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REGULATORY COMPLIANCE

Many industries require accreditation from regulatory bodies. From the FDA, to regional educational bodies, to federal institutions, all of these institutions have guidelines, review processes and rules in which they govern their members. Some have strict guidelines that specify measurements that must be met while others govern their members by overarching principles. In any of these situations there are frameworks that can be applied to help a company excel operationally while meeting these requirements.

W. Capra has leveraged its institutional knowledge of processes, governance and program management to define a methodology that companies and institutions can use to address regulatory issues. The following are the macro steps of the methodology that can assist your company or institution from being aware of regulators to being in control of its regulators.

Methodology Overview

Step 1. Define requirements. The first step is to define and document the regulator requirements and ensure expectations are aligned between the company and the regulatory body. It is recommended to engage a current or past member of the regulatory body to confirm the interpretation of the requirements. While this first step seems simple and black and white, if not completed correctly all future work will be for naught.

Step 2: Ensure compliance. Once the requirements are completed the company should engage an internal audit to baseline their current ability to meet the regulatory requirements. It is key in this process to be honest and not mask any regulatory issues to protect the current owner of process.

Step 3: Planning. Define an action plan to bring all regulatory issues to compliance. These action plans should be governed by a group of experts on the regulatory requirements but created by the owner of the process or policy. It is recommended that the process owner be responsible for defining the solution to the gap so the update can become an operational standard vs. a short term fix.

Step 4: Execute action plan. The execution of the action plan should be managed and controlled with solid industry proven PM practices. While not all changes will require the development of the deliverable it is important that evidence be gathered of the change. Where possible key performance or operational metrics should be used to show compliance.

Step 5: Operate. Reengaging operations with the updated processes or policies that meet the regulatory requirements is the most critical step. To ensure the process remains in compliance the company should institute ongoing quality assurance processes. There are many different QA processes that can be used to measure ongoing compliance including Six Sigma. It is important to select a practice that is appropriate for the importance of the accreditation to ensure the control process is not more costly than the penalty of not being in compliance.