23 IM Est Profile HACCP Info
23 IM Est Profile HACCP Info
23 IM Est Profile HACCP Info
References
1. FSIS Directive 5300.1 Managing the Establishment Profile in the Public Health Information System (PHIS), Dated 4-11-11. 2. PHIS Users Guide on the insideFSIS Intranet PHIS page 3. PHIS Quick Reference Guide 4. 9 CFR Part 300 to End
Introduction
The Establishment Profile (EP) is a left navigation menu option that appears after logging in to PHIS. The establishment profile is a series of web-pages that IPP use to enter data about official establishments including the HACCP system that the establishment has put in place. The EP information is essential to the Agencys goal of protecting public health.
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Hands-On Activity
The following hands-on section is intended to provide familiarity and experience with entering HACCP system information in the EP in PHIS. Open Beef, Inc., a beef slaughter and processing combination establishment, is the example that will be used for all of the activities. Follow these steps along with the instructor. Open the laptop Log-onto laptop: User Name: FSIS_user Password: FSIS Double click the Start Internet Explorer icon PHIS Log-in Select User: Robert Allen (#) Accessing an Establishments Home Page To access Open Beefs Homepage: 1. Click the down arrow next to Establishment Profile in left navigation menu to expand it. 2. Click Select Establishment in left navigation menu 3. Click My Establishments tab 4. Click the House icon associated with Open Beef 5. Click the down arrow next to Establishment Profile in left navigation menu again to expand it. IPP use the HACCP Processing page to document information about the establishments HACCP system. IPP use the establishments written hazard analysis and HACCP plan as the basis for entering the HACCP process categories, processing steps, food safety hazards controlled or prevented at each step, any prerequisite programs or supporting documentation referenced in the hazard analysis, and the CCPs listed in the HACCP plan. IPP select generic options from a drop down lists to assist in the collection of HACCP system information. FSIS does not require establishments to identify any of their HACCP system information or other documentation using the list of options in PHIS. 6. Click the HACCP link in the left navigation menu The HACCP Processing page is presented The Summary panel, hazard analysis grid and prerequisite programs and interventions links are always displayed. The Summary Panel lists the HACCP
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processing categories that are pertinent to the establishment. FSIS defines HACCP processing categories (9 CFR 417.2) based on food science principles. Recall from previous presentations, that HACCP processing categories are critical information because they affect the allocation of inspection tasks to the establishment task list and other PHIS functionality. The summary panel is a convenient way of accessing and verifying the processing categories. Purpose of the pre-requisite program link is to present a grid of the pre-requisite programs which are applicable to the establishment. HACCP categories are entered by the District Office from the Application for Federal Inspection, FSIS Form 5200-2 (AFI). The panel can be collapsed to allow more viewing area on the screen. 7. Click the up arrow in the right corner of the panel to collapse it 8. Click the down arrow in the right corner of the panel to expand it Adding/Creating a Hazard Analysis Open Beef has three existing hazard analyses that have already been entered into PHIS for training purposes. To add a new hazard analysis, IPP click Add Hazard Analysis. IPP are to complete the following information in PHIS for the establishments hazard analysis: Name the hazard analysis. If the establishment does not title their hazard analysis, IPP identify it using a name that other IPP can use to identify the plan easily (i.e., Raw Intact Steak Hazard Analysis). PHIS allows duplicate content for hazard analyses but the name must be unique. The date. Enter the date recorded on the hazard analysis. HACCP processing category. IPP are to select one or more HACCP processing categories from the list displayed in PHIS based on the establishments processes and finished product shipped from the establishment. When the slaughter HACCP processing category is selected, PHIS generates a list of Slaughter Class Group choices. Beef => Cattle, Calf Pork => Swine Other Meat => Goat, Sheep Poultry => Chicken, Turkey, Duck, Goose, Guinea, Squab, Ratite 1. Click Add Hazard Analysis Data entry fields for basic hazard analysis information are presented
