1. Scope of this document

This document contains the assessment and certification criteria for performing audits at applicant organizations/GMP+ Certified Companies which will result in (re)certification for the GMP+ Feed Certification scheme, Feed Safety Assurance (FSA) module.

2. Normative reference(s)

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.

• ISO/IEC 17021-1:2015 Conformity assessment – requirements for bodies providing audit and certification of management systems.
• ISO 22003-1:2022(E) Requirements for bodies providing audit and certification of food safety management systems.
• IAF MD 2:2017 - IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems.
• IAF MD 5:2019 - Determination of audit time of Quality, Environmental, and Occupational Health & Safety Management Systems.
• ISO/IEC 17020:2012 Conformity assessment – requirements for the operation of various type of bodies performing inspection.
• ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories.
• F0.1 Rights and Obligations.
• F0.2 Definition list.
• F0.3 Scopes for certification.
• CR1.0 Acceptation Requirements.
• CR3.0 Assessment and Certification of Feed Responsibility Assurrance.
• GMP+ Feed Safety Assurance Module 2020.

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. Principles

5. Process requirements

5.1. Pre-certification activities

5.1.1. Application

In addition, relevant details of the applicant organization as mentioned under 9.1.1. B) of the ISO/IEC 17021-1:2015 are:

• Gatekeeper files,
• Multi-site certification,
• Number of employees,
• Number of products.
• An up-to-date group structure of the applicant organization, including ultimate beneficiary ownership and management overview, as well as a statement indicating the applicant organization, its ultimate beneficiary owner’s or its management’s involvement in businesses similar to the applicant organization business, if any to confirm that the applicant organization complies with chapter 4 of the F0.1 Rights and Obligations.

And if applicable:

• Number of analysis;
• Accredited analysis;
• Partly accredited analysis
• Not accredited analysis.

5.1.2. Application review

In addition:

• Description of activities and/or processes to be assessed by the Certification Body during an audit.
• The scope of certification must not be misleading.
  

5.1.3. Certification agreement

Before conducting an initial certification audit/inspection, the Certification Body and the applicant organization must conclude a legally enforceable unique certification agreement and during the validity of a GMP+ certificate/temporary acceptance this legally enforceable unique certification agreement remains in force.

Certification agreement issued by a critical-/non-critical location must comply with the template approved by the Certification Body in question.

The Certification Body must be aware that:

• the certification agreement must always be concluded with the applicable legal entity.
• These agreements must be concluded for the provision and description of the applicable certification activities in accordance with the GMP+ Feed Certification scheme.
• It is not allowed to secure conditions in the certification agreement which are conflicting with GMP+ requirements.
• It is not allowed to determine and impose additional requirements to the applicant organization/GMP+ Certified Company other than specified in the GMP+ Feed Certification scheme, unless specified in the internal procedure of the GMP+ Certified Companies.

The following GMP+ specific requirements must be secured in the certification agreement:

1. The applicable scope(s)/module names covering GMP+ certification.
2. The minimum obliged audit times per scope(s)/module per type of audit/inspection are as stated in Appendix 2, referring to Appendix 2 is insufficient. It is not permitted to deviate from the minimum obliged audit times by way of invoicing based on re-calculation. If a longer audit time is applicable, then this can be done in consultation with the applicant organization/GMP+ Certified Company. In case of Multi-site certification the minimum obliged audit times as mentioned in Appendix 4 must apply.
3. Each multi-site location must be secured with its GMP+ registration number and the applicable minimum obliged audit time per type of audit as stated in Appendix 4, referring to Appendix 4 is insufficient.
4. The use of the GMP+ logo in accordance with the F0.1 Rights and Obligations.
5. The stipulation (if applicable), that, in case of a determined nonconformity of a permitted level of a contaminant, the GMP+ Certified Company is obliged to submit an EWS notification in accordance with the R1.0 Feed Safety Management Systems Requirements.
6. The obligated cooperation of the applicant organization/GMP+ Certified Company with ad-hoc audits (as stated in F0.1 Rights and obligations), witness audits and parallel audit (as stated in Acceptation requirements).
7. The forwarding of audit reports/audit checklists to GMP+ International.
8. The possibility to terminate the certification agreement before the end of the certification cycle.
9. If applicable, the unannounced audit (see article 5.2.1.4.2 of this document)
10. The possibility in case of an unsatisfactory appeal procedure that the GMP+ certified company can apply the Dispute procedure.
    

5.1.4. Audit team/inspection assignment

Related to Article 9.2.2.1.2 the additional requirements as stated in article 4.3.6 of the CR1.0 Acceptation requirements apply.

5.1.4.1. Rotation of auditors/inspector

An auditor must not be assigned to the same GMP+ Certified Company more than 3 consecutive years. Should an alternative auditor not be available, an exemption can be made by the Certification Body and the period can be extended for a maximum of 3 consecutive years. The decision must be motivated and documented.

Rotation of auditors/technical expert scope registered laboratory:

• The auditor and technical expert may only perform the desk study of the same GMP+ Certified Company six consecutive times. Then rotation of the auditor and technical expert must take place

Rotation of Inspector:

• A new inspector must be assigned after 3 consecutive inspections.

5.1.5. Audit plan

In addition, the applicant organization/GMP+ certified company must provide on request of the certification body the following documentation:

• Organizational chart and short process descriptions,
• List of GMP+ assured products,
• Information about the production site, and / or subcontractors,
• The FSMS Manual on site during the audit (paper or electronic version).
• List of applicable regulations,
• Any other information the auditor/operator may find useful/relevant.

The selection of all relevant personnel to be interviewed must adequately cover every relevant functional area.

For the surveillance or re-certification audit, the GMP+ certified company must provide the certification body with the following documentation/information:

• Changes in organization,
• Changes in FSMS Manual,
• Changes in applicable legislation,
• Scope information,
• And any other information which is relevant.

An audit plan is not applicable for the scope Inland waterway transport and short sea shipping of feed.

5.2. Certification process

5.2.1. Audits/Inspections

5.2.1.1. General

A Certification Body accepted by GMP+ International under the GMP+ Feed Certification scheme is entitled to certify companies through the Certification Body who have an interest for 1 or more GMP+ scopes for the feed sector as specified in GMP+ Feed Certification scheme.

The applicant organization/GMP+ Certified Company must cooperate fully with audits as specified in this document. During the audits/inspections the process for which the company is certified must be operational to be verified. Auditing may include taking samples of products and laboratory testing.

Through the Certification Body, the assessment will take place by means of an audit/inspection at the applicant organization/GMP+ Certified Company for conformity of the applicable scope(s) based on the general criteria as specified in Appendix 1 and the additional assessment criteria in the checklists.

This is applicable for the following audits:

1. Initial certification audit (ICA)
2. Announced surveillance audit (ASA)
3. Unannounced surveillance audit (USA)
4. Inspection
5. Recertification audit (RCA)
6. Expansion audit
7. Document assessment (DA)

In addition:

1. The assessment for the scope Registered laboratory will be performed by means of a desk study (or on site if applicable).
2. The administrative assessment of the scope Laboratory testing, if all analyses are accredited in accordance with ISO/IEC17025 must be performed once per year.
3. On site assessment of the scope Laboratory testing if not all analyses are accredited in accordance with ISO/IEC17025 must be performed once per year for the non-ISO/IEC 17025 accredited analyses.
4. On site assessment of the scope Laboratory testing if the laboratory is not accredited in accordance with ISO/IEC17025 must be performed once per year for system assessment.

In addition, special audits can also be carried out (see article 5.2.2.).

The certification cycle has a maximum duration of 3 years. All requirements must be assessed during each of the following audits: initial certification-, (un)announced surveillance- and recertification audit.

The minimum obliged audit times and the frequency are determined in Appendix 2 and Appendix 4.

In case a GMP+ Certified Company changes during the certification cycle their activities and/or location the GMP+ certified company must be audited on-site through the Certification Body.

This is applicable for production, transport and storage & transshipment. The GMP+ audit times must apply. It is up to the Certification Body to decide if the initial certification- or surveillance audit must be performed.

5.2.1.2. Opening meeting

In addition, not applicable for scope Inland waterway transport and short sea shipping of feed

5.2.1.3. Initial certification audit

A GMP+ certificate may or may not be granted, depending on whether the assessment criteria of this document are met. An Initial certification audit stage 1 must be conducted within 3 months after concluding a certification agreement with the applicant organization. The interval between stage 1 and stage 2 is maximum 4 months.

When the specific conditions as described in Appendix 5 “Not at the GMP+ Certified Company location” and/or Appendix 6 “Remote Audits” are met, the Initial certification audit can be performed accordingly.

Scope laboratory testing:

The most important analyses must be assessed during the initial certification audit. All analyses must be assessed during the certification cycle.

5.2.1.3.1. Temporary acceptance

It is possible, on the basis of a positive assessment of stage 1 of the feed safety management system documentation, to issue a temporary acceptance (maximum 4 months) as part of an initial certification audit at a company which is starting its GMP+ activities.

Regarding the location of the assessment the following applies:

• When a company carries out production and/or storage and/or transport activities (tractionairs excluded), then part of the assessment of the quality documentation must take place at the company location(s) so that the infrastructural facilities can be assessed.
• If the company carries out other activities, then part of the assessment of the quality documentation may take place at the company location(s) if the Certification Body considers this necessary.

The entire certification process must be finished within the validity of the temporary acceptance including the updating of the GMP+ Company Database (including status and certificate dates) through the Certification Body.

Companies not eligible for a temporary acceptance are:

• Companies transferred from another Certification Body.
• Companies who were GMP+ certified or had a temporary acceptance in the past.

5.2.1.4. Surveillance audits

All requirements must be verified during surveillance audits.

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

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

When the specific conditions as described in Appendix 5 “Not at the GMP+ Certified Company location” and/or Appendix 6 “Remote Audits” are met, the surveillance audit can be performed accordingly.

5.2.1.4.1. Announced surveillance audit

5.2.1.4.2. Unannounced surveillance audit

Certification Bodies must not schedule the unannounced surveillance audit within 2 months prior to or following the execution of other audits (initial certification, recertification and announced surveillance audits). Every twelve (12) months of the audit cycle, each GMP+ Certified Company can specify 15 days in that year during which the unannounced surveillance audit cannot be performed. If not indicated in advance the unannounced surveillance audit cannot be refused. It is up to the Certification Body to decide whether the legitimate motivation to postpone the unannounced surveillance audit, is justified.

Examples of legitimate postponing of the unannounced surveillance audit are:

• The Certification Body cannot visit the site of the GMP+ Certified Company because its flooded or there are other extreme weather conditions.
• The location of the GMP+ Certified Company is closed (yearly closing, maintenance, holiday) or the location of the GMP+ Certified Company is not conducting GMP+ activities (seasonal work).

The following prior notice periods to perform the unannounced surveillance audit are applicable:

• GMP+ Certified Companies (producers) located in the Netherlands: not allowed.
• GMP+ Certified Companies (producers) located in Germany: one working day.
• GMP+ Certified Companies (producers) located in other countries in Europe: two working days.
• GMP+ Certified Companies (producers) located outside Europe: three working days.

There are several options:

A: Mandatory unannounced surveillance audit

The unannounced surveillance audit is mandatory for GMP+ Certified Companies located in Europe* certified for one of the following scopes:

• Production of compound feed (incl. pet food),
• Production of premixtures,
• Production of feed additives,
• Production of feed materials (incl. pet food).

The unannounced surveillance audit will replace one of the announced surveillance audits during the certification cycle and must be registered in the GMP+ Company Database.

Option B: Voluntary unannounced surveillance audit

Those who apply for the voluntary unannounced audit, will be obliged to participate during the whole certification cycle. The unannounced surveillance audit will replace one of the announced surveillance audits during the certification cycle and must be registered in the GMP+ Company Database.

B1) For Europe* GMP+ Certified Companies certified for the following scope(s) :

• Trade in feed,
• Storage and Transshipment of feed,
• Road transport of feed,
• Rail transport of feed,
• Affreightment (all scopes).

European GMP+ Certified Companies (including GMP+ Certified Companies located in the Netherlands and Germany) who are certified for 1 of the production scopes and therefore obligatory participate in the unannounced surveillance audit for the production scope, can decide whether they want to apply the unannounced surveillance audit also for 1 of the scopes mentioned under option B1.

B2) For all GMP+ Certified Companies outside Europe certified for any GMP+ scope.

The unannounced audit can on a voluntary basis be applied for all scopes in any country.

5.2.1.5. Inspection

An certification inspection will be performed through the Certification Body in order to assess whether the company meets the criteria set out the checklist for Inland waterway and short sea shipping. The certification inspection must be conducted within 3 months after concluding a certification agreement with the applicant organization.

5.2.1.6. Recertification audit

A GMP+ certificate may or may not be extended, depending on whether the assessment criteria set out in Annex 1 of this document or in the GMP+ checklist Inland waterway transport and short sea shipping of feed are met. 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/inspection is not carried out before the expiry of the period of validity of the certificate, then an initial certification audit/inspection must be carried out. The GMP+ Certified Company is in the intervening period not GMP+ certified.

If the specific conditions as described in Appendix 5 “Not at the GMP+ Certified Company location” and/or Appendix 6 “Remote Audits” are met, the recertification audit can be performed accordingly.

5.2.1.7. Expansion audit

If a GMP+ Certified Company wishes to expand the range of his already granted certification with an additional scope(s) and the expansion cannot wait until the next audit, the expansion must be assessed through the Certification Body.

An Expansion Audit (stage 1 and stage 2) must only be focused on activities for which the expansion is applicable.

As a result of positive assessment of the expansion the Certification Body must add an additional scope(s) to:

• a GMP+ certificate
• GMP+ Company Database
• GMP+ certification agreement with the GMP+ Certified Company.

5.2.2. Special audits

The following special audits can be applicable, assessment must be done in accordance with Appendix 1 or the checklist Inland waterway transport and short sea shipping of feed.

5.2.2.1. Stricter supervision Audit (SSA)

If 1 or more Major nonconformities are observed through the Certification Body, the GMP+ Certified Company may be placed under stricter supervision for one audit:

• The cost of this audit is at the expenses of the GMP+ Certified Company.
• This audit is in addition to the normal audit cycle.
• The stricter supervision audit will take place, within a period of 3 months.
• Assessment will be based, but not limited to the established major nonconformity.
• A Major Nonconformity can also be handled administratively based on conformity measures formulated by the GMP+ Certified Company.

If 1 or more Critical nonconformities are observed through the Certification Body, the GMP+ Certified Company must at least be placed under stricter supervision:

• The cost of these audits is at the expenses of the GMP+ Certified Company.
• These audits are in addition to the normal audit cycle.
• The stricter supervision audits will be carried out monthly with a minimum of 3 months and a maximum of 6 months.
• Assessment will be based, but not limited to the established critical nonconformity.
• One stricter supervision audit must be conducted on-site. It is up to the Certification Body to decide if further stricter supervision audits are necessary. This decision must be motivated and documented.

5.2.2.2. Repeat audit (RPA) and Repeat Inspection (RI)

A repeat audit/inspection will be performed under the responsibility of the Certification Body. The reason for a repeat audit/inspection may be an EWS alert, complaints or incidents, or other special circumstances.

In principle the repeat audit/inspection is aimed on these reason(s) but can also be aimed at all requirements of the GMP+ Feed Certification scheme.

• GMP+ International may ask the Certification Body to carry out a repeat audit/inspection on short term in principle in the presence of a GMP+ International auditor/inspector and/or a technical expert.
• The repeat audit/inspection must be carried out by a GMP+ auditor. The involved Certification Body must motivate the choice of the GMP+ auditor/inspector and document its decision.
• The deadline will be assessed per case but ultimately determined by GMP+ International.
• The audit/inspection will be on-site. In addition, administrative checks and a sampling may be carried out.

• The required appointments and communication of the repeat audit/inspection will be made with the GMP+ Certified Company by the Certification Body in consultation with GMP+ International.
• In principle the costs of the repeat audit/inspection will be at the expenses of GMP+ International. However, if it appears that 1 or more Critical or Major nonconformities are observed, the costs will be charged to the GMP+ Certified Company.

5.2.3. Extraordinary events

If the Certification Body and/or Critical Location is confronted with an extraordinary event, GMP+ International must confirm this status. Also when the extraordinary event is specific to a company the Certification body must contact GMP+ International to confirm this status. When confirmed by GMP+ International, the Certification Body is obliged to follow the below guidelines based on the IAF Informative Document for Management of extraordinary events or circumstances affecting, Certification Bodies and GMP+ Certified Companies and which are described as follows:

1. The GMP+ Certified Company or business location does not exist because it is destroyed by terrorist acts or acts of war, or is taken over by soldiers or rebels and/or pandemic flooding, earthquake, or other man-made and natural disasters. The Certification Body, Critical/Non-Critical Location is informed by the management of the GMP+ Certified Company or business location or receives the information from another source(s). The Certification Body, Critical/Non-Critical Location is obliged to search for confirmation of the fact from a reliable source. After confirmation, the Certification Body withdraws the GMP+ Certificate and GMP+ International is informed directly in writing, including all the relevant details.

2. The GMP+ Certified Company or business location is closed by its head office because the region is not safe. The management of the company of the head office informs the Certification Body, Critical/Non-Critical Location. The Certification Body withdraws the GMP+ Certificate and GMP+ International is informed directly in writing, including all the relevant details.

The GMP+ Certified Company or business location cannot be audited because GMP+ International confirms the extraordinary event, the Certification Body, Critical/Non-Critical Location must follow one of the 2 options:

• If the audit frequency cannot be met and assuming that sufficient evidence was collected to provide confidence that the certified management system of the GMP+ Certified Company is effective, considerations may be given to postpone the surveillance or recertification audit for a period not exceeding 3 months. Otherwise the GMP+ Certificate must be suspended by the Certification Body. During the period of suspension the surveillance or recertification audit must be carried out, otherwise the certificate has to be withdrawn by the Certification Body;
• Perform the audit Full remote audit or a Guided remote audit based on the conditions and requirements of Appendix 6 of this document. When the specific conditions as described in Appendix 6 “Remote Audits” are met, the audits can be performed accordingly.

5.2.4. Identifying and Recording audit and inspection findings

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

In addition for the scope Inland waterway transport and short sea shipping of feed the following applies: If a “Not Conform” with a description is observed, a GMP+ certificate cannot be issued. The GMP+ certificate can only be issued if the “Not Conform” with a description is resolved.

If a nonconformity is identified in one of the FSA scopes in combination with an equivalent scheme as mentioned in chapter 3 of TS1.2 Purchase or with FRA, ,this applies for both FSA and FRA scopes.

Multi-Site certification:

If non-conformities are observed at the main office, these non-conformities apply to the whole GMP+ Multi-site organization. If non-conformities are observed at the level of a location, this can influence the location and/or the main office. This is to be assessed through the Certification Body.

Audit findings of the individual multi-sites must be considered indicative of the entire system and correction must be implemented accordingly.

5.2.5. Closing meeting

In addition, not applicable for scope Inland waterway transport and short sea shipping of feed

5.2.6. Audit report/checklist

For all type of audits/inspections, reporting will take place, in accordance with the model reports stated in Appendix 3.

Within a maximum of eight weeks following the execution of the audit/inspection, the Certification Body will send the GMP+ audit report/checklist to the applicant organization/GMP+ Certified Company.

The Certification Body must provide a written GMP+ audit report for each multi-site location being audited. It is also possible to integrate it into the GMP+ audit report of the main office.

If this is the case an overview must be included in the GMP+ audit report of the main office showing when all the locations / companies were audited. In both cases, a conform or a nonconform GMP+ checklist for each multi-site location must be uploaded in the GMP+ Company Database. Evidence for conform requirements can also be added to the GMP+ audit report/checklist of the main office.

If GMP+ International requests the GMP+ audit report/checklist then the Certification Body will make these available immediately. In the event of a repeat audit/inspection, GMP+ International must receive the GMP+ audit report/checklist within 5 working days.

For all type of audits/inspection (including documentation assessment) the following information must be entered into the GMP+ Company Database and shared with GMP+ International within a maximum of eight weeks following the execution of the audit on site:

• Audit findings/checklist;
• Nonconformities (if applicable);
• Final assessment of the applicant organization/GMP+ Certified Company.

5.2.7. Review

The Certification Body must have a process to conduct an effective review of all GMP+ audit/inspection reports/checklists, including, that:

1. the information provided by the audit team is sufficient with respect to the certification requirements and the scope for certification;
2. for any type of nonconformities, it has reviewed, accepted and assessed the correction and corrective actions;
3. that assessment of the applicant organization/GMP+ Certified Company took place in accordance with the applicable scope(s) based on the general criteria as specified in Appendix 1 and the additional assessment criteria in the checklist.

The conclusion and date of the review by the technical reviewer must be documented.

The technical reviewer must perform the review independent, meaning that the technical reviewer could not have been part of the GMP+ audit team, also not as an observer.

5.2.8. Certification decision

In addition, the assessment criteria of Appendix 1 of this document and/or the criteria of the checklist Inland waterway transport and short sea shipping of feed must be met.

5.2.9. Certificate and Temporary acceptance

5.2.9.1. Certificates

A certificate with a maximum period of validity of 3 years may be issued through the Certification Body, calculated from the date of a positive certification decision. The maximum period of validity for the scope Inland waterway transport and short sea shipping of feed is 2 years, calculated from the date of a positive certification decision. The duration of the GMP+ certificate must not exceed the validity of the certification agreement.

Within eight weeks following the execution of the audit/inspection, the certificate will be send through the Certification Body to the applicant organization/GMP+ Certified Company.

For multi-site location it must be clear were the multi-site location is certified for according F0.3 Scopes for certification. The main office must be certified for the scopes covering all activities of the multi-site locations.

For issuing a certificate the following applies:

• The certified multi-site location can be displayed in an Appendix linked to the certificate of the main location.
• Or an individual certificate can be issued per certified multi-site location, stating the following:
  • The activities performed for that specific site / legal entity which are covered by this certification,
  • There must be traceability with the main certificate, e.g. code.

5.2.9.2. Temporary acceptance

A temporary acceptance with a maximum period of validity of 4 months may be issued through the Certification Body. The duration of the temporary acceptance must not exceed the validity of the certification agreement.

However, if, during the initial certification audit (stage 2), the applicant organization does not appear to comply with the GMP+ requirements for the applicable scope(s) based on the general criteria as specified in Appendix 1 then the temporary acceptance must be withdrawn.

For multi-site location the following applies:

• A temporary acceptance will be issued per multi-site locations or mentioned in an Appendix linked to temporary acceptance of the main location.
• It must be clear where the multi-site location is accepted for according F0.3 Scopes for certification.

5.2.9.3. Certificate and Temporary acceptance templates

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

1. Text for certificate Feed Safety Assurance

2. Text for temporary acceptance

3. Text for a certificate for the scope Registered laboratory:

   Name of the Certification Body GMP+ International registration number of the Certification Body Certificate GMP+ FSA logo TS 4.2 Registered laboratory Name, location of the GMP+ Certified Company GMP+ International registration number of the GMP+ Certified Company The Certification Body =name of the Certification Body= states that GMP+ Certified Company =name GMP+ Certified Company= was audited in accordance with the applicable requirements of the TS 4.2 Registered laboratory and GMP+ Feed Safety Assurance Module 2020. The Certification Body =name of the Certification Body= states, based on a desk study, that the performance criteria as mentioned in the TS 4.2 Registered laboratory are met for the following analyses: Operation Material/matrix Feed materials Feed additives and premixtures Feed (compound feed and complementary feed) Mycotoxins Aflatoxin B1 Not Applicable Dioxins/PCBs Sum of dioxins and dioxin-like PCBs Dioxins Dioxin-like PCBs Non-dioxin-like PCBs Heavy metals Arsenic Lead Cadmium Mercury Not Applicable Fluorine Not Applicable Pesticides Pesticides Registered office of the Certification Body Certificate number Start date and end date of certificate

   
   

   In addition the following applies for all certificate templates and temporary acceptance:

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+ FSA logo on the certificate.
3. It is not permitted to use the GMP+ FSA 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

5.3. Suspension or Withdrawal of a certificate and Temporary acceptance

If it is established that a GMP+ Certified Company/temporary accepted company no longer complies with the requirements, sanctions must be imposed immediately, through the Certification Body, in accordance with Appendix 1.

The auditor must report Critical non-conformities as specified in Appendix 1 immediately to the responsible GMP+ coordinator.

In deviation, for the scope Inland waterway transport and short sea shipping of feed the following applies: If a “Not Conform” with a description is observed, the GMP+ certificate must be withdrawn. A GMP+ certificate can only be issued if the “Not Conform” with a description is resolved.

The responsible GMP+ coordinator must inform GMP+ International within 2 working days of non-compliance with the requirements by using the form Audit Finding Notification Critical Non-conformity in case of:

• A critical non-conformity,
• Suspension of the GMP+ certificate ,
• Withdrawal of the GMP+ certificate.

The GMP+ Company database must be adapted through the Certification Body to status: “suspended or withdrawn” with reason: “does not meet the requirements” within 2 working days. When the Certification Body has determined a critical non-conformity it is not allowed to withdraw the GMP+ Certificate with the reason of withdrawal “cancellation of agreement”. Once the certificate has been suspended or withdrawn the company cannot participate in the GMP+ Feed Certification scheme under any Gatekeeper Protocol.

GMP+ International is entitled to publish the suspended/withdrawn certificates.

5.4. Transfer to another Certification Body

During the validity of a GMP+ certificate, a GMP+ Certified Company is entitled to transfer to another Certification Body. Such transfer is subject to the following conditions:

5.4.1. Pre-transfer review

The departing Certification Body is obliged to make available all relevant information/data to the accepting Certification Body/Critical Location in question.

The accepting certification body must have a process for obtaining sufficient information in order to take a decision on certification and inform the transferring GMP+ certified company of the process. This information must as a minimum include arrangements regarding the certification cycle.

The accepting certification body must determine the competence criteria for personnel involved in pre-transfer review. The review may be conducted by one or more persons. The individual or group conducting the pre-transfer review must have the same competence that is required for an audit team appropriate for the scope of certification being reviewed.

The accepting Certification Body/Critical Location must carry out a review of the certification of the GMP+ Certified Company. This review must cover the following aspect and its findings must be documented:

1. confirmation that the GMP+ certified company’s certification falls within the accepted scope of the departing and accepting certification body;
2. the reasons for seeking a transfer;
3. that the site or sites wishing to transfer certification hold a valid certificate;
4. the initial certification or most recent recertification audit reports, and the latest surveillance report; the status of all outstanding non-conformities that may arise from them and any other available, relevant documentation regarding the certification process.
5. for the scope Inland waterway transport and short sea shipping of feed an evaluation of the last checklist to established if a “Non Conform” with description were observed. This evaluation can include other relevant documentation, regarding the (re)-certification process i.e. notes, etc.
6. if one outstanding non-conformity has the classification Critical transfer is not allowed;
7. complaints received and action taken;
8. any current engagement by the transferring GMP+ certified company with regulatory bodies relevant to the scope of the certification in respect of legal compliance;
9. Confirmation that the GMP+ Certified Company has no unfulfilled contractual obligations with the departing Certification Body.

5.4.2. Certification process during transfer

After successful pre-transfer review the following conditions apply:

1. The accepting Certification Body, Critical/Non-Critical Location has to conclude a GMP+ Certification Agreement with the applicant organization (see article 5.1.3.) before submitting the business request “Change of Certification Body” to GMP+ International. A new certification cycle must be started. An Initial certification audit must be carried out.
2. Open non-conformities issued by the departing Certification Body should be closed before transfer, otherwise the non-conformities must be closed by the accepting Certification Body/Critical Location during the Initial certification audit for the scope Inland waterway transport and short sea shipping of feed an open “Non Conform” with description established during the last inspection must be closed by the accepting Certification Body/Critical location during the initial inspection.
3. A new certificate must be issued within 5 months of the date of transfer. It is not allowed to transfer a GMP+ Certificate from the departing Certification Body to the accepting Certification Body. A Certification Body is not allowed to accept transfer of a Company which GMP+ Certificate has been suspended or withdrawn. Except for withdrawn on “cancellation of agreement”.

5.4.3. Cooperation between the departing and accepting Certification Bodies

6. Exclusion of GMP+ International liability

GMP+ International has no liability whatsoever with respect to the assessment of applicant organizations/GMP+ Certified Companies through the Certification Bodies. The Certification Bodies in question will indemnify GMP+ International in this respect.

7. 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.

8. 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+ FSA

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 Audit times

Frequency

Audits must be carried out in accordance with the following cycle.

This is a qualitative representation of the audit cycle for executing GMP+ audits.

The audit times are expressed in days, one day is eight hours. Audit times includes stage 1 & 2 for initial certification audit. The tables in this Appendix provide mandatory minimum audit times including preparation and reporting of the audit. The audit time on site must at least be 70% of the minimum obliged audit time for all types of audits (excluded the cases of not on-site Stage 1 audits). When properly documented and justified a reduction to the minimum obliged audit times can be issued to a less complex organization measured by a simple production process, size of the organization, product volume (including a limited number of products), seasonally being active, etc. The GMP+ Certified Company must receive an adapted offer/certification agreement. GMP+ International will check the reasoning and assess this during the annual Certification Body audit. The audit time reduction must be processed in the GMP+ company database.

The Certification Body cannot issue audit time reduction if:

• It exceeds more than 30% of the minimum obliged audit time.
• During the validity of the GMP+ certificate an audit time reduction already exists and no changes in activities have occurred.
• During the last 3 audits at the GMP+ Certified Company 1 Critical non-conformity was established.
• During the last 3 audits at the GMP+ Certified Company 1 Major non-conformity was established with a structural character or the Major non-conformity resulted in feed safety hazard.
• During the last 3 audits at the GMP+ Certified Company 20 or more Minor non-conformities were established.
• Audit time is reduced for a combined audit.
• Table 2 of this appendix is applied.

In addition, audit time reduction cannot be issued on the audit times of Appendix 4 of this document.

Through the Certification Body audit time reduction can only be granted on the initial certification audit if the Certification Body can demonstrate that they certified the company for another scheme as mentioned in this Appendix and/or an equivalent scheme as mentioned in TS1.2 Purchase and properly documented and justified. Audit time reductions are not allowed to be used for re-calculation of the minimum obliged audit times, except when during the initial certification audit as stated above.

This temporary deviation from the audit time is valid as long as:

1. no changes take place in the activities and organisation of the GMP+ Certified Company
2. no changes are made to this Appendix regarding audit times.
3. The GMP+ Certified Company does not transfer to another Certification Body. If the GMP+ Certified Company transfers to a new Certification Body, the new Certification Body has to assess if an audit time reduction can be issued.

In the event of repeat audits and stricter supervision audits as specified in article 5.2.2, the time will apply which is considered necessary through the Certification Body or GMP+ International. The audit times may increase if EWS, complaint, exemptions, incidents, etc, have to be investigated through the Certification Body.

The ranking must be applied as follows:

1. Production of compound feed
2. Production of premixtures
3. Production of feed additives
4. Production of feed materials
5. Production of Pet food
6. Trade in feed
7. Storage and Transshipment of Feed
8. Transport of feed
9. Affreightment

For the calculation of 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 (if applicable)+TFTE

Where:

Ts: minimum audit time

TD: is the basic audit time, in days;

TH1: is the number of audit days for additional GMP+ scopes;

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

Appendix 3: Reporting Model or Audit report and Inspection checklist

Reporting Model A:

1 General details

Details of main location:

Name of the GMP+ Certified Company:

Address:

Postal code and location:

Telephone:

E-mail:

GMP+ registration number:

Legal business registration number:

Contact person:

Spoken with:

Assessment is performed in accordance with GMP+ Feed Certification scheme 2020.

Overview of all business locations (incl. head office) and GMP+ scopes

List of locations in the event of multi-site certification (if applicable)

Audit details:

□ Initial certification audit – on si te

□ Initial certification audit – Full remote

□ Initial certification audit – Guided remote audit

□ Announced surveillance audit – on site

□ Announced surveillance audit – Full remote

□ Announced surveillance audit – Guided remote audit

□ Unannounced surveillance audit – on site

□ Unannounced surveillance audit – Full remote

□ Unannounced surveillance audit – Guided remote audit

□ Recertification audit – on site

□ Recertification audit – Full remote

□ Recertification audit – Guided remote audit

□ Expansion audit – on site

□ Expansion audit – Full remote

□ Expansion audit – Guided remote audit

□ Repeat audit

□ Stricter supervision

□ Documents assessment (in the event of a temporary acceptance)

□ Audit/Inspection* time (in days)

□ Combination audit yes/no applicable quality scheme:

□ Other;

Date of document assessment :

Date of audit :

Report date :

GMP+ Certified Companies representative including name and position:

Documents assessed :

Certification Body :

(Lead) Auditor(s) :

Co-auditor 1 :

Co-auditor 2 :

Technical expert(s) :

Name: ________________ Signature (Auditor) ______________________

2 Scope GMP+ Certified Company/locations.

Specify the type of GMP+ Certified Company and its activities. Describe the products and quantities. Specify the nature and the numbers of personnel (permanent, temporary) per location. Describe the organisational structure. Also take note of other companies on the same site or under the same holding (with similar names or incompatible activities). Provide a brief summary of the whole process and documentation of the management system, for example purchasing, production process, storage, sales and transport of main and subsidiary product streams (focusing on the relationship with the activities covered by the application). Also indicate whether the GMP+ Certified Company applies the Gatekeeper principle and describe the activities .

3 Audit objectives.

The audit objectives must describe what is to be accomplished by the audit and must include the following topics:

1. Determination of the conformity of the client’s feed safety management system, or parts of it, with audit criteria,
2. Evaluation of the ability of the Quality Management System to ensure the GMP+ Certified Company’s organisation meets applicable statutory, regulatory and contractual requirements.
3. Evaluation of the effectiveness of the Quality Management System to ensure the GMP+ Certified Company’s organisation is continually meeting its specified objectives.
4. as applicable, identification of areas for potential improvement of the management system.

4 Deviation from the audit plan/significant issues impacting the audit program.

Reason for deviation to be mentioned and significant issues impacting the audit program.

5 Which topics have been assessed and concluded.

In general, it must be clear in the report what has been assessed and what was the conclusion of the auditor.

Verification of effectiveness of taken corrective actions regarding previously identified nonconformities, if applicable.

Per audit objective a conclusion must be given.

6 Summary of the assessment and a general conclusion.

Start with a standard phrase such as “The GMP+ Certified Company was audited for a surveillance audit of the GMP+ requirements. The GMP+ Certified Company was assessed for the requirements of the applicable GMP+ scopes”.

Indicate whether the nonconformities observed in the previous audit have been resolved.

Make a summary per location and in total.

Give a brief summary of the general impression of the quality system of the GMP+ Certified Company.

Possible postscript after a final assessment by the technical reviewer: review of additional documents and follow-up.

Audit conclusion: the GMP+ Certified Company meets/fails to meet requirements of the GMP+ module.

Measures and sanctions: conformity audit, repeat audit, stricter supervision (including period of time), suspension, withdrawal.

7 Appendices

Checklists used, report forms for audit nonconformities.

Note: non-conformities observed must also be recorded in the English/German or Dutch language.

Reporting Model B:

Audit Report/Inspection Checklist*

(This is an impression of the Audit Report/Inspection Checklist*, consult for the latest version always the Audit Report/Inspection Checklist* processed in the GMP+ Database/Audit app)

* Initial Certification audit (ICA) Surveillance audit (SA) Unannounced Surveillance audit (USA) Recertification audit (RCA), Compliance audit (CA), Stricter Supervision audit (SSA), Repeat audit (RPA), Document assessment (DA)

Audit Objectives

Deviation from the audit plan/significant issues impacting the audit program.

General Information

GMP+ Certified Company/Location

Verification of effectiveness of taken corrective actions regarding previously identified nonconformities, if applicable.

Audit Conclusion

Appendix to the report NCR form yes/no

* When the terminology inspector / inspection / inspection checklist is used this refers to the scope Inland waterway transport and short sea shipping of feed as secured in CR 3.0.

Appendix 4A: Multi-site certification

Multi-site certification is possible:

1. at a GMP+ Certified Company with a main office with 100% subsidiaries, or
2. at a group of companies which have joined together as a quality community.

A multi-site organization does not have to be a unique legal entity, but all multi-site locations must have a legal or contractual link with the main office of the multi-site organization and be subject to a common management system, which is laid down, established and subject to continuous announced surveillance and internal audits by the main office. This means that the main office has rights to require that the multi-site locations implement corrective actions when needed in any multi-site location. Where applicable this must be set out in a formal agreement between the main office and the multi-site locations.

Multi-site certification is not to be used if various independent companies have joined together in a branch organisation, union, federation, association, via an independent consultancy office or similar.

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

• Production of Compound Feed;
• Production of Premixtures;
• Production of Feed Materials;
• Production of Feed Additives.
• Laboratory testing;
• Registered laboratory;
• Inland waterway transport and short sea shipping of feed.

Multi-site certification is permitted for all FSA scopes of:

• Trade in feed;
• Storage and Transshipment of feed
• Transport of feed;
• Affreightment.

1. General requirements

1. The multi-site organization falls under the same quality system which is managed by the main office. This quality system complies with the relevant GMP+ scope(s) and there must be compliance at all multi-site locations with the relevant GMP+ requirements (see also the helpful tip under Certification).
2. The same methods and procedures are used at the multi-site organization.
3. Corrective actions may be imposed from the main office on multi-site locations.
4. There must be a written agreement between the multi-site locations the main office. This agreement must be signed by all the participating parties and the signed agreement must be present at the main office and available to the auditor. The agreement will include at least:
   1. a commitment by the multi-location to the main office that it will comply with the requirements set in the quality system.
   2. that corrective actions imposed by the main office are binding
   3. that the above applies to all feed activities (and therefore those which are carried out more or less independently).
5. All the multi-site locations are included in the programme of internal audits. The internal audit must be performed 1 x per year at all multi-site locations.
6. The main office must show that it is able to collect data from every multi-site location, to analyse the data and, where necessary, to implement changes with respect to:
   1. System documents and changes
   2. Management review
   3. Complaints handling
   4. Corrective actions
   5. Planning of internal audits and improvement measures.
7. In case of unprocessed products all multi-sites locations must be located in the same country or in the bordering regions of neighbouring countries.

1.1 Certification

Before an initial certification audit can take place, a unique certification agreement/certification agreement template including the main office and the multi-site locations must be concluded and also the internal audit report must be available to be handed over to the Certification Body for assessment.

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.

The main office must be audited on-site annually.

If a new multi-site location joins a multi-site organization not during a regular audit, an assessment of the relevant subjects must take place at the main office, this can be done remotely. The new multi-site location must be audited in the current certification cycle. When requirements are met, Appendix 5 and/or Appendix 6 are met, these appendices can be applied.

Minimum obliged audit times in days per for multi-site organizations

1.2 Additional requirement

A transport company/tractionair can only be certified under multi-site requirements if the transport company/tractionair carries out all the transport of GMP+ assured feed for the main office exclusively. If this is not the case the transport company/tractionair must be independently certified.

Appendix 4B: Multi-site certification for trade to livestock farms

TS 3.1 Trade to livestock farms

For companies which apply TS 3.1 and which have extra storage locations and/or extra sales points or sales outlets, it is possible to make use of this option of multi-site certification.

Two types are distinguished for Distribution Centre (DC):

1. DC acts as the only supplier of the brokers. In this case DC can be seen as a part of the sales points and therefore falls under certification for TS 3.1. Multi-site certification is possible.
2. DC is one of the suppliers of the brokers. DC acts much more independently with respect to the brokers (and vice versa) as mentioned under a. In this case DC is seen as an “ordinary” trader and must become certified for the scope trade in feed. Multi-site certification is not possible.

1. General requirements

To be eligible for multi-site certification under TS3.1 Trade to livestock farms the multi-site organization must comply with the following criteria:

1. The multi-site organization has a main office from which activities are planned and directed
2. The multi-site organization has a network of storage locations and/or sales points
3. All storage sites and/or sales points fall under the same quality system which is managed from the main office. This quality system must be based on the GMP+ scope(s)and all the multi-site locations must meet the GMP+ requirements;
4. The same methods and procedures are used at all multi-site locations.
5. All the multi-site locations are included in the programme of internal audits
6. Corrective actions may be imposed from the main office on all storage locations and/or sales points
7. The main office must demonstrate that it is able to collect data from every multi-site location, to analyse the data and, where necessary, to make changes with respect to:
   1. System documents and amendments
   2. Complaints handling
   3. Corrective actions
   4. Planning of internal audits and improvement measures
8. If the main office is not the owner of the extra storage locations and/or extra sales points, the main office must have a written agreement with the multi-site locations (storage locations and/or sales points) in which they state:
   1. to sell GMP+ certified feeds directly to the livestock farmers. Selling to other GMP+ certified companies is not permitted;
   2. that the purchase of GMP+ certified feeds will only take place via the main office;
   3. to provide full cooperation to the main office with respect to the activities which are described in all the above points of this option.

This agreement must be signed by all the brokers participating in this Multi-site organization and the signed agreement must be present at the main office and must be available for assessment by the auditor.

In addition, all multi-site locations which have signed an agreement must be known to the Certification Body. The size of the random sample can be determined based on this data.

1.1 Certification

In the event of Multi-site certification for TS3.1 the audit frequency for the extra storage locations or extra sales points (with the exception of the main office) may be reduced in accordance with the following schedule:

Minimum audit time to be spent per audit in days:

As all storage locations and/or sales points must work in accordance with the same methods and procedures and under the same quality system, the assessment of the documentation can remain limited to verification of the presence of up-to-date documentation and the completeness of the documentation with respect to the multi-site location.

Appendix 5: Audits at another location

Definition:

See F0.2 Definition list.

Road transport of feed:

For the scope Road transport of feed the announced surveillance and recertification audit may also take place at another location than the registered offices of the GMP+ Certified Company. If a company is acting as a main office of a multi-site construction, the audit at another location is not allowed.

The following requirements apply:

1. The GMP+ Certified Company falls into the category: 1-5 FTE.
2. The GMP+ Certified Company does not have its own working area.
3. No changes are applicable to the company location and/or activities.
4. The GMP+ Certified Company offers at least 1 loading compartment which is used for GMP+ transport (trailer / semi-trailer, etc.) for checking.
5. The alternative location is suitable for carrying out audits:
   1. Checking of loading compartments causes no hazardous situations for those involved or bystanders.
   2. If there is a collective check (multiple companies are invited for audit at the same time) then the privacy of individual companies must be guaranteed.

Road transport of feed - mandatory sub-scope tractionair:

For the scope Road transport of feed, mandatory sub scope tractionair (multi-site location), the initial certification audit, announced surveillance audit and recertification audit may also take place at another location than the registered offices of the GMP+ Certified Company.

The following requirements apply:

1. No changes are applicable to the company location and/or activities.
2. The alternative location is suitable for carrying out audits:
   1. If there is a collective check (multiple companies are invited for audit at the same time) then the privacy of individual companies must be guaranteed.

Invoicing address:

For all scopes where the “invoicing address” is applicable (see F0.3 Scopes for certification), the announced surveillance audit and recertification audit may also take place at another location than the registered offices of the GMP+ Certified Company.

The following requirements apply:

1. The alternative location is suitable for carrying out audits.
2. No changes are applicable to the company location and/or activities.

PO Box:

For all scopes where the “PO Box” is applicable (see F0.3 Scopes for certification), the initial certification audit, announced surveillance audit and recertification audit may also take place at another location. During the initial certification audit the Certification Body has the responsibility to establish that the PO Box complies with the definition of a PO Box inF0.2 Definition list.

The following requirements apply:

1. The alternative location is suitable for carrying out audits.
2. No changes are applicable to the company location and/or activities.

Trade in feed:

For the scope “Trade in Feed” is applicable (see F0.3 Scopes for certification) the announced surveillance audit may also take place at another location than the registered offices of the GMP+ Certified Company.

The following requirements apply:

1. The alternative location is suitable for carrying out audits.
2. No changes are applicable to the company location and/or activities.

Affreightment of transport of feed:

For the scopes Affreightment of Inland waterway transport, short sea shipping, rail transport, road transport and sea transport, the announced surveillance audit and recertification audit may also take place at another location than the registered offices of the GMP+ Certified Company.

The following requirements apply:

1. The alternative location is suitable for carrying out audits.
2. No changes are applicable to the company location and/or activities.

Appendix 6: Remote audits

GMP + International establishes 2 types of Remote options of performing audits that can be used by certification bodies when fulfilling the following requirements:

If an audit is performed in combination with a FRA scope than the requirements as stated in this Appendix prevail.