PrimusLabs.com Facility Audit Paperwork Checklist

Transcription

1 PrimusLabs.com Facility Audit Paperwork Checklist v5.06 Audits Rev 3 Oct05 Please have the following paperwork available for the audit. The following list is a guide only and represents the minimum requirements for PrimusLabs.com audits. The auditor will potentially look at paperwork over the last year and/or since the last PrimusLabs.com audit. The list below is roughly in the order that the auditor will address the different sections of the audit. An organization chart and process flow diagrams are useful documents for the auditor to see at the start of any audit at medium to large facilities. Paperwork Listing & with with FDA Food Security Registrations Documentation Traceback and recall programs Mock recall paperwork (summary and supporting paperwork that shows traceability exercise logic) Regulatory inspection procedures Glass policy (statement, breakage procedure and if relevant glass register) "On hold" and "rejected" product handling procedures N N MSDS book (inc. index) Specimen labels Chemicals inventories and/or usage logs Pest control contract(s) Pest control license(s) Pest control insurance(s) Pest control trap map(s) Pest control service (visit) (inc. application details and corrective actions) Buyer rejections/ complaints/ corrective actions Consumer complaints and corrective actions Records and corrective actions for Federal & State visits, 3rd party and 2nd party audits e.g. water temperatures, chlorine, ph etc.

2 Hand dip logs (not required if hand gels or hand sprays are used instead) & with with N N Y 1 Y 1 Y Y Foot dip logs N N N N Y Y Daily start up inspection logs Equipment calibration Internal GMP self inspection Incoming (product and packaging) inspection Incoming specifications (product and packaging) Incoming letters of guarantee and/or supplier certifications Incoming truck temperature Incoming truck sanitation check Daily incident log and/or non usual occurrence corrective action (NUOCA) log N N Finished good temperature checks N N N N Y Y Preventative maintenance schedules Preventative maintenance completion Maintenance work logs Post maintenance sanitation /procedures N N Cleaning schedules (master sanitation) Cleaning procedures Records of cleaning operations (sanitation logs) Records of drain cleaning operations Records of cooling unit servicing Records of cooling unit cleaning Food safety committee listing N N Records of food safety meetings N N Records of new hire food safety training

3 & with with Records of existing ongoing employee food safety training Employee disciplinary procedures Equipment microbiological testing N Y 2 Y 2 Y 2 Y Y Equipment microbiological testing corrective action N Y 2 Y 2 Y 2 Y Y where necessary Environmental microbiological testing Y 3 Y 3 Y 3 Y 3 Y Y Facility microbiological testing corrective action where Y 3 Y 3 Y 3 Y 3 Y Y necessary Water microbiological testing (on site sample) Water microbiological corrective action where necessary Ice microbiological test result and/or letter of N Y guarantee Ice microbiological corrective action where necessary N Y /processing room temperature logs (if refrigerated) N N room temperature logs (probe(s) independent of thermostat) Shipping truck temperature logs Shipping truck sanitation logs training and certificates self audit Product descriptions Process flow charts Hazard analysis (charts and/or narratives) and CCP decisions chart showing CCPs, testing, frequencies, corrective actions, verification plans CCP monitoring CCP deviation, non compliance

4 & with with Evidence of discussions at the management level Action plans after verifications have shown issues with the plan Visitor and contractor signing In and out logs Inbound and outbound truck seal number Food security policies (manuals)) Food security training Log showing who has access to sensitive areas e.g. chemical stores Documented system for protecting the security of food safety documentation and computer systems Chemicals inventories and/or usage logs Records of "minors" work hours and types of work done (if minors were employed) Allergen sanitation procedures and (if allergens are used on site) Allergen training (if allergens are used on site) Written Standard Operating Procedures (SOP's) for food safety systems An index of the food safety SOP's SOP covering water changing (if used) and anti-microbial testing of the water (if used) Records for anti-microbial (free chlorine, ORP, ozone etc.) strength testing at start up and throughout the process N Y 4 Y 4 Y 4 Y 4 Y 4 N Y 5 Y 5 Y 5 Y 5 Y 5

5 & with with Internal food safety paperwork self inspection Training for sanitation staff SOP's for identified CCP monitoring processes Notes 1) Hand Dip Logs are required for packing houses that have products that are washed or unwashed, but are viewed as ready to eat. This includes berries, peppers, apples, stone fruit etc. Exempt products are those that need cooking or have an inedible peel. 2) Equipment microbiological testing are required in packing houses that wash the produce in some form except for produce that has to be cooked prior to consumption or has an inedible peel. Coolers that use ice and/hvacs are also expected to have these. 3) Enviromental microbiological testing are required in packing houses that wash the produce in some form except for produce that has to be cooked prior to consumption or has an inedible peel. Coolers and storage units that store wet product and/or store product at higher humidities are expected to have these. 4) SOP for water changing product is being washed. SOP for anti-microbial testing of the water is required where the water is being recycled and an antimicrobial is being used. 5) Records of anti-microbial testing of the water is required where the water is being recycled and antimicrobial is being used.