Umbra Cuscinetti. Quality Supplier Requirements

Transcription

1 Page: 1 of 4 Distribuzione controllata / Controlled Distribution Ciclo di Vita / Life cycle Prepared / Reviewed: Checked: Approved: M. Tozzi P.Trasciatti G. Sturniolo Indice Revisioni / Revision Index Revision No. Scope of the Revision Date Il presente documento contiene informazioni di proprietà della società Umbra Cuscinetti S.p.a. Qualsiasi suo utilizzo da parte di terzi senza autorizzazione della Umbra Cuscinetti S.p.a. sarà perseguito a termini di legge. File protetto contro modifiche non autorizzate. Il file coincide in contenuto e formato con la copia cartacea verificata ed approvata archiviata presso il Responsabile Qualità Fornitori. Le copie cartacee prive di una autorizzazione con firma in originale di approvazione non sono documenti ufficiali del SGQ. This Document contains proprietary information of Umbra Cuscinetti S.p.a. Any use by a third party without prior authorization by the Umbra Cuscinetti S.p.a. shall be pursued according to law. File protected against unauthorized copies. The content and the layout of the file coincides with the copy verified and approved. The paper copies without authorization by an original signature for approval are not official documents of the Supplier Quality System.

2 Page: 2 of 4 1. Applicability This document, defined about the Umbra Cuscinetti (UCS) Customer Requirements and Quality System Standars, defines the restrictions and requirements of the quality system applicable to products and services, supplied according to the design authority of UCS through drawings and specifications, or according to military and industrial standards. These requirements do not apply to standard products purchased from the catalogue. These standard products are defined as parts and materials conforming to a specification published by a qualified manufacturer or a national authority, whose characteristics are identified by a standard design, national and/or military specification or the manufacturer's catalogue. The requirements defined in this document are part of the binding contract between the Suppliers and UCS. This document is applicable to all suppliers when referenced by the Purchase Order or contract/written agreement between the parties and must be transferred in its entirety to all potential Subcontractors Annex 0 UCS Customer Requirements and Quality Mangement System Standards 2. Order of priority The order of priority of the requirements for products and/or services supplied is defined by: the contractual terms found in the purchase order, a possible/additional formal agreement between the two parties, this document All Suppliers and Subcontractors must meet these requirements unless otherwise agreed upon contractually 3. Restrictions Unless otherwise specified on the purchase order or on a different supply contract, the following restrictions must be applied: 3.1 Products with an expiration date - Products that still have 75% of remaining shelf-life can be sent toucs. The supplier must identify: the manufacturer's name, product brand, related specifications, lot number, date of manufacture and expiration date for each lot. 3.2 Electronic components and parts The management of electronic components and parts is described in Annex 4: Control of Electronic Device and Components. Mainly for components (e.g. transistors, integrated circuits, connectors, etc.) ordered according to military specifications. For each component, the packing list must identify the following: manufacturing specification, date of manufacture and lot number. 3.3 Protection from electrostatic fields - devices identified as being subject to electrostatic discharge, or which anyway use technologies subject to it, must be carefully handled, packaged and labelled in accordance with EN or MIL-STD Software Management: The management of software product supply intended for installation in systems in the aeronautic sector is described in Annex 5: Software Assurance Program for RTCA/DO Quality Requirements Unless otherwise specified on the purchase order or on a different supply contract, the following Quality Requirements must be applied: 4.1 Quality Management System Suppliers must implement and maintain a quality system that is at least complaint with ISO9001 (latest revision). When UCS requests quality system certification from suppliers according to EN9100, ISO9001, EN9110, EN9120, NADCAP, EASA Part 21, EASA Part 145 standards, the supplier is obliged to notify within 5 working days of any changes related to their organisational system, including renewals or extensions of approval goals. The supplier who loses a certification must notifyucs immediately and the latter will evaluate his status as an approved supplier. For more details see ANNEX 1 Supplier Qualification and ANNEX 11 Quality System Requirements by Commodity The Quality and Organisational system of the supplier will be monitored periodically as provided for respectively in Annex 2: Audit Management & Risk Management and Annex 12 Supplier System Audit Planning. The performance of the OTD and Quality supplier will be monitored as provided for in Annex 3: Supplier Evaluation 4.2 Storage and archiving (Record Retention) - Suppliers must retain Quality Records for a minimum of 10 years from the date of shipment, unless a longer period is specified.

