INSTRUCTIONS FOR CERTIFICATION OF FACTORY PRODUCTION CONTROL

Transcription

1 . August 2017 were approved by Manager of Product Certification Bureau of the Polish Register of Shipping on 25 August 2017 Copyright by, GDAŃSK, AUGUST /12

2 CONTENTS 1. Factory Production Control Definition of Factory Production Control General information Personnel responsibilities and authorizations Supervision of FPC documentation and records Control and checking of raw materials and material components to be used in production Control and examinations at the production time Supervision of production machinery and equipment Identification and traceability of finished product Supervision of measuring, control and testing equipment Activities taken in case of nonconforming products Supervision of corrective and preventive actions Product packaging, storage, CE marking and delivery Handling complaints Training List of external documents to be applied at FPC certification 10 2/12

3 1. Factory Production Control 1.1. Definition of Factory Production Control Factory Production Control (FPC) permanent, internal production control conducted by a manufacturer. All the elements, requirements and provisions adopted by the manufacturer are documented in a systematic manner in the form of written records or procedures. Production control system documentation ensures a common understanding of quality assurance and enables to achieve constancy of construction product performance and to verify effectiveness of factory production control system. The purpose of established and effectively implemented system of factory production control (FPC) is to ensure production stability and achieving, by a construction product, characteristics conforming to the technical specifications and to performance declared by the manufacturer. The FPC system shall be tailored to the performance of a construction product requirements and take into account level of production lines and machinery automation. The FPC system shall define: a) Responsibility, authorities and interrelations of the personnel who manage, execute and verify activities affecting product conformity with the requirements; b) Procedures related to functioning of factory production control, necessary to demonstrate constancy of product performance at relevant production stage; c) Principles of records keeping and supervising; d) Principles of training the personnel whose activities have effect on quality; e) Principles of complaints handling; f) Principles of conducting corrective actions, aimed at removal of disclosed nonconformities. The FPC documentation shall at least include, or refer to the below documents: FPC Manual describing the scope of factory production control; Note: If a manufacturer outsources realization of any process, which affects product conformity with the requirements, he shall ensure control over this process. The control method shall be defined in FPC documentation. Technical specifications: for products (in accordance with reference document, depending on intended use); for raw materials and materials to be used in production; for products at particular production stages; Documented procedures / instructions for: supervision of production process and conducting inspections and testing to demonstrate product conformity at particular stages of its production; supervision of equipment for inspection and testing of the product during all phases of its manufacture; assessments and verification of constancy of product performance basing on tests. dealing with nonconforming products; 3/12

4 complaints handling; carrying out corrective and preventive actions. Informative documents: legal regulations; technological descriptions; technical documentation; organizational chart. Factory production control documentation should be subject to surveillance by a duly designated person holding the relevant competences and authority. Such documentation shall be kept up-to-date and supplemented in the event of modifications to production process, product or factory production control system. The manufacturer shall keep specification of surveillance documents and records. Valid documents shall be available at places of their use General information According to the Regulation (EU) of the European Parliament and of the Council No. 305/2011 of 9 March 2011 (Construction Product Regulations CPR) and the Polish Act of 16 April 2004 on construction products (Journal of Laws, 2004, No. 92, item 881, as further amended), a construction product may be placed on the market and incorporated in construction works, if It has the CE marking affixed, It is included in the European Commission specification of products which do not essentially affect health and safety, for which manufacturer issued declaration of constancy of product performance, to recognized principles of building art. Procedure of declaring product performance and marking it with the CE marking: definition of harmonized technical specifications, i.e. depending on intended use of product. It may be a harmonized Polish Standard which is not a withdrawn standard or the European Assessment Document; performance of product conformity assessment with harmonized technical specification, with participation of a notified body (notified product certification body or a notified laboratory), if the applied conformity assessment system so require; when performed assessment of constancy of product performance demonstrate that the product fulfils the requirements given in harmonized technical specifications, the manufacturer of a construction product, or its authorized representative, issues at its own responsibility a declaration of performance for the product, acc. to Article 6 of Construction Product Regulations (CPR) and subsequently affix the CE marking to the product, acc. to CPR Article 8 and 9, enclosing required information thereto. derogations from drawing up a declaration of performance have been defined in Article 5 of the Regulation (EU) of the European Parliament and of the Council (UE) No. 305/ /12

