Position on Quality, Safety,and Compliance
BackgroundA commitment to quality, safety, and compliance is fundamental to Kenvue. Our goal is tomeet the high expectations of our customers and consumers and earn their trust by
developing high quality, innovative products which are safe, efficacious, and continuouslyavailable. By focusing on quality and safety throughout a product’s lifecycle, from the earlystages of Research and Development, during delivery to customers, and in support of thoseusing our products, we strive to meet our responsibility to put people first.
Our Quality, Safety & Compliance Organization
Our commitment to quality is driven by our Chief Executive Officer, as well as our Chief
Operations Officer, Chief Quality Officer, Chief Scientific Officer, and Chief Medical Officer.
They are supported by global Quality functions ensuring the quality of our products and that
manufacturing standards are met, as well as by a team of Medical Safety professionals who
provide a scientific and independent assessment of product safety.
The responsibilities of those teams span throughout all stages of a product lifecycle fromresearch and development phase to commercialization and post-market activities.
All Kenvue employees must contribute to our Kenvue commitment to quality, safety, andcompliance, by following laws, regulations and the stringent global Company policies, andprocedures we have in place.
Our Position
We maintain our commitment to end-to-end quality excellence and safety across all stages ofa product lifecycle through our quality and safety management approach, which is based on
the following proactive measures:••••

Adherence to Kenvue Quality System Principles;
Consumer-focused product design;
Stringent ingredient selection;
Innovative product development;Position on Quality, Safety, and Compliance•••••••

Quality and safety risk management, including continuous monitoring of productsafety;Process, equipment and product controls including qualification, validation, in-processmonitoring, and testing;Compliance monitoring through audits and inspections;
Rigorous procedures for internal communications and notification to management ofnon-compliance or product concerns;
Appropriate and timely field action to ensure integrity of marketed products;
Timely Integration of new acquisitions; andOngoing and consistent enhancement of talent and capabilities through training andeducation.

Our Policies and Principles: Our Quality System Principles define the requirements thatKenvue must meet to design, make, deliver and monitor the safety of our products, and if
needed, take risk minimization actions including in case of quality issues correcting or
recalling products from the market. They provide a common foundation for quality and safetysystems across Kenvue. The requirements are based on national and international standards
such as current Good Manufacturing Practices, International Organization for Standardization(ISO) series, and International Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use (ICH). Our Quality System Principles apply worldwide,requiring Kenvue to maintain the quality and safety of our products for our customers and tooperate in compliance with current regulations while anticipating and preparing for changes inregulations in the future.
Product Design: Quality and safety are built into our products from the very start. Ourproduct design informs the ingredients we use and involves input from our scientific andmedical experts to ensure the final product will meet the high bar we have set with our globalstandards.
Ingredient Selection: All ingredients are carefully selected and must pass stringent safety
and quality requirements. We ensure that their quality, purity, and manufacturing meetgovernment regulations, industry standards, and our strict internal policies. In addition, oursourcing and quality assessment teams thoroughly vet our suppliers and only accept vendorsthat meet our rigorous standards.
Product Development: Beyond design, our products also undergo further development andtesting, making sure ingredients are used in the right proportions and any potential issues areaddressed before the formula is finalized. Laboratory simulated and home-use tests are also
used in the development process and can rely on actual users.
Quality and Safety risk management: Risk management requirements are part of theKenvue Quality System Principles. They require that quality and safety risks throughout theproduct lifecycle be identified, assessed, and mitigated or minimized. We are committed tomonitoring the safety and quality of our products and have existing systems and appropriate
risk minimization strategies in place.

Position on Quality, Safety, and Compliance

Qualification and Testing: To ensure the final product meets its intended specification,
controls are in place. These controls enable consistency and include things like thequalification of equipment used to manufacture products, validation of key equipment andprocesses, and in-process monitoring to ensure performance meets expectation. Additionally,a testing plan for each product ensures upstream measures are effective.
Compliance monitoring: Kenvue has established an independent audit approach to ensure
our facilities and external manufacturing sites operate in compliance with our requirements, aswell as global health authority requirements. Our Quality audit program applies to all Kenvuefacilities that manufacture, store or distribute product. It also applies to external manufacturersthat provide materials, products and services to Kenvue. Through this Quality audit program,
we monitor, assess and identify opportunities to continuously improve the effectiveness of ourquality systems. Suppliers of Kenvue are audited to ensure compliance to our Quality
Agreements and to the regulations under which they operate. The audits are performed byrepresentatives of Kenvue and/or third parties. We monitor product safety information andensure timely reporting of relevant information to authorities in accordance with legislation.
In addition to our monitoring programs, robust oversight is maintained through appropriate
governance which is built into the safety and quality management systems, mandating
Kenvue management to review the quality and safety system performance, and to require andoversee improvements where necessary.
Internal communications and notification to management: As part of our Quality System
Principles, we maintain Standard Operating Procedures governing notification to management
for product safety concerns and quality issues that may arise. We have robust procedures fortimely escalation of safety or quality concerns to senior management. This includes additional
notification procedures such as external notification to relevant health authorities if required.
Product recall: As required by the Quality System Principles, Kenvue has a formal process
to evaluate concerns with the quality of product on the market. The process requires input ofleaders from Quality, Medical Safety and Regulatory Affairs. These technical leaders decide,independent of commercial considerations, whether actions need to be taken to correct orrecall a product from the market. Consumer safety supersedes any other factor in thisdecision-making.
Continuous improvement and post-market monitoring for quality complaints andadverse events: 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 develop corrective action plans tosystematically improve their quality systems and to prevent a recurrence of any deficiencies.
Once in the hands of our consumers, we are also continuously monitoring our products
through consumer feedback and tracking of adverse events, using this information to makerefinements and improvements to our products.
Integration of new acquisitions: Consumer safety and product quality are paramountconsiderations in the Kenvue approach to integrating new acquisitions. We have a welldefined process in place to ensure that when a new business unit joins Kenvue we takePosition on Quality, Safety, and Complianceprompt measures to align that quality and safety system to our Kenvue Quality and Safety
System framework. Our Quality and Safety teams participate in the due diligence activities
during the acquisition process and conduct detailed risk assessments of products, quality andsafety systems and processes.
Training and education: Continuous improvement of the skills and capabilities of our teammembers is essential for ensuring they have the competence needed to perform therequirements of their job in a regulated industry. All Kenvue employees are assigned trainings
throughout the year, based on their job responsibilities, and as required by the Kenvue Quality
System. This training ensures all associates are knowledgeable of the Current Good
Practices (cGxP) requirements for their work.
Health authorities and notified bodies regularly examine these training records during audits.
Further, we educate our workforce to develop their skills and capabilities beyond GxPregulatory requirements.
Last Updated: April 2023