Compliance Success For Long Lifecycle Products

While it is true that for industries requiring high-reliability printed circuit boards (PCBs), such as aerospace, medical, and automotive, compliance success may be paramount, when designing for extended lifecycle use, the challenges of compliance are intensified—changing regulatory landscapes, material obsolescence, and complex, interdependent supply chains make compliance success hard.

Luckily, by integrating the right tools to better manage documentation, traceability, component selection, and testing, companies can streamline compliance efforts across critical stages and effectively achieve compliance success for long-lifecycle PCBs.

Below, we explore seven challenges and strategies for ensuring that long-lifecycle PCBs meet rigorous compliance standards throughout their operational life and the Altium technology designed to shape compliance success.

Challenge 1: The Complexities of Compliance in Long-Lifecycle PCBs

Long-lifecycle PCBs must be designed for performance and compliance from the start, with careful consideration given to the technical and regulatory aspects that introduce potential risks, from the design and manufacturing stages to the later requirements for upgrades or replacements. Key challenges include:

Regulatory Shifts: Compliance standards evolve to keep pace with new technology, market needs, and environmental considerations. PCBs that initially meet compliance standards may face compliance issues due to regulatory changes over time, encountering updates to standards like RoHS, REACH, and industry-specific requirements that could impact their components or materials, especially if they are expected to remain in use for a decade or more. 

Supply Chain Complexity: The globalized nature of PCB supply chains means managing varying compliance laws, making it challenging to ensure materials and processes meet uniform standards.

Obsolescence Risk: Avoiding component unavailability or lack of compliance due to discontinued materials or processes requires proactive planning, as replacement parts may not meet the exact specifications or regulatory standards of the original components.

The Altium Solution: Data and Collaboration

The constant shifting of regulations makes continuous monitoring of changes and adaptability in design and production critical to compliance success for long-lifecycle PCBs. 

Altium Designer and Altium 365 are game changers in this area, offering features for real-time regulatory monitoring, supplier data management, and comprehensive documentation to help teams manage evolving compliance requirements efficiently.

• Altium Designer: Through integration with external databases, Altium Designer provides direct access to vendors' regulatory information and material compliance data, allowing designers to select compliant components based on real-time data, reducing the risk of non-compliance later in the lifecycle.
• Altium 365: This cloud platform supports collaboration across teams and with suppliers. It also allows for managing the detailed compliance documentation that regulatory bodies may require, ensuring traceability and quick response to compliance audits.

As a product continues to be revised over time, each regulatory change, component change, or functional change can be clearly specified and assigned using the requirements management features in Altium 365. PCB designers can then clearly see these requirements updates and assignments inside Altium Designer.

For example, as requirements for a product change over the product's lifetime, the Requirements and Systems Portal in Altium 365 allows requirements to be tagged onto specific design objects in a PCB layout. A notification can then be pushed to a design engineer, who can then quickly implement the required changes.

Challenge 2: Documentation and Traceability

Documentation and traceability are foundational to compliance in long-lifecycle products, providing a historical record of materials, processes, and testing that support reliability. As regulatory audits become more stringent, detailed records can streamline compliance verification processes.

Material Traceability: Ensuring all materials used in PCB manufacturing can be traced to their origins is critical for regulatory compliance, including documenting the chemical composition, origin, and supplier details of each material. Comprehensive records allow manufacturers to respond effectively to compliance inquiries and adapt to regulatory updates that might affect material choices.

Process Documentation: In long-lifecycle products, process documentation provides a foundation for assessing whether any updates are needed as standards evolve; every manufacturing step, from soldering techniques to quality assurance testing, must be meticulously documented.

Testing Records: Documenting tests required by regulatory bodies, including environmental stress testing, thermal cycling, and reliability testing, can help companies identify issues in the early stages while serving compliance needs.

Change Management: Long-lifecycle products often undergo changes, from minor updates to major component replacements. A structured change management process that evaluates and documents the compliance impact of any alteration ensures that the PCB continues to meet regulatory requirements even as updates occur.

The Altium Solution: Streamlined Record-Keeping

Comprehensive documentation and traceability are essential for responding to regulatory audits and addressing component obsolescence, a crucial part of compliance success. Altium products remove some of this burden, simplifying documentation, version control, and traceability management.

