AUDIT FORM AND GUIDANCE

Transcription

1 AUDIT FORM AND GUIDANCE Customer/facility understands and agrees that the information documented herein is for the customer s/facility information use only, and that the sole purpose of the audit process is to provide the Customer/facility with an independent evaluation and assessment of Customer s/facility gluten management conditions, at the time of the audit. The findings/results documented herein are not to be construed as insurance, or as a covenant, guarantee, warranty, or promise of any kind that facility is in compliance with any legal guidelines or requirements. Allergen Control Group Inc., any of the GFCP endorsing organizations and or, the third-party auditing company disclaims any liability or responsibility regarding the practices and operations of the facility and bears no responsibility or liability for whether the facility management carries out the recommendations contained in this document. Audit Details Company Name: Audit Date(s): Certification Body: Auditor: About the Audit Checklist and This document provides guidance to approved auditors the expected GFCP Audit process and an effective gluten-free management system (GFMS). The intended outcome is to provide an up to date operative status of the company s overall gluten-free management system, as it impacts on the control of gluten to meet regulatory and/or customer requirements. Although the GFCP audit is required to be risk-based in nature, it will only evaluate those activities impacting gluten controls, at the time of gluten-free production and it is expected that a recognized facility will have an auditable, HACCP/HACCP-based food safety system or equivalent in place, as a measure of commitment to achieving the required product safety outcome. Special attention must be given to establishing procedures and processes, which also control gluten-free products destined to the following markets: Canada with use of the CCA Trademark: The intentional or inadvertent introduction of any wheat, including spelt and kamut, or oats*, barley, rye, triticale or any part thereof, and The contamination from any source, which would result in final products having 20 ppm of gluten, or more as measured by appropriate and acceptable methods of testing. (e.g. Elisa R5 (Mendez) (* Note- oats are restricted in Canada only) USA with use of the NFCA Trademark: The intentional or inadvertent introduction of any wheat, including spelt and kamut, or barley, rye, triticale or any part thereof, and The contamination from any source, which would result in final products having < 20 ppm of gluten, or more as measured by appropriate and acceptable methods of testing. (e.g. Elisa R5 (Mendez)) (Note: individual ingredients must contain <20 ppm) Any products using both CCA and NFCA Trademarks (limits go to most restrictive): No intentional or inadvertent introduction of any wheat, including spelt and kamut, or oats*, barley, rye, triticale or any part thereof (*most limiting by default) Gluten-Free Certification Program

2 The Audit Report is divided into three (3) Parts: Part 1 Company Profile Part 2 Audit checklist and guidance Part 3 Summary Audit Report Overall Rating Criteria For each requirement and sub-requirement, assign the operation a mark of pass or NC in the column. A pass mark on each requirement and sub-requirement from is the minimum level of acceptable achievement. A NC would signify at least one non-conformity was observed. All non-conformities must be closed by the facility and evidenced, within 28 days of the on-site audit before a pass mark together with a recommendation for recognition in the program can be entered into the summary section. A Pass must be recorded for each requirement before recognition under the GFCP can be achieved. The Certification Body will make a written recommendation on recognition and submit the final completed audit report to the Allergen Control Croup Inc. (ACG), for their review and approval process. Auditor References GFCP Standards and Policies and GFCP Manual Canadian Celiac Association websites: & National Foundation for Celiac Awareness website: Gluten-Free Certification Program website: Recent GFCP Technical Releases Part 1 Company Profile Company Details Legal Operating Name: Address: Country Facility Contact Phone Number: Postal/Zip Code: Fax Number: Audit Scope(s) as per Schedule A : Is the Site a Dedicated Gluten-Free Facility? Yes No Is this Audit conducted in conjunction with a GFSI Audit? Yes No Gluten-Free Certification Program

