The Quality Manager

The quality manager reviews the complaints assigned to her. Her job is to determine if an investigation of the complaint is required and if the complaint needs to be reported to a regulatory agency.

The quality manager notices that a new product issue has been added to her queue. This complaint was initially reported as a service request and was escalated by a call center agent. It concerns a failure in a blood analyzer.

Upon taking ownership, the quality manager reviews the service request associated with the product issue, including the work done by the service engineer.

Next, the quality manager contacts the customer and obtains more details about the issue. She discovers that there are two product issues associated with this incident: the cartridge might have been faulty as reported in the service request, but also the third-party reagents used might have exacerbated the problem. The quality manager creates a second product issue to investigate the reagents.

To help guide the investigation and keep it on schedule, the quality manager applies an activity template that generates an activity plan — a list of activities that need to be carried out, some by her and some by other employees.

Her next step is to determine if the product issues are reportable. She answers the series of questions in the Assessments view and looks at the score. Scores of 75% and higher indicate that the product issues should be reported.

After completing the review, the quality manager changes the status of the product issue records to Review Complete. This locks down some data in the complaint file and makes other data read-only.