Start Here: Your Role in the Room

• What's your title and primary responsibility for recalls and traceability? Options: Quality Director/Manager, VP/Head of Food Safety, General Counsel/Legal, Operations/Plant Manager, Supply Chain/Distribution Lead, CEO/Executive Sponsor, Other
• How large is your company by revenue and number of SKUs? Options: < $50M / < 500 SKUs, $50M–$250M / 500–2,000 SKUs, $250M–$1B / 2,000–10,000 SKUs, > $1B / >10,000 SKUs, Prefer not to say
• How often has your team run a full mock recall in the last 24 months? Options: Never, Once, Twice, Annually (every year), Multiple times per year
• Who would be directly involved from your side during a discovery and pilot (names/titles)?
• Briefly describe a recent recall, near-miss, or audit finding that still matters to you.

If a Recall Happened Today, What Would Surprise You?

• What’s one thing about your current traceability that you suspect would surprise a regulator or your CEO in a live recall?
• How quickly could you currently identify all affected lots after a hazard trigger? Options: Under 4 hours, 4–24 hours, 24–72 hours, More than 72 hours, We don’t know
• Which systems and records hold your lot and movement data today? Options: ERP (e.g., SAP, Oracle), WMS, MES/line control, LIMS, 3PL / co-packer portal, EDI / trading partner records, Manual spreadsheets / paper, Other
• Walk me through — in one paragraph — what happens from ingredient receipt to finished-goods shipment for a single lot.
• Where in that flow do you most frequently lose traceability or visibility? Options: Batch consolidation/recipe blending, Co-packer / 3PL handoffs, Packaging/labeling errors, ERP/WMS integration gaps, Inbound supplier lot data missing, Customer shipment allocation unknown, Other

Where Does the Pain Hurt the Most?

• If you had to name the single failure that keeps you awake about recalls, what would it be?
• How often do communication breakdowns between Quality, Operations, and Sales occur during an incident? Options: Almost always, Often, Sometimes, Rarely, Never
• How frequently have you ended up over-recalling product because traceability wasn't granular enough? Options: Multiple times, Once, Rarely, Never, Not sure
• What are the top data or process gaps that prevent true one-up/one-down traceability at your sites? Options: No lot-level identifiers at receiving, Mixed-batch production without lineage, No serialized packaging data, Delayed shipment records from 3PLs, ERP/WMS fields not populated, Lack of timestamped location records, Other
• Tell a short story of a trace exercise that took longer or failed — what happened and what were the consequences?
• How do these traceability failures show up externally (regulatory findings, customer complaints, insurance/legal exposure)? Options: Regulatory inspection findings, Customer chargebacks/penalties, Rejected deliveries / lost accounts, Insurance or legal claims, Reputational/brand damage, No external consequences yet

What Are You Willing to Risk to Avoid This?

• If guaranteed a 1–4 hour end-to-end trace capability, how much operational disruption or budget are you willing to accept to get there? Options: Significant budget and planned downtime (>1 month), Moderate investment with phased cutover (weeks), Small incremental investment with no downtime, Only pilot/proof-of-value — we’re risk-averse, Unsure / need guidance
• What recall trace SLA would your leadership consider acceptable (time to identify and notify affected customers)? Options: Under 4 hours, 4–24 hours, 24–72 hours, Longer than 72 hours / not defined
• Which business consequences make traceability improvements non-negotiable for you? Options: Regulatory fines / enforcement, Customer contract loss, Litigation / liability, Major brand damage, Operational stoppage, Board/CEO scrutiny
• Who must approve investments in traceability improvements at your company (titles/functions)? Options: Quality Director, VP Food Safety, General Counsel, CFO/Procurement, COO/Operations, CEO/Board, Other
• How would you quantify ROI or success for a traceability program in the first 12 months?

Imagine a Recall That Doesn't Break You

• What would be the first tangible sign inside your company that a recall was handled flawlessly?
• Which measurable signals would prove to you the solution is working? Options: Trace speed (time to identify), Recall scope accuracy (% correct SKUs/lots), Percentage of product recovered, Customer notification SLA met, Root cause identified within SLA, Successful regulatory audit
• What operational or regulatory constraints must any solution respect (e.g., blackout windows, data residency, audit trails)?
• Who across Quality, Ops, and Legal would need to publicly endorse the outcome, and what would relief sound like to each?
• Which system integrations are absolute must-haves to realize this vision? Options: ERP (specify), WMS (specify), MES, 3PL portals / APIs, LIMS, EDI connections, Spreadsheets (if unavoidable), Other

What Would Success Look Like for Each Team?

