How To Create An Effective Compliance Program
Discussions about New Year’s Resolutions are common, yet it appears that individuals often find themselves revisiting the same resolutions repeatedly. This recurrence can be attributed to competing priorities taking precedence. Therefore, as you strategize for your 2024 compliance program, invest time in reflecting on your genuine priorities. Prioritizing injects a sense of urgency into a goal, fostering a compelling call to action.
Consider the aspects of your compliance program that evoke the most unease. What is it about these facets that raises apprehension? Evaluate whether there is a precedent indicating that these concerns, if unaddressed, could impose significant burdens on the organization.
How To Organize Your 2024 Compliance Goals
Organizing your compliance goals for the year 2024 is a strategic and essential process that involves careful planning, prioritization, and a clear roadmap. Here is a comprehensive guide on how to effectively organize your 2024 compliance goals:
Identify Your Goals
If you have multiple projects you need to complete, identify your organization’s goals, and rank them in order of importance. Be honest about the required resources to make your highest priorities come to fruition. Warren Buffet’s approach to goals mirrors CT’s risk-based method of looking at the Top 10 483s. Write down 25 goals and circle the Top 5. Ignore the other 20 until your Top 5 are completed. This is an effective method to prevent over-commitment.
Follow A Plan
Be sure that you have a plan for the five goals you select. A common approach is to employ SMART goals: Specific, Measurable, Achievable, Realistic, and Time-bound. If one of your Top 5 goals fail to meet these criteria, modify them so they can.
Once you made a Top 5 priorities list, break the tasks into manageable chunks in a Resource Plan. Sometimes it helps to work backward from the need-by date to determine how the schedule will work. An experienced Project Manager has the skills to coordinate the project’s moving parts.
Common Niche Goals In The Compliance Industry
In the compliance industry, common niche goals revolve around ensuring adherence to regulatory standards and promoting ethical business practices.
Key objectives include enhancing data security and privacy measures, implementing robust anti-corruption strategies, conducting thorough risk assessments, fostering a culture of compliance within organizations, and staying abreast of evolving regulatory landscapes. These goals collectively aim to establish and maintain a strong foundation for ethical and legal conduct, safeguarding businesses against risks and promoting transparency and integrity.
Medical Device Firms
If you are a Medical Device firm, consider MDSAP certification to reduce your audit burden, for considerable cost savings! Besides being a requirement for U.S. businesses to export to Canada, the worldwide scope of this inspection minimizes the cost of hosting inspections by multiple international jurisdictions. It also opens you to marketing worldwide – a business priority for sure!
Also, for Medical Device firms, the E-U Medical Device Regulation (EUMDR) will become effective in March, 2022. If you are affected by this regulatory change and need a boost to be ready by the implementation date, give us a call!
CAPA Programs: Why Use One?
In regulated industry, inspectors are keen to sense whether compliance problems are appropriately prioritized. For example, compliant CAPA programs track due dates and ensure that management is providing adequate resources for resolution in reasonable time. If a corrective action is found inadequate, compliant CAPA programs follow up with swift, decisive action. Conversely, weak CAPA programs may use eloquent language to downplay the impact of a concern, often resulting from fear of making meaningful change.
Does your CAPA program drive decisive, sustainable change, or are your CAPAs are written to justify why the identified nonconformity is not a priority for the organization? If called to defend such a CAPA in an inspection, how would you feel? Anxious? Maybe lost? Adequate CAPA preparation will boost your confidence during an inspection and make you successful!
The Costs Of Not Complying
Compliance risk also has cost—scrap cost, rework cost, and the cost associated with lost business and extra promotional costs to recover poor company reputation. These are just the tangible costs. Intangible costs affect productivity of a stressed-out workforce who call in for extra sick days and bicker in the halls instead of attending to the work at hand. How much more pleasant would life be if your compliance program were effective?
Another factor that makes it difficult to assess the costs of compliance risk is that correction of these deep-seated issues requires estimation of the costs – tangible and intangible – to repair a fractured corporate culture while investing in a greater compliance objective. Costs extend beyond the cost to correct a nonconformity, and include costs of lost customer goodwill, litigation, , recalls, warranties, and damage payments, which can exceed the cost of basic remediation. Do you have any areas in your company where you can save millions in cost avoidance by making a pennies-on-the dollar investment in quality? This is a significant priority to consider.
If you can calculate an ROI (Return on Investment) for your quality and compliance improvements, you are likely to have identified a high-priority project that you can sell up to management.
Tips For Maintaining Compliance
Tips for maintaining compliance with the Food and Drug Administration (FDA) involve a strategic and proactive approach to ensure that organizations in the regulated industries adhere to regulatory standards. Here’s an expanded guide on tips for maintaining compliance with the FDA.
Sustain Current Risk Management Files
While on the topic of EUMDR, the FDA is embracing the concept of creating and sustaining a current Risk Management File for every medical device in the product portfolio. The Risk Management File is both a compliance tool, and a useful guide to use when evaluating inevitable risks involving use of a medical device. This is a priority that will significantly enhance a compliance program!
Understand The Drug Supply Chain Act
The FDA is enforcing the Drug Supply Chain Security act, starting with wholesale distributors. The FDA may not be in full swing of enforcement yet, but it is always important to be alert to the quality practices of your wholesalers. To ensure you will be ready, consider auditing your high-risk trade partners to ensure that they are able to identify and segregate suspicious product. CT can help you evaluate the fitness of these quality systems.
Do any of the above ideas resonate with you for your organization? Which ones are business-critical for you? Will deficiencies in any of the above areas affect the business’s bottom line?
Ready To Comply?
We cheer on your successes, and we are here to support you and your organization! Goal-setting is a lonely task, but true success is achieved through teamwork, so assemble your team, and get started. If you need to look outside your organization to complement a team with qualified subject-matter experts, we are here for both big jobs and small. Through prioritization, teamwork and resource management, a prioritized plan can establish meaningful change—all because you transformed your “goals” into “priorities.