Quick start: a short snapshot of your recall readiness

• How frequently has your team run a full mock recall in the past two years? Options: Monthly, Quarterly, Once a year, Once in two years, Never
• Describe the last mock recall you ran, including who ran it and the main outcome
• Which role on your team is the primary owner of the recall standard operating procedure and execution? Options: Quality director, VP food safety, Operations manager, General counsel, Plant manager, Other
• On average, how long does an ad hoc lot trace take today from trigger to identification? Options: Under 8 hours, 8-24 hours, 24-72 hours, More than 72 hours, We cannot reliably identify
• What single result from a pilot mock recall would make you commit to a paid follow-on within 30 days?

If the FDA demanded a 24-hour trace, where would you expect the first failure to occur?

• Which links in your supply chain are not consistently lot-tracked today? Options: Ingredient receipt, Processing/batching, Finished goods serialization, Distribution/wholesale shipments, Customer deliveries, Contract co-packer
• When a trace fails, who usually discovers the gap and how long before the issue is escalated?
• How often do reconciliations between your ERP and WMS show missing or mismatched lot linkages? Options: Weekly, Monthly, Quarterly, Rarely reconciled, We do not reconcile
• What downstream costs or operational impacts do you experience when you over-recall product because traceability is insufficient?
• Is there a site, production line, or product family that, if not traceable to your standard, would prevent you from moving forward with an assessment? Options: Yes, No, Unsure

Regulatory and legal pressure in plain terms

• What regulatory timeline or FDA expectation do you use as your internal target for identification and customer notification? Options: Within 8 hours, Within 24 hours, Within 48 hours, Within 72 hours, No formal target
• Has your company experienced an FDA inspection or recall in the last five years? Options: Yes, recall, Yes, inspection only, No
• Which outcomes worry your general counsel most when a recall occurs — regulatory fines, civil liability, or reputational loss? Options: Regulatory fines, Civil liability, Reputation and brand, All of the above
• How long does a legal or security review typically take when a third party requests access to traceability data? Options: Under 1 week, 1-3 weeks, 3-6 weeks, Longer than 6 weeks, Unknown
• Would a legal requirement that forbids sharing certain records stop the engagement entirely? Options: Yes, No, Only with negotiated terms

Who needs to be in the room for this to work

• If we could prepare only three roles for the mock recall, which three would you choose and why?
• Which stakeholders must authorize data access and integration work before the assessment can begin? Options: Quality, IT, Operations, Legal, Procurement, Site leadership
• Who within your organization owns API credentials and integration approvals for your ERP and WMS? Options: Internal IT, Third-party managed services, Site operations, We are not sure
• How many employees can be dedicated to the assessment and mock recall on a part-time basis for the next 6 weeks? Options: 1-2, 3-5, 6-10, More than 10, None available
• Is there any single stakeholder whose refusal to grant access would stop the project immediately? Options: Yes, No, Unsure

The alternatives you are weighing

• Which alternative approaches are you actively considering right now instead of engaging an outside mock recall partner? Options: Keep incumbent vendor, Build internally with IT and quality, Hire external consultants, Run manual tabletop exercises only, No alternative
• If you were to stay with the current approach, what would need to be true about it for you not to change?
• Has anyone on your team proposed solving this entirely without an external partner? Options: Yes, IT proposal, Yes, quality department proposal, No, Not sure
• If a pilot proves faster and more accurate traceability, who on your team has authority to commit to a remediation budget? Options: Quality director, VP food safety, Operations leader, Procurement, CEO/board
• What would need to change in your current vendor or internal plan to keep things as they are?

Designing the mock recall so its results are decisive

• What failure in a mock recall would convince you the exercise was not a good use of time and budget?
• Which product lines, production sites, or SKU groups should the mock recall exercise target? Options: High-risk SKUs, Top revenue SKUs, Contract-pack SKUs, All SKUs at one site, Other
• Which identification window should the test use as success criteria, for example within 24 hours? Options: Within 8 hours, Within 24 hours, Within 48 hours, Within 72 hours, No target, exploratory
• What pieces of evidence must the mock recall capture to satisfy your compliance and legal teams? Options: Trace logs showing chain of custody, Contact history to customers, Timing and timestamped screenshots, One-up/one-down confirmations, Root cause notes
• If the mock recall meets your time and evidence targets, would you be prepared to approve a prioritized remediation roadmap? Options: Yes, immediately, Yes, after review, No

Data and integration reality check

• If we requested a full export of lot-level transactions from receipt through shipment this week, what would be missing or delayed?
• Which systems hold the lot-level data needed for traceability? Options: ERP, WMS, MES, TMS, Manual logs / spreadsheets, Quality lab system
• Are APIs available for these systems or will we need scheduled file extracts? Options: APIs available for all, APIs for some, extracts for others, Only file extracts, We do not know
• Who can grant API credentials or provide file extracts, and how long does that approval usually take?
• If required APIs or exports cannot be delivered within the agreed timeline, can you provide sanitized test data to keep the pilot on schedule? Options: Yes, Yes with limitations, No

People, timing, and the economics that decide the next move

• If a pilot at one site demonstrates a 50 percent reduction in trace time, what approval level is required to fund remediation work? Options: Quality director, VP food safety, Operations head, CFO or procurement, CEO/board
• Who controls procurement and signs statements of work for this type of engagement? Options: Procurement, Quality, Operations, IT, Central legal
• What is your target window to begin the assessment from the date of signature? Options: Within 2 weeks, 2-4 weeks, 1-2 months, Longer than 2 months, Unsure
• Are there blackout periods at any of your sites where testing or audits cannot occur? Options: Yes, seasonal production peaks, Yes, scheduled maintenance, No, Unsure
• If the assessment timeline slips by more than two weeks, would you pause, renegotiate, or continue? Options: Pause, Renegotiate, Continue as planned

Site and operational constraints we must clear up now

• Which single site restriction would immediately block a mock recall from proceeding?
• Do any sites restrict external personnel, remote access, or require special insurance and approvals? Options: Yes, external personnel restricted, Yes, remote access restricted, Yes, background checks required, No special restrictions, Unsure
• Which sites can provide named owners and on-site access within two weeks? Options: All sites, Selected sites only, No sites within two weeks, Unsure
• If physical access is denied for a site, can a remote-only assessment still meet your acceptance criteria? Options: Yes, Only partially, No
• Are there union, contractor, or local rules that add delays or require separate approvals? Options: Yes, No, Unsure

Acceptance criteria that will determine next steps

• Which metrics will you use to accept the assessment and remediation plan? Options: Identification time, Percent of lots traceable, Completeness of audit evidence, Cost estimate within budget, Legal signoff
• Who must sign final acceptance for the assessment and remediation roadmap? Options: Quality director, VP food safety, Legal, Operations leader, Procurement
• If the remediation plan meets the acceptance metrics, how quickly would you expect deployment work to start? Options: Within 2 weeks, 2-4 weeks, 1-2 months, Longer than 2 months
• What would make you stop after the assessment even if technical fixes are identified?
• If the assessment meets your defined acceptance metrics, can you commit to approving the next-step SOW within 14 days? Options: Yes, Yes with caveats, No

Final practical checks before we move from talk to pilot

• Which integration endpoints will be required for the pilot, and who owns each endpoint? Options: ERP, WMS, MES, TMS, Quality lab system, Manual logs
• Do you have named contacts who can provide test credentials and data extracts during the assessment? Options: Yes, named contacts available, Yes, but not yet named, No
• What internal technical capacity exists to support configuration work during remediation, for example developers or integration engineers? Options: Dedicated internal team, Shared IT support, No internal capacity, External IT partner
• Are there any contractual or vendor agreements that would prevent integrations or data sharing with a third party? Options: Yes, No, Unknown
• What is the single gating issue that, if unresolved, would prevent the pilot from starting on your preferred timeline?