3 Page: 3 of 4 The Quality records requested include the following among others: Certificates of Approved Compliance, Test Reports, Certificates of materials, Certificates of Special processes, Audit Reports, shipping documents, FAI First Article Inspection documentation. This data must be made available toucs upon request, at no additional cost. For more details, ANNEX 13 Data Retention is referred to. 4.3 Management of measuring tools - Measuring tools used at product acceptance and the compliance of products must ensure traceability and must be controlled in accordance with international or national measurement standards (e.g. ACCREDIA, NIST, UKAS). Procedures for periodic calibration and checking of due dates for instrument calibration must be established and kept under control. 4.4 Inspection and Control System - Suppliers must develop appropriate inspection procedures and keep completed records. The above records must be complete with evidence of successful inspection of products and services supplied to UCS. The supplier must show that the product was tested at all stages of the process, must identify the name of the official who certified the results (e.g. with stamps, signature, etc.) and where applicable must include inspection test results. If the Supplier uses third parties (sub-supplier) for the processing of products or services supplied to UCS, he must inform UCS this in advance. The Supplier will be held responsible for these third parties as for any other person/company used in meeting the contractual obligation. The supplier is obliged to inform UCS before implementing a possible modification regarding the product, the place of manufacture or the manufacturing process, describing and proposing the changes that must be made. The Quality Management of UCS reserve the right to require approval of changes before the supplier proceeds with their implementation. For this purpose, the supplier will be further requested to perform a new FAI inspection (First Article Inspection report). The supplier which shows the ability to control its manufacturing processes in terms of requested organisational and product requirements can be delegated by UCS for product inspection and source inspection. For more details refer to Annex 8: Delegating the supplier 4.5 First Article Inspection For parts intended for the aeronautic sector, as requested in ANNEX 9 Vendor Quality Assurance Provisions and ANNEX 10 Additional Quality Requirements by Commodity or by the supply contract for: the production of new parts, in case of changes to technical documentation and/or productive process, the checking and dispatch of First Article Inspection (FAI) documentation to UCS is required, according to EN9102 (Aerospace First Article Inspection Requirement) or an equivalent standard. UCS will formally request repetition of the FAI procedure in cases where the supplier has not produced the parts continuously for more than two years, or in cases where relevant non-conformity is detected. 4.6 Logistics - The supplier must have adequate procedures for logistics and related control systems aimed at guaranteeing product integrity, quality and configuration during all phases of production, handling and preservation. 4.7 Non-Compliant Products - Suppliers must ensure that a product which is non-compliant with required specifications is not shipped to UCS. The provisions for potential repair or Use As Is of products that feature UCS design must be formalised through authorisation requests and related written authorisation by UCS before shipping. Suppliers must notify the Quality Department of UCS within 24 hours about any potential non-compliance that may result in non-compliance of already shipped products. For more details refer to ANNEX 7 Non Conformity Management. 4.8 Statistical Techniques - Suppliers are responsible for keeping track of all possible variables that influence the production process, through the use of appropriate control sheets and SPC. In the absence of these procedures, sample inspections will be proceeded with in accordance with ANSI/ASQ Z1.4 (MIL STD 1916), Level II 1.0 AQL, c=0 or other equivalent plans approved by UCS. Suppliers that use the sample inspection method are not exempt from responsibility regarding the compliance of shipped parts. 4.9 Source Inspection - For New products, according to design or Specification by UCS and when explicitly requested by Supplier Quality Management, Source Inspection by UCS will be planned and carried out before the parts are shipped.

