{"schema_version":1,"research_id":"eoa_inverse_innovation_exp05_external_evaluation_20260803","source_assessment_id":"deadweight_loss_reduction__robotics_automation:P2:v0","cell_id":"deadweight_loss_reduction__robotics_automation","search_queries":["industrial robot software change validation regression testing change impact analysis functional safety IEC 61508","site:iso.org ISO 10218-2 robot integration validation software changes","site:iec.ch IEC 61508 modification impact analysis validation software","industrial automation change impact analysis regression testing PLC software safety","NIOSH industrial robots workplace fatalities official robot safety 2024","OSHA industrial robot software modification revalidation risk assessment","Ulewicz Vogel-Heuser regression test production automation industrial case study journal","industrial robot manufacturers software update validation change impact risk assessment","site:osha.gov robotics technical manual industrial robot verification validation risk assessment modifications","\"Novel Approach Using Risk Analysis Component\" collaborative robotics DOI","\"current regulations and standards require updates to the risk assessment for every change\" robotics","site:cdc.gov NIOSH robotics fatalities industrial robots 61"],"sources":[{"source_id":"S1","title":"Revised guidance document concerning functional safety of appliances using programmable electronic circuits (61/2586E/INF)","publisher":"International Electrotechnical Commission","url":"https://test-assets.iec.ch/public/tc61/61_2586ee_INF%20Guidance%20on%20functional%20safety.pdf?2022062008=","source_class":"OFFICIAL_GUIDANCE","publication_date":"2017-09-08","accessed_at":"2026-08-03","claims_supported":["Functional-safety modifications should be documented and subjected to impact analysis.","Verification and validation may be scoped to changed modules, affected modules, or the complete system rather than invariably repeating complete validation.","Version identification and traceability are necessary safeguards."]},{"source_id":"S2","title":"ISO 10218-2:2025 — Robotics — Safety requirements — Part 2: Industrial robot applications and robot cells","publisher":"International Organization for Standardization","url":"https://www.iso.org/standard/73934.html","source_class":"STANDARD","publication_date":"2025-02-05","accessed_at":"2026-08-03","claims_supported":["Industrial robot integration, commissioning, operation, and maintenance are governed by application-level safety requirements.","Robot manufacturers, integrators, users, safety bodies, and regulators are intended users of the standard.","The safety purpose includes protection against significant hazards and reasonably foreseeable misuse."]},{"source_id":"S3","title":"OSHA Technical Manual, Section IV, Chapter 4: Industrial Robot Systems and Industrial Robot System Safety","publisher":"Occupational Safety and Health Administration","url":"https://www.osha.gov/otm/section-4-safety-hazards/chapter-4","source_class":"GOVERNMENT_OR_REGULATOR","publication_date":"2022","accessed_at":"2026-08-03","claims_supported":["Unexpected program changes, software faults, interfacing errors, and hidden safety configurations can create worker hazards.","Robot risk assessments should be reviewed when applications change, and formal verification and validation are crucial.","OSHA identifies employers, integrators, operators, maintainers, and trained safety professionals as responsible participants.","Modified tasks require task-based risk assessment, and safety-related software must be tested against applicable ISO requirements."]},{"source_id":"S4","title":"Robotics in the Workplace: An Overview","publisher":"National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention","url":"https://www.cdc.gov/niosh/robotics/about/index.html","source_class":"GOVERNMENT_OR_REGULATOR","publication_date":"2024-02-09","accessed_at":"2026-08-03","claims_supported":["Robot safety is consequential: NIOSH identified 41 U.S. robot-related workplace fatalities during 1992–2017.","Workplace robot use is growing while knowledge gaps remain.","Unexpected contact, crushing, trapping, and other hazards require continuing attention as applications change."]