Plastics & Resins🇺🇸United States·

Recipe control and regrind traceability — for compounders and molders who supply regulated end-markets.

Built for ISO 9001, IATF 16949, FDA 21 CFR 177 (food contact), and USP Class VI.

← Different industry
Built around your regulators

The codes you're accountable to — at the data layer.

21 CFR 177
FDA indirect food additives — polymers
USP Class VI
Plastics for medical / pharmaceutical use
IATF 16949
Automotive QMS
ISO 9001
QMS baseline for industrial supply
REACH / RoHS
EU substance compliance
How V5 maps to your floor

Five steps from receive to release — with the regulator on the hook at the end.

Tap to expand · download as PNG · paste into an audit prep deck.

A day in the life

From login to release — no end-of-shift paperwork.

What the auditor receives
The record assembles itself as the operator works — no end-of-shift paperwork project.
FDA 21 CFR 177PLASTICS & RESINS COMPOUNDING FLOW (Food-Contact + CoA)
KDE CAPTURED
  • resin lot
  • supplier
  • grade
  • MoA
1
RECEIVE RESIN
KDE CAPTURED
  • recipe
  • additives
  • % w/w
  • operator
2
COMPOUND
KDE CAPTURED
  • line id
  • melt temp
  • rate
  • operator
3
EXTRUDE
KDE CAPTURED
  • MFI
  • color ΔE
  • spec
  • QA sig
4
QC (MFI)
KDE CAPTURED
  • lot
  • yield
  • moisture
  • operator
5
PELLETIZE
KDE CAPTURED
  • pack
  • lot
  • CoA
  • ship to
6
BAG / SILO + CoA
PHYSICAL EVENT INFORMATION EVENT
KDE = the minimum data fields required to trace the lot through this step. Captured automatically as the operator works.
FDA 21 CFR 177COMPLIANT· FOOD-CONTACT VERIFIED· CoA SIGNED
TRACE IT. TRUST IT.
  1. 07:00·step 01
    Recipe lock

    Compound recipe carries the regrind % limit. Operator can't push above the spec without an e-sig + reason code.

  2. 08:00·step 02
    Compound / mold

    Process parameters (melt temp, screw RPM, cycle time) stream straight onto the batch record.

  3. 11:00·step 03
    Dimensional QC

    CMM / gauge readings post directly. SPC charts update live; trend nudge fires before the spec is breached.

  4. 13:00·step 04
    Customer spec gate

    Lot release checked against the customer drawing tolerance. Out-of-band → contained, not shipped.

    ISO 9001 / IATF 16949
  5. 15:00·step 05
    PPAP / FAI ready

    First-Article and PPAP packs assemble from the same data — dimensional, material certs, control plan, all in one folder.

  6. EOD·step 06
    Signed lot record

    Lot record + CoA render together. Customer-specific PPAP element checklist stays green or surfaces the gap.

Speaking your language

The terms your auditor uses

V5's UI uses these names for plastics & resins workspaces — no cross-industry jargon to translate.
PPAP
Production Part Approval Process — automotive-style approval pack (AIAG).
FAI / FAIR
First Article Inspection (Report) — AS9102 for aerospace, otherwise a similar dimensional pack.
IATF 16949
Automotive QMS standard built on ISO 9001.
Regrind %
Recycled material allowed in a compound — capped by customer spec.
Control plan
Document listing every characteristic monitored at every step (input → output).
MRB
Material Review Board — the team that decides what to do with non-conforming material.
What keeps you up at night

Sound familiar? We built this for you.

!

Master batch recipes drift between the office and the floor.

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Regrind ratios aren't tracked by shot; spec compliance is a guess.

!

Customer Certificates of Compliance are produced manually and lag shipment.

!

Substance compliance (REACH SVHC, RoHS) is a manual lookup per customer request.

Self-Building Compliance Records

The record assembles itself as the work happens.

No paperwork project at end of shift. No reconstruction at audit time. The evidence IS the workflow.

One controlled recipe

Approved master batch recipe is the only recipe the line can run.

Regrind by shot

Virgin / regrind ratios captured per shot, with thresholds enforced against customer spec.

CoC with the shipment

Certificate of Compliance generated from the released lot data — ships with the truck.

Substance status per lot

REACH SVHC and RoHS status carried on every component and resolved per finished lot.

Ready to see it on your batches?

Spin up a workspace seeded for Plastics & Resins.

Default templates, validation rules, and report packs are pre-loaded for your industry. Run a real batch in under an hour.

Ask anything · No credit card · Onboard in days, not months