1. Scope of this document

This document contains assessment and certification/inspection criteria for:

• Feed Responsability Assurance Module (FRA).

2. Normative references

The following documents, in whole or in part, are normatively referenced in this document and are mandatory to comply with. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

• F0.1 Rights and Obligations
• F0.2 Definition list
• F0.3 Scopes for certification
• CR1.0 Acceptation requirements
• CR2.0 Assessment and Certification of Feed Safety Assurance scopes

3. Terms and Definitions

For GMP+ definitions see F0.2 Definition list. Throughout this document the terminology “through the Certification Body” is used indicating that all activities performed by critical-, non-critical locations are conducted under the responsibility/liability of the GMP+ accepted Certification Body.

4. Process requirements

4.1. Pre-certification activities

4.1.1. Application

The Certification Body must require an authorized representative of the applicant organization to provide the necessary information to enable it to establish the following:

1. the desired scope of the certification;
2. relevant details of the applicant organization as required by the specific certification scheme, including its name and the address(es) of its site(s), its processes and operations, human and technical resources, functions, relationships and any relevant legal obligations;
3. identification of outsourced processes used by the organization that will affect conformity to requirements;
4. the standards or other requirements for which the applicant organization is seeking certification;

Relevant details of the applicant organization including its name and addresses as specified in the official legal business registration by the competent authority and information as mentioned in Appendix 2 of this document. In addition the 5^th bullet of article 5.1.1. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes, applies.

4.1.2. Application review

Before proceeding with the audit, the Certification Body will carry out a review of the application and additional information for certification to ensure that:

1. the information about the applicant organization and its management system is sufficient for the conduct of the audit;
2. any known difference in understanding between the Certification Body and the applicant organization is resolved;
3. the Certification Body has the competence and ability to perform the certification activity;
4. the scope of certification sought, the location(s) of the applicant organization's operations, time required to complete audits and any other points influencing the certification activity are taken into account (language, safety conditions, threats to impartiality, etc.);
5. records of the justification for the decision to undertake the audit are maintained.

The certification body, following the review of the application, must either accept or decline an application for certification (the reasons for declining an application, the review of the application, must be documented and made clear to the client).

Based on the review, the Certification Body must determine the competences it needs to include in its audit team and for the certification decision.

The Certification Body must not exclude activities, processes, products and services from the scope of certification when these can have an influence on the feed responsibility. The application review is mandatory.

4.1.3. Certification agreement

Article 5.1.3 of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable. In deviation on requirement 5.1.3.b, the minimum obliged audit/inspection time per scope(s)/standard(s) as stated in Appendix 1 of this document per audit type is applicable, referring to Appendix 1 is insufficient.

4.1.4. Audit team assignment

Persons who are performing the audit must comply with the applicable requirement of Appendix 2 of the CR1.0 Acceptation requirements.

4.1.5. Rotation of auditors

Rotation of FRA auditors :

• Article 5.1.4.1 of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.1.6. Audit plan

An audit plan for each type of audit must be send to the GMP+ Certified Company prior to the audit.

4.2. Certification process

4.2.1. Audit

4.2.1.1. General

Article 5.2.1.1. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable. The minimum obliged audit frequency and audit times are determined in Appendix 2 of this document (CR3.0).

4.2.1.2. Initial certification Audit and inspection

An initial certification audit will be performed through the Certification Body in order to assess whether the company meets the criteria set out in Appendix 1 of this document. The initial certification audit must be conducted within 3 months after concluding a certification agreement with the applicant organization.

When the specific conditions as described in Appendix 4 “Not at the GMP+ Certified Company location” and/or Appendix 5 “Remote Audits” of this document are met, the Initial certification audit can be performed accordingly.

4.2.1.3. Temporary acceptance

The text of article 5.2.1.3.1 of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.2.1.4. Surveillance audits

The first surveillance audit must be executed each 12 months, plus and minus 2 months, after the certification decision date.

The second surveillance audit must be executed each 24 months, plus and minus 2 months, after the certification decision date.

When the specific conditions as described in Appendix 4 “Not at the GMP+ Certified Company location” and/or Appendix 5 “Remote Audits” are met, the surveillance audit can be performed accordingly.

4.2.1.5. Announced surveillance audits

An announced surveillance certification audit will be performed during the period of validity of the GMP+ certificate through the Certification Body in order to assess whether the company meets the criteria set out in Appendix 1 of this document. The frequency and the audit times of the announced surveillance audit are determined in Appendix 2 of this document.

4.2.1.6. Unannounced surveillance audits

See article 4.2.1.5 above. In addition if the FRA module is audited together with the FSA module the audit will be performed unannounced for all scopes.

4.2.1.7. Recertification audit

Prior to the extension of validity of a certificate a re-certification audit/inspection must be carried out through the Certification Body.

A GMP+ certificate may or may not be extended by the Certification Body based on the assessment criteria as specified in Appendix 1 this document.

Before the period of validity of the certificate expires, the total certification process must be finished including updating of the GMP+ company database (status and data of certificate) through the Certification Body. If a recertification audit is not carried out before the expiration date of the validity of the certificate, then an initial certification audit must be carried out. The company is in the intervening period not GMP+ certified.