• If Quality defined one line of acceptance criteria for a successful engagement, what would it read?
• If Operations wrote one success line about minimal disruption and handoffs, what would it be?
• If Legal wrote one line about liability and auditability they would require, what would it say?
• How should incident response roles be assigned across teams in an actual recall (who owns what)? Options: Quality Incident Lead, Operations Incident Lead, Plant Manager, General Counsel / Legal, Corporate Communications, Third-party recall vendor, External counsel
• Which vendor SLAs would you hold as contract requirements (select top priorities)? Options: Trace speed SLA, System uptime/availability, Support response time, Remediation deliverables & timelines, Annual mock recall cadence, Data security & access controls
• Are there any absolute dealbreakers or non-negotiable terms you need to see in a partner agreement?

What Would Make You Pull the Trigger?

• What single outcome, guarantee, or proof point would convince you to choose a partner today?
• Would you prefer to start with a paid mock recall, a traceability audit, or a small pilot? Which is most persuasive? Options: Paid mock recall (full test), Traceability audit & gap analysis, Pilot integration with one SKU/site, Proof-of-value workshop, Other
• How soon after agreement would you want the first pilot or mock recall to run? Options: 0–30 days, 31–60 days, 61–90 days, In 3–6 months, Depends on internal approvals
• What internal readiness signals do you need to see before starting (data access, IT resources, plant availability, budget)? Options: ERP/WMS data access, Test datasets available, Plant operations window, Assigned project owner, Budget approval, Executive sponsor
• Who are the decision makers and what is their expected timeline for a procurement decision?
• Which commercial or technical concerns do you want explicitly addressed in a proposal? Options: Liability & indemnity, Data security & privacy, Integration approach and timeline, Detailed SLAs & penalties, Training & change management, References and case studies
• Is there anything else — or any internal politics — we should understand so we can prepare a proposal that actually gets approved?

Quick Check: Where Are We Starting?

• In one sentence, how do you currently track a lot from raw ingredient receipt through finished goods shipping?
• Which systems currently hold the definitive lot record for items you manufacture or distribute? Options: ERP, WMS, MES/SCADA, LIMS, Standalone recall system, Spreadsheets (Excel/Google Sheets), Paper records, 3PL/Distributor system, Other
• Which teams update lot status day-to-day (who touches lot data operationally)? Options: Production/Manufacturing, Quality/QA, Warehouse/Shipping, Procurement, Lab/Testing, Customer Service, IT, Regulatory/Compliance, Other
• Approximately how many SKUs and active lot records does your organization manage at any given time? (brief estimate)
• How often do you reconcile lot information across systems (ERP vs WMS vs spreadsheets)? Options: Daily, Weekly, Monthly, Quarterly, Rarely/Never, Don't know

Is Your Lot Number Really Finding the Lot?

• When you ask to 'find all affected lots' today, does your lot number chain connect ingredient batches, processing steps, and finished goods without manual heroics? Options: Yes — automated linkage exists, Mostly — some manual joins required, No — significant manual effort, We don't attempt full chains
• What level of lot granularity do you currently maintain as a rule (pick the closest)? Options: Ingredient-batch level, Processing-lot/shift level, Finished-goods lot only, Pallet-level, Carton-level, Serial/unit level, Varies by product
• Describe a recent situation where lot ambiguity slowed a recall, investigation, or customer response—what delayed resolution and how did it feel internally?
• Which manual steps or people are required to join ingredient-to-finished-goods lot chains today? Options: Spreadsheet joins, Phone calls between sites, Handwritten batch records, ERP exports + manual matching, Barcode scanning but manual reconciliation, Third-party data requests, Other
• How confident are you that you could execute one-up/one-down traces within your desired timeframe? Options: Highly confident, Somewhat confident, Not confident, We don't have a target timeframe

Who's Actually Holding the Knowledge?