},{"source_id":"S5","title":"Validate the Project — GuardLogix 5580 and Compact GuardLogix 5580 Safety Controllers","publisher":"Rockwell Automation","url":"https://www.rockwellautomation.com/en-ie/docs/technical/logix5000/_online/1756-rm012/guardlogix-5580-and-compact-guardlogix-5580-safety/safety-applications/commissioning-lifecycle/validate-the-project.html","source_class":"OFFICIAL_PRODUCT_DOCUMENTATION","publication_date":"n.d.","accessed_at":"2026-08-03","claims_supported":["Certified functional-safety modifications require documented impact analysis.","The appropriate hardware and software revalidation level should follow the impact analysis.","Unchanged elements may be excluded where the validation plan permits, reducing certification effort.","Hardware, firmware, installation, wiring, network, safety-signature, and configuration identity constrain evidence reuse."]},{"source_id":"S6","title":"SWE-191 — Software Regression Testing","publisher":"National Aeronautics and Space Administration","url":"https://swehb.nasa.gov/spaces/SWEHBVD/pages/102695526/SWE-191%2B-%2BSoftware%2BRegression%2BTesting","source_class":"OFFICIAL_GUIDANCE","publication_date":"n.d.","accessed_at":"2026-08-03","claims_supported":["Exhaustive whole-system regression can be prohibitively expensive and time-consuming for complex systems.","Change-impact analysis, dependency tracing, criticality, and risk can guide regression-test selection.","Safety-critical affected areas still warrant comprehensive safety testing.","Safe selection requires defined conditions and careful balancing of missed-defect risk against testing resources."]},{"source_id":"S7","title":"An Industrial Survey of Safety Evidence Change Impact Analysis Practice","publisher":"IEEE Transactions on Software Engineering; repository record published by RISE Research Institutes of Sweden","url":"https://ri.diva-portal.org/smash/record.jsf?pid=diva2%3A1043624","source_class":"PRIMARY_RESEARCH","publication_date":"2016","accessed_at":"2026-08-03","claims_supported":["Safety-evidence change-impact analysis is practiced across multiple safety-critical domains.","A survey obtained 97 valid responses across 16 domains, 28 countries, and 47 safety standards.","Automation was low and insufficient tool support was the most frequently reported challenge.","Safety artefacts co-evolve, making narrow impact boundaries difficult to establish reliably."]},{"source_id":"S8","title":"Novel Approach Using Risk Analysis Component to Continuously Update Collaborative Robotics Applications in the Smart, Connected Factory Model","publisher":"Applied Sciences; record hosted by the German Aerospace Center","url":"https://elib.dlr.de/194561/","source_class":"PRIMARY_RESEARCH","publication_date":"2022-06-01","accessed_at":"2026-08-03","claims_supported":["Flexible collaborative-robot applications face a burdensome need to update risk assessments when components, parts, or interactions change.","A software tool already detects application changes and directs safety experts to affected risk-assessment content.","A user study reported better usability and fewer omission errors than the existing method.","The tool preserves expert review and formal change-management responsibility."]}],"problem_evidence":{"support":"MODERATE","rationale":"The broader problem is visible: exhaustive regression is costly, safety-evidence impact analysis is labor-intensive and poorly automated, and frequent robot-application changes complicate risk-assessment maintenance. Worker harm makes validation consequential. However, no source verifies the candidate's specific premise that an identifiable industrial site requires complete physical revalidation for every diagnostic, logging, or interface-only change. Rockwell, NASA, and IEC guidance instead already endorse impact-based scope, so the alleged blanket rule may be a local implementation defect rather than a general industry wedge.","source_ids":["S3","S4","S5","S6","S7","S8"]},"stakeholder_evidence":{"support":"MODERATE","rationale":"Identifiable adopters and authorizers include industrial employers, robot integrators, functional-safety owners, and safety-system users. Rockwell expressly instructs its users to choose revalidation scope from impact analysis; OSHA assigns employers and integrators risk-assessment and validation responsibilities; the industrial survey reports inadequate tool support; and the robotics user study reports usability and omission benefits. No named plant, change-control board, or funder has expressed demand for this exact proposed pilot.","source_ids":["S2","S3","S5","S7","S8"]},"prior_art":{"proximity":"ESTABLISHED_PRACTICE","closest_analogues":[{"name":"IEC modification impact analysis and tiered revalidation","similarity":"It requires a modification request, hazard-impact analysis, specified verification and validation, documentation, and permits re-verification of changed or affected modules or complete-system revalidation.","remaining_difference":"The candidate packages this established logic as a one-platform shadow review, adds explicit exclusions, independent