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S9.7 How to execute supplier assessments

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Ausführung: 1 März 2021

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1. Introduction

The selection, assessment, approval and evaluation of the suppliers of processes, products and/or services (referred to hereafter as 'supplier assessment') is an important part of assurance of feed safety in the feed chain. This supplier assessment must be carried in such a way that a GMP+ certified company can answer the question “What products or services do I get and what are the risks involved?”. This way the company can receive an order in a satisfactory condition, which meet the specifications as defined in the contract).

In practice there appears to be differences in the way in which the supplier assessment is carried out. A guideline is made with items for attention and background information with which a certified company can set up a good system for supplier assessment or with which he can improve an existing assessment method.

This guide must be seen as a tool for carrying out the supplier assessment within the framework of the GMP+ FC scheme. There are also references in various places to GMP+ requirements. This guide has no normative status under the GMP+ FC scheme.

First some background information is provided about the supplier assessment and the basic principles for a supplier assessment are explained. The steps are then covered which are normally taken when carrying out a supplier assessment .

Note: A number of terms and concepts are used in this guide. For the explanatory list of relevant terms and definitions see F 0.2 Definition list.

2. Background to the supplier assessments

2.1. The supplier assessment in the GMP+ FC scheme

In the GMP+ FC scheme there is an obligation for certified companies to evaluate and select the suppliers and to monitor the performance and periodically re-evaluate the suppliers which are already initially assessed.

The GMP+ FC scheme is a chain system. Each link in the chain must guarantee on the basis of equal principles the safety of feed (products) as expressed in (product) norms. The basic requirement for the purchase of products and services is that the supplier must have a quality management system which is certified by an independent body and which is focused on feed and food safety.

Carrying out a supplier assessment is a responsibility of the certified company itself. This is appliable for all kind of suppliers of products and services. For example a service supplier for pest control, but also in the event when the supplier provides a feed material and is (GMP+) certified. The third-party audit (for example the certification audit) is not a replacementfor the supplier assessment or vice versa. The supplier assessment is a full part of a certified company’s feed safety management system including in a situation where, as in the feed sector, third-party certification is required almost completely.

2.2. Elements and keywords

Five elements can be distinguished with respect to supplier assessment. This means that a certified company:

  1. has detailed specifications which are in accordance with the legislation and with the requirements of the relevant GMP+ standards;
  2. selects suppliers on the basis of their ability to deliver the specified process, product or service which complies with the product specifications and the required qualifications of the supplier (e.g. certification);
  3. regularly audits suppliers to assess whether they can meet their obligations in the field of feed safety or to assess results of audits which were carried out at the suppliers in question (not applicable for suppliers of non-feed products and services);
  4. carries out a monitoring programme established on the basis of a risk assessment;
  5. records complaints and deviations and handle them correctly.

These elements have been used as an important basic principle for this guide.

Important keywords for the above steps are:

  1. exchange of information between the certified company and the (potential) supplier;
  2. insight into the feed safety assurance used by the supplier and his attitude to feed safety assurance;
  3. the own responsibility of each link or company in the chain with respect to the-feed safety assurance.

Re. 1) Information

The certified company must set up and implement the supplier assessment in a structured way. In order to be able to make a good assessment of processes/products/services and suppliers, it is necessary to be properly informed about the process/product/service, the production process (if applicable) and the way in which identified risks are controlled by the supplier. This information should be supplied by the (potential) supplier, in a structured way.

This method of working ensures that the certified company also has information about identified risks and their control. Normally this data does not form part of the specifications given to the certified company by the supplier. The extra information is specific to the process/product/service and the company that supplies it and forms to some extent a part of the risk communication between the supplier and the certified company.

Re. 2) Insight

The information as mentioned above provides the certified company with an insight into the way in which the supplier assures the feed safety of the product/service and says something about the attitude of the supplier with respect to feed safety. The certified company can match the entry check and the method of working including the control measures to this.

Re. 3) Own responsibility

The certified company, by assessing suppliers in this fashion, provides proper compliance with the legal requirement demonstrably to take responsibility with respect to the processes/products/services which are provided by him.

3. The supplier assessment

3.1. Basic principles

The supplier assessment is an important instrument for a company in controlling feed safety. It covers the whole process of evaluation, selection, monitoring of performance and periodic re-evaluation of the supplier.

The supplier assessment should be set up and implemented systematically. It is quite feasible that a certified company carries out the supplier assessment together with othercertified companies in order to share the costs and knowledge. Each company retains its own responsibility in this case for correct implementation.

The assessment should preferably cover all suppliers of processes, products and/or services. The way in which the assessment takes place depends on the effect which a purchased process/product/service can have on the end product. For example: cleaning agents which are used during the cleaning of machines require different attention than those with which the canteen is cleaned.

