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.