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Professionals

  1. Improved reporting methods are mentioned (in Section 17.6) as possible solutions for an identified defect, though no change of performance practices is recommended in the associated CAPA.

a. Some SQA professionals believe that a CAPA has no place for changes in reporting methods. Do you agree? List your arguments.

b. If you do not agree, list possible contributions a CAPA can make based on changed reporting methods.

  1. Section 17.7 lists three main tasks of CAPA follow-up.

a. List the three tasks.

b. Explain, in your own words, the importance of the follow-up tasks to the success of the process.

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