US Food & Drug Administration / Center for Food Safety and Applied Nutrition / November 10, 2004; Updated October 2007

HACCP Validation Checklist

SUBJECT HACCP Validation Checklist	ISSUE DATE	PRODUCT
PLANT NAME	SUPERSEDES	PAGE 1 of 2
ADDRESS	SUPERSEDES	PAGE 1 of 2

Validation Type (check one):

Initial Validation (within 12 months of implementation)
Validation (Reassessment) due to changes made in raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product and rate or type of consumer complaints.
Annual Validation (Reassessment) of the HACCP plan including Hazard Analysis

Topic	Yes	No	If "Yes," Describe	Food Safety Implication?	Are modifications to the HACCP system required?
1. Evaluate product & process
Product description changed, e.g., intended use, consumer?
Formula changed?
Ingredients / Packaging changed?
Any new product consumption or storage methods?
Any new suppliers?
Process flow changed?
Equipment / computer software changed?
Finished Product Distribution changed?
Other, e.g., production volume increased:
2. Evaluate product / process history
Repeat CCP deviations?
Any recent industry recalls of similar product since the last annual validation?
New or emerging hazards, e.g., recent CDC Morbidity & Mortality problems identified with product?
Regulatory Agency recommendations, e.g., guidance documents, regulations?
Any confirmed food safety consumer complaints?
Other:

Topic	Yes	No	If "No," Describe	Food Safety Implication?	Are modifications to the HACCP system required?
3. Evaluate adequacy of CCPs, critical limits, monitoring, corrective action, CCP verification, and record keeping procedures. Review current CCP documentation.
Do the CCPs control the hazards?
Are the CCP critical limits adequate?
Do monitoring methods and frequency demonstrate control?
Do corrective actions properly address affected product and correct deviations?
Does validation include review of consumer complaints?
Other, e.g., Prerequisite Programs or procedures may affect the hazard analysis:

FDA/Center for Food Safety & Applied Nutrition
Hypertext updated by las/rog November 14, 2005