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Product Lifecycle Management
Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Complaints Management
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Risk Management
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Supplier Management
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Safety Management
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Environment and Sustainability
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
Make it easy for your people to manage, track and analyze environmental and sustainability metrics
Bring higher quality products to market quicker with design controls, projects & DHF
Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
Strategically manage the complete lifecycle of your product
Efficient Waste Management for Compliance & Sustainability
Relevant Information within reach - Always.
Assuring Quality Products and Services
Self-guided Product Tours
Product Demo Videos
Pricing
ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
Salesforce
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
CQ Platform
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
Recent Blogs
Recent Infographics
Recent Case Studies
Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
Recent Checklists
Featured Checklist
Complaint Handling Process for MedTech and Life Science Companies
Course Offerings
Recent CQ Guides
Featured CQ Guide
Datasheets
Brochures
Demo Center
Podcasts
Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Videos
Recent Webinars
Webinar
Unlocking the Value of Complaints
Recent Whitepapers
Whitepaper
Why You Need to Digitally Transform Your QMS
Recent Compliance
Compliance
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
Recent Toolkits
Featured Toolkit
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
Events and Webinars
Events
Upcoming Webinars
Featured Event
Interphex
01 Apr, 2025
New York, NY
About
About ComplianceQuest
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase product, quality, safety, and supplier as they bring their products from concept to customer success.
Meet the Leadership Team
Careers
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Corporate Citizenship
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
Customers & Testimonials
Newsroom
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
The risks that impact today’s enterprises are continuously increasing, changing, and becoming complex and interconnected. A company is vulnerable to several risks such as supplier relationships, disruption of the supply chain, manufacturing processes, employee safety, shipment of finished products, environmental incidents, and more.
Additionally, companies also have to deal with political and regulatory risks. Therefore, implementing a risk-based approach to quality & safety management has become key to maintaining a competitive advantage and mitigating the risks triggered by these factors.
Standards such as ISO and ICH Q9, are emphasizing a renewed focus on proactive risk management to improve quality performance. ISO 31000 provides organizations with guidance to develop an effective risk management strategy. This helps to identify and mitigate risks, ensuring the meeting of goals and protecting assets. ISO 31000 Risk management – Guidelines help businesses in any segment and any size manage risks by providing a framework.
The risk management process broadly encompasses:
Aiding businesses in the risk management process is the risk matrix that helps companies understand their risk environment at a granular level. It allows them to set risk tolerance thresholds and implement controls to eliminate or manage the risks.
A risk assessment matrix is a tool to visualize the potential risks impacting a business and is also called a probability and severity risk matrix. This visual tool helps plot the risk along the probability and severity matrices to assess how likely it is for a risk event to occur and the potential impact on the business. Based on the intersection between the two, risks can be categorized as low, medium, or high. This will help the company set priorities to develop an effective risk management strategy and process.
Risks can be of many types, including:
Color codes are used to plot the severity of the risk on a chart with likelihood and impact as its two axes. Establish the criterion for identifying the probability of a risk to occur – for instance, 61-90%, 31-60%, 10-30%, signifying high to low. Identify what kind of an impact it can have – revenue losses, damage to reputation/equipment, vulnerability to accidents, environmental and safety issues, and so on.
The business must also have an understanding of its risk appetite – no business can ever be free of any risk so a willingness to take some risks within certain thresholds is inevitable. Understanding this limit will help with devising buffers that will cushion the impact.
By plotting this chart, the risk assessment matrix provides a quick snapshot of the threat landscape, empowering risk, audit, and compliance leaders to identify and implement controls that help to minimize the impact. This view helps in developing a targeted risk-based management strategy. It also helps with tracking the evolving risk environment and becoming agile in preparing for and responding to crises.
A risk matrix can be created using a four-step process.
Step 1: Identifying the Risk Landscape – A comprehensive view of the risk landscape is essential for businesses to get a bird’s eye view of the growing complexity of business risks. The participation of all key stakeholders in sharing the risks in their areas is the first step in creating this matrix. The risk can be categorized as strategic, operational, financial, or external and the process can begin from the broader view to narrowing it down to the functional level.
Step 2: Establishing the Risk Criteria – The next step is to determine the criteria to evaluate the risks and the controls to mitigate them.
Step 3: Assessing the Risks – Using the measurement criteria, assess the risks and define a scale to enable qualitative risk analysis. Typically, the risk is measured as high, medium, and low.
Step 4: Prioritize the Risks – Having created a chart of risks plotted against the axes of likelihood and impact, the high probability, high impact risks need to be addressed first. Developing a risk assessment plan that effectively mitigates them is important.
Constantly review and update the risk matrix to keep it on par with the new risks emerging.
Manually identifying, sorting, assessing, and prioritizing risks can be challenging even for a small business. There are many uncertainties, and knowing how it will impact a business can be pure guesswork without sufficient data to back it up. That is one risk no business can afford to take.
The ability to maintain a centralized repository of identified risks, whether at the project, department, or company level, plays a crucial role in making strategic decisions regarding potential threats. This repository ensures alignment with the latest standards, such as ISO 31000, ISO 14971, ICH Q9, and the risk principles outlined in ISO 9001:2015, ISO 45001, ISO 13485:2016, and ISO 14001. ComplianceQuest Risk Management Solution facilitates this process by expediting assessments, identifying and analyzing risk trends, and efficiently driving risk mitigation activities. With this solution, organizations can streamline their risk management efforts, ensuring a proactive approach to risk and enabling informed decision-making for enhanced business outcomes.
Its AI and analytics capabilities facilitate identifying potential risks based on history and trending data along with key metrics. With embedded intelligence, quality and risk management leaders can proactively start their risk mitigation efforts before it becomes a major challenge.
Along with providing a complete and accurate picture of the risk landscape, it also helps to prioritize and collaborate on risk mitigation efforts. Risk assessments can be launched from anywhere within the ComplianceQuest platform to analyze hazards associated with any process or activity such as audits, CAPAs, change, customer complaints, deviations, nonconformances, safety analysis, and environmental impact.
It also allows for defining risk tolerance thresholds and policies, and when met, initiating risk assessment automatically. Capturing trends, identifying patterns, and gathering insights become possible with access to quality data from across the enterprise in a unified manner.
To know more about ComplianceQuest’s Risk Management Software to implement a risk-aware quality management strategy, visit: https://www.compliancequest.com/lp/risk-management-solution/
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