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Injection Mold Validation Guide: Tool Approval Requirements, FAI, PPAP & Capability

Reviewed by Ray Tao | Tooling Engineer Quality Review by Eddy Zhu | APQP / PPAP Coordinator

Ballooned drawing and FAI documents prepared for injection mold tool approval

Before approving an injection mold, buyers need more than a few visually acceptable samples and a dimensional report on non-critical features. A reliable approval decision should be based on four aligned elements: conformance to the active drawing revision, repeatability on CTQ features, measurement system credibility, and controlled approval documents.

This guide explains what evidence is actually required for standard industrial, automotive, medical, and China-sourced mold programs—so you can decide whether a tool is ready for release, should be held, or needs revalidation.

For typical submission contents, see our quality documents, PPAP, and FAI deliverables.

What is injection mold validation?

Injection mold validation is the process of proving that a mold, the molding process, the measurement system, and the approval documents are capable of producing repeatable, specification-compliant parts. It goes beyond a single dimensional report and is used to support tool approval for a defined released condition before mass production.

Minimum Tool Approval Evidence by Program Type

Program Type	Minimum Required Evidence	When It Is Usually Enough	Additional Validation Needed
Industrial / Commercial	T1 Trial Report, FAI (3-5 pcs), Material Cert (COA).	Programs with limited CTQs, low regulatory exposure, and no customer-specific PPAP requirement.	Moving mechanisms or critical assembly interfaces.
Automotive (IATF 16949)	PPAP level as required by the customer, dimensional results, control plan, Gage R&R, and capability evidence for CTQ features where required.	Automotive programs with defined PPAP scope, subject to customer-specific requirements and CTQ classification.	Safety-critical parts or structural engine components.
Medical (ISO 13485)	Defined IQ/OQ/PQ scope where required, material lot traceability, documented process qualification, and revision-controlled approval records.	Medical programs where validation scope, lot traceability, and process qualification requirements are already defined by the customer or regulatory framework.	Life-critical implants or high-risk diagnostic tools.
Export / China-Sourced	Steel certification, heat treatment records, agreed mold acceptance criteria, trial records, dimensional results, and revision-controlled release documents.	Tooling transfer programs where the mold is approved for shipment rather than full production release.	When the supplier is also responsible for process validation, trial optimization, and release documentation for production transfer.

Engineer reviewing mold validation records and dimensional evidence before tool approval

Verification Insight: Our engineering team performs a physical review of every validation package to ensure the "Released Condition" perfectly aligns with your frozen CAD revision.

What Is Injection Mold Validation for Tool Approval?

Ballooned drawing linked to CTQ dimensional report for mold validation review

Ballooned drawing linked to CTQ dimensional reporting for tool approval review.

What Validation Must Prove Beyond a Dimensional Report for Tool Approval

Injection mold validation is the process of confirming that a tooling system can repeatedly produce parts that meet the active drawing revision, defined CTQ requirements, and material specifications under a released manufacturing condition. It goes beyond a single dimensional report and is used to support tool approval for a defined released condition before mass production.

One acceptable trial sample does not prove a released mold. A dimensional layout is only a starting point and does not prove process stability, measurement reliability, or revision-controlled release status. True validation should show that the mold can hold agreed CTQ features under defined machine, material, and trial conditions that represent production use.

This requires CTQ tracking, repeatability evidence across defined trial conditions, and revision-control checks to ensure the physical steel matches the latest engineering data before establishing tool approval acceptance criteria.

The 4 Pillars Behind Injection Mold Tool Release

For controlled tool release, the mold should be evaluated through four approval pillars. A gap in any one pillar can delay release, trigger repeated tool corrections, or create unstable CTQ performance after launch.

Pillar	What It Proves	Typical Evidence	Common Approval Mistake
Pillar 1Tool Condition	Mechanical integrity and alignment of the physical mold.	Steel certification, heat treatment records, mold acceptance findings, steel correction history, and trial records.	Ignoring minor flash or gating issues during T1 that worsen over mass production cycles.
Pillar 2Process Stability	The process window can maintain agreed CTQ results across normal variations.	Process-window studies, DOE records, and capability evidence for CTQ features where required.	Accepting parts made at "ideal" settings that cannot be replicated across different material lots or shifts.
Pillar 3Measurement System	Dimensional data is accurate and operator-independent.	Gage R&R or MSA records where required, CMM calibration status, and validated measurement methods.	Using calipers on a flexible plastic part where a CMM or custom fixture is required for repeatability.
Pillar 4Approval Package	The controlled release package linking tool, data, and revision status.	FAI or dimensional layout results, PPAP records where required, and revision-controlled approval documents.	Losing the link between the final physical tool state and the latest engineering CAD revision/ECN.

What Minimum Evidence Is Required Before Tool Approval?

Tool approval should be based on controlled evidence tied to the active drawing revision, CTQ results, process conditions, and release documents. The required evidence package should match industry expectations, program risk, and whether the mold is being released for production or shipment transfer.

Quality engineer reviewing CTQ layout and trial records for industrial tool approval

Quality review of CTQ layout and trial-condition records for industrial tool approval.

Minimum evidence for standard industrial programs

For non-regulated industrial programs with limited CTQs and no customer-specific PPAP requirement, the minimum approval package is typically based on drawing revision control, CTQ verification, visual criteria, and documented trial conditions.

Agreed drawing revision (Frozen CAD/PDF)
Defined tolerance basis for critical interfaces
CTQ dimensional layout (First Article Inspection)
Defined visual standard and approved reference samples
Documented trial conditions (Press size, cycle time, temperature)
Final tool acceptance checklist

Download our injection mold validation document checklist.

Redacted PPAP records showing control plan, dimensional results, and MSA evidence

Redacted PPAP records showing dimensional results, control plan, and MSA evidence.

Automotive Program Requirements

Additional evidence for automotive PPAP programs

Typical automotive approval packages may include PPAP documents, control-plan records, MSA evidence, and capability data for CTQ features as required by customer scope.

PPAP level as required by the customer scope
Ballooned drawing mapped to dimensional results
Raw material certifications (COA) & Laboratory reports
Control Plan for production phase
MSA / Gage R&R for critical measurement fixtures
Process capability evidence for CTQ features where required

Learn more about PPAP documents and IATF 16949 certified manufacturing requirements.

Medical molding validation records showing lot traceability and process qualification evidence.

Additional evidence for medical molding programs

For medical molding programs, the approval focus shifts to documented process qualification, lot traceability, change control, and validation scope defined by product risk.

Full traceability (Material lot to cavity ID)
Documented lot control and material status records
Defined IQ/OQ/PQ scope where required
Validated process parameters (Frozen process window)
Documented change control discipline
Dimensional data for defined cavities and CTQ features

Engineer verifying revision-controlled handover records before China-sourced mold shipment release

Verification of handover records before China-sourced mold shipment.

What Must Be Verified Before Releasing a China-Sourced Mold

China-sourced molds should not be released for shipment until the approved tool condition, revision status, and handover documents are frozen and verified. Buyers should verify that the shipped mold and records match the released revision.

Run-off record: documented trial conditions and observations
Approved acceptance status: controlled sign-off records
Shipment release package: steel and heat-treatment records
Revision control: tool identification matches the latest CAD
Deviation approval: signed waivers for any non-conformance

Read our full guide to sourcing injection molds from China with quality gates →

FAI vs PPAP vs Gage R&R vs Capability Study: What Each One Proves for Tool Approval

In injection mold validation, different methods answer different approval questions about part conformance, measurement credibility, process stability, and release readiness. Validation depth should match program risk, customer requirements, CTQ sensitivity, and the consequences of release failure.

FAI and PPAP documents compared for injection mold approval evidence.

When FAI May Be Enough

For standard industrial projects with limited CTQs, low regulatory exposure, and no customer-specific PPAP requirement, a First Article Inspection (FAI) may be sufficient as the initial approval method. It shows that the mold can produce parts to print under defined trial conditions at a specific point in time.