dual review, monitoring, expiry, and rollback.","source_ids":["S1"]},{"name":"Rockwell GuardLogix impact-based revalidation","similarity":"It directly instructs safety-system owners to analyze each change, identify modified safety elements, choose an appropriate revalidation level, and avoid revalidating unchanged elements when the plan permits.","remaining_difference":"It is controller-product guidance rather than a complete industrial-robot site governance workflow with two reviewers and affected-party monitoring.","source_ids":["S5"]},{"name":"NASA risk-based regression-test selection","similarity":"It uses change impact, dependencies, criticality, traceability, and safe test-selection methods to avoid prohibitively expensive exhaustive regression while retaining comprehensive safety testing in affected critical areas.","remaining_difference":"It concerns mission software generally, not physical industrial-robot validation, worker-safety authority, or robot-instance configuration identity.","source_ids":["S6"]},{"name":"Connected-factory collaborative-robot risk-analysis component","similarity":"It detects changes to robot applications, highlights affected risk-assessment content, supports formal change management, and retains safety-expert review; it was evaluated with users.","remaining_difference":"It updates risk assessments rather than formally authorizing reduced physical regression-test scope and does not test the proposed retrospective dual-classification workflow.","source_ids":["S8"]}],"distinctive_claim_remaining":"Only a local, falsifiable implementation claim remains: for one specified robot platform, a prespecified low-risk change class can be independently classified from configuration-controlled evidence, with high reviewer agreement and no baseline test finding outside the predicted boundary, while requiring materially less total reviewer-plus-robot effort than the existing local pathway. The general concept of impact-scoped revalidation is not distinctive.","confidence":"HIGH"},"implementation_evidence":{"support":"STRONG","rationale":"Impact analysis, traceability, affected-module testing, risk-based regression selection, and configuration-sensitive evidence reuse are technically established. Rockwell documents an operational version of the pathway, and the robotics study demonstrates change-detection support with safety-expert review. Required data are change requests, dependency and configuration records, test specifications, complete-test findings, signatures, firmware/hardware identity, and time records. The first step is legally and operationally low risk because it is read-only. A live route would still require written site authority, applicable-standard review, cybersecurity concurrence, worker safeguards, independent classification, and default-to-full-validation behavior. The principal technical uncertainty is whether the selected platform's timing, shared libraries, communications, and safety/non-safety architecture allow a defensible low-risk boundary.","source_ids":["S1","S3","S5","S6","S7","S8"]},"scores":{"meaningful_impact":{"score":3,"rationale":"Avoided downtime and faster deployment could matter, and the protected outcome is serious worker safety, but the frequency and blocked value of qualifying changes are unmeasured.","source_ids":["S3","S4","S6"]},"stakeholder_pull":{"score":3,"rationale":"Manufacturers, integrators, safety owners, and practitioners visibly need usable change-impact methods, but no named site has requested this exact workflow.","source_ids":["S3","S5","S7","S8"]},"incremental_advantage":{"score":2,"rationale":"The workflow could improve a locally blanket process, but its core advantage over impact-based revalidation guidance and existing change-analysis tools is limited to governance details and local execution.","source_ids":["S1","S5","S6","S8"]},"distinctiveness_plausibility":{"score":1,"rationale":"Impact-scoped verification and revalidation are already documented practice; only a site- and platform-specific performance claim remains.","source_ids":["S1","S5","S6","S8"]},"technical_implementability":{"score":4,"rationale":"The dossier, traceability, shadow classification, targeted tests, configuration checks, and escalation rules use established methods. Hidden coupling and incomplete records prevent a maximum score.","source_ids":["S1","S5","S6","S7","S8"]},"adoption_authority_feasibility":{"score":4,"rationale":"An employer's change-control and safety authorities can conduct the read-only review and may govern a bounded pilot, subject to applicable standards and integrator or vendor constraints. Jurisdiction-specific authority was