2 replies to this topic

[Shuster.35]

We are a SQF Certified facility in the United States that repacks and grinds candies, cookies, granolas, RTE shelf stable items. Can someone tell me in either the SQF code or 21 CFR where it states we need to document DAILY "sanitary conditions of the manufacturing environment or adherence to cGMPS" We complete Monthly Audits, I'm wondering if we also are required to complete Daily DOCUMENTED CHECKS. 

[Slab]

We are a SQF Certified facility in the United States that repacks and grinds candies, cookies, granolas, RTE shelf stable items. 

 

Can someone tell me in either the SQF code or 21 CFR where it states we need to document DAILY "sanitary conditions of the manufacturing environment or adherence to cGMPS"

 

We complete Monthly Audits, I'm wondering if we also are required to complete Daily DOCUMENTED CHECKS. 

 

Hi, Shuster;

 

Sanitation controls are preventive controls for part 117 CFR 21 which falls under "monitoring"

 

 

 

Sec. 117.145 Monitoring.

 

As appropriate to the nature of the preventive control and its role in the facility's food safety system:

(a) Written procedures. You must establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive control; and

(b) Monitoring. You must monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed.

© Records. (1) Requirement to document monitoring. You must document the monitoring of preventive controls in accordance with this section in records that are subject to verification in accordance with 117.155(a)(2) and records review in accordance with 117.165(a)(4)(i).

(2) Exception records. (i) Records of refrigeration temperature during storage of food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens may be affirmative records demonstrating temperature is controlled or exception records demonstrating loss of temperature control.

(ii) Exception records may be adequate in circumstances other than monitoring of refrigeration temperature.

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016]

[Slab]

I forgot to mention the following from part 123 CFR 21, and since I can't edit my OP;

 

 

c) Sanitation control records. Each processor shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by paragraph (b) of this section. These records are subject to the requirements of § 123.9.

 

 

 

(b) Sanitation monitoring. Each processor shall monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices specified in part 110 of this chapter that are both appropriate to the plant and the food being processed and relate to the following:

 

 

This is a dated form of part 110 (now 117), which was the FDA's original GMP/Sanitation controls guidance. With the exception of seafood, most fall under part 117. The FDA will not specifically state "daily" as this may be impractical for your operation, however it does state at a frequency to adequately to provide necessary assurances. I.e. if you are operating daily, and clean daily, the auditing body will expect to see daily monitoring records.