12 We are advancing automation in manufacturing, quality systems and inspection and measurement methods such as Manufacturing Execution System (MES), Design Controls and Risk Management Software (The Vault), and InfinityQS. A Product Lifecycle Management tool, Windchill, is in the midst of a global implementation to simplify regulatory compliance while simultaneously increasing new product speed to market. The global use of this tool will create an ability for resources to work across the network seamlessly and formulate a single approach to deliverable completion. In addition to the Quality Begins With Me program launched in 2020, an upgraded compliance hotline process was launched across Zimmer Biomet in 2021 with a campaign called “ If You See Something, Say Something ”. Both the program and the hotline help us continue to promote a “blame free” culture where we drive appropriate behaviors, empower team members to promote operational excellence, and maintain focus on quality and compliance. We have continued with Green Belt and Black Belt certification programs so team members learn and apply LEAN tools to reduce waste, drive out variation (by applying Define, Measure, Analyze, Improve and Control problem- solving), and make data-driven decisions through proven quality tools and statistical methods. We are also working toward compliance and certification with the European Union Medical Device Regulation standards by 2024. Supplier Code of Conduct We are committed to achieving and maintaining the highest standards of corporate integrity and ethical behavior, and we expect our suppliers to conduct business with the same high standards. To establish guidelines for such standards, Zimmer Biomet has instituted a Code of Supplier Conduct, available at www.zimmerbiomet.com/content/dam/zimmer-biomet/ sourcing/Zimmer-Biomet-Supplier-Code-of-Conduct.pdf At a minimum, suppliers must conduct business in accordance with all applicable country, state, and local laws and regulations covering the jurisdictions in which they operate, including, without limitation, laws relating to employment, human rights, the environment, health and safety and trade. Each supplier is to comply with the commercial best practices of the supplier’s industry. Zimmer Biomet reserves the right to decline to deal with suppliers who do not comply with the law or our standards. We have also taken steps to ensure that slavery and human trafficking is not taking place in our supply chains or any parts of our business operations through the UK Modern Slavery Act of 2015 and the California Transparency in Supply Chains Act of 2010. www.zimmerbiomet.com/content/dam/zb-corporate/en/ suppliers/global-and-nam/uk-modern-slavery-act-and- california-transparency-in-supply-chain-act-statement.pdf Supplier Social Responsibility Audits Zimmer Biomet conducts Social Responsibility audits with all new suppliers in high risk regions and on existing suppliers every three years. The audit investigates child labor; forced labor and human trafficking; disciplinary practices; working hours and compensation; environmental protection; health and safety; and management practices. Forty-seven suppliers were audited in 2019 with no major findings. The next round of Social Responsibility audits will occur in 2022 and focus on high-risk suppliers. Supplier Diligence For all new proposed international suppliers, due diligence investigations are conducted by the Zimmer Biomet Compliance team to make sure the third party is not on a blocked person list, a specially designated national watchlist or otherwise a prohibited party. This global due diligence review starts at the front end of the request process. Ongoing due diligence is conducted periodically for existing suppliers. Supplier Quality Audits New and existing supplier audit plans are established based on the applicable Quality Management System (QMS) requirement for the product/service the supplier provides. The applicable QMS requirements are focused on FDA and International Organization for Standardization (ISO) standards. These standards include FDA 21 CFR 820 and ISO 13485. Zimmer Biomet has three global documents detailing the process: (i) the Supplier Questionnaire is used to collect a variety of information on the supplier, including an overview of the supplier’s quality system; (ii) the Supplier Qualification Report determines which audit plan will be followed and the supplier’s risk classification; and (iii) the Supplier Audit Report details the information found during the audit and the attendees.
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