QMS
What does QMS stand for?
Quality Management System
What is an ECO?
Engineering Change Order
What does TWD stand for?
Trackwise Digital system
What does CAPA stand for?
Corrective and Preventive Action
What does ETR stand for?
Electronic Training Record
Who is the Management Representative and San Jose Quality leader?
Dario Pedulla
What is the email for San Jose Document Control?
USSJO Document Control or USSJODocumentControl@thermo.com
What is name of the Quality System which process Complaints in San Jose?
TWD Complaints system
How many days can a CAPA be in the review/planning phase before it needs to be moved to implementation? (Please note this excludes an ER.)
30 days
Where are OP/WI accessed?
via OCPLM or OCPLM PIM (everyone must have access to one or the other)
Name 3 Quality processes required per the QMS?
CAPA, Complaint, Training, Document Control, Internal Audit, Management Review…
What is the new PLM system? or What is the ProductCenter replacement? or What is the Thermo Fisher San Jose’s product data management system?
Oracle Cloud PLM or OCPLM
How can a Complaint be received in the TWD system?
(any of the following): Direct Contact, Email, Telephone, Web, Service Support (C4S system)
What are the 3 different types of CAPAs?
Correction, Corrective Action, and Preventive Action
What is TFU Training?
Thermo Fisher University Training Corporate Training
What regulation San Jose site must follow to manufacture Medical Devices?
21 CFR Part 820
What are the EDA workflow steps that require approvers?
CCB & Approval
What is the goal of the TWD Trackwise Digital Complaint System?
To have a centralized Medical Device Complaint Handling system to document complaints, maximize control, minimize risk, and improve quality
What are the 2 factors used to determine the risk assessment for a CAPA?
Frequency and Impact
What is QMS Training?
Quality Management System (governed by ISO 9001 International general QMS, ISO 13485 International Med Device QMS & FDA 21CFR820 US
What ISO certification San Jose site holds?
ISO 13485:2016, ISO 9001:2015, ISO 27001:2012
What are the ECO workflow steps that require approvers?
Technical CCB, Operational CCB & Approval
When should a Complaint be reported to the FDA?
A medical device caused or contributed to a death or serious injury or has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Name all of the phases of a CAPA in the correct order.
Open, Review/Planning, Implementation, Verification/Final Review
How often should training profiles be reviewed?
Managers shall review training profiles at least once per year or when job role changes. Any changes shall be communicated to QA Training Compliance