• Unified Documentation with Altium Designer: Altium Designer allows for the automatic creation of BOMs (Bills of Materials), schematics, and layout documents with version control to keep records accurate and consistent. These documents provide the traceability needed for regulatory compliance and are essential for managing changes that may arise during the product lifecycle.
• Lifecycle and Version Management in Altium 365: Altium 365's cloud-based features allow stakeholders to access the latest, most accurate version of design documents, including lifecycle management capabilities, which help track the history and changes of components and materials over time, ensuring that every modification meets regulatory standards.

Challenge 3: Design Strategies That Ensure Long-Term Compliance

Designing with compliance in mind is a proactive approach that can significantly improve the likelihood of a PCB remaining compliant throughout its lifecycle. Some effective design strategies include:

Designing for Durability: Building PCBs to withstand environmental stressors, such as extreme temperatures, vibration, and humidity, helps ensure that the product maintains compliance with reliability standards over time. This includes selecting materials and components with high resistance to degradation.

Material Selection: As regulatory bodies restrict certain hazardous materials, choosing compliant and durable materials from the outset helps avoid compliance issues. Engineers should prioritize materials that meet current regulatory requirements and are less likely to be restricted in the future.

Modular Design: Implementing modularity in PCB design allows for easier upgrades or replacements of specific components without overhauling the entire board. Modular PCBs can be updated with newer, compliant components without compromising the integrity of the overall design.

Compatibility with Testing Standards: Design choices should also account for testing requirements that may apply over the product's lifecycle. For instance, designing boards that can undergo non-destructive testing methods can help re-verify compliance at various stages in the lifecycle.

The Altium Solution: Future-Proofing PCB Designs

Long-lifecycle PCBs are best designed with compliance and durability in mind. Altium provides tools for selecting materials and components that enhance longevity, ensuring PCBs remain compliant and functional over time.

• Altium Designer's Component Management Tools: Altium Designer integrates with supplier databases to ensure designers select durable, compliant components. Altium's ActiveBOM feature allows for direct tracking of component availability and compliance information, helping to avoid materials likely to face future regulatory restrictions.
• Simulations and Testing within Altium Designer: Designing for reliability and compliance can be bolstered with Altium Designer's simulation tools, including thermal, signal integrity, and stress tests. These simulations help validate that the design will meet regulatory standards, reducing risks associated with long-term wear or environmental exposure.
• Real-Time Component Data with Altium 365: Altium 365 can centralize component libraries with real-time updates from suppliers on part availability and compliance changes, helping designers proactively adapt to obsolescence and maintain continuity in long-term compliance.

Challenge 4: Proactive Compliance Monitoring and Supplier Management

Given the global nature of PCB manufacturing, where suppliers span multiple regions with varying compliance standards, managing supplier compliance is essential for long-lifecycle PCBs. Strategies include:

Supplier Audits and Qualification: Establishing a thorough supplier audit and qualification program ensures that all components and materials meet compliance standards. Audits should be conducted regularly, with attention to the supplier's adherence to relevant environmental and quality standards.

Proactive Compliance Monitoring: Compliance doesn't end with the design and manufacturing stages. Manufacturers must implement monitoring mechanisms to stay abreast of regulatory changes that may impact their products. This includes tracking shifts in RoHS, REACH, and IPC standards and assessing how changes might affect long-lifecycle products already in the field.

Strategic Supplier Relationships: Building strong, transparent supplier relationships can facilitate more effective compliance management. Trusted suppliers are more likely to communicate material or process changes that could impact compliance, enabling PCB manufacturers to adapt more seamlessly to evolving regulatory requirements.

The Altium Solution: Proactive Compliance Monitoring

Long-lifecycle PCBs require proactive compliance monitoring throughout the design, manufacturing, and deployment stages. Altium's tools help maintain oversight of compliance across every phase.

• Supplier and Compliance Monitoring: Altium 365 integrates supplier data, which keeps component and material specifications current and accessible. Any supplier changes that impact compliance status trigger updates within Altium 365, allowing teams to adjust designs proactively.
• Supply Chain Transparency via Altium 365: When regulatory changes arise, its important teams adjust quickly; this is why supply chain and procurement teams benefit from Altium 365's ability to monitor material and component statuses in real-time. The Altium 365 platform provides visibility into component availability and compliance data, supporting the proactive supplier management and compliance monitoring required to win at compliance.

