IKE Scenario 16-02: 9 CFR 416.17: Establishment Verification Plan: October 2, 2002

In the last scenario an NOIE was issued. It is very important to verify that all corrective actions in response to the NOIE are implemented by the establishment. A verification plan is an instrument designed to aid in the verification of the implementation of corrective actions stated in a response letter to an NOIE. The person or team developing a verification plan will depend on the exact circumstances. In this scenario, the District Office directed the Front Line Supervisor and the IIC to develop a verification plan for verifying that the establishment complies with the conditions of the NOIE response letter. The Front Line Supervisor will provide instructions to the IIC on the proper documentation and implementation of the verification plan.

The last scenario related the Rules of Practice in Part 500 to the SSOP and Sanitation Performance Standards (SPS) agency verification requirements. The result of this scenario was the issuance of an NOIE and the response by the establishment outlining corrective actions to be taken in the form of an action plan. The District Manager opted to defer an enforcement decision due to a belief that the establishment’s proposed corrective and preventive action may be adequate to eliminate the noncompliance. The District Manager (DM) will make a decision on the adequacy of the preventive action as soon as sufficient information becomes available. The reported results of the verification plan are an integral part of that information gathering process. In this scenario the DM has deferred an enforcement decision. Consequently, Front Line Supervisors will work with inspection personnel in gathering the information resulting from the implementation of the verification plan and submitting it to the DM in an agreed upon manner. The DM will use the information to determine the adequacy of the establishment’s proposed corrective action, and will notify the establishment in writing of their final decision.

As a review, here is the written response that the establishment provided to the District Manager following the issuance of the NOIE (see IKE 15):

In response to the NOIE received concerning the SSOP and Sanitation Performance Standard noncompliance’s in the recent weeks, we have taken the following actions:

  1. First, as we indicated in the response to a NR, we have sealed the outside door leading into the boiler room and repaired the holes in the wall. In addition, we have identified other points in the outside walls of the basement under the boiler room that could allow entrance into the facility and up into the boiler room. All new openings have been sealed.
  2. We have also hired a new extermination company with a certified pest control operator to perform a monthly service. They have inspected the outside grounds and inside areas of the plant. Tomorrow they will be installing additional bait stations outside of the boiler room and new traps in the basement and boiler room.
  3. We have re-evaluated our SSOP program and have determined that modification of the program was needed.
  4. We are modifying it to include a procedure for pest and rodent control in our operational sanitation SSOP. We have assigned a production person to make a daily rodent and pest check. QC will be monitoring the procedure daily and recording the results on the SSOP form.
  5. Since the installation of the ceiling fans has been insufficient to eliminate the condensation, we have hired an Environmental Engineer who is to visit the plant tomorrow to determine the best way of preventing the condensation from forming.
  6. We will be adding a procedure to the SSOP program for condensation. We have assigned a production person to identify and to remove condensation on an hourly basis, until our consulting engineer has determined what actions are needed for a permanent solution. The condensation procedure will be monitored by our QC personnel two times per day. If they identify condensation over product areas or in product and employee traffic areas, production will be stopped in that area until the problem has been corrected and further preventive actions have been determined and implemented. We will also take immediate actions and further planned actions for condensation found in the non-production areas by tagging the affected area until the problem has been corrected and further preventive actions have been determined and implemented.

The following plan is an example of how a verification plan might be designed.

Establishment 38

Verification Plan

Establishment 38 was issued an NOIE for failure to maintain sanitary conditions. This verification plan is designed to verify the corrective actions stated in the response letter.

Establishment Action

Regulation

CSI Verification

Re-evaluated SSOP and modified

Include daily rodent and pest inspection into SSOP
Include procedure to address condensation in SSOP
Include monitoring of pest and rodent control procedure in SSOP
Include monitoring of condensation procedure in SSOP

416.14

416.15

416.12

01C01/01C02 – Verify that the establishment has re-evaluated SSOP and included procedures and the monitoring of those procedures into the SSOP for pest and rodent control and condensation.

Sealed the outside door to boiler room and repaired all holes in the outside walls of basement.

416.2(b)(3)

06D01 – Verify that all outside openings that permit entrance of vermin have been sealed.

Extermination company will perform inspection of outside grounds and inside areas of plant and install additional bait stations outside the boiler room and new traps in the basement and boiler room.

416.2(a)

06D01 – Verify that extermination company has performed an inspection of premises and added bait stations and traps.

 

QC monitoring of pest and rodent control procedure

416.13(c)

01C01/01C02 – Verify that the establishment is monitoring its pest and rodent control procedure daily.

QC monitoring of condensation procedure

416.13(c)

01C01/01C02- Verify that the procedure is monitored by QC twice per day.

Contracted with an Environmental Engineer to address permanent solution to condensation problems.

416.2(d)

416.15

06D01-Verify engineer visited the establishment and review documentation of their recommendations to prevent future occurrences.

Appropriate action will be taken if condensation is observed over product areas or in product and employee traffic areas.

416.15

01B01/01B02 &/or 01C01/01C02 – Verify that establishment stops production in area until problem has been corrected & further preventative actions have been determined & implemented

Appropriate action will be taken if condensation is observed in non-production areas.

416.2(d)

06D01 – Verify that establishment controls the affected area, by tagging, until the problem has been corrected & further preventative actions have been determined & implemented.

 

Inspection program personnel will perform procedures (ISP procedures 01B01/02 and 01C01/02) to verify the adequacy and effectiveness of the establishment’s SSOP including the procedures specified in the SSOP.
These procedures can be performed as an unscheduled procedure, if the particular procedure is not scheduled on the Daily Procedure Schedule.
It should be verified that the establishment is conducting pre-operational procedures before it begins operations (9 CFR 416.13(a)). It must also be verified, that the establishment conducts any operational procedures at the frequencies specified in their SSOP (9 CFR 416.13(c)).

Scheduled Improvements

It is important to reemphasize that any scheduled facilities improvements, as provided in the establishment’s response on an NR, will be verified by using the ISP Code 06D01 on the anticipated completion date, if necessary, as an unscheduled procedure. The regulations that pertain to these improvements are found in 9 CFR 416.1-416.6 of the Sanitation Performance Standards. If there are multiple improvements that are proposed, the establishment may elect to develop a Plant Improvement Plan (PIP). In this situation the completion of the PIP should be tracked through a separate section in the verification



For IKE related questions, send mail to ike@fsis.usda.gov. For all other general questions, send to Tech Center address listed below.