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 into the markets we serve. In 2021, we continued to assess and improve our internal quality policies and standards to keep pace with the changing regulatory demands for our diverse portfolio of products.
Areas of progress we made include:
Supporting regulatory innovation: As one of nine companies participating in the FDA FDA U.S. Food and Drug Administration Digital Health Software Precertification (Pre-Cert) Pilot Program, we helped the program move to the next stage by evaluating and providing feedback on a Key Performance Indicator used in the proposed model. The Pre-Cert Program aims to accelerate the speed of medical devices software solutions to the U.S. market. The program will grant streamlined product regulatory reviews for digital health technology companies that demonstrate and maintain a culture of quality and organizational excellence. We also joined other industry leads in the Medical Device Innovation Consortium Digital Health Initiative to work with the FDA in developing innovative regulatory pathways for organizations to plan for easy and efficient product submissions and notifications while meeting high product quality and safety standards.
Improving data security for Quality & Compliance professionals: We commenced deployment of our new proprietary Compliance Insights Application (CIA) technology framework that simplifies the digital experience for our Quality & Compliance professionals. CIA provides a validated way of handling highest-level privacy data within our data science apps, giving strong protection for sensitive data. It also ensures a scalable means to publish datasets and data science applications as well as simplified methods for the management of access rights of users. This program was developed in-house by Johnson & Johnson technical experts and is now being expanded for use as part of our Pharmaceutical sector Quality & Compliance toolkit. For additional information on our data protection efforts, see section: Information Security & Data Privacy.
Digitalizing our processes: We continue to leverage the latest technology, including AI AI Artificial intelligence , data science and intelligent automation to digitalize our processes for greater efficiency and improved outcomes for patients and consumers. Automating documentation processes reduces the cycle time to get products to our customers while creating a digital record and database for process monitoring and evaluation. For example, in 2021, we automated the sterile release quality control procedure at DePuy Synthes. Using optical character recognition technology to convert text images to accessible electronic information, we were able to automate quality control against predefined acceptance criteria.
Improving processing of complaints: We expanded the use of a new product complaint solution called Envision. A key feature of the application is the ability to translate patient and consumer complaints from different languages using a tool called Language Weaver, avoiding the need for manual translations of complaints received. Language Weaver uses AI technology to optimize linguistic performance and facilitate speedier investigation and response times to complaints received. By the end of 2021, Envision, incorporating Language Weaver, was being used widely across the Enterprise, translating more than 66 million words during the year across almost 150 languages, enabling patients and consumers to make their voice heard in their own language.
Activating our annual Quality Month: This year, our annual Quality Month ran under the theme “Great Customer Experiences Start With Quality,” demonstrating our unwavering commitment to providing high-quality experiences to our patients, consumers and customers—all while having fun. Thousands of Johnson & Johnson employees joined virtual workshops, training and interactive educational sessions.
Product Quality Indicators
|Product Quality Indicators||2021||2020||2019|
|Number of FDA warning letters issued||0‡||0+||1+|
|Product recall rate* by business segment||
|Consumer Health Self-Care OTC**||0%‡||0%+||0.091%|
+ See PwC's Report of Independent Accountants in the 2020 and 2019 Health for Humanity Report.
* Product recall rate is defined as the 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 Johnson & Johnson 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.
** The Pharmaceutical and MedTech recall rates consider all products in each business segment. The Consumer Health product quality recall rate is inclusive of Consumer Health products from the Self-Care over-the-counter (OTC) business segment. It does not represent Essential Health and Skin Health/Beauty business segment products, including the voluntary recall of certain aerosol sunscreen products in 2021.