3 Audit Scope Category: 1 Raw Grain/Cereal/Seed Processing (cleaning, milling, packaging) 2 - Processing of Manufactured Meats and Poultry (poultry, pork & red meats products) 3 - Seafood Processing (fish & shellfish products) 4 - Dairy Processing (cheese, liquid milk, powder milk, cream, butter products) 5 Sweeteners & Syrups (Honey, Maple Syrup, Corn Syrup) 6 - Egg Processing (raw whole eggs, pasteurized egg products) 7 - Bakery 10 - Confectionary Manufacturing 11 Pharma & Natural Health Products 12 Dry Foods & Ingredient Manufacturing 13 - Oils, Fats and the Manufacture of oil or fat based spreads 14 - Manufacture of Cereal & Snack Products 15 - Canning & Pasteurization, UHT and Aseptic Operations (Cans & Glass Jams & Sauces) 16 Recipe Meals (RTE chilled meals and deserts, frozen meals, pizza, frozen pasta, soups, and meal solutions, sous vides products, and freeze-dried and dehydrated meals.) 8 Fruit, Vegetable & Nut Processing 17 - Manufacture of Dietary Supplements 9 Beverage Manufacturing 18 - Manufacture of Primary (Food Contact) Packaging Materials Gluten-Free Certification Program

4 Part 2 Audit Checklist and 1.0 Gluten-Free Certification Required Program Documents An original, current, copy of the following documents are on-site at the time of audit: GFCP Standards and Policies Document GFCP Manual Duly signed copy of a duly signed Schedule A available. Copy of the CCA Pocket Dictionary (recommended but not required) 2.0 Letter of Commitment The letter of commitment is current, signed, dated and reviewed annually by a senior management representative at the facility, with the authority to verify adherence to the GFCP requirements. 3.0 Documented application of HACCP principles and pre-requisite programs 3.1 Pre-requisite programs are implemented and documented Review pre-requisite programs to ensure they are: Documented and currently dated Reviewed by management Referenced back to the facilities documented hazard analysis process which addresses sources of gluten Include (but are not limited to): 1. Premises 2. Transportation, Purchasing/Receiving/Shipping and Storage 3. Equipment 4. Personnel 5. Sanitation and Pest Control 6. Recall 7. Gluten Control (can be identified as part of Allergen Control) Gluten-Free Certification Program

5 3.2 Supplier approval process in place for all ingredients entering the facility Procedures to review evaluate and act upon the supplier allergen/gluten control information obtained for all raw materials suppliers. Any discrepancies are noted and have documented corrective action A supplier approval program is in place that includes Questions on gluten controls are to provided by all suppliers including temporary or emergency suppliers (if used) Testing, letter of guarantee and/or purchase specifications A current list of approved suppliers and ingredients 3.3 GFCP employee training and education are conducted annually, and or for all new employees. 3.4 A documented gluten awareness and hygiene training program is in place. Training is documented (e.g. training materials, training records, testing). Some examples of considerations for training include: Traffic patterns Cafeterias, vending machines and personal food Clothing Job rotation practices Contractors, visitors and temporary employees Application of gluten control principles, policies and procedures are documented either as a separate plan or as part of the overall food safety system Operations with a dedicated gluten-free facility may not need a HACCP program if they have validated PRP s and address entry of potential sources of gluten into the facility; or Operations that have gluten in their facilities must have a documented HACCP plan that addresses gluten as a chemical hazard or covered a part of the allergen control program Gluten-Free Certification Program

