in order to ensure the overall quality of the products.
Crain, Clark R.
Managing Engineering for Profit in the Aerospace Industry6708352/1/1967
Management of engineering for profit is examined from the establishment of company objectives in the advanced planning stage through the planning and control of major programs. Five major areas are discussed: advanced program planning, managing small projects, developing the engineering processes leading to integrated major program plans, controlling the engineering effort, and managing the engineering rates. These five areas range from highly creative concepts to detailed control techniques. Approaches which have proven useful for reducing costs and maximizing profits are outlined. The delineation of authorities, responsibilities, and accountabilities is made where applicable. Actual examples from existing projects are included. The management techniques which are described are considered generally applicable to any large aerospace company where the major target is the capture and efficient execution of large complex programs. These management techniques could be extended to apply to other industries.
McCarthy, J. F., Aschenbrenner, F. A.
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