HC-MS-430a.1 |
Percentage of (1) entity's facilities and (2) Tier I suppliers' facilities participating in third-party audit programs for manufacturing and product quality |
Between 2019 and 2021, approximately 40% of Baxter's total facilities worldwide completed third-party audits based on ISO 13485 or ISO 9001 (including through the Medical Device Single Audit Program), approximately 50% completed ministry of health or equivalent audits (depending on location) related to manufacturing and product quality, and nearly 10% completed safety marking (such as CE marking) audits.
As of Dec. 31, 2021, 29% of Baxter's Tier 1 Suppliers had obtained third-party certification. See Continually Improve Manufacturing Capabilities and Supplier Audits in the Baxter 2021 Corporate Responsibility Report for related information.
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HC-MS-430a.2 |
Description of efforts to maintain traceability within the distribution chain |
Baxter has a range of systems and processes to maintain traceability of materials throughout the product supply and distribution chain:
- Traceability of materials from suppliers to Baxter, and throughout the manufacturing process, is maintained utilizing electronic systems.
- Products manufactured by Baxter are labeled with an identifier that is traceable from the manufacturing process to the customer and may utilize barcoding and serialization technology to facilitate electronic track-and-trace capability. Enterprise resource planning (ERP) systems are used to manage traceability to the point of sale. Baxter has business agreements with our wholesalers to ensure traceability is maintained within their distribution chains, and we can access related information if needed.
- Baxter maintains a range of compliance-focused initiatives to help ensure all products are labeled as required by local and regional regulations to enable traceability.
See section 7.11, Product Identification and Traceability of the Baxter Supplier Quality Standards and Customs Trade Partnership Against Terrorism program content in Industry Collaboration in the Baxter 2021 Corporate Responsibility Report for more information.
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