At Sheffield Precision, we possess extensive expertise in meeting the Production Part Approval Process (PPAP) requirements specified by major medical device companies. In the past 12 months alone, we have successfully completed PPAPs for three out of the top four orthopaedic Original Equipment Manufacturers (OEMs). Our comprehensive PPAP capabilities include, but not limited to the provision of:

  • Control Plans: Detailed documentation outlining the control measures implemented throughout the manufacturing process to ensure product quality and consistency.

  • First Article Inspection Records (FAIR): Thorough records documenting the inspection and validation of the initial production run to verify conformance to specifications.

  • Process Failure Mode and Effects Analysis (PFMEA): Every process at Sheffield Precision is systematically assessed for potential failure modes within the manufacturing process and their associated effects, enabling proactive risk mitigation.

  • Process Flows: Visual representations outlining the sequential steps involved in the manufacturing process, facilitating clear understanding and effective communication.

  • Contact Materials: Documentation of materials safety data sheets (MSDS) for every materials that may potentially come in contact with your products, including sub-contracted process. Our contact materials list is regularly maintained and our experienced QA team is well versed in providing additional assistance, ensuring all regulatory requirements are met with confidence. 

  • Conflict Minerals: We ensure compliance with conflict mineral regulations by regularly furnishing the CMRT documentation.

  • Gauge Repeatability and Reproducibility (R&R) Studies: Statistical analysis evaluating the precision and consistency of measurement systems, ensuring reliable and accurate inspection results.