not verified.","source_ids":["S2","S3","S5"]},"evidence_readiness":{"score":3,"rationale":"The retrospective design is ready, but all decisive prevalence, cost, reviewer-agreement, and boundary-miss evidence resides in proprietary site records and cannot be established from public sources.","source_ids":["S5","S7"]},"safety_net_benefit":{"score":4,"rationale":"Independent review, uncertainty-to-full-validation, immutable configuration identity, explicit exclusions, stop authority, and expiry provide a strong safety net. Their effectiveness still requires live governance evidence.","source_ids":["S1","S3","S5","S6"]},"scalability":{"score":3,"rationale":"The method can be replicated, but classifications and evidence reuse are platform-, application-, firmware-, hardware-, and environment-specific, limiting straightforward cross-site scaling.","source_ids":["S2","S3","S5","S7"]}},"score_confidence":"MODERATE","costs":{"first_evidence":{"band_2026_usd":"10K_TO_50K","scope":"Read-only review of up to 12 historical packages, dossier reconstruction, two independent shadow classifications, extraction of test findings and effort, affected-party analysis, and a written decision report.","confidence":"LOW","assumptions":["Approximately 80–200 combined engineering, safety-review, data-extraction, and analysis hours.","Existing records are accessible and do not require major reconstruction.","No production-robot operation, new hardware, or paid certification is included."],"source_ids":["S5","S7"]},"initial_deployment_startup":{"band_2026_usd":"50K_TO_250K","scope":"Design and approve the one-platform pathway, criteria, dossier template, configuration controls, reviewer training, metrics, cybersecurity review, test mapping, audit trail, and rollback procedure.","confidence":"LOW","assumptions":["Existing change-control and test infrastructure can be extended.","One robot platform and one enumerated low-risk class are included.","No major robot software architecture redesign or external certification campaign is required."],"source_ids":["S1","S3","S5","S8"]},"operational_launch":{"band_2026_usd":"250K_TO_1M","scope":"Time-limited live pilot covering governance, targeted and baseline comparator testing, controlled robot downtime, independent review, instrumentation, incident monitoring, operator communication, and evaluation.","confidence":"LOW","assumptions":["Pilot runs on one production platform with a small number of qualifying changes.","Production downtime and specialist reviewer availability dominate resource-equivalent cost.","Full revalidation remains available for every ambiguous or escalated package."],"source_ids":["S3","S5","S6"]},"annual_recurring":{"band_2026_usd":"50K_TO_250K","scope":"Ongoing dossier review, targeted regression execution, periodic full-path audits, reviewer calibration, configuration maintenance, metrics, training, and annual renewal review for one platform.","confidence":"LOW","assumptions":["A modest annual volume of qualifying updates.","No dedicated full-time team or new validation cell.","Periodic sampled full revalidation is retained to detect classifier drift and cumulative interactions."],"source_ids":["S1","S5","S7"]}},"verified_pipeline_gates":{"externally_supported_problem":{"status":"UNCERTAIN","reason":"Public evidence supports costly and difficult change-impact assurance, but not the specific local premise that every low-risk robot change is assigned complete physical revalidation. Existing guidance already permits scoped revalidation.","source_ids":["S5","S6","S7","S8"]},"externally_credible_adopter_or_authorizer":{"status":"YES","reason":"Industrial employers, integrators, functional-safety owners, and safety-system users are identifiable authorizers and adopters; OSHA and ISO assign them safety responsibilities, while Rockwell provides an operational impact-based route.","source_ids":["S2","S3","S5"]},"distinct_testable_incremental_claim":{"status":"YES","reason":"The remaining site-specific claim can be tested through reviewer agreement, boundary misses found by complete tests, total effort, deferred-change incidence, and protected-outcome checks against the existing local pathway.","source_ids":["S5","S6","S7"]},"bounded_next_evidence_step":{"status":"YES","reason":"A non-deployment retrospective review of up to 12 packages with two independent classifiers, baseline-test comparison, and explicit falsifiers is bounded and reversible.","source_ids":["S1","S5","S7"]},"no_unresolved_safety_or_authority_stop":{"status":"YES","reason":"The proposed first step is read-only and changes neither software nor approvals. Any live pilot must retain independent authority, configuration