Where your traceability starts today

• How many plants or production lines do you need end-to-end traceability for? Options: 1 line, 2-5 lines, 6-20 lines, More than 20 lines
• Which product families or SKUs create the most recall risk for your team today?
• Walk me through the last time a customer complaint or quality event triggered a lot investigation, what happened and how did your team trace it?
• In that incident, how much of the required genealogy came from automated equipment feeds versus paper or manual logs? Options: Mostly automated feeds, Mixed automated and manual, Mostly manual records, Unknown
• How often do you run an internal recall-simulation or traceability drill today? Options: Quarterly or more, Twice a year, Annually, Never
• Which teams do you include in those drills, and who makes the final call to start a live investigation? Options: Quality/QA, Manufacturing/Operations, IT/OT, Supply chain, Regulatory/Compliance, Other
• Is there any plant, product line, or supply node that must be excluded from scope, and if so would that exclusion prevent a meaningful pilot? Options: All sites available, One site excluded, pilot still viable, Key site excluded, pilot not viable, Unsure

When a recall lands, what actually breaks?

• When a suspect lot surfaces, how long does your team currently take to identify all impacted finished goods across plants? Options: Under 30 minutes, 30–60 minutes, Same day, Multiple days
• What single traceability failure from your last recall would have stopped the investigation from narrowing scope effectively?
• How did that failure affect recall scope, direct cost, or customer exposure, please share numbers or a rough estimate if available?
• Who on your team led the investigation and who escalated to site leadership or corporate?
• Are there suppliers, subcontractors, or contract packing sites that were invisible or delayed during the investigation? Options: Yes, multiple, Yes, one or two, No, Not sure
• Which of these consequences worries your leadership most when traceability fails? Options: Over-broad recalls, Regulatory fines, Customer churn, Production stoppage, Brand reputation, Other

Data capture and equipment fit, reality check

• If labels smear or peel in your process, how many stations still capture lineage without manual input? Options: All critical stations, Most stations, A few stations, None
• Which automatic capture technologies are already in use on your lines? Options: Barcode scanners, RFID readers, Machine vision cameras, Direct part mark readers, PLC signals only, None
• Do your test stands, inspection machines, or weighing systems expose digital outputs we could integrate with? Options: Yes, standard API/OPC or TCP, Yes, but custom adapter required, No, only manual records, Not sure
• Who owns control systems and equipment interface work at each plant, and can that person approve a test connection?
• What would it take in time or budget to add a digital output or retrofit a legacy station so it produces lineage automatically? Options: Under 2 weeks / low cost, 2–8 weeks / moderate cost, More than 8 weeks / high cost, Unclear
• Which stations would you prioritize for automatic capture during a pilot? Select all that apply. Options: Receiving and raw material intake, High-speed assembly, Test/inspection benches, Packaging and serialization, Case packing and palletizing, Shipping
• Which single legacy station, if it cannot provide lineage, would prevent a successful proof of concept for your highest-risk product?

People, shifts, and the human gaps

• Who on your front line is most likely to skip a scan when the line falls behind schedule, and why does that happen?
• Describe the current training regimen and incentives you use to keep operators compliant with scanning and record requirements.
• How many operator actions per minute is a typical station expected to perform during peak production? Options: Under 5 actions/min, 5–15 actions/min, 15–30 actions/min, More than 30 actions/min
• If operator resistance persists after a pilot, what specific decision would stop broader rollout? Options: Stop for redesign, Limit to partial rollout, Cancel project, Other
• What level of operator training investment would you accept for a pilot to prove adoption? Options: 30–60 minutes per operator, 2–4 hours per operator, Half day, Full day or more
• Who is the escalation contact for traceability failures during night or weekend shifts?

The other options on your table

• If your incumbent vendor matched our recall-simulation result exactly, why might you still consider changing systems?
• Select which options you are actively evaluating right now. Options: Remain with current system, Upgrade an MES traceability module, Purchase a barcode-only vendor, Build an internal solution, Evaluate a new traceability vendor, No decision yet
• Which internal capability would have to exist for you to successfully build this without an outside partner? Options: API engineering team, OT/control systems team, Data model and lineage expertise, Integration testing lab, None of the above
• If you chose to keep your current approach, what performance threshold must it meet to avoid replacement? Options: Query time under target, 99% lineage coverage, Zero manual rework, Lower total cost, Other
• Who internally is pushing for build versus buy, and which stakeholders must be convinced to change? Options: Operations leadership, Quality leadership, IT/OT, Finance, Supply chain, Other
• What would have to be true about your current approach for you to stay with it instead of switching?

Integration and infrastructure, can we plug in?

