2019 Health for Humanity Report
Responsible Business Practices
Responsible Business Practices Product Quality, Safety & Reliability
SASB
  • HC-BP-250a.3
    Number of recalls issued, total units recalled
  • HC-BP-250a.5
    Number of FDA enforcement actions taken in response to violations of current Good Manufacturing Practices (cGMP), by type
  • HC-MS-250a.1
    List of products listed in the Food and Drug Administration’s (FDA) MedWatch Safety Alerts for Human Medical Products database
  • HC-MS-250a.4
    Total amount of product accepted for takeback, reuse, or disposal

Making Quality a Priority

Our commitment to quality, safety and reliability is the foundation for everything we do. We believe our patients and consumers deserve consistent, reliable and high quality every time they use or experience a Johnson & Johnson product. We partner with health authorities, government agencies and industry and advocacy groups to raise the bar on quality across the healthcare industry. See our Position on Quality and Compliance which describes our approach to quality policies and standards, risk management, compliance monitoring and more.

One measure of our performance is our product recall rate. Our recall rate remains low because of the rigor of our Quality Standards. Our continuous improvement efforts across all our businesses help to ensure a reliable supply of high-quality products. Initiating a field action, such as removing a product from the marketplace when an issue has been identified, is the right thing to do for our patients and consumers. As required by the Quality Standards, each operating company has a formal Quality Review Board (QRB), which convenes when necessary to evaluate concerns with the quality or safety of a product in the market. The QRBs consist of leaders from Quality, Medical Affairs, Medical Safety and Regulatory Affairs. The QRBs decide, independent of commercial considerations, whether actions need to be taken to correct or recall a product from the market. Patient and consumer safety supersede any other factor in this decision-making.

  • 156
    independent audits completed at our internal sites
  • 264
    independent audits completed at our external manufacturing sites

Initiatives to advance quality in 2019 include:

Updating quality policies: The Johnson & Johnson Quality Policy Standards across our Family of Companies cover the lifecycle of our products from R&D to the consumer and patient experience. These Policy Standards provide a common foundation of quality expectations and help to ensure a reliable supply of high-quality products across all our business segments. In 2019, to position Johnson & Johnson to leverage emerging technologies and better serve our customers, we undertook a program to improve clarity, map requirements to applicable regulatory requirements and incorporate Health Authority expectations while enabling flexibility for our diverse business segments. This restructuring of our Policy Standards resulted in the addition of six new Quality Policies that better reflect the lifecycle of our products.

Supporting a pilot to improve quality in software-based medical devices: We continue to engage with the U.S. Food and Drug Administration (FDA) in the Digital Health Software Precertification (Pre-Cert) Program. In the current pilot phase, we are testing a working model and providing guidance. The purpose of the pre-certification program is to develop a regulatory framework for oversight of software-based medical devices. In the pilot stage, the focus is on how a company reliably engages in high-quality software design, testing and ongoing maintenance of its software-based medical devices. In 2019, as one of nine selected participants in this pilot, we conducted testing of the Pre-Cert working model v.1.0 published by the FDA early in 2019. In addition to testing the integrated components, we provided guidance on other program considerations in the certification process for manufacturers who use third-party software developers. In 2020, we are planning end-to-end testing of the Pre-Cert model, including its relationship to real-world performance analytics. Ultimately, when completed, the Pre-Cert process will improve speed to market of important medical devices while supporting high quality throughout the lifecycle of medical device products.

Hosting the 2019 Kilmer Conference: In June 2019, Johnson & Johnson hosted the 10th Kilmer Conference in Dublin, Ireland, convening over 350 innovative leaders in the field of microbiological quality and sterility assurance. The Kilmer Conference is a premier global forum focused on sterility assurance and sterilization for invited professionals from industry, academia, government agencies and healthcare delivery organizations. The 2019 conference demonstrated the community’s ability to think differently to advance the science of microbiological quality and sterility assurance through collaborative innovation under the theme “Passion for Patients, Driving Collaborative Innovation.” Beyond the conference, we continue our engagement through the Kilmer Collaboration Teams that support innovation to address specific challenges and deliver better outcomes for customers and patients. The Kilmer Fund provides grants to support innovative research and scholarships for individuals who pursue academic studies and potential career paths relating to microbiology quality and sterility assurance.