When the specific conditions as described in Appendix 4 “Not at the GMP+ Certified Company location” and/or Appendix 5 “Remote Audits” are met, the recertification audit can be performed accordingly

4.2.1.8. Expansion audit

Article 5.2.1.7. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.2.2. Special audits

The following audits can be applicable, assessment must be done in accordance with Appendix 1 of this document.

4.2.2.1. Stricter supervision Audit (SSA)

Article 5.2.2.1. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.2.2.2. Repeat audit (RPA)

Article 5.2.2.2. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.2.3. Extraordinary events

Article 5.2.3. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.2.4. Identifying and Recording Audit findings

If the applicant organization/GMP+ Certified Company does not comply with the applicable requirements of the GMP+ Feed Certification scheme, the sanctions as specified in Appendix 1 of this document apply.

If nonconformity identified in one of the MI5.4 GMO controlled scopes this applies for both the FRA and FSA scopes.

4.2.5. Audit report

The text of article 5.2.6. and Appendix 3 of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.2.6. Review

Article 5.2.7. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.2.7. Certification decision

The certification decision must be based on:

1. For any type of nonconformities, the Certification Body has reviewed, accepted and verified the correction and corrective actions;
2. Assessment of the applicant organization/GMP+ Certified Company took place in accordance with Appendix 1 of this document.
3. The assessment and decision of a Certification Body must be demonstrably based on objective evidence of conformity and non-conformity obtained.

4.2.8. Certificate and Temporary acceptance

4.2.8.1. Certificates/ Statement

A certificate has the following maximum validity:

• FRA certificates (all MI 5.1, MI 5.2, MI 5.3, MI 5.4, MI 5.6 and MI5.7): 3 years,
• FRA statement (MI 5.5): 14 months

calculated from the date of a positive certification decision. Within 8 weeks following the execution of the audit on site, the Certification Body will send the certificate/ statement to the applicant organization/GMP+ Certified Company. The duration of the GMP+ certificate/ statement must not exceed the validity of the certification agreement.

4.2.8.2. Temporary acceptance

For FRA temporary acceptance see article 5.2.9.2 of CR2.0 Assessment and Certification of Feed Safety Assurance scopes. However, if during the initial certification audit on site (if applicable), the applicant organization does not appear to comply the GMP+ requirements conform Appendix 1 of this document (CR3.0) then the temporary acceptance must be withdrawn.

4.2.8.3. Certificate and Temporary acceptance templates:

The Certification Body must put the following text on the certificate or temporary acceptance:

1. Text for a certificate

¹ Only in case of an individual multi-site certificate, these sentences must be included in the certificate

2. Text for temporary acceptance

¹ Only in case of an individual multi-site certificate, these sentences must be included in the certificate

3. Text for statement

In addition the following applies for the above certificate, temporary acceptance and statement:

1. The data of the GMP+ Certified Company/temporary accepted company must exactly be the same as registered in the legal business registration. (for example Chamber of Commerce/registration at competent authority, tax/vat number)
2. It is mandatory to show the GMP+ FRA logo on the certificate.
3. It is not permitted to use the GMP+ FRA logo on a temporary acceptance. In addition, the document may not be called a “certificate” but must be designated as a “temporary acceptance”.
4. It is not permitted to use the logos of Critical Location and non-Critical Location on the GMP+ certificate and temporary acceptance other than the GMP+ accepted Certification Body.
5. The start date of the certificate/temporary acceptance is a date which is in any event equal or after the date of the positive certification/temporary acceptance decision.
6. In case of expansion of scopes the end date of the valid GMP+ certificate may not be extended. The Certification Body can also grant the GMP+ Certified Company a new GMP+ certificate for the additional scope.
7. It is not permitted to specify brand names in any way whatsoever on the certificate or temporary acceptance.
8. (Contractual) conditions/ requirements are not allowed on the GMP+ certificate/temporary acceptance/statement.

4.3. Suspension or Withdrawal of a Certificate Temporary acceptance

The text of article 5.3 of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.4. Transfer to another Certification Body

Article 5.4. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.4.1. Pre-transfer review

Article 5.4.1. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.4.2. Certification process during transfer

Article 5.4.2. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

4.4.3. Cooperation between the departing and accepting Certification Bodies

Article 5.4.3. of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable

5. Exclusion of GMP+ International Liability

Chapter 6 of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable.

6. Tariffs

The Certification Body will use its own tariff. On behalf of GMP+ International, through the Certification Body, relevant tariff as listed in GMP+ CR4.0 Tariffs are charged.

7. Disputes between Certification Bodies and GMP+ certified companies

Disputes between Certification Bodies and applicant organization/GMP+ Certified Companies with respect to the assessment will initially be handled in accordance with the dispute regulation of the Certification Body. If this does not lead to a solution, then the dispute can be handled in accordance with the F0.5 Disputes procedure.

Appendix 1: Assessment criteria and sanctions for audits GMP+ FRA

Non-conformities are to be classified based on:

• The general assessment criteria as mentioned in this Appendix
• The specific assessment criteria as shown in the checklists.

