Seven Elements of a Regulatory Compliance Program

What is a Regulatory Compliance Program?

Any program that supports the coordinated efforts of managing and monitoring compliance regulations is considered a regulatory compliance program.

Typical activities in a regulatory compliance program

• Identifying key areas of regulatory compliance and the management infrastructure. Examples include- HIPAA, Research Administration, Finance, Data Privacy and Security.
• Establishing training for the education of compliance regulations.
• Managing required resources to manage regulation compliance geared towards certain sectors.
• Monitoring any compliance risks.
• Developing strategies to mitigate risks.
• Establishing a systematic approach to monitoring laws and regulations for compliance requirements.

There is no one-set of standards used to develop a compliance program. It is a long term approach to a broad set of guidelines. Each program does share some core themes of regulatory compliance such as-

Risk Assessment- Each key area is systematically evaluated to determine any compliance risks. Processes are put in place to regulate risks in an ongoing basis to control their impact.

Responsible Parties and Roles- Each party involved in the overview of regulatory compliance should have clearly identified roles. These roles should be documented with the full authority the role possesses as it pertains to the compliance program.

Standards and Procedures- Documentation of standards and procedures should be clearly communicated. They should meet the criteria needed to reduce the risk of any conduct that is non-compliant.

Program Oversight- A compliance officer should be put in place to oversee the implementation of the compliance program. They should be tasked with the responsibility of reporting questions or concerns to the governing body as they related to monitoring the regulatory compliance program.

Awareness, Education and Training- Specific regulations for different corporate compliance programs will need to have additional training for each individual. Training materials should be clear and handed out in a timely manner in regards to education of the compliance program.

Processes for Corrective Actions- It should be firmly denotated that failure to comply to regulations will have corrective action that comes with it. Non-compliance measures should be an adequate representation of the infraction made. These corrective measures will address any short term non-compliance and prevent any future breakdown in the chain.

Seven Elements of an Effective Compliance Program

Creating a compliance program will be specific to the organization. The following elements are some that can be addressed to ensure compliance measures are met.

• Implementing Policies, Procedures, and Standards of Conduct- The policies, procedures, and standards of conduct need to be clear and documented. Any changes to policy should be addressed with haste and made available as soon as the changes are meant to take effect, if not before. Communications within these standards should be relevant to job functions to allow no confusion for regulatory compliance issues.

• Designating a Compliance Officer and Compliance Committee- Having a designated compliance officer or committee in place will minimize non-compliance within the organization. Having a compliance officer who oversees the elements within the compliance program will be an added support measure for establishing clear resources and communicative efforts designed around the program.

• Training and Education- Annual compliance training is minimal for effective training and education of the materials within a compliance program. Formal training and education should be maintained as a clear job requirement. Continued training will allow individuals to remain up-to-date on any changes affecting the guidelines within.

• Effective Communication- Open lines of communication are imperative to a well-developed compliance program. It also establishes a means to report instances of non-compliance in a swift nature to deter any further infractions. Remaining approachable on matters which ensured confidentiality will promote feedback on the program itself.

• Monitoring and Auditing- Compliance audits are commonplace within a working environment. An annual plan dedicated to internal monitoring will assess risk factors and address any weak points within the compliance program itself.

• Disciplinary Guidelines- Documented disciplinary guidelines should be in place and be easily accessible. These guidelines are meant to ensure continued compliance throughout the organization and the results if one is non-compliant. All personnel regardless of status should be required to follow the compliance guidelines set forth.

• Detecting Offenses and Corrective Action- With disciplinary guidelines in place, the next logical step is to establish a method to track compliance problems. Any non-compliance should be documented, thoroughly investigated, and have a clear resolution in place. Swift action with corrective measures will be imperative to have an effective compliance program in place.

Conclusion to Regulatory Compliance Programs

• A regulatory compliance program pulls together the activities that comprise monitoring regulatory compliance regulations and laws to ensure compliance is met continually.
• Standards and guidelines are unique within businesses. However, certain core topics like education and documentation are established across the boards of regulatory compliance programs.