INSTRUCTIONS TO COMPLETE THE SELF EVALUATION CHECKLIST In order to prepare you and your organization to move toward becoming a recognized facility under the Gluten Free Certification Program (GFCP), we feel that it is prudent to give you a tool to measure your readiness. You can do this yourself or use the information from previous audits, either internal or by third parties, when completing the Self Evaluation Checklist. As you review the checklist, it should be clear that having Good Manufacturing Practices (GMP s) or the application of other tools such as HACCP in place are advantageous. The Self Evaluation Checklist is divided into two parts: Part 1 Company Profile Part 2 Detailed Report by Element Complete Part 1 and then using the legend that appears on Page 1, rate each item in Part 2 to the best of your ability rating. Keep track of your comments and intended actions for deficiencies. You will need this information to advance further into the GFCP application process. Remember that in making a gluten free claim and to eventually be successful in the GFCP, special attention must be given to procedures and processes that control the introduction of any wheat, including spelt and kamut, or oats, barley, rye or triticale or any part thereof either directly or as a contaminant from any source. When you are finished, visit http://www.surveygizmo.com/s3/545982/gfcp preapp to submit your information in electronic form. 1
SELF EVALUATION CHECKLIST GLUTEN FREE CERTIFICATION PROGRAM PART 1: Company Profile Company: Address: Dedicated or Non Dedicated: Contact: Tel/email: Accountable Person(s): Auditor: LEGEND: NE = Not Evaluated = Available and acceptable NI Needs Improvement X = Unacceptable (No GF Recognition) NA = Not Applicable 2
PART 2: Detailed Report by Element A. Documented pre requisite programs Premises Transportation, Purchasing/Receiving/Shipping and Storage Equipment Personnel Sanitation and Pest Control Recall Allergen Control Monitoring procedures Deviation procedures Record keeping 3
B. Gluten Free Management System (GFMS) completed, approved and current Identified and addressed gluten free and nongluten free components Incorporated major and minor ingredients including processing aids, flavours, seasonings Primary packaging source assessed for use wheat or corn based release agents Hazard analysis conducted on the above components Product & personnel flow charts identify areas where a potential cross contamination risk can occur The GFMS defines gluten free testing of finished product as a CCP or equivalent The GFMS establishes the critical limits, monitoring procedure, corrective action, verification procedure, records and validation The GFMS for gluten free products is reviewed annually at a minimum or whenever there is a major change (e.g. ingredient, equipment) All GFMS reviews are documented Validation testing of gluten free finished products conducted annually 4
C. Cross contamination prevention for gluten free products in place Facility zoned to prevent cross contamination of gluten free products Dedicated production lines for gluten free products Production scheduling used to prevent crosscontamination between gluten free and glutencontaining products ( e.g. gluten free products at start of production) Where necessary, barrier devices protect production lines crossing over each other from potential gluten cross contamination of glutenfree products Appropriate change over procedures in place Movement of personnel working with gluten containing products is restricted to designated areas. If moving to a gluten free area, appropriate measures taken to eliminate crosscontamination risk (e.g. change uniforms, shoes, gloves, dedicated utensils, etc.) Gluten free change over & pre operational inspections conducted &documented Observations and interviews made during previous audit to verified programs were being followed 5
D. Supplier appraisal process Formal gluten free supplier selection (approval) program in place Current approved gluten free supplier list Supplier Appraisal Questionnaire (SAQ) sent to all suppliers, including primary packaging, requesting gluten free status information Audits of all gluten free suppliers conducted to ensure they are gluten free (or equivalent) Suppliers have appropriately identified gluten containing allergens in the SAQ Allergens, including any source of gluten, in a incoming material are identified on the material ingredient list Ingredient specifications indicates the ingredient is gluten free Ingredient specifications reviewed on a regular basis with supplier to ensure all gluten free ingredients are identified (documented) Approval process in place for use of temporary suppliers of gluten free products Procedure defines corrective action to be taken when cross contact with a gluten containing product is suspected and are documented Validation testing of incoming materials used in gluten free products The facility reviews and signs off all COAs from gluten free suppliers Interviews of employees responsible demonstrated an understanding of the program 6
E. Policy & Procedure for Handling Rework/Holdover of Gluten Free Products Formal policy & procedures in place for handling gluten free rework/holdovers Policy/Procedure clearly defines what products can be used in gluten free products as rework Policy/Procedure clearly defines who authorizes rework & quantity of gluten free product to be reworked in order to ensure finished product meets all food safety, legal & quality standards All gluten free containing re work is identified (e.g. colour coding or other means) from gluten containing rework Containers for gluten free containing rework, are identified, separated, cleaned & swabbed to verify cleaning All equipment used to handle gluten free rework (e.g. grinders, mixers) are identified Gluten free rework is tracked on production batch sheets 7
