GLUTEN-FREE CERTIFICATION PROGRAM

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GLUTEN-FREE CERTIFICATION PROGRAM

Self Evaluation Checklist

Use this checklist to internally review your facility policy and procedures to determine how they compare with the requirements needed to successfully pass the Gluten-Free Certification third party audit.

1.0 Gluten-Free Certification Required Program Documents

Status Comment

Guidance

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 the GFCP Program License Agreement (PLA) and schedule A.

(A copy of Schedule A should be attached to this report)

• Copy of the CCA Pocket Dictionary 2.0 Letter of Commitment

Guidance

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

Guidance

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

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GLUTEN-FREE CERTIFICATION PROGRAM

3.2 Supplier approval process in place for all ingredients entering the facility

Guidance

A supplier approval program is in place that includes

• Questions on gluten for 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

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

3.3 GFCP employee training and education are conducted annually, and or for all new employees.

Guidance

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

3.4 Application of HACCP principles, policies and procedures are documented either as a separate plan or as part of the overall food safety system

Guidance

• Operations with a dedicated gluten-free facility may not need a certified HACCP program if they have validated GMP’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

3.5 An end product food safety outcome is documented for gluten-free finished product(s).

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GLUTEN-FREE CERTIFICATION PROGRAM

Guidance

• 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

• Internal label claims/declarations regarding gluten that are more strict that <

20ppm (e.g. 5ppm) are reflected in the company policy and procedures 3.6 Potential sources of gluten are identified and controlled in all ingredients/raw materials at

receiving and internal management.

Guidance

• 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 match the HACCP 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

3.7 Potential for cross-contamination is controlled and managed during manufacturing, packaging and storage

Guidance

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

• Disposal of obsolete materials that could be a source of cross contamination

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GLUTEN-FREE CERTIFICATION PROGRAM

*Note: This may be N/A for dedicated gluten free-facilities

3.8 There is a system for upstream and downstream traceability for raw materials and finished products

Guidance

• 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 a mass balance exercise including one gluten- free product or a gluten-containing raw materials

3.9 Product labels are reviewed and controlled for accuracy

Guidance

• 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

• Verify that labels are accurate

• Verify that gluten-free packaging label checks are implemented and documented as defined in the procedures

3.10 Internal audits are conducted annually to verify the GFMS is operating according to the documented specifications

Guidance

• 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

3.11 The efficacy of the overall gluten control program is validated

Guidance • 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

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GLUTEN-FREE CERTIFICATION PROGRAM

or testing data

• There is a documented system for reviewing actions taken in response to situations such as:

o Client or consumer GF food safety complaints o Unsatisfactory test results

o Non-compliant activities resulting in a recall o Non-conformity during audits

3.12 Documented verification testing and analysis of gluten-free products is conducted according to the GFMS

Guidance

• Verification testing and analysis is appropriate for the product and process

• Testing methods and protocols and 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

Guidance

Gluten control procedures are reviewed annually, or 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