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2. Enter the following information: Document Name: Date: HACCP Processing Category: Class Group: Lot Definition 3. Click Save If the slaughter HACCP processing category was selected, PHIS determines if an appropriate slaughter line is defined for the establishment after the Save button is clicked. If not, a warning is issued to the inspector such as slaughter line information has not been recorded for the selection. The warning did not appear at the top of the page because a slaughter line has been recorded in the pre-filled hazard analysis for Open Beef already entered in PHIS. 4. Click Cancel Note: IPP must create a hazard analysis before PHIS allows users to enter HACCP plans and product information. Adding a New Process Step Once IPP save the new hazard analysis, IPP click the edit (pencil) icon for the newly created hazard analysis on the HACCP Processing page to add process steps. IPP may also click on the edit (pencil) icon for exiting hazard analysis to view the process steps that have already been entered. IPP are to enter all of the process steps identified in the hazard analysis. For this hands-on demonstration, only 3 process steps will be entered: viscera processing, head processing, and packaging and labeling. 5. Click the Edit icon for the Slaughter, and Raw Intact /Raw Non-Intact Product hazard analysis you created The Show Process Steps link is presented at the bottom of the page 6. Click the Show Process Steps link An empty Process Step grid is presented 7. Click Add new Process Step The Process step selection drop down list is presented Type Type Slaughter and Raw Intact/Raw Nonintact Product 8/24/2011
Check RawNon Intact, RawIntact, and Slaughter Check Beef Type 8 hours production
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IPP select processing steps from a generic list that best represent the process steps contained in the establishments hazard analysis based on their knowledge of the establishments process. Hazard analyses are unique to each establishments process and products. Consequently, the establishments processing steps may not exactly match the generic list in PHIS. The processing step options are generic and represent well-known processing steps where establishments typically apply its controls and interventions based on industry practices. If the establishments hazard analysis refers to processing steps that are more broad or specific than the options in the drop down list, IPP are to observe the process and inquire with the establishment in order to select the processing steps that best represent the establishments process. Note: If Other is selected as a Process Step on the HACCP Processing page, IPP can type in a custom description. 8. Enter the following information: Process Step: Select Viscera Processing An Empty Food Safety Hazard grid is presented 9. Click Add new Hazard The hazard data fields are presented in a grid IPP select the chemical, physical, and biological food safety hazards that correspond to each processing step from a list of options. If the establishments hazard analysis refers to generic terms such as pathogens, IPP are to inquire about the specific pathogens to which the establishment is referring. Table 1 contains the list of hazards available in PHIS.
TABLE 1: Drop-Down List of Hazards Biological Other Biological Biological E. coli O157:H7 Biological - Listeria monocytogenes (Lm) Biological Salmonella Biological - Spore Forming Pathogens Biological Campylobacter Biological Other Pathogens
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TABLE 1: Drop-Down List of Hazards Biological Specified Risk Material (SRM/BSE) Physical Metal Physical Bone Physical Foreign Material Physical Other Physical Physical Specified Risk Material Chemical Allergens Chemical Chemical Contamination Chemical Other chemical Biological - E. coli O157:H7 and Lm; Biological - E. coli O157:H7 and Salmonella Biological - E. coli O157:H7, Salmonella and Lm.
