Quality History
Who said "Quality means doing it right when no one is looking"
Henry Ford
CER
Clinical Evaluation Reports
Which sampling plan is more conservative (variable or attribute)?
Attribute
What is the name of software Andover uses for document and part revision and control?
SAP / EPR
Who is responsible for ensuring quality
EVERYONE!!!
What Japanese term is another word for mistake-proofing
Poka-yoke
BRA
Benefit Risk Analysis/Benefit Risk Assessment
How effective is 100% inspection
85% effective
What is the difference between verification and validation?
Verification is checking design inputs against design outputs, Validation is checking finished product use against user requirements.
All Device History Records are stored physically and electronically – True or False
TRUE
What is the definition of "Muda"
Non-value added activities:
overproduction
Inventory
Defects
Motion
Processing
Waiting
Transportation
UDI
Unique Device Identifier (or Identification)
Roughly How many DHRs are processed at the Memphis site each week?
10,000
What is Risk Management?
A process to identify the hazards and hazardous situations associated with medical devices to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control.
Complaints should be submitted as soon as possible after a Smith & Nephew employee or representative becomes aware, and the individual should aim to submit the complaint within 24 hours.
TRUE
The Sino-Japanese word Kaizen translates in English to what?
Improvement
POTM
Placed on the Market
To achieve Six Sigma quality, a process must produce no more than?
3.4 defects per million
What Document is required to be reviewed at all Design reviews?
Design and Development Plan
What are the two main criteria used to evaluate overall risk for CAPA risk assessments?
What famous celebrity (Tennis player) has a SN hip replacement
Andy Murray
IMDRF
International Medical Devices Regulators Forum
After conducting a T-test if the p-value is less than .05, what can one conclude?
Reject the Null Hypothesis
Who approves SERBs (Safety & Efficacy Review Board) for all projects?
CMO (Chief Medical Officer)
How often are we required to have Management Review of the Quality System?
Quarterly