Internal quality issue and external quality issue and decided capa through 8 D

Question

Accepted Answer

Internal and external quality issues require 8D methodology for CAPA resolution.

Internal quality issue refers to problems within the organization, while external quality issue refers to problems outside the organization.
8D methodology is a structured problem-solving approach that includes steps like defining the problem, implementing corrective actions, and preventing recurrence.
CAPA stands for Corrective and Preventive Actions, which are taken to address quality issues and prevent their reoccurrence.
Examples of internal quality issues could include defects in products manufactured by the company, while external quality issues could involve complaints from customers about product performance.
Using the 8D methodology, the team would first define the problem, conduct a root cause analysis, implement corrective actions, and then prevent recurrence through preventive measures.