Requirements for the acceptance of quality systems by the Netherlands Food and Consumer Product Safety Authority (NVWA)

Transcription

1 Requirements for the acceptance of quality systems by the Netherlands Food and Consumer Product Safety Authority (NVWA) NVWA, adopted 4 June 2014 Introduction As the government must make sure there is a suitable infrastructure for compliance supervision, investigation and prosecution under current legislation, the NVWA has adopted internal requirements on quality systems, certification and accreditation. 1 Under the general hygiene requirements, Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004 mention that the general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators' responsibility. In a well-functioning quality system, certification can play an important role in compliance supervision as the NVWA can take account of the certification and/or accreditation results when prioritising its compliance tasks. In doing this, the NVWA only checks if and to what extent a specific quality system and/or certificate contributes to compliance with legislation. The NVWA accepts systems meeting the criteria described in this document as being supportive of NVWA tasks regarding compliance supervision. In executing its monitoring tasks, participants in accepted systems have a lower priority for the NVWA than other participants. Principles The NVWA follows the following principles: Businesses 1. Businesses are responsible for compliance with relevant legislation. The NVWA supervises this compliance and intervenes where required. 2. It is completely up to the business itself as to whether it makes use of certificates and/or quality marks. The NVWA is not involved in this. 1 The quality systems mentioned in this document are voluntary systems of bodies under private law, but not private bodies with a designated task. It concerns self-monitoring systems that supervise the (affiliated) individual businesses in a specific branch or sector. This supervision can be done by a trade or professional organisation, or by an external private certifying institution, etc. Pagina 1 van 7

2 NVWA 3. The acceptance of a system or certification scheme means the scheme was tested by the NVWA through verification in practice against this document s basic requirements, and that it meets these requirements. It is not a formal approval or recognition and the NVWA makes its own assessment about the level of supervision required. Participation in the accepted systems plays a role here but it is not the only requirement. 4. Assessments are made individually (per system or scheme) or on a broader level (per sector, group, format). Scheme owners 5. In principle, the scheme owner (scheme manager; holder of the procedure) is the first point of contact for the NVWA regarding the scheme s content and management. The scheme owner decides which certifying bodies (CBs) may carry out the certification and under what conditions this may be done. If the scheme owner is located abroad, communication with CBs in the Netherlands can also take place, but only if there are valid reasons to do as such. The scheme owner will be informed about this. 6. The scheme owner is also the person who decides the norm/scope and method of the quality mark or certificate (independent, quality, scope) and the requirements for businesses to be admitted. Criteria for supervision support 7. The NVWA applies the features of a good quality system as mentioned below as a requirement for supervision support. These requirements are guidelines for scheme owners. The NVWA assesses to what extent the requirements have been met. 8. Currently, several schemes do not meet all guidelines/requirements mentioned in this document as the scheme owners did not choose ISO/RvA accreditation and/or because the so-called second party auditing (auditors come from their own sector, although mostly from other businesses) was chosen. However, these sector-specific schemes of the so-called second level can have added value: a specific scheme with second party auditors can (in theory) address the specific risks of the relevant sector in greater depth. These schemes, however, must also have sufficient depth and be transparent on how they assure integrity. This means that at least the requirements as included in annex 1 must be met. If such systems/schemes are intended to be active on the so-called first level (as described below under Guidelines/requirements for a good quality system ), a plan of action can be drawn up in consultation with the NVWA. Pagina 2 van 7

