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Quality Requirements for Suppliers QRS-01 Page 2/37
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CHANGES LOG
Issue Approval Date Main changes Interested Paragraphs
01 March 2003 Joint document created from Agusta AQM 002 revision A and Westland Q500 issue 4.
All
02 March 2005 Various changes (as identified by the bar in the margin) agreed by WHL, Agusta and WTL
Various
03 April 2015 Completely re-written and re-formatted All
REFERENCE DOCUMENTS
Documents level Document code (, paragraph) and title
Regulatory
EASA PART 21 Implementing rules for the airworthiness and environmental Certification Procedure for Aircraft and Related Articles and Parts
EASA PART 145 Continuing airworthiness of aircraft and aeronautical articles, parts and appliances, and on the approval of organisations and personnel involved in these tasks).
FAA CFR 14 Part 21 Certification Procedure for Products and Parts
FAA CFR45 Approved Maintenance Organisation
CCAR 561 Approved Manufacturers
CCAR 573 Approved Maintenance Organizations
Regulation (EC) No. 1907/2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Contractual (applicable when required by PO’s / Contract)
AQAP Series of Documents
AER-Q-2110 Requisiti di assicurazione Qualità della D.G.A.A. concernenti la progettazione, lo sviluppo e da produzione
STANAG 4107 Mutual Acceptance of Government Quality Assurance and Usage of the Allied Quality Assurance Publications
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International
ARP6178 Fraudulent/Counterfeit Electronic Parts; Tool for Risk Assessment of Distributors
AS5553A Fraudulent/Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition
AS6081 Fraudulent/Counterfeit Electronic Parts: Avoidance, Detection, Mitigation, and Disposition - Distributors
AS6174 Counterfeit Materiel; Assuring Acquisition of Authentic and Conforming Materiel
AS6462 AS5553, Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition Verification Criteria
EN/AS/SJAC9103 Variation Management of Key Characteristics
EN/ARP9107 Direct Delivery Authorization Guidance for Aerospace Companies
EN/ARP9114 Direct Ship Guidance for Aerospace Companies
EN/AS/SJAC9116 Aerospace Series – Notice of Change (NOC) Requirements
EN/AS/SJAC9131 Quality System – Non Conformance Documentations
EN/AS/SJAC9132 Data Matrix Quality Requirements for Parts Marking
EN9130 Retention of Documents and Records
EN/AS9133 Qualification Procedure for Aerospace Standard Parts
EN/ARP9134 Supply Chain Risk Management
EN/AS9136 Aerospace series Guideline Root Cause Analysis and Problem Solving
EN/ARP9137 Guidance for the Application of AQAP 2110 within a 9100 Quality Management System
EN/ARP/SJAC9162 Aerospace Operators Self Verifications Program
ANSI / EIA-649 National Consensus Standard for Configuration Management
IAQG SCMH IAQG Supply Chain Management Handbook
Commercial
ISO10001 Quality management - Customer satisfaction - Guidelines for codes of conduct for organizations
ISO10002 Quality management - Customer satisfaction - Guidelines for complaints handling in organizations
ISO10003 Quality management - Customer satisfaction - Guidelines for dispute resolution external to organizations
ISO TS10004 Quality management – Customer satisfaction - Guidelines for monitoring and measuring
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ISO10005 Quality management systems - Guidelines for quality plans
ISO10006 Quality management systems - Guidelines for quality management in projects
ISO10007 Quality Management – Guidelines for Configuration Management
ISO10012 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO TR10013 Guidelines for quality management system documentation
ISO10014 Quality management - Guidelines for realizing financial and economic benefits
ISO10015 Quality management - Guidelines for training
ISO10018 Quality management - Guidelines on people involvement and competence
ISO10019 Guidelines for the selection of quality management system consultants and use of their services
ISO14001 Environmental Management Systems – Specification with guidance for use
ISO21500 Guidelines on project management
ISO31000 Risk management - Principles and guidelines
ISO/IEC31010 Risk management - Risk assessment techniques
ISO/IEC12207 Systems and software engineering - Software life cycle processes
Applicable Documents
EN/AS/JISQ9100 Quality Management Systems – Requirements for Aviation, Space and Defense Organisations
EN/AS/SJAC9101 Quality Management Systems Audit Requirements for Aviation, Space and Defense Organisations
EN/AS/SJAC9110 Quality Management Systems – Requirements for Aviation Maintenance Organisations
EN/AS/SJAC9115 Quality Management Systems - Requirements for Aviation, Space and Defense Organisations – Deliverable Software
EN/AS/SJAC9120 Quality Management Systems – Requirements for Aviation, Space and Defense Distributors
EN/AS/SJAC9102 Aerospace First Article Inspection Requirement
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CONTENTS
1 INTRODUCTION ............................................................................................................................................. 7
1.1 THE GROUP OF COMPANIES ................................................................................................................................ 7 1.2 LEGAL NOTES ................................................................................................................................................... 7 1.3 RIGHT OF ACCESS .............................................................................................................................................. 8 1.4 CUSTOMER COMMUNICATION ............................................................................................................................. 9
2 SCOPE .......................................................................................................................................................... 10
3 APPLICABILITY.............................................................................................................................................. 11
4 QRS-01 MODULES ........................................................................................................................................ 12
5 EFFECTIVE DATE ........................................................................................................................................... 14
6 OWNERSHIP ................................................................................................................................................. 14
7 ACRONYMS, DEFINITIONS AND ABBREVIATIONS ......................................................................................... 14
7.1 ACRONYMS AND ABBREVIATIONS........................................................................................................................ 14 7.2 DEFINITIONS .................................................................................................................................................. 15
8 MEANS OF UNDERSTANDING ...................................................................................................................... 16
9 PURCHASING ............................................................................................................................................... 17
9.1 PURCHASING PROCESS ..................................................................................................................................... 17