• Solution Experience — Recall Scenario Walkthrough

• Confirm the current state and its cost
• You confirm the live trace using your scenario locates affected lots within the FDA timeframe or identify the exact remaining gaps preventing that outcome.
• Run the sample trace in the sandbox using the provided scenario and deliver the trace logs and time-to-identify metrics before the follow-up session.
• Walk through the recall scenario you provided
• You accept the proposed remediation and integration boundaries as sufficient to reach the stated future state or request precise changes.
• Provide a CSV extract of lot, batch, and shipment records for the scenario plus any available customer/ship-to mappings and the primary recall owner contact.
• Run the end-to-end trace using your scenario
• Confirm the acceptance thresholds for trace time and the minimum evidence package required for legal and regulatory sign-off.
• You agree the evidence and time-to-identify metrics that will be used as decision criteria for moving to assessment and remediation work.
• Prepare a proposed window and stakeholder list for the mock recall audit, including sites and systems in scope.
• Demonstrate how the remediation plan and integrations close the gap
• Validate the future state explicitly
• Agree next deliverables and decision criteria

• Solution Experience — Recall Scenario Walkthrough
• Solution Experience Deck
• Solution Brief

• meeting
• slides
• document

• Deploy recall management software platform
• Integrate platform with current ERP and WMS
• Implement lot-level traceability capture (raw-to-finished)
• Configure one-up/one-down trace workflows
• Configure full forward-backward trace reporting
• Migrate historical lot and batch records
• Run full-scale operational mock recall exercise
• Run tabletop recall simulation for leadership and comms
• Develop and deploy customer notification templates
• Train recall response team on SOPs and tools
• Provide live recall execution support (on-call)
• Coordinate product recovery and disposition operations
• Deliver root-cause investigation and containment support

Deploy recall management software platform

• Provide the list of production sites and lines you want the platform deployed to and the expected go-live window for each site
• List the core recall use cases you expect the platform to support (for example: consumer complaint triggered recall, ingredient contamination, labeling error) and rank them by priority
• Identify which existing master documents should be stored or surfaced in the platform (for example: recall SOP, supplier specifications, QA checklists)
• Specify any regulatory references or standards your organization must meet (for example: FDA 21 CFR part references, GFSI scheme rules) that must be reflected in workflows
• Who will be the named owner for platform administration and who will manage user provisioning for your quality and operations teams
• How many named users (by role: quality, operations, distribution, legal) should be licensed at initial deployment Options: Less than 10, 10-25, 26-100, More than 100

Integrate platform with current ERP and WMS

• Provide the names and API capabilities of your current ERP and WMS and indicate whether you have sandbox API credentials available for integration testing Options: ERP API available, WMS API available, Only ERP API available, Only WMS API available, No APIs available / need connector development
• List the specific ERP and WMS fields that contain lot identifiers, production run IDs, and shipment SSCCs that the platform must read or write
• Identify which integration endpoints should be one-way (ERP to platform) versus two-way (real-time trace queries and updates) and the expected frequency Options: One-way batch (nightly), One-way real-time, Two-way real-time, Two-way batch
• Specify acceptable API performance thresholds for trace queries (for example: max latency in seconds for a single lot forward/backward trace) Options: <1s, <3s, <10s, Accept higher latency
• Confirm which data security requirements apply to integration endpoints (for example: mutual TLS, IP allowlist, SFTP with PGP) and provide any required certificates or contact for network auth
• What evidence will validate successful integration boundaries and trace query accuracy (for example: signed test plan, sample API trace outputs, reconciliation report) Options: Signed test plan with sample traces, Automated reconciliation report, Manual validation checklist

Implement lot-level traceability capture (raw-to-finished)

