Usage:  

Third tab is QA Review. Th is page is designed for Quality Assurance purposes.  

 

Navigation: Customer Complaint Manager form > Open an existing complaint > QA Review

(Complaint Manager in the Main menu or open the Customer form first > select a customer > then navigate to Customer menu > Customer Complaints ) .

Complaint Investigation form with QA Review tab

 

What are the options on this form:

1. A couple of options that require Yes or No answers, such as: Reviewed Risk Analysis, New Risk Identified or Follow up with Correspondence.

2.Complaint Status - select between: Confirmed or Not Confirmed.

3. CAPA - stands for Corrective Action and Preventive Action. Corrective and Preventive Action (CAPA)  is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence. To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions undertaken. CAPA is part of the overall quality management system (QMS).

4. Sent to Regulatory Affairs - enter date

5.MDR No -  is Medical Device Recall number  if any

6.QA Authorizing Signature

7.Complete QA- if checked then the user name and date will be automatically filled in after save.

8. Customer Contacts and Correspondence - a note area to record the correspondence with the customers. To add Notes click on , type the info and click OK.

 

See also:

Customer Complaints form description