identity, affected-safety testing, and default escalation to complete revalidation.","source_ids":["S1","S3","S5","S6"]},"credible_cost_scope_and_range":{"status":"UNCERTAIN","reason":"Activities and cost drivers can be bounded, but no source supplies site labor rates, package volume, robot downtime value, certification expense, or record-reconstruction effort; all bands are assumption-based.","source_ids":["S5","S7"]}},"next_evidence_step":"Randomly select the most recent 12 completed change packages for one robot platform, or all packages from the prior six months if fewer. Reconstruct a configuration-controlled dossier for each and have two independent functional-safety reviewers classify it using prespecified criteria. Comparator A is the actual local full-revalidation pathway and its test findings; Comparator B is the Rockwell/IEC-style impact-scoped route; a secondary comparator is author-only classification to quantify the value of independence. Measure agreement, classification time, complete versus targeted reviewer and robot time, deferred or batched deployment decisions, configuration discrepancies, and every complete-test finding outside the proposed boundary. Treat ambiguous dependencies as safety-relevant. Falsify advancement if no qualifying change was delayed by the baseline, reviewers cannot reproduce the low-risk class, any omitted baseline test found out-of-bound safety-relevant behavior, total scoped effort is not materially lower, records cannot establish configuration identity, or burden merely shifts to authors or reviewers. Do not change an approval or deploy software during this step.","blocking_evidence":["No external evidence shows that a named site currently sends every robot software or configuration change through complete physical revalidation.","The prevalence and operational value of deferred, batched, or withdrawn low-risk updates are unknown.","Reviewer agreement and the rate at which complete tests reveal effects outside proposed boundaries are unknown for the selected platform.","Loaded labor rates, robot downtime value, package volume, certification costs, and record quality are unavailable.","Applicable jurisdiction, contractual obligations, vendor certification conditions, and the site's exact authority chain have not been verified.","Cumulative interaction risk across multiple individually scoped changes has not been measured."],"research_disposition":"KNOWN_PRACTICE_DIFFUSION","world_novelty_boundary":"World novelty, patentability, freedom to operate, market size, and realized impact were not measured. The search establishes only that impact-based, change-scoped verification and revalidation are already documented in official guidance, first-party product documentation, safety-critical regression practice, and collaborative-robot research. It does not establish whether this exact combination of dual independent shadow classification, one-platform scope, affected-party monitoring, expiry, and rollback has appeared identically elsewhere.","arm":"COMPLETE_PROPOSAL_PORTFOLIO","candidate_version":0,"controller_recommendation":{"action":"STOP_DIFFUSION","repairable":false,"material_progress_observed":true,"progress_targets":["Reframe the work as adoption and local conformance of established impact-based revalidation practice, not as a novel intervention.","Verify from proprietary records whether the local blanket pathway actually exists and quantify qualifying deferred changes before allocating pilot resources.","Map the site procedure explicitly to applicable ISO, IEC, OSHA, vendor, cybersecurity, and configuration-control obligations.","Run the bounded retrospective shadow audit and require reproducible reviewer classifications with zero safety-relevant boundary misses before considering a live pilot.","Produce site-specific cost and incidence estimates, including shifted author and reviewer burden, downtime, worker exposure, and periodic full-audit costs."],"reason":"The core intervention substantially collides with established practice: IEC guidance distinguishes changed-module, affected-module, and complete-system revalidation; Rockwell explicitly tells safety-system users to select revalidation scope by impact and avoid unchanged-element revalidation where permitted; NASA documents risk-based regression selection; and robotics research already supports change-focused risk-assessment updates. The remaining contribution is a local implementation and audit package. The precise local blanket-rule problem and performance of the proposed classifier require proprietary records, but those gaps do not restore conceptual distinctiveness."},"proposal_index":2}