ANNEX IISupplementary provisions
ANNEX II Arrangements with regard to conformity of production 1. Definitions For the purposes of this Annex the following definitions shall apply: 1.1. ‘quality management system’ means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved; 1.2. ‘audit’ means an evidence-gathering process used to evaluate how well audit criteria are being applied; it should be objective, impartial and independent, and the audit process should be both systematic and documented; 1.3. ‘corrective actions’ means a problem-solving process with subsequent steps taken to remove the causes of a nonconformity or undesirable situation and designed to prevent their recurrence; 2. Purpose 2.1. The conformity of production arrangements aim to ensure that each engine is in conformity with the specification, performance and marking requirements of the approved engine type or engine family. 2.2. Procedures include, inseparably, the assessment of quality management systems, referred as ‘initial assessment’ and set out in section 3 and verification and production-related controls, referred to as ‘product conformity arrangements’ and set out in section 4. 3. Initial assessment 3.1. Before granting EU type-approval, the approval authority shall verify the existence of satisfactory arrangements and procedures established by the manufacturer for ensuring effective control so that engines when in production conform to the approved engine type or engine family. 3.2. Guidelines for quality and/or environmental management systems auditing set out in the EN ISO 19011:2011 standard shall apply to the initial assessment. 3.3. The approval authority shall be satisfied with the initial assessment and the product conformity arrangements in section 4 taking account as necessary of one of the arrangements described in points 3.3.1 to 3.3.3 or a combination of those arrangements in full or in part as appropriate. 3.3.1. The initial assessment and/or verification of product conformity arrangements shall be carried out by the approval authority granting the approval or an appointed body acting on behalf of the approval authority. 3.3.1.1. When considering the extent of the initial assessment to be carried out, the approval authority may take account of available information relating to the manufacturer's certification which has not been accepted under point 3.3.3. 3.3.2. The initial assessment and verification of product conformity arrangements may also be carried out by the approval authority of another Member State, or the appointed body designated for this purpose by the approval authority. 3.3.2.1. In such a case, the approval authority of the other Member State shall prepare a statement of compliance outlining the areas and production facilities it has covered as relevant to the engines to be EU type-approved. 3.3.2.2. On receiving an application for a compliance statement from the approval authority of a Member State granting EU type-approval, the approval authority of another Member State shall send forthwith the statement of compliance or advise that it is not in a position to provide such a statement. 3.3.2.3. The statement of compliance shall include at least the following: 3.3.2.3.1. group or company (e.g. XYZ manufacturing); 3.3.2.3.2. particular organisation (e.g. European division); 3.3.2.3.3. plants/sites (e.g. engine plant 1 (United Kingdom) — engine plant 2 (Germany)); 3.3.2.3.4. engine types/engine families included 3.3.2.3.5. areas assessed (e.g. engine assembly, engine testing, after-treatment manufacture) 3.3.2.3.6. documents examined (e.g. company and site quality manual and procedures); 3.3.2.3.7. date of the assessment (e.g. audit conducted from 18 to 30.5.2013); 3.3.2.3.8. planned monitoring visit (e.g. October 2014). 3.3.3. The approval authority shall also accept the manufacturer's suitable certification to harmonised standard EN ISO 9001:2008 or an equivalent harmonised standard as satisfying the initial assessment requirements of point 3.3. The manufacturer shall provide details of the certification and undertake to inform the approval authority of any revisions to its validity or scope. 4. Product conformity arrangements 4.1. Every engine EU type-approved pursuant to Regulation (EU) 2016/1628, this Delegated Regulation, Delegated Regulation (EU) 2017/655 and Implementing Regulation (EU) 2017/656 shall be so manufactured as to conform to the approved engine type or engine family by meeting the requirements of this Annex, Regulation (EU) 2016/1628 and the abovementioned Delegated and Implementing Regulations. 4.2. Before granting a EU type-approval pursuant to Regulation (EU) 2016/1628 and the delegated and implementing acts adopted pursuant to that Regulation, the approval authority shall verify the existence of adequate arrangements and documented control plans, to be agreed with the manufacturer for each approval, to carry out at specified intervals those tests or associated checks necessary to verify continued conformity with the approved engine type or engine family, including, where applicable, tests specified in Regulation (EU) 2016/1628 and the delegated and implementing acts adopted pursuant to that Regulation. 