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Process Validation

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Process Assessment

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Cross Sectioning

Services: Process Validation
Process Validation Services
Process validation is an analysis protocol designed to determine the baseline condition of a manufacturer's existing or proposed process. Validation is accomplished by identifying the materials used in the manufacturing sequences, analyzing the thermal excursions seen by the product, and extracting residues remaining on the finished assemblies. Subsequent analysis of these residues will identify specific ionic elements and correlate the electrochemical performance characteristics in regards to reliability. Foresite engages in consultation with each customer prior to any activity 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.

Foresite Final Report Deliverables
  • Specific Project Goal — defined at time of quote
  • Description of customer specifications — cleanliness levels, SIR
  • Description of test protocol to accomplish project goal
  • Process Sequence Flowchart — as defined by customer
  • Material matrix indicating fluxes and chemistries used in process
  • Residue analysis data — identification and amount of residues present
  • Electrical performance data — from specified tests
  • Education regarding the general sources of the specific residues found
  • Foresite cleanliness limit recommendation for each ionic species identified
    • Foresite limits derived through 10 years of Failure Analysis and Process Qualification experience
  • Foresite interpretation of data and conclusions from our technical team
  • Foresite recommendations for any process optimizations or corrective action plan
  • Formal project report electronically sent to customer project contact (fax or e-mail)
  • Original hard copy report mailed upon completion of project
  • Telephone support included for discussion of report
Project Completion Timing Options
  • IC Testing:
    • Standard — Final Report completion in ten working days after project start
    • Fast Turn — Analytical results (verbal discussion) in 48 hours after project start — analysis of up to 100 samples
    • Analytical results (verbal discussion) in 72 hours after project start — analysis of 100-250 samples
    • Final Report completion in three working days after project start
  • SIR Testing:
    • SIR schedule will be determined at time of quote acceptance
Project Start Requirement — Receipt of Approved Purchase Order via fax or mail

Foresite Inc. Process Validation Requirements
To provide the customer with the deliverables mentioned, a process profile must be established. This process profile is used to outline all of the pertinent facts required to make a valid assessment of the assembly process and resulting characteristics of the final assemblies produced. The information collected will become a basis for the final report analysis and recommendations. The accuracy and completeness of the requested information is imperative to the success of the project.

The following information will be required for process validation:
  • What is the established standard or specification being applied?
  • Has your company qualified the current manufacturing process? How? By whom?
  • Is the process to be validated an existing operation or new installation?
  • What are the product requirements and goals for field reliability? (IPC Class 2 or 3)
  • What is the product classification? (automotive, medical, military, general commercial)
  • What is the service environment of the products produced?
  • Is the product manufacturing a captive operation or contract service?
  • Where is the assembly plant located?
To validate process performance, the materials and process options must be identified:
  • Laminate specifications — base laminate material, surface finishes, solder resist
  • Solder resist vendor and formulation nomenclature
  • Flux types used — OA (water soluble), NC (no-clean/low-residue), other
  • Flux vendor and formulation nomenclature
  • Flux application method (spray or foam)
  • Cleaning technology used — tap water, DI water, solvent
  • Cleaner type — vendor, batch or in-line
  • Stage(s) at which assembly will cleaned (post reflow, post wave, hand, rework)
  • Assembly equipment to be used (automated and hand)
  • Types of components to be assembled (thru-hole, surface mount, COB, BGA, HDI)
  • Thermal profiles for all heat excursions product will see (reflow, wave, hand, rework)
  • Atmosphere to be used during reflow and wave process — (oxygen or nitrogen)
  • Solder pot temperature
  • Other assembly materials (adhesives, temporary masks)
  • Conformal coating material (if used) — manufacturer, formulation, solvent, application
  • All hand operations and materials (post-wave, irons used, cleaning methods)
  • Procedure and instrument used to measure and record ionic cleanliness levels
Process samples will be required at specific stages (as applicable)
  • bare boards (all suppliers)
  • after wave soldering
  • after hand soldering (rework, repair, hand placement)
  • after conformal coat (if used)
  • after Surface Mount
  • finished product ready to ship
  • assembly drawings
  • process sequence flow charts
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