10 PRODUCTION AND SERVICE PROVISION ...................................................................................................... 19
10.1 PRODUCTION DOCUMENTATION ........................................................................................................................ 19 10.2 CONTROL OF PRODUCTION PROCESS CHANGES ..................................................................................................... 20 10.3 CONTROL OF SERVICE OPERATIONS .................................................................................................................... 20 10.4 IDENTIFICATION AND TRACEABILITY..................................................................................................................... 20
10.4.1 Stamp Control ...................................................................................................................................... 20 10.4.2 Serial Numbers ..................................................................................................................................... 21 10.4.3 Identification after Paint ...................................................................................................................... 21 10.4.4 Bag and Tag ......................................................................................................................................... 21 10.4.5 Non-Metallic Material .......................................................................................................................... 21 10.4.6 Metallic Material .................................................................................................................................. 21 10.4.7 Identification and Control of Unqualified Products (Colour Banding) .................................................. 22 10.4.8 Safety Hazard ....................................................................................................................................... 23 10.4.9 Preservation of Product ........................................................................................................................ 23 10.5 CONTROL OF MONITORING AND MEASUREMENT EQUIPMENT ................................................................................. 23
11 SUPPLIER SELECTION, APPROVAL, RESPONSIBILITY AND CONTROL ............................................................. 25
11.1 SELECTION ..................................................................................................................................................... 25 11.1.1 Quality Management System and Aerospace Approval ....................................................................... 25 11.1.2 Airworthiness Regulation Approval ...................................................................................................... 27 11.1.3 Special Process Accreditation (see QRS-104) ....................................................................................... 28 11.2 APPROVAL ..................................................................................................................................................... 28
11.2.1 Supplier Classification .......................................................................................................................... 28 11.2.2 Suppliers Approved by a Civil Authority ............................................................................................... 30 11.3 RESPONSIBILITY .............................................................................................................................................. 31
11.3.1 General ................................................................................................................................................. 31 11.3.2 Digital Manufacturing (DMFG) ............................................................................................................ 31 11.3.3 Contract Review ................................................................................................................................... 31 11.3.4 Changes affecting AW approval ........................................................................................................... 31 11.3.5 Control of records ................................................................................................................................. 32 11.3.6 Supplier Commitment ........................................................................................................................... 33 11.4 CONTROL ...................................................................................................................................................... 34
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11.4.1 Surveillance .......................................................................................................................................... 34 11.4.1.1 Non conformities management ........................................................................................................... 34 11.4.1.2 Suspension of AW Approval ................................................................................................................. 35 11.4.1.3 Withdrawal of AW Approval ................................................................................................................ 36
12 ANNEXES ..................................................................................................................................................... 37
13 APPENDIXES ................................................................................................................................................. 37
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1 Introduction
1.1 The group of Companies
Finmeccanica S.p.A (Italy) have merged its helicopter businesses into a joint Company, named AgustaWestland S.p.A., who fully owns and control AgustaWestland Ltd., AgustaWestland Philadelphia Corp. and PZL-Swidnik S.A. The Company legal entity is: AgustaWestland S.p.A. Piazza Monte Grappa, 4 00195 Roma Italia
The Company main addresses are: AgustaWestland S.p.A. AgustaWestland Ltd. Via Giovanni Agusta, 520 Lysander Road 21017 C. Costa di Samarate (Varese) Yeovil, Somerset, BA20 2YB Italia England
PZL-Swidnik S.A. AgustaWestland Philadelphia Corp. Al. Loynikow Polskich 1 3050-3076 Red Lion Road Swidnik 21-045 Philadelphia, PA 19114 Poland United States of America
Specific documents can be found at:
http://www.agustawestland.com/content/Supplier-quality-assurance-sqa
1.2 Legal Notes
Throughout this document AgustaWestland S.p.A., AgustaWestland Ltd., PZL-
Swidnik S.A., AgustaWestland Philadelphia Corp. and Other Legal Entities are jointly referred to as AgustaWestland (AW). AW shall mean either AgustaWestland S.p.A., AgustaWestland Ltd., PZL-Swidnik
S.A., AgustaWestland Philadelphia Corp. or Other Legal Entities depending upon which of these companies is contracting with the Supplier. Quality is the fundamental key that provides AW to maintain its competitiveness in the global market and consequently AW is expecting from Suppliers a supportive
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commitment to Quality by maintaining an effective Aerospace Quality Management System (AQMS), the cornerstone for the continuous improvement of articles, services and processes. AW is committed to a step change in its Supply Chain for the continual improvements through people, processes and tools, leading to “On Time Delivery (OTD)” and “On Quality Delivery (OQD)” articles which ultimately generate continual reduction of costs.
