CAPA
This is what CAPA stands for.
What is Corrective and Preventive Action?
This type of monitoring device is commonly used to record temperature data over time in storage and transportation.
What is a data logger?
This system provides a structured approach for managing and improving quality across an organization.
What is a Quality Management System (QMS)?
This simple method involves repeatedly asking this question to dig deeper into the root cause.
What is the 5 Whys?
This process involves testing various points within a storage area to ensure consistent temperature distribution.
What is temperature mapping?
This process in QMS manages modifications to ensure changes are evaluated, approved, and documented before implementation.
What is Change Control?
Effectiveness Verification is done after this action has been implemented in CAPA.
What is the Corrective Action or Preventive Action?
In temperature monitoring, this term refers to instances where products are exposed to temperatures outside of specified limits.
What are temperature excursions?
This term refers to any departure from established procedures or specifications that may impact product quality.
What is a deviation?
A Preventive Action in CAPA is meant to prevent these from occurring.
What are potential nonconformances or issues?
This specific temperature mapping document is used to visually represent hot and cold spots within a facility.
What is a temperature map?
This document type outlines specific processes or procedures and must be updated when changes impact its contents.
What is a Standard Operating Procedure (SOP)?
This type of CAPA, if found ineffective after verification, may signal the need for deeper, more comprehensive changes in processes.
Temperature mapping should be conducted during these times to validate storage conditions under real-world conditions.
What are seasonal extremes (e.g., summer and winter) or during peak usage times?
What FDA requirements talks about Quality System Regulation (QSR).
What is FDA 21 CFR Part 820.?