McNeese Customs & Commerce also offers assistance with Auditing, Regulatory Training and Remediation with Government Agencies.
A compliance audit is a process of independently evaluating to what extent an organization is following regulatory requirements such as laws, regulations, rules, agency policies and guidelines. If you are importing or exporting products regulated by government agencies you must be well prepared for one of the following audits:
These audits are aimed at verifying the compliance level, in order to obtain a benefit such as Authorized Economic Operator (AEO) for Customs-approved benefits, risk-based U.S. Customs Focused Assessment (FA) audits, FDA Food Safety Modernization Audits (FSMA) compliance facility inspection audits, USDA approved foreign establishment audits, Canadian Food Inspection Agency (CFIA) audits and assessments of the food control systems, etc.
Once an importer or exporter is registered and/or approved, routine audits to verify stable compliance levels are to be expected and welcomed since it is an opportunity to demonstrate compliance and be considered a “trusted partner” by government agencies and customers. Audits are also an occasion for constant improvement through continuous learning.
In this case, an agency is following up on an agreed improvement plan, as in the case of an FDA Warning Letter. Or an agency is trying to see if the promises made by a company to terminate a registration suspension have been kept.
For-Cause (investigational) audit:
An agency has a specific mission and the audit’s
purposes are always fully disclosed. It could be the result of a whistleblower, or because an agency has probable cause from a Customs-related OLAF report in the EU or answers that an importer gave in the US Custom Request-for-Information Form.
The aforementioned audits should be taken seriously and a company should request the services of a trained professional in audit methodology. We provide in-depth, reliable, interdisciplinary audit assistance in order to help our clients shine with our tailored service and extensive knowledge.
Regulatory training can improve regulatory compliance levels thereby impacting a company’s profitability, customer retention, reputation with government agencies, and public image. Many import-export contracts have specific clauses requiring regulatory compliance.
The challenges of compliance training are the following:
It needs to be practical for audit performance and for upper management buy-in to increase.
Regulatory material can be boring for employees.
Regulations and agency interpretations change in time.
Martin McNeese is a guest instructor at Michigan State University and a past Toastmaster public speaker, so he is able to make compliance training interesting and motivate your staff to turn theory into productive practice.
Remediation with Government Agencies
Regulatory remediation is the process of addressing regulatory gaps or non-compliance issues with regulatory requirements. Regulatory remediation measures are based on regulatory gaps; some remediation measures are statutory while others are best practice tools.
We assist organizations when a regulatory incident occurs such as, but not limited to: a Customs Request-for-Information, an FDA Warning Letter, placement on FDA Import Alert, or a regulatory investigation. In such event, we can provide any combination of the following services: