RTCA DO-178B and EUROCAE ED-12B set rigorous safety standards on the commercial aerospace industry governing both the quality of the flight software embedded in aircraft and the processes and tools used to produce the software. The standards require engineering organizations to implement lifecycle processes that emphasize requirements-based development and independent verification for safety-critical embedded applications. Strong emphasis is also placed on change and configuration management as the basis for repeatability, traceability, and third-party reviews. Further, organizations must apply these processes uniformly across all product development lifecycle artifacts, from requirements to test plans and results, rather than simply to software configurations.
There are numerous updates and enhancements included in DO-178C/ED-12C. Among them are modernization of the standards to address newer development methods such as model-based development, object-oriented technology, and formal methods. The new standards also provide more comprehensive guidance on tool qualification across the lifecycle, including practitioner tools used to automate the new practices already mentioned.
Organizations already using PTC Integrity to unify the lifecycle have been able to adapt to the additional requirements of the 'C' revisions with less disruption because they already have an integral view of all lifecycle information. They also find it easier to adopt newer methods, such as model-based development, adapting their lifecycle processes to meet certification requirements associated with the new methods using PTC Integrity's single, integral data model and workflow engine.
Mounting Challenges in Software Certification and Tool Qualification
Certification agencies, Designated Engineering Representatives (DERs), manufacturers, and suppliers are facing numerous challenges as they attempt to adapt to the relentless pace of change in the industry. Certification and qualification processes that were sufficient just a decade ago are failing to address the industry shift to software-driven innovation. Among the many challenges the industry is struggling to solve:
- Software changes relentlessly, in much greater volume, at a much faster rate, across the entire product lifecycle, including engineering, manufacturing, and service. This creates myriad challenges in change and configuration management processes and tools, especially when change must be tracked across such a wide range of engineering lifecycle artifacts
- Establishing, maintaining, and tracking traceability across all artifacts and throughout the full product lifecycle becomes overwhelming
- Modern engineering practices make certification and qualification using a standard that is nearly two decades old more challenging:
- Model-based development places models traditionally used peripherally for design into a much more central role in the lifecycle, including simulation, verification, and validation — challenging traditional approaches to certification and tool qualification
- Agile/lean methods are employed to increase agility and reduce lifecycle cost and schedule, but must be adapted to engineering development lifecycles designed to meet the stringent requirements of aircraft certification
PTC Integrity addresses the challenges of DO-178/ED-12
PTC Integrity enables engineering organizations to solve these challenges by providing a single, integral source of truth for the entire engineering lifecycle, including software artifacts. It is purpose-built to enable tracking of change, configuration, and traceability across all lifecycle artifacts in a single data model. Tool suites built by lashing many point tools together fail to provide the same comprehensive visibility, control, and tracking across all lifecycle artifacts, leaving the organization to collect the information needed to satisfy the standards from multiple sources which often overlap in some areas and leave gaps in others — resulting in an incomplete and inconsistent view of the lifecycle.
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International standards such as ISO 26262, a new functional safety standard for the automotive industry, provide frameworks to improve company policies, practices and processes. Public perception and government regulations compel automotive development organizations to adhere to the relevant standards. While these standards are an opportunity to improve process and product quality and safety, they also impose risks to cost efficiency and development cycle time. The ultimate responsibility for compliance is on the vehicle manufacturer. Thus a higher capability level in CMMI or Automotive SPICE and ISO 26262 compliance gives suppliers significant competitive edge.
Implementing standards can be time-consuming and expensive. It has been estimated that complying with ISO 26262 may cost the automotive industry hundreds of millions of dollars. This is further complicated by the global and differentiated development environment of today's automotive industry; applying standards to processes and artifacts across multiple isolated systems and disciplines is a daunting task.
Automobile engineering companies have turned to PTC Integrity as a compliance solution certified by compliance certification bodies such as TÜV SÜD Automotive GmbH. The following are examples of capabilities provided by PTC Integrity that have reduced the cost and the time required to implement and prove compliance:
- Manage all assets and processes in a single data model, from requirements to test results, models and calibrations, and risks and mitigations
- Manage end-to-end traceability of these assets and be able to show that every requirement has been validated and every risk has been mitigated
- Ensure strict change management procedures are adhered to across all lifecycle assets
- Automate and enforce compliance requirements for model-driven development (MDD), providing trace-through model support
PTC has been a trusted partner to leading OEMs and suppliers in the automotive industry for more than ten years. Our customers have been able to reach and demonstrate compliance in the following standards quickly and efficiently:
- Automotive SPICE (ISO/IEC 15504) — With the shift to a greater reliance on software for product innovation and differentiation, automobile engineering companies are turning to ISO/IEC 15504, otherwise known as Automotive SPICE, to improve the way that software is developed and as a means to evaluate the capabilities of potential suppliers. PTC has been a thought leader in software development for more than 10 years, and has provided custom software development process management solutions to major automotive engineering companies
- ISO 26262 — Safety is one of the key issues of today's and tomorrow's automobile development. With the complexity, software content, and electronic implementation in today's vehicles, there are increasing risks of systematic failures that can lead to unsafe conditions. ISO 26262 is being developed to reduce risks by providing feasible requirements and processes
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The FDA and ISO 14971:2007 both acknowledge that the use of medical device technology entails some level of risk. The goal of risk management is to reduce product risk and to identify and understand the level of remaining risk and the impact that has on the user's safety and the effectiveness of the product. PTC Integrity provides a configurable framework to apply the risk management practices of ISO 14971:2007 which allows organizations to improve the safety and effectiveness of their devices and enables them to demonstrate regulatory compliance. The benefits of using PTC Integrity for risk management of medical devices include:
- Compliance with ISO 14971:2007 — The PTC Integrity solution for medical device companies provides a configurable Risk Management platform that leverages ISO 14971 risk management methodologies through the implementation of Hazard and Risk Analysis documentation, coupled with risk management and risk control processes that can be traced to product design as well as verification and validation records.