5 1.3. Personnel responsibilities and authorizations The manufacturer shall appoint a person responsible for management and surveillance of factory production control (e.g. FPC Proxy). In relation to the personnel, the manufacturer shall define and document responsibilities and appointed authority, interrelations of the personnel managing, executing and verifying activities which have effect on product conformity with the requirements, and in particular those in respect to: establishing necessary procedures; defining requirements for raw materials and materials to be used in production; release of raw materials and materials for production; assessment of subcontractors; supervision of production process, including breaking the process; assessment and verification of performance of product essential characteristics at particular production stages; defining requirements for finished construction product; release of finished construction product; supervision of marking and securing finished construction product; issue of declaration of performance; supervision of the nonconforming product; finding nonconformities and analysing their causes; analysis of complaints; establishing appropriate corrective actions; supervision of production machinery and equipment; control of monitoring and measuring equipment; execution of any other activities within the scope of FPC, such as inspections and testing, identification and traceability. The manufacturer shall ensure training for the personnel, whose activities affect the product conformity with the requirements Supervision of FPC documentation and records The manufacturer shall determine a period of time and a place for keeping documents and records as well as the method of handling them to demonstrate conformity and effectiveness of factory production control. The manufacturer is obliged to keep any records pertaining to particular products or product batches for a period of time defined in technical specifications or appropriate legal regulations. 5/12

6 1.5. Control and checking of raw materials and material components to be used in production The manufacturer shall establish and supervise method of evaluation of suppliers of production means (materials, components, subassemblies) and subcontractors of services affecting factory production control and shall define the requirements for such means and services. When choosing the method of supervision, the control made by the manufacturer and documented conformity evidences (conformity declarations, attestations, certificates, test reports, safety data sheets, acceptance protocols and other) shall be considered. The manufacturer shall ensure that supplied production means have been verified for their conformity before being applied or processed. The manufacturer shall keep records to document purchasing process. The manufacturer shall perform inspections and examinations of deliveries (raw materials, materials and components) and define: requirements for raw materials and components at particular stages of production; criteria of assessment of inspections and test results (for raw materials, components); method of conducting control of deliveries conformity with orders (including control method of documents confirming conformity of the delivery with requirements), method of taking samples for inspections and tests, appropriate plan of tests to cover: tested features, methods, frequency and responsible persons; principles of supplies release for production and the persons responsible for execution thereof; kind of records of inspections and tests. The manufacturer shall have appropriate technical competences to carry out inspections and tests or use services of laboratories having such competency Control and examinations at the production time The manufacturer shall supervise the process of construction product manufacturing and carry out inspections and testing to make product conforming with requirements. The manufacturer shall, in particular: define stages of the production process; define type, scope, frequency and methods of tests carried out during production; define the parameters to be controlled together with assumed tolerances; define the persons responsible for carrying out inspections and examinations; provide document specifying product performance and containing appropriate workplace procedures/ instructions; provide appropriate equipment for inspections and examinations. 6/12

7 The manufacturer shall keep records to document inspections and testing activities during production. When any nonconformities have been identified during production process, the manufacturer shall take appropriate corrective actions provided by factory production control system. After removal of the nonconformities, inspection or testing shall be repeated to prove that the fault has been eliminated Supervision of production machinery and equipment The manufacturer shall provide supervision of production machinery and equipment, including their maintenance, inspections, overhauls and repairs, in accordance with prepared schedule. Execution of these activities shall be controlled. The manufacturer shall also define the method of post-repair and post-overhaul control activities. Performed activities shall be recorded Control and testing of finished product The manufacturer shall carry out examinations in accordance with test plan, within the scope, by methods and with frequency specified in technical specifications and/or other reference documents. The manufacturer shall define the method of taking samples, as well as sample and batch sizes. Procedures for examinations shall define criteria of assessment of examination results and the principles of finished products release for sale shall be established. The manufacturer shall keep records confirming execution of the activities. The records of inspection and examination results shall include at least: product identification; date of manufacture, size of product batch; method of taking samples for inspection and examinations; methods of examination of particular properties; examination procedures, as indicated in the reference document; examination results; assessment of conformity of the inspection/examination results with the criteria established in harmonized technical specifications; identification and signature of the authorized person, who performed the inspections/ examinations. In the case the product does not comply with the requirements, the manufacturer shall take necessary corrective/correction actions provided by factory production control. After nonconformity removal, inspection or examination of the product shall be repeated, to demonstrate that the nonconformity has been eliminated Identification and traceability of finished product The manufacturer shall establish a method of identifying product at the stages of its manufacturing (if it is possible) and of finished product. Particular products or product batches shall be capable of being identified and their production history shall be traceable. The manufacturer is obliged to keep records for 7/12

