REGULATION FOR PRODUCTION CONTROL OF PERSONAL

Transcription

1 Page 1 of 6 INDEX 1 PURPOSE AND PREMISE ENTRUSTMENT OF ASSIGNMENT INSPECTION OPERATIONAL ACTIVITY Methodology Sampling Verifica della omogeneità della produzione Frequency and method of sampling Sampling Safety at work Presence of observers of Control Bodies/Accreditation CHECK ON PPE SAMPLED Performance of the tests Test results Management of PPE subject to sampling and testing CERTIFICATION General principles First issue Renewal of the EC-type examination Certificate Extension of the EC-type examination Certificate Reduction of the EC-type examination Certificate Modification of the EC-type examination Certificate Suspension of the EC.type examination Certificate Revocation of the EC-type examination Certificate RESPONSIBILITY OF THE MANUFACTURER DISCLOSURE UNDER THE L.D. OF JUNE 30, 2003 N AMOUNTS APPEALS COMPLAINTS UPDATE OF REGULATION USE OF MARKS AND LOGOS... 6

2 Page 2 of 6 1 PURPOSE AND PREMISE This Regulation establishes the procedures followed by ITALCERT aimed to the production control of Personal Protective Equipment (hereinafter referred to as PPE) by checking a sampling of finished products according to Art.11A of Directive 89/686/EEC and the relevant Manufacturer responsibilities who has given formal assignment to ITALCERT to carry out the above mentioned control. For clarity is an excerpt from Directive 89/686 / EC on the control procedure according to Art. 11A: A manufacturer shall take all steps necessary to ensure that the manufacturing process, including the final inspection of PPE and tests, ensures the homogeneity of production and the conformity of PPE with the type described in the EC type-approval certificate and with the relevant basic requirements of this Directive. Paragraphs modified from the previous version of the regulation are highlighted with a right sidebar. The elimination of an entire paragraph is identified with a symbol (...). 2 ENTRUSTMENT OF ASSIGNMENT The Manufacturer who intends to entrust to ITALCERT the task to carry the production control of their PPE in accordance with Art.11A of Directive 89/686/EEC, must submit a formal application using the forms prepared by ITALCERT. The Application Form is filled by the Manufacturer or his Authorized Representative (Mandatory). 1 The submission of the Application must be accompanied by full copy of the EC-type examination Certificate relating to PPE to be checked (only for PPE with EC-type examination Certificate not issued by ITALCERT). 3 INSPECTION OPERATIONAL ACTIVITY 3.1 Methodology Sampling ITALCERT performs product control through appropriate sampling of specimens of manufactured PPE, chosen at random, and so they are sufficiently representative of the type / model certificates. The selected samples are examined in order to verify their conformity with the approved type and with the essential health and safety requirements. This is done by subjecting the selected PPE both for visual examination (including control of marking and instructions for use) and for laboratory testing; the latter are made on the basis of the standards being used for certification. It is not expected to repeat all the tests carried out in certification, but only those parts considered by ITALCERT useful to evaluate the characteristics most representative and / or criticism Verifica della omogeneità della produzione In addition to the checks referred to in the previous paragraph, ITALCERT shall also verify the homogeneity of production. This is done by means of a production review and the review conducted by Manufacturer recordings. Such a review should be carried out in the production facilities where the final product is assembled. ITALCERT could also used as a reference for the production review the description of the control included in Technical Files. 3.2 Frequency and method of sampling Production review and PPE sampling shall will be performed at least once per year. However ITALCERT could, when justified, increase sampling frequency. The first inspection shall be performed before 12 months from the EC certificate issue. The term of the inspection aimed at the selection and removal of PPE to be tested depends on the number and variability of PPE to be checked; practice it is between 0.5 and 1 day. 3.3 Sampling Sampling of PPE produced by the Manufacturer shall be performed on the basis of criteria determined by ITALCERT. Sampling shall take into account of several factors including: - quantities produced in a given time 1 In common cases the request to submit to ITALCERT product control is included in EC certification application form)

