MODULE D1- Quality Assurance of the Production Process

MODULE D1- Quality Assurance of the Production Process

1. Quality assurance of the production process is the conformity assessment method in which the manufacturer fulfills the obligations listed in the second, fourth and seventh articles and ensures and declares the compliance of EU fertilization products with the relevant rules of the technical legislation within the framework of its own responsibility.

2.The producer creates a technical file containing the necessary risk analyzes and assessments to determine that the EU fertilization product complies with the relevant legislation. This file is directly related to the conformity assessment of the product and details the design, manufacturing process and functionality of the product. In each case, the technical file must contain at least the following information:

• a) A comprehensive description of the EU fertilization product and a description of its intended use corresponding to its declared function,
• b) EU fertilization product concept design, a list of component materials used, information on manufacturing processes,
• c) Declaration of conformity of the EU fertilization product,

d) Drawings, diagrams and explanations necessary to understand the manufacturing, storage and recovery process of the EU fertilization product,

• d) Sample of a label or brochure or both containing the required information
• e) In the case of partially applied harmonized standards or common specifications, technical documents include the applied sections,
• f) Technical and administrative evidence showing that the EU fertilization product complies with the application procedures or adopted national measures, if it contains by-products,
• g) If the EU fertilizer product contains derived products, the commercial documents or health certificates required under the legislation in question and documents proving that the derived products have reached the final point in the production chain within the scope of this legislation,
• h) results of calculations and examinations,
• I) Product test reports
• i) Hazardous waste calculations for EU fertilizer products containing certain substances
• The manufacturer must keep technical documentation available to the relevant national authorities for 5 years after the EU fertilizer product is placed on the market.
• The manufacturer must operate an approved quality system for production, final product control and testing for EU fertilizer products referred to in Article 5 and must be subject to the inspection specified in Article 6.
• The procedures and principles regarding the quality system are stated below:
• a) The manufacturer applies to a notified body of his choice to evaluate the quality system he applies for his products. The application must contain the following information:

a-1) The name and address of the manufacturer, and in case the application is made by the authorized representative, also the name and address of the authorized representative.

a-2) Written statement stating that the same application has not been made to another approved organization,

a-3) All relevant information for the planned EU fertilization product category,

a-4) Documentation regarding the quality system.

a-5) The technical file specified in the second article.

• b) The quality system ensures that the products comply with the relevant rules of the technical legislation. All elements, rules and provisions adopted by the manufacturer are kept systematically and regularly in the form of written policies, procedures and instructions. Quality system documentation; It is organized in a way that allows quality programs, plans, manuals and records to be interpreted consistently. The quality system documentation includes sufficient information and explanations, in particular:

b-1) Management’s quality objectives and organizational structure, as well as its responsibilities and authorities regarding product quality.

b-2) Relevant production, quality control and quality assurance techniques, processes and systematic actions to be taken.

b-3) Inspections and tests to be carried out before, during and after production and the frequency of their performance.

b-4) Quality records such as inspection reports, test and calibration data, qualification reports of the relevant personnel.

b-5) Tools for the supervision of ensuring the desired product quality and the effective operation of the quality system.

• c) The notified body evaluates the quality system to determine whether it meets the conditions specified in paragraph (b). The notified body assumes that the elements of the quality system in accordance with the relevant rules of the national standard implementing a relevant harmonized standard and/or technical specification comply with the requirements specified in point (b). In addition to experience in quality management systems, at least one member of the auditing group must have evaluation experience in the relevant product field and product technology and knowledge of the relevant rules of technical legislation. The audit also includes an evaluation visit to the manufacturer’s workplace. The inspection team reviews the technical file referred to in the second article in order to verify the manufacturer’s ability to identify the relevant rules of the technical legislation and to carry out the necessary inspections to ensure that its product complies with these rules. The notified body notifies the manufacturer of its decision. The notification also includes the results of the audit and justified evaluations of the decision.

d) The manufacturer undertakes to fulfill its obligations arising from the quality system as approved and to maintain the quality system in a way that remains adequate and effective.

• d) The manufacturer informs the notified body that approved the quality system about any changes it intends to make to the quality system. The notified body evaluates the proposed changes and decides whether the modified quality system meets the requirements specified in point (b) or whether a re-evaluation is required. . The notified body notifies the manufacturer of its decision. The notification also includes the results of the audit and justified evaluations of the decision.
• The procedures and principles of surveillance under the responsibility of the approved body are stated below:
• a) The purpose of surveillance is to ensure that the manufacturer fully fulfills its obligations arising from the approved quality system.
• b) The manufacturer allows the notified body to enter the production facilities, inspection and testing laboratories and warehouses in order to make the evaluation, and provides the notified body with all necessary information and documents, especially the following:

a-1) Documentation regarding the quality system.

a-2) The technical file referred to in the second article.

a-3) Quality records such as inspection reports, test and calibration data, qualification reports of the relevant personnel.

• b) The notified body conducts periodic inspections to ensure that the manufacturer maintains and implements the quality system and issues an inspection report to the manufacturer.
• c) The notified body may additionally make visits to the manufacturer without notice. During these visits, the notified body may, if necessary, conduct or have product tests performed to confirm that the quality system is functioning correctly. The notified body issues a visit report to the manufacturer and a test report if testing has been carried out.
• Manufacturer;
• a) The manufacturer shall affix the CE marking and the identification number of the notified body referred to in Article 5 on each individual packaging of each EU fertilizer product that meets the requirements of the relevant technical legislation or, if supplied unpackaged, in a document submitted together with the EU fertilizer product.
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• b) The manufacturer must issue a written EU declaration of conformity for an EU fertilizer product or type and keep it, together with the technical documentation, for submission to national authorities for 5 years after the EU fertilizer product has been placed on the market. The EU declaration of conformity must identify the EU fertilizer product or type for which it is issued.
• c) A copy of the EU declaration of conformity should be available upon request from the relevant authorities.
• The manufacturer must keep the following documents available to national authorities for 5 years after the EU fertilizer product has been placed on the market:
• a) Documents specified in paragraph (a) of the fifth paragraph.
• b) The changes specified in subparagraph (d) of the fifth paragraph, as approved,
• c) Approved body decisions and reports specified in subparagraph (d) of the fifth paragraph and subparagraphs (c) and (d) of the sixth paragraph.
• Each notified body shall inform the competent bodies that designated it of the quality system approvals it has granted or withdrawn, and shall regularly or upon request provide to these competent bodies a list of the quality system approvals which it has refused to grant, suspended or otherwise restricted. Each notified body shall inform other notified bodies of the quality system approvals it has refused, suspended, withdrawn or otherwise restricted and granted upon request.
• The manufacturer’s obligations listed in the third article, fifth article subparagraphs (a) and (d) and seventh and eighth articles can be fulfilled by the authorized representative, provided that it is done on the manufacturer’s behalf, is under his responsibility and is specified in the relevant assignment.