In addition to the above, AW support the certification of suppliers at the highest levels considering also the efforts and resources to be dedicated for the Supplier’s Surveillance activities. The missing of such certifications represents additional workload, and consequently costs, for AW therefore this aspect will be considered in the selection of Suppliers (see Table 1). AW will regulate its Surveillance activity concerning the aspects of frequency and flow down of requirements based on the certification held by Suppliers.
The requirements defined by this document are an integral part of the binding contract between Suppliers and AW and will be recalled in all AW contracts and
P.Os.
AW is one of the world’s leading helicopters manufacturers, which:
Design, manufacture and support Aircraft and associated articles for various Civil and Military Customers.
Have to demonstrate to Regulatory Authorities that they have the capability to
design, manufacture and support articles to the maximum safety level (Airworthiness) and maintain the effective Airworthiness of the articles
Is a world-class alliance committed to delivering outstanding Articles to its
Customers whilst maximising value for its stakeholders.
1.3 Right of Access
Given reasonable notice, AW shall have the right of access to any Supplier involved with AW article, included any Sub-tier Supplier. Providing reasonable notice is given, the Supplier shall provide AW Customers (or the Customers authorised representatives) and /or Regulatory Authorities rights of access to premises where AW work is being performed. Such access shall be used to verify the Quality Assurance activities being undertaken meets the requirements of the AW contract/order.
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For orders placed in furtherance of a Ministry of Defence Contract (MoD) or of a Department of Defence (D.O.D.) (or where MoD / D.O.D. are acting as an agent on the behalf of a Customer) the following statement applies: “This contract/order is in aid of a Ministry of Defence (MoD) contract and may be subject to quality assurance activity at your works by the MoD or their authorised representative. You shall provide at no additional cost to the MoD (or their representative) such reasonable accommodation, facilities and assistance as the MoD may require. Such accommodation shall be adequately furnished, lighted, heated and ventilated and shall include suitable cloakroom and telephone facilities”. Suppliers are requested to notify AW when an AW Customer (or Customer representative) request access to the Supplier’s facilities. In all cases, access by the Customer shall be arranged by AW only. AW reserves the right to accompany any Customer during a Supplier visit. When invoked contractually, access to the supply base shall be required by the in-country Government Quality Assurance Representative in accordance with STANAG4107 [Mutual Acceptance of Government Quality Assurance and Usage of Allied Quality Assurance Publications (AQAP)]. All access and article acceptance requirements shall be co-ordinated by AW.
1.4 Customer Communication
The Suppliers Management Representative shall be the principal link between the Supplier and AW Suppliers Quality Assurance and Quality Controls. This shall be on all matters affecting the quality of article submitted to AW.
All other communication required by a programme shall be as specified and agreed by AW by the Contract and/or Quality Plan.
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2 Scope
AW Quality requirements for Suppliers are contained in this document. The requirements specified in this document are complementary (not alternative) to EN9100 series and contractual and applicable law and regulatory requirements. This document contains also:
Supplier requirements for AW recognition of certification documentation issued
by an accredited Certification Body (CB) in accordance with International Aerospace Quality Group (IAQG) requirements.
AW expectation for all of its Suppliers today and in the future.
Allowance to deviate from the AW requirements within this document is at the sole discretion of AW and will have to be agreed with AW Supplier Quality Assurance (SQA). Authorized deviations will be managed under AW “Limited Approval” process and noted in the Supplier’s Scope of Approval.
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3 Applicability
This document is applicable to all activities allocated to all the types of Suppliers described in the following Table 1 in accordance with an AW Contract / Purchase
Order and/or any other associated documentation and shall be flowed-down to all Sub-tier Suppliers involved in fulfilment of the Contract / Purchase Order.
The following Table 1 includes also the minimum certification criteria required by AW to be held by the Supplier and, based on the approval granted by AW, also describes the correlation between Statement of Approval Category and activities performed by the different type of Suppliers.
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4 QRS-01 Modules
The set of AW requirements that each Supplier signing a Contract, accepting a
Purchase Order and delivering parts / services to AW, commits to fulfil are described in this document (QRS-01 General Requirements for Suppliers). The set of requirements that the Supplier commits to fulfil and flow-down to its Sub-
tier Suppliers is composed by a general section (applicable to all categories and types of Suppliers) and a set of dedicated procedures (QRS-XXX) applicable according to the category and type of the Supplier and its approval (see Table 1). The entire body of documents (General Requirements plus QRS-XXX) forms the AW Quality Requirement for Suppliers. This document is complementary to EN9100 series requirements that shall be fulfilled by the Supplier.
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Supplier Type
Description: Minimum certification required
Statement of Supplier Approval
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Type A Engineering Design AS/EN/ JISQ 9100 with “Design and Development”
X X
Type B Production of equipment items, assemblies, sub-assemblies, standard parts developed by AW. Offloads.