The hazards from Table 1 that are available in the option list depends on the type of hazard that is selected, i.e., chemical, physical, or biological. For instance, for a cattle slaughter process only the biological choices and Bovine Spongiform Encephalopathy (BSE) choice are available when the IPP selects biological for the hazard, and the physical hazard choices are only available for a physical hazard selection and so forth. Note: IPP should only select the Lm or Listeria monocytogenes biological hazard from the pick list for a HACCP processing category that is associated with RTE product. IPP are to complete information on whether the establishments hazard analysis considers a hazard to be reasonably likely to occur at a process step. If any of the hazards are reasonably likely to occur in the establishments process, IPP identify the CCP designed to control the food safety hazard. IPP are to select a type of CCP that most closely matches a CCP in the establishments HACCP plan from a drop down list of options in PHIS, and identify the process step where the hazard is controlled. IPP are to name the CCP using a name that other FSIS
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personnel can use to identify the CCP easily (e.g., 2B fecal zero tolerance, 3B carcass antimicrobial rinse, etc.). PHIS allows duplicate CCP names, so giving each CPP a unique descriptive name can provide a clearer representation of the establishments HACCP plan. Table 2 contains the list of options for CCP types. Note: The step where the hazard is introduced into the process may not be a CCP. The hazard may be controlled at a step or steps (a CCP/CCPs) later in the process. In this case, the IPP may need to use the To Be Specified (TBS) CCP selection as a placeholder until the subsequent step where the hazard is controlled is entered into PHIS. After entering this step, IPP will need to edit the step with the TBS selection and replace the TBS selection with the proper CCP name. If the establishment identifies the hazard as not reasonably likely to occur based on its supporting documentation, IPP are to select the option that indicates that the establishment has supporting documentation on file. If the establishment identifies the hazards as not reasonably likely to occur because of a measure such as a prerequisite program, IPP are complete information on the prerequisite program. IPP select the type of prerequisite from a drop down list of options that most closely matches the prerequisite program referenced in the establishments hazard analysis. IPP are to name the prerequisite program using a name that other FSIS personnel can use to identify the program easily, e.g., purchase specifications, allergen program, or temperature program. Table 2 also contains the list of drop down options for prerequisite programs.
TABLE 2: Drop Down List of CCP & Prerequisites:
Temperature Control - (freezing, refrigerating, cooking, chilling, hot-packing, etc.) Purchase Specifications (Includes Letter of Guarantee or Certificate of Analysis) Microbiological Testing (Routine) Allergen Program BSE Program Lm Program: Sanitation Lm Program: Sanitation/Testing Lm Program: Intervention: Antimicrobial Process or Agent Applied Ingredient Control and Labeling
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When no hazard is identified at a process step in the hazard analysis, IPP select No Hazard Identified. No other information is required. Using this option is required because every process step in the hazard analysis must be entered and PHIS requires each step to have at least one selection from the hazard list. This option is basically a placeholder for the step. Note: IPP should use the BSE Program option only when the slaughter HACCP processing category is selected and the associated Slaughter Class Group is Beef. 10. Enter the following information: Hazard Category: Hazard: Reasonably Likely to Occur? Basis: Name: Type: Select Biological Select E. coli O157:H7, Salmonella Click Select Type Select Yes CCP CCP 3B Viscera Antimicrobial Rinse Intervention: Antimicrobial Process or Agent Applied
Process Step Where.. Hazard...Controlled: Select Viscera Processing 11. Click Save The hazard is saved The Process step is also saved (in alphabetical order) because this is the first hazard
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All of the steps in the establishments hazard analysis must be entered into PHIS. So, add another example step. 12. Click Add new Process Step The Process step selection drop down list is presented 13. Enter the following information: Process Step: Select Head Processing An Empty Food Safety Hazard grid is presented and a hazard can be entered 14. Click Add new Hazard The hazard data fields are presented in a grid 15. Enter the following information: Hazard Category: Select Hazard: Select Reasonably Likely to Occur? Click Basis: Select Name: Type Type: Select Process Step Where.. Hazard...Controlled: Select Biological E. coli O157:H7, Salmonella Yes CCP CCP 1B Head Fecal Zero Tolerance Product Examination Head Processing
16. Click Save The hazard is saved The Process step is also saved (in alphabetical order) because this is the first hazard If the processing step has more than one hazard (the hazard can be same type of hazard, e.g., biological such as Specified Risk Materials (SRMs) and pathogens, or a different types of hazards, e.g., biological and physical, or chemical and physical) associated with it, then the required information for EACH hazard has to be entered in the process step grid. All of the hazards identified at a particular process step must be entered into PHIS. For this example, although the biological hazard is the same (E. coli O157:H7 and Salmonella), the establishment implements another process intervention (an antimicrobial rinse) to control it at the head processing step. Therefore, the IPP must make another biological hazard entry at the head processing step to identify the establishments additional control measure.
