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Risk and Compliance

Consolidate audit, risk and compliance systems on one platform to enable strategic, predictive and integrated risk management to make better decisions to drive activities that protect, and enhance your organization’s value.

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Why CQ Risk Management

The risks that impact today’s businesses are continuously growing, changing, increasingly complex and interconnected. A company is vulnerable to countless risks such as supplier relationships, manufacturing processes, employee safety, shipment of finished products, environmental incidents, and more.

New and modified rules and regulations across regional, national, and international borders continue to intensify and now include an increasing focus on leveraging risk-based management strategies. Regulators advocate a risk-based approach because it shows that the company actually knows and thinks about its risks. No matter how large, small, or diversified your organization is, almost every part of it touches a complex web of constantly evolving regulations.

CQ Risk Management solution brings together data often found in siloed risk, quality and safety repositories and gives risk management teams and first line defenders a comprehensive set of solutions, tools, reports and dashboards to identify, assess, evaluate, treat and monitor risks consistently across the enterprise.

Challenge

Given the vulnerability to the market, regulation or legislation changes, your own internal processes and other factors, you never know when you will have an encounter with risk. In many cases risk results from inadequate controls or issues related to training, due diligence and human error.

But you can’t manage your company’s operational, quality, safety and compliance risk if you don’t understand what your risks are. Risk plans will accomplish little if they remain in silos and do not address the right risks. If a risk manager is unable to communicate risk information effectively, top management may make decisions that are badly informed, or they may develop an overoptimistic perception of the risk position of the firm. Without close risk and compliance function collaboration, blind spots to risk will inevitably result for key stakeholders throughout an enterprise, and impact strategic, financial and operational initiatives.

Failure to manage risks is inherently risking failure.

Financial Impact

  • Cost of compliance violations and fines, health and safety risks, lawsuits and settlements
  • Unexpected holds or stopped production lines
  • Costs of cycle time and risk assessments
  • Increased cost of internal and supplier audits
  • Maintaining disparate processes and system (i.e., CAPA)

Brand Impact

  • Immature business resiliency
  • Decrease in brand reputation
  • Lack of stakeholder and regulators confidence
  • Company and product reputation

Quality Impact

  • Inability to effectively assess, manage and mitigate various types of risk activities across all business functions
  • Unable to uncover systemic issues, under-performing controls and prioritize events by risk
  • Lack of trending risk data and inability to perform real-time meaningful analytics
  • No single, comprehensive visibility into both risk exposure and relationships
  • Inability to prioritize internal audits based on risk indicators

Time Impact

  • Inability to respond quickly to adverse risk incidents
  • Slow to gain visibility into risk mitigation and effectivity
  • Inability to collaborate and complete regular audits
  • Inefficient scheduling and excessive time to keep audits up to date

Gain a Clear, Consolidated View of your Organization’s Risk

Turn risk into a competitive advantage by anticipating future challenges and acting ahead of threats.

To achieve successful and timely product launches, companies need to avoid quality and safety risks, which add costs and cause delays. Integrating Risk and Compliance framework into your business will enable your organization to identify the right approaches that contributes to process efficiency, improved risk management and internal controls. The advantages of risk management are, besides a regulatory requirement in some industries and countries, reduced uncertainty for the future, learning and improvement, awareness, a tool for making the right decisions, proper projection of performance results, and improved culture. This complete view of compliance and risk and seeing it as a vital performance lever, enables organizations to take on risks with confidence for competitive advantage.

CQ’s Risk Management Solution provides a complete and accurate picture of the risk landscape across product lines, business processes, and business units. 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, etc. The CQ Risk and Compliance solution provides a framework for defining operational risk tolerance thresholds and policies complying to these thresholds are employed and followed for risk assessment and required analysis across the organization.

Gain a Clear, Consolidated View of your Organization’s Risk

Turn risk into a competitive advantage by anticipating future challenges and acting ahead of threats.