The sanctions specified must be imposed as a minimum. Through the Certification Body it is allowed to impose stricter sanctions.

If in this table is mentioned certificate it also applies for the temporary acceptance.

* Sanctions can be applied starting at any level.

Appendix 2: Frequency and Audits times

See Appendix 2 of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes. The audit times in Table 1 below are in addition to a GMP+ FSA scope (or equivalent as mentioned in chapter 3 of TS1.2 Purchase). Reduction of audit times for the applicable FRA scopes in Table 2 only applies when the audit is simultaneously performed with the FSA scopes (or equivalent as mentioned in chapter 3 of TS1.2 Purchase) by the same audit team. The audit team assessing the FRA scopes must have a valid GMP+ acceptation covering the relevant FRA scopes. These audit times include preparation, reporting and audit time reduction is not allowed.

Ranking of scope groups

For calculating the minimum audit time, the group of FRA scopes must be ranked as follows:

• scope group A: GMO – Controlled*
• scope group B: RTRS, Responsible pig & poultry feed, Responsible dairy feed, Responsible feed*
• scope group C: Feed environmental footprint

Ranking of Supply chain models

For calculating the minimum audit time, the audit time for each supply chain model shall be ranked as follows:

• Segregation
• Mass Balance, Area Mass Balance, Book & Claim.

Formula for calculation

For calculating the minimum obliged (Initial Certification audit (ICA); (Un)Announced Surveillance audit (USA/ASA) and Recertification audit (RCA)) audit time for a single site the following formula will be used:

Ts= TD + TH1 + TH2 (if applicable)+ TFTE

Where:

Ts: minimum obliged audit time, in days

TD: the sum of the basic audit time of the first scope per scope group (A, B, C), in days;

TH1: the sum of the audit time for each additional GMP+ FRA scope for scope group A, in days;

TH2: the sum of the audit time for each additional supply chain model per individual scope in scope group B, in days;

TFTE: : Is the number of audit days per number of employees.

When a main office has additional production location(s) and the following conditions are met, Certification Bodies can decide to audit the additional production location(s) from the main office, and the minimum obliged audit times in Table 3 are applicable for the main office.

• All FRA scopes certified at each additional production location, as specified in Table 3, must be secured in the feed responsibility management system (FRMS) of the main office.
• The main office is fully responsible for managing a common material accounting system that secures all scopes and supply chain models, and the same calculation tool(s) used at all additional production locations.
• The main office holds full responsibility and performs the following activities for all additional production locations:
  • purchase of ingredients/raw materials of final feed products produced by the additional production location(s),
  • formulation of product recipes of final feed products produced by the additional production location(s),
  • sales of final feed products produced by the additional production location(s),
  • production planning and/or transport planning of final feed products produced by the additional production location(s),
  • collection and calculation of relevant data for feed environmental footprint of all additional production location(s),
  • all relevant documentation is (digitally) available at the main office.

For calculating the minimum obliged (Initial Certification audit (ICA); (Un)Announced Surveillance audit (USA/ASA) and Recertification audit (RCA)) audit time for each additional production location(s). The following formula must be used:

Ts= TD + TH1

Where:

Ts: minimum obliged audit time for additional production location(s) that can be audited from the main office, in days.

TD: the sum of the audit times per scope to be added to the main office, in days.

TH1: the sum of the audit time for each additional supply chain model for per individual scope in scope group B, in days.

Appendix 3: Multi-site certification

Appendix 4 of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes is applicable. In addition:

Multi-site certification is not permitted for the FRA scopes:

• Production of compound feed - GMO controlled,
• Production of premixtures - GMO controlled,
• Production of feed materials - GMO controlled,
• Production of feed additives - GMO controlled.

Multi-site certification is permitted for the FRA scopes:

• Trade in feed - GMO controlled,
• Storage and Transshipment of feed - GMO controlled,
• Road transport of feed - GMO controlled,
• RTRS*
• Responsible pig & poultry feed*
• Responsible dairy feed*
• Feed environmental footprint*
• Responsible feed*

* With the exception of:

• any location which is certified for the aforementioned scopes that produces feed products;
• when these scopes are audited in combination with a scope for which multi-site certification is not allowed (both FRA and FSA scopes).

Audit frequency for a multi-site organization:

• With a main office and equal or less than 20 multi-site locations, all multi-site locations must be audited at least once during one certification cycle.

With a main office and more than 20 multi-site locations, all multi-site locations must be audited at least once during two consecutive certification cycles.

Minimum obliged audit time in day’s per multi-site location

Appendix 4: Auditing not at the GMP+ certified company location

The requirements as stated in Appendix 5 of CR2.0 Assessment and Certification of Feed Safety Assurance scopes are applicable for the following scopes:

• Trade in feed – GMO Controlled;
• Road transport of feed – GMO Controlled;
• Road transport of feed – GMO Controlled mandatory sub-scope Tractionair;
• “Invoicing Address”;
• “PO-Box”.

Appendix 5: Remote audits

If an audit is performed in combination with a FSA scope then the requirements as stated in Appendix 6 of the CR2.0 Assessment and Certification of Feed Safety Assurance scopes prevail.