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17. Click the Edit icon for the Head Processing step 18. Click Add new Hazard 19. Enter the following information: Hazard Category: Hazard: Reasonably Likely to Occur? Basis: Name: Type: Select Biological Select E. coli O157:H7, Salmonella Click Select Type Select Yes CCP CCP 2B Head Antimicrobial Rinse Intervention: Antimicrobial Process or Agent Applied
Process Step Where.. Hazard...Controlled: Select Head Processing 20. Click Save The hazard is saved Another biological hazard (SRM) is identified at the head processing step, so another hazard entry has to be made. 21. Click Add new Hazard 22. Enter the following information: Hazard Category: Hazard: Reasonably Likely to Occur?: Basis: Name: Select Biological Select Specified Risk Material Click No Select Pre-requisite Program Type Tonsils (SRM) Removal
23. Click Save The hazard is saved 24. Click Cancel Add the last step for the hands-on demonstration. 25. Click Add new Process Step The Process step selection drop down list is presented 26. Enter the following information: Process Step:
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An Empty Food Safety Hazard grid is presented 27. Click Add new Hazard 28. Enter the following information: Hazard Category: Select No Hazards Identified 29. Click Save The hazard is saved The process step is also saved (in alphabetical order) because this is the first hazard Expanding the Process Steps for Viewing If IPP want to view specific information about each process step such as the hazards associated with the step, whether the hazard is reasonably likely to occur, and the measure used to control the hazard, IPP click the arrow next to the name of the step to expand the record. The hazard information presented in the grid is the information that was entered when the process step was added to the hazard analysis. 30. Click the Arrow icon next to each step to verify the following: Viscera Processing step exists and has one hazard Head Processing step exists and has three hazards Packaging / Labeling step exists and has no hazards identified 31. Click the Arrow icon again to collapse the record. Moving Process Steps When IPP enter the process steps for a new hazard analysis, they should enter them in chronological order. However, if IPP add a new process step to an existing hazard analysis in PHIS, the step is likely to be out of order with the process flow. If headquarter personnel review an establishments hazard analysis in PHIS, it would be confusing if the process steps did not follow the expected process flow, e.g., the animal was eviscerated before the hide was removed. In this hands-on exercise, the steps were not entered in the correct order. 32. Place mouse cursor over the Head Processing step, left click and hold down 33. Drag the cursor up until a dashed line appears above Viscera Processing, then release the mouse 34. Click Cancel above the Show Process Steps
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Editing an Existing Hazard Analysis IPP click the Edit (pencil) icon in PHIS to make changes to an existing hazard analysis, process step for the hazard analysis or the hazard for the process step. For instance, clicking the edit icon in column for the desired step expands the process step grid allowing IPP to make the necessary changes. 1. Click the Edit icon for the Slaughter, and Raw Intact / Raw Nonintact hazard analysis you created 2. Click the Show Process Steps link 3. Click the Edit icon for the Head Processing Step The Process step and the existing Food Safety Hazard grid is presented 4. Click the Edit icon for the First Biological Hazard 5. Click the down arrow next to Product Examination, then select Sanitary Dressing Program 6. Click Save Sanitary Dressing Program replaces Product Examination in the Food Safety Hazard grid 7. Click Cancel 8. Click Cancel again Deleting an Existing Hazard Analysis If an IPP needs to delete a hazard analysis from PHIS all data associated it such as the process steps, HACCP plans and all products (in the Products Page) must be deleted or removed prior to deleting the hazard analysis. 1. Click the Trash Can icon for the Slaughter, and Raw Intact / Raw Non-intact hazard analysis you created A confirmation dialog is presented 2. Click the OK button Error message is displayed because Process Steps still exist The Hazard Analysis is not deleted Adding/Creating a HACCP Plan and CCPs At least one hazard analysis must exist for an establishment in order to create a HACCP Plan. Multiple HACCP plans may be associated with a given hazard analysis. HACCP plans for a hazard analysis are sorted alphabetically (A - Z) by plan name. IPP are to complete the following information in PHIS for the establishments HACCP plan:
