IKE Scenario 11-02: 9 CFR 416.14 Maintenance of Sanitation SOPís, July 10,2002
This IKE Scenario is an extension of the last IKE Scenario (10-02) dealing with 9 CFR 416.15. Please refamiliarize yourself with the above-mentioned scenario in order to be able to fully follow along with this one. The first part of this scenario is only added to ensure closure with the corrective actions required in 9 CFR 416.15, as they were initiated in scenario 10-02. The second portion of this scenario actually deals with the maintenance of the establishmentís SSOPís, as required in 9 CFR 416.14.
In the last IKE Scenario (10-02), we left off with the IIC awaiting a response from plant management on what they were proposing as corrective actions in accordance with 9 CFR 416.15(b). This is the continuing dialogue:
NOTE:THIS IS A SCENARIO ONLY-THIS IS NOT ENDORSED AS THE ONLY RESPONSE THE ESTABLISHMENT CAN GIVE IN THIS PARTICULAR SCENARIO!
The plant manager proposes allowing them to run the product remaining on the lines into vats and to rework the product, as necessary, to ensure that all of the contamination is removed. He/she then outlines how he/she proposes to perform this to ensure the adulterated product is returned to a wholesome state. You are satisfied with this response and temporarily remove your US Retained tag from the start switch, in order for the plant to start the line. You do not allow any new product to be hung on the line at this time and retag the switch after the product has been removed.
The plant manager then proposes several steps of cleaning the lines and oiling them to prevent this black substance from falling on the product. He/she indicates to you that he has contacted the sanitation advisor of their chemical supply company and that the outlined procedure is what they had suggested. You indicate to the plant manager that you have no objection to his/her plan of action. You then inform him/her that he/she will have to demonstrate to you that sanitary conditions have been restored before you will remove your regulatory control action and allow full operations to resume.
While the plant is performing their emergency clean-up procedures, the plant manager again approaches you to discuss the disposition of the affected product and preventive measures. He/she outlines a plan of reinspecting and reworking the affected product, to which you have no objection. He/she also states to you that the sanitation advisor of their chemical company was arriving later that day to train the maintenance department on the proper use of their approved lubricant on the lines to prevent this black substance from forming again. He/she also tells you they plan on adding a procedure to their SSOP to physically check the rails after each production break and before hanging birds for any buildup of this black substance. He/she informs you that this will all be added in their written response to the NR.
After the plant is finished with their procedures, the plant informs you they are ready to resume operations. You are satisfied that their measures have restored sanitary conditions and that the requirements of 9 CFR 416.15(b) have been met in the slaughter portion of the operations. You subsequently allow them to start their operations back up by removing your tag from the start switch.
After verifying that the affected product has been properly reconditioned and is back in a wholesome state, you allow the shipment of this product by removing the US Retained tag.
The next day the plant manager returns the NR to you with their written response. It includes all of the pertinent data, including the fact that upon reevaluation of the SSOP they had added the above-mentioned procedure of checking the rails after each break. No further modifications were deemed necessary, since the SSOP team had determined this to be a training issue that had been resolved. You verify that the modifications actually have been made to the SSOP and sign off on the NR to close it out.
This concludes the corrective actions portion of the scenario.
You subsequently go on two weeks of well-deserved annual leave. When you return to the plant, well rested and ready for work, you notice a definite improvement in the condition of the rails and chain. During a routine walk-through of the plant you notice three new pieces of equipment suspended up in the air, one on each line. Curious, you ask a nearby supervisor what these highly technical looking devices are. He/she proudly indicates to you that these are the plantís newly acquired automated line oilers. He said that he/she did not understand the whole concept but that the maintenance manager could explain them to you.
You call the maintenance manager, who promptly explains to you that these are computerized automatic oilers that are set up to be operated at a certain frequency to dispense a very precise amount of lubricant onto the track and chain of each line. This will effectively prevent rust build-up on the track and chain without causing the accumulation of black substance that could fall on the birds. He/she explains to you that they had set up a schedule to operate the oilers each day before production and then once during each scheduled production break. He/she said they had been doing that for the past week and it was working better than they had hoped.
You go to the QC office, which is where the plant keeps their SSOP records, and request to see the written procedures. You note that the changes that were made to the procedures as a result of the black substance falling on the product (checking the rails after each break) are the last modifications made to the written procedures. You question the QC manager as to whether any maintenance to the plan is being discussed and receive a negative reply. Just to make sure, you contact the plant manager and ask him/her whether any modifications to the plan are being considered. The plant manager acts surprised at this question and replies that nothing has changed in the process to warrant any revisions to the written procedures.
As a critical thinker, what is your next action?
Later that day, in the weekly joint FSIS-plant meeting you bring up your concern. You ask the plant manager about the new oiling system that had been put in place to prevent direct product contamination. You bring up that you are aware of the stringent frequencies placed on the oiling procedure in order for the minimal amounts of lubricant used by the system to be effective. You also add that the maintenance manager has already confirmed that an oiling frequency has been established, according to the manufacturerís recommended interval, to prevent the build-up of the previously formed black substance and the contamination of product.
You subsequently remind the group of 9 CFR 416.14, which states:
Maintenance of SSOPís:ďEach official establishment shall routinely evaluate the effectiveness of the SSOPís and the procedures therein in preventing direct contamination or adulteration of product(s) and shall revise both as necessary to keep them effective and current with respective changes in facilities, equipment, utensils, operations, or personnel.Ē
You then inform them that they have a responsibility to meet the regulatory requirements provided in 9 CFR 416.14.
Several days later you review the establishmentís written SSOPís. The plant had updated their written procedures to include the new oilers. At this point, they are in compliance. Had they not, you would document the non-compliance on a NR and await the plantís response.
Note: 9 CFR 416.14 only requires routine maintenance of and revisions to the SSOPís as necessary. There is no annual reassessment requirement of SSOPís.