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 2017 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 the current legal and business troubles at Theranos, an IVD manufacturer. While it is difficult to dissect this company’s issues as an outsider, study of the company as a case study reveals that compliance concerns played a considerable role in its layoff of 495 people when they discovered that their clinical laboratories were unable to pass inspection.
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 timeframe. 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? In the Theranos example, the company now faces litigation risk, and the cost of litigation alone, added to the potential costs of making damage payments, may have surpassed the costs of running compliant laboratories. 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 2017 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 one year 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) leaves the pilot program and goes to operational phase in 2017. 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 2017.
- If your organization needs to perform submissions for FDA approval, ensuring that your system is compatible with eCTD (Electronic Common Technical Document) will speed the approval process. Starting on May 5, 2017, the FDA will only accept NDAs, ANDAs, BLAs and Drug Master Files in electronic format, using the FDA Electronic Submission Gateway. If you need to make drug submissions in 2017, you must obtain Gateway accounts for all of your users. Do this soon, because the FDA needs to process requests from many users and companies across the industry.
- The Drug Supply Chain Security act indicates a due date of 11/27/2017 for all manufacturers to place a unique product identifier (serialization) on certain drug packages. Repackagers have until 11/27/2018 to serialize. These serialization systems need to be designed, installed and validated to assure that they provide accurate data.
- The Cures Act recently passed into law on December 13, 2016. This law suggests a deregulation of many services offered by the FDA, including focus on innovation, and better defining requirements for clinical studies and drug approval to streamline the drug approval process, especially for orphan drugs, compassionate use drugs, low-risk medical devices, and combination products. If you are a company involved with production of such products, stay informed.
- In April of 2016, the FDA released a Data Integrity guidance. Until this guidance was released, Part 11 was the only guide even though the FDA admitted, more than a year ago, that they would not be enforcing Part 11. Some of the information in this guidance supersedes information previously published in Part 11. Prioritize a gap assessment relative to this guidance in time to make corrections before your next FDA inspection.
Do any of the above tasks 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 2017, 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. In any case, 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.”