Obviously, a certified company purchases only from suppliers who has been assessed positively. Purchasing a process/product/service on impulse from supplier who has not been assessed does not happen.

3.2. The supplier assessment step by step

3.2.1. Input for the supplier assessment

A good supplier assessment starts with the exchange of information between the (potential) supplier and the certified company. The certified company enters into agreements with the supplier about the provision of information on:

  1. the process, product (including the production process and its control) or service to be supplied ;
  1. the functioning of the feed safety system / assurance of the supplier. For example, information about the results of the monitoring and verification carried out by the supplier, his management review or external and internal audits held at the supplier.

3.2.2. The initial supplier assessment

The certified company then carries out an assessment. This includes at least the following steps:

  1. The certified company verifies that the process, product or service:
    1. is safe for use in / as / with feed, and
    2. complies with the relevant GMP+ requirements
    3. complies with all relevant feed legislation

Besides this is verified that the supplier has the relevant qualifications.

The basic requirement for the purchase of feed processes/products/services is that the supplier must have a certified feed safety management system. Approved certificates are recorded in TS 1.2 Purchase.

In summary:

    1. The supplier is GMP+ certified.
    2. The supplier is certified on the basis of another standard which is approved in the GMP+ FC scheme.

It is particularly important to establish whether the processes/products/services to be received falls within the scope of the certificate of the supplier.

Certain processes/products/services may be purchased without one of the above certificates. In that case the supplier must be assured by the certified company via gatekeeper conditions. The gatekeeper options are laid down in TS 1.2 Purchase.

  1. In the case of a feed material the certified company will find out whether there is a generic risk assessment for this feed material in the Feed Support Products.
    Only feed materials for which a generic risk assessment has been included in the Feed Support Products will be accepted in the GMP+ FC scheme and may be used for the production of feed

For feed materials this is done on the basis of data which is specified in the generic risk assessment in the Feed Support Products or in a feed safety sheet provided by the supplier. Any other available data such as monitoring results from the supplier or audit reports can be included in this analysis.

The certified company decides on the basis of the above:

  1. whether it approves the supplier;
  2. which information (for example monitoring results) it wishes periodically to receive from the supplier;
  3. which entry check it will additionally carry out on the processes/products/services to be received from this supplier;
  4. which control measures it wishes to take if any.

The certified company will record the reason for the decisions including any agreements with the supplier. This makes it clear to everyone (both external and internal) how the assessment process was done.

It is also advisable for reasons of communication to feed back the results of the assessment to the supplier. This is certainly important if possibilities for improvement are observed. These can be used by the supplier.

An agreement between the supplier and the certified company contains the following elements:

    1. compliance with relevant requirements;
    2. responsibilities (‘who is doing what’, make sure there are no gaps!);
    3. exchange of relevant information;
    4. any other issue, relevant for assuring the safety of the feed.

3.2.3. The periodic reassessment

It is also important from time to time to reassess the status of all suppliers. The certified company must also take this on systematically. It is preferable to insert this reassessment into the yearly cycle in which the evaluation of complaints, the internal audit and the management review are carried out.

For the reassessment the certified company will collect relevant data per supplier and analyse this. In addition to the items specified in 3.2.2 the certified company also includes in the assessment:

  1. the results of its own entry check and monitoring possibly supplemented with other information (for example information provided by the supplier about deviations, audit results, monitoring, etc.)
  2. the recorded and handled complaints and deviations in as far as they relate to the suppliers and the processes/products/services delivered by them.

On this basis the certified company decides:

  1. whether it will continue to approve the supplier
  2. which entry check it wishes to carry out on the processes/products/services to be received from this supplier
  3. which control measures if any it wishes to take
  4. whether a audit at to the supplier is desirable

The frequency of a second party audit depends on the nature and the risk profile of the process/product/service to be obtained, such as the results of the monitoring, inspections, the results of previous discussions, possible complaints or nonconformities, etc.

New suppliers should be given special attention when establishing the frequency.

The results of the reassessment are also recorded by the certified company and preferably exchanged with the supplier so that opportunities for improvement are made use of.

3.2.4. Second party audit to the supplier

During a second party audit at least the following items are addressed:

  1. the feed safety assurance used by the supplier where there is also an assessment of the local and the method of working,
  2. the information provided in the feed safety sheet,
  3. the monitoring / inspection results (from the certified company and/or the supplier)
  4. the recorded complaints, deviations and items for improvement and their follow-up.

The certified company also ends this stage with a decision:

  1. whether he will continue to approve the supplier
  2. which entry check it will additionally carry out on the processes/products/services to be received from this supplier
  3. which control measures if any it wishes to take

The certified company will make a short report of the second party audit in which it will record its findings. The results of the audit are exchanged with the supplier so that opportunities for improvement are made use of. Further agreements can also be made for the future.