It confirms dimensional compliance for an initial batch but does not prove long-run process stability under production conditions. FAI reflects sampled conformance at a defined point in time, not long-run process behavior. It is most useful when the active drawing revision is frozen, CTQ scope is limited, and sample status is clearly identified.

When PPAP Is Typically Required

What does PPAP prove in injection molding?
PPAP is formal production approval evidence showing that the supplier, tool, process, material, and supporting documents are aligned for repeatable production release as defined by customer scope. It is formal evidence that the manufacturing system can consistently meet all requirements during a production run.

PPAP is typically required for automotive or similarly controlled supply chains when the customer requests formal production approval evidence. It is used to show that the supplier, tooling, process, and supporting documents are aligned for production release, ensuring the supplier understands the design intent under mass production conditions.

Gage R&R report used to verify measurement credibility before capability study.

Why Gage R&R Must Come Before Capability

For supplier approval, data is only as credible as the measurement system used to generate it. Before capability data can be used as release evidence, the measurement method should be validated for the feature type, material behavior, and required repeatability through Gage R&R or MSA where applicable.

We perform Gage R&R (Measurement System Analysis) to ensure that variations in data come from the molding process, not from the operator or the gauge itself. Learn more about our gage R&R before capability review.

Engineer reviewing CTQ capability data and process records for mold validation.

When Cpk/Ppk Data Is Meaningful

Capability evidence should be tied to defined CTQ features, approved measurement methods, controlled material conditions, and a sampling plan relevant to the release decision. A single successful trial does not establish statistically meaningful capability evidence.

We utilize Cpk and Ppk for injection molding process capability to demonstrate that the process is capable of maintaining agreed tolerances under defined material and shift-to-shift variations.

When IQ/OQ/PQ Is Required by Validation Scope

IQ/OQ/PQ is typically required when validation scope, product risk, or regulatory context (such as medical device programs) calls for documented installation, operational, and performance qualification. This may include Installation Qualification of equipment, Operational Qualification of defined process limits, and Performance Qualification under approved production conditions.

Validation Method Comparison Matrix

Method	What It Proves	When Required	What It Does Not Prove
FAI	Dimensional conformance of the sampled parts.	Standard Industrial / Low Risk.	Long-run process behavior or stability.
PPAP	Full production readiness and intent.	Automotive / Controlled Supply Chains.	Success if material or design changes occur.
Gage R&R	Measurement system credibility.	Prerequisite for any capability data.	Part quality or actual process stability.
Cpk/Ppk	Statistical process capability for CTQs.	Critical-to-Quality (CTQ) tracking.	100% inspection results (it is a prediction).
IQ/OQ/PQ	Regulatory & process qualification.	Risk, regulatory or validation scope.	Cost-efficiency or production speed.

How to Decide Whether a Mold Can Be Released, Held, or Revalidated

Final tool release is a controlled approval gate that determines whether the mold can be used for production or transferred with documented acceptance status. Tool readiness should be classified using release evidence tied to revision status, CTQ results, measurement credibility, and controlled documents.

Minimum Conditions for Tool Release

A mold should be considered ready for release only when physical performance, active drawing revision, and approval documents are verified and aligned. Release criteria should cover CTQ conformance, measurement-system credibility, process evidence where required, and revision-controlled documentation.

Condition	Minimum Evidence Required	Release Status	Risk If Missing
Part Specification Match	FAI or dimensional results on sampled parts under defined trial conditions, matched to the active drawing revision.	RELEASE	Assembly failure; costly downstream rework.
CTQ Stability	Capability or process-stability evidence for CTQ features where required by customer scope or program risk.	RELEASE	Inconsistent batches; high scrap rates.
Measurement Alignment	Validated measurement method matched to the feature type, with Gage R&R or other MSA evidence where required.	RELEASE	"False Pass" parts reaching your production line.
Document Integrity	Material status records, trial logs, revision-matched files, and deviation or ECN records where applicable.	RELEASE	Loss of traceability or revision mismatch.

