ALPMA-001 |
Portion cutting machine scope reviewed against EN 13870 requirements |
critical |
Hybrid |
Compliance overlay |
REF-FOOD-EN13870 |
ALPMA-002 |
Food-contact materials declaration includes EU 1935/2004 and EU 10/2011 linkage |
critical |
Hybrid |
Compliance overlay |
REF-FCM-EU-1935-2004, REF-FCM-EU-10-2011 |
ALPMA-003 |
Stainless stock callout ties grade to EN 10088-3 where applicable |
major |
Hybrid |
Compliance overlay |
REF-MAT-EN10088-3 |
ALPMA-004 |
General tolerance baseline for CNC pilot parts is explicitly declared (ISO 2768-fH) |
major |
Deterministic |
Compliance overlay |
REF-TOL-2768-FH |
ALPMA-005 |
Locating fits for dowel/kinematic interfaces are declared (ISO 286 H7/m6 intent) |
major |
Hybrid |
Compliance overlay |
REF-FIT-286 |
ALPMA-006 |
Anodic oxidation specification declared when aluminum corrosion/hygiene finish is required |
major |
Hybrid |
Compliance overlay |
REF-COAT-7599 |
ALPMA-007 |
Pipe-thread designation is explicit for fluid/service interfaces (ISO 228-1 where used) |
major |
Hybrid |
Compliance overlay |
REF-THR-228-1 |
ALPMA-008 |
General tolerance baseline is explicit for concept drawings (ISO 2768-mK) |
major |
Deterministic |
Compliance overlay |
REF-TOL-2768-MK |
AUTO-001 |
Automotive QMS requirements (IATF 16949 aligned with ISO 9001) drive design control discipline |
major |
LLM-assisted |
Compliance overlay |
REF-AUTO-QMS |
AUTO-002 |
VDA 6 |
major |
LLM-assisted |
Compliance overlay |
REF-VDA-6-3 |
AUTO-003 |
Control plan linkage expected in CSR examples |
major |
LLM-assisted |
Compliance overlay |
REF-GM-CSR |
AUTO-004 |
Layout inspection expectation (example: dimensional requirements on ≥5 parts) |
major |
LLM-assisted |
Compliance overlay |
REF-GM-CSR |
AUTO-005 |
Special characteristics tagging supported (CTQ/CC/SC) |
major |
LLM-assisted |
Compliance overlay |
REF-GM-CSR, REF-VDA-6-3 |
FOOD-001 |
Hygienic design: machine must be cleanable |
critical |
Hybrid |
Compliance overlay |
REF-FOOD-EN |
FOOD-002 |
Avoid crevices/gaps/steps |
major |
LLM-assisted |
Compliance overlay |
REF-HYG-1 |
FOOD-003 |
Prefer self-draining geometry |
major |
LLM-assisted |
Compliance overlay |
REF-HYG-1 |
FOOD-004 |
Food-contact surfaces target smoothness (Ra guidance), and generous internal radii |
major |
LLM-assisted |
Compliance overlay |
REF-HYG-1 |
FOOD-005 |
Hygiene requirements + intended use info provided by manufacturer |
major |
LLM-assisted |
Compliance overlay |
REF-FOOD-ISO |
HVAC-001 |
EN 378 expects design/construction/testing/marking/documentation coverage for systems |
major |
LLM-assisted |
Compliance overlay |
REF-HVAC-EN |
HVAC-002 |
Refrigerant/system changes require reassessment of conformity to EN 378 parts |
critical |
LLM-assisted |
Compliance overlay |
REF-HVAC-EN |
LAB-001 |
Safety requirements for lab/measurement equipment apply (product category match) |
critical |
Hybrid |
Compliance overlay |
REF-LAB-IEC |
LAB-002 |
Mechanical hazards + protection measures considered (covers more than drawings) |
critical |
LLM-assisted |
Compliance overlay |
REF-LAB-IEC |
LAB-003 |
Labeling/documentation expectations captured in template |
major |
LLM-assisted |
Compliance overlay |
REF-LAB-IEC |
LAB-004 |
Reasonably foreseeable misuse considered (design & documentation) |
major |
LLM-assisted |
Compliance overlay |
REF-LAB-IEC |
LAB-005 |
Electrical safety constraints impact enclosure/clearances (tie to enclosure CAD checks) |