• Which core systems must be integrated during a pilot and which of those provide APIs today?
• Select the system categories that must be connected for a meaningful pilot. Options: ERP / financial system, MES / execution system, WMS / warehouse, LIMS / lab, SCADA / historian, PLC / edge controllers, Custom SQL databases
• Who owns network and firewall rules at each plant and can approve outbound connections for a pilot?
• Are there maintenance windows, auditor visits, or planned shutdowns that would block cutover or testing for a defined period? Options: No constraints, Yes, short windows under 2 weeks, Yes, multi-week blackout, Unsure
• Do you have a sandbox or test endpoint available for integrations, or will we need to test against production systems? Options: Sandbox available, Staging environment only, Must use production, Unknown
• If a required API or digital output is unavailable, would you fund an adapter build or would that prevent the pilot from moving forward? Options: We would fund adapter build, We would not fund, pilot stops, Depends on cost and timeline, Undecided

Regulatory timeboxes and recall response

• What is your target time in minutes to produce a complete genealogy when a recall is declared?
• Select the time target your recall plan requires. Options: 15 minutes, 30 minutes, 60 minutes, Same day, Other
• Which regulatory reports or artifacts must the traceability system generate automatically during an investigation? Options: Lot genealogy report, Chain-of-custody logs, Operator action logs, Material test results, Audit trail for changes, Other
• Who must sign off that the new traceability record becomes the official production record at site level and corporate level?
• If a pilot passes functional tests but cannot meet your regulatory timebox, would you proceed to deployment anyway? Options: Proceed with remediation plan, Delay deployment until timebox met, Cancel deployment, Undecided

Acceptance criteria and the decision path

• If a recall-simulation proves we can narrow scope to within your target, what approvals remain between that result and a signed purchase order?
• Which of the following should count as success for a pilot, select all that apply. Options: Genealogy queries meet time SLA, Complete lineage for 99% of sampled units, No increase in line cycle time, Stable integrations over 2 weeks, Operator adherence above set threshold, Other
• Who are the commercial and legal signatories required to approve terms and a statement of work?
• What budget line or procurement window would you use to fund a pilot and potential rollout this fiscal year? Options: Operational budget, Capital expenditure, Project contingency, Next fiscal year, Undecided
• If the pilot meets the agreed acceptance criteria, who has authority to sign the SOW and when could they sign?

Pilot logistics and next steps

• If we agreed to run a two-week simulation on one production line, what commitments would you need to provide to start within six weeks?
• Which of the following commitments can you provide within six weeks? Options: Dedicated site coordinator 0.2 FTE, Scheduled plant access windows, Integration sandbox or test account, Operator training slots reserved, Budget approval for minor adapters, None of the above
• Who will be the primary point of contact for daily scheduling and coordination during the pilot?
• How do you want pilot success measured operationally, through query SLA, reduction in recall scope, defect rate, or another metric? Options: Query SLA, Recall-scope reduction, Defect/escape rate, Operator compliance, Other
• Would you like a short executive review after the first simulation run to decide next steps and potential rollout timing? Options: Yes, schedule review, Maybe, depending on results, No, use normal cadence

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• Install edge data capture hardware
• Deploy RFID tagging and reader network
• Integrate machine-vision and camera readers
• Install direct-part-mark (DPM) reading systems
• Integrate production equipment and PLCs
• Integrate MES, ERP, and quality systems
• Configure product genealogy and data model
• Implement serialization and lot assignment
• Connect inspection and test equipment
• Migrate existing lot and batch records
• Run recall simulation and trace exercise
• Train operators and quality teams
• Enable offline resilience and data buffering

Install edge data capture hardware

• Which production station IDs or line numbers require new edge hardware installation?
• How many concurrent reads or transactions per second must each edge unit support at peak production? Options: Less than 10, 10-50, 51-200, More than 200
• Identify the existing physical mounting constraints at each station (cabinet space, DIN rail, ambient temperature range).
• List the available local interfaces at the station for edge hardware (digital I/O, RS-232/RS-485, Ethernet, OPC-UA). Options: Digital I/O, RS-232/RS-485, Ethernet, OPC-UA, Other
• Provide the required ingress protection (IP) rating or washdown classification for devices at each station. Options: No special rating, IP54, IP65, IP66+, Specify in free response
• Describe available onsite resources for electrical and network drops versus work that will require third-party site work.
• Who is the plant contact authorized to approve lockout/tagout (LOTO) and machine access for installation?

Deploy RFID tagging and reader network

• Which product families or SKUs will use RFID tags instead of barcode labels?
• How many read points per line are required to achieve full material flow coverage? Options: 1-2, 3-5, 6-10, More than 10
• Identify the RFID tag form factors needed (on-package wet inlay, UHF rugged tag, metal-mount tag) and where they will be applied. Options: Wet inlay, UHF rugged tag, Metal-mount tag, Other
• List environmental conditions affecting RFID performance at read points (metal, liquids, distance, forklift traffic).
• Provide the expected tag identifier scheme (EPC structure or custom lot/serial format) and maximum identifier length.
• Specify whether antenna diversity or shielding will be required to avoid cross-reads between adjacent lines. Options: No, Yes — specify locations, Assess during site survey
• Who will manage tag inventory and tag-programming at receiving or kitting?