AS/EN/ JISQ 9100 X X X
Type C Repaired/maintained/overhauled article. AS/EN/SJAC 9110 X
Type D Manufacturers’ articles stored and re-selled AS/EN/SJAC 9120 X
Type E Commercial office (only commercial relationship with AW) Not applicable X
Type F Testing and measuring activities ISO/IEC 17025 X X
Type G Training services ISO 9001 X
Type H Manpower service or support activities (technical publications, consultancy services, training equipment’s, etc.)
ISO 9001 X
Type I Special processes NADCAP X X X X
Type J Raw materials or standard parts in accordance to international standards
AS/EN/JISQ 9100 series X X X
Type K A Supplier responsible to develop software (airborne) AS/EN/JISQ 9100 including compliance to AS/EN/SJAC 9115
X X X
Type L Non-airborne articles (test benches, tooling, etc.) that can impact airworthiness
AS/EN/JISQ 9100 X X X X
Type M COTS AS/EN/JISQ 9100 X X X X
Table 1
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5 Effective date
July 2015.
6 Ownership
AW Supplier Quality Assurance (SQA).
7 Acronyms, definitions and abbreviations
7.1 Acronyms and abbreviations
AQMS Aerospace Quality Management System CA Corrective Action CAR Corrective Action Request CB Certification Body CFR Code of Federal Regulation CofC Certificate of Conformity COTS Commercial Off the Shelf DOA Design Organisation Approval D.O.D. Department of Defence EASA European Aviation Safety Agency EASA Form One European Aviation Safety Agency – Release Certificate FAA Federal Aviation Administration FAA Form 8130-3 Federal Aviation Administration – Release Certificate GSE Ground Support Equipment IAQG International Aerospace Quality Group IAQG-OASIS International Aerospace Quality Group – On line Aerospace
Supplier Information System (www.iaqg-sae.org/oasis) ICOP Industry Controlled Other Party ISO International Standardization Organisation MOD Ministry of Defence NAA National Airworthiness Authority OEM Original Equipment Manufacturer PMA Parts Manufacturer Approval POA Production Organisation Approval PO Purchase Order PRI Performance Review Institute PRI-NADCAP Performance Review Institute - National Aerospace and
DEFENSE Contractors Accreditation Program QMS Quality Management System SP Special Process STC Supplemental Type Certificate TC Type Certificate TSO Technical Standard Order
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7.2 Definitions
An Article is: raw material, processes, tooling, gauging, equipment, detail parts, sub-assemblies, assemblies, avionics, software, CAD/CAM/CATIA media (including Digital Data Definition), documentation, aircraft, airborne/non-airborne equipment and service may be provided.
A Batch Number (lot) is a unique number allocated to a definite quantity of items produced to the same design at one time, under conditions that are considered uniform.
The Buyer is the AW entity issuing a Contract or a Purchase Order. A Catalogue Part is a proprietary part specified in the Manufacturer’s own publication which contains sufficient technical data for the user to select and confirm that the part/product satisfies the design intent and end user application. A Commercial Off the Shelf (COTS) is an article ready-made and available for sale, lease, or license to the general public. A Contract or a Purchase Order is the legal agreement, independently of the format (paper or electronic) or the designation (order, contract, delivery order), between the Supplier and the Buyer to provide articles, materials and/or services. A Critical Part is an article, the failure of which could have a catastrophic effect upon the rotorcraft, and for which critical characteristics have been identified which must be controlled to ensure the required level of integrity. A Product is: aircraft, aircraft engine, or propeller A Qualified Part is an article for which the ability to fulfil specified requirements is demonstrated by documentation. A Serial Number is a unique number or alpha-numeric code that is one of a series, used to provide identification of an article to enable traceability. A Standard Part is a part manufactured in complete compliance with a Government or an established industry specification A Supplier is a company (according to the different types and categories) that receives a Purchase Order/Contract and/or Agreement from AW. For general definitions, please refer to EN ISO 9000 and to specific documents of Legal Entities, where applicable.
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8 Means of Understanding
The use of shall, should, must, will and may within this document shall observe the following rules: the word shall in the text denotes a mandatory requirement: deviations from such
a requirement is not permissible without formal agreement, the word should in the text denotes a recommendation or advice on implementing
such a requirement of the document; such recommendations or advice is expected to be followed unless good reasons are stated for not doing so,
the word must in the text is used for legislative or regulatory requirements and
shall be complied with, the word will in the text denotes a provision or service or an intention in
connection with a requirement contained in this document, the word may in the text denote a permissible practice or action; it does not
express a requirement contained in this document. These means of understanding are applicable in the entirety of the document.