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Name the HACCP plan. If the establishment does not title their HACCP plan, IPP identify it using a name that other IPP can use to identify the plan easily (i.e., Raw Intact Steak HACCP Plan). PHIS allows duplicate content for HACCP plans but the name must be unique. The date. Enter the date recorded on the HACCP plan. HACCP processing category. IPP are to select one or more HACCP processing categories from the list displayed in PHIS. The Slaughter and Raw Intact and Raw Non-intact hazard analysis that was created above does not have any HACCP plans associated with it. 1. Click the Arrow icon next to the Slaughter, and Raw Intact / Raw Non-Intact Product hazard analysis to expand it 2. Click the Add HACCP Plan The HACCP plan page is presented 3. Enter the following information: Plan Name: Signature Date: Hazard Analysis: Type Type Already Selected Slaughter and Raw Intact/Raw Non-Intact Product 8/24/2011 Slaughter and Raw Intact/Raw Non-Intact Product Slaughter, Raw-Intact, and Raw Non-intact
Note: The HACCP processing category options presented are the ones selected when the hazard analysis was created. At least one HACCP processing category must be selected. 4. Click Save An empty CCP grid is presented 5. Click Add CCP The CCP selection drop down list is presented The options that appear in the CCP Name drop-down list are from the hazard analysis that is associated with the HACCP Plan. All CCPs that are defined for the hazard analysis including the TBS placeholder (when applicable) are listed. PHIS allows CCPs to have the same name. If multiple CCPs with the same name are recorded for a hazard analysis, the name will occur multiple times in the CCP
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Name option list. For instance, if the IPP put antimicrobial rinse in twice, antimicrobial rinse would have appeared twice in the CCP list. This is why it is a good idea to give each CCP a unique name so each CCP can be associated with the correct process step in the HACCP plan. IPP select the CCP that most closely matches a CCP in the establishments HACCP plan from the drop down list. When the CCP is associated with the HACCP Plan it is removed from the option list. The Process Step Where the Hazard is Controlled is exactly the same information that is accessible through the hazard analysis. 6. Enter the following information: CCP Name: Select CCP 1B Head Fecal Zero Tolerance
The CCP Type, Hazard Category, Hazard, and Process Step Where the Hazard is Controlled fields are automatically populated with data because this data was entered when the process step was created. 7. Click Save The CCP is associated with the HACCP Plan and appears in the CCP grid IPP continue to add CCPs until all of them have been added to (associated with) the HACCP plan. CCPs may be selected in any order. For the training session we are starting at the top of the hazard analysis process step list and working down. 8. Click Add CCP The CCP selection drop down list is presented 9. Enter the following information: CCP Name: Select CCP 2B Head Antimicrobial Rinse
10. Click Save The CCP is associated with the HACCP Plan and appears in the CCP grid 11. Click Add CCP The CCP selection drop down list is presented
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12. Enter the following information: CCP Name: Select CCP 3B Viscera Antimicrobial Rinse
13. Click Save The CCP is associated with the HACCP Plan and appears in the CCP grid Adding Additional HACCP System/HACCP Plan Components Additional HACCP system and HACCP plan components, (e.g., critical limits, monitoring procedures and frequencies, verification procedures and frequencies, and critical parameters for prerequisite programs) are added by an EIAO during a Food Safety Assessment (FSA). This information is view only for IPP. When IPP identify new data or changes regarding critical limits, prerequisite programs and interventions , they are to forward this information to their immediate supervisor, who will in turn communicate this information to the District Office Supervisory EIAO (SEIAO). The SEIAO, or designee, will update the information into PHIS. 14. Click the double-arrow (more icon) to the far right of the CCP 1B Head Fecal Zero Tolerance CCP Detailed information about the CCP is presented in a grid 15. Click