EMPB, ISIR or PPAP?
If the question is which customer approval system applies, use the EMPB vs ISIR vs PPAP comparison . This page assumes PPAP is already the agreed submission route.
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Request Engineering ReviewA PPAP Level 3 package for an injection-molded part is not a fixed bundle that every project must submit in the same way. The customer, OEM, Tier-1 requirement, drawing, and applicable customer-specific requirements define the submission level and which records must be sent for approval.
For molded parts, a release-ready package should make one approval basis traceable across the current drawing revision, PSW, mold and cavity identification, resin or material records, dimensional evidence, process-risk documents, and any MSA or capability evidence required by the customer.
Use the injection molding validation and release guide for the wider validation path.
This page owns: the Level 3 document package, submitted-versus-retained evidence, molded-part traceability, common customer HOLD reasons, and resubmission triggers. Detailed FAI reporting, process-window development, production sampling, SPC, and final mold acceptance are intentionally handled elsewhere.
This page focuses on the document package used to support a Level 3 PPAP submission for injection-molded parts: what is submitted, what may be retained, how the evidence remains traceable, and when a change may require resubmission. It is not intended to replace separate approval, inspection, or process-validation procedures.
If the question is which customer approval system applies, use the EMPB vs ISIR vs PPAP comparison . This page assumes PPAP is already the agreed submission route.
Detailed dimensional-report structure, inspection fields, and FAI approval logic belong in the injection molding FAI report requirements . FAI evidence may support PPAP, but it is not the complete PPAP package.
This guide may identify MSA, capability, process, material, or production-intent evidence when applicable, but it does not teach GR&R methodology, capability calculations, DOE, process-window development, production sampling, SPC, or final mold acceptance.
Keep the approval question separate from the evidence question: this page explains what belongs in the PPAP submission package and how the records must align; customer-specific requirements still determine the final submission scope.
“Level 3” does not mean that every possible PPAP record is automatically sent as a fixed document bundle. Each applicable requirement should be classified according to the customer-approved submission scope: evidence may be submitted for review, retained by the supplier and made available on request, or identified as not applicable with an appropriate basis. The applicable PPAP requirement and customer-specific requirements take precedence over a generic checklist.
Records included in the customer submission package for review or approval. Typical examples may include the PSW and applicable dimensional, material, risk-control, MSA, capability, or supporting evidence required for that project.
Applicable records maintained under document control by the supplier but not necessarily transmitted with the package. They should remain traceable to the approved part and be retrievable when requested by the customer or during an audit.
An element may be treated as N/A when it does not apply to the specific product, process, submission level, or customer requirement. N/A should be a documented determination—not a convenient substitute for missing evidence.
PPAP review rule: classify each required element before assembling the package. A controlled Submit / Retain / N/A decision is more reliable than assuming that Level 3 always means “send every file.”
A Level 3 package should not be treated as a universal stack of “18 mandatory files.” The applicable PPAP elements, their submission status, and the amount of supporting evidence depend on the customer, product, drawing, process, and program requirements. For molded parts, the practical review is whether each required element is current, traceable to the production-intent basis, and consistent with the final PSW and released product definition.
| PPAP Element | Typical Treatment | Molded-Part Evidence | Applicability | Common HOLD Risk |
|---|---|---|---|---|
| Design Records & Engineering Changes | Submit / reference as required | Released drawing, part number, specification revision, approved engineering changes, and any customer-approved deviation affecting the molded part. | Normally applicable | Drawing, PSW, inspection report, or change status refers to a different revision. |
| Process Flow, PFMEA & Control Plan | Submit or retain per scope | Production flow, molding and inspection risks, controls, reaction logic, and CTQ handling aligned to the intended process. | Customer / program defined | Risk controls do not match the actual process, inspection method, or Control Plan. |
| Dimensional Results | Common submission evidence | Drawing-linked measurement results with part, revision, sample, mold, and cavity identification where the approved inspection scope requires cavity-level traceability. | Scope defined by customer | Missing feature traceability, mixed cavity data, incomplete drawing coverage, or obsolete revision. |
| Material & Performance Evidence | Submit / retain where applicable | Resin grade, supplier or source record, material certificate, colorant or additive identification, and required functional or performance evidence. | Product-specific | Material identity, lot, specification, or approved source cannot be reconciled with the submitted sample. |
| MSA & Capability Evidence | Where required | Measurement-system and capability evidence for characteristics identified by the applicable customer or program requirement. | Not universally required | Unsupported measurement method, wrong characteristic, or capability evidence that does not match the approved process. |
| Samples, Master Evidence & PSW | Customer-defined | Production-intent samples, retained or approved sample evidence, submission status, and the PSW that identifies the final approval basis. | Submission-level dependent | Samples, supporting records, and PSW cannot be traced to the same part, revision, mold, cavity, material, or production basis. |
Do not convert this matrix into a universal mandatory-file list. The applicable PPAP manual, customer-specific requirements, drawing, purchase or program requirements, and approved submission level determine what must be submitted, retained, reviewed on site, or marked not applicable.
PPAP terminology and submission concepts should be checked against the applicable AIAG Production Part Approval Process (PPAP-4) and the customer’s current CSR or program requirements. AIAG describes PPAP as the industry process used to confirm that production parts can consistently meet the engineering design record and specification requirements.