Related Note: Refer to our full tool approval acceptance criteria for specific tolerance standards.

Quality engineer reviewing hold status and deviation records before mold release.

Hold conditions that block release

A HOLD status should be used when release evidence is incomplete, inconsistent, or no longer representative of the approved tool condition. Blocking release is a necessary risk management step if CTQ results are unstable or if the revision control trail is broken.

MSA Gap: Data provided before Measurement System Analysis (Gage R&R) is verified for precision features.
ECN Mismatch: Tool changes not reflected in the latest CAD revision or approved deviation waiver.
Approval Basis: Visual criteria or approved reference samples not yet controlled and linked to release status.
Documentation: Missing material certification, traceability records, or other release documents required by customer scope.

Records required for HOLD resolution: Deviation Log, Hold/Release Status Sheet, Signed Approval Record.

ECN records and revision-control documents used for mold revalidation review

ECN records used for mold revalidation review.

Revalidation triggers after tool or process changes

Engineering changes are a common cause of validation drift when approved conditions are not rechecked. Revalidation should be considered whenever a change can affect approved features, validated process settings, or release-document integrity.

Gate size/location change or hot runner modification.

Cooling channel corrections or critical steel rework.

Resin grade substitution or new masterbatch supplier.

Measurement method change or new fixture implementation.

Drawing revision change (even if nominals remain the same).

Mold transfer to a different press when machine sensitivity affects CTQs.

"Previous FAI or capability data may no longer represent the released condition after a tool, process, material, or revision change."

View engineering change management for mold revalidation →

Tolerance, Inspection, and Acceptance Criteria

Which Tolerance Standard Is Active: Customer Drawing, Program Requirement, or ISO/SPI Default?

Validation should begin only after the active drawing revision, datum scheme, and tolerance basis have been agreed and frozen. Without an agreed tolerance basis, dimensional results cannot be used as reliable release evidence. Tolerance authority should be resolved in the following order:

1. Customer Drawing

2. Customer-Approved Program Requirements

3. Industry Defaults (ISO/SPI)

Tolerance standards such as injection mold tolerance standards by ISO, SPI, and automotive rules should be reconciled with CTQ features before dimensional results are used for approval.

Engineer reviewing T1 T2 mold trial records during tool validation

Engineer reviewing T1 and T2 mold trial records during tool validation.

What Should Be Checked at T1, T2, and Final Run-Off Before Release

Tool approval should be built through defined trial stages, with different objectives at T1, T2, and final run-off. Trial stages are used for correction and risk discovery, while release stages are used for verification and approval.

Initial Risk Discovery Initial dimensional review to identify major gaps, tooling issues, and steel-safe correction opportunities.

Stabilization Verification Verification of steel corrections and repeatability, with initial process-window definition where required by CTQ risk.

Final

Release Verification Formal run-off verification, final dimensional or PPAP records as required, and confirmation of approved process settings and handover documents.

Download T0 T1 T2 mold trial guide and checklist →

Cosmetic, fit, function, and CTQ acceptance rules

Part approval should be based on four parallel checks: cosmetic criteria, fit, function, and CTQ performance. Approval data must be generated from defined trial conditions and matched to the active revision status.

Approved molded part samples used for cosmetic and fit acceptance review

Cosmetic & Fit

Must be based on approved limit samples or another controlled visual standard, not verbal alignment.
Defined inspection distance, lighting condition, and approved visual reference basis.
Assembly checks and functional verification, with mechanical testing where required by application.

Ballooned drawing and CTQ verification records used for part acceptance review

CTQ Precision

CTQ features must be clearly identified on Ballooned Drawings indexed to measurement data.
Statistical evidence for CTQs should be provided where required by customer scope, launch risk, or validation plan.
Any waiver or deviation must be controlled through an approved ECN or equivalent change process.

Process Validation for Repeatable Production

The Process Validation Foundation

"A successful trial sample does not establish a validated process, especially when material, setup, or machine variation has not been bounded."