6 3.5 An end product food safety outcome is documented for gluten-free finished product(s). 3.6 A documented end product food safety outcome for gluten-free finished product(s) shall be reflected in the company documented policy and must be less than 20ppm for Canada and USA (CCA and/or NFCA trademark). (Note: ingredients <20 ppm) Internal label claims/declarations regarding gluten that are more strict than < 20ppm (e.g. 5ppm) are reflected in the company policy and procedures and are accountable for that level. Potential sources of gluten are identified and controlled in all ingredients/raw materials at receiving and internal management. 3.7 There is a policy for keeping gluten out of the facility and identification of materials not allowed in the facility (dedicated facilities only) There is a product development and approval process for new and modified product formulations There are policies or procedures to ensure only approved ingredients, with a gluten content <20 ppm, are received from approved sources Hidden sources of gluten in processing aids or packaging are included in the raw materials analysis Verify that the ingredients controlled match the Raw Materials Hazard Analysis Verify the plant has a protocol for identifying gluten in their raw materials specification and frequency of review has been established Potential for cross-contamination is controlled and managed during manufacturing, packaging and storage Procedures or policies are in place to prevent cross-contamination between gluten containing and non-gluten containing ingredients, materials and end products. This includes but is not limited to: Segregation or separation procedures such as production scheduling or dedicated lines Equipment and facility design Gluten cleaning and validation Receiving and storage practices Procedures for weighing/blending/mixing/formulation Handling and storage of rework products containing gluten Dedicated utensils, equipment and areas to handle gluten Gluten-Free Certification Program

7 3.8 Disposal of obsolete materials that could be a source of cross contamination Traffic patterns and traffic flow of employees and products that handle or contain gluten *Note: This may be N/A for dedicated gluten-free facilities There is a system for upstream and downstream traceability for raw materials and finished products The traceability system can track all raw materials from suppliers through all stages of production to the point of dispatch and, if appropriate, delivery to known customers. Effectiveness of the traceability system is tested at least annually Verify traceability by conducting an exercise including one gluten-free product or a gluten-containing raw materials 3.9 Product labels are reviewed and controlled for accuracy 3.10 There are procedures related to labeling of gluten-free finished product to ensure labeling is accurate Procedures and documentation is accurate and up-to-date Auditor to verify that labels are accurate Auditor to verify that gluten-free packaging label checks are implemented and documented as defined in the procedures Internal audits have been conducted within the previous 12 months to verify the GFMS is operating according to the documented specifications Internal audits are carried out by appropriate personnel and do not evaluate their own work. Internal audit results are documented including action taken and timelines for any corrective actions or non-compliance Gluten-Free Certification Program

8 3.11 The efficacy of the overall gluten control program is validated 3.12 Current, validation documentation is available to ensure the GFMS is capable of achieving the intended level of hazard control Validation documentation may include scientific, technical or regulatory support or testing data There is a documented system for reviewing actions taken in response to situations such as: o Client or consumer gluten-free food safety complaints o Unsatisfactory test results o Non-compliant activities resulting in a recall o Non-conformity during audits Documented verification testing and analysis of gluten-free products is conducted according to the GFMS Verification testing and analysis is appropriate for the product and process Testing methods and protocols are documented Verification testing may be done: o On incoming ingredients and raw materials o To verify sanitation procedures o On end products or in-process as appropriate Verify testing is completed as documented and that appropriate follow-up actions are taken 3.13 Gluten Control procedures are reviewed and updated Gluten control procedures are reviewed annually, or more often as required, when any of the following occur: Changes to product formulation Addition of new products to gluten-free line Process and/or equipment change Reports show deviations from acceptable results Gluten-Free Certification Program

9 Part 3 Summary Report Requirement s Summary of Non-Conformances (Repeat as needed for multiple NC s) Requirement No. Details Corrective Actions / Evidence Provided Closed: Yes No Date: Auditor: Note: All non-conformances must be closed out within 28 days from the date of audit. Evidence of each closure should be submitted directly to the auditor for review and final reporting. Recommendation Date: Auditor (name): Signature: e-signature accepted Report Sign-Off Date: Technical Reviewer (name)*: Signature: e-signature accepted Technical Review needs to be performed by a person who has achieved GFCP Approved Auditor status and must not the originating auditor of record. The Gluten-Free Certification Program (GFCP) is owned and operated by the Allergen Control Group Inc. (ACG). Unauthorized use of any of its owned or managed trademarks, without ACG s prior written consent is strictly forbidden. ACG and the GFCP are responsible for reviewing the correct use of its owned and managed trademarks on packaging labels and are not responsible for any other printed content, regulatory requirements and or legal obligations; in any way, shape or form. Gluten-Free Certification Program