By David Shan, EVP & Chief Quality Officer

World Quality Day is a time to reflect on our role in developing safe, effective products and solutions that advance global health outcomes. We looked back at our 125-year history to note how quality has, and always will be, part of who we are. The 2022 World Quality Day theme, “Quality Conscience: Doing the Right Thing,” shares our core values: “we do what is right” and “we demand quality.”

Our quality past

While the BD founding story has been shared in the past, what may not be as well-known is our commitment to quality from the start. In 1898, BD expanded to make fever thermometers, with more than half of the 70 required manufacturing steps focused on inspections and tests. BD's first logo stood for "B&D — It's a Guarantee of Superiority."
 

In a company-wide quality slogan competition in 1953, BD associates, as engaged in building our quality culture back then as they are today, drafted taglines. One employee penned a ten-stanza poem, while another submitted an oil painting of a mother robin feeding her chicks entitled “BD - Where Quality is Born!”

In the following decades, our emphasis continued:

Late 1950s – BD created quality procedures for sterilization to match innovations in disposable needles and syringes and developed its first sterilization process and control laboratory.

1963 – BD formed the Biological Safety and Control Department (BSCD). The department soon became responsible for setting requirements for toxicity, safety, and related testing on all single-use sterile products.

1983 – BD adopted the Juran Quality Improvement Program. It was an intelligent hands-on approach to improving quality. Globally, the Company established numerous quality improvement teams.

2017 – Our Plymouth, UK facility, part of Integrated Diagnostic Solutions, was the first BD site to be Medical Device Single Audit Program (MDSAP) certified.

Present progress

As part of our BD 2025 strategy, we’re making steady progress with Inspire Quality, our multi-year path towards best-in-class healthcare quality. This approach delivers a harmonized, simplified Quality Management System (QMS); investments in digital tools and technology for enhanced data-driven insights; and training and development that empowers our people to do their best work. Together, our ongoing actions, a culture of quality, and a continuous improvement mindset enhance product quality delivery.

Recent changes designed to move us towards best-in-class healthcare quality include cross-functional governance mechanisms that have been implemented to provide continued governance for key quality, regulatory and medical matters and to align on joint goals and initiatives. Data-driven insights are leveraged to proactively identify and address potential quality deviations quicker and more accurately.

Our QMS journey progresses to plan over the five-year roadmap. We have developed 30 global policies and procedures, with 14 released for implementation globally. We are on track to initiate the development of all 40 QMS elements by the end of FY23. Our QMS redesign is supported by an inspiring culture of quality, our continuous improvement mindset and a network of Global Process Owners (GPOs) accountable for sustainable progress.

We are proactively building patient safety into our redesigned QMS policies and procedures. For example, our new Global Risk Management process introduced standardized risk assessment across the product life cycle, from design through post-market. This tool allows us to be proactive in managing patient safety.

Twice a year, each BD facility and business unit is included in a Quality System Management Review where identified issues are brought to proper governance forums, including the Corporate Quality & Regulatory Board (CQRB). The CQRB meets monthly to review key inputs from Quality, Regulatory, Medical and Enterprise Risk to provide companywide direction regarding product-related quality and regulatory compliance matters, insights and trends. Key metrics reviewed at the CQRB include audits and inspections, field actions and medical device reporting (MDR). The CQRB ensures recommendations and actions are implemented.

In the last two years, we’ve trained or retrained 100% of the top 300 leaders on management controls, adequate resourcing, monitoring and measuring, and continuous improvement. The introduction of the Quality Audit Network has enhanced our auditor qualification program, built auditor competency and raised our compliance excellence. We’ve strengthened the capabilities of over 500 associates through internal and external training and industry-recognized certifications. 

Last year we announced our Environmental, Social & Governance (ESG) strategy, Together We Advance, with an emphasis on quality. Quality’s role in our ESG strategy extends to governance and transparency, which we further strengthen today with the debut of Quality on BD.com.

Continuously Improving

We’re strengthening our commitment to transparent quality communications with the Quality Transparency Center by creating space for all BD quality matters on BD.com. Quality has prominent placement on homepage headers and footers to simplify customer access to information, including Recalls and Field Actions. The center houses recall and field action information in one easy-to-navigate location, Customer Care. This was the right thing to do and reflects our focus on patient safety.

We intend to build on our new platform, and our legacy of quality and transparency, for the next 125 years. As we progress, you can expect more proactive communications about our ongoing journey towards best-in-class healthcare quality.