• Provide the current lot code format(s) used across raw ingredient receiving, production, and finished-goods (for example: YYYYMMDD-PLANT-LINE-BATCH)
• List which touchpoints currently capture lot information (for example: receiving scale, batching HMI, packaging PLC, pallet label scan at staging)
• Identify which steps require new capture hardware (for example: handheld barcode scanner at filling, fixed scanner at case packing) and approximate counts per site Options: No new hardware, Handheld scanners, Fixed scanners, Printer-labelers
• Specify how your master production schedule (MPS) references lot or batch IDs and whether lot creation is automated or manual in ERP Options: Automated lot creation in ERP, Manual lot creation, Hybrid
• Indicate required lot-level attributes to capture for each record (for example: production date/time, shift, recipe/version, allergen flags, refrigeration temp at packaging)
• Identify who will own lot capture accuracy and daily reconciliation between floor records and ERP batch records

Configure one-up/one-down trace workflows

• Provide your existing one-up/one-down procedures from receiving through shipment and note any manual handoffs that break electronic traceability
• List the typical trade documents that must be associated with one-up/one-down traces (for example: supplier lot certificate, purchase order, bill of lading, delivery receipt)
• Identify the scope of one-up/one-down testing you want configured (for example: inbound ingredient to production lot, finished case to pallet SSCC, customer invoice to shipment) Options: Inbound ingredient to production lot, Production lot to finished case, Finished case to pallet SSCC, Full chain
• Specify failure thresholds for one-up/one-down tests (for example: acceptable missing link rate as a percentage of sampled traces) Options: 0%, 0.1-1%, 1-5%, Acceptable above 5% requires remediation
• Who will be responsible for remediating missing links found during one-up/one-down workflows and what SLA should be set for corrections Options: QA team, Operations team, Warehouse team, Cross-functional
• Indicate any packaging or repack operations (for example: co-packing, rework) that create split or merged lot relationships that the one-up/one-down flow must model

Configure full forward-backward trace reporting

• Specify the maximum time-to-identify target for a forward or backward trace (hours) you must meet to satisfy regulatory or internal SLA Options: <1 hour, <4 hours, <24 hours, 48+ hours acceptable
• List the recipients and distribution channels for trace reports (for example: legal, regulatory affairs, trading partners via EDI, C-suite via email) and desired report formats (PDF, CSV, API payload)
• Identify the minimum dataset that must appear in every trace report (for example: lot number, production date/time, GTIN, quantity on hand, disposition)
• Determine whether forward/backward trace outputs should include chain-of-custody timestamps and scanned evidence images for each node Options: Include timestamps only, Include timestamps and images, Images on request only
• Assess any partner requirements for trace exchange (for example: customer portal access, EDI event types, SFTP drops with signed manifests) and list key trading partners
• Identify the data retention period required for trace histories and archived evidence to satisfy audit or legal needs Options: 1 year, 3 years, 7 years, Custom

Migrate historical lot and batch records

• Provide the time window for historical records to migrate (for example: last 12 months, last 36 months) and the systems where those records currently reside Options: Last 12 months, Last 24 months, Last 36 months, All historical
• List the export formats available from your systems for migration (for example: CSV with defined schema, XML, database dump) and whether data is normalized by SKU/lot Options: CSV export, XML export, Database dump, No direct export
• Identify key data quality rules we must enforce during migration (for example: required lot fields, no duplicate lot IDs, production date present)
• Specify the migration completeness threshold that will constitute acceptable delivery (for example: 95% of migrated production lots reconciled to ERP) Options: 99-100%, 97-99%, 95-97%, Below 95% requires scope change
• What evidence will validate migration completeness and data accuracy (for example: reconciliation report, sample record sign-off, checksum comparison) Options: Reconciliation report, Signed sample validation, Automated checksum results
• Assign who in your organization will validate migrated batches and provide access to subject matter experts for data mapping

