Tag Archive for: Product Development & Management Page 17
Tag Archive for: Product Development & Management
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Reuters, titled “Canada investing C$350 million to boost drive for sustainable aerospace industry” – originally reported by David Ljunggren, edited by Jonathan Oatisand, and published on June 19, 2023.
Canada Investing C$350 Million to Boost Drive for Sustainable Aerospace Industry
OTTAWA, June 19 (Reuters) – Canada is investing C$350 million ($265 million) to help fund efforts to make the aerospace industry more environmentally sustainable, Innovation Minister Francois-Philippe Champagne said on Monday.
The focus will be on hybrid and alternative propulsion, aircraft systems, the transition to alternative fuels, and aircraft support infrastructure, he said in a statement.
“(This) … will help drive and accelerate the green industrial transformation of Canada’s aerospace industry, generating high-value jobs while strengthening supply chains and supporting the transition to a net-zero economy,” he said.
Earlier this month, global airlines called for broad co-operation to reach “very tough” emission targets. Aviation, which produces around 2% of the world’s emissions, is considered one of the hardest sectors to decarbonise.
The C$350 million includes a C$49 million aerospace innovation investment announced in 2019.
Airbus said in 2021 it was working on hybrid-electric propulsion among the options for reducing jetliner emissions. It has pledged to introduce the first hydrogen-powered commercial plane in 2035.
In 2019, Vancouver-based seaplane operator Harbour Air carried out the world’s first fully electric, commercial flight.
($1 = 1.3202 Canadian dollars)
https://www.jamasoftware.com/media/2023/06/Canada-AD-Investment.png5121024Jama Software/media/jama-logo-primary.svgJama Software2023-06-27 03:00:142024-01-17 23:55:02Canada Investing C$350 Million to Boost Drive for Sustainable Aerospace Industry
Solving Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry with Jama Connect®: Part 2
Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®
Six Key AECO Challenges Continued…
CHALLENGE #4 – Inability to Track and Manage Owner Changes
The AECO industry is a complex and dynamic industry that involves many stakeholders and moving parts. One critical aspect of managing AECO projects is conducting change impact analysis, which involves evaluating the potential effects of proposed changes to a project’s design, scope, schedule, and cost. The inability to effectively track and manage change can lead to significant negative impacts on project outcomes.
For example, without a proper analysis, changes may be implemented without understanding their full downstream consequences, resulting in unexpected delays, cost overruns, safety hazards, and quality issues. Furthermore, failing to conduct a change impact analysis can undermine project team collaboration, trust, and communication, leading to increased conflicts and disputes. Therefore, incorporating change impact analysis into AECO projects is crucial for ensuring project success and minimizing risks.
A real-world example might be: One contractor decides to make a window larger. This change might impact the structure of the building, air conditioning needs, electrical placement, the roof, and even violate building codes. While a simple change like this may seem insignificant, it will often have ripple effects throughout the development process. Without proper visibility, collaboration, and consideration, this can result in rework, delays, and increased costs across the board.
Jama Connect is a powerful tool that can help the AECO industry effectively manage change by providing a centralized platform for capturing, tracking, and analyzing changes across the end-to-end project development lifecycle. Jama Connect’s change management capabilities enable project teams to quickly assess the impact of proposed changes and make informed decisions about their implementation. With Jama Connect, project teams can easily collaborate and communicate about change requests, ensuring that all stakeholders are aware of the potential impacts and can provide input. Additionally, Jama Connect provides real-time visibility into the status of changes, allowing project teams to proactively identify and address any issues that arise. This level of transparency and control helps to reduce the risk of errors and delays, ensuring that projects are delivered on time and within budget. Overall, Jama Connect is an essential tool for the AECO industry to effectively manage change and ensure project success.
In the AECO industry, design review processes are critical to ensure the quality and compliance of construction plans. However, inefficient design review processes can lead to significant delays, cost overruns, and mistakes in the final product. One common issue is the lack of clear communication and coordination between different stakeholders, such as architects, engineers, contractors, and clients. This can result in conflicting feedback, revisions, and approvals that prolong the design review process. Additionally, outdated or manual review methods, such as paper-based markups and physical meetings, can further slow down the process and increase the likelihood of errors. Overall, improving the efficiency of design review processes in the AECO industry requires better collaboration tools, streamlined workflows, and clear communication channels.
Jama Connect can play a significant role in streamlining the design review (and design verification) process in the AECO industry by enabling collaboration, improving communication, and reducing errors. It is required that engineering firms provide specific validation of how their proposed design meets the original owner’s requirements, and with Jama Connect, that process is simple.