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9 Purchasing
9.1 Purchasing Process
The Supplier shall be responsible for all Sub-Tier Suppliers activities. A Product Quality Plan and/or Software Quality Plan shall be provided when required by AgustaWestland. AgustaWestland requirements shall be flown-down to, understood and implemented by Sub-tier Suppliers prior to commencing any work. Subcontractors shall: Procure materiel from either:
Approved AgustaWestland Suppliers (for critical parts)
The recognized OEM
The qualified manufacturer as defined by the appropriate authority Use only AgustaWestland approved Suppliers unless otherwise agreed and
identified in a Quality Plan / Side Agreement Letter
Note: alternative or equivalent parts shall not be sourced without prior formal AgustaWestland approval. When AgustaWestland are not the Design Authority for the product, the Design Authority approved Suppliers shall be used Stockist/Distributors shall: Only purchase products from other approved Stockist, when full traceability can
be demonstrated back to an authorized manufacturer Ensure the product is checked against the specifications on receipt and records
are kept Ensure alternative parts are not delivered without prior written approval from
AgustaWestland Ensure the OEM’s CofC or Airworthiness Certificate is attached and referred to
into the Stockist CofC Requirements for Suppliers of GSE: Raw material shall be as required by the drawing and may be procured from
commercial sources. A CofC is required. Alternative materials are only permitted when defined by AgustaWestland
documentation and pre-authorized by the applicable Material Laboratory Procurement of standard parts, adhesives and fasteners from sources approved
by the Supplier must be supported with a CofC.
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Proof load testing of GSE is to be completed by companies approved to National and International Standards for the applicable testing. A “Certificate of Test and Examination” in accordance with Governments statutes shall be supplied to certify each product.
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10 Production and Service Provision
10.1 Production Documentation
Each work instruction document (e.g. traveller, batch card, planning, and operation list) is to be kept with the product at all times.
The document shall have, at least, provision for: A unique batch number, part number, product description and quantity Drawing number, issue/version/revision Manufacturing/process layout issue/revision status List of individual operations Authorised inspection stamp/signature, quantity and date, at each operation Evidence that the material issued is in accordance with the drawing(s) Inspection operations prior to, and after subcontract operations The material specification, identity (i.e. cast number, heat number or unique
identity traceable to the release note number) Operations for temporary protection, to be defined at interim stages and for
transit to and from Sub-tier Suppliers
Note: AgustaWestland shall approve alternative materials prior to starting
manufacture.
and when applicable: Reference any Manufacturing Quality Plan (number and issue) as applicable
to High Integrity Parts. Class/category of product e.g. Vital Part, Category F, Flight Safety Part,
Critical Part, class 1 etc. Product serial number(s) Critical operations which shall be highlighted
High Integrity Part key characteristics and critical operations shall be highlighted as detailed in the Manufacturing Quality Plan
The specification reference, applicable to each AgustaWestland approved special process
Process specifications which invoke other specifications, have individual operations for each specification requirement which is defined
Split batches with traceability to and from the original document maintaining the same issue/revision status
Non-conformance details e.g. concession, production permit, scrap, and rework note numbers
Tooling and/or software revision status. NOTE: The Supplier shall ensure that the Equipment/Supplies comply with the Registration, Evaluation, Authorization and restriction of Chemicals Regulation (EC) No. 1907/2006 (Referred to as REACH regulation) and any future amendments made
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10.2 Control of Production Process Changes
AgustaWestland shall approve proposed amendments to Critical Part instructions. Amendments to work instructions are to be completed by authorised personnel only. An amendment shall be made by a single line through the original text using permanent ink. A stamp, signature (or electronic equivalent) and date shall be placed adjacent to an amendment. Correction fluid shall not be used.
10.3 Control of Service Operations
Where the Civil repair/overhaul contract is for Part 145 release, the Supplier shall have Part 145 approval with the correct scope to include the product, as defined by the applicable Capability List.
10.4 Identification and Traceability
All products are to be identified and traceable in accordance with the Design Instructions or as agreed with AgustaWestland. The traceability system employed shall reduce the probability of the need to conduct a full product recall in the event of product non-compliance. This shall take into consideration the following: Traceability of the sub assembly parts/components (including raw material) Manufacturing methods, techniques and processes Criticality, safety and reliability data Complexity of design and processes employed Maturity and historic performance of the design/product. High Integrity Parts must have full manufacturing, design and material traceability.
10.4.1 Stamp Control
Manufacturing and Inspection stamps issued to authorised holders shall be recorded with specimen signatures of the holder, and a definition of the scope of approval for which the stamp is to be used. If a stamp is withdrawn for any reason, it shall not be re-issued for at least six
months and the reason for withdrawal shall be documented.
If a stamp is lost, this will require the withdrawal of the remainder of a set of stamps bearing the same identity, for at least one year. An illegible stamp shall be replaced.
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10.4.2 Serial Numbers
Shall be allocated and remain unchanged from the earliest, defined operation, throughout the life of the product. Subcontractors producing identifiable products will allocate (unless otherwise specified by AgustaWestland) a serial number that shall consist of 3 alpha and 4 numeric characters in order to guarantee identification and traceability of the products.
For Boeing design authority products, the Supplier allocated 4 digit number is prefixed by the Boeing ASIS number.
10.4.3 Identification after Paint
Where product identity could be lost due to the in-fill by paint etc., ensure additional ink marking (in accordance with the relevant design / manufacturing specification) is applied in the position defined by the drawing.