To achieve successful and timely product launches, companies need to avoid quality and safety risks, which add costs and cause delays. Integrating Risk and Compliance framework into your business will enable your organization to identify the right approaches that contributes to process efficiency, improved risk management and internal controls. The advantages of risk management are, besides a regulatory requirement in some industries and countries, reduced uncertainty for the future, learning and improvement, awareness, a tool for making the right decisions, proper projection of performance results, and improved culture. This complete view of compliance and risk and seeing it as a vital performance lever, enables organizations to take on risks with confidence for competitive advantage.

CQ’s Risk Management Solution provides a complete and accurate picture of the risk landscape across product lines, business processes, and business units. 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, etc. The CQ Risk and Compliance solution provides a framework for defining operational risk tolerance thresholds and policies complying to these thresholds are employed and followed for risk assessment and required analysis across the organization.

Who We Help

CQ Risk Management helps your organization manage operational risk tracking, evaluation, mitigation and monitoring processes efficiently.

Compliance

Reduce your compliance risk and avoid future costs

Business is changing so rapidly that the old, reactive ways of managing compliance risks might lead organizations to fall behind the competition or leave them exposed to larger compliance risks than they ever expected.

Compliance’s objective is fundamentally operational – looking at the present and towards the future to ensure that all activities are carried out in compliance with the prevailing regulatory and legal requirements. If an organization doesn’t meet its compliance obligations, it may face significant penalties, fines or even lawsuits and reputational damage.

Organizations need a better way to better manage compliance risks and be more risk intelligent, which involves being more aware of today’s risks. It requires a holistic approach toward managing compliance in an organization applied to policies, assessments, controls, audits, and other areas. Assessing compliance risk may be simple, requiring a brief inspection to find out whether rules were followed or not and certainly can be analyzed using common risk-assessment, control, and mitigation frameworks.

But you need an integrated compliance model at every level of the organization to keep quality, workplace health & safety, environmental and compliance risk in check and to ensure that policies are followed. A good compliance framework can enable an organization to better handle any risks and

  • ensure transparency across the supply chain
  • automate assignments to improve accountability
  • reduce compliance costs
  • enable wise resource use
  • prevent undesirable outcomes

Managers can use real-time data and trending to make the best strategic decisions to offset new risks and improve operations.

Compliance

Reduce your compliance risk and avoid future costs

Business is changing so rapidly that the old, reactive ways of managing compliance risks might lead organizations to fall behind the competition or leave them exposed to larger compliance risks than they ever expected.

Compliance’s objective is fundamentally operational – looking at the present and towards the future to ensure that all activities are carried out in compliance with the prevailing regulatory and legal requirements. If an organization doesn’t meet its compliance obligations, it may face significant penalties, fines or even lawsuits and reputational damage.

Organizations need a better way to better manage compliance risks and be more risk intelligent, which involves being more aware of today’s risks. It requires a holistic approach toward managing compliance in an organization applied to policies, assessments, controls, audits, and other areas. Assessing compliance risk may be simple, requiring a brief inspection to find out whether rules were followed or not and certainly can be analyzed using common risk-assessment, control, and mitigation frameworks.

But you need an integrated compliance model at every level of the organization to keep quality, workplace health & safety, environmental and compliance risk in check and to ensure that policies are followed. A good compliance framework can enable an organization to better handle any risks and

  • ensure transparency across the supply chain
  • automate assignments to improve accountability
  • reduce compliance costs
  • enable wise resource use
  • prevent undesirable outcomes

Managers can use real-time data and trending to make the best strategic decisions to offset new risks and improve operations.

Risk-based Thinking for Proactive Risk-based Audits

Effective audits are the foundation for risk and compliance throughout your organization. 

Latest releases of standards, such as ISO 9001, ISO 13485, ISO 14971, ICH Q9, ISO 31000, ISO 45001, ISO 14001 etc. include “risk-based thinking.” Risk based audits build on an approach which is focusing more on the areas of the highest risk to the organization and then uses a different starting point: business objectives rather than controls. The advantages of risk-based audit approach are that the organizations become proactive rather than being reactive, preventing the undesired effects and promoting continual improvements. When developing a top-down, risk-based audit plans, there is usually no better place to start with than looking at what your risk management has identified as key risks.

