IKE Scenario 08-02: 9 CFR 416.13 Implementation of SOP: May 29,2002

The next several IKE scenarios are designed to illustrate the SSOP requirements as delineated in 9 CFR 416.13 (Implementation of SSOPís), 9 CFR 416.14 (Maintenance of SSOPís), 9 CFR 416.15 (Corrective Actions), and 9 CFR 416.16 (Recordkeeping requirements). These requirements are verified through the performance of the SSOP 01 and 02 procedures.

There are two procedures, recordkeeping ("01") and review and observation ("02"), for both pre-operational and operational sanitation. The procedure codes for pre-operational sanitation begin with "01B" (01B01/01B02) and the codes for operational sanitation begin with "01C" (01C01/01C02).

The SSOP 01 Procedures (01B01 and 01C01):

The SSOP 01 procedures are the "recordkeeping" procedures that are used by inspection personnel to verify that the daily documentation of the establishmentís implementation and monitoring of their procedures are being properly performed and that corrective actions are taken as needed. They are also used to verify that the records are available to FSIS, and that they are authenticated by the responsible establishment employee with his or her initials and date.

Unlike the HACCP 01 procedure, which has a recordkeeping component and a review and observation component (see IKE scenario 05-02), the SSOP 01 procedures are based solely on review of records. In other words, the SSOP 01 procedure requires the inspector to verify all requirements of that portion of the SSOP (pre-operational or operational, depending on whether the 01B or 01C procedure is being performed) strictly through the review of records.

Simply put: The SSOP 01 procedures are to review establishment records to verify that SSOP procedures are being followed by plant personnel before and during operations, monitored activities are conducted at the specified frequency, all three requirements of corrective action are implemented and documented, and establishment employees/positions authenticate records with their initials and date.

Also, unlike the HACCP 01 procedure, non-compliances found during the performance of the SSOP 01 procedure do not lead to performance of the SSOP 02 procedure.

To re-emphasize, SSOP 01 procedures are purely record review procedures. SSOP 02 procedures are review and observation procedures. HACCP 01 and HACCP 02 both have records review and review and observation components. See IKE Scenario 06-02 to review HACCP 02 procedures.

The SSOP 02 Procedures (01B02 and 01C02):

The SSOP 02 procedures are the "review and observation" procedures that includes three parts:

Direct observation of the establishmentís implementation and monitoring of the SSOPís and required corrective actions;
Assessment of sanitary conditions through organoleptic examination of a sample of facilities, utensils, and equipment; and
A comparison of inspection findings with plant records.

Inspection personnel do not have to complete all three parts of the "02" procedure each time it is performed-this is left up to the inspectorís judgement, the situation at hand, and supervisory input. As a general rule though, when performing either the direct observation or the assessment components separately, it will always be in conjunction with a comparison of the inspection findings with plant documentation.

Although the method used to "review and observe" the establishmentís SSOPís is flexible, the performance of the SSOP 02 procedures is not random. All requirements of the portion of the SSOP (pre-operational or operational) that are being verified are included in the performance of the procedure. That is: Implementation, maintenance, corrective actions, and recordkeeping requirements are verified through review and observation of the establishment carrying out the procedures described in their plan.

In the following scenario we are going to concentrate on the requirements of 9 CFR 416.13, Implementation of SOPís:

ß 416.13(a): "Each official establishment shall conduct the pre-operational procedures in the Sanitation SOPís before the start of operations." ß 416.13(b): "Each official establishment shall conduct all other procedures in the Sanitation SOPís at the frequencies specified. ß 416.13(c): "Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOPís."

You are an inspector assigned to a small establishment that slaughters beef and lamb. The procedure schedule for the shift includes the "01C01" (operational sanitation/recordkeeping) procedure and you review the operational sanitation records from the previous day for:

Implementation of the establishmentís SSOPís; including monitoring of implementation (ß 416.13)
Maintenance (routine evaluation of effectiveness) of the establishmentís SSOPís (ß 416.14)
Corrective actions taken, when necessary (ß 416.15)
Compliance with the recordkeeping requirements (ß 416.16)

The establishmentís written operational SSOP includes several procedures to be performed at specified frequencies. One of the procedures included in the operational SSOP is that "employees will wash and sanitize hands after every break or whenever becoming contaminated." The SSOP also names the "slaughter supervisor" as the employee responsible for conducting the daily operational sanitation monitoring as required by 9 CFR 416.13(c).

Upon review of the establishmentís operational sanitation records, you determine that they show the implementation of all of the procedures was monitored daily according to ß 416.13(c), except for one. There is no record demonstrating monitoring of the establishmentís procedure of "employees washing and sanitizing their hands after every break or whenever becoming contaminated. You discuss this issue with the slaughter supervisor who states that he "was called away for a meeting" during the time when he was to monitor the procedure. Consequently, according to the supervisor, this procedure could not be monitored for that shift. You further discuss this issue with the supervisor who informs you that there has been no past history of problems with employees washing their hands. He is basing this statement on his experience and is backing it up with prior records showing no previous problems with this procedure.

As a critical thinker, you ask yourself if the establishment is in compliance with 9 CFR 416.13-and what, if any, action(s) to take?

You review all of the pertinent information you have gathered, including your detailed discussions with the supervisor. You subsequently determine that the establishment is in compliance with 9 CFR 416.13(b). According to the establishmentís documentation and the other information provided to you by the establishment, it is apparent that all of procedures listed in the SSOPís were conducted at the frequency specified.
You then determine that the establishment has not met the requirements of 9 CFR 416.13(c). This regulation states that the establishment shall monitor daily the implementation of the procedures in the SSOPís. You found that the establishmentís records did not indicate this procedure was monitored the previous day. The slaughter supervisor subsequently confirmed that the procedure was not monitored on this day. This is a regulatory non-compliance due to the establishment not monitoring this procedure at least daily as required by the regulation. If the establishment had elected to include a monitoring frequency other then daily in their SSOP and donít monitor at the specified frequency, then this would also constitute regulatory noncompliance. 9 CFR 416 does not require the establishment to specify a monitoring frequency.
Finally, you determine that the establishment had met the requirements in 9 CFR 416.14 through 416.16.
You document the noncompliance on an NR, under the 01C01 procedure code. You reference 9 CFR 416.13(c) as the regulatory citation and mark the SSOP/monitoring indicator. You then await the establishmentís response.


If the establishment concludes that product contamination/adulteration occurred as a failure to implement their procedures, they would also have to meet the corrective action requirements of 9 CFR 416.15.


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