3 Page 3 of 6 - criticality of PPE - adequacy of control systems and tests adopted by the Manufacturer - type of PPE subject of previous sampling - previous checks results 3.4 Safety at work At the inspections to its headquarters and under existing legislation on safety and accident prevention at work, the Manufacturer undertakes to provide those in charge of ITALCERT the necessary information concerning any existing risks in the work environment in which they are intended to carry out their activities, and ensures taking all possible precautions for their protection in relation to health and safety. 3.5 Presence of observers of Control Bodies/Accreditation The Manufacturer undertakes to allow access at its headquarters during the activities carried out by ITALCERT by observers appointed by Control Bodies / Accreditation in performing monitoring and control tasks of the activities performed by ITALCERT as Inspection and Certification Body. The presence of these observers will always be accompanied by staff of ITALCERT. The notification of presence of these observers may occur with a minimum notice (less than 3 days), without implying the non-acceptance of their presence by the Manufacturer. Failure to accept the presence of these observers by the Manufacturer determines the suspension of the EC-type examination Certificate applicable and its possible subsequent revocation if persists the refusal concerned. 4 CHECK ON PPE SAMPLED 4.1 Performance of the tests Samples of PPE collected are subject to tests by ITALCERT, at its own laboratory or arranged at affiliated and qualified laboratories, to verify the homogeneity of PPE to the type described in the EC-type examination Certificate and to the reference standards to certify the conformity of PPE themselves. In exceptional circumstances the control can take place at the premises of the Manufacturer, using one s test and monitoring equipment under the supervision of the person in charge of ITALCERT. This practice is acceptable only if the outcome of tests is documented using the forms of the Manufacturer and signed for approval by the test performer and if the Manufacturer provides to ITALCERT a copy of the calibration certificates of instrumentation used and aimed to prove the metrology traceability and adequacy. 4.2 Test results After the tests ITALCERT issues to the Manufacturer a report of inspections performed, normally through a Test Report. Should the tests performed reveals lack of homogeneity in production or that the PPE tested do not comply with the type described in the EC-type examination Certificate or with the applicable essential requirements, ITALCERT shall immediately notify the Manufacturer, who must provide ITALCERT a timely assessment of causes of non-compliance. Based on the type of defect and on the assessments provided by the Manufacturer, ITALCERT may require the Manufacturer one or more of the following actions: a) production outages of PPE models subject of non-compliance; these models will be similarly removed from the certificate of conformity 11A; b) implementation of changes to the production process; c) recall of products already on the market. According to criticalities emerged, ITALCERT should consider that non-compliance reported may have a potential impact on other models with similar characteristics, though they have not been sampled and therefore were not subject to testing; in this event ITALCERT may request an additional sampling of PPE to carry out further tests and checks. 4.3 Management of PPE subject to sampling and testing The PPE sampled and tested are preserved by ITALCERT for a period of 12 months from the date of test. At the end of this period, ITALCERT returns the PPE, duly identified, to the Manufacturer which has the responsibility to preserve them and ensure their traceability for a period not less than the useful life (expiry) of PPE intended by the Manufacturer.

