4 replies to this topic

[Suzie B]

Hello,

I am an SQF Auditor, and I just took over as FSQA at a Produce Processing plant. Their last Primus GFS audit resulted in an automatic failure because the site was not monitoring the CLO2 levels every half hour. I am not familiar with Primus GFS, and I am unable to find a regulation, standard, or requirement that states that frequency is required. We have performed our risk assessment, implemented preventive controls, verify levels at the beginning of each run, and validate levels twice per shift.

Can someone point me to the standard that defines frequency of monitoring CLO2 in produce processing?

Thank,
Suzie

[Scampi]

At the time, did the policy they were using say that they would check every 1/2 hour? Even if it did, an auto failure seems like an awfully harsh reaction (unless they weren't checking at all??)

[Scampi]

Have you seen the guidance?  It would appear that Primus will give a zero for a couple of strange things, including NOT having a document that tells you how to write an SOP??? Can you elaborate on what the auto fail actually said?  And whether or not they changed their program post audit and prior to your arrival?

 

http://www.primusgfs...FSMSModule1.pdf

 

1.06.01: Are there current written food safety related specifications for all raw products, ingredients, materials and services purchased? Total compliance (5 points): A specification is an explicit set of requirements or criteria to be met. Specifications are accurate, acceptable and ensure conformance with relevant customer and legislative requirements. There are documented specifications for all products, ingredients, materials and services purchased or provided that have an effect on product safety, addressing the required Good Agricultural and/or Good Manufacturing Practices. Documented specifications are easily accessible to users and there is a documented procedure for review, amendment and approval of all specifications. Government registration and/or label information (e.g. EPA) for crop protection and processing aid products is acceptable in lieu of an actual specification provided there is evidence products are used according to label instructions. Specifications should be reviewed on at least an annual basis and there should be at least the following specifications available to review (where applicable):  seeds (e.g. lettuce or leafy greens, sprouts, microgreens)  transplants,  fertilizer/crop protection materials/adjuvants,  ingredients (e.g. product raw materials, ice),  processing aids (e.g. anti-microbials, buffers, post-harvest fungicides),  packaging materials (material/components manufactured with),  other materials with potential for direct product contact based on risk assessment, for example labels in direct contact with product, 07/20/2017 v2.1-2c PrimusGFS FSMS (Module 1) Guidelines AZ-R003 Page 26 of 33  services (contract sprayers, pest control, chemical suppliers, water and waste utilities, transport, maintenance and sanitation services) purchased/provided. Note that contracted auditee operations such as co-packers, harvest crews, etc., that use materials or services that are supplied and/or selected by their customers, i.e. not purchased by the auditee should still have copies of specifications for the item provided. For example, a harvest crew that has some or all of their packaging provided by their contracting customer should obtain a copy of the up- to-date specification(s) from the customer. Minor Deficiency (3 points) if:  Single/isolated instance(s) of omissions or incorrect data in the records. Major Deficiency (1 point) if:  Numerous instances of omissions or incorrect data in the records. Non compliance (0 points) if:  No records.  Failure to maintain records

 

1.04.04: Are there documented calibration procedures for measuring and monitoring devices used in the operations that are related to the safety of the product? Total compliance (10 points): There are documented policies and/or procedures for the calibration for measuring and monitoring devices used in the operation. Regular calibration ensures correct and accurate operation. For the farm (GAP option), this covers items such as fertilizer and crop protection application equipment, crop protection measuring equipment (e.g. scales), ORP and pH meters, and other equipment related to the safety of the product. For the facility (GMP option) this includes equipment used for measuring and monitoring processes (hand held and automated) related to food safety e.g. thermometers, metal detectors, ORP meters, flow meters and pH meters. Equipment is calibrated regularly to ensure correct and accurate operation. Calibration procedures should describe the frequency of testing, the testing method and the acceptable range of variation. Procedures should require that all test solutions/strips are within date code, appropriate for the concentrations used and stored correctly (especially light and temperature sensitive materials). Corrective actions should be detailed when applicable. Legal requirements, manufacturer recommendations, best practice and experience of equipment drift help to determine the frequency. Both internal (where the company checks the equipment for themselves) and external (where equipment is sent away or an outside specialist company comes on site and checks the equipment in situ) calibrations should be documented and on file. Proof of calibration includes records, invoices and on machines labels. Hand application of fertilizers is not recommended as it is difficult to assure an even distribution of fertilizer or crop protection product. If done however, it is important to choose a pace that is easy to maintain and duplicate http://pubs.ext.vt.e...Calibration.pdf http://www.ugaurbana...g-your-spreader Minor Deficiency (7 points) if:  Single/isolated instance(s) of omissions in the procedure(s).  Single/isolated instance(s) of omissions or incorrect data in the records.  Single/isolated instance(s) of piece/set of equipment omitted from the scheme. Major Deficiency (3 points) if:  Numerous instances of omissions in the procedure(s).  Numerous instances of omissions or incorrect data in the records.  Numerous instances of pieces/sets of equipment omitted from the scheme. Non compliance (0 points) if:  No procedure  No records  Failure to maintain records.

[SQFconsultant]

audit resulted in an automatic failure because the site was not monitoring the CLO2 levels every half hour.

 

.......................

How was the write up done? What did the auditor actually write down?

 

There is nothing in the PrimusGFS that leads to every half hour - - however if your company had documents indicating that it was to have been checked every half an hour and it was not being done then that would be the smoker.

[nlesperance]

I have to agree with what the others stated above. There must be something in your SOP's stating that you check every half hour, and you were not complying with your own SOP.

 

For future reference, if you are unsure of your auditor's particular downscore (or in your case, automatic fail) or simply disagree, you are allowed to ask them to explain further, and have them specifically show where/why you lost points in regards to the Guidelines. 

 

Nic