Federal Electronics’ service clusters ensure that original equipment manufacturers (OEMs) with special needs are supported with robust solutions. The Mission Critical Assist service cluster provides focused support for medical devices and other products with significant regulatory requirements. It includes robust production qualification requirement support, traceability, device history recordkeeping and customized quality reporting.
Companies in the military, aerospace and medical market niches typically must comply with more stringent regulatory and/or industry requirements than their industrial counterparts. Our strategy to assist these companies include:
- Requirements gap analysis: In many instances, the requirements for a particular program can exceed conventional industry standards. This could be due to a customer’s own internal expectations or those imposed by the end customer. Regardless of the source, when requirements deviate from typical industry standards, we conduct a gap analysis, which is reviewed and approved by the customer, to assure that our quality system accurately reflects the customer’s expectations.
- Production qualification: Every product we manufacture undergoes a rigorous first article process which validates the product to the customer’s specifications as well as the process used to produce it. Upon completion, the approved process becomes the baseline from which all improvements or modifications are made. In particularly critical applications, the process is also “locked‐down” such that NO modifications are allowed without prior customer approval.
- Process qualification: Some products require the introduction of new or non‐standard processes. In these instances, we implement and validate new processes through the introduction of Manufacturing Process Control Procedures (MPCPs) which address equipment requirements, process instructions, and establishment of critical characteristics, training requirements and raw material specifications. The MPCP becomes the governing baseline document which serves as the point of reference for all activities moving forward.
- Traceability and recordkeeping: Mission critical products typically require more complex traceability and device history recordkeeping. Our systems can record and track dates of manufacture, operators, tooling, and raw material lot codes to end product lot code and/or serial number.
- Ongoing metrics reporting: Some programs/products require specific, periodic metrics reporting of key performance indicators. We establish those requirements at the onset of the program and provide data on a scheduled or as‐needed basis