critical |
LLM-assisted |
Compliance overlay |
REF-LAB-IEC |
MACH-001 |
Risk assessment required |
critical |
Hybrid |
Compliance overlay |
REF-MACH-ISO |
MACH-002 |
Risk reduction measures documented (design + safeguarding) |
major |
LLM-assisted |
Compliance overlay |
REF-MACH-ISO |
MACH-003 |
Machine design must meet EU machinery health/safety requirements |
critical |
Hybrid |
Compliance overlay |
REF-MACH-REG |
MACH-004 |
Maintenance access considered (guards, pinch points, access panels) |
major |
LLM-assisted |
Compliance overlay |
REF-MACH-ISO |
MACH-005 |
Safety-related control functions require structured design approach |
critical |
LLM-assisted |
Compliance overlay |
REF-MACH-ISO, REF-MACH-REG |
MED-001 |
Must meet EU MDR requirements for placing devices on market + safety/performance |
critical |
Hybrid |
Compliance overlay |
REF-MDR-EU |
MED-002 |
QMS (ISO 13485) design/production controls: traceability + validated processes expectation |
major |
LLM-assisted |
Compliance overlay |
REF-MED-QMS |
MED-003 |
Risk management process (ISO 14971): hazards → risk controls → residual risk monitoring |
critical |
LLM-assisted |
Compliance overlay |
REF-MED-RISK |
MED-004 |
Design changes: controlled, reviewed, documented |
major |
LLM-assisted |
Compliance overlay |
REF-MED-QMS |
MED-005 |
Cleanability/bioburden-related design constraints treated as DFM risks when relevant |
major |
LLM-assisted |
Compliance overlay |
REF-MED-RISK, REF-HYG-1 |
PILOT-001 |
Pilot release includes machinery CE framework context where customers still require 2006/42/EC mapping |
major |
LLM-assisted |
Compliance overlay |
REF-MACH-DIR-2006-42 |
PILOT-002 |
Machine hygiene design cross-check against EN ISO 14159 and EN 1672-2 intent |
critical |
Hybrid |
Compliance overlay |
REF-FOOD-ISO, REF-FOOD-EN |
PILOT-003 |
Additive prototype route declares process framework (VDI 3405) when used |
major |
LLM-assisted |
Compliance overlay |
REF-ADD-VDI-3405 |
PRES-001 |
Pressure equipment must meet essential safety requirements |
critical |
Hybrid |
Compliance overlay |
REF-PED-EU |
PRES-002 |
Pressure boundary joints: welding/testing documentation required where applicable |
major |
Hybrid |
Compliance overlay |
REF-PED-EU, REF-WLD-1 |
PRES-003 |
Correct classification/category influences conformity assessment |
critical |
Hybrid |
Compliance overlay |
REF-PED-EU |
PSTD-001 |
ISO 9409-1 robot interface geometry must match selected flange pattern |
critical |
Hybrid |
Compliance overlay |
REF-ROBOT-9409-1 |
PSTD-002 |
Robot/end-effector drawings must reference ISO 9409-1 when that interface is used |
major |
Deterministic |
Compliance overlay |
REF-ROBOT-9409-1 |
PSTD-003 |
Fit-critical mating holes/shafts must have an ISO 286 fit designation |
major |
Deterministic |
Compliance overlay |
REF-FIT-286 |
PSTD-004 |
Computed ISO 286 fit outcome must match the intended fit type |
critical |
Hybrid |
Compliance overlay |
REF-FIT-286 |
PSTD-005 |
General tolerance note must be present when ISO 2768-mK is used |
major |
Deterministic |
Compliance overlay |
REF-TOL-2768-MK |
PSTD-006 |
Anodizing callouts must reference ISO 7599 when anodic oxidation is specified |
major |
Deterministic |
Compliance overlay |
REF-COAT-7599 |
PSTD-007 |
Pipe thread callouts must explicitly state ISO 228-1 for G-threads |
major |
Deterministic |
Compliance overlay |
REF-THR-228-1 |
