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Key Areas to Audit When Selecting a Contract Manufacturer

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Selecting a contract manufacturer for mission critical applications can be more challenging than selecting a contract manufacturer in other industries. The regulatory environment associated with these projects is more complex than most commercial products. Traceability and associated documentation requirements are more detailed. Procurement and supply chain management may require specialized knowledge and procedures. Volumes can be low and production builds may only be done a few times a year rather than continuously. Specialized production skills or equipment may be required to support processes required by harsh operating environments. Consequently, the OEM selection team must look beyond production capabilities to determine if the contract manufacturer has the industry-specific processes and expertise to correctly address the requirements associated with each product.

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