Here are some specific ways Jama Connect can help with the design review process:
Centralized platform for design review: Jama Connect provides a centralized platform for design review, allowing all stakeholders to access the latest designs, review comments, and feedback in real-time. This eliminates the need for stakeholders to send design documents back and forth via email, which can be time-consuming and result in errors.
Collaborative review process: Jama Connect enables collaboration between all stakeholders during the design review process and documents the history of every change, who made it, and why. Stakeholders can provide feedback and comments on designs, and other stakeholders can respond to those comments, creating a collaborative feedback loop. The ability to trace designs back to the original requirements is a key component of moving smoothly through the design process, and with Live Traceability™ within Jama Connect, this traceability is automatically created as you go through the design and review process and gives an owner a complete record for their project. This helps to ensure that all stakeholders are on the same page, reducing errors and misunderstandings.
Version control and tracking: Jama Connect provides version control and tracking features that allow stakeholders to see the history of design changes, track who made each change, and ensure that everyone is working with the latest version of the design. This helps to avoid errors that can occur when stakeholders work with outdated or incorrect design documents.
Approval workflows: Jama Connect allows organizations to define and enforce approval workflows for design reviews. This ensures that designs are reviewed and approved by the appropriate stakeholders before being finalized, reducing the risk of errors and ensuring compliance with industry standards and regulations.
Reporting and analytics: Jama Connect provides reporting and analytics features that allow organizations to track the progress of design reviews, identify bottlenecks, and analyze review data. This helps organizations to continuously improve their design review process, reducing errors and improving efficiency over time.
Accountability is essential in the AECO industry, as it ensures that all stakeholders are responsible for their actions and decisions. This includes ensuring that project requirements are met, timelines are followed, and budgets are managed effectively.
Jama Connect can help solve this challenge by providing a platform for managing project requirements. This includes defining responsibilities and tracking progress against milestones. This helps ensure that all stakeholders are accountable for their actions and decisions.
Conclusion
In conclusion, while the AECO industry is facing many unique challenges, there is also an opportunity for process improvement that will allow stakeholders to reduce delays, project risk, and overspending. Jama Connect can help facilitate collaboration, prevent scope creep, reuse requirements, designs, knowledge, and components, and improve the design review process. By leveraging Jama Connect, AECO organizations can overcome many of the challenges they face and meet the evolving needs of clients and society while navigating a rapidly changing business landscape.
Click HERE for part 1 of this series and HERE to download the entire whitepaper,
“Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®“
https://www.jamasoftware.com/media/2023/06/2023-6-20-AECO-part2-1-1.jpg5121024Peter Billante/media/jama-logo-primary.svgPeter Billante2023-06-20 03:00:082024-01-18 00:01:34Solving Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry with Jama Connect®: Part 2
Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know
As a product development team working in the medical device sector, assuring the dependability and safety of your products is crucial. FMEDA, or failure modes, effects, and diagnostic analysis, is a method frequently used to assess potential failure modes and their consequences on the entire system.
What is FMEDA?
FMEDA is a rigorous and structured analysis technique used to predict the potential failure rates, failure modes, diagnostic capabilities, and their impact on a system or product. It is a quantitative approach that helps in understanding the failure rates and probabilities of different components, the suitability of the diagnostic functions of the design for subsystems of a product.
FMEDA is an essential step in the product development process since it aids in the detection of probable faults and their effects on the performance of the system as a whole. It also evaluates the potential efficacy of the implemented diagnostic functions in the subsystem or product design. It is used to assess a product’s dependability and safety and aids in the detection of any possible system failures.
FMEDA is frequently applied to complicated systems with numerous components and subsystems. It is commonly used in the medical device sector to assess the product’s safety characteristics, and to confirm that the design is suitable and safe to be used in the medical device industry.
There are various steps in the FMEDA process. The system or the subsystem is first divided into all of its component designs. The impact of each failure mode on the safety related functions of the design, as well as the diagnostic functionality coverage to identify the failure modes and to prevent occurring those, are then taken into consideration while evaluating the safety characteristics of the system or subsystem design.
The severity, frequency, and detectability of the failure modes are all taken into account while rating them. The impact of the failure on the system’s or product’s overall performance is referred to as severity. The terms “occurrence” and “detectability” describe the possibility that a failure will occur and the capacity to identify the failure mechanism, respectively.
Based on the system’s capacity to identify the failure mechanism and take appropriate action to lessen the effects of the failure, the diagnostic coverage is assessed.
The data is then utilized to determine the system or product’s overall failure rate and probability after each component’s failure modes, their consequences, and diagnostic coverage have been assessed for each one.
What makes FMEDA crucial?
