Quality Assurance and Quality Control
All Trustpass Consulting LLC. production is done according to clients’ specifications and subjected to stringent QA/QC procedures.
Our Quality Management System complies with European and USA regulations, consisting in a twofold quality assurance and quality control procedures stages.
Acceptance criteria for raw material used by us, such as Silicone, Medical-grade Silicone (all medical-grade silicone has to abide by the criteria established in Applied Silicone corp. material compendia outlining the physical, chemical and biological testing of raw material specific to each long term implantable silicone), PVC, TPE, and others are full compliance with European and USA norms.
All materials used, are Phthalates free and BPA Free.
This ensures that our products are free of components banned for toys and food contact such as
- di-(2-Ethylhexyl) phthalate (DEHP), CAS No 117-81-7
- di-n-butyl phthalate (DBP), CAS No 84-74-2
- butyl benzyl phthalate (BBP), CAS No 85-68-7
- diisononyl phthalate (DINP), CAS No 28553-12-0
- diisodecyl phthalate (DIDP), CAS No 26761-40-0
- di-n-octyl phthalate (DNOP), CAS No 117-84-0
The raw material is stored at an appropriate temperature while awaiting quality assurance verification and until transferred to the production rooms.
Exacting standards of hygiene and cleanliness are applied to all our production rooms, where all workers are required to wear hygiene protective wear (latex gloves, dental hygiene shoes, hairnet, and masks).
Our production room schedule incorporates daily cleaning and disinfecting schedules, in sync with the worker’s rotation and machines’ cooling time.
This further guarantees the safety of the high-quality electric motors used in the relevant products.
As part of our quality assurance procedure, all electrical components are tested on a randomized basis compliant with regulations before being assembled. Electric motors are repeatedly tested during numerous steps of the production and the finished product is then tested again upon leaving the assembly line.
For non-electric parts, analysis and detection of impurities and identification of physical and chemical defects testing routine are implemented at key stages of production.
Finished products are then subjected to Quality Control procedures. QC includes verification of steps taken to ensure quality and specification compliance of raw materials, verification of compliance with intermediary subroutine testing during production, and of compliance to final testing routine.
Randomized tests on all finished products are an integral part of the QC procedure.
Our company is proud of its quality management that goes above and beyond the required quality specifications required by the USA and European regulations and are designed to remain valid even if the USA and European regulations are tightened.