Requirements Traceability and Product Risk

Requirements Traceability and Product Risk

Requirements Traceability and Product Risk

Give your teams the needed visibility to track and manage all design inputs, outputs, validations and verifications along with integrated management of product risks

A living document that is always up to date for all your user requirements and risks. Gain 100% traceability over your design development process for better control over design inputs, requirements, and risks.

Requirements Traceability and Product Risk
Requirements Traceability and Product Risk video

With ComplianceQuest’s Requirements Traceability and Product Risk solution you can benefit from a living design file that changes how your teams can work together to ensure all user requirements are met, and the Product Risk document ensures all product related risks are accounted for.

The unified view of user requirements simplifies collaboration between your engineering and quality teams and can be easily shared at any time during your product’s lifecycle with the click of a button.

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Related Assets

Complete Traceability of Product Requirements

Keeping track of all design inputs, requirements, and outputs can be challenging and time-consuming, yet it is vital for high quality product development.

CQ’s Product Design Management solution provides your team with a living Requirements Traceability Matrix (RTM) file that is always up to date. CQ’s RTM offers 100% visibility over links between user requirements, design inputs, outputs, validations, and verifications.

complete traceability with product risk management
identify and control all product risks

Identify and Control All Product Related Risks

There are many inherent risks in product development. It is a real challenge for teams to assess, identify and mitigate all the risks involved, especially if relying on spreadsheets or papers.

With embedded product risk management, you can assess and document all product related risks and link them to specific parts or requirements, then document and implement the appropriate risk controls along with residual risk assessment for full compliance. With CQ’s Product Risk solution you can also add hierarchical codes to risks to make sure your organization’s hierarchical system for risk is being followed during product design for a complete risk management approach.

Impact of Living Records on the Design Process

Single Source of Truth

All departments involved must be able to easily access shared records, not only engineering teams, but quality and regulatory teams as well.

CQ offers your teams a unified repository for all requirements and risks making them easily accessible to all members. Both RTM and Product Risk files are easy to edit, with filters and easy cut/paste and clone options for a simple interface. You can even bring in product data from other sources (ERP, Jira..) and keep your quality and engineering teams in sync, with a complete document stack.

single source of truth
always up to date product risk documents

Always Up to Date

Requirements are subject to change throughout the product design lifecycle. That’s why it is vital for engineering and quality teams to have access to the latest inputs, validations and verifications.

In addition to serving as a single source of truth for all teams, CQ’s RTM and Product Risks documents are living documents that are always up to date. Changes in requirements are instantly flagged to make sure that no step is missed and that all regulatory and quality standards are met.

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Support Your Entire Organization

product risk - management
Management

Reduce costs and increase product quality with a comprehensive and systematic approach to product design that satisfies all quality and regulatory requirements.

product risk - engineering
Engineering

Gain complete traceability over product requirements and risks and simplify documentation for your teams so they can focus on innovation.

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Quality Leaders

Ensure that quality processes and procedures are effortlessly maintained and documented by anyone involved in product development.

product risk management regulatory
Regulatory

Minimize human errors, simplify documentation, and ensure compliance with relevant quality and regulatory standards.



Powerful, complete eQMS

We conducted a thorough, comparative review of systems within our budget and CQ was a clear winner. The system is powerful and versatile, even with an out of box implementation. The functionality is complete, covering every significant aspect of a quality system. Validation is straightforward with the use of OQ scripts from CQ, which can be modified to fit your implementation. It ensures that processes implemented through the system and records generated by the system are compliant for medical device companies. But, the biggest benefit we’ve received is through the collaborative partnership with CQ personnel. They listen and understand our needs. They are creative in helping us make implementation as easy as possible. Having been in large companies and small, I can see this system fitting in either environment and budget.

Jackie Jaskula,
Director of QA and Regulatory

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origen logo

Requirements Traceability and Product Risk Features

complete product design data

Complete Product Design Data

Living record across a product’s lifecycle that documents all design related parts, requirements and risks.

requirements traceability matrix

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

Automatically Flagged Changes

Easily spot changes to product requirements thanks to automatic flagging and make sure all required steps are taken.

embedded product risk management

Embedded Product Risk Management

Document all product related risks, with risk assessment and classification per part or requirement.

product risk hierarchical codes

Hierarchical Codes

Assign hierarchical codes to product risk and integrate with risk management solution for a complete approach.

embedded product risk control

Embedded Product Risk Control

Establish and assess risk controls for any identified product risk per part or requirement with residual risk assessments.

easy publish

Easy Publish

Generate and print design data, documents, and records with one-click at any time during the product lifecycle.

team collaboration

Team Collaboration

An easy-to-use platform accessible by team members anywhere.

Track and Manage all Design Inputs, Outputs, Validations and Verifications with CQ's Requirements Traceability and Product Risk Solution

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Related Checklists

Quality-centric Companies Rely on CQ QMS

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Frequently Asked Questions

  • Product risk management identifies, assesses, and mitigates potential risks associated with a product throughout its lifecycle. It involves analyzing design flaws, manufacturing defects, regulatory compliance, and market dynamics to minimize the likelihood of adverse events or financial losses. It is a proactive approach that helps companies ensure product safety, quality, and reliability while protecting their reputation and minimizing legal liabilities.

  • Identifying product risks involves a systematic evaluation of various factors:

    • Market Research: To understand customer needs, preferences, and competitive products, study the market.

    • Technical Analysis: Examine design, manufacturing, and technological aspects for vulnerabilities.

    • Regulatory Compliance: Ensure the product adheres to industry standards and government regulations.

    • Supplier Assessment: Assess the reliability of suppliers and their components.

    • User Feedback: Gather insights from users or beta testers to uncover potential issues.

    • Historical Data: Analyze past product issues and recalls for patterns.

    • Risk Assessment Workshops: Conduct brainstorming sessions with cross-functional teams to identify potential risks.

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