A visually acceptable T1 sample does not prove that the process can hold CTQ features under defined machine, material, and setup conditions. Without process validation, variation in material behavior, machine condition, or environmental shifts can move CTQ performance outside the approved range.

Engineer reviewing process-window records and DOE evidence for CTQ stability

Engineer reviewing process-window records and DOE evidence during mold validation.

When Process Window Validation and DOE Are Needed for Tool Release

Process-window studies and DOE are most useful when buyers need evidence that CTQ results remain stable across a controlled operating range rather than at one successful setup. For high-precision or higher-risk programs, scientific molding methods and DOE may be used to define a process window that supports repeatable CTQ performance.

Tighter CTQ Tolerances

Features where normal process variation could affect assembly, sealing, or cosmetic acceptance.
Multi-cavity molds where cavity-to-cavity balance can affect dimensional consistency.

Material & Flow Complexity

Materials with higher shrink variation, glass-fill sensitivity, or flow behavior that affects warpage.
High-performance resins (POM, PBT, PPS) where thermal stability is critical to part geometry.

See our process window validation for CTQ stability for examples of how process ranges can be documented for release review.

Cavity pressure records and capability sheets used for CTQ stability review.

Cavity Pressure, CTQ Stability, and Capability Evidence for Release Decisions

Cavity pressure data is not required for every program, but it can be valuable when standard dimensional results do not fully explain fill consistency, transfer behavior, or cavity imbalance. It can help identify process drift, fill inconsistency, or cavity imbalance that may not be visible in dimensional results alone.

What we monitor for release readiness:

Cavity Imbalance: Evidence that cavity-to-cavity behavior remains consistent within the defined acceptance limits.
Fill Consistency: Monitoring of viscosity shifts and pressure peaks across multiple cycles.
Capability Reports: Statistical evidence used to assess whether CTQ performance is likely to remain within the agreed limits.
Supporting Records: Anonymized capability charts and process-window study sheets used as supporting evidence.

Note: All process validation data is linked to the approved tool condition and active drawing revision for final release.

What Belongs in a Complete Validation Package?

Redacted PPAP binder and release records for injection mold validation package

Redacted PPAP binder and release records for mold validation package.

What should be included in an injection mold validation package?

A complete injection mold validation package should include ballooned drawings, dimensional or FAI records, PPAP documents where required, material certifications, and capability or process-stability evidence where required by customer scope or CTQ risk. It should also include documented revision history and ECN records so the physical tool and approval documents align with the latest engineering design before release or shipment transfer.

Ballooned drawing and dimensional layout records for injection mold validation

Ballooned drawing and dimensional layout records for tool approval review.

FAI and dimensional layout records

The dimensional layout should map measured features back to the approved drawing and identified CTQ requirements so the link between engineering data and the physical part is verified. This record serves as the primary dimensional baseline for the released condition.

Ballooned Drawing: features numbered and indexed to measurement data.
Layout Report: dimensional results covering the required drawing scope, with cavity-specific data where applicable.
CTQ Identification: defined measurement frequency and evidence for critical features according to the validation plan.
Sample Status: physical samples identified and tagged to match the reported records.

PPAP and Control-Plan Records for Production Release

For automotive and other controlled programs, formal PPAP documents may be required to show that the process, documents, and approval status are aligned with the customer-defined release scope.

Submission Level: as defined by customer PPAP scope or program requirement.
Control Plan: inspection frequency and methods for the production phase.
Process Flow: documented manufacturing and release steps from material input through approved shipment status.
Deviation Notes: documented waivers for any approved non-conformance.

ECN records, revision history, and shipment traceability logs for mold validation release.

Material Certifications, CoC, and Part Traceability Records

Traceability records should link the approved part to its material lot, cavity identification, revision status, and shipment record so the released condition can be traced back to source. A passed sample cannot be used as release evidence if it does not match the current approved revision and related ECN history.

