US Food & Drug Administration / Center for Food Safety and Applied Nutrition / November 10, 2004; Updated October 2007
SUBJECT
HACCP Validation Checklist |
ISSUE DATE | PRODUCT |
PLANT NAME | SUPERSEDES |
PAGE
1 of 2 |
ADDRESS |
Validation Type (check one):
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: |