Risk Management  >  Quality Risk Management Software

Quality Risk Management Software

Global supply chains have made processes complex and prone to several quality risks. These quality risks exist in all industries and extend across all processes and departments. So, every organization must have formal risk management processes to manage these risks using a risk-based approach. Quality Risk Management can help reduce risk by enabling the review, identification, and monitoring of risks and planning responses to mitigate risks or threats. These are critical elements in implementing quality risk management, and the process should be examined regularly and after any major incident or variation.

quality risk management software
quality risk management software
quality risk management software video

What is Quality Risk Management?

Quality risk management is a continuous process that facilitates risk managers to analyze risks and develop strategies to control future outcomes by taking proactive measures. Effective risk management allows risk managers to reduce repetitive losses and maximize project success by analyzing risk patterns. Quality risk management software is also considered an awareness and learning tool that can identify and track risk to control the negative impact and future outcomes.

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Why Quality Risk Management is Important

Why Quality Risk Management is Important?

Quality Risk Management helps organizations identify, assess, and mitigate risks that could impact product quality and patient or customer safety. It is used in various industries, including pharmaceuticals, healthcare, and manufacturing.

It helps evaluate potential hazards and uncertainties. When these risks are known, organizations can take proactive measures to reduce the likelihood of defects, errors, and product recalls. This approach protects consumer well-being and helps companies meet regulatory requirements and maintain a strong reputation.

Quality risk management fosters continuous improvement, resource optimization, and informed decision-making, ensuring the delivery of high-quality products and services while minimizing adverse outcomes and financial losses.

What are the principles of Quality Risk Management?

ComplianceQuest’s Quality Risk Management Software has unique AI and analytical capabilities and embedded intelligence. This solution helps organizations to identify potential risks based on history and trending data. Quality and risk management leaders can use the software to support their proactive risk mitigation efforts before it becomes an unprecedented challenge. Here are some of the principles of quality risk management software:

  • Go From Reactive to Proactive: Stakeholders can prioritize risk mitigation efforts to make efficient decisions to nullify new risks and improve operations.
  • Easy Collaboration: Addressing risks properly on priority, depending on the severity, is essential for evaluating them and defining metrics for real-time insights. ComplianceQuest’s Quality Risk Management increases your organization’s value by being flexible and integrated to drive activities.
  • Get Current Insights: This can help you to get current insights into key risks, risk trends, root causes, corrective and preventive action plans, and potential incidents for suitable strategies for risk mitigation.
  • Resolve Future Issues with Embedded Intelligence: With embedded intelligence ComplianceQuest’s Quality Risk Management solution can enable an organization to initiate a quality risk assessment by determining risk tolerance thresholds and policies. Thus, you can find out and respond to the highest risks using historical data on past risk factors to avoid future issues.
quality risk management principles

Steps involved in Quality Risk Management

The quality risk management process is a framework to take proper actions to protect business value, ensure product quality, and keep customers and employees safe from harm. It is a five-step process that includes identifying risks, analyzing the potential risks, prioritizing the risk based on severity, implementing a solution, and continuously monitoring the risk.

quality risk management steps

  • Finding out the Risk:

    The initial step is to find the risks within the system. A robust quality risk management software can help keep all the information in a centralized location. Thus, every stakeholder can access all the details within the organization.

  • Analyzing the Risk:

    After identifying the risks, the severity and criticality of the risk need to be analyzed. Implementing CQ’s quality risk management solution can help you to map risks and inform the risk manager of their impact.

  • Ranking the Risk:

    After identifying and analyzing the risk, it needs to be evaluated and prioritized. Prioritizing the risk is important as it enables the organization to gain a comprehensive view of the risk landscape of the entire organization.

  • Implementing a Solution:

    After prioritizing the risks based on severity, the next step is to either contain or eliminate the risks by connecting with the experts to which the risk belongs. An integrated Risk Management Solution can send updates directly from the dashboard. A resilient quality risk management solution can send notifications to all the relevant stakeholders.

  • Monitoring and Reviewing the Risk:

    Two risks always need to be monitored and reviewed: market risks and environmental risks. An integrated quality risk management solution helps to monitor and review the complete risk framework of the organization that assures business continuity.