Integrate machine-vision and camera readers

• Which station IDs require machine-vision reads for codes, seal checks, or visual inspection?
• How many unique camera models or readers are currently in use where integration is required? Options: 1, 2-3, 4-10, More than 10
• Identify the camera output format(s) available at each station (decoded string output, image file, JSON over HTTP). Options: Decoded string output, Image files, JSON/API, Other
• Describe the code conditions that fail automatic reads (smear, partial print, orientation) and acceptable error thresholds.
• Provide the target latency for a read-to-system round trip at the camera station in milliseconds. Options: <100 ms, 100-500 ms, 500-2000 ms, >2000 ms
• Who is responsible for camera calibration and field of view adjustments during deployment?

Install direct-part-mark (DPM) reading systems

• Which part numbers or substrate materials require DPM reading (metal stamp, laser etch, dot-peen)?
• How many parts per minute must the DPM reader decode at peak throughput? Options: Less than 10, 10-50, 51-200, Over 200
• Identify acceptable mark quality levels and whether 1D/2D or OCR will be required for the DPM marks. Options: 1D, 2D (DataMatrix), OCR, Mixed
• List any finish treatments (coatings, anodizing) that affect mark contrast and may need special imaging settings.
• Provide the required mounting footprint and access constraints for the DPM hardware at each station.
• Who will own verification of DPM read rates during the acceptance run?

Integrate production equipment and PLCs

• Which PLC models and firmware versions are installed on the lines to be integrated?
• How many distinct PLC tags or machine signals must be mapped into the traceability events (e.g., lot_in, lot_out, cycle_complete)? Options: 1-10, 11-50, 51-200, More than 200
• Name the available connectivity protocols on the PLCs (Modbus TCP, OPC-UA, Ethernet/IP, Custom TCP). Options: Modbus TCP, OPC-UA, Ethernet/IP, Custom TCP, Other
• Specify whether the PLCs can host additional logic for tag injection or if a separate edge controller is required. Options: PLC can host logic, Edge controller required, Undecided — assess during PoC
• Indicate expected cycle times and whether trace events must be generated synchronously with each cycle. Options: Synchronous per cycle, Aggregated per batch, Hybrid
• Identify who will provide PLC ladder access and any credentials required for integration testing.

Integrate MES, ERP, and quality systems

• Which enterprise systems must be integrated (your MES transaction types, ERP inbound receipts, quality test result tables)?
• How many API endpoints or integration interfaces does each system expose for read/write (provide counts or names)?
• List the key document types and transactions to exchange (ASN, goods receipt, lot creation, CAPA records).
• Specify the expected data freshness for each integration (real-time, near real-time under 5 minutes, hourly batch). Options: Real-time, Under 5 minutes, Hourly, Daily
• Identify authentication method supported by each system (OAuth2, API key, basic auth, VPN). Options: OAuth2, API key, Basic auth, VPN/IP allowlist, Other
• Who is the IT owner for each enterprise system to coordinate test credentials and sandbox access?

Configure product genealogy and data model

• Which finished SKUs and their bill-of-material (BOM) depth must be represented in the genealogy (levels from component raw material to finished unit)?
• Describe the lot and serial identifier formats you use today (example: GTIN + 10-digit lot + MMYY).
• Specify the minimum sample of SKUs and production dates for which genealogy must be validated during acceptance. Options: Top 5 SKUs by volume, All SKUs from last 30 days, Custom — describe in free response
• Indicate required query SLAs for recall investigations (maximum time to return complete upstream genealogy for a finished lot). Options: Under 5 minutes, Under 30 minutes, Under 2 hours
• What are measurable acceptance criteria that will confirm the data model captures parent-child links and process parameters required for regulatory recall responses? Options: 100% parent-child links in sampled traces, Genealogy query returns within agreed SLA, Both of the above, Custom — describe
• Identify any regulatory record elements that must be stored with the genealogy (e.g., lot disposition code, quarantine flag, CCP timestamps).

Implement serialization and lot assignment

• Which SKUs require unit-level serialization versus lot-level assignment? Options: Unit-level serialization, Lot-level only, Mixed — specify SKUs
• How is lot numbering currently assigned at receiving and at the start of production (manual, MES-generated, ERP-assigned)? Options: Manual, MES-generated, ERP-assigned, Other
• Specify the serialization format and encoding requirements (human-readable, 2D DataMatrix, EPC URI) for each SKU.
• Estimate daily volumes of serialized units to size printing and verification stations. Options: Less than 1k, 1k-10k, 10k-100k, More than 100k
• How will you verify serialization correctness during acceptance (single-unit read pass rate threshold)? Options: 98% read rate, 99.5% read rate, 100% for sampled run, Custom — specify
• Who owns printed label quality validation and replacement thresholds on the production floor?

