Product/Supplier Quality
The definition of IP for Product Quality.
What is Inspection Plan?
This is what NPDI stands for.
What is New Product Development and Introduction?
This is what ESD stands for.
What is Electrostatic Discharge?
This is what CAPA stands for.
What is Corrective Action and Preventative Action?
This is the definition of QMS.
What is Quality Management System?
This is what DPU stands for.
What is Defects per Unit?
What is OpenText?
This is the acronym for Registration, Evaluation, Authorization and Restriction of Chemicals
What is REACH?
This is the software package used in San Jose to capture CAPA's/Complaints.
What is Trackwise Digital (TWD)?
The two ISO standards that the San Jose site is certified to.
What is ISO 9001 and ISO 13485?
The San Jose site's primary supplier.
Who is Jabil?
This is the number of phases in the San Jose site's NPDI process.
What is 5 phases?
The geographic region associated with the CE certification logo on the San Jose site's product labels.
What is Europe?
This is the final phase of a CAPA prior to closure.
What is Verification of Effectiveness (VoE)?
Three of the annual internal audit's conducted at the San Jose site.
What is any of these three departments:
Supplier Quality, Document Control, Management Responsibility/Management Review, Resources/Facilities, Design & Development, Order Fullfilment/Purchasing/Receiving Inspection, Calibration/Validation, & NCM/CAPA?
What is warranty or installation?
Name two of the phases of the San Jose site's NPDI process.
What is Discovery, Feasibility, Implementation, Design Transfer, & Commercialization?
The geographic region associated with the "25" logo on the San Jose site's product labels.
What is China (China RoHS)?
This is the target date for closure of a medical device reportable complaint.
What is 30 days?
The San Jose site's Senior Quality & Regulatory Affairs Director.
Who is Dario Pedulla?
This is the difference between an SCR and an EDA.
What is an SCR is initiated by the supplier and an EDA is initiated by internal manufacturing engineering?
This is the difference between an EP and an MP.
2014/30/EU refers to this directive.
What is Electromagnetic Compatibility Directive (EMC)?
The number of points it takes to trigger a CAPA, according to the CAPA scorecard.
What is 15?
This is our Quality Policy.
What is we fulfill our Mission to enable our customers to make the world healthier, cleaner, and safer by continuously improving the quality of our products and services and by ensuring global regulatory compliance?