Programs that skip or compress the pre-production sample stage in composite manufacturing may encounter challenges during first article inspection if the production process does not produce a conforming part. By that stage, tooling may already be committed and production resources allocated, making any required requalification more costly and time-consuming than a thorough pre-production evaluation.
A common source of this issue is treating a sample produced with approximate tooling or an approximate process as validation of the production process, when it may have validated only the design. A pre-production sample intended to support production approval should be produced using the production tooling and defined production process, then inspected against the drawing acceptance criteria before production is committed.
A pre-production sample that provides a sound basis for production approval is produced on the production tooling that will be used for every subsequent production run, using the defined production process, and inspected against the drawing acceptance criteria before any production commitment is made. That is the deliverable that closes the gap between a prototype that confirms the design is right and a first article that confirms the process is right. CMI fabricates pre-production samples using production tooling and the defined production process, with the inspection and documentation required to support the production approval decision. Contact our engineering team through our contact page or call 949-361-7580 to discuss pre-production sample fabrication for your program.
CMI’s pre-production sample fabrication process begins with the production tooling used for full production runs, not bridge tooling or soft tooling built for prototype evaluation. The layup sequence, materials, and cure cycle parameters are defined for the production process and documented in enough detail to allow any qualified technician to execute the process consistently. Inspection of the pre-production sample covers all drawing dimensions and features identified in the inspection plan, with dimensional records generated and reviewed against the acceptance criteria before the sample is delivered. When the program requires nondestructive inspection, CMI performs it using the inspection methods defined in the program quality plan. The documentation package delivered with the pre-production sample includes the dimensional inspection records, material certifications for the materials used in production, cure cycle records, and any nondestructive inspection results required by the program. For regulated medical programs, this documentation is structured to support design history file assembly where applicable. More detail on CMI’s inspection methods is available on our composite solutions page, and our program timeline page describes where pre-production sample fabrication fits in the full program lifecycle.
The validity of a pre-production sample as evidence of production process capability depends on the quality of the production tooling and the fidelity with which the production process is executed. At CMI, both are governed by the same engineering team. A critical part of CMI’s competency is in-house tool fabrication, where the engineers who designed the molds work alongside the fabricators, minimizing opportunities for misinterpretation and ensuring the final product meets specification, as confirmed on our composite solutions page. This engineering continuity from design through tooling through pre-production sample reduces the risk of dimensional translation errors that arise when tooling is outsourced to a vendor operating independently from the design team. For programs where the pre-production sample must serve as evidence of production process capability, the quality of the tooling fabrication and the fidelity of the process execution are not secondary concerns. They are the primary determinants of whether the pre-production sample evidence is valid. More detail on our in-house tooling capability is available on our in-house design and engineering page.
CMI fabricates pre-production samples for both commercial and regulated medical programs, and the process controls and documentation requirements differ based on program type. For commercial programs, pre-production sample fabrication follows CMI’s standard production quality controls with dimensional inspection and material traceability documentation appropriate to the program requirements. For regulated medical programs, pre-production sample fabrication operates within CMI’s ISO 13485-compliant quality management system, with process validation scope, inspection requirements, and documentation deliverables confirmed at program intake based on the device regulatory classification and the OEM’s quality agreement. CMI has maintained FDA registration since 1985, and its quality system aligns with the FDA’s QMSR that took effect February 2, 2026, as described on our medical manufacturing page. The specific scope of controls for any pre-production sample program is confirmed at intake. Contact our engineering team through our contact page to discuss the requirements for your specific program.
The pre-production sample stage exists because the gap between a prototype that confirms the design is right and a first article that confirms the process produces a conforming part costs programs significantly when discovered at first article rather than at pre-production sample evaluation. CMI’s in-house tooling fabrication, vertically integrated engineering and production capability, and quality management system are structured to produce pre-production samples that provide valid, documented evidence of production process capability before full production resources are committed. Contact our engineering team through our contact page or call 949-361-7580 to discuss pre-production sample fabrication for your program, or review how the full composite program lifecycle is structured on our program timeline page.
