Across
- 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 Permanent, unalterable historical documents providing objective evidence of activities performed.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.
Down
- 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.