Key Best Practices for Requirements Traceability and Product Risk Management
Blog | December 19th, 2022

Key Best Practices for Requirements Traceability and Product Risk Management

The product design and development process begins with establishing the requirements. During the development lifecycle, as several variables undergo changes, it is essential to ensure that the end product conforms to the original requirement.

The Requirements Traceability Matrix (RTM) is a living document that is always up to date with the latest user requirements. The primary purpose of the RTM is to give stakeholders 100% traceability of the design and development process – for better control over all design inputs, requirements and risks.

It helps identify product risks earlier in the lifecycle, which minimizes both cost and time.

An automated RTM and Product Risk Management Solution will provide greater visibility, access to relevant data and collaboration to facilitate better management of the product design process.

This blog focuses on the various best practices a business must implement around Requirements Traceability and Product Risk management. We also explore the benefits of using a single platform ;to automate the entire product design and development workflow.

Is RTM a Necessity?

Adopting an RTM is critical to the success of product development. It helps with ensuring the requirements are consistently met throughout the product’s lifecycle – from conceptualization to manufacturing and post-market. For medical device manufacturers, RTM is defined in ISO 13485:2016 under Design Controls traceability and is considered an excellent tool to view the entire design history, including evidence of quality controls to ensure that the design goals are duly met.

Advantages of using RTM

  • An important component of the design control process as defined by ISO 130485:2016
  • Enables better testing of the product
  • Helps to highlight, assess and document all product-related risks and missing or documented inconsistencies
  • Acts as a record that holds all design-related parts, requirements and risks
  • Enables assessing and establishing risk controls for any identified product risk

Five Best Practices for Better Collaboration and Proactive Risk Management

Best Practice #1 – Categorize requirements to remain traceable during testing and verification
Organizing and prioritizing your project requirements with a document helps you identify what’s missing, contradictory or duplicated. This practice will make it easier for medical device manufacturers to determine the actions that must be taken during test management. While documenting requirements, it is also recommended that they are organized hierarchically based on priority and dependency.

Best Practice #2 – Keep the communication lines open for stakeholders to collaborate
Engineering and quality teams must be able to work together right from the early stages of the design phase due to the highly integrated nature of the product development process. Any product’s success depends on meeting the feature specifications and customer requirements. Each requirement in the system has various team members associated with it, from architects and developers to the quality assurance team and product managers. Keeping communication among all of these people involved ensures there is no lag in the decision-making process. With an integrated requirements traceability matrix, businesses can close the loop of capturing customer feedback or quality issues earlier in the lifecycle.

Best Practice #3 – Easy access to data and documents
Implement a robust product design solution with an inbuilt Requirements Traceability Matrix (RTM) to create complete visibility. It acts as a single source of truth with a unified repository allowing quality and engineering teams to remain in sync and ensure all parties have the latest data to make informed decisions. To achieve complete traceability, manufacturers must remove any gaps across user requirements, design inputs, outputs, validations and verifications.

Best Practice #4 – Conduct periodic reviews in compliance with internal controls
Companies in the medical devices industry must comply with regulatory requirements. A dedicated team must actively conduct periodic reviews to minimize human errors, simplify documentation and ensure compliance with relevant quality and regulatory standards. A requirements management solution with built-in formal reviews and reporting for auditors makes this process more reliable and less cumbersome.

Best Practice #5 – Automate the RTM process
Use a modern solution like ComplianceQuest Product Design Management to automate and streamline the product design management process. This improves compliance, reduces the risk of human errors, and ensures that the product meets the requirements defined at the beginning of the process. Using a flexible and scalable solution is also crucial.

ComplianceQuest’s Requirements Traceability and Product Risk Solution

CQ’s Product Design Management solution provides your team with a living Requirements Traceability Matrix (RTM) file that is always up to date. The unified view of user requirements simplifies collaboration between your engineering and quality teams. It can be easily shared at any time during your product’s lifecycle with the click of a button.

With the solution, you can support your entire organization, including management, engineering, quality leaders and regulatory.

ComplianceQuest’s RTM and Product Risk solution features include:

  • Embedded Product Risk Management: Document all product-related risks, with risk assessment and classification per part or requirement
  • Embedded Product Risk Control: Establish and assess risk controls for any identified product risk per part or requirement with residual risk assessments
  • Easy Publish: Generate and print design data, documents and records with one click at any time during the product lifecycle
  • Team Collaboration: An easy-to-use platform accessible by team members anywhere
  • Complete Product Design Data: A living record across a product’s lifecycle that documents all design-related parts, requirements and risks
  • Requirements Traceability Matrix (RTM): Track all requirements, inputs, outputs validations and verifications in an always up-to-date living document with automatic change alerts
  • Automatically Flagged Changes: Easily spot changes to product requirements thanks to automatic flagging and make sure all required steps are taken

Try ComplianceQuest’s Requirements Traceability and Product Risk solution, a part of our product design management offering, to manage all your product-related risks with a living design file. Request a demo here:

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