• If your lead quality person was unavailable during an incident, could someone else run a complete trace to FDA expectations? Options: Yes — backup trained, Partially — would be slow, No — single point of failure, We haven't tested this
• Who is formally responsible for the recall SOP and yearly mock recall sign-off? Options: Quality Director, VP Food Safety, Operations/Plant Manager, General Counsel, Combined committee, No formal owner
• List the primary internal roles (not names) you would route data or approvals through during a trace (e.g., IT for exports, Legal for notifications).
• How often do table-top or mock recall exercises include IT, Operations, and Legal together? Options: Monthly, Quarterly, Bi-annual, Annual, Rarely/Never
• Who typically makes the call on recall scope (e.g., lot vs product vs shipment) in your current process? Options: Quality, Legal/GC, Operations, Incident Response Team, Executive leadership, Combined approval

If a Recall Hit Today, Could You...?

• Could you map every customer, pallet, and carton that received an affected lot within 24 hours without calling ten people? Options: Yes — easily, Yes — with effort, No — would require many calls, No — not possible currently
• What is your typical end-to-end trace time in a simulated recall (from trigger to list of affected customers)? Options: Under 1 hour, 1–4 hours, 4–8 hours, 8–24 hours, 24–72 hours, More than 72 hours, We don't measure
• When you've run mock recalls, what percentage of records returned are complete and usable without manual cleanup? Options: >95%, 80–95%, 50–80%, 20–50%, <20%, Not tracked
• How do you identify downstream customers and distributors from your shipping records today (describe the practical steps)?
• Have you ever over-recalled because traceability was uncertain? If yes, what happened and what was the impact? Options: Yes — significant impact, Yes — minor impact, No — never, Don't know

Where Do Systems Drop the Ball?

• Which single system would cause the most damage to a trace if it were unavailable or inaccurate? Options: ERP, WMS, MES, Standalone spreadsheets, LIMS, 3PL/Distributor system, Other
• Which systems currently share lot-level data via integrations you rely on? Options: ERP, WMS, MES, LIMS, CRM, TMS, EDI trading partner feeds, Third-party logistics 3PL, None
• How are lot IDs passed between systems in practice? Options: Barcode/scan-driven, Manual key-in, API/real-time integration, Scheduled file exports (CSV/Excel), EDI, Paper transfer
• How would you describe your integration maturity between critical systems (data timeliness and automation)? Options: Automated real-time, Automated batch, Semi-automated with manual steps, Manual exports and reconciliation, No integration
• Where do you see the most frequent data mismatches (example: lot format, truncated IDs, missing ship-to fields)?

What Conversations Break Down Under Pressure?

• When an incident happens, which handoff between teams becomes the bottleneck more often than not? Options: Production to Quality, Quality to Legal, Quality to IT/data, Warehouse to Distribution, Customer communications handoff, Other
• How are customers and trading partners notified of recalls today (select all that apply)? Options: Email templates, Phone calls, Customer portal message, EDI/ASN notifications, Postal letters, Distributor-managed notifications, Ad-hoc outreach
• Who approves outbound customer communications during a recall before they are sent? Options: Legal/GC, Quality, Communications/PR, Operations, Executive leadership, Cross-functional approval
• Do you have pre-approved communication templates and contact lists for all major customers and distributors? Options: Yes — complete and current, Partial coverage, Templates exist but contacts incomplete, No — nothing ready
• Describe a recent communication delay or failure during an elevated issue—what broke down and what was the downstream impact?

Hidden Gaps You’ve Learned to Live With

• What traceability compromises have you quietly accepted because 'that's how manufacturing is' in your operations?
• Are there product lines, plants, or distribution channels you consider 'hard to trace'? Options: Yes — specific plants, Yes — specific SKUs/product lines, Yes — specific channels (3PL/retail transfers), No — all are traceable
• Which stages most commonly lose lot linkage (select all that apply)? Options: Receiving/raw materials, Processing/blending, Packaging/line changeover, Warehouse consolidation, Distribution/3PL handoff, Retail transfer
• Have supplier lot records been insufficient to connect to your finished goods before? How often? Options: Often, Sometimes, Rarely, Never, We don't exchange supplier lot detail
• What manual workarounds keep you operational today but undermine auditability or speed in a real recall?
• How long has your single biggest known traceability gap existed? Options: Less than 6 months, 6–12 months, 1–3 years, More than 3 years, Unsure

What Would 'Good' Actually Feel Like?