3 If a system does not meet all mentioned requirements, the NVWA will assess it separately regarding the missing elements and decide if it constitutes enough depth, safeguarding, independence and self-correcting properties. In addition to a scheme s set-up, organisation and requirements, the performance of the certified businesses (the scheme s effect in practice) is also an important factor in accepting a scheme. Guidelines/requirements for a good quality system The NVWA accepts a quality system if it has the following features: General 1. The independence of the quality system s manager (hereinafter: scheme owner) and the executing CBs, is guaranteed. The scheme must meet the ISO standards as relevant for that scheme, for example: a. ISO/IEC (fundamentals and product certification guidelines for certification schemes) b. ISO/IEC/17000:2004 (general principles relating to conformity assessment) c. ISO/IEC/17021:2011 (specifically for CBs, for schemes related to management systems) d. ISO/IEC 17065:2012 (specifically for CBs, for schemes related to products, procedures or services) e. The NVWA takes Global Food Safety Initiative (GFSI)-accepted standards as a basis for global food safety systems. Scope 2. The quality system must provide a framework for the areas of European and national legislation that apply to the relevant sector in regards to food safety (the scope of the system). The requirements, set for the management system of participating businesses, are included in Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004 of the European Parliament and the Council of 29 April 2004 regarding food hygiene. These requirements are an integral part of the quality system or scheme businesses are affiliated to. Related legislation, such as microbiological provisions, contact materials, import requirements, etc., must also fall under the scope of the scheme. The essential aspect of Regulation (EC) No 852/2004 is that businesses (except primary businesses) must use an HACCP-system that meets the following requirements: a. the system must cover the legal requirements; b. all food safety hazards must be covered; c. control measures must be determined for all relevant hazards; d. critical control points must be established; e. critical limits must be determined for each critical control point; Pagina 3 van 7

4 f. corrective measures must be determined for each critical control point; g. the monitoring procedures must be sufficient; h. sufficient verifications must have been built-in; i. registration and documentation must be sufficient; j. the system must work independently. If a system has not included all legal aspects in its scope, it is important for the NVWA to know which aspects are not covered. Also, in case this constitutes standards in the scheme exceeding the statutory entitlement, the basic principle should be that at least the legal provisions should be met. Where legislation constitutes open standards, the scheme should include a provision on how to deal with possible differences in interpretation. The NVWA must be able to have a clear view of the scope of these standards. The system should specifically focus on product integrity; the system must include provisions that indicate that product specification, name, content, origin, nature and properties, claims, etc. should be mentioned in such a way that this cannot result in misleading the consumers (according to Article 29 of the Labelling (Commodities Act) Decree or a lack of clarity in the trade between businesses. Implementation 3. The quality system must include measures that safeguard compliance with legislation of the participating businesses in the following manner: a. The scheme owner shows the performance of the participating businesses in regards to the relevant requirements. The scheme owner also indicates possible improvement plans for the scheme. b. The quality system includes audits and/or on-site inspections of participating businesses. c. The quality system includes a transparent implementation of sanctions to safeguard the value of the certification system. 4. The quality system sets requirements for the organisations/certifying bodies (CBs) carrying out inspections of the participating businesses. a. The scheme owner guarantees that the participating CBs are properly accredited following specific standards: the accreditation standard must have been recognised by an accreditation organisation that is a member of the International Accreditation and has signed the IAF Multilateral Recognition Arrangement (MLA). This means that the CB must have been accepted by the scheme-owner and have been accredited according to ISO Pagina 4 van 7

