By Regina Fullin, Director of Compliance Consulting Services, Compliance Team, Inc.
People talk all the time about New Year’s Resolutions, but it seems like people make the same resolutions over and over. The reason for this is that priorities get in the way. Priorities are more powerful than resolutions because prioritization puts a sense of urgency to a goal that creates a rallying cry to action.
So, when you plan your 2018 compliance program, take some time to contemplate your true priorities. What areas of your compliance program cause you the most discomfort?
What is it about these areas that give reason for concern? Is there precedent that such concerns will create a significant cost burden to the organization if left unresolved? One precedent to consider is CTI’s latest list of Top 10 483s for 2017. It is clear from this list that the FDA is changing focus with Program Alignment and it is important to stay on top of the latest trends.
In regulated industry, inspectors are keen to sense whether compliance problems are receiving appropriate prioritization. For example, compliant CAPA programs track due dates and ensure that management is providing adequate resources to resolve the cited issue in a reasonable time frame. If a corrective action is found inadequate, compliant CAPA programs follow-up with swift, decisive action. Conversely, a non-compliant CAPA program use eloquent language to downplay the impact of a concern, to distract the reader from seeing the need for meaningful change. Non-compliant CAPAs are written to justify why the identified nonconformity is not a priority for the organization. How would you feel if you were called upon to defend such a CAPA? Likely, you would feel anxious, and would resolve, shortly after the audit, to ensure that you never have that experience again.
Are you able to assess your compliance risk into a cost estimate for management? Maybe you can’t do that, but you might be able to estimate the number of man-hours it will take to achieve a certain compliance objective. Costs are not only the cost to correct a nonconformity, but the potential added costs of lost customer goodwill, litigation, making 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 pennies-on-the dollar investment in quality? 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.
Here are some of the priorities that your organization may consider for its 2018 goals:
- If you are a Medical Device firm, you may need to update your Quality Management System to meet ISO 13485:2016 standards. The Medical Device industry is two years into the 3-year grace period for new system implementation. Early planning is a cornerstone for success, and if your organization has not started to make the changes, you need to start now.
- Also, for Medical Device manufacturers, the MDSAP (Medical Device Single Audit Program) is now in full swing. This is an opportunity to consolidate your audits to multiple regulatory authorities and have your audits performed by a single audit authority. Because you will need to prove that you fulfill multiple requirements, the inspection will be more rigorous, but consolidation of multiple audits into a single inspection is a cost-saving measure, and may be prioritized in 2018. It is also important to remember that if a U.S. company markets product in Canada, Health Canada requires an MDSAP audit.
- The Drug Supply Chain Security act extended the enforcement for serialization on primary packaging from 11/27/2017 to 11/27/2018. Repackagers still have the 11/27/2018 due date for serialization. These serialization systems need to be designed, installed and validated to assure that they provide accurate data.
- Along with pharmaceutical serialization, the Drug Supply Security Act requires that key quality systems be integrated with the serialization system. CTI has some expertise in evaluating the fitness of these quality systems. If interested, ask us for an evaluation.
- The FDA is in full swing with Program Alignment and with auditing for Data Integrity. Due to the Program Alignment, the FDA is sending subject matter experts to sites to for inspections, and data integrity experts are part of those subject matter experts. Be sure to internally assess your data integrity program, especially on your laboratory instrumentation!
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?
If you have several projects you need to complete in 2018, identify your organization’s goals, and rank them in order of importance. Be honest with yourself on the required resources to make your highest priorities come to fruition, and determine whether your goals are SMART goals: Specific, Measurable, Achievable, Realistic, and Time-bound. If not, determine the necessary modifications to either the goal or the method of achievement to ensure that the goal meets these five criteria.
Once you’ve made your prioritized list, it is time to make your resource plan and schedule to break down the tasks into manageable parts. It sometimes helps to work backward from the need-by date to determine how the schedule will work. An experienced project manager has the skills to ensure co-ordination of all the project’s moving parts.
Remember, you need not accomplish all these tasks on your own. No man (or woman) is an island. You may need to look outside your organization for subject-matter expertise to assure project success, and I would personally love to discuss how Compliance Team is able to help. Whether Compliance Team is part of your resource plan or not, teamwork and application of appropriate resources will transform a prioritized action plan into meaningful change — all because you had the initiative to elevate your “goals” and make them “priorities.”
How can Compliance Team help you in 2018?
Contact us to learn more about services or just get your questions answered from one of our subject matter experts!
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