19 Quality Compliance Resolutions for 2019

19 Quality Compliance Resolutions for 2019

Be the change you want to see in 2019. We asked members of the Pilgrim blogging community to tap into their subject matter expertise to compile a list of some behaviors or routines that have been proven to fuel success. Consider these 19 suggested resolutions for Quality and Compliance practices, and think about how you can turn them into daily habits to drive your organization’s continuous improvement this year and beyond.

As a Quality professional, I resolve to:

  1. Identify my organization’s quality compliance needs and then secure the appropriate resources to ensure that our quality compliance practices effectively support operational challenges and opportunities, and our overall business mission. Rick Lowrey, General Manager, Pilgrim Quality Solutions, an IQVIA company
  2. Leverage our Quality Compliance partner’s knowledge, expertise, and technologies for increased efficiencies, greater collaboration, compliance-readiness, high-quality products, and maximum ROI. Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company
  3. Expand the use of the enterprise Quality Management System (eQMS) within my organization and our supply chain to increase our Culture of Quality. Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company
  4. Adjust current processes and procedures prior to choosing an eQMS platform, and then use the selected platform to capture the data that is needed to both be efficient and to improve the quality of our product. Bernard Jee, Product Manager, Pilgrim Quality Solutions, an IQVIA company
  5. Embrace, rather than resist change, by undertaking or planning more frequent ongoing upgrades to aged quality management systems and processes in accordance with the latest security updates and current compliance best practices including ISO 13485 and the EU Medical Device Regulation (EU MDR). Larry Ferrere, IQVIA MedTech
  6. Assess my organization’s readiness for the EU Medical Device Regulation transition and ensure we have determined our strategy and secured the right resources as we enter the transition period’s final year. Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA
  7. Implement the new Manufacturer’s Incident Report form for reporting vigilance cases to EU competent authorities. Caroline Freeman, Principal Consultant, MedTech Regulatory, IQVIA
  8. Integrate quality processes with other business systems through automation to reduce error, keep processes running smoothly, and build a consistent language for reporting, thereby advancing my organization’s quality maturity. Massimo Franza, Senior Director of Software Engineering, Pilgrim Quality Solutions, an IQVIA company
  9. Expand our Quality reporting and analytical capabilities to identify process improvements through our own organization as well as our supply chain. Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company
  10. Rate and rank my suppliers, taking into consideration their performance and the extent of risk to which those suppliers could potentially expose my company. Kevin Lee, Senior Sales Engineer, Pilgrim Quality Solutions, an IQVIA company
  11. Never allow a compliance mindset to overshadow continuous improvement; continuous improvement is key to improving quality of products and processes while minimizing manufacturing and regulatory risks. Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
  12. Ensure that quality assessments of medical devices include privacy and security to protect patient health data. Stanley Curtis, Senior Director, IT, Pilgrim Quality Solutions, an IQVIA company
  13. Increase security awareness training around “vishing,” social engineering attacks via telephone; do not be caught off guard. Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions, an IQVIA company
  14. Engage with all the functional heads (marketing, service, operations, legal, training, etc.) across the organization and identify, collect, and analyze valuable Post Market Data; a proactive Post Market Surveillance system reaps many other product and commercial opportunities. Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA
  15. Reduce CAPA processing times to average less than 30 days by leveraging the efficiencies of an electronic QMS system, and proactively notify users of their tasks and deadlines. Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company
  16. Ensure my organization readily embraces a culture of change, flexibility, and adaptability to better enable it to adapt to evolving internal and external regulatory requirements. Davor Milosevic, Quality Assurance Manager, Pilgrim Quality Solutions, an IQVIA company
  17. Abide by the tenet that ‘doing it right the first time’ is more efficient than doing it multiple times. Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
  18. Adopt an automated training management system along with other internal continuing education efforts to ensure a skilled and compliant workforce. Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company
  19. Broaden the sphere of quality compliance influence in our business and across our extended network. Rick Lowrey, General Manager, Pilgrim Quality Solutions, an IQVIA company

Keep in mind that the resolutions you choose to make are only as good as the high-quality nature of the goals and objectives you chose to tackle. Be aligned with your colleagues as you strive for a successful 2019. Good luck this year on your individual and collective quests for quality and your pursuit of continuous improvement.

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