4.3. The holder of the EU type-approval shall: 4.3.1. ensure the existence and application of procedures for effective control of the conformity of engines to the approved engine type or engine family; 4.3.2. have access to the testing or other appropriate equipment necessary for checking conformity to each approved engine type or engine family; 4.3.3. ensure that test or check result data are recorded and that annexed documents remain available for a period of up to 10 years to be determined in agreement with the approval authority; 4.3.4. for engine categories NRSh and NRS, except for NRS-v-2b and NRS-v-3, ensure that for each type of engine, at least the checks and the tests prescribed in Regulation (EU) 2016/1628 and the delegated and implementing acts adopted pursuant to that Regulation are carried out. For other categories tests at a component or assembly of components level with appropriate criterion may be agreed between the manufacturer and the approval authority. 4.3.5. analyse the results of each type of test or check, in order to verify and ensure the stability of the product characteristics, making allowance for variation in industrial production; 4.3.6. ensure that any set of samples or test pieces giving evidence of non-conformity in the type of test in question gives rise to a further sampling and test or check. 4.4. If the further audit or check results referred to in point 4.3.6 are deemed not to be satisfactory in the opinion of the approval authority, the manufacturer shall ensure that conformity of production is restored as soon as possible by corrective actions to the satisfaction of the approval authority. 5. Continued verification arrangements 5.1. The authority which has granted EU type-approval may at any time verify the conformity of production control methods applied in each production facility by means of periodic audits. The manufacturer shall for that purpose allow access to the manufacture, inspection, testing, storage and distribution sites and shall provide all necessary information with regard to the quality management system documentation and records. 5.1.1. The normal approach for such periodic audits shall be to monitor the continued effectiveness of the procedures laid down in sections 3 and 4 (initial assessment and product conformity arrangements). 5.1.1.1. Surveillance activities carried out by the technical services (qualified or recognised as required in point 3.3.3) shall be accepted as satisfying the requirements of point 5.1.1 with regard to the procedures established at initial assessment. 5.1.1.2. The minimum frequency of verifications (other than those referred to in point 5.1.1.1) to ensure that the relevant conformity of production controls applied in accordance with sections 3 and 4 are reviewed over a period consistent with the climate of trust established by the approval authority shall be at least once every two years. However, additional verifications shall be carried out by the approval authority depending on the yearly production, the results of previous evaluations, the need to monitor corrective actions and upon a reasoned request from another approval authority or any market surveillance authority. 5.2. At every review, the records of tests, checks and production records, and in particular the records of those tests or checks documented as required in point 4.2, shall be available to the inspector. 5.3. The inspector may select random samples to be tested in the manufacturer's laboratory or in the facilities of the technical service, in which case only physical tests shall be carried out. The minimum number of samples may be determined according to the results of the manufacturer's own verification. 5.4. Where the level of control appears unsatisfactory, or when it seems necessary to verify the validity of the tests carried out in application of point 5.2, or upon a reasoned request from another approval authority or any market surveillance authority, the inspector shall select samples to be tested in the manufacturer's laboratory or sent to the technical service to perform physical tests in accordance with the requirements set out in section 6, in Regulation (EU) 2016/1628 and in the delegated and implementing acts adopted pursuant to that Regulation. 5.5. Where unsatisfactory results are found by the approval authority during an inspection or a monitoring review, or by an approval authority in other Member State, in accordance with Article 39(3) of Regulation (EU) 2016/1628, the approval authority shall ensure that all necessary steps are taken to restore conformity of production as rapidly as possible. 6. Conformity of production test requirements in cases of an unsatisfactory level of product conformity control as referred to in point 5.4. 6.1. In case of an unsatisfactory level of product conformity control as referred to in point 5.4 or point 5.5, conformity of production shall be checked by emissions testing on the basis of the description in the EU type-approval certificates set out in Annex IV to Implementing Regulation (EU) 2017/656. 6.2. Except otherwise provided in point 6.3, the following procedure shall apply: 6.2.1. Three engines and, if applicable, three after-treatment systems shall randomly be taken for inspection from the series production of the engine type under consideration. Additional engines shall be taken as necessary to reach a pass or fail decision. For reaching a pass decision, a minimum of four engines needs to be tested. 