An audit can apply to an entire organization or might be specific to a function, process, business structure, suppliers, and information systems. It provides a systematic, disciplined approach to evaluating and improving the effectiveness of the organization’s risk management, compliance, quality, safety, and internal control processes.

CQ Audit Management can help a company monitor, evaluate and identify weaknesses in risk and compliance across an organization. It can promote fresh thinking and can bring about significant improvement or address previous blind spots. It plays a vital role in overall operational enhancement and has become an important component of proactive, forward-thinking organizations that strive for continuous process improvement while seeking to reduce organizational risk.

For an end-to-end Enterprise Risk and Compliance, combine multiple ComplianceQuest compliance solutions under one seamless connected platform or use independently.

  • Issues, Complaints and CAPA Management
  • Change Management
  • Investigation and Findings Management
  • Policy & Procedure Document Management
  • Training Management

Risk-based Thinking for Proactive Risk-based Audits

Effective audits are the foundation for risk and compliance throughout your organization. 

Latest releases of standards, such as ISO 9001, ISO 13485, ISO 14971, ICH Q9, ISO 31000, ISO 45001, ISO 14001 etc. include “risk-based thinking.” Risk based audits build on an approach which is focusing more on the areas of the highest risk to the organization and then uses a different starting point: business objectives rather than controls. The advantages of risk-based audit approach are that the organizations become proactive rather than being reactive, preventing the undesired effects and promoting continual improvements. When developing a top-down, risk-based audit plans, there is usually no better place to start with than looking at what your risk management has identified as key risks.

An audit can apply to an entire organization or might be specific to a function, process, business structure, suppliers, and information systems. It provides a systematic, disciplined approach to evaluating and improving the effectiveness of the organization’s risk management, compliance, quality, safety, and internal control processes.

CQ Audit Management can help a company monitor, evaluate and identify weaknesses in risk and compliance across an organization. It can promote fresh thinking and can bring about significant improvement or address previous blind spots. It plays a vital role in overall operational enhancement and has become an important component of proactive, forward-thinking organizations that strive for continuous process improvement while seeking to reduce organizational risk.

For an end-to-end Enterprise Risk and Compliance, combine multiple ComplianceQuest compliance solutions under one seamless connected platform or use independently.

  • Issues, Complaints and CAPA Management
  • Change Management
  • Investigation and Findings Management
  • Policy & Procedure Document Management
  • Training Management

CQ Risk and Compliance Benefits

Increase Visibility to overall Risk and Compliance

  • Reduce dependency on manual methods of pulling business-critical information around risk and compliance
  • Increase organizational/process communication and transparency
  • Early view of potential problem trends to proactively initiate resolutions
  • Gain a single source of truth about the overall health and effectiveness of risk and compliance
  • Make effective decisions based on real-time insight of risk and compliance information

Reduce Risk and Exposure

  • Reduce the likelihood of a major non-compliance event
  • Ensure organizational risk tolerance is not exceeded
  • Improved scoring and proper mitigation of residual risks
  • Eliminate loss of information from one audit to another
  • Increase focus on business-relevant risks

Improve Compliance

  • Ensure quality processes are in compliance with international standards and regulatory requirements
  • Accelerate audit process and report delivery
  • Easily convert gaps into corrective and preventative actions
  • Unite and collaborate teams across the enterprise and with suppliers on compliance
  • Maintain an Audit / Inspection ready status

Improve Business Operations

  • Increase efficiency and economies of scale by eliminating redundancies in your business practices and procedure
  • Reduce costly delays due to data silos, human errors, and review cycle times
  • Achieve timely product launches while ensuring compliance by mitigating risks in every phase of a product’s lifecycle
  • Instill a culture of risk-based thinking into your entire quality, safety and environmental ecosystem

Our customers use ComplianceQuest to:

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Competitive Advantage

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Continuous Improvement

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Significant Business Challenge

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