8 particular products or product batches, together with relevant detailed information pertaining to product s manufacture and characteristics. Retrieval of any essential information such as: manufacture date, applied raw materials, materials, components and products, product batch, product type, designation or intended use, method of marking product with safety mark, date of sale, product recipient, etc., shall be possible on the basis of the records made Supervision of measuring, control and testing equipment The manufacturer shall establish and document a method of supervision, calibration/ verification and maintaining in appropriate condition of measuring, control and testing equipment. The manufacturer shall supervise equipment and: define instruments necessary for measuring, control and examination, taking into account appropriate level of accuracy (on the basis of tests plan); keep the list of all own equipment and keep it identified; prepare the schedule of metrological verifications for the instruments and supervise realization of the schedule; have manuals of operation and current verification of the instruments; maintain calibration and verification by the method ensuring maintaining measurement traceability; perform calibration by the national metrological institution (in Poland it is Central Office of Measures), by accredited calibration laboratories or in own capacity, if having appropriate technical facilities; define a method of proceeding with damaged measuring equipment; define persons responsible for supervision of the equipment and give them appropriate authorizations. Supervision of equipment shall also cover standard measures (control instruments) used in internal verifications. If the manufacturer has no appropriate technical competences to carry out inspections and testing, he may subcontract the services. The manufacturer shall keep records to document supervision activities over equipment and/or subcontracted services. Calibration certificates issued by accredited measurement laboratories shall be subject to supervision in accordance with the recording principles Activities taken in case of nonconforming products The manufacturer shall ensure identification and supervision of nonconforming product so as to prevent its inadvertent use or delivery to recipient. The manufacturer shall ensure that: nonconforming product is duly marked and isolated to prevent its release for use; activities to eliminate disclosed nonconformities as well as corrective actions have been taken; further steps with nonconforming product have been established; records have been kept on the nature of nonconformity and on any follow-up actions taken; responsibilities and authority concerning the method of handling the nonconforming product have 8/12

9 been defined for person(s) responsible for management and supervision of factory production control (e.g. FPC Proxy) Supervision of corrective and preventive actions The manufacturer shall determine a method of proceeding in case of taking corrective and preventive actions. Corrective actions shall include: analysis of product nonconformity causes, production process, FPC system; determination of the method of eliminating established causes and taking appropriate actions; assessment of effectiveness of taken actions. Preventive actions shall cover: use of available information sources, their analysis considering elimination of causes of potential product nonconformities, production process, FPC; determination of method of proceeding to eliminate established causes of nonconformities and taking appropriate actions; assessment of effectiveness of performed actions. The manufacturer shall keep records to document preventive and corrective actions Product packaging, storage, CE marking and delivery The manufacturer shall define and describe a method of handling finished product, a method of its packing, storage, marking and transportation. The method shall meet the principles specified in valid relevant regulations and instructions contained in relevant technical specifications. The manufacturer shall ensure that packaging and storage conditions do not have negative effect on the product quality and that the product compliance with requirements will be maintained. If it is necessary and may affect product quality/conformity, the manufacturer shall ensure proper environmental conditions for product storage and monitor them, if necessary. The conditions for receiving finished product into a warehouse shall be explicitly defined and appropriate records shall be made on the process of product receipt into a warehouse and its further dispatch. The manufacturer is obliged to attach the below information to the construction product marked with The CE mark: name, seat and address of the manufacturer and address of manufacturing plant, if other than that of manufacturer seat; name, trade name, type, variety, brand, class according to the technical specifications; designation of the harmonized technical specification, which performance of construction product conformity was assessed with (number of the harmonized standard or the European Technical Assessment and the year of its issue); number and date of issue of a declaration of product performance; name of certification body, if the body participated in the conformity assessment; other data according to the harmonized technical specification. 9/12

