Tag Archive for: Risk Analysis

IEC 61508

In this blog, we preview our eBook IEC 61508 Overview: The Complete Guide for Functional Safety in Industrial Manufacturing. Download the entire eBook to learn more!

IEC 61508 Overview: The Complete Guide for Functional Safety in Industrial Manufacturing

Industrial manufacturing firms are undergoing rapid transformation as they navigate talent shortages, supply disruptions, digital adoption acceleration, and more. At the same time, they work diligently to accelerate time to market, streamline risk
management, and keep accuracy and safety at the forefront.

Eliminating 100% of risk is not always possible, but manufacturers continuously seek strategies to mitigate potential safety issues. That’s why industry experts in industrial manufacturing have created standards
such as IEC 61508 to reduce risk and support the development of safety-sensitive products.

However, if you haven’t implemented such standards in the past, you may have many questions. What is IEC 61508? What organizations need to adhere to it? And why does this standard matter?

Understanding the answers to these questions will assist you with implementing the necessary strategies and tools to mitigate potential safety issues and achieve IEC 61508 compliance for industrial product development.

What Is IEC 61508?

Industrial manufacturing firms need to prevent dangerous failures that may occur with the use of their system. The challenge is that oftentimes systems are incredibly complex with many interdependencies, making it difficult to fully identify every potential safety risk.

According to the International Electrotechnical Commission, leading contributors to failure include:

  • Systematic or random failure of hardware or software
  • Human error
  • Environmental interference, such as temperature, weather, and more
  • Loss of electrical supply or other system disturbance
  • Incorrect system specifications in hardware or software

IEC 61508 creates requirements to ensure that systems are designed, implemented, operated, and maintained at the safety level required to mitigate the most dangerous risks. The international standard is used by a wide range of manufacturers, system engineers, designers, industrial companies, and others that are audited based on compliance. The standard applies to safety-critical products including electrical, electronic, and programmable-related systems.

RELATED POST: Requirements Traceability Benchmark

In our eBook, IEC 61508 Overview: The Complete Guide for Functional Safety in Industrial Manufacturing, we examine:

  • What IEC 61508 is, and why it matters
  • The seven parts of the functional safety standard
  • Hazard and risk analysis for determining SIL

Download the entire eBook to learn more!


requirements traceability live traceability

Requirements Traceability – How to Go Live

Requirements traceability is required by many industry standards to ensure product quality and safety. The industry standards are based on decades of progress made in systems and quality engineering research with requirements traceability at the core. Benefits from requirements traceability are achieved if and only if traceability is used as a tool during the product development process. These benefits include greatly reduced or eliminated delays, defects, cost overruns, and rework. Here is an overview of the best practice approach to achieve Live Traceability™.

Live Traceability vs. After-the-fact Traceability

Let’s start with some definitions to make sure we are all on the same page. Requirement traceability is defined as tracking the development progress of product requirements from definition and design through development, testing, verification, and validation. There are two forms of requirement traceability: after-the-fact traceability and Live Traceability.

  • After-the-fact traceability occurs after the product has been developed and is typically a highly manual effort to try and re-create artifacts to demonstrate traceability that should have occurred during the development process but did not. This effort is undertaken solely for complying with industry standards and satisfying auditor requests for demonstration of process maturity.
  • Live Traceability occurs in real time as the product development process progresses to improve overall productivity (by ensuring engineers across disciplines are always working off the most recent and correct versions) and to reduce the risk of negative product outcomes (delays, defects, rework, cost overruns, recalls, etc.) through early detection of issues. The benefits of early detection of issues are significant. Research by INCOSE found that issues not found until verification and validation are 40 to 110 times more costly than if found during design. For this reason, most companies want Live Traceability but are stuck with legacy tools and spreadsheets that do not support it. Since each engineering discipline is allowed to choose its own tooling, the result is a large number of tools with no relationship rules or mechanisms to create Live Traceability across them.

RELATED POST: Requirements Management Guide: Requirements Traceability

So how do you achieve Live Traceability?

Step 1: Define a Traceability Model

Live Traceability requires a model of the key process elements and their relationship rules to monitor during the development process. The systems engineering V Model is a useful framework to start with for data object and relationship definition. Jama Connect® uniquely provides a point and click, configurable, relationship rule capability to enable Live Traceability. Below you see a sample relationship rule diagram from Jama Connect. Relationship rules vary by industry and company-specific requirements. Best practice templates are provided to comply with industry standards and configured to meet client-specific needs. The definition of a traceability model forms the foundation for model-based systems engineering since it defines model elements and their relationship to each other in a consistent manner across the entire system architecture.

Step 2: Setup Continuous Sync for Siloed Tools/Spreadsheets

Once the relationship rules are defined, the next step is to set up continuous sync with best-of-breed tools and spreadsheets used by the various engineering disciplines. The traceability diagram below shows a typical example of best-of-breed tools and where they sync in the Jama Connect relationship model to deliver Live Traceability.