PSTD-008 |
ISO 228-1 pipe threads must be parallel and match designated size |
critical |
Hybrid |
Compliance overlay |
REF-THR-228-1 |
PSTD-009 |
Food-contact designs must not include enclosed/trapped volumes in product/splash zones |
major |
Hybrid |
Compliance overlay |
REF-FOOD-EN |
PSTD-010 |
Food machinery drawings must state hygiene/cleanability assumptions needed for correct use |
major |
Deterministic |
Compliance overlay |
REF-FOOD-EN |
PSTD-011 |
If the product is a portion cutting machine, documentation must reference EN 13870 |
info |
Deterministic |
Compliance overlay |
REF-FOOD-EN13870 |
PSTD-012 |
Hygienic designs should avoid non-drainable pockets and inaccessible crevices in hygienic zones |
major |
Hybrid |
Compliance overlay |
REF-HYG-1 |
PSTD-013 |
Food equipment docs should reference EHEDG hygienic design guidance when claimed |
info |
Deterministic |
Compliance overlay |
REF-HYG-1 |
PSTD-014 |
Food-contact materials must have framework FCM compliance evidence and traceability controls |
critical |
Hybrid |
Compliance overlay |
REF-FCM-EU-1935-2004 |
PSTD-015 |
Food-contact plastics must have EU 10/2011 declaration of compliance and supporting documentation |
critical |
Hybrid |
Compliance overlay |
REF-FCM-EU-10-2011 |
PSTD-016 |
Stainless steel material specs must be stated per EN 10088-3 where applicable |
major |
Deterministic |
Compliance overlay |
REF-MAT-EN10088-3 |
PSTD-017 |
General tolerance note must be present when ISO 2768-fH is used |
major |
Deterministic |
Compliance overlay |
REF-TOL-2768-FH |
PSTD-018 |
Machinery Directive technical file and EC declaration must exist for CE-marked machinery |
critical |
Hybrid |
Compliance overlay |
REF-MACH-DIR-2006-42 |
PSTD-019 |
Hygienic-zone geometry must minimize crevices and inaccessible joints |
major |
Hybrid |
Compliance overlay |
REF-FOOD-ISO |
PSTD-020 |
Hygienic machinery documentation must include cleaning/maintenance information |
major |
Deterministic |
Compliance overlay |
REF-FOOD-ISO |
PSTD-021 |
Additive manufacturing drawings must document AM process and key quality parameters when VDI 3405 is applied |
major |
Deterministic |
Compliance overlay |
REF-ADD-VDI-3405 |
PSTD-022 |
GD&T feature control frames must be syntactically complete per ISO 1101 |
major |
Deterministic |
Compliance overlay |
REF-GPS-2 |
PSTD-023 |
Datum references used in GD&T must be defined per ISO 5459 |
major |
Deterministic |
Compliance overlay |
REF-GPS-6 |
PSTD-024 |
GPS drawings should reference ISO 8015 when ISO GPS rules are intended to apply |
info |
Deterministic |
Compliance overlay |
REF-GPS-1 |
PSTD-025 |
If general tolerances are used, the drawing must reference ISO 2768-1 and the tolerance class |
major |
Deterministic |
Compliance overlay |
REF-GPS-3 |
PSTD-026 |
If ISO 2768-2 is referenced, it must be explicitly dated or migrated because ISO 2768-2 is withdrawn |
major |
Deterministic |
Compliance overlay |
REF-GPS-4 |
PSTD-027 |
Surface texture indications must include parameter/value per ISO 1302 when used |
major |
Deterministic |
Compliance overlay |
REF-GPS-7 |
PSTD-028 |
Metric thread callouts must include tolerance class/position when ISO 965-1 is applied |
major |
Deterministic |
Compliance overlay |
REF-THR-1 |
ROBOT-001 |
Robot-side mounting interface compatibility is declared to ISO 9409-1 intent |
major |
Hybrid |
Compliance overlay |
REF-ROBOT-9409-1 |