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Tools used in Quality Risk Management

Here are some tools used in Quality Risk Management software, such as:

Risk Matrix

Risk Matrix:

The risk matrix helps to minimize risks by visualizing the potential risks and assessing the possibility of a risk event occurring. The organization can set the priorities for an effective quality risk management strategy.

decesion tree

Decision Tree:

By embedding a decision tree, ComplianceQuest’s Quality Risk Management software can help to identify reportable hostile events.

Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA):

FMEA is a diagram of the operation and details of all components that encompass engineering, manufacturing, and the field, by providing a single definition of failure modes.

Best-Practice Form Design

Best-Practice Form Design:

ComplianceQuest’s this feature helps users to collect and track relevant data for assessing risks.

Analytics and Reporting Tools

Analytics and Reporting Tools:

This feature in ComplianceQuest’s quality risk management tool is designed with preconfigured or customized reports depending on users’ needs.

Collaboration

Collaboration:

By integrating with different processes, including CAPA, nonconformances, change management, etc., ComplianceQuest’s quality risk management software tool makes it easier for all stakeholders to participate in risk management activities. Therefore, stakeholders can collaborate and prioritize risk mitigation efforts that could impact product quality and improve operations.

  • Risk Matrix

    Risk Matrix:

    The risk matrix helps to minimize risks by visualizing the potential risks and assessing the possibility of a risk event occurring. The organization can set the priorities for an effective quality risk management strategy.

  • decesion tree

    Decision Tree:

    By embedding a decision tree, ComplianceQuest’s Quality Risk Management software can help to identify reportable hostile events.

  • Failure Mode and Effects Analysis (FMEA)

    Failure Mode and Effects Analysis (FMEA):

    FMEA is a diagram of the operation and details of all components that encompass engineering, manufacturing, and the field, by providing a single definition of failure modes.

  • Best-Practice Form Design

    Best-Practice Form Design:

    ComplianceQuest’s this feature helps users to collect and track relevant data for assessing risks.

  • Analytics and Reporting Tools

    Analytics and Reporting Tools:

    This feature in ComplianceQuest’s quality risk management tool is designed with preconfigured or customized reports depending on users’ needs.

  • Collaboration

    Collaboration:

    By integrating with different processes, including CAPA, nonconformances, change management, etc., ComplianceQuest’s quality risk management software tool makes it easier for all stakeholders to participate in risk management activities. Therefore, stakeholders can collaborate and prioritize risk mitigation efforts that could impact product quality and improve operations.

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Overview of Quality Risk Management Software

Quality risk management software helps business leaders make consistent and risk-based decisions by offering the right tools and practices that can extend across the product lifecycle. Integrating ComplianceQuest’s Quality Risk Management software into your processes enables you to prevent problems, including the loss of time, financial penalties, and goodwill due to unanticipated product failures, by taking proactive steps and having processes in place to resolve them when they do.

Implementing a quality risk management strategy is a five-step process that includes:

  • Identification of all the main processes within the organization
  • Design risk management framework linked to these operations
  • Determine quality risk assessment tools and people involved
  • Encourage risk-based thinking by implementing tools
  • Implement mitigative steps to manage risks

ComplianceQuest’s Quality risk management software is an integral part of the Enterprise-wide Quality Management System with numerous advantages, including:

End-to-End Holistic View of Data

End-to-End Holistic View of Data

ComplianceQuest’s Quality Risk Management software integrates seamlessly with other enterprise systems such as ERP, CRM, and SCM to get an end-to-end holistic view of data. Thus, managers can determine potential risks, evaluate and reduce them effectively, and monitor to assess their effectiveness with visibility and transparency into processes.

Better Pricing

Better Pricing

ComplianceQuest ‘s Quality Risk Management software can be implemented based on need as a modular, cloud-based solution. So you don’t require investment in additional resources.

Efficient Training

Efficient Training

The training module of the CQ EQMS delivers training as per the requirement so that business leaders can evaluate each employee’s risk identification and management skills.

Security

Security

The CQ EQMS integrates with security features, including authentication, authorization, and permission-based access control aligning with all regulations and standards.

Key features of CQ Quality Risk Management Software

  • Risk Intake: Risk intake can help configure different risk types and access all risk-related documentation for assessing various operational risks.

  • Risk Mitigation: This feature empowers employees to participate in risk mitigation activities using electronic workflows and signatures.

  • Risk Detection: ComplianceQuest’s Quality Risk Management Software comes with AI and analytics-based features that help to identify potential risks.

