40 2021 ESG Report Appendices Transparency Healthy workforce and communities Responsible supply chain Climate change Introduction Product impact Inspiring quality compliance BD continues to drive increased transparency in quality & regulatory compliance across the organization. By evaluating external regulatory trends, BD has been able to provide insights and to work to establish best practices for regulatory compliance, while enabling BD businesses to proactively identify potential improvement opportunities. For example, as we continue the QMS redesign, the Quality & Regulatory Compliance team collaborates with the cross-functional teams to incorporate these insights into the development of the newly harmonized processes and procedures. The Quality Audit Network (QAN), a consortium of quality auditors across BD, is leveraged to identify and drive the resolution of potential compliance gaps. In FY 2021, there was also a focused effort to enhance auditor competency by improving training and establishing uniform auditor qualifications. This has helped BD to drive consistency in audits and compliance assessments across the BD businesses and regions. Additionally, BD has participated in the FDA Remote Regulatory Assessment (RRA) program, a voluntary program for medical device manufacturers. Through this participation, the compliance at three BD facilities was assessed by an FDA investigator. Participation in this program not only provides a review of the site’s regulatory compliance posture, but also strengthens BD’s rapport with the FDA. FY19 FY20 FY21 Number of inspections by worldwide regulatory agencies 34 41 42 Percentage with zero observations 59% 81% 69% Number of FDA inspections 15 6 4 Percentage with zero observations 73% 50% 50% Number of corporate audits 35 47 65 Inspiring quality with registration excellence Global health authorities are modernizing and evolving their standards of care to keep pace with the challenges of managing public health. Regulations, standards and policies must also change to meet these standards. As these transformations occur at a significantly increasing rate, the Regulatory Affairs team has become more agile and efficient in identifying, advocating for and assessing these changes to ensure we have registrations that comply with current health authority expectations. BD Regulatory Affairs has centralized regulatory intelligence monitoring and linked this activity to BD’s global standards process to ensure a structured approach to conducting risk assessments, identifying gaps, remediating and ultimately updating our regulatory filings as needed. In 2021, 44 draft regulations and 125 new and revised regulations were monitored for impact to BD products. At BD, we are also empowering cross-functional teams within each business unit and region to drive accountability for incorporating new requirements from standards and regulations into our new-product development process as well as legacy products, re-baselining historical regulatory submissions for products that have evolved over time, and enabling future innovation by refreshing product data on file with regulatory authorities. In addition to working on significant initiatives like compliance with new EU medical device and in vitro diagnostic medical device regulations (MDRs and IVDRs), we are also focusing on countries that have seen significant changes to their product regulatory framework. To that end, the BD Regulatory Affairs team and partnering functions—R&D, Manufacturing, Quality, Cybersecurity, Sterilization, EHS, Medical Affairs, Clinical Development, Marketing, and Compliance—work together to ensure that our product registrations are compliant with global laws, regulations, standards and policies. We are also digitizing and connecting registration-related processes and content management to enable efficient global registrations that are compliant and will positively impact public health. Inspiring quality in industry We are committed to enabling healthcare providers deliver the best possible patient care. Through our memberships in organizations and trade associations such as AdvaMed , the Medical Device Innovation Consortium (MDIC) and the Association for the Advancement of Medical Instrumentation (AAMI), BD works to drive quality and shape the external environment through industrywide standards and initiatives consistent with our Purpose of advancing the world of health™ . Enforcement action While we have implemented, and continue to improve upon, programs and management systems addressing product quality and safety, we are, on occasion, subject to enforcement action. For a description of certain enforcement matters, see our Form 10-Q for the quarterly period ended March 31, 2021, and our subsequent SEC filings.