Testing & dispatch | our primary concern : the optimum quality of your prostheses
A rigorous testing system adapated to the critcal nature of your parts
All product batches are tested during their manufacture and prior to dispatch. This testing programme is defined after a risk analysis: according to the end use of the part, the customer’s requirements and feedback from past manufacturing. The testing programme is formalised in a quality assurance plan that is submitted to the customer for validation. Any significant modification of the manufacturing and/or testing process is submitted to the customer for validation.
Numerous tests are carried out on your parts. We adapt them to your specifications. The main tests are listed below.
FLUORESCENT DYE PENETRANT INSPECTION
This is carried out on 100% of the surface of all parts by staff with COFREND (French confederation for non-destructive testing) level 2 qualifications. The tests are carried out in accordance with standards NF EN 10228-2 and ISO 3452-1. The penetrant inspection line is an SREM line specifically for products intended for the medical market. Our products are sensitivity level S3. A brand-new penetrant inspection system was installed in 2016.
These are carried out at the various stages in the production process and at the end of the process, prior to delivery. Manual tools (callipers, gauges, profile projectors, etc.) or automatic tools (3D machine) are used for this.
MECHANICAL AND MICROGRAPHIC TESTS
- Micrographic structure
- Grain size
Additional subcontracted tests
FORGINAL medical has a comprehensive list of approved subcontractors for carrying out additional tests.
All our subcontractors are COFRAC (French accreditation body) accredited. They can carry out tensile testing in accordance with ASTM E8/E8M or ISO 6892-1.
Full traceability is assured, and control of the service provided is guaranteed by the use of precise specifications. Other tests can be carried out on request, according to our customers’ specific requirements (hydrogen content, alpha-case depth, grain flow, etc.)
Testing Department equipment and production facilities
- Mitutoyo Crysta-Apex 3D machine
- Universal hardness testing machine
- Microscope and preparation equipment (cutting sections, mounting, polishing)
- SREM sensitivity level S3 penetrant inspection line for medical products
Testing / Quality team
This is made up of 10 people, 2 of whom are COFREND (French confederation for non-destructive testing) level 2 qualified penetrant inspection and magnetic particle testers. The average experience of the team is over 15 years. The testing team is multi-skilled.
With FORGINAL medical for 10 years
I set up the testing department and implemented all the in-production and final quality monitoring. You need a firm grounding in quite a few areas, including metallurgy, heat treatment and measuring systems. I am still learning every day and it is fascinating!