Meet manufacturing compliance management demands with NAVEX One
Proactively manage your manufacturing company’s risk with GRC solutions that cover supply chain, GMP compliance management, and OSHA, FCPA and more.
What is manufacturing risk and regulatory compliance?
Manufacturing regulatory compliance refers to the adherence to laws, regulations, standards, and guidelines set by governmental authorities and industry bodies within the manufacturing sector (such as the FCPA, OSHA and GMP compliance management). These regulations ensure that products are manufactured safely and consistently and meet specific quality standards. Compliance with these regulations is essential for manufacturers to operate legally, maintain product quality, protect consumer safety, and minimize environmental impact.
Manufacturing compliance is not easy...
In the intricate landscape of manufacturing, adherence to regulatory standards and risk management practices is paramount. Here are some key considerations:
- What measures can we implement to address potential hazards concerning regulatory compliance, workplace safety, and ethical sourcing within our manufacturing processes?
- What mechanisms can we establish to ensure our workforce and stakeholders remain updated and compliant with training mandates?
- How do we continuously monitor, evaluate, and adapt our organization’s policies and procedures to align seamlessly with evolving regulatory requirements and industry best practices, safeguarding against compliance gaps and potential liabilities?
- How can we ensure our third parties and vendors also comply with the latest regulatory risk and compliance legislation?
Unpacking the challenges of risk and compliance in manufacturing
Navigating challenges within the realm of risk and compliance in the manufacturing industry demands a strategic approach. Here’s a breakdown of common hurdles:
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Cultivating a unified understanding among teams
Manufacturing companies with dispersed operations and intricate processes struggle to ensure compliance with regulations. Neglecting essential employee and stakeholder training can lead to non-compliance or unethical practices, exposing the organization to reputational and financial consequences.
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Elevating documentation practices beyond mere compliance
Insufficient documentation poses a significant risk of non-compliance and undermines the organization’s ability to demonstrate adherence to regulatory standards. Inadequate records may lead to mishandling of policies, ultimately jeopardizing the integrity of the compliance framework.
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Ensuring whistleblowing compliance
With manufacturing companies often have a wide-spread workforce over multiple locations, it is essential to ensure employees can raise concerns about culture, bribery, cyber risks or non-ethical business practices. Without a well-communicated whistleblowing process in place, reports and cases may leak externally.
Our top compliance resources on manufacturing regulatory compliance
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What’s in it for your organization?
Ensuring your company remains compliant can have many benefits:
- Legal compliance: Adhering to compliance regulations is essential for avoiding legal consequences such as penalties and fines.
- Ethical responsibility: Following compliance standards demonstrates a dedication to ethical business conduct, fostering employee trust.
- Reputation management: Conforming to compliance requirements safeguards your company’s reputation. Stakeholders, including customers, investors, and partners, increasingly value businesses committed to sustainable and ethical supply chain practices.
- Market access and partnerships: Aligning with compliance expectations opens opportunities for international trade and partnerships with organizations advocating responsible supply chain management.
- Risk mitigation: Compliance helps mitigate risks related to supply chain disruptions, legal issues, and potential reputational harm.
Manufacturing risk and compliance essentials
Start your journey to strengthen manufacturing compliance risk management with these essential steps.
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Establish a comprehensive code of conduct
Develop and implement a Code of Conduct that outlines the organization’s values, core policies, and expected behaviors for all stakeholders, including employees, executives, board members, and third parties. This code should serve as the foundation for ethical conduct throughout the organization, fostering a culture of integrity and respect.
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Implement role-specific training programs
Utilize a scalable ethics and compliance training solution to provide role-specific training that aligns individuals with the organization’s values and compliance requirements. This training should be strategically designed to address specific risks and regulatory obligations relevant to each role within the manufacturing process, ensuring that employees are equipped to make ethical decisions and mitigate risks effectively.
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Conduct regular risk assessments
Perform comprehensive risk assessments to identify and evaluate potential risks inherent in the manufacturing process, considering industry standards, regulatory requirements, geographical factors, third-party relationships, and other relevant variables. By systematically assessing risks, organizations can proactively identify areas of vulnerability and implement targeted mitigation strategies to minimize exposure to compliance breaches and operational disruptions.
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Establish an effective reporting mechanism
Implement an open and anonymous hotline and incident management system to encourage stakeholders, including employees, third-party vendors, and other relevant parties, to report ethics and compliance violations without fear of retaliation. This reporting mechanism should enable timely identification and investigation of potential issues, allowing organizations to address concerns promptly and prevent recurrence. Additionally, administrators should regularly analyze reporting trends to identify emerging risks and implement corrective actions as necessary.
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Leverage automation for policy management and third-party risk
Deploy automated solutions for policy management and third-party risk management to streamline compliance processes and enhance operational efficiency. These solutions enable the centralized creation, management, and distribution of critical policies across the organization, ensuring alignment with regulatory requirements and facilitating stakeholder attestation and auditability. Additionally, automated tools can facilitate the onboarding, screening, monitoring, and administration of third-party engagements, enabling organizations to manage risks associated with external partners and vendors effectively.
How NAVEX can help your manufacturing organization manage risk and compliance
Discover the NAVEX products that can help you throughout your governance, risk and compliance journey.
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Policy & Procedure Management
Centrally manage your entire policy and procedure lifecycle.
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Whistleblowing & Incident Management
Ensure regulatory compliance, engage your people and build trust in your reputation with NAVEX reporting and whistleblowing solutions.
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Ethics & Compliance Training
Educate and engage your people with online training that speaks in their language, to their experiences.
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Third Party Screening & Monitoring
Easily identify third parties that share your vision and safeguard your most valuable partnerships with NAVEX One.
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Simplified Vendor Risk Management
Quick to launch, quick to deliver – NAVEX IRM out-of-the-box is your express route to mastering vendor risk management.
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More you need to know about manufacturing compliance
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What is risk in the manufacturing industry?
Risk in the manufacturing industry refers to the possibility of encountering adverse outcomes or events that can impact production processes, product quality, safety or profitability.
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What is manufacturer compliance?
Manufacturer compliance refers to adhering to various regulations, standards and guidelines set by authorities, industry associations, or customers to ensure products are manufactured safely, ethically and by legal requirements.
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What are the three types of compliance?
The three types of compliance are production compliance, OEM (Original Equipment Manufacturer), and product regulatory compliance.
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What is production compliance?
Production compliance involves meeting standards and specifications throughout manufacturing to ensure products are produced consistently and meet quality requirements.
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What is OEM compliance?
OEM compliance involves meeting the requirements and standards set by the original equipment manufacturer when producing components or products for them.
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What is product regulatory compliance?
Product regulatory compliance involves ensuring products meet all the relevant regulations, standards and guidelines set by governmental bodies or industry authorities to ensure safety, quality and environmental responsibility.
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What is a certificate of compliance in manufacturing?
A certificate of compliance is a document issued by a manufacturer or a third-party certifying agency to confirm a product, process or system meets specified requirements, standards or regulations.
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What is operational risk in manufacturing?
Operational risk in manufacturing refers to the potential for disruptions, losses or failures within the manufacturing process due to factors such as equipment breakdowns, supply chain interruptions, or human error.
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What is an example of a production risk?
An example of a production risk could be equipment malfunction leading to unexpected downtime, disrupting production schedules and resulting in delayed deliveries or increased costs.
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What is risk analysis in manufacturing?
Risk analysis in manufacturing involves identifying, assessing and mitigating potential risks within the manufacturing process or supply chain to minimize the likelihood and impact of adverse events on operations, quality and profitability.