5 standards: ISO/IEC Guide or ISO/IEC 17021:2011³ (supplemented by ISO/TS 22003). 3 b. The scheme owner sets clear requirements for the knowledge and expertise of the auditors (ISO 22003) and supervises this. The quality of the audits is also monitored through witness audits and/or audits of the implementing CBs. c. The agreement between the business and the CB includes a stipulation regarding the CB applying a system of announced and unannounced inspections. The (unannounced) inspections at businesses are risk-based. This requirement ([un]announced, risk-based inspections) must be included in the scheme / quality system in due course. d. The scheme owner has an integrity programme which monitors the CBs functioning and adjusts this where required: the scheme owner monitors whether the CBs carry out the inspections of businesses and settle nonconformities in a proper manner, and if they apply sanctions in a consistent manner. The scheme owner has insight into the functioning of the system (reliability) and if required will take additional measures to improve this; self-corrective procedures must have been built in and checked in regard to their functioning. Performance 5. If systems have been accepted, the NVWA will have to remain confident that the private systems function properly. Systems will have to show that in practice they are sufficiently effective, meaning they deliver what is expected of them. The NVWA can use several instruments to track the effectiveness. The use of instruments and their frequency can be different for each system. In terms of instruments, the following can be considered: the accreditation results, following performance indicators by the system itself and/or the NVWA, an NVWA audit of the system, an NVWA monitoring of the practice (reality checks through audits and/or inspections), a periodical analysis of the available data from the system, etc. The NVWA and the scheme s owner/manager hold regular consultations whereby the findings will be discussed reciprocally by both parties. Information exchange scheme owner and NVWA 6. The quality systems are transparent for the NVWA. Information and relation with NVWA supervision are arranged as follows: 2 ISO/IEC 17065: Conformity assessment Requirements for bodies certifying products, processes and services. 3 ISO/IEC 17065: Conformity assessment Requirements for bodies carrying out audits and certification of management systems. Pagina 5 van 7

6 a. The scheme owner gives the NVWA insight into the functioning of the system. b. The scheme owner gives the NVWA periodic insight into possible changes in the quality system as well as in its functioning. c. The scheme owner will at least give the NVWA insight into which businesses are certified. d. Verification by the NVWA in practice takes place through audits and inspections of businesses, also known as reality checks. The results of this verification are discussed with the system owner/scheme-owner. The possibility for the NVWA to examine the system in greater depth (by performing an audit) can be part of the agreements between the parties (NVWA and scheme owner). e. Government involvement in governance bodies of the schemes (such as a Central College of Experts): In a certification scheme s operational stage, involvement of the government as observer should in principle be recommended. This way the government can learn about the developments in the market sector and the functioning of the certification scheme, and the role of the parties involved. f. Parties (NVWA, scheme owner, CB and business) should be able to share information about the business under certain specific conditions. Parties should in particular be informed about cases of serious non-compliance that can lead to unsafe situations. This can be managed centrally (made legally possible) or by including this requirement in contracts entered into by CBs with the businesses. g. The agreement between the business and CB, or the scheme, must specify that it is compulsory for the business to report serious deviations with the CB. In addition, the business has the legal obligation (Regulation (EC) No 178/2002) to report unsafe situations with the NVWA. If this is omitted, the CB must take proper action (stricter supervision and sanctions, suspension or revoking of the certificate). It should be made legally possible for a scheme-owner and/or CB to inform the NVWA in the event of such serious matters and unwillingness. h. If it is legally possible, the NVWA wants under certain conditions to be fully transparent about its findings at certified businesses if scheme owners and CIs request this. In addition, the NVWA wants to be able to inform the scheme owner in case of a serious violation (as determined by the NVWA), so the CB can take corrective measures. Pagina 6 van 7

7 Annex 1: Criteria for sector-specific quality systems/schemes Second level quality systems/schemes must meet the following criteria: - The scheme must at least cover the legal requirements in the area of food and animal feed safety, that apply to the specific sector. - The scheme s content is transparent and easily available for interested parties. - There is a scheme owner who is responsible for the scheme s management and integrity, sets requirements for the auditors involved and is responsible for compliance. - The scheme owner keeps a transparent and publicly available list of all certified businesses. - The scheme owner must make sure there is a sufficiently independent audit procedure by qualified auditors. If this is not yet the case, the auditors must meet at least the following requirements: - At least three years of relevant work experience in the sector. - Successfully completed auditor training under ISO Qualified by or on behalf of the scheme owner to carry out a second party audit. - Independent position regarding the audited businesses. - Attending a training or harmonisation day, organised under the responsibility of the scheme owner twice every three years. - The scheme owner commissions an accredited CB or an expert independent auditor to carry out annual witness audits. - The scheme owner must have a training and qualification programme to maintain the knowledge level of the qualified auditors. Pagina 7 van 7