Material Certifications: supplier COA and related material records where required by customer or program scope.
Certificate of Compliance (CoC): included where required by customer, industry, or shipment scope.
Cavity Identification: measurement data segregated by individual mold cavities.
Revision History: controlled history of tool changes and steel corrections linking to the current release status.

The release package should include a controlled history of tool changes and approved deviations so the released condition of the physical tool remains clear to all stakeholders.

Validation Record Checklist by Program Type

Record Type	Purpose	Industrial	Automotive	Medical	Before Release
FAI Report	Dimensional verification	✓	✓	✓	Required for release scope
Ballooned Drawing	Feature indexing	✓	✓	✓	Required for release scope
Control Plan	Quality maintenance	Optional	Typically required by program scope	As required by validation scope	As required for controlled release
Material COA	Resin compliance	✓	✓	✓	Required for release scope
Gage R&R / MSA	Data credibility	If required by CTQ measurement risk	As defined by customer or PPAP scope	As required by validation scope	Required when credibility affects CTQ approval
ECN / Revision Hist.	Change control	✓	✓	✓	Required for release scope

Common Validation Failures That Delay Tool Approval

Tool approval delays usually come from repeatable failure patterns in process evidence, measurement credibility, revision control, or package completeness. The following four failure patterns commonly delay mold approval and show what evidence is needed to resolve them.

Dimensions Passed, but Process Stability Was Not Proven

Capability evidence showing unstable process despite acceptable initial dimensional results

NCR Log: Process variation vs. initial FAI results.

Failure Pattern The FAI report shows acceptable sampled dimensions, but capability or repeatability evidence indicates variation that is still too high for release. Why SQE Reject It A successful dimensional snapshot does not prove repeatability across production conditions, shifts, or thermal variation. Buyers may face unstable results after launch. Evidence Fix Continuous run-off records and case: CTQ stability improved after mold and process changes.

Measurement Data Was Collected Before MSA

Quality engineer reviewing Gage R&R and fixture validation records

Verification: Audit of measurement credibility.

Failure Pattern High-precision dimensions are reported, but the measurement fixture or method has not undergone Gage R&R or MSA verification. Why SQE Reject It Without MSA, there is no evidence that the reported result reflects the actual part condition. The data cannot be trusted as reliable release evidence. Evidence Fix A verified Gage R&R record paired with case: why passing samples still failed under production conditions.

Tool Changes Invalidated Previous Approval Data

ECN records and delta verification evidence after tool modification

NCR: Tool modification without delta verification.

Failure Pattern A minor steel correction was made, but no delta dimensional verification was completed for the modified area and adjacent affected features. Why SQE Reject It The approved sample status no longer matches the physical tool, creating a revision-control gap that blocks formal quality release. Evidence Fix Full ECN revision history and Delta-FAI reports specifically targeting modified features and affected dimensions.

Reports Were Submitted, but No Controlled Approval Package Was Provided

Controlled approval package linking validation records and shipment-release information

Structure: Integrated release binder vs. scattered reports.

Failure Pattern The buyer receives disconnected reports for FAI, material certifications, and trial records instead of a controlled approval package. Why SQE Reject It An unorganized data set increases audit time and creates traceability gaps that block formal release review by the quality department. Evidence Fix A controlled approval package with revision-linked records, required submission documents, and shipment-release information.

When Full Validation Is NOT Required

Not every mold program requires full PPAP, capability studies, or formal qualification records. Over-validating low-risk projects increases lead time and documentation burden without improving the release decision.

"Validation depth should be matched to program risk, tolerance sensitivity, regulatory exposure, and the consequences of release failure."

Engineer reviewing prototype tooling documents for limited-scope validation.

Prototype or Bridge Tooling Cases with Limited Validation Scope

For prototype or bridge programs focused on functional verification or early launch support, a full PPAP package is often unnecessary unless specifically required by the customer. In these programs, approval evidence is usually centered on fit, function, material confirmation, and basic dimensional verification rather than full statistical process validation.