10.4.4 Bag and Tag
When products do not require individual identification, the products shall be ‘bagged and tagged’ as follows:
The ratio of tags (labels) to items is a minimum of 1:20 Identification and traceability shall be maintained during storage and dispatch Identify the packaging for a standard product e.g. rivets, washers etc. with at
least the manufacturer/Supplier name, part number, and description, quantity and inspection stamp.
10.4.5 Non-Metallic Material
Ensure non-metallic raw material is identified with:
Product reference and specification reference Batch number, quantity and date of manufacture Date of life expiry or shelf life When applicable, cure date and category of rubber.
10.4.6 Metallic Material
Metallic raw material shall be identified in accordance with the requirements of the relevant specification (heat/lot/melt number as applicable), with the manufacturers identification permanently marked on the material as follows:
All lengths of a metal bar are permanently marked Small diameter metal bar e.g. wire is identified by batch, using a metal tag or
label
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Sheet material is marked in lengthwise rows, recurring at intervals not greater than one metre, with one central row and two side rows, spaced equal distance from the centre line to the edge of the sheet.
When traceability cannot be achieved, obtain written authorisation from AgustaWestland (Materials Laboratory) prior to dispatch.
10.4.7 Identification and Control of Unqualified Products (Colour Banding)
Unqualified products must be identified and controlled to maintained Airworthiness standards. Therefore, a Supplier shall not release an unqualified product to AgustaWestland without receiving authorisation from AgustaWestland and correctly identifying the product prior to despatch. For AgustaWestland S.p.A.
The Supplier shall declare on the delivery documentation the Airworthy condition of the parts. For AgustaWestland Ltd.
Unqualified products have two conditions. o No Flying permitted:
Product and packaging shall be identified with a RED BAND.
o Flying is permitted, with or without limitations: Products and packaging shall be identified with a BLUE BAND.
Method of Identification for either category: If the unqualified condition is permanent, the colour banding shall be
permanent. e.g. For permanent test or training purposes, use paint.
If the unqualified condition is temporary, the colour banding shall be
temporary. e.g. Temporarily pending Technical / DDP clearance, use tape.
The following controls shall be followed : Unqualified products shall not be released without written authorisation, from
the AgustaWestland Ltd. Procurement Department, to release the product in the unqualified condition specified as either RED of BLUE.
In all cases, both the Product and Packaging shall be colour BANDED, RED or
BLUE accordingly.
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In addition, the release documentation shall also be endorsed as applicable
with:
“THIS IS A ( ‘RED’ or ‘BLUE’ ) BANDED UNQUALIFIED PRODUCT”.
10.4.8 Safety Hazard
A Supplier shall provide clear identification, control and training in accordance with National and International standards if a product is a safety hazard e.g. Beryllium copper, lithium batteries etc. Safety data sheets shall be provided.
10.4.9 Preservation of Product
Do not use Polyvinyl Chloride (PVC) film, Vapour Corrosion Inhibitor (VCI) and/or Vapour Phase Inhibitor (VPI) treated materials and/or absorbent materials for packaging. These cause the Products to deteriorate/corrode during storage and/or delivery to AgustaWestland and/or their Customer. Reference shall be made to the applicable AgustaWestland standard. Aircraft products shall be segregated from commercial products. This includes the storage of software, software libraries and archives. Products that are (or contain) Electro Static Sensitive Devices (ESSD) or operate at high voltage shall be clearly marked accordingly and packaged in accordance with National and International specifications. Exposed pipe ends, electrical connectors, coaxial cable and exposed openings are to be sealed externally, where possible, to prevent contamination. Plugs, caps or other devices shall: not leave deposits on the openings when removed e.g. not made from
aluminium be easily identifiable not deteriorate when brought into contact with fluids. Limited life materials are to be identified and controlled so that ‘out-of-life’ materials are not used.
Maintain a stock rotation system to ensure that completed products being delivered are less than five (5) years old from date of manufacture unless specified by the shelf life or requested by AW.
10.5 Control of Monitoring and Measurement equipment
The supplier shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.
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The supplier shall also maintain a register of the monitoring and measuring equipment and define the process employed for their calibration/verification including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria. The supplier shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. The supplier shall ensure that environmental conditions are suitable for the calibration, inspection, measurement and testing being carried out. NOTE: both secondary and primary instruments shall be calibrated by an external ISO/IEC 17025 certified laboratory or a National Aviation Authority approved laboratory.
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11 Supplier Selection, Approval, Responsibility and Control
11.1 Selection
11.1.1 Quality Management System and Aerospace Approval
All the Suppliers shall have a Quality Management System compliant with Table 1 and certified against 9100 series applicable for their scope of certification by a Certification Body accredited by IAQG Industry Controlled Other Party (ICOP) Aerospace Sector Certification Scheme operating in accordance with EN/AS/SJAC 9104-001, “Requirements for Aerospace Quality Management System Certification / Registrations Programs”. Certification shall be registered in the IAQG OASIS Database and the Supplier shall grant to AW the access to the private part of the OASIS database. The Supplier shall ensure to:
maintain objective evidence on file at its facility, in accordance with the quality
record retention requirement contractually specified; of the certification which includes :
the accredited AQMS certificate(s) of registration.
the audit reports, including all information pertaining to the audit results in accordance with the applicable certification/registration scheme.
copies of all CB finding(s), objective evidence of acceptance of corrective action, and closure of the finding(s).
notify AW in writing when changes in the utilized CB occur. implement a services agreement with the CB that provides for “right of access” to
all CB records by AW, applicable Accreditation Body, applicable Registration Management Committee or Certification Body Management Committee and other regulatory or government bodies for the purpose of verifying CB certification / registration criteria and methods are in accordance with the applicable IAQG certification/registration scheme.
notify AW in writing when its certification is suspended or withdrawn or the
accredited status of the CB utilised has been withdrawn provide AW identified system nonconformities and quality / delivery
performance data to the CB prior to the initial (Stage two) audit, surveillance audits and recertification activity.
coordinate with their CB, upon receipt of AW non-conformance(s) against its QMS
that is classified as Level 1, in order to provide them awareness and description of Corrective Action taken.
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notify their CB within five business days and make arrangements for a Special Short-notice Audit (Reference ISO 17021 § 9.5.2, EN9104 § 8.2.3 / EN9104-001 § 8.1.3) in the event that AW changes Supplier’s approval status from Approved to Suspended or Disapproved;
This audit scope will include investigation of nonconformities that resulted in the change of status to Suspended or Disapproved and assessment of impact to certification.
grant, upon request, AW access to the tier two assessment results data contained within the IAQG On-line Aerospace Supplier Information System (OASIS).
AW reserves the right to :
Make final determination regarding compliance to AW requirements. Change AW approval status of Supplier based on its contract compliance. Terminate supplier’s AW approval status, regardless of previous or current
recognition and regardless of Seller’s certification status. Conduct assessment of Supplier Quality Management System and issue of any
AW identified quality system findings.
AW reserves the right to accept Suppliers not EN/AS/JISQ9100 series certified in
exceptional circumstances only. In this case : AW reserves the right to conduct a full or partial assessment, on a case by case
basis, of the Supplier’s Quality Management System. Supplier shall issue, at its own expense, a Quality Plan to cover the delta of the
EN/AS/JISQ9100 series and the QRS-01 requirements, to be submitted for approval to AW SQA.
Supplier shall ensure the Sub-tier Supplier’s Quality Management System is
satisfactory by performing a risk assessment / audit. AW article requirements shall be defined in the Contract / Purchase Order, this document and any other documents referred to in the Contract / Purchase Order. The Supplier and any Sub-tier Supplier shall comply with these requirements except where agreed. The Supplier shall flow down the requirements included in this document (QRS-01) to all its Sub-tier Suppliers.
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Depending on Supplier Approval Held, all the requirements of this document shall apply and may be checked and monitored for compliance by AW.
11.1.2 Airworthiness Regulation Approval
Production
Suppliers of safety critical parts and equipment or “major assemblies” (structural elements affecting safety of flight) are expected to have a Production Organization system in accordance with one of the following : EASA Part 21G or FAA CFR 14 Part 21 CCAR 561 Military Airworthiness Approval Equivalent recognized (e.g. bi-lateral agreement with NAA)
Compliance shall be demonstrated and provided to AW by means of an official approval issued by the relevant Regulatory Body. Arrangements shall be implemented between AW (TC holder) and interested Suppliers. Deviation from the above requirements shall be considered in an exceptional base and will be dealt with on a case by case base.
The Supplier shall inform AW SQA of any airworthiness directive affecting its equipment when fitted on AW Aircraft Maintenance
OEM and other Suppliers performing maintenance activities shall have a Maintenance Organization system approval in accordance with: EASA Part 145 or FAA CFR 14 Part 145 or FAA CFR 14 Part 43 CCAR 573 Equivalent recognized (e.g. bi-lateral agreement with NAA) Additionally, all suppliers certified against EASA Part 145 operating also on military programs shall obtain the EMAR 145 certification. Where the OEM or Suppliers holds an EASA Part 145 and/or an FAA CFR 14 Part 145, the OEM or the Supplier shall apply also for the Canadian CAR 573 approval. Compliance shall be demonstrated and provided to AW by means of an official approval. When requested by AW, the OEM or Supplier shall be requested to have a dual release certification capability (FAA/EASA Part 145).
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The Supplier shall inform AW SQA of any airworthiness directive affecting its equipment when fitted on AW Aircraft.
11.1.3 Special Process Accreditation (see QRS-104)
As part of its continuous improvement, AW Suppliers and Sub-tier Suppliers shall gain and maintain appropriate NADCAP certification for their Special Processes. Special Processes called-up in AW approved design data will be compliant with PRI NADCAP Accreditation program requirements; additional requirements may be requested by AW. Irrespective of NADCAP certification, Suppliers and Sub-tier Suppliers shall remain responsible in terms of article qualification and quality. In any case, exceptions to AW Technical Specifications shall be submitted to AW in writing and shall be formally approved by AW before proceeding. If the Supplier is a POA holder, the Supplier shall obtain authorisation from its NAA before alleviating its surveillance on NADCAP certified Sub-tier Suppliers.