Run full-scale operational mock recall exercise

• Provide the scope and scenario for the full-scale mock recall (for example: simulated allergen contamination in finished SKU X affecting production batches from date range)
• List the sites, shifts, and teams that must participate in the exercise (for example: plant A packaging shift 2, distribution center inbound/outbound)
• Identify the physical trace tests to run during exercise (for example: trigger-to-identification, one-up/one-down sampling, forward/backward trace of 50 sampled units) and sample sizes Options: Trigger-to-identification only, Trigger plus one-up/one-down sampling, Full forward/backward with sampling
• Specify any speed benchmarking targets for the exercise (for example: identify affected lots within X hours, notify top 10 customers in Y hours)
• What acceptance criteria will confirm successful completion of the mock recall and traceability audit (for example: identification within target hours, evidence capture on X% of traces, signed after-action report) Options: Identification within target hours, Evidence on specified % of traces, Signed after-action report required
• Indicate whether exercise outputs should feed an automated remediation ticket backlog and who will prioritize the remediation list Options: Yes, automated backlog, No, manual handoff, Partial automation

Run tabletop recall simulation for leadership and comms

• Provide the leadership roles that should attend the tabletop (for example: VP Quality, General Counsel, Head of Operations, Communications lead) and their expected availability
• List the crisis communications channels to test during tabletop (for example: customer email lists, trade partner portal, press release templates, social media) and ownership for each channel
• Identify the regulatory notification steps to rehearse (for example: FDA notification timeline, state department of agriculture contacts) and whether legal will pre-approve draft language
• Determine tabletop deliverables you expect (for example: decision log, approved initial customer notice, escalation matrix) and who must sign off on them
• Specify the scenario depth for the tabletop (for example: high-impact consumer illness, limited contamination, labeling error) and any external stakeholder involvement Options: High-impact illness, Limited contamination, Labeling error, Custom scenario
• Indicate preferred facilitation style (for example: guided script with injects, open discussion, timed decision-making rounds) and duration Options: Guided script with injects, Open discussion, Timed rounds

Develop and deploy customer notification templates

• Provide the communication audiences to cover with templates (for example: direct customers, distributors, consumers, regulators) and any required legal disclaimers
• List the data fields required to populate notification templates automatically (for example: customer name, shipped lot numbers, invoice numbers, return instructions)
• Identify preferred delivery channels for customer notifications and whether transactional channels (EDI, portal) must be used for trading partners Options: Email, Phone/SMS, EDI/portal, Press release
• Specify any legal approvals required before sending templates (for example: counsel sign-off, VP Quality approval) and typical review turnaround time
• Indicate localization needs for templates (for example: languages, country-specific regulatory statements) and which SKUs/markets require them
• Select whether templates should include return instructions with disposition codes and a contact for coordination of product returns Options: Include disposition codes, Include contact only, Do not include return instructions

Train recall response team on SOPs and tools

• Provide the roles and headcount to train (for example: plant QA leads, warehouse supervisors, customer service reps) and preferred training modality Options: In-person workshop, Live virtual, Recorded modules, Blended
• List the SOP documents and job aids that training must cover (for example: recall activation flowchart, sample collection checklist, customer notification playbook)
• Identify success criteria for training (for example: pass rate on scenario quiz, demonstrated trace within target time) and post-training evaluation method Options: Quiz pass rate, Demonstration exercise, Attendance only
• Assign who will provide site-level access and scheduling for hands-on floor exercises during training
• Determine whether training requires certificates of completion for regulated sites and record retention period for training evidence Options: Certificates required, Certificates optional, No certificates
• Describe ongoing refresher cadence you prefer (for example: annual mock recall, quarterly tabletop, monthly micro-sessions) and which roles need more frequent refreshers Options: Annual, Bi-annual, Quarterly, Monthly micro-sessions

• Master Services Agreement (MSA)
• Statement of Work (SOW) — Assessment & Remediation
• Software Subscription Order Form
• Data Processing Agreement (DPA)
• Data Access Authorization
• Fee Schedule & Payment Terms
• Project Timeline & Kickoff Acceptance
• Change Order Agreement
• Confidentiality Agreement (NDA)
• Regulatory Compliance Addendum (FSMA/FDA Triggered)
• Termination & Transition Agreement

