Criteria

Factory Development.

Suppliers to WETRA-XT Group are required to document the following steps in the product’s lifecycle and have that documentation available for WETRA-XT Group upon request.
Design Review – Confirmation from an accredited third party or accredited in-house laboratory that the product meets all applicable federal, state and local laws, in addition to all WETRA-XT Group performance and functional requirements.
Quality System Assessment – Documentation of regular, random inspections of manufacturing process by an accredited third party or accredited in-house auditor. The audits should document that quality assurance systems are in place to assure that the product meets all applicable federal, state and local laws, in addition to all US

WETRA-XT Group performance and functional requirements. These systems include, but are not limited to:
Supplier Management and control
Process control
Calibration and Maintenance of machinery and test fixtures
Organizational structure
Document Management
Corrective Action Process
Continuous Improvement activities

Manufacturing Process Control – Verification that the factory in which the product is being produced has adequate quality procedures and capacity. Points for verification include but are not limited to:
Incoming component and raw material inspections
In-line/In – Process quality inspections
Finished product inspection and testing
Capacity Analysis

Change Management – Documentation of all approval processes (internal and external approvals) for modifications to the product that affect:
Aesthetics/Cosmetics
Safety
Material Substitution
Packaging
Performance
Graphics / Copy Text (packaging)
Alternative components

Suppliers are also required to have the factory information available upon request for the USA WETRA-XT Group. This information may be required if there are quality issues or violations of government regulations. If the factory information is requested, the supplier is required to submit all information related to the factory including, but not limited to the information referenced above.