F. Cleaning & Sanitizing Formal procedures in place for cleaning after production run containing gluten containing products or gluten free changeovers All equipment used with gluten free containing rework is cleaned. Cleaning is verified & documented (e.g. ELISA) Sanitation/Cleaning of production lines & utensils after gluten containing production, before gluten free production, is verified and documented (e.g. ELISA) Corrective actions documented when gluten residue is found Final rinse of CIP sampled & tested for gluten residues Cleaning procedures, including CIP/COP, are validated using an allergen protein specific test or other method (please describe) CIP system checked regularly for pitting & rough welds to prevent trapping of allergenic material Post sanitation inspection documented Interviewed employees understood cleaning SOPs for gluten free production 8
G. Change Control Process Change over control procedure (or equivalent) in place to identify, communicate and control changes in ingredients, formula, processing, equipment, packaging material & labels, etc., that may affect gluten free status In house ingredient specifications are up to date with respect to gluten free production Current & approved gluten free formula used in manufacturing Procedures define process for accounting for & removing obsolete specifications, formulations & process instructions related to gluten free manufacturing Batch sheets reflect approved gluten free formula Obsolete packaging materials (including labels) are segregated & destroyed New ingredients evaluated in the GFMS Documented product development process is in place for the development of gluten free products (includes HACCP, ingredient reviews, labels, etc.) for addition to the GFMS 9
H. Label Verification Process Procedure in place to ensure correct gluten free labels (packaging) are being used in gluten free production (e.g. visual/bar code scanning) Allergens used in specific products are declared in the ingredient list Allergen statement such as May Contain... or similar statements on labels for inadvertent allergens The Gluten Free Certification Logo and statement appropriately displayed on the principal display panel of the label Tracking of gluten free labels is conducted for all labels for those products declared as Gluten Free and labels are compared to formulations & ingredient specifications Interviewed employees understood label change over procedure for gluten free products 10
I. Training Procedure and Records Gluten free training conducted during induction & annual refresher training All gluten free training documented, testing as required Employees are tested for understanding of gluten free training Is the gluten free training part of the HACCP or GMP training Hand washing is part of the GMP program for gluten free manufacturing Gluten free training related to cleaning of equipment & utensils conducted & documented for appropriate personnel Gluten free training includes procedures for handling gluten containing items throughout the production process Training for storing and weighing out gluten free material provided to appropriate personnel Interviewed employees understood demonstrated knowledge on what gluten free meant and the health implications 11
J. Handling of Gluten Free Materials Gluten free and other materials clearly identified during receiving Gluten free materials stored in separate area to eliminate cross contamination risk (e.g. like with like, separate area, bottom slot of racking) Dedicated equipment for processing/harvesting Pre operation inspection of production line prior to gluten free production Separate/dedicated equipment, measuring devices & utensils (e.g. scoops) and containers for gluten free products in place Gloves, plastic aprons or appropriate clothing used to prevent cross contamination as required Gluten free materials are handled during production to prevent cross contamination Finished gluten free product stored separately from non gluten free storage areas If employees allowed to bring gluten containing items into facility, they should be stored away from gluten free production areas Consider all potential sources of gluten including vending equipment in the cafeteria Employees wash hands after handling gluten products before entering gluten free areas Interviewed employees understood demonstrated knowledge on what gluten free meant and the health implications 12
K. Laboratory testing procedures Gluten free testing is performed by an accredited laboratory as per the GFMS Test kits stored properly to maintain shelf life dated and within Expiry Date In house labs, conduct gluten free testing participate in collaborative to verify analysts proficiency and accuracy (e.g. internal/external) Training given to employees responsible for gluten free testing & training is documented Calibration program for all CCP instrumentation/records maintained Collaborative test results are on file Test results recorded indelibly Test methods maintained in a manual, valid, current, signed, dated Gluten free testing is part of the positive release program for finished product Record review conducted prior to positive release Interviewed employees understood demonstrated knowledge on what gluten free meant and the health implications 13
L. Formulae Approved & Current Formulae and method of production is written, formally approved, logged, filed and clearly referenced and showing that all ingredients have been assessed under the GFMS Procedures in place to ensure that appropriate labels and packaging are used for the appropriate product formulation Interviewed employees understood demonstrated knowledge on what gluten free meant and the health implications 14
M. Internal audits conducted and documented Internal audit plan to be used to verify the application of the GFMS Results are documented and corrective actions applied as written in the GFMS CAR s are due dated, followed up to show closure or not by the due date and documented Annual review of all deviations and consumer complaints or more often as needed Validation of programs must be conducted as per the GFMS (e.g. annual is minimum) Interviewed employees understood demonstrated knowledge on what gluten free meant and the health implications 15