Attention: renewed unannounced surveillance audit

22 February 2018

The renewed unannounced surveillance audit requirements will be implemented on February 22, 2018. In this newsletter, we inform you of the consequences of this for your company.

In accordance with article 11.1 of the GMP+ A1 General Regulation, this change is implemented by Executive Decree. This decree will be valid until publication of the new C documents on the website of GMP+ International. 

 

4 Things you must know

  1. The unannounced audits are mandatory for all Dutch companies certified for all productions scopes
  2. They are voluntary for all Dutch companies certified for service scopes (see below) and all certified companies outside the Netherlands certified for one or more GMP+ scope(s)
  3. An unannounced surveillance audit can replace ONLY an announced surveillance audit during the certification cycle
  4. Prior notice of the unannounced surveillance audit from the Certification Body to the company is not allowed 

 

Mandatory
For the mandatory unannounced surveillance audit the following requirements apply:

  • The unannounced surveillance audit is only mandatory for all Dutch participants certified for one or more of the following production scopes: 
       o   Production of compound feed. 
       o   Production of pre-mixtures. 
       o   Production of feed additives. 
       o   Production of feed material. 
       o   Production of pet food.
  • An unannounced surveillance audit can replace an announced surveillance audit during the certification cycle but can never replace an initial- or recertification audit.
  • The audit times for the unannounced surveillance audit will be the same as for the announced surveillance audit (Annex 2 of the GMP+C3/C6).
  • The unannounced surveillance audit must be secured in the contract between Certification Body and the participant.
  • After the unannounced surveillance audit is performed, registration in the GMP+ database is mandatory.
  • Each participant can indicate at the beginning of every twelve months 15 days in that year the unannounced surveillance audit cannot be performed. If not indicated upfront, the unannounced surveillance audit cannot be refused. Examples of legitimate postponing of the unannounced surveillance audit are: 
       o   The Certification Body cannot visit the site of the participant because it’s flooded or there are other extreme
            weather conditions. 
       o   The location of the participant is closed (yearly closing, maintenance, holiday) or the location of the 
            participant is not conducting GMP+ activities (seasonal work).
  • Prior notice to perform the unannounced surveillance audit from the Certification Body to the participant is not allowed.   

 

Voluntary 
For the voluntary unannounced surveillance audit the following requirements apply:

  • The voluntary unannounced surveillance audit is applicable for: 
    a) all Dutch participants certified for one or more of the following scopes: 
        o  Trade 
        o  Storage & Transshipment 
        o  Road- & Rail transport 
        o  Affreightment 
        o  Short sea shipping and inland waterway transport 
    b) all participants outside the Netherlands certified for one or more GMP+ scope(s). 
  • Once applied for the voluntary unannounced surveillance audit, it becomes mandatory for the participant during the certification cycle and must be secured in the contract between the participant and the Certification Body.      

Besides this, the same requirements as defined for the mandatory unannounced surveillance audit apply for the voluntary unannounced surveillance audit. 

 

General guidance 
Possibility 1: 
GMP+ certified companies already participating in the existing unannounced surveillance audit (add on) can switch to the new unannounced surveillance audit (replacing a regular surveillance audit) after their 3 years certification cycle has ended. 

Possibility 2: 
New companies applying for GMP+ certification for the first time. Because the unannounced surveillance audit cannot replace the initial certification audit (ICA), these companies can participate in the unannounced surveillance audit program from the first or the second surveillance audit, being after 12 or 24 months after the ICA. 

Possibility 3: 
GMP+ certified companies not participating in the existing unannounced surveillance audit (add on). Pending on their performed audits in already started certification cycle, they can participate 12 or 24 months after the recertification audit (RCA). When at the GMP+ certified company the second surveillance audit has been performed, the first possibility to participate in the unannounced audit program will be 12 months after the recertification audit.

 

ICA/RCA

12 months

SA/UA

12 months

SA/UA

12 months

RCA

12 months

SA/UA

1st Possibility

 

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 (add on unannounced surveillance audit)

 

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2nd Possibility

 

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3rd Possibility

 

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3rd Possibility

 

 

 

 

 

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  • Dutch participants who are certified for one of the production scopes (and therefore mandatory participating in the unannounced surveillance audit), have the possibility to decide if they want to apply the unannounced surveillance audit also for one of the service scopes.
  • GMP+ certified companies who want to replace two announced surveillance audits with two unannounced surveillance audits are allowed to do so. The initial- and recertification audit shall always be an announced.
  • GMP+ certified companies who wish to participate in the unannounced audit as soon as possible are allowed to do so. However, having the unannounced audit performed earlier than 12 months after the last audit will automatically result in shortening the certification cycle once. It is recommended to refrain from scheduling the unannounced surveillance audit within 2 months prior to or following the execution of other audits (initial, extension and announced surveillance audits).

 

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