Product quality & safety
We are responsible to the millions of people who use our products each day. Our Quality Policy guides us to consistently provide superior products and services worldwide, achieved through customer focus, continuous improvement and maintaining an effective quality system. From our suppliers, we expect superior levels of service, quality, cost effectiveness and innovation. Finally, compliance with existing and emerging regulations is the foundation of what we do.
Quality Management and Training
Quality Management is key to BD’s success. We are driven by our vision of an organization where transactions are correct the first time, where efficient and effective processes drive our competitiveness, and where Quality associates can successfully demonstrate the intent and spirit of BD’s Quality Policy.
Our quality systems help ensure compliance with application global regulations and establish standards for product design, manufacturing and distribution. Prior to marketing or selling most of our products, we must secure approval from the U.S. Food and Drug Administration (FDA) and counterpart regulatory agencies outside of the United States. Once a product is introduced, these agencies periodically review our quality systems, product performance and promotional materials. We regularly analyze our own quality processes and specifications to ensure efficiency and effectiveness.
Beginning at orientation, associates are trained on the quality and regulatory requirements for the healthcare industry. On average, each Quality associate spends 40 hours per year on training. BD’s Quality Academy serves as a platform where we develop, share and deploy this training, which includes reviewing our quality assurance policies, programs and standards and information about regulations and medical device directives.
ISO 13485 Certification
All BD manufacturing facilities are certified to ISO 13485 – a set of quality management system requirements for designing and manufacturing medical devices. BD is also rolling out ISO 13485 certification across our distribution network, inclusive of facilities in Asia, Europe, Latin America and North America.
Supplier Management and Audits
Our supplier management program oversees the quality and safety practices of our 1,000 core suppliers that provide key materials and services. Our program focuses on four areas:
- Performance Management comprises the procedures that govern how BD identifies, classifies and assesses the qualifications of our suppliers, and manages our relationship with each of them.
- Supplier Continuous Improvement programs employ our operational excellence methodologies (Lean and Six Sigma), with specific vendors to define, plan and execute projects that bring significant improvements in performance, savings and overall value to BD.
- Supplier Engagement is central to our ability to identify and partner with suppliers capable of brining innovation and new technology to the market.
- Supply Base Risk Management quantifies and mitigates risks posed to our supply chain, such as business discontinuity, financial liquidity, price fluctuations and pandemics.
In addition, Quality Systems Assessments (QSAs) are conducted for key suppliers, determined by both a fixed frequency and the quality history of the supplier’s site. QSAs ensure that the facilities manufacturing materials or components we procure have quality systems in place to ensure the final product will consistently comply with our specifications and adhere to all regulatory requirements.
In 2014, BD’s plan called for 366 QSAs. Of those, 241 were on-site audits and 125 were supplier self-assessment surveys. If a supplier is unable to meet any of our quality standards, we will work with them to investigate and resolve the issue.Learn more about our Procurement Strategy >
The Regulatory Affairs and Compliance program at BD encompasses all product related regulatory processes, from product concept through to obsolescence.
BD’s Global Regulatory Affairs monitoring Initiative (GRAMI), a system that links 180 of our worldwide regulatory associates, is set up to allow the global regulatory team members to monitor changes in regulations, requirements and regulatory agency policies that could affect BD operations and products. The GRAMI team is comprised of BD regulatory professionals with expertise in worldwide regulatory policy areas including compliance, product registrations, labeling standards and other areas of pre-and post-approval regulatory requirements. When changes are identified, they are communicated to individuals in relevant business units, functions and manufacturing sites who are part of the GRAMI notifications system. In addition, BD regulatory leaders in various regions engage in meaningful dialogue with their regulators and trade associations to seek better understanding, alignment, and improvements in regulatory requirements and processes that affect BD as well as the regulated medical technology industry.
BD’s Compliance Review board, a cross-functional team of Corporate Officers from the Regulatory, Quality and Operations functions, meets monthly to assess and respond to relevant regulatory and quality trends.
During our fiscal year 2014, BD had no significant findings of non-compliance with regulations or voluntary codes regarding the design, labeling or manufacturing of our products.For information about legal proceedings regarding the marketing and advertising of our products, please see BD’s 2014 10-K >