Most companies prioritize the areas of the traceability model that are most prone to lead to costly issues in the absence of a continuous sync. Most commonly, these areas are:

  • Software task management – directly linking the decomposition of requirements into user stories enables Live Traceability through the software development process through testing and defect management. The most common best-of-breed tools used are Jira and Azure Dev Ops.
  • Test automation – test cases are managed in Jama Connect to align to requirements and ensure traceability across all engineering disciplines with the test automation results sync’d to the traceability model at the verification step. The most common test automation tools are TestRail and qTest.
  • Risk analysis (DFMEA/FMEA) – is most often conducted in multiple Microsoft Excel spreadsheets and the assumption has been that Live Traceability was not possible with Excel. Jama Connect is the first requirements management solution to enable Live Traceability with Excel functions and spreadsheets. Risk teams can now work in their preferred spreadsheets AND for the first time achieve live traceability to stay in sync with changes made by any engineering team. Ansys Medini is also a supported integration.
  • Model-based systems engineering (MBSE) – the first step in MBSE is to define a relationship model between all product requirements. Once a relationship model is defined, then specifications can be determined through modeling. Jama Connect uniquely provides model-based requirements to sync logically with a SysML modeling tool like Cameo No Magic. Other requirements management tools do not ensure a model-based approach, which most often leads to inconsistent and conflicting fields across teams and projects and provides no coherent relationship model.

Step 3: Monitor for Exceptions

Live Traceability provides the ability, for the first time, to manage by exception the end-to-end product development process across all engineering disciplines. The traceability model defines expected process behavior that can be compared to actual activity to generate exceptions. These exceptions are the early warning indicators of issues that most often lead to delays, cost overruns, rework, defects, and recalls. Below is a sample exception management dashboard in Jama Connect.

Benefits of Live Traceability

The main benefits of Live Traceability across best-of-breed tools are as follows:

  • Reduce the risk of delays, cost overruns, rework, defects, and recalls with early detection of issues through exception management and save 40 to 110 times the cost of issues identified late in the process.
  • Comply with industry standards with no after-the-fact manual effort.
  • No disruption to engineering teams that continue working in their chosen best-of-breed tools with no need to change tools, fields, values or processes.
  • Increase productivity and satisfaction of engineers with the confidence that they are always working on the latest version, reflective of all changes and comments.


Companies are facing intense pressures to bring complex products to market faster than ever. In addition, those delivering products in safety-critical markets must also create and execute against a risk management plan for expanding standards and regulatory oversight.

In these cases, inefficiencies and blind spots in the development process can lead to risk management errors which not only throw releases off schedule but can put lives in jeopardy.

To help raise awareness around these issues, prominent research and consulting firm Frost & Sullivan recently observed the product development landscape and its relationship to risk. The output is a recently-released brief, “Safeguarding Regulated Products Amidst Growing Complexity,” that spotlights Jama Connect™ as a remedy for ineffective risk analysis in product development.

Symptoms of Ineffective Risk Management

The Frost & Sullivan brief outlines the current competitive environment facing organizations producing products in regulated industries and makes the case that relying on outdated processes impedes success.

“Many businesses in these spaces have invested heavily over the years in their document-based systems to manage their product development process and are hesitant to upgrade to unknown technologies or solutions,” writes Frost & Sullivan. “These antiquated systems are often static and spreadsheet- or even paper-based. And while they may offer a (possibly false) sense of reassurance against the costs and risks associated with a live digital system, they end up creating more costs and causing more harm.”

As we’ve heard from many companies, performing requirements management and risk analysis through versioned spreadsheets and extensive meetings not only drains resources, slows development, and creates errors, but it’s just no longer an effective strategy when you need to build safe products quickly.

Gain a stronger handle on ISO 14971 — the FDA’s mandatory standard for risk assessment in medical devices — by grabbing our whitepaper.

Strengthening Collaboration During Development

One other notion dispelled by Frost & Sullivan is the idea that remote development teams can operate at maximum efficiency without a powerful, shared solution for centralized enablement.

For instance, with regulated companies, there’s too much at stake to leave issues around requirements, risk mitigation, and compliance up to emailed documents.

“A strong, platform-based solution can provide a virtual space in which different but interdependent teams can collaborate, key stakeholders can review and weigh in on decisions, and regulators can trace end-to-end compliance,” writes Frost & Sullivan. “It can also enable risk mitigation as an ongoing, semi-automated process that catches and integrates changing conditions. Such a solution can help ensure compliance across processes, functions and locations, as well as with product definitions and design, processes and test cases.”

Learn how how a Fortune 100 semiconductor company is meeting the challenges of developing automotive-related technology by downloading our case study.

A Better Risk Management Solution

For businesses still hesitant to invest in improvements to their risk management process, it’s not always strictly a question of budget. The move involves a change in mindset and executable process, according to Frost & Sullivan. For instance, tracking and managing risk needs to be an intrinsic, collaborative, ongoing part of the development process, and not something performed by a specialized team in a silo.

Some organizations, especially newcomers to regulated industries, may not even be sure where to start with complex standards like ISO 14971, let alone assembling a risk management plan. It’s in these cases you’re more likely to see a development team dig into a risk management framework in the later stages of development, potentially adding rework and cost when schedules and budgets may not allow for either.

Frost & Sullivan contends Jama Connect is worth a look for all organizations interested in mitigating product risk, as it can “provide risk management, collaboration, efficiency and regulatory compliance as aspects that strengthen, rather than complicate, each other.”

Whichever path a company chooses, what Frost & Sullivan make clear is that staying the course with an ineffective risk management process isn’t really an option at all.

“Teams will otherwise struggle to get their people up to speed, across the globe and across groups,” writes Frost & Sullivan. “A team-based approach… is the ideal solution in heavily regulated industries.”

Access the full Frost & Sullivan brief, “Safeguarding Regulated Products Amidst Growing Complexity” by downloading it now.