FMEDA is significant for a number of reasons. It is beneficial to first recognize probable failure modes and how they may affect a system or product. The evaluation of the efficiency and suitability of the diagnostic coverage of the design provides further insights for developers on system or product safety. This information is essential for identifying any hazards the product can have and making sure it complies with all applicable regulations.
Secondly, FMEDA contributes to ensuring the product’s dependability and safety. Product development teams can take the necessary steps to reduce the consequences of probable failure modes and enhance the product’s overall performance and dependability by identifying potential failure modes and assessing their influence on the system or product.
Finally, FMEDA decreases the overall cost of product development. Early in the development process, teams can identify potential failure modes and take the necessary steps to mitigate those failures before they become significantly more expensive and time-consuming to fix.
The bottom line is, FMEDA is a crucial step in the creation of new products for the medical device sector. It helps organizations ensure product’s safety and dependability, the identification of probable failure modes and their effects on the system or product, and the reduction of the overall cost of the product development process.
Understanding the FMEDA method and how it’s applied to improve the safety and dependability of your products is crucial for the product development team. You can make sure that your products comply with regulations, are trustworthy and safe, and satisfy the demands of your customers by incorporating FMEDA into the development process.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by McKenzie Jonsson and Vincent Balgos.
https://www.jamasoftware.com/media/2023/06/2023-06-15-fmeda-1.jpg270520Vincent Balgos/media/jama-logo-primary.svgVincent Balgos2023-06-15 03:00:242024-01-17 23:58:44Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know
Solving Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry with Jama Connect®: Part 1
Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®
Introduction
The AECO (Architecture, Engineering, Construction, and Operations) industry faces various challenges and opportunities as it adapts to changing market trends and technological advancements.
AECO is the largest industry in the world, according to McKinsey, and makes up 13% of global GDP. The industry has seen a steady increase in demand for sustainable and energy-efficient designs, as well as for innovative building materials and construction techniques. Additionally, digital technologies such as Building Information Modeling (BIM), cloud-based collaboration, and requirements management tools have become more prevalent, enabling better communication and project management across different stakeholders.
However, the industry is also grappling with issues such as a shortage of skilled labor, rising material costs, and increasing regulatory requirements. As such, the AECO industry is undergoing a transformation as it seeks to meet the evolving needs of clients and society while navigating a rapidly changing business landscape.
One of the challenges in adapting to changes in AECO is that a typical project involves many stakeholders, including architects, engineers, contractors, owners, and regulators, often with different business models and goals. These stakeholders must work together to design, build, and maintain the built environment, but structural and contractual agreements often make it difficult to communicate with each other to deliver projects on time and budget.
In this whitepaper, we will explore some of these challenges and how a requirements management solution like Jama Connect® can help solve them.
CHALLENGE #1 – Lack of Collaboration and Poor Communication
Collaboration and communication are essential in the AECO industry but can be difficult to achieve. With dozens, if not hundreds of individual firms involved in any given project, each stakeholder brings their own expertise, agenda, and perspective, which can lead to misunderstandings and communication breakdowns. This can result in rework, delays, and increased costs throughout the development process.
A requirements management solution like Jama Connect can help facilitate collaboration by providing a central repository for all project requirements. For example, the owner could post their original requirements into a Jama Connect environment allowing all stakeholders, project managers, and contracted firms access to the same information to jointly verify that their work is aligned to achieve project goals. Using Jama Connect to manage this process goes beyond just document sharing, by creating a record of verification that the requirements are met, or if there are changes, that those modifications are also tracked and validated back to the source.
CHALLENGE #2 – Scope Creep
Scope creep is a common issue in the AECO industry, where projects can become more complex and costly than initially planned. Scope creep occurs when project requirements expand beyond the original scope, leading to additional work, time, and costs that were not anticipated in the project plan. Broadly, this is referred to as the ‘change order’ process and results in project delays in addition to cost increases. Sometimes the changes result from a lack of clear communication and project management, where changes or additions to the project scope are not properly documented or approved. Additionally, external factors such as changes in regulations, client requirements, or unexpected site conditions can also contribute to scope creep. Managing scope creep in the AECO industry requires a proactive approach, including regular communication and documentation of changes, proper project planning and risk management, and stakeholder engagement to ensure that project expectations are aligned with project scope.
Jama Connect can help prevent scope creep by providing a platform for managing project requirements. This includes defining the scope of the project and ensuring that all stakeholders are aligned on project objectives and their plans are validated against the owner’s project requirements documents. Any changes to the project scope can be easily tracked and managed — in real time — within Jama Connect.