Close 16. Click Cancel Editing an Existing HACCP Plan To view or edit an HACCP Plan for an existing Hazard Analysis, IPP click the arrow icon adjacent to the Hazard Analysis on the HACCP processing page to expand the record. Then, IPP click the Edit (pencil) icon adjacent to the HACCP plan to access the HACCP plan page. When editing the HACCP Plan, the plan name and signature date fields are available for updating. Changes can also be made to a CCP by clicking the Edit (pencil) icon for the CCP. However, only the Process Step Where the Hazard is Controlled may be modified on the page. Changing the process step on this page also changes it in the hazard analysis. To make modifications to the other data, e.g., the CCP type, hazard category, hazard, etc., the IPP has to edit the hazard analysis. 1. Click the Arrow icon next to the Slaughter, and Raw Intact / Raw Non-intact hazard analysis to expand it 2. Click the Edit icon for the Slaughter, and Raw Intact / Raw Nonintact HACCP plan The HACCP plan name and date information is presented
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3. Click the Edit icon for CCP 1B Head Fecal Zero Tolerance in the CCP grid 4. Click Cancel Deleting an Existing Hazard Analysis If an IPP needs to delete a HACCP plan associated with a hazard analysis from PHIS, all the CCPs associated the HACCP plan must be deleted or removed prior to deleting the HACCP plan. 1. Click the Arrow icon next to the Slaughter, and Raw Intact / Raw Non-intact hazard analysis to expand the record 2. Click the Trash Can icon for the Slaughter, and Raw Intact / Raw Non-intact HACCP plan you created A confirmation dialog is presented 3. Click the OK button Error message is displayed because CCPs and food safety hazards still exist The HACCP plan is not deleted Note: IPP may designate an existing HACCP plan as inactive in PHIS. An inactive HACCP plan will not appear in the pick-list on Inspection Results page or on the Products page. Prerequisite Programs The purpose of the Pre-requisite Program link is to present a grid of the prerequisite programs which are applicable to the establishment. The HACCP Pre-requisite Program page is a convenient way of accessing and reviewing the prerequisite programs. IPP will need to be familiar with the prerequisite programs the establishment implements when they conduct HACCP inspection tasks. The information on the HACCP Pre-requisite Program page is view only for IPP. IPP identified the prerequisite programs utilized by the establishment when the processing steps was recorded for the hazard analyses, thus if IPP need to make changes they will have to edit the individual hazard analysis that references the prerequisite program. An EIAO has or will enter the components for each prerequisite program into the PHIS database during the performance of an FSA. 1. Click the Pre-requisite Programs link Prerequisite programs that are associated with all the hazard analyses are presented
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2. Click the double arrow (more icon) to the far right of the Tonsils (SRM) Removal prerequisite program Detailed information about the pre-requisite program is presented in a grid 3. Click Close 4. Click the HACCP processing breadcrumb near the top of the screen Interventions The interventions link is used in very special circumstances to enter a process intervention thats outside the HACCP system, i.e., the process intervention is not referenced in the establishments hazard analysis. The purpose of the Interventions link is to present the HACCP Interventions page with a grid of the process interventions which are applicable to the establishment. An EIAO has or will enter the components for each process intervention into the PHIS database during the performance of an FSA. 1. Click the Interventions link The HACCP intervention page with a process interventions grid is presented 2. Click the Add new Intervention 3. Enter the following information: Intervention Name: Hazard Category: Hazard: Type Select Select Aerobic Plate Count (APC) Biological General Pathogens
4. Click Save The process intervention is added to the grid Notice the process intervention is not associated with a hazard analysis or processing step (N/A is entered in the grid). 5. Click the double arrow (more icon) to the far right of the Aerobic Plate Count (APC) intervention Detailed information about the intervention is presented in a grid 6. Click Close Sign-Out Click Sign Out on right side of the screen near the top.
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