Copyright by Polski Rejestr Statków S.A., PRINCIPLES OF FACTORY PRODUCTION CONTROL /INFORMATION FOR ORGANIZATIONS/ GDAŃSK, AUGUST 2017

Transcription

1 August 2017 were approved by Product Certification Bureau Manager of the Polish Register of Shipping on 25 August 2017 Copyright by, GDAŃSK, AUGUST /14

2 CONTENTS 1. General provisions 3 2. Declaration 3 3. FCP certification process 4 4. Information for Organization Application Preparation for FPC Inspection Preparation for Initial Inspection and any other one Execution of Initial Inspection and any other one Post-inspection Activities Performed by the Organization Special FPC Inspections Evaluation and Decision Making Notification to Organization on Granting FPC Certification Surveillance of FPC System Suspension of FPC Certification Withdrawal of FPC Certification Restriction to FPC Certification Extent Extension of FPC Certification Scope Transfer of Rights Appeals Complaints Use of Certification Mark and Identification Code (Notification) Confidentiality Certificates issued by Notified Certification Bodies or Approvals of the System by Other Notified Bodies Information to the Notifying Body and the Notified Bodies Carrying out Similar Activity 13 2/14

3 1. General provisions 1.1. Certification body CERTIFICATION BODY: POLISH REGISTER OF SHIPPING Product Certification Bureau NOTIFICATION NO: 1463 ADDRESS: AL. GEN. JÓZEFA HALLERA GDAŃSK, POLAND TELEPHONE: FAX: INTERNET: The below principles apply in particular to: Certification of Factory Production Control for steel and aluminium structures for compliance with standards: PN-EN A1:2012; PN-EN A1:2012 and PN EN : Certification of Factory Production Control for building aggregates for compliance with standards: PN-EN A1:2010; PN-EN 13043:2004; PN-EN :2003; PN-EN :2006; PN-EN 13139:2003; PN-EN A1:2010; PN-EN 13450:2004; PN-EN :2003 and PN-EN : Declaration The Polish Register of Shipping Product Certification Bureau (PRS) is a certification body open to all applicants whose activity is covered by the scope of its accreditation. No unreasonable financial demands are imposed and certification availability depends neither on the size of organization nor the membership in any association or group. We declare: - impartiality of the conducted processes of assessment and verification of constancy of building products functional properties, - objectivity of building products certification activities, - confidentiality and professionalism of FPC inspectors and technical experts, - high level of services due to long-time management experience, - short terms of orders realization, - openness and practical approach, - non-conflict cooperation. 3/14

4 PRS Product Certification Bureau identifies, analyses and documents potential conflicts of interests resulting from certification process, including all conflicts due to any liaisons between PRS Product Certification Bureau and other parties. The Polish Register of Shipping Product Certification Bureau of offers Factory Production Control certification and product certification. Other parties cannot influence decisions made by the Product Certification Bureau. An Organization by choosing PRS Product Certification Bureau as a notified and accredited product certification body can be assured that a certification process will be performed by the team of experienced and competent FPC inspectors/technical experts. 3. FPC certification process The certification is available to all organizations and suppliers whose activity is covered by the accreditation scope applied for. The subject is a certification of a Factory Production Control (FPC), being the regulatory requirement for marking (by a manufacturer) construction products with CE construction mark. The certification is performed by the system 2+, in accordance with the Regulation of the European Parliament and the Council (EU) No. 305/2011 of 9 March Certification may be applied to an implemented Factory Production Control system, which means that it: complies with specified requirements, the manufacturer is aware of the responsibility for the product conformity with requirements, sufficient number of objective evidences exist documenting efficient implementation of the FPC system, an efficient surveillance is established in the scope of product design and manufacture. 4. Information for Organizations Having received a certification inquiry, the Manager of the Product Certification Bureau sends an Application for Certification of Factory Production Control Form 1/PCW-01/ZKP to the Organization. At the request of the Organization, the following documents are provided: o information on accreditation/notification, which is the basis for PRS Product Certification Bureau activity and on the accreditation scope, as well as Construction Products Regulation (CPR) requirements, general information on fees charged in relation to the FPC system certification and surveillance process, the Instructions for Certification of Factory Production Control, the above documents are also made available through INTERNET: The Manager of the Product Certification Bureau informs the Polish Centre for Accreditation (PCA) on activity conducted outside the territory of Poland to ensure that all locations, where key activities are performed, are properly assessed. 4/14

5 4.1. Application An Organization applying for certification submits to the Product Certification Bureau an Application for Certification of Factory Production Control Form 1/PCW-01/ZKP or a notice in any other documented form including information necessary for an offer preparation. In the case an Organization makes an invitation to tender for certification, the course of proceedings is in accordance with valid legal regulations. On the basis of information included in the Application, the price offer is prepared. The time-period necessary for planning and executing complete and efficient FPC inspection is determined in accordance with valid Procedure PCW-01/ZKP, where the principles for determining the inspection time are given. After the Organization accepts the offer, the agreement is sent to the Organization for signature. The agreement specifies conditions ensuring PRS Product Certification Bureau independent and professional action and includes an obligation for the Organization s necessary cooperation. After concluding an agreement and submitting required documentation to PRS, a Customer Service Officer assigns to the Organization an identification code to be used for marking all documents associated with certification of the given Organization. PRS Product Certification Bureau declares performance of the certification process within time-period agreed with the Organization. In case of the inspection of the Factory Production Control combined with certification of system conforming to ISO 9001 and/or ISO 3834, the proceedings is in accordance with the program of quality management system certification PCS-01/QMS and/or PCS-01/WELD, taking into account requirements of PCW-01/ZKP programme Preparation for FPC Inspection The FPC lead inspector and inspectors/experts are chosen from the register of FPC inspectors maintained by the Product Certification Bureau. As a principle, inspections are performed by FPC inspectors having appropriate competences, training, qualifications and professional experience. External FPC inspectors and technical experts may be appointed to the inspection team by the procedure specified in PC-02A Procedure for qualifying FPC experts/auditors/inspectors. FPC inspectors whose engagement could lead to impartial or discriminative actions, e.g. those which provide consultative services for the Organization, may not be appointed as members of the inspection team. Prior to each inspection, inspectors/ technical experts sign Impartiality Statement on Form 11/PCW-01/ZKP. The Product Certification Bureau notifies the Organization of the members of the FPC inspection team and, at request, makes available basic information concerning each member of the FPC team, in due advance, to enable the Organization to object against appointment of particular FPC inspector or technical expert and to make possible PRS to replace the inspection team member. 5/14

6 In case of conflict of interests, the Organization has the right to submit to the Product Certification Bureau an objection against particular FPC inspector/technical expert. In such case the inspection team is changed. If the Organization does not submit the objection, it is regarded as acceptance of the presented team of FPC inspectors/technical experts Preparation for Initial Inspection and any subsequent inspection The purpose of the initial inspection is to evaluate the implementation of FPC system, including its effectiveness and it covers at least: - the examination of FPC documentation, - the identification of legal requirements related to products covered with the requirements of CE marking and specific requirements, - the documentation of Initial Type Examination for the product covered with CE marking requirements, - the examination of design process (where applicable), - checking the responsibility, authorizations and qualifications of personnel employed at manufacturing and control, - checking of applied manufacturing procedures, - the control and checking of raw materials and component materials for the production, - checking the control and measuring equipment, - the control and examinations of finished product, - product identification and traceability, - the methods of control and keeping records on product assessment, - the declaration on performance properties of the product and its CE marking. Prior to inspection, the FPC lead inspector agrees with the Organization, by an , its date and extent, using the FPC Inspection Schedule - Form /PCW-01/ZKP. At developing the Inspection Schedule, the FPC lead inspector makes appropriate agreements with the Organization to enable objective assessment of the FPC system on the basis of inspections at manufacturing works, in accordance with FPC Inspection Questionnaire Form 6/PCW-01/ZKP. The Organization shall make accessible necessary machinery or objects associated with FPC inspection. The manufacturer s inspection equipment may be utilized, at its consent. If the Organization outsources execution of essential processes that require assessment within FPC system, it is obliged to gain subcontractor s consent and make any agreements related to the inspection. The inspection at subcontractor is covered by the Inspection Schedule after agreeing that with the Organization. 6/14

7 4.4. Execution of Initial Inspection and any subsequent Inspection FPC Inspectors conduct examination of the Organization s FPC system in accordance with FPC Inspection Schedule transferred previously to the Organization, based on the documents of FPC system, recording inspection findings and positions of the interviewed persons. FPC Inspectors conduct examination of: o compliance with requirements contained in normative documents, through inspection of manufacturing works and Factory Production Control, o operation (continuous surveillance, relevance of assessment criteria and the system of acceptance/non-acceptance) of Factory Production Control. Identified nonconformities and/or observations are reported, in writing, to the Organization. At the end of inspection, the FPC inspection team meets with the Organization s management and designated personnel at a closing meeting, where the FPC lead inspector presents found nonconformities and observations and gives conclusions of the recommendations related to issuing/endorsing FPC Certificate. The lead inspector gains acceptance of the Management representative (FPC Proxy) for FPC Inspection Findings (Form 7/PCW-01/ZKP) and informs the Product Certification Bureau on the proceedings with nonconformities and/or agrees further proceedings of the Organization. The FPC lead inspector retains a copy of FPC Inspection Findings in the Organization, while its original is enclosed with FPC Inspection Report. In the case of FPC inspections carried out jointly with other certifying bodies or joined FPC inspections, the documents enclosed with the Inspection Report may be prepared using other forms, except for FPC Inspection Report Form 8/PCW-01/ZKP. After receiving the FPC Inspection Report, the Organization may send possible remarks on the Report to the Product Certification Bureau, within 10 days from the Report receipt date. The Product Certification Bureau is the owner of the Report Post-inspection Activities Performed by the Organization The Organization performs correction and corrective actions related to disclosed nonconformities and observations in accordance with own procedure. The Organization is informed on the need to analyze the grounds for nonconformities and describe the correction and corrective actions taken or planned for execution aimed at eliminating revealed nonconformities. The Organization is obliged to carry out these actions within 90 days, except when other execution dates have been agreed. FPC Certificate is issued under the condition that all correction and corrective actions are completed. Organization notifies, in writing, the Product Certification Bureau thereof by transferring appropriate evidences of performed correction and corrective actions. The FPC lead inspector decides on the form of assessment of these activities during the closing meeting. The assessment of correction and corrective actions may include an additional, special checking inspection or a documented evidence subject to assessment. 7/14

8 The assessment of effectiveness of carried out correction / corrective actions presented in the form of a documented evidence is made by FPC inspection team during next inspection of Organization s FPC system. Acceptance of the actions is confirmed by appropriate entry in the relevant Inspection Report Special FPC Inspections Special inspections may take place: when objective evidences are required to confirm implementation of correction and/or corrective actions. The FPC lead inspector notifies the Organization on the need to carry out special inspection on the closing meeting. The special checking inspection covers only he areas where nonconformities occurred; at the request of Organization, to extend the scope of granted certification; within the scope defined by the Manager of Product Certification Bureau, e.g. for examination of complaints against the Organization or in response to changes submitted by the Customer or within the framework of handling suspended Customers. The result of the special inspection is FPC Inspection Report in a written form. In the case of a negative result of the special checking inspection, the Manager of the Product Certification Bureau makes a decision on breaking the certification process. The Organization has the right to appeal against the decision to the Director for PRS Certification Division Evaluation and Decision Making Evaluation and decision making on certification are based on: FPC Inspection Report containing recommendation for the issue of a certificate and all conditions and observations; Comments to nonconformity and, where appropriate, to taken correction and corrective actions; Confirmation of information supplied to the Product Certification Bureau and applied at the review of Certification Information. The Manager of the Product Certification Bureau makes a decision on the issue or non-issue of final document (e.g. FPC Certificate). The assessment and decision making may not be subcontracted Notification to Organization of Granting FPC Certification FPC Customer Service Officer from the Product Certification Bureau notifies the Organization, by a letter, of the decision on granting certification. A Certificate draft is enclosed with the letter. In case of refusal to issue the Certificate, the notification shall include the reason thereof. The Organization has the right to appeal against the decision of the Manager of the Product Certification Bureau. The appeal is considered in accordance with valid PCW-01/ZKP Programme. The final document is delivered to the Organization after correction and corrective actions have been accepted and a payment for certification process has been transferred. 8/14

9 The FPC Certificate issued in the system 2+ is valid without time-limit until there are changes in examination methods and/or the requirements related to Factory Production Control contained in the harmonized standard, used for the assessment of performance of essential characteristics, and until changing significantly the construction product or its manufacturing conditions. The certificate maintains its validity provided it is not suspended or withdrawn by the unit certifying the factory production control. Issue of a certificate is also conditioned upon execution of surveillance inspection. At a request of the Organization, in accordance with the table B.1 of EN :2009+A1:2011 Standard, the Welding Qualification Certificate Welding Certificate associated with the FPC Certificate may be issued. The Welding Certificate is valid for a period of 3 years unless conditions specified for the FPC Certificate change. The Director for PRS Certification Division signs the certificates to be given to the Organization Surveillance of FPC System Continuous surveillance inspections are carried out in accordance with the provisions of harmonized standards, taking into account that the first inspection held after certification may not be performed later than 12 months after last day of the initial inspection. Surveillance inspections cover at least: review of all changes made in the Organization and the system, review of activities taken in relation to nonconformities identified during previous inspection, handling of claims and complaints, functioning of procedures for conformity assessment and review in accordance with the requirements of the Organization s FPC, surveillance of operation processes in accordance with the requirements of normative documents, use of an identification code, certification marks and/or reference to certification (if applicable). The Product Certification Bureau maintains certification on the basis of evidences that the Organization continues to fulfil requirements of appropriate reference document Suspension of FPC Certification Certification may be suspended in the case it has been found that the Organization did not proceed with the concluded Agreement on Certification and Surveillance of FPC System and in particular when: the certified system of the Customer permanently or to a great measure does not fulfil the certification requirements, including the requirements related to FPC efficiency, the certified Customer does not allow for carrying out FPC surveillance inspections with required frequency, the certified Customer itself requested certification suspension, the certified Customer fails to fulfil the financial obligations in relation to PRS, 9/14

10 the certified Customer has not taken, at agreed time, activities for implementation of changes in FPC which were due to the change of requirements contained in references the certification and surveillance of FPC system is based on. The certified Customer is informed that within the period of the FPC certificate suspension he should stop using the certification mark in all his advertising materials and products containing any reference to the status of a certified organization. Information on certification suspension is made public on PRS internet website. The Manager of the Product Certification Bureau defines the period of the certificate suspension. In most cases the suspension shall not exceed 6 months and in exceptional cases one year. Certificate validity may be reinstated upon receipt of the information from the certified Customer that he fulfils the suspension cease conditions. The Manager of the Product Certification Bureau makes the decision on reinstatement of the certificate. The Product Certification Bureau limits the scope of the Customer certification in order to exclude the part of certification where requirements are not fulfilled permanently or to a great measure by the Customer Withdrawal of FPC Certification FPC certification may be withdrawn in the below cases: - The Organization is not able to remove the reasons for certification suspension in due time; - The Organization stopped the manufacture of the products covered by the FPC certificate; - The Organization does not allow for carrying out inspections with required frequency; - The Organization fails to fulfil financial obligation in relation to PRS; - The Organization has not taken, at agreed time, activities which were due to the change of requirements contained in reference documents to be the base for certification; - The Organization has not carried out, at agreed time, the activities in response to the claim in relation to certified product, which was received in PRS Product Certification Bureau; - Surveillance over the Organization reveals inefficiency of the FPC system of the nature indicating necessary essential changing thereof; - At the written request of the Organization. Certification withdrawal is preceded by a written notification to the Organization describing the grounds thereof. The Manager of the Product Certification Bureau is the person making a decision on certification withdrawal. The certified Customer is informed that within the period of the FPC certificate withdrawal he should stop using the certification mark and identification number in all his advertising materials and products containing any reference to the status of a certified organization. The Product Certification Bureau decides on dissolving the Agreement on Certification and Surveillance of FPC System and withdraws certification. The Organization is notified of the fact by a letter which states the date of withdrawal. 10/14

11 The Organization may appeal against the decision on certificate withdrawal to the Director for PRS Certification Division. PRS makes information on the Organization s certification withdrawal public in the Internet. The Manager of the Product Certification Bureau informs the notifying body and notified bodies carrying similar activity on each case of certificate withdrawal Restriction to FPC Certification Extent Certification extent is restricted with the purpose to exclude the part of certification where requirements are not fulfilled permanently or to a great measure by the Organization. Certification extent may be restricted or temporarily restricted after an inspection which disclosed that the Organization is not able to carry out activities within the full scope of granted certification, or without inspection at the request of the Organization. Each restriction shall be in accordance with the requirements of the standard being the base for certification Extension of FPC Certification Scope Certification extension means changing the scope of already granted certification, within the framework of the same harmonized technical specification or different parts of a technical specification. The extension process is initiated with submission of a written application by the Organization. The extension process may be combined with the surveillance inspections or additional special checking inspections. The application shall contain information on extension scope and on changes introduced in FPC system since previous FPC inspection at site. Together with an application letter, the Organization shall send technical particulars for the products, FPC system documents amended respectively to the extension scope, as well as other applicable documents as agreed with the Product Certification Bureau. Certification extension is of formal nature and is generally executed by the documentation review. In the process of certification extension, the need for special FPC inspection is determined on individual basis and depends on the kind of extension applied for by the Organization and on the results of previous FPC inspections. A revised certificate is issued as a result of completion of the extension process Transfer of Rights Transfer of rights from the Agreement on Surveillance of FPC System is effected at the request of the Organization, as a result of changes of its legal status. If the document issued by an appropriate court enclosed to the request and the entries in current FPC Manual indicate that only the legal status of the Organization has changed, PRS Product Certification Bureau may decide on transfer of rights from the agreement without carrying out FPC inspection. 11/14

12 If it is clear after review of the presented documents that not only the legal status, but also other changes took place, the decision on transfer of rights needs an inspection to be made Appeals The Organization may turn to PRS, in writing, in matters concerning the decisions made by the Manager of the Product Certification Bureau, who is responsible for all decisions made at all stages of the process of considering appeals. Persons designated for consideration of appeals are not the same as those who were engaged in the FPC inspections and making decision on certification. Submission, consideration of, and making decisions on, appeals do not result in any discriminative actions against the Organization submitting the appeal. The Certification Division Secretariat receives and registers the appeals. The request for consideration of an appeal shall include: the name of the Organization, the surname, address, phone, fax, of the person submitting the appeal, clear description of the appeal subject. Information on actions taken with the purpose to settle the appeal, report on the course of its consideration and results of these activities are transferred by the Customer Service Officer to the person who submitted the appeal. Accepted appeals are considered within 14 days from the date of their receipt. The Director for PRS Certification Division makes a decision as regards the reasonability of the appeal. If the appeal concerns the decision made by the Director for PRS Certification Division, respective decision is made by the President of the PRS Board. PRS Product Certification Bureau notifies formally the person submitting the appeal on completion of the appeal consideration process Complaints A person or an Organization may submit to PRS, in writing, a complaint concerning activity of the Product Certification Bureau or a certified Customer. Each complaint is registered by the Certification Division Secretariat and accepted for consideration by the Manager of the Product Certification Bureau. If the complaint concerns the certified Customer then: o during examination of the complaint, efficiency of FPC is taken into account, o the complaint is directed to the Client for receiving his position in respect of complaint subject. The process of accepting, assessing and decision making in relation to complaints is covered with the principle of maintaining confidentiality in relation to the person submitting the complaint and to its subject. The Director for PRS Certification Division makes, reviews and approves decisions communicated to the person submitting the complaint. 12/14

13 After completion of the complaint consideration, the Director for PRS Certification Division, within not more than 14 days from the date of receiving the complaint letter, notifies formally the person submitting the complaint on completion of the process of its consideration. The Director for PRS Certification Division, together with the Customer and the person submitting the complaint, decides if, and if so then to what degree, the subject of complaint and the way of its settlement should be made public Use of Certification Mark and Identification Code (Notification) The Organization has the right to use certification marks in accordance with the conditions specified in the agreement. Principles of using identification code of a notified body are given on the website The Organization granted valid FPC certificate places the identification code on the CE marked product label (or on the product) and in the Declaration of performance. In case of unjustified use of certification mark or the identification code, actions foreseen in the a.m. Principles will be taken Confidentiality The Product Certification Bureau has established for all levels of its organizational structure, including FPC inspectors and external technical experts acting on behalf of the Bureau, appropriate, lawful settlements concerning protection of information received during certification activities. All persons engaged in certification process sign the confidentiality declaration in which they oblige themselves to keep any information and documentation submitted by the Organization confidential. The Product Certification Bureau may not disclose any information related to the certified Organization to a third Party without consent of the Party interested. If legal regulations require disclosing any information to a third party, the Organization is notified of the contents of disclosed information within the scope permitted by the law Certificates issued by Notified Certification Bodies or Approvals of the System by Other Notified Bodies The PRS Product Certification Bureau recognizes certificates issued by notified certification bodies on the basis of received reports from assessments performed by these bodies Information to the Notifying Body and the Notified Bodies Carrying out Similar Activity The Manager of the Product Certification Bureau informs the notifying body: - of refusal, restriction and withdrawal of a certificate, - of any circumstances which may have adverse influence on the notification scope and conditions, - of each demand from the market surveillance bodies for information on executed tasks associated with a conformity assessment, 13/14

14 - at request, of taken actions tied with conformity assessment, being subject of the notification and on other performed tasks, including cross-border and subcontracting activity. The Manager of PRS Product Certification Bureau transfers information on the cases where conformity assessment results were negative and, upon demand, on the cases with positive results, to other bodies notified on the basis of the same EU harmonization regulations, carrying out similar activity in scope of a conformity assessment and dealing with the same products. Approved Manager of PRS Product Certification Bureau Formal approval is put on the original document. 14/14