CHALLENGE #3: – Redoing Similar Work Across Multiple Projects
Requirements reuse is a practice in the AECO industry that involves leveraging existing design requirements to develop new projects. By reusing requirements, designers and engineers can save time and resources while improving project quality and consistency. This can be particularly useful for large-scale projects or projects with similar design requirements, where requirements can be adapted and refined to fit new project contexts. Reuse of requirements can also help to ensure compliance with regulations and standards, as existing requirements can be used as a baseline for new projects.
While reuse can save an incredible about of time and money for all stakeholders involved, there needs to be an upfront investment in both tools and processes. To facilitate reuse of requirements, effective requirements management processes and tools are needed to capture, store, and manage requirements. Additionally, collaboration across different stakeholders is important to ensure that requirements are applicable and relevant to new projects.
Jama Connect is a powerful platform that can help the AECO industry with reuse in a number of ways.
Here are some examples:
Requirements reuse: In the AECO industry, many projects have similar requirements. By using Jama Connect, organizations can create reusable templates and structures to reuse requirements across projects, saving time and effort. This can be especially useful for organizations that work on multiple projects simultaneously or for those that have a large number of projects with similar requirements.
Design reuse: Just like with requirements, many projects in the AECO industry require similar designs. Imagine a wind farm project for example, where each of the turbine structures are identical in design. By reusing designs, organizations can reduce design time, improve consistency, and minimize errors. Jama Connect allows organizations to easily store and retrieve design artifacts, making it easy to reuse them across projects.
Knowledge reuse: Over time, organizations in the AECO industry accumulate a lot of knowledge about their projects, including best practices and lessons learned from experience. Jama Connect provides a central repository for this knowledge, making it easy to share and reuse across projects.
Process reuse: Many organizations in the AECO industry have well-established processes for managing projects, for example processes like issue resolution and design-change tracking. By using Jama Connect, organizations can capture these processes and reuse them across projects, improving consistency and efficiency.
Stay tuned for part 2 of this two-part series. Click HERE to download the entire whitepaper,
“Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®“
https://www.jamasoftware.com/media/2023/06/2023-6-13-AECO-part1-1.jpg5121024Peter Billante/media/jama-logo-primary.svgPeter Billante2023-06-13 03:00:032024-01-18 00:03:20Solving Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry with Jama Connect®: Part 1
What is DevSecOps? A Guide to Building Secure Software
DevSecOps has gained popularity as a secure and dependable software development methodology in the fast-paced world of software development. But what is DevSecOps really, and why is it so crucial?
DevOps is a set of techniques that stresses collaboration and automation between development and operations teams. DevSecOps is the integration of security practices into this methodology. DevSecOps seeks to establish a security culture that guarantees the software is secure and complies with compliance standards by integrating security into every phase of the software development lifecycle, from planning through deployment.
The ability to identify and address security risks earlier in the development process is one of the main advantages of DevSecOps. This means that security is incorporated into the software at the outset instead of being added later, which can be expensive and time-consuming. Also, DevSecOps plays a big role in decreased risk of security breaches and data leaks by identifying vulnerabilities earlier.
The fact that DevSecOps helps to ensure compliance with laws and standards is another crucial feature of the practice. In many businesses, especially those that deal with sensitive or private data, including healthcare and banking, compliance is becoming more and more crucial. DevSecOps aids in ensuring that the software complies with requirements by incorporating compliance into the development process.
How does DevSecOps work?
What does DevSecOps look like in practice? DevSecOps is fundamentally about cooperation and communication between teams working on development, security, and operations. This implies that everyone bears some kind of responsibility for security, not just the security team. Instead of adding security features later, development teams collaborate with security and operations teams to incorporate security into the software from the start.
The automation of DevSecOps is a crucial element. Automation makes the development process more efficient, reduces errors, and ensures consistency. DevSecOps can aid in the quicker and more precise detection of vulnerabilities and threats by automating security testing and other security operations.
Continuous monitoring is a key component of DevSecOps. This means that maintaining security involves ongoing monitoring and improvement rather than being a one-time action. DevSecOps can assist in identifying and mitigating risks before they turn into significant concerns by continuously monitoring the program for security threats and vulnerabilities.
DevSecOps also depends on a culture that values security. As a result, security is more than just a collection of guidelines; it’s also a way of thinking and conducting business. Organizations may ensure that security is always a top priority and that everyone is aware of the significance of security in their work by developing a culture of security.
DevSecOps is a vital method of software development that places an emphasis on teamwork, automation, and constant monitoring. DevSecOps contributes to the creation of a security culture that guarantees the software is secure and complies with regulatory standards by integrating security into every phase of the software development lifecycle. Organizations that implement DevSecOps are well-positioned to produce secure and dependable software that satisfies the needs of their stakeholders and customers given the growing relevance of security in today’s society.