6.2.2. After the inspector's selection of the engines, the manufacturer shall not carry out any adjustment to the engines selected. 6.2.3. Engines shall be subjected to emissions testing in accordance with the requirements of Annex VI, or, in the case of dual fuel engines, in accordance with Appendix 2 of Annex VIII, and shall be subject to the test cycles relevant for the engine type in accordance with Annex XVII. 6.2.4. The limit values shall be those set out in Annex II to Regulation (EU) 2016/1628. Where an engine with after-treatment regenerates infrequently as referred to in point 6.6.2 of Annex VI, each gaseous or particulate pollutant emission result shall be adjusted by the factor applicable to the engine type. In all cases each gaseous or particulate pollutant emission result shall be adjusted by application of the appropriate deterioration factors (DFs) for that engine type, as determined in accordance with Annex III. 6.2.5. The tests shall be carried out on newly manufactured engines. 6.2.5.1. At the request of the manufacturer, the tests may be conducted on engines which have been run-in, up either 2 % of the emission durability period or, if this is a shorter period of time, 125 hours. Where the run-in procedure shall be conducted by the manufacturer who shall undertake not to make any adjustments to those engines. Where the manufacturer has specified a run-in procedure in point 3.3 of the information document, as set out in Annex I to Implementing Regulation (EU) 2017/656, the run-in shall be conducted using that procedure. 6.2.6. On the basis of tests of the engine by sampling as set out in Appendix 1, the series production of the engines under consideration is regarded as conforming to the approved type where a pass decision is reached for all the pollutants and as non-conforming to the approved type where a fail decision is reached for one pollutant, in accordance with the test criteria applied in Appendix 1, and as shown in Figure 2.1. 6.2.7. When a pass decision has been reached for one pollutant, this decision may not be changed as a consequence of a result from any additional tests made in order to reach a decision for the other pollutants. If a pass decision is not reached for all the pollutants and no fail decision is reached for any of the pollutant, a test shall be carried out on another engine. 6.2.8. If no decision is reached, the manufacturer may at any time decide to stop testing. In that case a fail decision shall be recorded. 6.3. By derogation from point 6.2.1, the following procedure shall apply for engine types with a sales volume within the EU of less than 100 units per year: 6.3.1. One engine and, if applicable, one after-treatment system shall be taken randomly for inspection from the series production of the engine type under consideration. 6.3.2. If the engine meets the requirements outlined in point 6.2.4, a pass decision is reached and no further test is necessary. 6.3.3. If the test does not satisfy the requirements outlined in point 6.2.4, the procedure outlined in points 6.2.6 to 6.2.9 shall be followed. 6.4. All these tests may be conducted with the applicable market fuels. However, at the manufacturer's request, the reference fuels described in Annex IX shall be used. This implies tests, as described in Appendix 1 of Annex I, with at least two of the reference fuels for each gaseous-fuelled engine, except in the case of a gaseous-fuelled engine with a fuel-specific EU type-approval where only one reference fuel is required. Where more than one gaseous reference fuel is used the results shall demonstrate that the engine meets the limit values with each fuel. 6.5. Non-compliance of gaseous-fuelled engines In the case of dispute concerning compliance of gaseous-fuelled engines, including dual-fuel engines, when using a market fuel, the tests shall be performed with each reference fuel on which the parent engine has been tested, and, at the request of the manufacturer, with the possible additional third fuel, as referred to in points 2.3.1.1.1, 2.3.2.1 and 2.4.1.2 of Annex I, on which the parent engine may have been tested. When applicable, the result shall be converted by a calculation, applying the relevant factors ‘ r ’, ‘ r a ’ or ‘ r b ’ as described in points 2.3.3, 2.3.4.1 and 2.4.1.3 of Annex I. If r , r a or r b are less than 1, no correction shall take place. The measured results and, when applicable, the calculated results shall demonstrate that the engine meets the limit values with all relevant fuels (for example fuels 1, 2 and, if applicable, the third fuel in the case of natural gas/bio-methane engines, and fuels A and B in the case of LPG engines). Figure 2.1 Schematic of production conformity testing NO YES A pass decision is reached for one or more pollutants NO NO YES YES Series accepted Series rejected Test of an additional engine Is a pass decision reached for all pollutants? According to the appropriate appendix does the test statistic result agree with the criteria for passing the series for at least one pollutant? Computating of the test statistic result According to the appropriate appendix does the test statistic result agree with the criteria for failing the series for at least one pollutant? Test of three engines