Bridge Tooling: temporary or lower-life tooling intended to support early production, pilot runs, or volume transition before the final production tool is released.
Validation Scope: Focus on critical assembly interfaces, material performance, and basic functional check.
Evidence: sampled dimensional review, functional verification, and controlled approval records appropriate to the prototype or bridge scope.

Low-risk industrial parts with limited CTQs

If a part has wider tolerances, limited CTQs, and no critical safety function, a simplified validation package is often sufficient. This is most applicable to non-regulated programs with limited CTQs and no customer-specific PPAP or formal submission requirement.

Explore our rapid tooling vs production mold decision matrix to select the right approach for your project.

Checklist and formal submission records compared for mold validation planning

Checklist vs. formal submission paths for mold validation planning.

When a Checklist Is Enough vs When a Formal Submission Is Required

The approval format should be based on the minimum evidence needed to support the release decision for that program type. The goal is to avoid unnecessary documentation while still keeping approval evidence aligned with part risk and intended release use.

Program Type	Evidence Required	Approval Format	Recommended Path
Prototype / R&D	Functional verification	Controlled sample approval record or short-form checklist review	Checklist enough
Low-Volume Industrial	Sampled dimensional review	Short-form approval records appropriate to the program scope	Checklist enough
Consumer Goods (High-Vol)	FAI, visual acceptance criteria, and additional capability evidence where required	Standard Approval Package	Formal Submission
Automotive / Medical	Formal approval package defined by customer scope, PPAP, or qualification plan	Full Technical Binder	Formal Submission

Validation Evidence Buyers Should Request Before Releasing the Mold

Tool approval should be based on controlled evidence rather than informal agreement or sample-only confirmation. The following evidence should be requested before authorizing mold shipment or production release so the tool condition, active drawing revision, CTQ evidence, and supporting documents all remain aligned.

For typical supplier submission contents, see our quality documents, PPAP & FAI deliverables.

Tooling Evidence

Final mold acceptance record with controlled approval status.
Complete steel correction & rework history (ECN logs).
Continuous run-off records, with video or additional logs where required.
Spare parts list and critical wear-item risk assessment.
Final mold cooling maps and wiring diagrams where required for shipment.

Verification of physical tool integrity and handover scope.

Part Release Evidence

CTQ dimensional layout mapped to the active drawing revision.
Approved reference sample status linked to release records.
Defined visual standard and approved limit samples.
Weight or cavity-to-cavity consistency tracking where required by design.
Functional assembly and fit verification report for mating components.

Verification of dimensional, cosmetic, and functional release status.

Process-Stability Evidence

Final trial condition record (Press settings and parameters).
Process window study or DOE records where required by CTQ risk.
Capability data for CTQ features where required by validation plan.
Tool condition and process evidence for features affecting repeatability.
Cycle-time verification where capacity is part of the release scope.

Verification of repeatability under defined release conditions.

Documentation & Traceability

Raw material certification and supplier COA records.
Certificate of Compliance (CoC) where required by industry scope.
Cavity identification and mold identification cross-reference.
Controlled revision history and ECN records linked to tool status.
Documented deviation log and approved waiver records.

Verification of traceability, revision control, and document integrity.

Upload Your Drawing for a Tool Approval and CTQ Review

Share your drawing revision, CTQ list, target tolerances, and approval requirements so release status can be based on defined evidence before shipment.

Expected Output: You will receive a technical review focused on CTQ risk identification, tolerance feasibility, and the specific validation evidence package (FAI/PPAP) required for your program release.

Latest CAD Revision & 2D Drawing (PDF/STP)

Program Type (Industrial / Automotive / Medical)

CTQ / Critical Features List

Tolerance Basis (Drawing / ISO / SPI / Specific)

Release Type (Shipment Transfer / Production Release)

PPAP / FAI Requirement or Unknown

Define supplier approval requirements before shipment so the released condition is based on controlled data, not on post-launch corrections. This review is intended to clarify the required validation scope and identify any change-control risks that could block tool release.

Upload CAD for DFM and Validation Review