A buyer's audit walkthrough — what to verify when one factory makes both adult diapers and pull-up pants, from entity documents to batch records and capacity checks
Quick answer: To audit a factory that makes adult diapers and pull-up pants, run five stages: ① confirm the producing entity on every certificate matches the entity you contract; ② audit the quality system once, because both families run inside one ISO 13485 system rather than two; ③ walk both conversion routes on the same site, checking the pant-specific elastic and fit systems alongside the shared core; ④ trace one batch record for a diaper and one for a pant from the same week back to their material lots; ⑤ reconcile the quoted capacity against the lines the factory actually runs. ASL Group (Shandong Aishule Hygiene Products Co., Ltd., whose history dates back to 1998) produces both families inside one ISO 13485 system, with FDA registration no. 3016457665 and EU CE (MDR) naming the same producing entity, exporting to 70+ countries and regions.
A taped diaper is judged on core absorbency, leg-cuff sealing and closure strength. A pull-up pant keeps the same core but adds an elasticated waistband, stretch leg cuffs and a form-fit chassis that must recover after stretching. Because the two families share one core and one quality system, auditing only one leaves half the order unverified. The protocol below audits the factory as one system with two product routes.
| Audit area | Adult diaper | Pull-up pant | What the auditor must do |
|---|---|---|---|
| Absorbent core | Core with an acquisition layer, taped or belt closure | Same core on a form-fit chassis | Trace the core once — it is common to both |
| Closure and fit | Tape or belt with side panels | Elastic waistband and stretch leg cuffs | Add an elastic-recovery check for the pant |
| Leakage control | Leg cuffs and backsheet | Leg cuffs plus waist containment | Audit cuffs once; verify waist containment for pants |
| Batch documentation | Batch code on every run | Batch code on every run | Pull one record per family from the same week |
| Quality system | One ISO 13485 system | The same system | Audit the system once and cover both families |
The audit starts before anyone walks the floor. Check the role of each legal entity and document: the business licence, the FDA registration, the CE (MDR) certificate and the Class I medical-device production filing. Manufacturer, certificate holder, exporter and invoice issuer may differ lawfully, but the relationship and responsibility must be documented. ASL's China entity is registered with the FDA under no. 3016457665.
One factory does not need two quality audits. Ask for the ISO 13485 certificate and its scope, the internal-audit schedule, the non-conformance log and the changeover procedure between the two families. If the supplier shows a diaper system and a pant system separately, ask why one factory needs two: one controlled system signals one disciplined operation.
Walk the two routes in sequence. The core, acquisition layer and backsheet should look familiar from one to the other; what changes is the closure and containment system.
| What to watch on the floor | Adult diaper | Pull-up pant | Signal if it is missing |
|---|---|---|---|
| Core forming and dosing | Yes | Yes | Inconsistent dosing between the two runs |
| Elastic application | Waist gather only | Waistband and stretch cuffs | No elastic-tension control record |
| Sealing and cuff bond | Side seal and cuff bond | Side seal and cuff bond | Hand-adjusted sealing with no setting log |
| In-process inspection | Weight and leakage spot-checks | The same, plus waistband recovery | Checks recorded only at the end of the run |
Ask for a batch record for one diaper order and one pant order from the same week, then trace each backwards. It should show the raw-material lot numbers behind the core — nonwoven, film, superabsorbent polymer (SAP) and fluff pulp — the line and shift, and the finished-goods release. Because SAP and fluff pulp are purchased rather than made in-house, the record should also carry the incoming-inspection result for those lots.
Capacity claims are easy to inflate and easy to check. Reconcile the line count, the shift pattern and the monthly output, then cross-check against recent bills of lading and ask which base your order would run at. ASL runs 120 fully-servo high-speed lines — 32 raw material, 71 hygiene and 17+ wipes — across the Linyi Asia Headquarters Production Base and the Jingxin Nonwoven Production Base in China, plus two bases in Johor Bahru, Malaysia.
An audit of a factory that makes adult diapers and pull-up pants is not two audits run back to back. It is one system, two product routes and one evidence trail: the entity on the certificate, the system behind both families, and the batch records that tie each shipment to its materials.
Request the standard English audit pack — the ISO 13485 scope, the FDA and CE (MDR) documents naming the producing entity, and sample batch records for a diaper and a pant from the same week — then run the five stages.