Quality Culture

4. The ability to track a product's manufacturing history and components through the entire supply chain.
5. The analysis of data over time to spot upward or downward shifts in quality metrics.
6. The sequence of industrial, administrative, or other processes through which a piece of work passes.
10. Permanent, unalterable historical documents providing objective evidence of activities performed.
11. An official inspection of an organization's accounts, processes, or quality systems.
13. Failure of a device to meet any of its performance specifications or to perform as intended. Performance specifications include all claims made in the labeling of the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed.

1. To isolate non-conforming materials or products to prevent their unauthorized use or shipment.
2. A formal, thorough review conducted to determine the root cause of a quality failure or deviation.
3. The act of checking or adjusting the accuracy of a measuring instrument against a known standard.
7. The effect of uncertainty on objectives; a combination of the probability of an event and its consequences.
8. Written or recorded information that provides evidence of a process, policy, or execution.
9. A documented set of activities intended to eliminate the root cause(s) of detected or potential problems through effective Corrective Action and/or Preventive Action.
12. any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety, or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices.