Public Health Information System Establishment Profile Update – Hazard Analysis and Critical Control Point Details
- PURPOSE
This notice instructs Inspection Program Personnel (IPP) on the actions to take to accurately document information about the HACCP system in the establishment profile in the Public Health Information System (PHIS). This notice instructs IPP to complete the Hazard Analysis and Critical Control Point (HACCP) plan name for establishments with one or more Critical Control Points (CCPs) in a HACCP plan or to enter “No HACCP Plan” for establishments that have a supportable hazard analysis that has determined there are no food safety hazards reasonably likely to occur and therefore no CCPs (no HACCP plan) for that HACCP process category. This information is necessary to ensure the task distributor accurately assigns HACCP verification tasks to the establishments, even when no HACCP plan exists. Previously, when there was not a HACCP plan, IPP were instructed to perform the Hazard Analysis Verification task for those products, and it was unclear whether the HACCP verification tasks were also to be performed. FSIS Directive 5000.1, Verifying an Establishment’s Food Safety System clarifies that the HACCP verification tasks are to be performed whether there is a HACCP plan or not. Those instructions are in Section H. on the top of page 34. Information about the hazard analysis and HACCP plan was previously captured in PHIS as two separate steps, but the Establishment Profile has been updated to streamline this process by removing the hazard analysis section. This notice also clarifies policy when a product group is produced under multiple HACCP Plans. - BACKGROUND
- FSIS has updated PHIS to streamline data entry for HACCP systems. The establishment profile update requires information in the HACCP Plan Name field when adding product groups in the Establishment Profile. In Figure 1 below, the orange oval highlights the field now marked with a red asterisk (*) that denotes a required field in PHIS when entering a product group.
Figure 1: Screen shot of the Product Groups Add Product Group entry screen in the Establishment Profile of PHIS highlighting the required HACCP Plan Name field. - The HACCP Plan Name field is a drop down menu, populated from the information in the HACCP page of the Establishment Profile that will now include a “No HACCP Plan” option.
- The HACCP plan name is used to document both the name of the HACCP plan and when there is no HACCP plan for that process or product because the establishment has performed a hazard analysis and determined there are no food safety hazards reasonably likely to occur (9 CFR 417.2(b)).
- FSIS has updated PHIS to streamline data entry for HACCP systems. The establishment profile update requires information in the HACCP Plan Name field when adding product groups in the Establishment Profile. In Figure 1 below, the orange oval highlights the field now marked with a red asterisk (*) that denotes a required field in PHIS when entering a product group.
- IPP RESPONSIBILITY
- Upon issuance of this notice, IPP are to verify the HACCP system information is accurately entered in the PHIS establishment profile as instructed in FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System. This task can be completed during the next routine Update Establishment Profile task.
- IPP are to add a HACCP plan with the title “No HACCP Plan” when the establishment has a supportable hazard analysis with no food safety hazards reasonably likely to occur and therefore no CCPs (no HACCP plan). IPP are also to:
- Enter the Signature Date of the most recent reassessment of the hazard analysis (9 CFR 417.4(b));
- Verify the status is active;
- Type “No HACCP Plan” into the Plan Name* field (see Figure 2 below); and
- Select the processing categories from the list that have no HACCP plan as shown in Figure 2.
Figure 2: Screen shot of the HACCP Plans screen, Add HACCP Plan tab, to add “No HACCP Plan” as the Plan Name when making a selection from the required Processing Categories options.
- The options for processing category listed on the new HACCP plan screen are based on information listed in the grant of inspection. IPP are to review the information listed on the grant of inspection page in the establishment profile and verify the accuracy of the information if the expected processing category is not available to select in the new HACCP plan screen. IPP are to contact their supervisor for assistance if the grant of inspection information in the establishment profile is not accurate.
NOTE: PHIS user guides about managing the establishment profile are available for IPP on PHIS Help. - IPP are to add Product Groups, or edit existing Product Groups, according to the instructions in FSIS Directive 5300.1 and select the applicable HACCP plan for the HACCP Plan Name field. IPP are to select the “No HACCP Plan” option from the drop down when the product is produced under a supportable HACCP system with no HACCP plan.
- If the Product Group is produced under more than one HACCP Plan, IPP are to select the HACCP Plan with the largest production volume or the HACCP Plan closest to, or under which, finished product is produced and shipped from the establishment. A Product Group should not be entered more than one time for the purpose of documenting “No HACCP Plan.” The purpose of the “No HACCP Plan” entry is to assure HACCP verification tasks are assigned for product whose process never includes a HACCP Plan. An example entry is shown in Figure 3 below. This is an example only; IPP are to complete the fields with the applicable data based on their direct knowledge of the HACCP system at the official establishment.
Figure 3: Screen shot of the Product Groups Add Product Group screen for entry of a product group for a product with no HACCP plan. - IPP are also to verify the HACCP Volumes are accurate based on recent establishment production history when a product group is updated or added. The HACCP volumes listed on the HACCP Volumes tab of the Products page in the Establishment Profile are often directly related to task distribution. IPP are to refer to FSIS Directive 5300.1 for instructions on updating the HACCP volumes and average daily volumes.
- IPP are to refer to the instructions in FSIS Directive 5000.1 or FSIS Directive 5000.6, Performance of the Hazard Analysis Verification (HAV) Task, if there are concerns about the support for an establishment’s hazard analysis decisions. IPP are to discuss concerns with their supervisor.
- QUESTIONS
Refer questions regarding this notice to your supervisor or as needed to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select General Inspection Policy as the Inquiry Type.
NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.