Do you ever wonder how many individuals truly commit to their New Year resolutions? How many actually follow through? The figure is difficult to calculate because more often than not, there is no system of checks and balances, no accountability for individuals’ behavior. In 2018, consider not only your own personal Quality and Compliance goals and resolutions, but engage your colleagues in sharing them with you. Be one another’s support network and ensure that those intentions are realized. Make the behaviors that support them a part of your organization’s Quality Culture for 2018.
As you and your colleagues are preparing to launch into this new year with the best of intentions for your organization’s quality and compliance success, Pilgrim and IQVIA experts are here to help you start the year off right.
In today’s post, we’ve asked our experts, “As a quality and compliance professional, what is your top resolution for 2018?” Here are 18 responses that will lead you and your organization to a happy and prosperous new year.
1. Think beyond traditional quality management, and start envisioning quality as an integrated, participatory business process in your organization’s overall eco-system – one that embraces technology, enables quick qualitative and quantitative decision-making, and contributes to the overall bottom line, while improving quality of life and safety for the patient. Then, invest to make it happen. – Bill Buzzeo, Quality & Compliance Center of Excellence Leader
2. Resolve to fully and honestly understand your company’s Quality Maturity, the true total Cost of Quality (COQ), and the savings tied to maturity improvements from implementing integrated enterprise quality, compliance, and risk management solutions. – Larry Ferrere, Product Strategy, Business Development & Marketing Leader
3. Update your system to support the new FDA Guidelines for eMDR by June 2018. – Bernard Jee, Product Management Manager
4. As a Pharmaceutical company, consider replacing age-old, on-premise QMS solutions that do not fully handle Combination Product business needs with Pilgrim Quality Solutions, the leading cloud-based EQMS solution for life sciences companies. – Keith Pensabene, Quality & Compliance Sales Leader
5. Make 2018 the year of action on transitioning to the EU Medical Devices Regulation (MDR). Start taking some major readiness steps now: prepare technical documentation; assess the adequacy of clinical data; and, start re-writing procedures for post-market surveillance and vigilance to take into account that more events will be reportable and that the 30-day reporting period is reduced to 15 days. – Caroline Freeman, Medtech Regulatory Principal Consultant
6. Make sure that your company’s quality and compliance leaders have a seat at the table in strategic and executive conversations, and the decisions that lead to EQMS 4.0, Quality 4.0, and Industry 4.0 strategies. – Kari Miller, Regulatory and Product Management Leader
7. Encourage Medical Device QA/RA executive managers to convince executive management that sufficient budget will be required to align products to meet the major QA/RA requirements being implemented over the next 1-3 years, including those in the EU and Canada, to avoid serious adverse commercial impact on the organization. Don’t wait until it’s too late! – Phil Johnson, Quality & Compliance Services Medtech Regulatory Leader
8. Drive continuous improvement through the supply chain. – Joshua Centner, Industry Solutions Group Leader
9. Make sure to set realistic KPIs that you can measure against to contribute to quality process improvements in your organization. – Christoph Knez, EMEA Account Executive
– Rick Lowrey, Pilgrim Quality Solutions Leader
10. Reduce the costs of quality by eliminating waste and defects. – Kevin Lee, Industry Solutions Consultant
11. Manage and mitigate risks efficiently throughout the value chain, and make sure processes, systems, and resources are aligned. – Florian Czaszewicz, EMEA Industry Solutions Consultant
12. Plan for periodic upgrades to reduce risks that can result from unanticipated operational disruptions and evolving regulations and restrictions, and prepare for the future. – Massimo Franza, Software Engineering Leader
13. As security threats and breaches increase in 2018, build a strong defense by providing continual security awareness training and teach teams about the specific threats. – Tom Colgan, Cyber Security Leader
14. Think about continuous operational effectiveness to repeatedly perform the same tasks to contribute to exceptional performance and ensure successful results. Consider Software-as-a-Service (SaaS) solutions to guarantee that life science industry requirements are met at the appropriate level of integration and support, and at the right price. – Ninoshka Ortiz, Validation Specialist
15. Stay current on industry trends and news, be curious about emerging technology, and be as proactive as possible when it comes to regulations. – Justin Smith, Product Management Leader
16. Pay closer attention to trends to determine if a nonconformance is an anomaly or part of a greater concern that should trigger a CAPA process. Trend analysis and risk management can help to avoid the costly and time consuming “everything is a CAPA” syndrome. – Stanley Curtis, Technology and Engineering Leader
17. Consider shifting your in-house Quality Management System to the Cloud to eliminate burden on your organization’s own IT team to install and validate software, reduce the time to implement upgrades or additional solutions, and boost security measures. – Charles Murphy, Support and Cloud Leader
18. Review and update existing training management systems. Employees can be better qualified for their role requirements, training costs can be reduced, and compliance can be achieved faster when efficient, up-to-date training processes are in place. – Liz Corey, HR Leader
The Case for Quality System Transformation
Learn how compliance, quality system maturity, and a quality culture all feed into a successful global quality system.