There are numerous online resources, like blogs, podcasts, and online courses, that you may use to learn more about DevSecOps. In the world of DevSecOps, there is something for everyone, whether you are a developer, security expert, or operations specialist.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by McKenzie Jonsson.
https://www.jamasoftware.com/media/2023/06/2023-6-8-devsecops-1.jpg5121024McKenzie Jonsson/media/jama-logo-primary.svgMcKenzie Jonsson2023-06-08 03:00:342024-01-18 00:02:33What is DevSecOps? A Guide to Building Secure Software
European Cooperation for Space Standardization (ECSS) Standards and Engineering Guidance
The exploration of space and the development of technology have long been at the forefront of human ambition and ingenuity. As organizations in the European space sector strive to build new space systems, cooperation and standardization become vital components for success. The European Cooperation for Space Standardization (ECSS) plays a crucial role by setting standards and providing engineering guidance in Europe. In this blog post, we will delve into the significance and impact of the ECSS standards and engineering guidance on space missions.
Setting the Stage for Collaboration
The European Cooperation for Space Standardization (ECSS) initiative was established in 1993 to encourage collaboration among European space agencies, industries, and research institutions. Its primary objective is to create and maintain a consistent set of standards and engineering guidance for space-related operations. By aligning standards and technical procedures, the ECSS enhances the compatibility of systems and equipment across various European space programs, thereby improving the cross-nation development supply chain, security, and effectiveness of those space programs.
ECSS Standards: Unifying Framework
ECSS standards provide a comprehensive framework for space development, covering engineering, management, and various fields such as software engineering and testing. Adhering to these standards ensures consistent development, operation, and maintenance of space systems and missions, promoting collaboration and minimizing duplication of efforts among European space stakeholders.
In addition to the standards, the ECSS also provides engineering guidance documents that offer practical advice and insights for implementing the standards effectively. These guidance documents address specific technical topics and challenges faced by space engineers and designers. They provide detailed instructions, methodologies, and examples to aid engineers in making informed decisions and tackling complex engineering problems. The engineering guidance documents serve as valuable references, enabling engineers to navigate the intricacies of space systems design, development, and verification.
Benefits and Impact
The ECSS standards and engineering guidance have numerous benefits and far-reaching impacts on the European space sector. Firstly, they promote consistency of requirements and compatibility across European member nation space projects, facilitating cooperation and enabling the sharing of resources and knowledge. This leads to cost savings, as the reuse of proven solutions and common practices reduces development time and effort. Secondly, the standards improve quality and functional integrity by establishing rigorous requirements for design, manufacturing, and testing. By adhering to these standards, space organizations can reduce costs, improve cross-organization communication, and have a greater chance of mission success.
The ECSS is a comprehensive resource that provides engineering guidance documents in addition to its standards. These documents offer practical insights and advice on how to implement the standards effectively, addressing specific technical topics and challenges faced by space engineers. They provide detailed methodologies, instructions, and examples to help engineers make informed decisions and tackle complex engineering problems. With these resources, engineers can navigate the intricacies of space systems design, development, and verification with confidence.
Conclusion
The European space sector benefits greatly from the ECSS standards and engineering guidance. Firstly, they promote consistency and compatibility among European space projects, facilitating cooperation and enabling the sharing of resources and knowledge. This leads to significant cost savings, as the reuse of proven solutions and common practices reduces development time and effort. Secondly, the standards enhance safety and reliability by establishing rigorous requirements for design, manufacturing, and testing. By adhering to these standards, space organizations can mitigate risks and ensure mission success with confidence.
How Can Jama Connect® Help?
Jama Connect®‘s digital engineering techniques play a vital role in supporting customers’ adherence to the ECSS space standards, ensuring compliance and fostering efficiency. Jama Connect’s model-based systems engineering capabilities provide an easy way to allow teams to view, reuse, tailor, and show traceability of space product design to the ECSS standards themselves. It acts as a crucial bridge between teams, enhancing their design and engineering processes.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Decoteau Wilkerson and Cary Bryczek.
https://www.jamasoftware.com/media/2023/06/2023-06-06-ecss-space-standardizationjpg-1-1.jpg270520Cary Bryczek/media/jama-logo-primary.svgCary Bryczek2023-06-06 03:00:502024-01-18 00:04:51European Cooperation for Space Standardization (ECSS) Standards and Engineering Guidance
ARP4754A / ED-79A: Enhancing Safety in Aviation Development
Safety is always put first in the aviation sector. Strict adherence to rules and demanding standards helps to preserve this commitment to safety. This is where ARP4754A, a significant standard, comes into play. In this blog post, we will discuss the importance and function of ARP4754A (and its EASA equivalent ED-79A, henceforth ARP4754A) and how it impacts the design of civil aircraft and systems.
Understanding ARP4754
ARP4754A, commonly known as “Guidelines for Development of Civil Aircraft and Systems,” is an industry standard published by SAE International. Its goal is to create a structured procedure for the development and certification of aircraft and related equipment in order to guarantee adherence to safety rules. From initial concept to final certification, these rules are intended to serve as a reference for engineers, designers, and manufacturers. ARP4754A is recognized as an appropriate standard for aircraft system development and certification. The corresponding EASA Acceptable Means of Compliance AMC 25.1309 (included as a section of CS-25) does recognize ARP4754/ED–79 as well.
ARP4754A’s main goal is to increase aviation safety by encouraging a methodical and uniform approach to designing and developing aircraft and systems. It aims to reduce risks and dangers related to aircraft operations by resolving potential flaws and vulnerabilities. The standard’s goals consist of:
Safety Assessment: ARP4754A stresses performing in-depth safety evaluations to pinpoint dangers, weigh the risks, and put in place the right countermeasures. Revision A, specifically addresses functional safety and the design assurance process.
System Development: It offers recommendations for the development of aviation systems, including requirements management, verification and validation, and configuration management.
Considerations for Certification: ARP4754A guarantees that systems and aircraft adhere to legal criteria and certification procedures, supporting their secure integration into the aviation industry.
Development Lifecycle
The development lifecycle outlined by ARP4754A recommends adherence to established systems engineering principles and emphasizes the significance of iterative and incremental procedures, stakeholder collaboration, and requirement traceability throughout the lifecycle stages. The typical key processes covered by ARP4754A are well-defined:
Planning Process: This stage defines the means of producing an aircraft or system which will satisfy the aircraft/system requirements and provide the level of confidence which is consistent with airworthiness requirements.
Safety Assessment Process: Prescribes close interactions between the safety assessment process and system development process to capture safety requirements imposed on the design.
Architecture Planning and Development: The system architecture is established, including hardware, software, and interfaces
Requirements Process: Detailed system requirements are defined, considering functional, performance, security, and safety aspects.
Design Process: Detailed hardware and software item requirements are defined and allocated to system requirements.
Implementation Process: The system components are developed, integrated, and tested according to the defined design requirements.
Verification and Validation Process: This includes the activities necessary to demonstrate that the item requirements are complete, correct, and consistent with the system needs and architecture.
Integral Processes: ARP4754A describes additional processes that are applicable across all of the above processes. They are: Safety Assessment; Development Assurance Level Assignment; Requirements Capture; Requirements Validation; Configuration Management; Process Assurance; Certification & Regulatory Authority Coordination
The policy related to ARP4754A plays a crucial role in ensuring safety in the aviation industry. It employs a step-by-step approach to identify and address potential hazards and risks during the early stages of development. This policy prioritizes safety assessments, risk reduction, and thorough testing, ultimately minimizing the chances of any mishaps or incidents in practical scenarios.
Moreover, ARP4754A promotes a culture of collaboration where stakeholders can effectively share knowledge and communicate throughout the development process. This ensures that safety concerns are addressed, and all parties involved have a clear understanding of their respective roles and responsibilities. The result is a coordinated effort that leads to a successful outcome.
Conclusion
The aviation industry relies heavily on ARP4754A as a fundamental benchmark and acceptable means of compliance for the development of civil aircraft and systems. By adhering to a structured approach to development, it ensures aviation safety and minimizes possible risks. Its systematic lifecycle stages, emphasis on safety assessments, and compliance with certification requirements significantly contribute to the overall reliability and integrity of aviation products. Even as the aviation industry progresses, ARP4754A remains a critical reference point, promoting a safety-first mindset and reinforcing the industry’s dedication to passenger safety.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Decoteau Wilkerson and Cary Bryczek.
https://www.jamasoftware.com/media/2023/05/2023-05-30-arp4754-ed79a-1-1.png5121024Cary Bryczek/media/jama-logo-primary.svgCary Bryczek2023-05-30 03:00:392024-01-18 00:08:27ARP4754A / ED-79A: Enhancing Safety in Aviation Development
Learn about the critical role of benefit-risk analysis in the development of safe and effective medical devices, including the use of ISO 14971, regulatory requirements, and optimizing for patient needs and healthcare costs.
The Importance of Benefit-Risk Analysis in Medical Device Development
Benefit-risk analysis is a crucial stage in the creation of medical devices. It entails evaluating the device’s possible benefits as well as drawbacks and deciding if the advantages outweigh the disadvantages. This examination aids in ensuring that medical devices are reliable, safe, and capable of being used by patients without harm.