• desired_state
• current_state
• stakeholders
• gaps
• success_criteria
• decision_readiness
• desired_state
• decision_readiness
• current_state
• success_criteria
• gaps
• stakeholders
• desired_state
• success_criteria
• stakeholders
• gaps
• current_state
• decision_readiness
• decision_readiness
• decision_readiness
• decision_readiness
• decision_readiness

• Confirm delivery of remediation findings report
• Approve prioritized remediation roadmap
• Lock and sign acceptance criteria document
• Execute implementation SOW or change-order
• Confirm resource and data-access prerequisites
• Sign off on integration boundaries and out-of-scope items
• Approve testing and validation plan for implementation
• Approve contingency and rollback plan
• Lock implementation schedule and milestones
• Obtain legal/regulatory acceptance of terms affecting implementation

• 30-Day Outcome Check
• 90-Day Performance Review
• Quarterly Operational Review
• Annual Mock Recall Planning and Continuous Improvement Review

• Escalate any remediation items older than the SLA to the executive escalation queue for attention.
• Reduce the number of open remediation items or improve their average age according to the operational targets agreed previously.
• Agree the prioritized enhancement list for the next quarter and the expected delivery windows.
• Confirm the shared continuous improvement channel SLOs for acknowledgement and resolution are defined and being met.
• Publish the prioritized enhancement backlog for the next quarter with estimated delivery windows.
• Update the shared channel SLOs and onboarding notes to ensure new team members can use it effectively.
• Reconfirm targets recorded in Remediation Plan Acceptance
• Set the annual mock recall date window, scope, and owners for execution and evidence capture.
• Review prior 12 months mock recall metrics
• Confirm that mock recall success rate and median trigger-to-identification time targets are understood and that any deviations have remediation plans tied to Remediation Plan Acceptance.
• Agree on annual targets for remediation resolution and an operating cadence for the continuous improvement channel.
• Publish the annual mock recall plan with scope, date window, evidence checklist, and execution owners.
• Add the annual mock recall to the shared calendar and confirm site access and data sources needed for execution.
• Set quarterly checkpoints to track progress against the annual remediation resolution targets.
• Confirm whether the median trigger-to-identification time meets the target recorded in Remediation Plan Acceptance or document the delta and corrective plan.
• Confirm current one-up/one-down trace accuracy rate and agree corrective actions for any accuracy shortfall.
• Establish owners and target dates for the top 3 remediation items to be resolved before the next checkpoint.
• Publish the 30-day performance snapshot and root-cause notes to the shared channel within 48 hours.
• Create remediation tickets for the top 3 issues with clear acceptance criteria and target resolution dates.
• Schedule a technical detailed review for any integration errors identified in the diagnostics.
• Present 90-day trend for trace times
• Verify whether forward and backward trace times meet the numeric targets recorded in Remediation Plan Acceptance or document required fixes and timelines.
• Confirm mock recall evidence capture completeness percentage and any evidence gaps to be closed before the next quarter.
• Produce a time-bound closure plan for all remaining remediation items with clear acceptance checks.
• Publish the 90-day performance report that maps each outstanding remediation item to its impact on trace times and evidence completeness.
• Open remediation timelines in the shared tracker with target dates and acceptance criteria referenced to Remediation Plan Acceptance.
• Schedule any required configuration or data-correction tasks needed to improve trace time performance.
• Quarterly status of open remediation items
• Present 30-day performance data
• Define next annual mock recall scope and window
• Trace accuracy and operational incidents
• Review mock recall evidence capture completeness
• Backlog and residual remediation review
• Evidence capture and acceptance checklist
• Diagnose gaps and root causes
• Enhancement and defect triage
• Agree closure plan and timelines
• Continuous improvement commitments
• Shared continuous improvement channel health check
• Open issues and blockers review
• Agree immediate remediation actions and timeline