Context
A French distributor of industrial safety equipment had been supplying EN-certified cut-resistant work gloves to manufacturing and logistics clients across France for three years. The gloves carried a valid CE mark under EU PPE Regulation 2016/425, backed by an EU Type Examination Certificate from a recognised Notified Body. Procurement was straightforward — one Guangzhou supplier, consistent pricing, no significant complaints. The distributor engaged MAXAM Group as part of a routine quality review of its Asian sourcing portfolio, expecting to establish a baseline framework before adding new suppliers. The audit found something that had already been going wrong for at least fourteen months — quietly, and without any of the visible signals that normally prompt a supplier review.
Our Mission
Establish whether the certified specification matched the product currently being shipped, manage the regulatory and commercial exposure created by any discrepancy, and restore a compliant, continuous supply of EN 388-certified cut-resistant gloves to the distributor's clients without triggering a stockout.
Our Approach
MAXAM Group conducted physical product sampling at the Guangzhou factory and a line-by-line comparison against the EU Type Examination Certificate. The audit found that the supplier had reformulated the palm coating and substituted a lower-grade blended yarn for the certified HPPE liner — a change that affected cut-resistance performance, was never re-submitted for type examination, and continued to ship under the original CE marking. MAXAM ran the response on three simultaneous tracks. An interim supply was secured from a Portuguese EN 388-certified PPE manufacturer within eleven days, removing stockout risk while shipments from Guangzhou were suspended. Re-qualification of the Chinese supplier was managed end-to-end — formal notification to the original Notified Body, sample submission from the modified production, and a fresh type examination under EN 388:2016+A1:2018 — with the new certificate issued seventeen weeks after submission. In parallel, the team helped the distributor compile a documented internal assessment covering the period of non-conforming distribution, the performance parameters affected, and the corrective actions taken — establishing a defensible record of due diligence in the event of a future regulatory inquiry. The standard purchasing contract was rewritten to require pre-approval of any supplier material or process change before implementation, prohibiting the application of existing CE marking to any modified product without confirmed re-examination.
Before & After Results
| Metric | Before | After |
|---|---|---|
| Spec verification method | Document-based only | Physical product audit |
| Time to alternate qualified supply | 0 (single source) | 11 days (Portugal) |
| Notified Body re-examination | Never initiated | 17 weeks to new certificate |
| Material change governance | No supplier obligation | Pre-approval contract clause |
"We assumed a valid CE marking and a Notified Body certificate were the end of the verification process. MAXAM showed us they were the beginning of one. The audit caught a material substitution that had been live for over a year and that no document on file would ever have revealed."
Quality & Compliance Director
Quality & Compliance Director — French Industrial Safety Distributor