A medical device contract manufacturer, ISO 13485 certified, with 140 active parts and an 18-element PPAP taxonomy per part. Quality engineers signed off on packets where a control plan carried the wrong revision more often than anyone wanted to admit. We built the validation layer: LlamaParse on typed submissions, LandingAI on stamped acceptance signatures, every PPAP element checked against the customer requirement list before release.
| PPAP | Part | Supplier | Level | Elements | Cpk | Status |
|---|---|---|---|---|---|---|
| P-04812 | MD-220 cannula assy | Northbridge Precision | 3 | 18 / 18 | 1.84 | PSW signed |
| P-04813 | MD-318 valve subassy | Pinehurst Medical Molding | 3 | 18 / 18 | 1.67 | PSW signed |
| P-04814 | MD-145 catheter hub | Cedar EMS | 3 | 17 / 18 | 1.42 | MSA re-run |
| P-04815 | MD-507 housing, lower | Granite Tool & Die | 3 | 18 / 18 | 1.91 | PSW signed |
| P-04816 | MD-262 electrode pad | Riverbend Medical | 4 |
| 16 / 18 |
| 1.21 |
| Cpk < 1.33 |
| P-04817 | MD-410 luer fitting | Northbridge Precision | 3 | 18 / 18 | 1.58 | PSW signed |
| P-04818 | MD-198 sensor housing | Pinehurst Medical Molding | 3 | 17 / 18 | 1.55 | capability re-run |
| P-04819 | MD-355 tubing set | Cedar EMS | 3 | 18 / 18 | 1.72 | PSW signed |
At a glance
One quality team, 140 active parts, one PLM of record. The revision-and-element check was the piece the SQEs could not get done inside the customer's window.
The engagement
The stack
ISO 27001 · ISO 9001 · ISO 13485 · DPA and NDA signed at kickoff.
Before, the quality desk
SQEs ran through every packet against the customer requirement list for that part. The list changed by customer, the parts changed by program, and the revision level was the easiest thing to miss.
The SQE opened the packet, pulled the customer requirement list, and matched each of the 18 elements against the document. On a clean packet, 45 minutes of SQE time. On a packet with a missing element, up to two hours to find the gap and chase the engineering team.
Pre-build baseline: 45 to 120 minutes of SQE time per packet, across 90 packets a month.
A part revision bumped on Wednesday; the control plan in the PPAP was stamped from Tuesday. The SQE caught most of these, but not all. When a customer caught it first, the packet came back rejected, which was the audit note.
Pre-build baseline: approximately 7% of packets caught downstream with a wrong-revision element.
Customer A wanted capability studies at level 3. Customer B wanted them at level 2. The list varied by program. Senior SQEs kept the variations in their head; newer staff worked from a binder that was a quarter behind. The variation showed up in audit as "one team, two answers."
Pre-build baseline: customer-list agreement varied by SQE, measurable in quarterly audit sample.
What we built
The pipeline follows the same five stages we run on every PPAP engagement. The customer-requirement matcher is tuned against this client's active customer list and part register.
Customer portal downloads, supplier-quality mailbox polled on a 10-minute cadence, engineering drop to SFTP. Every submission assigned a single PPAP ID tied to the part.
Each element tagged to its PPAP slot. Submission warrant, control plan, PFMEA, dimensional results, material certs, capability studies routed separately but linked by PPAP ID.
Part number, revision level, control characteristics, Cpk values, signature stamps. LlamaParse on typed elements, LandingAI on stamped acceptance signatures.
Each element checked against the customer's requirement list for the part. Revision level cross-checked against the part register. Below 0.90 confidence, the packet holds for SQE review.
Clean packets posted to Arena Solutions PLM against the part record, with the customer acknowledgement and element evidence attached. Held packets route to a named SQE queue with the flag named in plain English.
After, the numbers the quality desk signs off
Same SQEs, same 140 parts, same customers. The pipeline ran the 18-element check and the revision match before the packet left for the customer. Rejection cycles dropped, and so did the audit notes.
SQEs still own the release. They still sign off every PPAP. The difference is that the 18-element list, the revision check, and the customer list run before the SQE opens the file, and the ones that advance are the ones ready for the customer.
From the desk
Wrong-revision rejections used to come back from the customer. Now they get caught before we release, which is where they should be caught.
Quality leadMedical device contract manufacturer, New England
Handover
The engagement ends at a clean handover. The quality team runs the pipeline; Hexaa stays on call for a fixed retention period, then steps back.
Related cases
Each links to a named client, a named document, and the system the clean data lands in. We publish only what the client signed off to publish.
PPAP audit packs assembled from the QMS and posted to the customer portal, with CofA and control-plan revisions matched at release.
→Manufacturing · 2025Industrial components manufacturer · NCR 8D closeoutNon-conformance reports closed out with 8D completeness enforced at the CAPA owner. Built on LlamaParse, integrated with ETQ Reliance.
→Logistics · 2025Global freight forwarder · port-side customs packets28,000 packets a month reconciled inside a four-hour clearance window. LlamaParse on the intake, CargoWise as the system of record.
→Free 30-minute call
You'll leave with a clear next step.
A PPAP submission arrives with a warrant, a control plan, and a PFMEA. The pipeline checks each element against the customer's 18-element requirement list, cross-checks the revision level against the part register, and holds the packet if an element is missing or stamped at the wrong revision.
