- Product definition and contamination sensitivity
- Assembly-level STEP or STP model and matching PDF drawing, assembly number and revision, BOM line items and quantities, component identity, hardware identity and revisions, approved alternates, purchased or customer-supplied component status, material and finish condition, incoming and pre-cleaned state, sensitive cavities and flow paths, critical contact surfaces, no-touch and protected surfaces, orientation, assembly sequence, access, adjustment, lubrication or adhesive state, permissible exposure limits, and foreign-material risks
- Environment and operational-control definition
- ISO 14644-1 or other governing standard or customer specification and revision, customer-specified ISO class, occupancy state, airborne-particle sizes and particle concentration limits, local zone or separative-device boundary, pressure, airflow, temperature and humidity conditions when specified, monitoring parameters, locations, method, frequency and action limits, environmental-monitoring record fields when required, personnel and material entry and exit, transfer boundary, gowning, cleaning, maintenance, access and segregation, ESD controls and other electrostatic requirements, chemical-contamination and viable-contamination requirements, and response to an excursion or contamination event
- Materials, consumables, cleaning, and handling
- Approved consumables; approved and prohibited components, materials, finishes, tools, fixtures, gloves, garments, wipes, swabs, bags, containers, cleaning agents, lubricants and adhesives; material compatibility with the product and process; required particle, chemical, viable, outgassing, shedding and electrostatic attributes; incoming package state; unbagging and transfer sequence; cleaning method, agent concentration and residue limit when specified; rinse, drying, verification and re-clean triggers; cleaning validation status and owner when applicable; gowning requirements; glove-change, handling method, exposure-time, hold-time and protected-surface instructions; and substitution rules
- Packaging, acceptance, identification, and records
- Assembly and in-process checks, inspection method or test method, surface-cleanliness or residue method when specified, sample and measurement locations, operating condition, sampling or coverage, acceptance and rejection criteria, nonconformance response, inner and outer bag or pouch materials, bagging or pouch sequence, closure or seal method, label location and allowed marking materials, package opening boundary, preservation, storage and handling conditions, packaging validation status and owner when applicable, sterilization or sterile-barrier requirement only when specified with its controlling process and validation owner, traceability requirement, component, lot or serial mapping, requested record fields, record-retention requirement and deliverable boundary, quantity, and target timing