Moving from prototype to mass production is not a single step. It is a series of evidence-based gate reviews. This checklist maps the gates Jaycon runs for injection molded products: Phase 0 design freeze, EVT, DVT, PVT and mass production. Use it to align engineering, tooling, quality and supply chain before you cut steel, approve PPAP or ship first parts.
Quick definition
A pre-production readiness checklist turns launch risk into a structured gate review. Each gate should have a clear checkpoint, evidence requirement, owner and pass/fail/hold decision before the program moves forward.
How to Use This Checklist
Gate-based reviews: Treat each phase as a formal review gate. Do not advance until every item is pass, resolved with an approved deviation, or assigned as a tracked action.
Owner-assigned tasks: Each row needs an accountable owner. For cross-functional programs, use a RACI model so engineering, quality, supply chain and the molder know who signs each item.
Evidence required: Every checkpoint should point to evidence such as a CMM report, first article inspection, material certificate, mold trial photo log, SOP, control plan or PPAP document.
Pass, fail or hold: Use pass/fail/hold decisions instead of vague status updates. A hold can still move forward if the deviation is documented, risk-rated and approved by the right stakeholders.
Pro tip
Print the downloadable PDF and post it in your NPI war room. Cross off items in real time during gate reviews and keep the Excel version as the live action tracker.
Phase 0: Design Freeze and DFM Sign-Off
Gate objective: Engineering and the molder agree that the design is tooling-ready. This gate prevents a prototype CAD file from moving into tooling before drawings, materials, tolerances and mold strategy are locked.
| # | Checkpoint | Evidence | Owner | P/F/H |
| 0.1 | 2D/3D drawings released: STEP and PDF with CTQs, GD&T and finish callouts per zone | Drawing rev in PLM | ME | |
| 0.2 | DFM review completed and signed: draft, wall thickness, undercuts, gate/ejector locations and shrink compensation | DFM report and redlines | Molder | |
| 0.3 | Material spec locked: grade, color, dry spec, regrind limit and required certifications | Material spec sheet | ME/Purchasing | |
| 0.4 | BOM finalized: all components, inserts, hardware, packaging and labels | BOM rev in ERP | PM | |
| 0.5 | Tolerance stack-up analyzed: critical dimensions verified as feasible | Stack-up report | ME | |
| 0.6 | Regulatory requirements documented: UL, FDA, RoHS, REACH, flammability or biocompatibility | Compliance matrix | QA/RA | |
| 0.7 | Mold class selected per volume, life requirement and expected cavitation | Tooling quote | Molder | |
| 0.8 | Project timeline baselined with T0, T1, T2, PPAP and MP dates plus buffers | Milestone tracker | PM |
Exit criteria: Design is tooling-ready, DFM is signed, material is locked, mold class is selected and no unresolved design risks remain without an approved deviation.
Phase 1: EVT – Engineering Validation Test (T0 to T1)
Gate objective: First molded parts prove the concept. Major mold debugging and adjustments are expected at this stage, so the goal is not perfection. The goal is to capture data, identify defects and build a clean T1 action plan.
| # | Checkpoint | Evidence | Owner | P/F/H |
| 1.1 | T0 trial scheduled: mold on press, water, electrical and hot runner verified | Mold trial plan | Molder | |
| 1.2 | Material dried and verified: certificate on file and dryer logs match spec | Dryer log and COA | Molder | |
| 1.3 | T0 shots produced: short shots acceptable, but photos, weights and cycle time are captured | T0 photo log and shot data | Molder | |
| 1.4 | Critical dimensions measured on 5 parts and compared to the print | CMM or optical report | QA | |
| 1.5 | Visual inspection completed for sink, flash, short shots, weld lines and blush | Defect map and photos | QA | |
| 1.6 | Tooling adjustments listed: steel-safe vs. weld/EDM and schedule impact noted | Adjustment tracker | Molder | |
| 1.7 | Gate, vent or ejector changes proposed with simulation or engineering rationale | Engineering change note | Molder/ME | |
| 1.8 | T1 plan approved with scoped adjustments, timeline and production-intent material | T1 trial plan | PM |
EVT exit criteria: All pass/fail/hold items are resolved, T1 adjustments are scoped and no show-stopper defect remains open.
Phase 2: DVT – Design Validation Test (T1 to T2)
Gate objective: Parts are in spec, the process is becoming stable and the design is frozen before PVT. DVT is where dimensional performance, functional fit and cosmetic standards need to converge.
| # | Checkpoint | Evidence | Owner | P/F/H |
| 2.1 | T1 trial completed using virgin production resin and production cycle parameters | T1 process sheet | Molder | |
| 2.2 | Full FAI completed: 100 percent of drawing dimensions measured on 5 pieces | FAI report | QA | |
| 2.3 | Cosmetic inspection completed per acceptance standard with finish and ejector locations checked | Cosmetic sign-off sheet | QA/ME | |
| 2.4 | Process capability Cpk >= 1.33 on CTQ dimensions using 30 consecutive shots | Cpk report | QA | |
| 2.5 | Material property verification completed for tensile, Izod, HDT or other required properties | Lab test report | QA | |
| 2.6 | Assembly fit and function verified with mating parts, hardware and torque specs | Assembly test report | ME | |
| 2.7 | Mold maintenance PM completed: clean, lube, wear inspection and water flow balance | PM checklist | Molder | |
| 2.8 | Texture or finish applied if planned between T1 and T2 | Texture cert and photos | Molder | |
| 2.9 | T2 trial plan approved with only minor tuning expected | T2 plan | PM |
DVT exit criteria: FAI is 100 percent pass, Cpk is at least 1.33 on CTQs, no critical visual defects remain and the design is frozen.