4 Page: 4 of 4 It is the responsibility of the supplier to communicate the need to perform an inspection 5 days in advance to the Quality department of UCS Special Processes The UCS has approved a list of suppliers of special processes in accordance with the specifications defined in the drawings. The use of a sub-contractor approved by the UCS does not relieve the supplier product liability also provided if deemed reliable by 'UCS. Annex 6 Special Process is referred to Inspection of Suppliers - Flow-down of Requirements - All suppliers, including distributors, are responsible for ensuring that the requirements applicable to purchase orders, and reported in this document and its attachments, are imposed (flow-down of requirements) at all levels of the supply agreement, both for the traceability of materials and for the manufacturing processes and/or services offered. For details, Annex 9 Vendor Quality Assurance Provisions is referred to 4.12 Counterfeit Prevention - Suppliers must implement a program to prevent the delivery of counterfeit parts or materials. All parts, materials and assemblies (electronic, mechanical or raw materials) must be procured exclusively from suppliers with exclusive rights, OEM (Original Equipment Manufacturer) or CMO (Original Component Manufacturer). If this is not possible, a request for authorisation must be sent toucs. The supplier is responsible for the flow-down of the requirements contained in this document to his subcontractors so that they are respected. Another regulation on the prevention of counterfeit parts can be found in the documents SAE AS5553 (Electronics) and AS6174 (Material) Right of Entry - Representatives of UCS, their customers and the authorities, as long as reasonable warning has been given, have the right to access the sites of suppliers to access and verify: management procedures, instructions and operational activities, process document verification, inspection of configuration and documents related to quality control and contractual requirements or orders. The supplier must communicate any changes in the company, so that UCS can plan potential audits on the organisational system. UCS reserve the right to inspect the quality of processing, records and material management Product Traceability and Identification - Suppliers must ensure that individual articles, materials and lots are identified and separated from other articles, materials and lots. The records of articles must include the part number, the revision edition, the lot number, the serial number if applicable, cast number, lot, date code, date of manufacture, etc. Materials or articles supplied by UCS for operations or external processing must be identifiable with UCS's serial numbers and lot number, which must be recorded on all documents and certifications Compliance Certificate - The compliance certificate must be sent together with the product to UCS. This document is a quality record which must include: the UCS product code, the P/N and its revision, technical specifications of materials and special processes, purchase order number, quantity, shipment date, the name of the manufacturer and the authorised signature. In addition, the supplier must provide information on processes entrusted to subcontractors by performing the flowdown of these requirements. To issue the compliance certificate and the corresponding documentation to be sent along with the shipped parts, explicit reference must be made to: ANNEX 9 Vendor Quality Assurance Provisions and ANNEX 10 Additional Quality Requirements by Commodity Responsibility for Compliance - Successful product acceptance by UCS cannot be used as proof of effective quality control of the supplier and does not absolve the supplier of the responsibility for any non-compliant products found by clients of UCS as indicated in the general conditions of purchase. For more details, ANNEX 7 Non Conformity Management is referred to Industrial and Standard Specifications - for all specifications and military and industrial standards, the supplier must comply with the current revisions at the time when the purchase order is issued by UCS Training - Suppliers must ensure that all personnel involved in the manufacturing of UCS products are adequately prepared and trained. The staff must be qualified based on their education level, training and experience. In addition, the supplier must ensure that the records on training are maintained and available upon request

5 Page: 5 of Management, Packaging and Preservation - It is the responsibility of the supplier to make sure that the packaging is adequate for the protection of the components during transport, until their deposit at the warehouse. The packaging must be proportional to the size, weight and fragility of the components. Allegati / Annexes Annex 0: UCS Customer Requirements and Quality Mangement System Standards Annex 1: Supplier Qualification Annex 2: Audit Management & Risk Management Annex 3: Supplier Evaluation Annex 4: Control Electronic Device and Components Annex 5: Software Assurance Program RTCA/DO 178 Annex 6: Special Process Annex 7: Non Conformity Management. Annex 8: Delegating the supplier Annex 9: Vendor Quality Assurance Provisions Annex 10: Additional Quality Requirements by Commodity Annex 11: Quality System Requirements by Commodity Annex 12: Supplier System Audit Planning Annex 13: Data Retention