• If traceability were a competitive advantage at an audit or with a major customer, what would you want to be able to demonstrate quickly?
• Which measurable success signals matter most to you for a traceability program? Options: Trace speed (time to identify affected product), Recall scope accuracy (false positive rate), % of impacted product identified, % of product recovered, Customer communication SLA, Audit readiness
• What SLA for full forward+back trace time would satisfy legal and quality leadership? Options: Under 1 hour, 1–4 hours, 4–12 hours, 12–24 hours, 24–72 hours
• What minimum lot granularity would eliminate your most costly recall exposures (ingredient batch → carton/pallet level)? Options: Ingredient batch link to finished goods, Processing-lot with shift traceability, Finished-goods lot/pallet level, Carton-level, Serial/unit-level
• How would improved traceability change regulatory, legal, or operational risk in concrete terms?
• Which ROI metrics would leadership use to justify investment in fixing traceability gaps? Options: Reduced recall cost, Lower liability exposure, Faster regulatory responses, Improved customer retention, Insurance premium benefits, Operational efficiency

What Would It Take to Close the Gap?

• If you had a guaranteed 90‑day roadmap to close your top traceability gap, what would you book on calendars first?
• Which resources would you realistically commit to a remediation effort? Options: Dedicated project manager, IT integration budget, External consultants, Plant-level champions/operators, Legal review and approvals, Training budget, 3PL/supplier onboarding resources
• Which integration points would you prioritize (select all that must be fixed first)? Options: ERP ↔ WMS, ERP ↔ MES, ERP ↔ LIMS, EDI with distributors/customers, 3PL system integrations, Supplier data feeds
• What is the single biggest internal barrier to making the necessary changes? Options: Budget constraints, IT bandwidth/capability, Cultural resistance at plant level, Competing strategic priorities, Supplier/3PL cooperation, Regulatory uncertainty
• How quickly could you run a full, integrated mock recall if the integrations and data were in place? Options: This week, Within 30 days, 30–90 days, 3–6 months, More than 6 months, Unsure
• Who (roles) needs to sign off to start remediation and pilot work?

Next Steps — Let's Make This Concrete

• What would make you confident enough to commit to a pilot: demonstrable results, legal risk control, or predictable pricing? Options: Demonstrable trace results, Clear legal/risk mitigation, Predictable cost/price, Minimal operational disruption, Other
• Would you be willing to share a sample dataset (anonymized or limited) to run a scoped mock recall? Options: Yes — anonymized full dataset, Yes — limited fields only, Yes — but need NDA, No
• Preferred timeline to schedule an initial traceability workshop? Options: Within 1 week, 1–2 weeks, 2–4 weeks, 1–3 months, Later/unsure
• Which KPIs should we include in the pilot acceptance criteria (select top priorities)? Options: Trace time to full list, Accuracy of identified impacted product, % of impacted product located, Time to customer notification, Data completeness across systems, Successful mock recall execution
• Are there immediate constraints, compliance issues, or supplier sensitivities we should know before drafting a remediation plan?
• Who else from your organization should be included in the discovery and pilot conversations (roles and best contact method)?

Quick Win: What’s Already in Place?

• Who are the 1–3 people we should expect to work with most during deployment (names, roles, best contact method)?
• What ERP and WMS do you run in production today? Options: SAP ECC / S/4HANA, Oracle E-Business Suite / Cloud, Microsoft Dynamics 365 / AX, NetSuite, Infor, Custom / Homegrown, Other
• Do you currently capture lot-level identifiers for finished goods and key ingredients? Options: Yes — finished goods and ingredients, Yes — finished goods only, Yes — ingredients only, Not consistently, No
• Have you run a full mock recall in the last 12 months? Options: Within 3 months, 3–12 months ago, More than 12 months, Never
• If you’ve done mock recalls, what was the single biggest lesson learned (brief example)?

Would Your Data Survive a Real Recall?

