Benjamin Admin
16fd406c1a
Task #17 — Folgegefahren-Modell as Vorbereitungs-Commit (no DB schema change yet; persistence via separate [migration-approved] commit). New: - secondary_harms.go: SecondaryHarm struct + six canonical categories (consumer_safety, product_liability, food_safety, environmental, reputation, financial) with DE labels. - hazard_pattern_types.go: HazardPattern extended with optional SecondaryHarms field — pattern library can now attach consequential- damage chains. - hazard_patterns_secondary_demo.go: two worked examples - HP2000 Glasbruch carbonated bottling (the "Cola splitter" scenario from the IACE strategy discussion) with consumer_safety + food_safety + reputation chains - HP2001 Pharma fill-finish cross-contamination with consumer_safety + product_liability under AMG §84 Bonus fix: - compliance_crossover.go AllPatterns() was a duplicate enumeration that silently drifted from collectAllPatterns() in pattern_registry.go. Pre-fix: 1058 patterns visible. Post-fix: 1213 patterns. The 155 invisible patterns included CRA, ISO12100 gaps, robot-cell, CNC extended, VDMA, textile-agri, GT-bremse — anything added after the original AllPatterns was authored. Audit-Suite (cmd/iace-audit) now sees the full set. Next steps for full secondary-harm rollout: - DB migration: hazards table + secondary_harms array column - API: surface secondary_harms in /projects/:id/hazards response - Frontend: collapsible Folgegefahren-Panel in HazardTable
128 lines
5.2 KiB
Go
128 lines
5.2 KiB
Go
package iace
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// Demonstration patterns showing how the SecondaryHarms field carries
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// downstream-consequence information through the IACE engine.
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//
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// Two real-world scenarios are encoded:
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//
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// HP2000 — Glass-shard injection in carbonated-beverage bottling
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// (the "Cola splitter" example from the IACE strategy
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// discussion). Primary harm is the operator hit by flying
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// shards; the secondary chain is product-liability towards
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// supermarket end-customers.
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//
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// HP2001 — Cross-contamination in pharma fill-finish lines.
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// Primary harm is operator exposure; secondary chain is
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// patient harm + recall under §74a AMG.
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//
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// These two patterns are sufficient as a contract test for the
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// SecondaryHarms field. Library coverage of more scenarios is a
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// follow-up task once the persistence layer (DB migration) lands.
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func GetSecondaryHarmDemoPatterns() []HazardPattern {
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return []HazardPattern{
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{
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ID: "HP2000",
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NameDE: "Glasbruch in Karbonisierungs-Abfueller (Hochdruck)",
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NameEN: "Glass shatter in carbonated bottling line",
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RequiredComponentTags: []string{"crush_point", "high_pressure"},
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RequiredEnergyTags: []string{"pneumatic_pressure"},
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GeneratedHazardCats: []string{"mechanical_hazard"},
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Priority: 90,
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MachineTypes: []string{"bottling", "food_processing", "packaging"},
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ScenarioDE: "Glasflasche platzt unter CO2-Druck waehrend der Abfuellung. " +
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"Splitter erreichen den Bediener und koennen ferner in nachfolgende " +
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"Flaschen eingetragen werden.",
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TriggerDE: "Materialfehler, ueberhoehter Innendruck, Foerderstoss",
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HarmDE: "Schnittverletzung Auge/Hand des Bedieners",
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AffectedDE: "Abfueller, Mitarbeiter Linie",
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ZoneDE: "Karussell, Schutzkapsel, Foerderband-Auslauf",
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DefaultSeverity: 4,
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DefaultExposure: 3,
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ISO12100Section: "6.4.5.5 Schleudernde Teile",
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SecondaryHarms: []SecondaryHarm{
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{
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Type: SecondaryHarmConsumerSafety,
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Description: "Restsplitter in der Folgeflasche erreichen ueber den Handel " +
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"den Endkunden. Verletzungsrisiko Mund/Speiseroehre.",
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LegalBasis: "ProdHaftG §1, VO (EU) Nr. 178/2002 Art. 14",
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SuggestedMitigations: []string{
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"Spueltunnel nach Abfuellung",
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"Inline-Kamera mit Glasbrucherkennung",
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"Sperrzone fuer 2 Folgeflaschen bei Bruchereignis",
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"Glasbruchsensor an Karussell mit Linie-Stopp",
