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Quality Assurance Crossword April 2018

Across
Perform inspection of incoming material.
Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.
An acronym that stands for Medical Device Reporting.
Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
The probable rate of occurrence of a hazard causing harm and the degree of severity of the harm.
Any Written electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
Any state of unfitness for use, or non-conformance to specification.
Down
An early sample, model or release of a product built to test a concept or process or to act as a thing to be replicated or learned from.
Will perform a final visual inspection and check of each instrument and accessories before packaging is completed.
Immediate action needed to eliminate a dominant cause of, or symptom of, a non-conformity and to prevent it from spreading.
Database used for inventory and shipping of instruments, modules and parts.
European Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals.
A complaint handling software.
Systematic approach that includes action needed to correct, avoid recurrence and eliminate the cause of potential non-conforming product and other quality problems.