The global standard for risk management of medical devices is ISO 14971. It offers a framework for recognizing, assessing, and managing hazards related to medical devices. Manufacturers must follow the standard and conduct a benefit-risk analysis as part of the risk management procedure. To ensure that the level of risk connected with a medical device are acceptable and that the benefits outweigh the risks, this analysis is crucial.
To start a benefit-risk analysis, it is important to first determine the device’s intended use(s). The device’s intended use should be defined in detail and contain information on the patient group it is meant for, the medical problem it is intended to support, and the clinical environment in which it will be used.
Finding the potential advantages of the device is the next step after defining its intended usage. Benefits could include better health outcomes, more comfortable patients, and lower healthcare expenses. These advantages should be measured and contrasted with any possible risks connected to using the technology.
A medical device’s dangers may include physical harm to the patient, adverse events, and device failure, according to the definition of harm within ISO 14971. The possibility and seriousness of each risk should be evaluated, and these risks should be identified and quantified.
Even after risks have been lowered as far as possible with risk controls, there may still be some unacceptable level of risks. This is why a benefit-risk analysis is so important in medical device development.
The following stage is to assess the benefit-risk balance after the potential advantages and risks have been determined. This entails weighing the device’s possible advantages and disadvantages to decide whether the benefits outweigh the risks.
If the benefits outweigh the risks, the device may be considered safe and effective for use in the intended patient population. However, if the risks outweigh the benefits, the device may not be considered safe or effective and may need to be redesigned or modified to reduce the risks, a medical device manufacturer might also make the decision not to launch the product to market.
Benefit-risk analysis must be optimized to guarantee the safety and efficacy of medical devices.
The benefit-risk analysis should be an ongoing process throughout the development and life cycle of the device. As new information becomes available, the analysis should be updated to ensure that the benefits still outweigh the risks, as prescribed in various regulations and standards such as 14971:2019, and EU MDR/IVDR.
Regulatory standards for medical devices should also be considered in the benefit-risk analysis. The Food and Drug Administration (FDA), which oversees medical device regulation in the US, requires manufacturers to prove their devices are safe and effective before they can be marketed or sold.
The FDA requires med device manufacturers to perform a benefit-risk analysis as part of the product development process. This analysis is used to determine whether the benefits of the device outweigh the risks and whether the device is safe and effective for use in the intended patient population.
Conducting a benefit-risk analysis is a critical step in the development of med devices. It involves identifying and evaluating potential benefits and risks and determining whether the benefits outweigh the risks. ISO 14971 provides a framework for performing a benefit-risk analysis as part of the risk management process.
Optimizing benefit-risk analysis is important for ensuring that medical devices are safe and effective, meet regulatory requirements, and are reimbursed by healthcare payers. A systematic approach that considers all relevant factors, including patient needs and preferences, and clinical outcomes.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by McKenzie Jonsson and Vincent Balgos.
https://www.jamasoftware.com/media/2023/05/2023-05-25-benefit-risk-med-1.jpg5121024Vincent Balgos/media/jama-logo-primary.svgVincent Balgos2023-05-25 03:00:412025-04-30 10:28:28The Importance of Benefit-Risk Analysis in Medical Device Development
Jama Connect® Earns Top Marks on TrustRadius
Thank You to Our Customers!
Jama Connect® has earned its position as an outstanding solution on TrustRadius, solidifying its reputation as a leading platform for requirements, risk, and test management. With its intuitive interface, robust features, and exceptional customer support, Jama Connect has consistently earned praise from users for its ease of use, reliability, and reliability. Organizations across various industries have highlighted its ability to streamline collaboration, improve traceability, and enhance overall product development processes.
Reviewers have praised Jama Connect for its scalability, configurability, and advanced reporting capabilities, which have made it a top choice for businesses of all sizes. This recognition underlines Jama Connect’s unwavering commitment to delivering a reliable and efficient solution that empowers teams to drive innovation and achieve exceptional results.
Visit the full report to see why customers love using Jama Connect for product, systems, and software development.
As the leading provider of requirements management software, Jama Software® is proud to receive recognition for our services. We value the feedback from our clients who have used Jama Connect and are committed to providing them with the best support, resources, and expertise to help them succeed.
“I’m VERY likely to recommend Jama to a colleague because they’d struggle to get anything done without using it! That’s the tool we’re using for Req Management now, so I recommend to my colleagues that they get amongst it!”