  • Reporting and Analytics: You can create any number of reports and dashboards using preconfigured best practices-based reports. ComplianceQuest Quality Risk Management Software helps to track progress, monitor, and measure the success of risk mitigation measures, creating a risk-aware culture that minimizes business risks for faster growth and innovation.

benefits

  • Risk Assessment and Analysis: This feature generally helps to determine operational risk tolerance thresholds and policies for risk analysis and evaluation.

  • Monitoring Risk: This feature can help you to monitor the performance of mitigated risks to ensure their effectiveness.

  • Risk Registry: A centralized risk registry records all identified risks at the department, project, or company levels. This can help to make strategic decisions on potential threats aligning with the latest standards to increase evaluations, detect and review risk trends, and drive risk mitigation activities.

  • Mobile friendly: ComplianceQuest Quality Risk Management Software is cloud-based and mobile-ready. You can even use the mobile app to do a quality risk assessment to analyze hazards associated with any process or activity.

Great product, support, and people to work with!

We have rolled-out CQ across our company to automate various elements of QMS requirements such as Document Management, Complaints, Non-conformances, Corrective Action (8D and A3), Supplier Management and Audit Management. We have been using the software for more than 2 years. We are glad to see how well the system is being used across the company. We have several thousand users on the system currently and working to scale the usage further. CQ solution has been configured to meet our needs, works elegantly across languages, across time zones, and business verticals. With integration between CQ and SAP to exchange critical data, the process automation provides a lot of productivity.

Lia Budiman,
Solution Consultant, Continental Contitech

continental contitech
continental contitech
CQs Quality risk management

Issues that occur while considering Quality Risk Management and how ComplianceQuest helps to overcome them?

Managing risk and providing the best quality to your customers is essential for any organization’s financial stability and durability. Organizations must uncover challenges by identifying and preventing potential harm in terms of safety, quality, and compliance to avoid severe consequences. Here are some of the challenges of quality risk management, including:

  • Improper use of risk metrics
  • Mis-assessment of known risks
  • Failure to take effective action on the identified risks
  • Failure to communicate the risks to top management
  • Failure to monitor and manage risks properly

ComplianceQuest’s Quality Risk Management Solution provides a framework that gives a holistic view of the risk landscape across business processes, product lines, and business units. Integrating with Audits, CAPAs, Change, Customer Complaints, Deviations, Nonconformances, etc., It provides a comprehensive set of tools, dashboards, and reports, to identify, assess, evaluate, treat and monitor risks regularly across the organization. This solution helps in determining operational risk tolerance thresholds and policies.

Analyze risks and develop strategies to control future outcomes by taking proactive measures with ComplianceQuest’s Quality Risk Management Software

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Quality-centric Companies Rely on CQ QMS

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  • verily mono
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  • tupperware mono
  • continental logo mono
  • vyaire mono
  • lifescan mono
  • janssen mono
  • lundbeck mono
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  • qlik mono
  • csa group mono
  • impossible mono
  • fluence mono

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Frequently Asked Questions

  • Organizations, regardless of size, consider a top-down approach to managing risk adequately. By creating a risk assessment matrix, you can detect risks and implement risk management strategies to mitigate each risk. Quality risk management software can help businesses:

    • Avoid: You can avoid risk-causing factors if you have control of the activity. Eliminate the root cause or consequence of the identified risk and reconfigure the project, so the risk disappears or is minimized to an acceptable value.

    • Reduce: You can minimize the negative effects or likelihood of the risk occurring by establishing early warning systems through data collection. An automated quality risk management solution can help you to evaluate and mitigate various types of risk more precisely by streamlining processes.

    • Accept: You should accept the risk in cases where the risk mitigation strategies are more expensive than the possible problems caused by the risk occurring.

    • Transfer: Additionally, you can transfer risk to a third party, such as an insurance company or subcontractor.

  • Identifying, understanding, measuring, and proactively managing quality risk is crucial for every organization to ensure a smooth business process that can add value to your organization. Managing risks will help achieve the objectives of an efficient and effective quality function and prevent the risks of inefficiency and ineffectiveness.

  • Choosing ComplianceQuest’s quality risk management solution can provide a comprehensive picture of the pulse of all quality and safety-related risks associated with any process or activity. ComplianceQuest’s solution helps minimize damage and protect business assets and resources by identifying, assessing, evaluating, and monitoring risks. Quality risk assessment evaluates hazards that define operational risk tolerance thresholds and policies.

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