Phase 3: PVT – Production Validation Test (PPAP-Lite to MP)
Gate objective: The production line, packaging, quality system and supply chain are validated. This is where the team confirms that good parts can be produced repeatedly, inspected reliably and shipped without uncontrolled risk.
| # | Checkpoint | Evidence | Owner | P/F/H |
| 3.1 | T2 trial completed with production-intent process and no tooling adjustments needed | T2 process sheet | Molder | |
| 3.2 | PPAP Level 3 package submitted or customer-specific level prepared | PPAP binder | QA | |
| 3.3 | Gage R&R completed on all inspection fixtures and CMM programs | MSA report | QA | |
| 3.4 | Process control plan live with reaction plans, SPC charts and sampling frequency | Control plan | QA | |
| 3.5 | Packaging and labeling validated with ship tests, label durability and barcode scan | Pack validation report | Supply Chain | |
| 3.6 | Work instructions and SOPs approved for setup, startup, in-process, shutdown and changeover | SOP docs | Molder | |
| 3.7 | Operators trained and certified on setup, quality checks and defect identification | Training records | Molder/HR | |
| 3.8 | Supply chain secured for resin, mold spares, hot runner spares and color masterbatch | POs and agreements | Purchasing | |
| 3.9 | Golden samples signed by customer, Jaycon QA and engineering, then stored controlled | Golden sample log | QA | |
| 3.10 | Containment plan for non-conformance approved | Containment SOP | QA |
PVT exit criteria: PPAP is approved, zero open SCARs remain, the control plan is active, golden samples are signed and supply chain status is green.
Phase 4: MP – Mass Production Green Light
Gate objective: The program has moved from launch validation into steady-state production. The focus shifts to consistency, OEE, SPC, preventive maintenance and continuous improvement.
| # | Checkpoint | Evidence | Owner | P/F/H |
| 4.1 | First production lot released against the control plan with zero deviations | Lot release record | QA | |
| 4.2 | OEE tracking live with availability, performance and quality targets set | OEE dashboard | Molder | |
| 4.3 | SPC charts active and all CTQs in control with Cpk >= 1.33 maintained | SPC software | QA | |
| 4.4 | Preventive maintenance schedule running for mold, press and auxiliary equipment | PM calendar | Molder | |
| 4.5 | Voice-of-customer loop established with 30/60/90-day check-ins | VOC log | PM |
Common Failure Modes This Checklist Prevents
| Risk | What happens | How to prevent it |
| Advancing before DFM sign-off | Tooling changes, longer T1 corrections and unclear accountability | Hold gate until DFM report is signed or deviation is approved |
| Missing evidence links | Gate reviews become opinion-based instead of data-based | Require every row to reference a report, photo log, certificate or approval record |
| No owner assigned | Open items drift between engineering, QA, molder and supply chain | Assign a named owner per checkpoint and review open items weekly |
| Skipping capability studies | Parts may pass one inspection but fail in production | Require Cpk on CTQs before PVT exit |
| Packaging validated too late | Good parts can still fail during shipping or customer handling | Validate packaging before MP gate approval |
FAQs About Pre-Production Readiness for Injection Molding
What are T0, T1 and T2 in injection molding?
T0 is the first shot run from a new mold and is used to debug the tool. T1 is the first corrected trial using production-intent material and process parameters. T2 is final tuning before production validation.
What is the difference between EVT, DVT and PVT?
EVT validates design feasibility. DVT validates the design and process capability with FAI, Cpk and functional testing. PVT validates the production line, packaging, quality system and supply chain.
When should I run a production readiness review?
Run a gate review before each major phase transition, especially before T0, before T1 and before PPAP submission.
What documents are needed for PPAP Level 3?
Typical documents include design records, engineering change documents, DFM evidence, FAI, MSA or Gage R&R, control plan, PSW, appearance approval, material certifications and sample parts.
How long does pre-production take for injection molding?
A typical program takes 8 to 14 weeks after tooling starts, but complex multi-cavity tools or major design corrections can add 4 to 6 weeks.
Download the Pre-Production Readiness Checklist
Use the checklist as an Excel or PDF template for gate reviews. The template should include tabs for Phase 0, EVT, DVT, PVT, MP launch, RACI matrix and deviation log. For teams preparing to launch an injection molded product, Jaycon can also review the gate package before the next trial or PPAP submission.
Related reading
Get a quote with a pre-tooling DFM review. Upload a STEP file with your volume and resin and get tooling and piece pricing back before you commit to a gate. Start a quote.