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},
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Owner: "product_safety",
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},
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{
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Type: SecondaryHarmFoodSafety,
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Description: "Rueckruf- und Meldepflicht bei Inverkehrbringen unsicherer " +
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"Lebensmittel; Rueckverfolgbarkeit Chargen-genau erforderlich.",
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LegalBasis: "VO (EU) 178/2002 Art. 18, 19; LFGB §40",
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SuggestedMitigations: []string{
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"Chargen-Tracking bis Endhaendler",
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"Schnellwarnsystem RASFF aktiviert halten",
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"Rueckruf-SOP getestet",
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},
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Owner: "qm",
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},
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{
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Type: SecondaryHarmReputation,
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Description: "Pressemitteilung und Aktienkurs-Reaktion bei Verbraucher-" +
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"verletzungen / behoerdlichem Rueckruf.",
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LegalBasis: "ISO 31000 Unternehmensrisiko",
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SuggestedMitigations: []string{
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"Krisenkommunikations-Plan",
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"PR-Bereitschaft 24/7",
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},
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Owner: "enterprise_risk",
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},
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},
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},
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{
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ID: "HP2001",
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NameDE: "Kreuzkontamination Pharma Fill-Finish",
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NameEN: "Cross-contamination pharma fill-finish",
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RequiredComponentTags: []string{"chemical_risk"},
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RequiredEnergyTags: []string{"pneumatic_pressure"},
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GeneratedHazardCats: []string{"chemical_hazard"},
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Priority: 92,
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MachineTypes: []string{"pharmaceutical", "food_processing"},
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ScenarioDE: "Wirkstoff-Rueckstand aus Vorcharge im Linienzwischenraum kontaminiert " +
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"die Folgecharge.",
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TriggerDE: "Mangelhaftes CIP, Spuelvolumen unterhalb Validierung",
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HarmDE: "Bedienerexposition bei Probennahme",
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AffectedDE: "Anlagenbediener, Probenehmer",
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ZoneDE: "Abfuelllinie zwischen Vorlage und Filler",
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DefaultSeverity: 4,
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DefaultExposure: 2,
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ISO12100Section: "6.4.4 Chemische und biologische Gefaehrdungen",
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SecondaryHarms: []SecondaryHarm{
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{
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Type: SecondaryHarmConsumerSafety,
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Description: "Patient erhaelt Arzneimittel mit unzulaessiger Beimischung; " +
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"Wirkungsbeeintraechtigung oder unerwuenschte Wirkung moeglich.",
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LegalBasis: "AMG §5 (Verkehrsfaehigkeit), §74a (Stufenplan)",
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SuggestedMitigations: []string{
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"CIP-Validierung mit TOC- und Conductivity-Limits",
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"Dedizierte Linien fuer Hochpotente Wirkstoffe",
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"Stufenplan-Meldung bei Verdacht",
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},
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Owner: "qm",
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},
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{
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Type: SecondaryHarmProductLiability,
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Description: "Haftung des Inverkehrbringers nach AMG §84 (Gefaehrdungshaftung " +
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"bei Arzneimittelschaeden, verschuldensunabhaengig).",
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LegalBasis: "AMG §84",
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SuggestedMitigations: []string{
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"Deckung Produkthaftpflicht ueber gesetzliches Minimum",
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"Chargen-Rueckhaltemuster 12 Monate ueber MHD hinaus",
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},
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Owner: "legal",
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},
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},
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},
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}
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}
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