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We recently met a group of renowned business leaders at an industry conference.

One of them asked: “what is the biggest takeaway from the pandemic? What could we have done better?”

“Never take your suppliers, partners and supply chain stakeholders for granted,” said one. “Focus on the controllable factors; there’s always going to be things happening around us that we cannot control,” added another.

One business leader in the life sciences sector said something that resonated with everyone: “When it comes to technology adoption, move fast. The pandemic forced us all to digitalize much faster than we had planned. Why didn’t we move at this pace before?” he asked aloud.

Finally, one manufacturing sector veteran pointed out: “My biggest takeaway is around risk planning. All of our challenges could have been tackled better had we been more proactive and data-oriented with our risk management processes.” And, that is what this blog is about.

A more detail-oriented, collaborative approach for risk management must involve the following:

  • A dedicated process is in place to uncover all potential risks in the business across all departments and areas of operations
  • A “continuous” and constantly revisited risk assessment plan
  • Focused risk management efforts around workplace safety, employee well-being
  • Risk-aware approach to quality management
  • Strong risk analytics framework with data at the core
  • Last but not the least, a risk assessment framework across the following areas – business and strategy, compliance, finance, brand, people and talent, supply chain, and industry shifts

According to an EY finding, 55% of board members surveyed believed that risk management lags behind business strategy changes. In the same EY survey, 61% of the CEOs identified risk management as a top priority and emphasized on the need for better risk analytics frameworks.

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To enable this, business leaders need an integrated risk management (IRM) solution that will help perform advanced risk quantification and analytics by analyzing data from various data sources including the ERP, CRM, eQMS, EHS, PLM, etc.

Nowadays, sustainability is also gaining importance, and companies are expected to invest in improving environment, social, and governance (ESG) practices. Businesses, therefore, also need an ESG risk profile that is compliant with standards and regulations.

Regulatory Guidelines for Integrated Risk Management

Regulatory bodies and standards such as ISO and FDA have always been stressing on the need for IRM. ISO 31000, for instance, provides a guideline for risk management that addresses operational continuity. This helps businesses identify opportunities and threats and mitigate risks through effective allocation and utilization of resources.

ISO 9000:2015 and ISO 9004:2009 also encourage a risk-based approach when undertaking planned innovation activities and quality management. With risk-based thinking, organizations can determine the factors that could potentially cause deviation from expected results.

The IRM approach enables assessing the potential impact of change management initiatives and ensures preventive controls are in place while change is being implemented.

Unified Data for Improved IRM

IRM requires businesses to have greater risk visibility and an insights-driven decision-making process. The idea here is to spot opportunity amidst risk and be nimble enough to drive competitive advantage with a better risk mitigation strategy in place.

But typically, risks are addressed in silos, with different teams handling different kinds of risks. This fragmented approach can prove counterproductive, with businesses unable to spot the connection between different risks. This can limit the effectiveness of certain risk management actions that have been planned.

To create an optimal risk management strategy, businesses need a unified view of the data to help evaluate, control and monitor risks. This helps identify potential quality, safety, and environmental issues that can impact production. Placing effective controls can help prevent full-blown quality events or incidents – often reducing the impact if prevention is not entirely possible.

They can also monitor relevant KPIs and constantly fine-tune their quality and safety management systems to protect business and stakeholder interests.

An effective IRM should include the following processes:

  • Identification, analysis, and assessment of various risks
  • Risk treatment
  • Risk control
  • Predictive risk analytics
  • AI-enabled analysis for better prioritization
  • Communication
  • Monitoring

ComplianceQuest for Integrated Risk Management

ComplianceQuest Enterprise-wide Quality Management System (EQMS) and Environment, Health, and Safety System (EHS) are cloud-based quality and safety management systems built on the Salesforce platform. Our products leverage next-gen technologies including AI, NLP, ML, and advanced analytics to make life easier for various stakeholders involved in the quality, safety, and risk management lifecycle.

Most importantly, being aligned to the leading regulatory standards such as ISO, FDA, cGMP, and so on, the two solutions provide a risk-based approach to quality and safety management. They seamlessly integrate with enterprise systems such as CRM, ERP, and SCM, to identify potential risks and their severity with an enterprise-wide view, rather than a siloed approach.

It helps gain a clear, consolidated view of the organization’s risks through identification, evaluation, mitigation, and continuous monitoring. With CQ Risk Management Software, you can:

  • Maintain a centralized repository of identified risks at the project, department, or company level
  • Drive strategic decisions on potential threats with a solution that is aligned with the latest standards (ISO 31000, ISO 14971, ICH Q9, and risk principles in ISO 9001:2015, ISO 13485:2016, ISO 45001, and ISO 14001)
  • Accelerate assessments, identify and analyze risk trends and drive risk mitigation activitiesl
  • Identify the right approaches that contribute to process efficiency, improved risk management, and internal controls with the CQ risk framework

By providing a holistic view of the risk landscape, stakeholders can prioritize and collaborate on risk mitigation efforts. It helps them in making data-backed strategic decisions to offset new risks and improve operations.

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.

The CQ Risk Management Software also comes with reporting and dashboards to spot potential risks based on history, trending data, and key metrics. With embedded intelligence, quality and risk management leaders can proactively start their risk mitigation efforts before it becomes a major challenge.

CQ Risk Management also enables defining risk tolerance thresholds and policies. When these thresholds are met, it automatically initiates a risk assessment. With Einstein Analytics and a centralized registry of risks, businesses can spot patterns and gather insights from quality data across the enterprise.

To know more about CQ Risk Management Software, visit:
https://www.compliancequest.com/risk-management-software/

If you wish to deploy integrated risk management in your enterprise with the power of automation and digital transformation, request a demo: https://www.compliancequest.com/online-demo/

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