- Automation of Complex Reports — ISO 14971:2007 and the regulatory requirements based upon this standard have specific reporting requirements, including the generation of a Risk Management File which details the risk analysis, risk evaluation, the implementation and verification of the risk control measures; and the assessment of the acceptability of any residual risk(s). PTC Integrity automates the generation of this report through built-in traceability reports, allowing companies to easily export all of the risk documentation and any traced artifacts and verification results.
- Configurable Risk Metrics and Policies — Organizations can tailor the PTC Integrity solution and refine the terminology to suit their needs. For example, the values for Severity and Occurrence on a Risk may have their definitions modified to be quantitative rather than qualitative. The computations used to determine Risk Level (Acceptable, Unacceptable, Investigate) may also be tailored for the organization on a per-project basis to allow the solution to be applicable to a variety of devices with distinct intended uses. Support is also provided for RPN calculations of Risk.
- Risk Coverage Charting and Reporting — Through real-time charting and reporting, PTC Integrity enables engineers to at a glance determine coverage across each of the risk domains. This includes the ability to identify Hazards that have no corresponding Risks, Risks that have no corresponding Mitigation or Control Measure, as well as Risk Control Measures which have not been verified.
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Automotive SPICE (ISO/IEC 15504)
Since the release of SPICE (ISO/IEC 15504) as an international standard in 2006, many engineering organizations are driving initiatives to achieve compliance on both organizational and project levels. Based on ISO 12207, SPICE describes best practices and standards for primary, supporting and organizational processes for software engineering in a system context. The industry-specific adoption "Automotive SPICE" is the standard for supplier assessments.
PTC Integrity is a platform to manage engineering processes and activities in one common platform, using one powerful workflow engine and a single coherent repository. It supports organizations to implement the generic practices and comply step by step with the nine process attributes that are required to move from SPICE level 1 to 5.
PTC Integrity does not force engineering organizations to adopt heavyweight process models when there is no need. Instead it allows them to start with the most important core processes and to expand the global development process to cover the other relevant processes and generic practices, achieving higher SPICE levels step by step.
- One single platform to manage all engineering assets throughout the software development lifecycle (work product management)
- Full traceability between engineering assets and process items such as change requests
- Powerful workflow modeler and engine for business rules (process definition and deployment)
- Multi-level relationships keep processes in synchronized and form one coherent process environment
- Metrics and Dashboards for process measurement
- Coherent platform and workflow engine for global process control
- Defined feedback process on global process fosters continuous global process improvement
- Process tailoring capabilities for projects enable project teams to comply with global process definition and still work as efficiently as possible
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TL 9000 is a variation of the ISO 9000 standard specific to the telecommunications industry. It was developed more than a decade ago to meet the supply chain quality requirements of the global communications industry and it defines quality system requirements for design, development, production, delivery and service. In addition to quality systems it specifies consistent measurements that organizations can use to evaluate the effectiveness of quality implementation and improvement programs and to compare to industry benchmarks.
However, the standard has drawbacks. The additional overhead in implementing, maintaining and certifying compliance to the standard as well as compiling the metrics makes many organizations hesitant to apply it. TL 9000 includes four additional areas that are not in the ISO 9000 standard, including the TL 9000-S certification for software development and lifecycle management. The increasing reliance on software as a differentiator in the high-tech electronics industry, combined with the high velocity of change characteristic of software development, makes achieving TL 9000-S or TL 9000-HS certification a daunting prospect.
As the global software development solution chosen by market-leading suppliers and providers in the telecommunications industry for close to 10 years, PTC Integrity has the capabilities organizations need to reduce the overhead of TL 9000 certification and maximize its potential efficiency gains.
PTC Integrity is a truly integral global software development solution which incorporates all software development processes and artifacts in a single source of truth. It delivers:
Comprehensive and easily demonstrable traceability
- Organizations that rely on a collection of tools, documents and spreadsheets to manage software development activities find the demands for traceability of requirements and design changes to software releases in section 7 of the standard extremely time-consuming and error-prone. PTC Integrity seamlessly connects every activity and asset to related activities and assets throughout the entire product development lifecycle. Requirements can be traced to designs, models, tests, code, and releases in a single source of truth, and traceability can be demonstrated with mouse clicks.
Change control and configuration management
- At the core of the PTC Integrity solution are process-driven software configuration, software change management (SCCM) and software reuse capabilities that deliver the control of design and development changes and the release and delivery of software products stipulated in section 7.
- PTC Integrity's test management enables engineering organizations to improve product quality efficiently through its support for requirements-based testing and parameterized testing, and its test artifact reuse capabilities. PTC Integrity's test management orchestrates testing activities and documentation, enabling communications development companies to quickly meet the TL 9000 test planning and execution requirements.
Real-Time Cross-Discipline Visibility into Product and Process
- PTC Integrity provides dashboards and reports with real-time metrics gathered automatically from development activities, including key TL 9000 metrics such as defects and software fixes. Instead of requiring person-days of aggregating and compiling data from multiple systems, PTC Integrity provides the data at a mouse click, even across disparate teams.
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