• If regulators showed up tomorrow asking for every lot produced in the last 30 days, how confident are you that you could produce an accurate list within the FDA-recommended timeframe? Options: Very confident, Somewhat confident, Not confident, We haven't measured
• Where are your canonical lot and traceability records stored (select all that apply)? Options: ERP batch tables, WMS lot module, Shop-floor MES, Manual logs / spreadsheets, Third-party trace system, Other
• Describe any known gaps in the required fields for a trace (lot ID, timestamp, quantity, source lot) and how often they occur.
• What is the timestamp resolution on production events (e.g., to the minute, hour, only production date)? Options: Second-level, Minute-level, Hour-level, Date only, Varies by system
• Can we get a sample extract of 30–90 days of trace data to validate schema and quality before integration? Options: Yes — full extract available, Yes — partial/sample available, Need to prepare, No — not possible

Who Would You Trust at 2 AM?

• When a trace is needed outside business hours, who is empowered to run it and notify customers? Options: Quality Director, Plant Manager, Operations Manager, Dedicated Recall Lead, Legal signs off before notification, No defined after-hours owner
• Do the people who own traceability have direct system access to run queries, or do they rely on IT/BI to pull reports? Options: Direct access — Quality/Operations, Rely on IT/BI, Hybrid (some direct, some via IT), No access defined
• How do you currently escalate a suspected contamination event (steps, channels, legal notification threshold)?
• Who must be included on customer notification approvals (legal, CEO, quality, sales)? Please list roles required for approval. Options: General Counsel, Quality Director, VP Operations, CEO / Exec Sponsor, Sales/Customer Success, Other
• How comfortable are your after-hours contacts with running a mock query under pressure (1–5)? Options: 5 — Very comfortable, 4, 3, 2, 1 — Not comfortable

Which Systems Are Likely to Stall Our Timeline?

• Which integration method will be required to connect your ERP/WMS to our platform (APIs, flat files, EDI, direct DB access, middleware)? Options: REST/SOAP APIs, Flat file SFTP, EDI, Direct DB read, Middleware / ESB, Other
• Do you have versioning/customizations in your ERP/WMS that could impact field names, tables, or API endpoints? Options: Highly customized, Some customizations, Mostly standard configuration, Unknown
• Are there overnight batch processes or latency windows that would prevent real-time traceability queries? Options: Yes — nightly batch windows, Some latency, but manageable, No — near real-time data, Unsure
• Who owns integrations on your side and what is their availability during the next 60 days?
• If we run into an API limit or throttling, what fallback mechanism exists (e.g., hourly dumps, queueing, manual extracts)? Options: Hourly flat-file export, Manual ad-hoc extracts, Retry queue, No fallback defined, Other

Is Your Test Environment Real or a Mirage?

• Can you provide a sandbox or staging environment that mirrors production data structures and typical transaction volumes? Options: Yes — production parity, Yes — partial parity, Only limited test data, No sandbox available
• Are customer names, addresses, and sensitive fields masked in test data, and are there policies limiting what we can use? Options: Fully masked and OK to use, Masked but needs approval, Unmasked but restricted, No masking — production data
• How often is test data refreshed from production (daily, weekly, monthly, ad-hoc)? Options: Daily, Weekly, Monthly, Ad-hoc, Not refreshed
• Will we be permitted to run an end-to-end mock recall in the sandbox that includes notification workflows and simulated customer contacts? Options: Yes — fully allowed, Yes — with constraints, No — notifications disabled, Depends on approvals
• If test environments are limited, what’s your preferred approach to create realistic test scenarios (synthetic data, partial extracts, partner-assisted replay)? Options: Synthetic generated data, Partial production extracts, Replay from audit logs, Partner assistance to seed data, Other

Where Will Traceability Noise Make Us Over-Recall?

• How granular is your lot structure (unit-level serial, pallet-level lot, batch/day-level)? Options: Unit / serial-level, Pallet-level, Batch / lot per run, Daily lot, Inconsistent across SKUs
• Do you frequently rework, repackage, or co-pack products that mix multiple lots into a single sellable SKU? Options: Often, Occasionally, Rarely, Never
• How do you capture inbound supplier lot information — on PO receipt, at QA release, or not consistently? Options: At PO receipt, At QA release, Captured sporadically, Not captured
• Are there SKUs or processes prone to orphaned or manually corrected lot records (e.g., bulk totes, rework bins)? Options: Yes — multiple known processes, A few identified SKUs, No known issues, Unsure
• Share an example of a past recall or near-miss where traceability scope grew or shrank unexpectedly — what drove that change?

What Happens If the Integration Misses a Deadline?

