Methodology

How TraceReady Works: The 60-Day Methodology

TraceReady is a guided compliance program, not a platform. A named compliance lead runs weekly working sessions with your QA, supply chain, and IT stakeholders. The 60 days is structured around three phases with concrete artifacts at each handoff. This page walks through what happens week by week.

The program at a glance

Week  1    2    3    4    5    6    7    8
      │    │    │    │    │    │    │    │
      ▼────▼    ▼────▼────▼────▼    ▼────▼
      Diagnostic   Remediation         Handoff
      ─────────    ──────────────      ───────
      FTL scope    Lot linkage         Mock recall
      CTE map      KDE capture         24-hr test
      Gap audit    Supplier outreach   Audit binder
      Severity     Export stand-up     Scorecard
      ranked       SOPs + training     response

Horizontal axis: program weeks. Vertical: primary workstream deliverables.

Three phases, concrete artifacts

Every phase produces artifacts your leadership team can point to

Weeks 1–2
Gap Diagnostic

We map your FTL scope against every KDE and CTE the rule requires, then benchmark what you already capture against what auditors and retailers are asking for. You finish the first two weeks with a prioritized, severity-ranked remediation list. Not a 60-page report nobody reads.
Weeks 3–6
Guided Remediation

We run weekly working sessions with your QA, supply chain, and IT leads to close the highest-severity gaps first: lot-linkage between inbound and outbound, machine-readable export, supplier KDE flow, and written SOPs. You keep your existing ERP, WMS, and ReposiTrak/FoodLogiQ seat. We bolt process and data fixes onto what you already run.
Weeks 7–8
Audit-Ready Handoff

We run a full mock recall against your FTL scope end-to-end, time the 24-hour record retrieval, and hand you an audit-defense binder: SOPs, data-flow diagrams, supplier data agreements, and the exact retailer-scorecard responses you can send back to Kroger or Albertsons. When the next request comes in, you answer it in an afternoon, not a fire drill.

Weeks 1–2: Gap Diagnostic

The diagnostic week is front-loaded. You'll spend 4–6 hours of stakeholder time across QA, supply chain, and IT. We handle everything else. The kickoff walks through your FTL scope, your current tooling (ReposiTrak, FoodLogiQ, TraceGains, ERP modules), and the retailer relationships most likely to drive a scorecard request.

By the end of week 2 you have: a ranked gap register with severity and effort estimates, a first-pass CTE map across receiving, transformation, and shipping, a live lot-linkage trace on one FTL SKU end-to-end, and a prioritized remediation backlog for weeks 3–6. The gap register is the artifact; everything downstream is measured against it.

Weeks 3–6: Guided Remediation

Four working weeks, three workstreams running in parallel. Each workstream has its own weekly cadence and owner on our side, synced at a single program standup.

Workstream A: CTE mapping and lot linkage

We build the data flow that ties inbound lots to outbound lots, including across transformation. This usually means structured reports from your ERP or WMS, cleaned and joined in a lightweight middleware layer we stand up inside your environment. By week 6 you can pull a full traceback for any FTL SKU in under 30 minutes manually, and in under 5 minutes via the export we automate.

Workstream B: KDE capture and machine-readable export

We configure KDE capture at every in-scope CTE, either inside your existing platform (if one is installed) or via structured reports against your transaction systems. The deliverable is a tested, sortable CSV (or EPCIS format if your retailers require it) that contains every KDE for every CTE across your FTL scope.

Workstream C: Supplier activation

Supplier onboarding is where most traceability projects die. We don't deploy a portal. We run a 30-day outreach sequence against your top FTL suppliers: scripted initial ask, technical clarification call, escalation to supplier leadership, and contract-leverage escalation for non-responders. Standard data-agreement templates, weekly status stand-up, and explicit escalation ownership. Target: 70%+ Tier-1 activation in 30 days.

Weeks 7–8: Audit-Ready Handoff

The final two weeks prove the work and produce the artifacts you hand over when the next request lands.

Full mock recall. We pick a random FTL SKU, simulate a contamination event, and time the end-to-end traceback. Documented result, including anything that failed.
24-hour retrieval timing test. A simulated FDA request run under real conditions (not a dress rehearsal) to time sortable export generation.
Audit-defense binder. SOPs, data-flow diagrams, supplier data agreements, mock-recall result, retailer scorecard response templates. The binder is what you hand to an FDA inspector or upload to a retailer portal.
Handoff session. A two-hour session with your QA, supply chain, and leadership to walk through the binder, name the ongoing accountable owner, and scope any residual work for the monthly subscription period.

What you keep after the 60 days

Everything we build stays with you. The gap register, the CTE map, the lot-linkage middleware, the machine-readable export, the SOPs, the supplier data agreements, the audit-defense binder: all yours, all documented, all transferable to your ongoing team or a future consultant. The monthly subscription after the 60 days covers ongoing audit-defense access, retailer scorecard response support, and quarterly mock-recall drills. You can cancel the subscription and retain everything we built without losing compliance posture.

See the methodology applied to your actual operation.

The free FSMA 204 Readiness Guide walks through the eight gaps we see most, why they matter, and the 60-day plan we use to close them.

Get the free guide See pricing