Challenge 5: Managing Obsolescence and Continuity of Compliance

The risks for long-lifecycle PCBs heighten as components may become unavailable or unsupported over time, forcing manufacturers to find compliant alternatives. Hence, managing obsolescence effectively requires a proactive approach that considers future-proofing the product against component phase-out.

Forecasting and Inventory Planning: Planning for the obsolescence of critical components and maintaining sufficient stock or securing last-time-buy options helps manufacturers keep compliant parts available for the product's expected life.

Component Substitution Management: To avoid compliance or reliability issues, a compliant substitute must be identified and verified with all regulatory and performance standards when a component becomes obsolete.

Compatibility with Updated Standards: Obsolescence also offers opportunities to update the product to meet newer compliance standards. For instance, a component upgrade can serve as an opportunity to ensure the product complies with the latest version of a standard like RoHS or IPC-A-610.

The Altium Solution: Real-time Tracking, Substitution Support, and Lifecycle Management

Changes stemming from component obsolescence can disrupt compliance if replacement parts fail to meet the same regulatory standards. Altium products provide practical tools for obsolescence management and continuous compliance:

• ActiveBOM for Real-Time Obsolescence Tracking: Altium Designer's ActiveBOM feature provides direct access to component availability, pricing, and compliance data. If a component becomes obsolete or faces regulatory changes, ActiveBOM highlights these updates, allowing for quick action in finding suitable alternatives.
• Component Substitution Support: When replacements are needed due to obsolescence, Altium Designer's component management features enable seamless substitution while maintaining compliance. Designers can ensure that replacements meet necessary standards and regulatory requirements, ensuring continuity for long-lifecycle products.
• Historical and Lifecycle Management with Altium 365: Altium 365's lifecycle management capabilities help track the entire history of components and materials used, a valuable feature when a product requires maintenance or refurbishment to remain compliant, as teams can easily reference accurate historical data.

Challenge 6: Cross-Functional Collaboration

Compliance for long-lifecycle products in PCB manufacturing isn't confined to one department; it requires cross-functional collaboration to effectively anticipate and address regulatory challenges.

Engineering and Design: Design and engineering teams must work closely to build compliance into the product from the outset, selecting materials and processes that align with regulatory requirements.

Supply Chain and Procurement: Supply chain teams play a crucial role in sourcing materials and components that meet compliance standards and managing relationships with suppliers to ensure continuity in compliance.

Quality Assurance and Compliance Teams: Quality assurance teams are responsible for testing, documentation, and regulatory updates, ensuring the PCB remains compliant throughout its lifecycle.

The Altium Solution: Fostering Cross-Functional Collaboration for Compliance

If everyone is moving forward together, then success takes care of itself — Henry Ford

With transparent, real-time data sharing and coordination across departments in a cloud-native environment, finally, design, compliance and all relevant stakeholders, including the extended supply chain, can come together and achieve compliance success.

• Centralized Document Access: Altium 365 provides a central repository for all PCB design and compliance documentation, allowing each team member to access current, accurate information.
• Real-Time Stakeholder Communication: Working within the Altium 365 environment, teams across different departments and sites, as well as external suppliers, can collaborate seamlessly, abolishing information silos and enabling efficiency by ensuring all stakeholders have immediate access to the latest compliance data.
• Compliance-Driven Design Reviews: Facilitating compliance-driven design reviews and empowering cross-functional teams to assess designs based on regulatory requirements and identify and address potential non-compliance early in the design phase, Altium 365 helps teams mitigate risks and plan for resiliency.

By integrating digital enablers such as Altium Designer, Altium 365, and ActiveBOM, PCB manufacturers can achieve compliance continuity despite complexities, mitigate the risks of regulatory shifts, and create long-lifecycle products that remain viable, reliable, and compliant over time- it's a digital framework for resiliency.

Don't let yourself drown in requirements management tasks for long-lifecycle products. As your product compliance status changes, let Altium 365 Requirements and Systems Portal streamline your workflow and keep your design team productive. We think you'll experience a seamless transition to a new workflow that expands your reach and capabilities.