FDA Procedures for Standardization and Certification
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Cover Memo
Contents
Expanded Contents
(Note: This document is for optional use only, and is not a requirement for the Standardization Procedure)
Establishment Name: | Type of Facility: | ||||||||
Physical Address: | Person in Charge: | ||||||||
City: | State: | Zip: | County: | ||||||
Inspection Time In: | Inspection Time Out: | Date: | Candidate's Name: | ||||||
Agency: | Standard's Name: | Indicate Person Filling Out Form:
(circle one) Candidate's Form / Standard's Form |
|||||||
Cold Holding Requirement For
Jurisdiction: [5 °C (41 °F)_____] or [7 °C (45 °F)_____ ] or [5 °C (41 °F) and 7 °C (45 °F) combination:______] |
Yes____ No _____
DESCRIBE:___________________________________________________________
______________________________________________________________________
______________________________________________________________________
2. Was there a need to change the food establishment HACCP plan because of these menu changes?
Yes_____ No _____
3. List Critical Control Points (CCPs) and Critical Limits (CLs) identified by the establishment HACCP plan?
CCPs | CLs |
____________________________________ | ____________________________________ |
____________________________________ | ____________________________________ |
____________________________________ | ____________________________________ |
____________________________________ | ____________________________________ |
4. What monitoring records for CCPs are required by the plan?
Type of Record | Monitoring Frequency | Record Location |
_______________________ | _______________________ | _______________________ |
_______________________ | _______________________ | _______________________ |
_______________________ | _______________________ | _______________________ |
_______________________ | _______________________ | _______________________ |
5. Record compliance under 4G of the FDA Standardization Inspection Report (ANNEX 2 Section 1). Are monitoring actions performed according to the plan?
Yes_____ No______ Describe under 4G of the FDA Standardization Inspection Report .
6. Is immediate corrective action taken and recorded when CLs established by the plan are not met? Yes________ No_______
DESCRIBE:___________________________________________________________
______________________________________________________________________
______________________________________________________________________
7. Are the corrective actions the same as described in the plan? Yes_____ No______
DESCRIBE:___________________________________________________________
______________________________________________________________________
______________________________________________________________________
8. Who is responsible for verification that the required records are being properly maintained?
___________________________________________________________________
______________________________________________________________________
______________________________________________________________________
9. Did employees and managers demonstrate knowledge of the HACCP plan?
Yes____ No____
DESCRIBE:___________________________________________________________
______________________________________________________________________
______________________________________________________________________
10. What training has been provided to support the HACCP plan?
___________________________________________________________________
______________________________________________________________________
______________________________________________________________________
11. Describe examples of any documentation that the above training was accomplished?
___________________________________________________________________
______________________________________________________________________
______________________________________________________________________
12. Are calibrations of equipment/thermometers performed as required by the plan?
Yes ____ No_____
DESCRIBE:___________________________________________________________
______________________________________________________________________
______________________________________________________________________
Additional Comments:
Person Interviewed:______________________
Retail Food Inspections Table of Contents