10 Finished construction products shall be marked in accordance with the requirements of reference documents and valid law regulations. The product marking is possible only when the manufacturer has implemented and maintains the FPC system, has carried out conformity assessment in accordance with appropriate conformity assessment system as well as issued a declaration of performance Handling complaints The manufacturer shall establish procedures for dealing with complaints, both submitted by construction product recipients and made by the manufacturer against suppliers of raw materials, materials, product components to be used in production. The manufacturer is obliged to: keep records of complaints about conformity of product with the requirements of harmonized technical specifications; take appropriate actions as regards complaints and any detected product faults; carry out periodical assessment of complaints, including analysis of nonconformity causes, analysis of effectiveness of corrective actions taken and justness of decisions made; use own complaints for the periodical assessment of suppliers of raw materials, materials and product components; keep records to document actions taken within complaint procedure and corrective and/or preventive actions resulting from these complaints Training The manufacturer shall establish training procedures and ensure training of personnel engaged in activities affecting construction product quality. The manufacturer shall keep records to document performed training. Records on training shall be kept up-to-date and stored. 2. List of external documents to be applied at FPC certification Legal basis Item Document name Designation 1. Act of 16 April 2004 on construction materials (in force in Poland) Journal of Laws, No. 92, item 881, as further amended 2. Act of 30 August 2002 on the conformity assessment system (in force in Poland) 3. Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonized conditions for the marketing of construction products and repealing Council Directive 89/106/EEC 4. Commission Delegated Regulation (EU) No 157/2014 of 30 October 2013 on the conditions for making a declaration of performance on construction products available on a website Journal of Laws, No. 204, item 2087, as further amended Official Journal of the European Union (entry into force ) Official Journal of the European Union (entry into force ) 10/12

11 Item Document name Designation 5. Commission Delegated Regulation (EU) No 568/2014 of 18 February 2014 amending Annex V to Regulation (EU) No 305/2011 of the European Parliament and of the Council as regards the assessment and verification of constancy of performance of construction products 6. Commission Delegated Regulation (EU) No 574/2014 of 21 February 2014 amending Annex III to Regulation (EU) No 305/2011 of the European Parliament and of the Council on the model to be used for drawing up a declaration of performance on construction products 7. Commission Delegated Regulation (EU) 2016/364 of 1 July 2015 on the classification of the reaction to fire performance of construction products pursuant to Regulation (EU) No 305/2011 of the European Parliament and of the Council (valid from ) 8. Commission communication in the framework of the implementation of Regulation (EU) No 305/2011 of the European Parliament and of the Council laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC Standards for products Item Document name Designation 1. Execution of steel structures and aluminium structures. Requirements for conformity assessment of structural components 2. Execution of steel structures and aluminium structures. Technical requirements for steel structures 3. Execution Of Steel Structures And Aluminium Structures - Part 3: Technical Requirements For Aluminium Structures Official Journal of the European Union of (entry into force 20 days from publication) Official Journal of the European Union of (entry into force 3 days from publication) Official Journal of the European Union L 84/4 of Official Journal of the European Union 2017/C 267/04 of EN :2009+A1:2011 EN :2008+A1:2011 EN : Aggregates for concrete EN 12620:2002+A1: Aggregates for bituminous mixtures and surface treatments for roads, airfields and other trafficked areas 6. Lightweight aggregates. Lightweight aggregates for concrete, mortar and grout 7. Lightweight aggregates. Lightweight aggregates for bituminous mixtures and surface treatments and for unbound and bound applications EN 13043:2002 EN :2002 EN : Aggregates for mortar EN 13139: Aggregates for unbound and hydraulically bound materials for use in civil engineering work and road construction EN 13242:2002+A1: Aggregates for railway ballast EN 13450: Armour stone. Specification EN :2002 Requirements 11/12

12 Item Name of document Designation 1. Conformity assessment Requirements for bodies certifying products, processes and services Other requirements ISO/IEC 17065:2013 Item Name of document Designation 1. EA Document on Accreditation for Notification Purposes EA-2/17 INF 2. Accreditation of product certification bodies. Detailed requirements DACW-01, ed. 4 of Accreditation of bodies participating in the process of assessment and verification of construction products performance with reference to the Regulation (EU) of the European Parliament and of the Council No. 305/2011 (CPR)) 4. Polish Centre for Accreditation policy on provision of measurement traceability DA-06 DAN-01 ed. 2 of Approved by PRS Product Certification Bureau Manager Formal approval on the original document 12/12