CAPA Investigation Workbook
A Field Workbook for Corrective Action, Preventive Action, and Root Cause Investigation
A bench-ready CAPA workbook covering the full investigation cycle: problem statement, containment, root-cause analysis (5 Whys, fishbone, and the 6-root-cause framework), corrective action, preventive action, effectiveness verification, and CAPA closure. Built for the quality engineer, CAPA owner, or investigation lead in a regulated environment. Every section is a worksheet, not a theory chapter. Includes the documentation pattern that supports both internal closure and external audit defense. Framed for ISO 9001, ISO 13485, and FDA 21 CFR 820 environments. Written for quality engineers, quality managers, and CAPA program owners. Pairs with The CAPA Playbook by Wade Prescott.
View on AmazonA bench-ready CAPA workbook covering the full investigation cycle: problem statement, containment, root-cause analysis (5 Whys, fishbone, and the 6-root-cause framework), corrective action, preventive action, effectiveness verification, and CAPA closure.
Built for the quality engineer, CAPA owner, or investigation lead in a regulated environment. Every section is a worksheet, not a theory chapter. Includes the documentation pattern that supports both internal closure and external audit defense.
Framed for ISO 9001, ISO 13485, and FDA 21 CFR 820 environments. Written for quality engineers, quality managers, and CAPA program owners. Pairs with The CAPA Playbook by Wade Prescott.