Integration of FMEA and ISO standards, as well as regulatory requirements, provides a comprehensive system of record to manage risk and help companies manage product development complexity
Portland, Ore., May 21, 2019 – Jama Software, the leading product development platform provider for building complex products and integrated systems, announced they have expanded the Jama Connect™ Risk Management Center to all industries and platforms – both cloud and self-hosted. Until today, the center was piloted exclusively for medical device companies and was only available on the cloud.
“From working with hundreds of customers in regulated industries, we realized that risks are requirements,” said Jama CEO, Scott Roth. “There are nuances in how risk is handled from industry to industry, but risk management is a core principle of product development, just like requirements. When you bring risks directly into requirements management, they are much easier to control.”
Aerospace, automotive, semiconductor and other industries face a growing risk management dilemma. Mistakes can endanger lives and permanently mar a company’s reputation. In addition, product safety regulations are getting stricter and recalls are on the rise. At the same time, risk management can be cumbersome, frustrating and inefficient. Many companies use multiple spreadsheets, paper records or software that is ill-suited for risk management and requirements tracking, as well as for following industry standards such as FMEA and ISO 14971.
In a recent white paper, Frost & Sullivan noted:
Legacy systems struggle to keep up with changing regulations, which can lead to compliance costs down the road. They can also introduce challenges with version control and be prone to errors. Due to their complicated functionality, legacy systems also inadvertently promote silos, forcing teams to prioritize the accuracy and timeliness of specific tasks in a way that can inhibit collaboration with other teams.
Jama Connect Risk Management Center addresses these challenges by providing industry-standard customizable templates, enhancing collaboration, and offering a single system of record for risks and requirements. The platform enhances risk analysis, giving teams better tools to identify and mitigate issues and move rapidly through the development process. Specifically, the center helps teams:
- Participate in risk assessment, including preliminary hazard analysis (PHA) and risk mitigation;
- Incorporate FMEA and ISO 14971- aligned risk management templates;
- Connect verifications to requirements; and,
- Export plans for approval.
“Risk management should not be siloed away from product requirements,” added Roth. “There must be a streamlined mechanism for all teams to work together towards common goals. We believe the Risk Management Center equips companies with the tools they need – to identify mistakes before they become serious regulatory and reputational problems, and to rapidly develop successful, sustainable products.”
About Jama Software
Jama Software is a leading product development platform provider for companies building complex products and integrated systems. The Jama Product Development Platform helps companies establish a Predictive Product Development process — to mitigate risk, improve quality, identify opportunities and decrease time to market — via an integrated solution for guiding the product lifecycle from idea to launch. More than 600 innovative companies use Jama Software to modernize their product development process. The company is headquartered in Portland, Ore. To learn more, visit www.jamasoftware.com.
