Process qualification is a test protocol used to provide objective data indicating whether an existing or proposed manufacturing process meets the minimum requirements for the applicable manufacturing standard or specification. The requirements selected may be an industry standard, such as IPC-610, or an internal quality standard.
Process qualification generally follows a down-selection of candidate materials and processes. Ion chromatography (IC) testing may be included in the qualification test protocol to identify any resultant process residues. Surface insulation resistance (SIR) testing may be used to examine the effects of those residues when environmentally exposed.
Other qualifications tests can be executed as needed.
Information Requested Prior to Process Qualification
Foresite engages in consultation with each client prior to any project to identify project goals, design an applicable test matrix and provide technical information derived from our experience and knowledge of contamination effects on product reliability.
Requirements for Process Qualification
To provide our client with the outlined services, cleanliness and reliability parameters must be established to evaluate whether the proposed process meets the specifications. The background information collected will become the foundation for the test matrix design, down-selection criteria, final report analysis, and process verification. Complete and accurate information is imperative to project success.
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