A molded-part PPAP package should allow a reviewer to reconstruct the production-intent basis behind the submitted evidence. The part number and released drawing revision should connect to the actual mold and cavity configuration, approved resin or material record, molded sample, inspection results, and final PSW. When cavity-level identification is required, dimensional or approval evidence should preserve that identity instead of combining results in a way that hides variation between cavities.
Use one traceable approval chain. Sample labels, dimensional reports, material records, mold and cavity identifiers, and the PSW should refer to the same released production basis. Revision-controlled records should make that relationship easy for the customer or SQE to verify.
Mixed cavity data, an unlinked resin lot, an obsolete drawing revision, or samples that cannot be tied to the stated mold and process basis can stop approval even when the individual reports appear complete.
PPAP measurement evidence should demonstrate that the submitted results are traceable to the released requirements and are supported by an appropriate measurement and production basis. The package does not need the same dimensional, MSA, or capability evidence for every characteristic; the applicable customer and program requirements determine what is required.
Measurement results should map to the released drawing and identify the inspected sample or cavity where required. Detailed inspection-report structure belongs in the injection molding FAI report requirements .
Where required, the measurement-system evidence should support the specific characteristics and inspection method used for the PPAP results. This section does not prescribe a universal GR&R method or acceptance threshold.
Initial process or capability evidence should relate to the customer-defined characteristics, sample basis, and production conditions being approved. No universal Cpk or Ppk threshold is assumed here. PPAP may require capability evidence for selected CTQs, but the submission package does not define the statistical method itself. For sampling basis, cavity-level analysis, measurement-system risk and Cpk interpretation, see the Cpk capability guide for injection-molded CTQ dimensions .
This section checks evidence alignment, not statistical-method development. GR&R methodology, sampling plans, process-window development, SPC, and detailed capability-study design remain outside this page.
A new part normally requires an initial approval path, while changes to an already approved part may require the PPAP basis to be reviewed or resubmitted. The trigger itself does not automatically determine the submission level or mean that every Level 3 element must be sent again; the applicable customer and change-control requirements determine the required scope.
A new production part, new mold, replacement tool, or newly approved cavity configuration may require an initial PPAP submission.
Drawing, specification, geometry, CTQ, or approved engineering changes should be checked against the customer’s resubmission requirements and controlled through the applicable injection molding ECN process .
Resin grade, approved source, colorant, additive, or other controlled material changes may affect the original PPAP evidence.
Major mold repair, insert replacement, cavity addition, cavity replacement, or tool modification may require the approval basis to be reviewed.
Manufacturing transfer, significant equipment or process change, or another production-condition change may require customer review or updated PPAP evidence.
OEM, Tier-1, program, or purchase requirements may define additional triggers, evidence updates, periodic review, or a specific submission level.
A change does not automatically require a complete Level 3 resubmission. Review the customer-specific requirement, drawing or approved change, purchase or program requirement, and change-control decision to identify which PPAP elements must actually be updated and resubmitted.
A PPAP package may be placed on HOLD even when the molded samples appear acceptable. Review delays often occur because the submitted evidence does not describe one consistent, traceable approval basis across the part revision, mold and cavity, material, measurement records, process controls, and customer-specific requirements.
The PSW, drawing, dimensional report, or engineering-change status refers to a different part or revision.
Results cannot be linked to the submitted sample, mold, cavity, material lot, or production basis where that traceability is required.
Documented process risks, controls, inspection methods, or reaction logic do not match the production-intent process.
Required MSA or capability evidence does not support the characteristic, measurement method, sample basis, or process condition being approved.
Samples were produced before required tooling, material, or process changes were closed and therefore do not represent the approval basis.
The generic package appears complete, but an OEM, Tier-1, drawing, purchase, or program-specific PPAP requirement is missing.
A PPAP HOLD is not automatically a manufacturing defect. Missing, conflicting, uncontrolled, or incomplete approval evidence can stop customer review even when the physical molded parts are acceptable.
Use this engineering checklist before customer submission to verify the evidence status, revision control, molded-part traceability, HOLD risks, approval status, and change-driven resubmission scope. It is designed to support a customer-defined Level 3 review rather than impose a universal mandatory-file list.
The downloadable checklist includes Submit / Retain / N/A status, owner, revision, evidence file, customer approval status, mold and cavity traceability, common HOLD signals, and resubmission triggers. Final requirements remain subject to the applicable customer, program, drawing, and PPAP instructions.
Before release, confirm the submission scope, evidence status, molded-part traceability, required measurement support, and customer-specific requirements against the same production-intent approval basis.
No. The applicable customer, program, drawing, and PPAP requirements determine what is submitted, retained, or marked N/A.
No. Preserve cavity identity when the customer, drawing, inspection plan, or approval scope requires cavity-level evidence.
No universal rule applies. Use the customer-defined characteristics, Control Plan, and approved PPAP scope.
No. Review the affected approval basis and customer requirements to determine which PPAP elements must be updated or resubmitted.
Send the released drawing, requested PPAP level, customer-specific requirements, material specification, and available quality records. SPI can review the package scope and identify missing or conflicting evidence before submission.