Connect inspection and test equipment

• Which inspection or test systems must feed results into trace records (AOI, functional testers, torque testers)?
• Name the output formats available from each test system (CSV, XML, REST API, database table). Options: CSV, XML, REST API/JSON, Database export, Other
• Detail the mapping between test result fields and the traceability data model (pass/fail, measurement values, operator ID).
• Indicate whether test equipment can attach lot or serial identifiers to results at source or require middleware to correlate results. Options: Attach at source, Requires middleware, Unknown — assess during PoC
• Provide acceptable data retention for test results associated with trace events (days, months, years). Options: 90 days, 1 year, 3 years, Custom — specify
• Who will sign off on test equipment integration verification during site acceptance?

Migrate existing lot and batch records

• Which historical systems hold the lot and batch records to be migrated (paper records, MES batch DB, ERP batch tables)? Options: Paper, MES database, ERP batch tables, Other
• How many historical records are in scope for migration and what date range must be covered? Options: Last 30 days, Last 6 months, Last 2 years, All records
• List required data fields that must survive migration for recall readiness (raw material lot, supplier lot, production timestamp, operator ID).
• Specify the acceptable data quality thresholds post-migration (completeness percentage, allowed nulls per field). Options: 95% complete, 99% complete, 100% for critical fields, Custom — specify

• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Subscription Order Form
• Hardware and Equipment Order Confirmation
• Service Level Agreement (SLA)
• Data Processing Agreement (DPA)
• Regulatory Compliance Addendum (conditional)
• Acceptance Test Plan and Sign-Off Certificate
• Change Order Agreement
• Payment Schedule Agreement

• Go-live Health Check (weeks 1-4)
• First Measurement Review (weeks 4-10)
• Acceptance Gate Review (around day 90)
• Quarterly Success Review (ongoing)

• Document agreed enhancement priorities and include acceptance criteria aligned to Solution Scope targets.
• Restate acceptance criteria and numeric targets
• Produce a documented pass or fail for each Solution Scope acceptance criterion with the decision recorded.
• Capture remediation tasks and deadlines for any failed criteria so the loop is closed before ongoing success reviews.
• Confirm the incumbent system is either decommissioned or formally retained read-only and that data migration/archival tasks are complete or scheduled.
• Record the acceptance decision and associated signatory in the project record.
• Create and publish the remediation plan for any failed acceptance criteria with verification steps and deadlines.
• Execute final data migration or archival steps and publish confirmation that the incumbent is decommissioned or retained read-only.
• Periodic health summary
• Validate that recall-simulation pass rate and integration uptime remain at or above the Solution Scope targets or have a remediation plan in place.
• Reduce the count of high-priority open incidents and validate progress against resolution timelines.
• Triage enhancement requests into agreed workstreams with clear acceptance criteria and expected delivery windows.
• Publish the quarterly health dashboard showing the named metrics and trendlines for the shared channel.
• Open or update tickets for high-priority incidents with revised target dates and verification steps.
• Re-confirm success criteria and owners
• All deployment acceptance criteria from the Solution Scope are re-confirmed with named owners.
• High-severity issues are identified, prioritized, and assigned with target resolution dates.
• A short-term remediation plan is agreed to stabilize operations before the first measurement review.
• Publish the go-live issue log with owners and target resolution dates to the shared channel.
• Enable or tune monitoring alerts for integration error rates and hardware station heartbeat signals.
• Schedule operator refresher sessions for any stations showing low activity or frequent errors.
• Present first-period results against targets
• Determine whether average genealogy query time and operator data-capture completeness are trending toward the Solution Scope targets.
• Identify root causes for each metric that is off-target and commit corrective actions with deadlines.
• Confirm a realistic timeline to the acceptance gate or escalate timeline risk if needed.
• Open remediation tickets for each off-target metric with clear success criteria and due dates.
• Implement query performance tuning or caching changes identified during diagnosis.
• Run targeted operator training sessions focused on the specific data-capture steps showing incomplete coverage.
• Deployment and migration validation
• Open incidents and ticket burn-down
• Root-cause diagnosis for any metric gaps
• Present outcome data against each criterion
• Agree corrective actions with dates
• Document pass or fail per criterion and record decision
• Enhancement and change request triage
• Early adoption signals and usage patterns
• Confirm readiness timeline to the acceptance gate
• Blockers and open issues
• Agree remediation plan for any failed criteria
• Action agreement and next review timing
• Incumbent system wind-down and data archive confirmation
• Agree immediate remediation actions