National drug take back day
In support of the U.S. Drug Enforcement Agency’s National Drug Take Back Day, we encouraged our U.S. employees to take an active part and dispose of their non-controlled substance medicines at a list of locations we provided. Members of our Pharmacists Network Employee Resource Group held a series of events ahead of National Drug Take Back Day to highlight the importance of medication safety and remind us that safety is a shared responsibility.


Annual Quality Month: Held every October, in 2019, under the theme of “Quality Doesn’t Quit!,” our global sites took the time to reflect, celebrate, and recommit to Our Credo responsibility that “everything we do must be of high quality” through workshops, trainings and interactive educational sessions.

Maintaining quality throughout our supply base: We strive to achieve world-class supplier reliability as part of our commitment to product quality. We collaborate proactively with our suppliers to develop programs, such as those for proactive risk identification and mitigation, to manage, measure and improve quality. Our suppliers demonstrate their commitment to meeting our quality and reliability standards through using our suite of proactive tools, many co-developed with our suppliers, such as Technical Assessments, Supplier Quality Excellence in Execution tool, Robust Process framework and our Supplier Quality Academy.

Feedback received from our suppliers in 2019 includes:

  • Jabil Healthcare: “For years, Jabil Healthcare and Johnson & Johnson have enjoyed an incredibly productive and sustaining partnership; we are now moving on into our second decade. Throughout this period, we have worked diligently together to drive quality management while improving our processes. Johnson & Johnson introduced a powerful and effective suite of management tools for both Technical Assessment and Supplier Quality Maturity Assessment out of our Auburn Hills, Michigan site. Deployment of these tools is based on pre-defined criteria to evaluate processes and practices at our site operations. The results have been excellent, driving efficiencies and value across our operations. We are deeply appreciative of the robust nature of our collaboration and are eager to continue moving forward with Johnson & Johnson.” Z. Ali Choudary, Quality and Regulatory Affairs Manager, Jabil Healthcare
  • Tecomet, Inc.: “The Supplier Quality Excellence in Execution Maturity Assessment has been a powerful tool for identifying and targeting improvement opportunities between our sites. It provides dual benefits—identifying both strengths and improvement opportunities between our global locations. This subsequently brings our teams together, promoting focused sharing and learning between sites. An exceptionally effective process.” Steve Hinora, Executive Vice President, Quality Assurance/Regulatory Affairs, U.S. Operations, Tecomet, Inc.
  • VIANT Medical: “Innovative Source Quality programs rolled out by Johnson & Johnson, such as Technical Assessments and Maturity Assessments, have aided in developing a true partnership with our organizations. These activities provide a true open forum for information sharing and provide lasting improvements that enhance product quality and reduce long-term risk. There is great value to gaining a deep understanding of processes through the execution of these well-designed tools. The systemic approach is easy to use and sets the stage for continual improvement through all aspects of the product lifecycle." Von F.Kramer IV, Vice President, Quality Assurance and Regulatory Affairs, VIANT Medical

Our Performance

Product Quality Indicators

2019

2018

2017

Number of regulatory inspections of Johnson & Johnson sites by worldwide health authorities 521 619 557
Percentage of inspections that resulted in zero observations 73% 78% 71%
Number of FDA inspections of Johnson & Johnson sites 17 24 63
Percentage of FDA inspections that resulted in zero observations 76% 75% 83%
Average number of observations per FDA inspection 0.6 0.6 0.7
Number of independent audits of Johnson & Johnson sites to ensure compliance with Johnson & Johnson Quality Policy & Standard 156 179 179
Number of independent audits of external manufacturing sites to ensure compliance with Johnson & Johnson Quality Policy & Standards 264 237 Not reported
Number of FDA warning letters issued 1 0 0
Product recall rate*, by business segment
Pharmaceutical
0.002% Not reported Not reported
Medical Devices 0.041% Not reported Not reported
Consumer Health** 0.091% Not reported Not reported
* Product recall rate is defined as number of lots removed from market per total globally manufactured, based on field action removals where there is a reasonable probability that the product may cause temporary or medically reversible adverse health consequences and in certain cases will cause serious adverse health consequences.

** For Consumer Health, the product recall rate reflects over-the-counter (OTC) products.

See PwC’s Report of Independent Accountants

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