Quality is a fundamental value of our products. We believe our patients and consumers deserve consistent, reliable and high quality every time they use or experience a Johnson & Johnson product. We work hard to make this happen by instilling and maintaining a proactive quality excellence culture throughout the enterprise.
The focus on quality starts at the top with our Chairman & CEO and our Executive Committee. They, along with the Chief Compliance Officer and the Chief Quality Officer, advocate that all employees must contribute to our enterprise-wide Quality and Compliance Core Objective established by the Johnson & Johnson Board of Directors. It is the responsibility of every employee to adhere to the principles set forth in this enterprise-wide Core Objective, and such principles are embedded in our evaluation and compensation processes.
Led by the Chief Quality Officer, our global Quality & Compliance (Q&C) organization, functionally independent from commercial interests, has harmonized quality management by ensuring consistent implementation of quality systems across our Johnson & Johnson Family of Companies. Q&C has oversight of quality and regulatory compliance across the Enterprise. Q&C leadership establishes the enterprise-wide Johnson & Johnson Quality Policy and Quality Standards. At our operating companies, the scope of Q&C responsibilities includes quality management activities at all stages of a product lifecycle—from R&D, to manufacturing and commercialization. Our R&D and manufacturing sites have designated Quality heads to establish, implement and maintain quality systems at our sites and ensure quality regulatory compliance.
As it states in Our Credo, everything we do must be of high quality. It’s our first responsibility to more than a billion people around the world who use and trust Johnson & Johnson products. Every employee of our Company proudly accepts this responsibility every day. Using our deep expertise and looking beyond our own Company for best practices, we have developed and implemented benchmark processes in quality, compliance and safety to improve outcomes for patients, consumers and customers at some of the most sensitive and important moments of their lives. Building on our strong reputation for quality, we are prepared to meet ever-rising expectations and are investing in new technology and solutions to ensure a reliable supply of safe and effective products when and where they are needed.
Our quality management approach is based on the following proactive measures that help ensure end-to-end quality excellence:
- Adherence to Johnson & Johnson quality standards and policies;
- Quality risk management principles;
- Compliance monitoring through audits and inspections;
- Continuous improvement;
- Ongoing and consistent enhancement of talent and capabilities through training and education.
In 2018, we optimized our Global Quality Services organization to more effectively and efficiently manage and govern the Johnson & Johnson Quality Standards and to provide Quality services across our three segments. The Quality Services organization harnesses the expertise within our various companies, which then provide that expertise as services to all companies across the Enterprise, thus reinforcing the benefit of our size and diversity of experiences and expertise.
Quality Policy and Standards
Our Quality Policy and Quality Standards define the requirements that our operating companies across Johnson & Johnson must achieve to design, make and deliver our products, and if needed, take actions to correct or recall products in the market. They provide a common foundation for quality systems across the Johnson & Johnson Family of Companies. The requirements are based on national and international standards such as current Good Manufacturing Practices (cGMPs), International Organization for Standardization (ISO) series, and Johnson & Johnson best practices. These Quality Standards are put in place worldwide to help assure the quality of our products for our customers and to assure the operation of our businesses in compliance with regulations.
We have established a closed-loop, independent audit approach to help ensure our facilities and external manufacturing sites operate in compliance with our internal Johnson & Johnson Quality Standards, as well as global health authority requirements. Our Quality Audit Program applies to all Johnson & Johnson facilities that manufacture, store or distribute product. It also applies to external manufacturers that provide materials, products and services to our businesses. It is through this Quality Audit Program that we monitor, assess and identify opportunities to continuously improve the effectiveness of our quality systems.
In addition to our monitoring programs, there is a Management Review process that is built into the quality system of each operating company, mandating its executive management to review the effectiveness of the elements of the quality system, and to require improvements where necessary. These Management Reviews are conducted every six months.
We proactively monitor and evaluate our systems, standards, industry landscape and regulatory environment, incorporating changes where necessary to drive continuous improvement. Further, when appropriate, sites found to require improvements in their operation develop corrective action plans to systematically improve their quality systems and to prevent a recurrence of any deficiencies. Such ongoing proactivity helps us “self-detect” and “self-correct” potential issues to ensure compliance with regulatory requirements. Results, status and progress are all reported to business leaders and the Johnson & Johnson Family of Companies’ governing bodies to help them support their sites’ efforts to achieve compliance in a timely manner. Regular updates on this topic are provided by the Johnson & Johnson Chief Quality Officer to the Regulatory Compliance Committee.
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 of product in the market. The QRBs consist of leaders from Q&C, Medical Affairs, Medical Safety and Regulatory Affairs. The QRBs decide, independently of commercial considerations, whether actions need to be taken to correct or recall a product in the market. Patient and consumer safety supersede any other factor in this decision making.
Quality Risk Management
Risk management requirements are part of the Johnson & Johnson Quality Policy. They require that quality risks throughout the product lifecycles be identified, assessed, and mitigated or minimized. In addition to mandatory product risk management principles, we developed a proprietary risk mapping tool to identify, assess and mitigate risks across the entire manufacturing value stream. Based on a comprehensive data-driven methodology, the tool helps identify opportunities for strengthening quality controls at every phase of a product lifecycle, thus enabling continuous process improvement and proactive quality control.
Training and Education
Continuous improvement of the skills and capabilities of our employees is essential in ensuring personnel have the competence needed to perform their responsibilities within health authority regulated activities. All applicable employees receive extensive trainings on their responsibilities under the Quality System. Our Quality Training Academy is a centralized platform for our Quality employees to access training and development opportunities. In addition to mandatory trainings, we offer several learning and professional development courses.
We apply the same training and education philosophy to our work with suppliers. Through our Supplier Quality Academy, we provide training to suppliers and supplier-facing Johnson & Johnson employees to build and strengthen strategic competencies that impact the overall quality and performance of the end-to-end supply chain. Over years, we have identified many best practices that improve the quality of our products and processes at our sites. The Supplier Quality Academy enables us to share those learnings with our suppliers and external manufacturers. The platform offers several courses delivered through a variety of training methods—from face-to-face instructor-led trainings to virtual instructor-led conferencing and self-led online modules.
Integration of New Acquisitions
Patient and customer safety and product quality are paramount considerations in our approach to integrating new acquisitions. We have a well-defined process in place to ensure that when a new company joins our Johnson & Johnson Family of Companies, we take prompt measures to align that company’s quality system to our Johnson & Johnson Quality System framework. Our Quality teams participate in the due diligence activities during the acquisition process, and conduct detailed risk assessments of quality systems and processes. The risks are prioritized, and action plans are developed to ensure compliance with our internal Quality Policy and Quality Standards.
Proactive Compliance: Improving Quality, Increasing Speed to Market
Industry and regulators continue to strive to improve product quality and patient experience while increasing speed to market—getting high-quality products to patients and customers sooner. To this end, Johnson & Johnson is participating in two pilots with the U.S. Food and Drug Administration (FDA):
Since 2017, Johnson & Johnson, one out of nine selected participants, has been engaging with the FDA to develop a precertification program for non-embedded software devices. The purpose of this program is to assess whether a company consistently and reliably engages in high-quality software design and testing (validation) and ongoing maintenance of its software products. Johnson & Johnson’s participation helped to shape a new Digital Health regulatory framework that will increase product speed to market at a lower cost.
Johnson & Johnson is participating in the FDA Case for Quality Voluntary Improvement Program pilot, which utilizes a Capability Maturity Model Integration (CMMI) model to assess an organization’s quality processes. CMMI model provides guidance for improving processes that meet the business goal of an organization and is used as a framework for appraising business processes and quality system maturity of an organization. Through this pilot program, the FDA hopes to accelerate new product submissions. Johnson & Johnson is currently working on three launch sites for CMMI assessments.
“Johnson & Johnson is synonymous with Quality & Innovation, and through the implementation and use of the tools provided from the Maturity assessment our Quality System has improved exponentially. It provides a systematic approach to deal and improve People Behavior, Equipment, Quality, Health & Safety. In particular, the Change Management Protocol and Focus on Customer segments had a huge impact on driving the quality of our products, our system and employee interaction. We are sure that with continual assessment and innovation we can build and grow our company in balance with our quality management system, thus providing a product of high quality and on time to Johnson & Johnson.”
Bronwyn Coghlan, Quality Assurance Manager, VVF Life Sciences South Africa, commenting on Johnson & Johnson’s Maturity Assessment
“We found great value in getting a better understanding of the processes; but more importantly a deep understanding of the purpose for the Critical to Quality (CTQ) features. As a result, measuring equipment was improved and it definitely helps to have a much more realistic picture of the process output. Initiatives like these are appreciated especially when executed in conjunction with the customer, because the relationship between both parties gets as robust as the process.”
Christian Sterling, Quality Assurance Manager, Precision Concepts, Costa Rica
"Initiatives like Technical Assessment and Micro Risk Assessment proposed by Johnson & Johnson are evaluated by Interfill as a manifestation of partnership. This way of collaboration promotes open discussion and information exchange. This is a new experience for us, and the knowledge from the assessments helped in the microbiological production area for hygienic design of equipment, providing new tools to analyze efficiency of current processes and identify fields of possible improvements. Such workshops help us in a constantly growing production culture and staff involvement.”
Elena Zagortseva, Quality Manager, Interfill, Russia
Product Quality Indicators
|Number of regulatory inspections of Johnson & Johnson sites by worldwide health authorities||619||557||505|
|Percentage of inspections that resulted in zero observations||78%||71%||not reported|
|Number of FDA inspections of Johnson & Johnson sites||24||63||45|
|Percentage of inspections that resulted in zero observations||75%||83%||not reported|
|Average number of observations per FDA inspection||0.6||0.7||not reported|
|Number of independent audits of Johnson & Johnson sites to ensure compliance with Quality Policy & Standard||179||179||179|
|Number of independent audits of external manufacturing sites to ensure compliance with Quality Policy & Standards||237||not reported||not reported|
|Number of FDA warning letters issued, total for enterprise||0||0||not reported|
|Number of FDA warning letters issued, by business segment|
|Medical Devices||0||0||not reported|
|Global product recall rate*||0.056%||0.133%||not reported|