OEM Audit Checklist for an Electronics Manufacturing Services (EMS) provider

MexicoSMT is pleased to offer a free OEM Audit checklist for Electronics Manufacturing Services (EMS) providers. This checklist is designed to assist you in assessing key manufacturing support and functional departments within EMS providers. It covers a range of topics such as quality systems, software tools, testing and standards, prototyping, and more to help you make informed decisions when selecting an EMS provider. We are committed to helping you ensure the successful production of high-quality products that meet your customers’ expectations.

OEM Audit Checklist for EMS

Quality Systems and Document Control

  • Is the EMS provider certified to any quality management standards, such as ISO 9001, ISO 13485, or AS9100?
  • Can the EMS provider provide documentation to demonstrate their adherence to these standards?
  • How does the EMS provider control and track changes to documents, such as work instructions, process sheets, and quality procedures?
  • How are non-conforming products identified and segregated? Is there a system for tracking and resolving non-conformances?
  • How are corrective and preventive actions (CAPAs) handled, and what is the process for implementing and verifying the effectiveness of these actions?

Software Tools

  • What software tools does the EMS provider use for managing production, quality, and inventory?
  • How are these tools integrated with each other and with customer systems, such as enterprise resource planning (ERP) systems?
  • Are these software tools validated and maintained to ensure they meet regulatory and customer requirements?
  • Does the EMS provider provide access to these software tools for their customers?

Benchmarking for Improvements and Customer Field Returns

  • Does the EMS provider have a process to benchmark performance against industry standards and best practices?
  • How does the EMS provider measure and track key performance indicators (KPIs) related to quality, cost, delivery, and customer satisfaction?
  • What processes does the EMS provider have in place to analyze KPI data and identify areas for improvement?
  • How are customer field returns handled, and what is the process for analyzing and resolving root causes of issues?

Failure Analysis, Recovery, and Internal Systems Support

  • What processes does the EMS provider have in place for failure analysis, including root cause analysis and corrective actions?
  • How does the EMS provider handle component shortages or obsolescence, and what processes are in place for finding alternate sources or redesigning products?
  • What processes does the EMS provider have in place for managing change requests, and how are these changes communicated to customers?
  • How does the EMS provider ensure the security and confidentiality of customer data and intellectual property?

RMA Cycle Time

  • What is the typical turnaround time for returning products for repair or replacement?
  • How are returns tracked and reported, and what is the process for analyzing and improving RMA cycle time?

Testing and Standards

  • What testing capabilities does the EMS provider have, including environmental, electrical, and functional testing?
  • How are these tests validated and maintained, and what processes does the EMS provider have in place for calibrating and maintaining test equipment?
  • How does the EMS provider ensure compliance with regulatory and customer-specific testing standards?
  • Does the EMS provider have a process to test components and finished products?
  • Does the EMS provider have testing capabilities for environmental conditions (e.g. temperature, humidity, vibration)?
  • Does the EMS provider follow industry and customer-specific testing standards?
  • Does the EMS provider have a process to document test results?
  • Does the EMS provider have a process to communicate test results to customers?

Design Tools and Product Launch Readiness

  • What design tools does the EMS provider have in place, including computer-aided design (CAD) and simulation software?
  • How does the EMS provider ensure the manufacturability of products during the design phase?
  • What processes does the EMS provider have in place for ensuring readiness for product launch, including pilot production runs and risk assessments?

Production Roadmaps

  • What is the EMS provider’s capacity for volume production, and what is the typical lead time for production runs?
  • Does the EMS provider have a process to develop production roadmaps?
  • Does the EMS provider have a process to manage production schedules and capacity?
  • Does the EMS provider have a process to communicate production schedules to customers?

Prototyping

  • What prototyping capabilities does the EMS provider have, and how are these services priced and delivered?
  • Does the EMS provider have a process to support prototype builds?
  • Does the EMS provider have a process to manage design changes during prototyping?
  • Does the EMS provider have a process to provide engineering support during prototyping?

Process Technology Capabilities

  • What production and process technology capabilities does the EMS provider have, including surface mount technology (SMT), through-hole assembly, and automated testing?
  • How does the EMS provider ensure the quality and consistency of products during the production process?
  • Does the EMS provider have the production and process technology capabilities required for the customer’s products?
  • Does the EMS provider have a process to evaluate and improve production and process technology capabilities?
  • Does the EMS provider have a process to ensure the availability and maintenance of production and process technology?