4 Page 4 of 6 5 CERTIFICATION 5.1 General principles ITALCERT issues a certificate that identifies PPE to be tested to any Manufacturers requiring to submit their PPE to the production control. In compliance with Art.13 of Directive 89/686/EEC, the Manufacturer must affix the identification number of ITALCERT (0426) on these PPE together with CE marking logo. The certificate clearly identifies the PPE for which the Manufacturer is authorized to affix the identification number of ITALCERT. 5.2 First issue Upon receipt of the application of entrustment to ITALCERT about the control on finished products in accordance with Art.11A of Directive 89/686/EEC, ITALCERT: a) issues a certificate identifying the PPE for which the Manufacturer is authorized to affix the CE marking associated with the notification number of ITALCERT (0426) in case of PPE for which the Manufacturer has obtained the EC-type examination Certificate in the 3 previous months b) carries out sampling of PPE to be checked and tested if the application concerns PPE previously controlled by another Notified Body or for which the EC-type examination Certificate has been issued more than 3 months after submission of the Application to ITALCERT. The EC-type examination Certificate will be issued as a result of a positive outcome of checks required. The expiration of the EC-type examination Certificate is normally planned: - at 31 st of December of the year of first issue of EC-type examination Certificate 11A when it is issued before March 31 st - at 31 st of December of the year following the year of first issue of EC-type examination Certificate 11A when it is issued after April 1 st. 5.3 Renewal of the EC-type examination Certificate On its expiry the EC-type examination Certificate is reissued for further 12 months provided that ITALCERT has had the opportunity to carry out the sampling of PPE as in 2 above, before its expiry and that tests results carried out have been positive. The certificate shall not be renewal if: A) The manufacturer has not given availability to carry out the inspection at its factory B) The manufacturer has declared that there was no production since the last inspection. In these cases ITALCERT will send a formal communication which will set out the conditions to restore the control of the product and the subsequent certification. Under certain conditions the certificate can be renewed for a shorter period than normally expected, for example in the case of: New reference standard not yet take in account No PPE available for sampling during inspection Evidence of poor homogeneity of production, resulting from the verification data carried out on samples taken or following a review of the manufacturing process. 5.4 Extension of the EC-type examination Certificate Whether the Manufacturer, according to the procedure referred to in Art.11A, requests to check further PPE than those already identified in the current EC-type examination Certificate, ITALCERT will update the Certificate by entering the identification data of such PPE in order to keep regularly updated the list of PPE for which the Manufacturer can use the identification number of ITALCERT, while respecting the principles set out in 5.2 concerning the first issue of the EC-type examination Certificate. 5.5 Reduction of the EC-type examination Certificate The Manufacturer may request to reduce the list of PPE covered by the EC-type examination Certificate 11A. This request may be made by written notice to ITALCERT or during a collection of PPE samples to be checked. 5.6 Modification of the EC-type examination Certificate Whether the Manufacturer modifies its references (registered office and / or operational site, corporate name) he is required to give notice to ITALCERT, so that the EC-type examination Certificate 11A can be updated accordingly.

5 Page 5 of Suspension of the EC.type examination Certificate The EC-type examination Certificate may be suspended by ITALCERT in the following cases: - where the PPE sampled point out serious criticalities, waiting to review the assessments of the causes of non conformities that the Manufacturer must provide ITALCERT and to examine any corrective actions the Manufacturer intends to take. - non-payment of the amounts due for the activities covered by this Regulation. The provision for suspension shall be communicated to the Manufacturer by registered letter R.R., being entitled to anticipate the communication by fax and / or . During the period of suspension of the EC-type examination Certificate 11A, the Manufacturer can not use the identification number of ITALCERT in association with the CE marking on PPE covered by the Certificate. 5.8 Revocation of the EC-type examination Certificate Once suspended, the Certificate may be permanently revoked by ITALCERT in the following cases: - inadequacy or lack of responses by the Manufacturer to the criticalities raised on PPE to be checked - persisting of non-payment condition of the amounts due for the activities covered by this Regulation. The provision for revocation shall be communicated to the Manufacturer by registered letter R.R., being entitled to anticipate the communication by fax and / or . Following the revocation of the EC-type examination Certificate 11A, the Manufacturer must stop using the identification number of ITALCERT in association with the CE marking on PPE covered by the Certificate. 6 RESPONSIBILITY OF THE MANUFACTURER By giving charge to ITALCERT to carry out production controls according to Art.11A, the Manufacturer assumes the responsibility to: a) take all necessary measures to assure that the manufacturing process ensures the homogeneity of production and conformity of manufactured PPE with the type described in the EC-yype examination Certificate. b) identify the need to implement the necessary adjustments to PPE and / or to technical documentation describing the PPE (Technical File) where updating of the harmonized standards on which the presumption of conformity of manufactured PPE is based and which are subject to production control by ITALCERT. c) notify ITALCERT of any significant changes in manufacturing processes that may affect the homogeneity of production. Falls within this context, the possible relocation of the production site of PPE. d) provide full cooperation to the appointee of ITALCERT during inspections aimed to PPE sampling e) using the CE marking in accordance with the relevant graphic formats as laid down by Directive 89/686/EEC f) do not affix the identification number of ITALCERT on PPE products whether the EC-type examination Certificate 11A issued by ITALCERT is invalid 7 DISCLOSURE UNDER THE L.D. OF JUNE 30, 2003 N. 196 According to D.Lgs. N. 196/2003 and subsequent amendments and additions, the personal data supplied by the Manufacturer to ITALCERT will be processed by ITALCERT to ensure a proper performance of contractual relationships. In relation to the above mentioned aims, personal data processing is done by computer, manuals and electronics devices, with logic strictly correlated with the same purposes and, however, to guarantee safety and confidentiality of information. The personal data conferred by the Manufacturer are therefore essential in relation to the proper performance of contractual relationships with the consequence that any refusal to provide them, would not permit to ITALCERT to pursue the same relationships. The personal data (e.g. corporate name, address, VAT number, name of contact person, telephone and fax numbers, addresses) are collected and processed by ITALCERT with the only purpose of managing and coordinating the activities planned by this Regulation and to perform administrative / accounting practices. The product data (e.g. identification / code of PPE, tests results, etc..) are collected and processed to meet the obligations that Directive 89/686/EEC requires the Notified Body responsible for supervision. In relation to these obligations the retention time of such data can not be less than 10 years. The data collected may be disclosed to third parties only in respect of the obligations that ITALCERT must

