THE GIFT
To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life
What is Medtronic Mission Statement
An official inspection of an individual's or organization's accounts, typically by an independent body.
What is an audit
A record created and maintained to provide evidence of compliance to quality system and regulatory requirements.
What is a Quality Record
The four QBwM behaviors:
What are accountable, courageous, patient-focused, and preventative.
What is a Sharpie
The four Leadership Expectations are the actions and behaviors that all employees must develop and demonstrate in pursuit of our Mission.
What are Shape, Engage, Innovate and Achieve.
True reason for the non-conformance and/or failure in a process, component or product. _____ are the basic reasons for why causal factors occur or persist.
What is Root Cause
pre-approved deviations from the current operational document or system, covering a specified period of time or number of batches
What is planned deviaiton
Who is the current Senior VP, Chief Quality Officer of Medtronic?
Who is Noel Colon
The error code does TR stand for?
Transcript error
This regulatory body audited Medtronic recently in October 2021 (must know full name to get credit)
Who is Therapeutic Goods Administration
(TGA)
Processes that identify or measure the conformance or nonconformance of product, process, and quality system requirements. For example, complaints, nonconforming material, internal and external audits, clinical trials, environmental monitoring, or quality records.
What is CAPA
The documented process of demonstrating that a system or process meets a defined set of requirements.
What is Validation
The year in which QBwM was introduced to all employees when Covidien and Medtronic combined companies
What is 2016
Nonconforming product that is detected at a location other than at the operation that created it.
What is an escape.
The year in which Magnifuse was launched on site.
What is 2009.
a method of assessing the performance of a business unit to determine whether business requirements or objectives are being met and, if not, what steps should be taken to meet them.
What is Gap Analysis
a process—either formal or informal—used to ensure that changes to a product or system are introduced in a controlled and coordinated manner
What is Change Control
Electronic notification generated in SAP to document a nonconformance related to a quality event that impacts product. The QN is equivalent to a hard copy generated MCDR
What is a QN- Quality Notification
Besides Agile and Site Builder this is another area to access Quality Documents
QMS- Quality Management Systems Portal
This tissue bank was the first established tissue bank in United States in 1949 by founder Dr. George Hyatt
What is the United States Navy Tissue Bank.
The ___ principle provides guidance on how to continuously improve product quality by reducing the number of defects seen at a given work-step. Do not make defects.
What is First Time Quality (FTQ)
This type of FDA form is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts
What is Form 483
a Japanese term that means “mistake-proofing,” refers to any tool or mechanism that keeps a person from being able to perform an action in an incorrect manner
What is Poka Yoke
What FDA title number is associated with the Code of Federal Regulations that govern GDP guidelines for medical devices
Title 21 also known as 21 CFR