The Quality Manager

The quality manager is the owner of the complaint investigation about a faulty cartridge in a blood analyzer system. The investigation is coming to a close: the product analysis has been completed and a corrective action has been logged.

The quality manager has been assigned two activities:

• To communicate the status of the product issue with the customer who made the initial complaint

• To give a short presentation about the product issue at the CAPA team’s weekly meeting

To Brief the Customer

The quality manager prepares two sets of documents. First, she generates a report. The report takes a standard template for product issue reports and automatically incorporates data from the product issue into the report. She reviews the report in MS Word, making edits and changes as necessary.

There are five contacts associated with the account that made the initial complaint. As a courtesy, the quality manager wants to send each of them a copy of the report. She uses the Correspondence feature to generate five personalized cover letters to be mailed with the report.

To Present Data to Colleagues

The quality manager is routinely asked to present information about various product issues at the weekly CAPA meeting. The administrator has prepared a Power Point template which she uses to generate a standard product issue presentation, incorporating specific data from the selected product issue.

Conclusion

After mailing the report packages to the customer contacts and delivering her presentation at the CAPA meeting, the quality manager changes the status of her two activities to Closed.