• If integrations slip, what is your tolerance for delayed go-live and what business activities must continue uninterrupted? Options: 2 weeks, 1 month, 2+ months, No delay tolerated
• Do you have a rollback or phased activation plan (e.g., pilot one plant or SKU family first)? Options: Pilot plant/SKUs, Parallel run with old process, Immediate full cutover, No plan in place
• Which acceptance criteria would you require before calling deployment 'ready' (select up to 3)? Options: Trace speed under X minutes, One-up/one-down accuracy ≥ X%, Successful full mock recall, Customer notification SLA validated, Integration stability ≥ 99.9%
• Who needs to sign off on deployment readiness from your side (roles and escalation path)?
• What are the non-negotiable legal or compliance checkpoints we must meet before live notifications can be sent? Options: Legal approval required, QA sign-off required, Executive approval required, Regulatory submission needed, Other

Ready to Book the First Full Mock Together?

• What 2–3 week windows in the next 60 days are acceptable for the first full mock recall and integration dry-run? Options: Next 2 weeks, 2–4 weeks, 4–8 weeks, 8–12 weeks, Not ready yet
• Which deliverables can you commit to providing before the mock (sample data extract, schema documentation, integration credentials, stakeholder availability)? Options: Sample data extract, Schema / ERD, Integration credentials, Sandbox access, Stakeholder availability schedule, Other
• What outstanding approvals or procurement steps could block scheduling (security review, legal SOW, PO issuance)? Options: Security review, Legal SOW, Purchase order, Budget approval, None
• Who will be the final readiness approver and how will they communicate sign-off (email, platform acceptance, meeting)? Options: Email approval, Platform acceptance checkbox, Executive meeting sign-off, Other
• If we leave this conversation with one clear next step, what would be most valuable to you (data extract, technical kickoff, governance workshop, legal review)? Options: Data extract, Technical kickoff, Governance workshop, Legal/commercial review, Other

Start With What Keeps You Up at Night

• Who on your team will be the primary decision-owner for recall and traceability improvements? Options: Quality Director, VP Food Safety, General Counsel, Head of Operations, IT/ERP Lead, Other
• How recently have you executed a full mock recall or been through a regulatory recall response? Options: Within 6 months, 6–12 months, 1–3 years, More than 3 years, Never
• On a scale from 1–10, how confident are you that your current systems can locate an affected lot within FDA-recommended timelines? Options: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
• When you picture your team during a real recall, what's the single emotion you most commonly expect to describe the experience? Options: Panicked, Frustrated, Calm but focused, Overwhelmed, Confident, Resigned
• Briefly describe a recent production or distribution incident where traceability felt inadequate—what happened and what were the consequences?

If One Hour Cost You Millions, Could You Find the Product?

• If you had to locate every lot impacted by a contamination signal in one hour, what would likely break first? Options: Data access, Data quality/granularity, System integrations, People coordination, Customer notifications, Other
• How long does it currently take your team to perform a one-up / one-down trace from finished goods to immediate suppliers in a realistic scenario? Options: <30 minutes, 30–60 mins, 1–4 hours, 4–24 hours, >24 hours, Don't know
• Describe the last time a trace took longer than expected—what specific data or process gaps extended the timeline?
• Which queries are instantaneous vs. manual work today (e.g., lot creation lookups, pallet to case mapping, customer shipment lookups)? Options: Instantaneous (automated), Partially automated, Manual spreadsheet lookups, Phone/email to sites, Don't track
• Who on your team is currently responsible for running trace queries during an incident, and who backs them up? Options: Quality/Recall Lead, Operations/Plant Manager, IT/ERP Analyst, Distribution/Warehouse Lead, External consultant, Other

Where Do Your Records Betray You?

• Which systems hold your lot and movement data today (select all that apply)? Options: ERP (e.g., SAP, Oracle), WMS, MES/Plant systems, Manual logs/Spreadsheets, 3PL partner systems, Supplier portals, Other
• How consistently do you track lot-level granularity for these stages: ingredient receipt, batch production, packaging, palletization, outbound shipment? Options: Always, Mostly, Sometimes, Rarely, Never
• Where do handoffs rely on human transcription or scanned PDFs rather than structured, queryable data?
• Are there supplier or co-manufacturer partners that intentionally or unintentionally limit data sharing needed for end-to-end traceability? Options: Yes, several, Yes, a few, No, Unsure
• If we asked for a sample dataset to run a mock recall, which of the following could you provide within 5 business days? Options: Lot genealogy file, Shipment history, Production batch records, ERP/WMS API access, Redacted customer contact list, None of the above

Who Gets Blamed When Communication Breaks?

• When a recall notification must go out, what usually slows or complicates customer outreach most? Options: Identifying affected customers, Legal review delays, Marketing/PR alignment, Contact data quality, Channel coordination (retail/distributor), Other
• Who is the legal approver for external notifications and what SLA do they need to sign off? Options: General Counsel, Outside Counsel, VP Food Safety + GC, No formal approver, Unsure
• Describe your preferred notification channels and any regulatory constraints we should know about (e.g., retailer portals, direct email, FDA MedWatch).
• Do you maintain templated notification language and customer scripts that are pre-approved, or are they created ad hoc each time? Options: Pre-approved templates, Partially templated, Ad hoc each time, Don't have templates
• Who in your organization is responsible for external stakeholder communication during a recall (e.g., retail partners, distributors, consumers)? Options: Quality/Recall Lead, Corporate Communications/PR, Sales/Account Management, Legal, Other

What Would 'FDA-Ready' Actually Look Like for You?

• If the FDA walked in tomorrow, which measurable outcomes would prove your team is ready? Options: Trace speed under X hours, Accurate scope to lot level, Customer notification within SLA, Complete audit trail, Annual mock recall cadence, Other
• What are the numeric targets your executive team would accept for trace speed, scope accuracy, and notification time?
• Which internal KPIs do you already track that relate to recall readiness (e.g., time-to-trace, % of traced product, data completeness)? Options: Time-to-trace, % traceable by lot, Data completeness score, Mock recall pass rate, None tracked, Other
• What would the cost of a false-positive over-recall look like for you (inventory value, customer disruption, brand impact) and how do you currently estimate it?
• Which governance cadence would you consider acceptable to keep readiness maintained after deployment (e.g., monthly, quarterly, annual mock recall)? Options: Monthly, Quarterly, Bi-annual, Annual, Ad hoc

What Would Change If Your Mock Recall Actually Passed?

• If a mock recall validated your systems tomorrow, what would that success enable you to stop worrying about?
• Who inside the business would gain the most credibility from a successful mock recall and how would that change their priorities?
• Which remediation deliverables would convince procurement and legal to proceed to full deployment (select all that apply)? Options: Updated Recall SOP, Integration spec and timeline, Training plan and owners, Acceptance test/validation checklist, Runbook for incidents, Other
• What level of executive sponsorship (e.g., CEO, COO, Board) is required to secure budget and cross-functional cooperation? Options: CEO/Board, COO/VP Ops, VP Quality/VP Food Safety, No executive required, Unsure
• Imagine you ran an annual mock recall and passed — how would you measure long-term ROI from that capability?

What Would Make Deployment Feel Safe?

• What are the non-negotiable data access or security requirements we must meet before any integration work begins?
• Which of these test artifacts can you provide for validation (choose all that apply)? Options: Redacted production datasets, Synthetic test dataset, API credentials for sandbox, ERP/WMS schema documentation, None available
• Who will own each of these workstreams during deployment: data, integrations, validation, and training?
• What constraints (maintenance windows, blackout periods, audit seasons) will limit when we can run integrations or a full mock recall?
• How do you prefer acceptance testing to be structured: staged checkpoints with sign-offs, a single final validation, or rolling validations by module? Options: Staged checkpoints, Single final validation, Rolling validations, Other

Decision Time—What Would Make This Irresistible?

• If we delivered a successful pilot mock recall, what contractual or commercial terms would you need to feel comfortable moving to full deployment? Options: Fixed scope & price, Milestone-based payments, Performance SLAs, Pilot-to-production discount, Other
• Who must be included in final procurement approvals and what role will legal play in shaping SLAs related to traceability performance?
• What timeline feels realistic for a pilot, remediation, and production deployment from your perspective? Options: <1 month (pilot), 1–3 months, 3–6 months, 6–12 months, >12 months
• What are the top three internal objections you anticipate and who would raise them?
• What would constitute a small, low-risk first step we could run together in the next 30 days to build momentum? Options: Scope a mini-mock recall, Provide a data readiness checklist, Run a quick traceability audit, Deliver an executive briefing, Other