The Johnson & Johnson Quality Policies and Standards across our Family of Companies cover the lifecycle of our products from R&D to the consumer and patient experience. They provide a framework and common foundation of quality expectations and help ensure a reliable supply of high-quality products across all our business segments. See our Position on Quality and Compliance and our Johnson & Johnson Quality Management Framework.
In 2020, we continued to assess and improve our internal quality policies and standards to ensure we are keeping pace with the changing regulatory demands for our diverse portfolio of products. Employing thousands of individuals across the Enterprise, our Quality and Compliance functions are increasingly adopting digital innovations to drive effectiveness and efficiency within our quality processes. In our clinical quality programs, we are expanding data science partnerships with external experts and providers, as well as industry peers, to accelerate insights and embed predictive signaling. We have deployed Robotic Process Automation capabilities that deliver process efficiencies and increase the accuracy of trial monitoring and data management activities.
Areas of progress in 2020 include initial deployments of:
Digital acceleration: With the rise of digital, artificial intelligence (AI), and Big Data we are advancing our digital strategy in different ways:
- AI for complaints: Our team developed AI and machine learning methods that read narratives from customer complaints and turn the customer feedback into insights. The algorithms can predict categorization, allowing higher automation of the process and greater contextualization of information, helping to share actionable insights.
- Intelligent Automation: We have expanded our use of Intelligent Automation in our partnership with our Regulatory Affairs organization that enables us to evaluate Company data more rapidly, more consistently and with improved accuracy.
- Real-time controls: We are raising the visibility of data through highly targeted dashboarding and signaling, accompanied by decision assist methods that present data clearly and support real-time, data-driven decisions in our product development process. We have developed tools that offer significant reductions in cycle time and lower levels of error.
- Natural Language Processing: We are currently using Natural Language Processing methods to unlock knowledge from quality text data with new methods that compare the similarity of new quality records to past data. This allows rapid identification of similar historic occurrences with a proven track record of solutions.
Shaping the future regulatory model for software-based medical devices: We continue to partner with the FDA FDA U.S. Food and Drug Administration in the Digital Health Software Precertification (Pre-Cert) Pilot Program. The FDA’s Pre-Cert Program is envisioned to accelerate speed to U.S. market for Software as a Medical Device solution. The intention is to grant streamlined product regulatory reviews for digital health technology companies that demonstrate and maintain a culture of quality and organizational excellence. The focus of the pilot phase of the program is to build and test the pre-cert model with select pilot participants within the industry, including Johnson & Johnson. In 2020, we shared with the FDA our perspective on key measures to evaluate and monitor organizations and to conduct excellence appraisals of organizations. In addition, we tested and suggested improvements for the FDA’s proposed tools and enablers, which would drive components of the pre-cert model. For 2021, our focus will continue to be on testing the pre-cert model and helping the FDA develop policy related to device classification. Upon completion, we believe the Pre-Cert Program will provide an innovative regulatory pathway for organizations to submit their products with ease and efficiency while meeting high product quality and safety standards.
Annual Quality Month: In October 2020, we activated our annual quality month under the theme: “Quality starts with me!” We embarked on a modified virtual program to engage our global sites and employees in reflection, celebration, and recommitment to quality through virtual workshops and interactive educational sessions.
Enabling clinical trial execution using digital tools: Innovations within clinical trial execution grew rapidly in response to the constraints of the COVID-19 pandemic. Working together with R&D partners, we introduced new capabilities for digital quality monitoring of clinical sites and created new means for conducting quality oversight of innovative methods of patient data capture to enable home healthcare. We also rapidly expanded virtualization of audits, which aided in continued quality oversight during periods of reduced on-site interactions. See our United in Defeating COVID-19 section.
Product Quality Indicators
Product Quality Indicators
Number of regulatory inspections of
Johnson & Johnson sites by worldwide health authorities
Percentage of regulatory inspections that resulted in zero observations
|Number of FDA inspections of Johnson & Johnson sites||10‡||17+||24|
|Percentage of FDA inspections that resulted in zero observations||80%‡||76%+||75%|
|Average number of observations per FDA inspection||1.7‡||0.6+||0.6|
|Number of independent audits of Johnson & Johnson sites to ensure compliance with Johnson & Johnson Quality Policy & Standards||165‡||156+||179|
|Number of independent audits of external manufacturing sites to ensure compliance with Johnson & Johnson Quality Policy & Standards||230‡||264+||237|
|Number of FDA warning letters issued||0‡||1+||0|
|Product recall rate,* by business segment|
|Medical Devices||0.034%‡||0.041%||Not reported|
|Consumer Health||0%‡||0.091%||Not reported|
+ See PwC's Report of Independent Accountants in 2019 Health for Humanity Report.
* Product recall rate is defined as number of lots removed from market per total globally manufactured, based on field action removals where it has been determined internally by a Quality Review Board, and aligned by Enterprise Compliance, that 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. Consumer Health over-the-counter (OTC) product removals are included.