6 Page 6 of 6 comply about the transparency of the Certificates issued. Moreover ITALCERT can / shall transmit this information to the competent Authorities, for example in case of non-conformities detected on PPE being controlled, as provided in paragraph 5 - Art.11A of Directive 89/686/EEC. If such notification is necessary, ITALCERT will forward to the Manufacturer for information a copy of this notice. "Owner" of personal data is ITALCERT S.r.l., headquartered in Avenue Sarca 336, Milan; According to Art.7 (right of access to personal data and other rights) of Legislative Decree no. N. 196/2003, the Manufacturer may, at any time, have access to their personal data processed by ITALCERT, for example in order to request the updating, rectification or additions. 8 AMOUNTS The amounts for the activities planned under this Regulation are established in the TARIFF and / or in specific offer documents, according to the applicable. In general the amounts are expected for the following activities: - time of inspections at the premises of the Manufacturer (including travel time if applicable). - costs incurred for the transfer of persons appointed, from the headquarter of ITALCERT to the Manufacturer s plant - conducting tests on PPE collected - issuance, renewal, updating, reduction, modification of the Certificate. 9 APPEALS The Manufacturer may appeal against a decision taken by ITALCERT through written communication to be transmitted by fax or registered letter R.R. To be eligible, the application must: a) contain a description of the disputed decision b) a clear and detailed reason supporting the appeal c) be transmitted to ITALCERT within 45 days from the date of the notified decision, subject to the appeal. Upon receipt of the appeal, ITALCERT formally communicate to the Customer within 7 days if the appeal was deemed to be eligible or not and, if eligible, the date by which a decision is made (within 30 days of receipt of the application). The eligible appeals are evaluated by a Committee of Experts independent from the staff involved in the actions that led to the decision, subject to the appeal. The decisions taken on the appeal shall be communicated to the Customer by fax and / or registered letter R.R. 10 COMPLAINTS The Manufacturer can make a complaint to ITALCERT for the activities under this Regulation. Every complaint will be managed by people not involved in relevant activities and will be managed in compliance to accreditation rules when they have been received in writing (letter, fax or ); any verbal complaint will be handled in a documented way, as appropriate. The management of the complaint states: a) written response (letter, fax or ) within 7 days from receipt of the complaint, with the analysis of the complaint and any actions planned for its management, with its timing; b) written response (letter, fax or ) upon completion of planned actions. 11 UPDATE OF REGULATION In the event of future updates and modifications to this Regulation, ITALCERT make the new document available on site in the section dedicated to PPE certification and will notify the Manufacturer by fax, registered letter R.R. or . The Manufacturer has 60 days to formally communicate the rejection of the modifications, that involves the waiver of the Certification. After 60 days without communications from the Customer, the new edition of this Regulation will be deemed accepted for tacit consent. 12 USE OF MARKS AND LOGOS Regarding the activities described in the present regulation it is not provided nor allowed the use of ITALCERT or ACCREDIA logos.