-From review collected and hosted on TrustRadius – Ian Webb, Systems Engineering Technical Writer – Enphase EnergyElectrical & Electronic Manufacturing
“Jama Connect is a solid framework for systems engineering that can integrate many design processes into a single tool. At a fundamental level, it is a great tool for handling requirements management and traceability but offers a variety of other features such as risk management and verification and validation. For someone who works in the medical device industry, the tool also complies with CFR requirements for electronic approvals and can be validated for such use.”
-From review collected and hosted on TrustRadius – User in Engineering, Medical Devices Company
From all of us at Jama Software to all of you, thank you!
https://www.jamasoftware.com/media/2023/05/2023-05-24_top-marks-trust-radius-top-rated-1.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2023-05-24 03:00:012023-06-21 10:04:34Jama Connect® Earns Top Marks on TrustRadius
What Are DO-178C and ED-12C?
Safety is the top priority in the aviation industry. Whether it’s a civilian plane, a military jet, or an uncrewed aerial vehicle, the reliability and integrity of onboard software are essential to guaranteeing safe and secure operations. This blog will look at the importance of DO-178C (and its EASA equivalent ED-12C, henceforth DO-178C), the sector it affects, and the mechanisms it uses to demonstrate compliance.
The Aviation Industry and its Unique Challenges
The aviation business has complex systems, cutting-edge technologies, and strict safety regulations. Software tools are essential to use during the design and development of these systems. A systematic approach to software development and verification is mandated by the regulatory bodies such as FAA and EASA given the rising reliance on software and the potential risks it poses. Here, DO-178C enters the picture.
What is DO-178C?
The DO-178C, also known as “Software Considerations in Airborne Systems and Equipment Certification,” is a standard that was released by the RTCA (Radio Technical Commission for Aeronautics). It outlines the goals and methods for creating the software used in airborne systems. By outlining the procedures, actions, and artifacts required for compliance, DO-178C offers a formal framework for guaranteeing airborne software’s security, dependability, and maintainability.
DO-178C Compliance
The primary objective of DO-178C is to ensure that software used in airborne systems functions as intended and does not pose any safety risks. The compliance process encompasses all aspects of software development, from planning and requirements to coding, testing, configuration management, and verification. Compliance levels, also referred to as Software Levels (DAL A, B, C, and D), are determined based on the significance of the software’s function, as well as the size, complexity, and functionality of the code. The higher the DAL level, the more rigorous controls are required from software developers. And as you might expect, a DAL A system will cost a lot more time and money to produce based on the development constraints and evidence one must produce for certification.
Software Planning: In this preliminary stage, plans for the development and verification of software, including its traceability, resources, and timetables, are defined. This lays the groundwork for the succeeding steps.
Software Requirements: To make reliable software, you need clear, precise requirements. This is emphasized by DO-178C, which requires that a software requirement is traceable to a higher-level system requirement, its SW function, its verification cases, as well as the code.
Software Design: The design phase makes an architectural plan to do what the specifications say. To make sure it does that, you use procedures, models, and reviews.
Software Implementation: During this phase, the software is coded and documentation produced, including standards, instructions, and test cases. This is required by the DO-178C standard and has code reviews and coding standards to reduce errors.
Software Verification: Verification activities, like unit testing, integration testing, and system testing, are needed to make sure the software meets expectations and criteria. Functional and structural coverage analysis must be included depending on the DAL level Also, depending on the DAL level, one must show independence. This means that the person that writes a requirement must be different than the person that reviews the requirement. The person that writes the software code must be different than the person that tests that code.
Configuration Management: DO-178C focuses on configuration management to make sure changes to software are monitored, tracked, and documented throughout development.
Benefits and Impact
The aviation industry gains many advantages by following DO-178C. By adhering to these strict criteria, organizations can ensure they are following the processes called out in the regulations and that they are meeting the highest standards of aviation development safety:
Enhanced Safety: By focusing on safety, DO-178C reduces the chance of problems caused by software.
Regulatory Compliance: The Federal Aviation Administration (FAA) and European Union Aviation Safety Agency (EASA) recognize DO-178C as an acceptable means of compliance for software safety, as a condition of issuing an airworthiness certification.
Jama Connect®‘s digital engineering strategy is absolutely essential for any organization looking to boost efficiency and dependability. This strategy serves as a critical link between teams and optimizes design and engineering processes. With its comprehensive perspective of the entire system and reliable source of information, it’s an indispensable tool for success.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Decoteau Wilkerson and Cary Bryczek.
https://www.jamasoftware.com/media/2023/05/2023-05-23-what-is-do-178.png5121024Cary Bryczek/media/jama-logo-primary.svgCary Bryczek2023-05-23 03:00:072024-01-18 00:12:06What Are DO-178C and ED-12C?