If the Supplier is working under AW POA, the Supplier shall obtain authorisation from AW before alleviating its surveillance on NADCAP certified Sub-tier
Suppliers.
11.2 Approval
11.2.1 Supplier Classification
AW classifies their Suppliers into different specific categories. This helps to maintain records that relate to the supplier base and target the specific requirements to those suppliers that AW need to use. Once a supplier is approved by AW, approval is considered valid without expirations unless otherwise advised by AW SQA. Manufacturer (also known as Vendor) An AW Supplier that: Designs and manufactures article for which they hold the proprietary rights and
design responsibility.
Designs and manufactures article for which they provide a specialist design, development, validation and/or manufacturing facility against AW requirement specifications.
Manufactures raw materials (metallic and non-metallic).
Subcontractor
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An AW Supplier that: Manufactures, tests and / or processes article to drawings, 3D models, standards
and/or process specifications for which they are not design responsible. The design requirements shall be provided by AW when AW is directly design responsible, or when AW have been granted manufacturing rights by another design responsible organisation.
Procures raw material as defined by their Statement of Approval/Scope of Approval.
Manufactures articles in compliance to national and/or international standard specifications
Offload An AW Supplier that completes manufacturing operations originally planned for departments within AW or is already part of a planned AW manufacturing process. Note : The original AW work instructions will be provided, completed and
returned with the article. This identification includes also Subcontractors which are not allowed by AW to procure raw material. Maintenance An AW (and/or the Design Responsible Company’s) Supplier that repairs / maintains / overhauls article. Stockist An AW Supplier that stores and re-sells a manufacturer’s article and manages his supply chain for the quality aspects. Distributor An AW Supplier that stores, and re-sells, managing also the quality aspects of a manufacturer’s article under a licence agreement of an AW Approved Manufacturer. Service Provider An AW Supplier that: Provides an Engineering Design / Consultancy service for AW Provides a training service for AW Provides a manpower service for AW
This identification includes also Companies of logistic services. The quality requirements of the involved services will be directly dealt with by the AW involved
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Plant where the Company operates and the identified need of training and qualification for operators will be under direct responsibility of the AW involved Plant. Laboratories A specific class of Suppliers used by AW as external laboratories. The approval of such Suppliers will be based only on a desk review of the standard certification that applies for the international commodity of laboratories. AW reserves, in any case, the right to assess compliance to its requirements through an on-site audit. For Suppliers that supply consumable material (e.g., thinner for the plants and labs) no specific approval will be performed by AW. The use of such Suppliers and any needed verification of the supplied material will be directly dealt with and under the responsibility of the receiving AW plants and laboratory. Note : The above ‘Type of Supplier’ identifications are valid from the date this
procedure is issued. Agent
A Supplier that represents a manufacturer and/or stockist (distributor) and arranges for their article to be distributed. For these suppliers only a scope of approval (and not a statement of approval) will be issued. Such suppliers will not be included within AW SQA’s supplier surveillance plan.
11.2.2 Suppliers Approved by a Civil Authority
Suppliers manufacturing, overhauling and repairing articles, components or subassemblies in accordance with TC or STC holder and having a civil authority approval (EASA Part 21G, EASA Part 145, CFR 14 Part 21, PMA, CFR 14 Part 145, C CAR 561, CCAR 571, etc.) are operating under the supervision of their NAA and they shall assure that all their activities are recorded in their Capability List / limitation records. Through the issuing of appropriate agreements with AW (e.g., DO-PO Arrangements, PMA’s, etc.) they shall deliver any part included in the AW civil programme with an airworthiness tag (EASA Form 1, FAA TAG 8130-3, etc.). Surveillance activity to such Suppliers is ruled according the certification hold and the criticality of the articles delivered to AW.
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11.3 Responsibility
11.3.1 General
Where the Supplier is not responsible for the design of the article, the Supplier shall only use AW approved Suppliers for Special Processes. Where the Supplier is responsible for the design of the article, and AW specifications don’t recall AW Special Processes, the Supplier can use its own approved special processes, or address them to its approved Suppliers for these processes.
11.3.2 Digital Manufacturing (DMFG)
Suppliers manufacturing articles using AW 3D Design Data Set shall comply with the requirements contained in QRS100 and will be submitted to an approval process.
11.3.3 Contract Review
During Contract Review, the Supplier shall check their scope of approval, issued by AW, to ensure it is correct for the Contract / Purchase Order. It is the Suppliers’ responsibility to regularly check the AW Website to ensure they are using the latest issue of AW published standards, specifications and documentation.
11.3.4 Changes affecting AW approval
A Supplier shall send timely, written notification to AW SQA in case of changes to:
Organization o Relocation to new premises o Change in the industrial organisation (partnership, suppliers, design
work sharing). o Change in the parts of the organisation that contribute directly to the
airworthiness or environmental protection.
Responsibilities o Change of the management staff (such as Quality Manager, Project
Manager, Technical Director, Accountable Manager, General Manager). o New distribution of responsibilities affecting airworthiness or
environmental protection o For organisations designing minor changes to type design or minor
repairs to products
Procedures Change to the procedures related to:
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o the classification of changes and repairs as ‘major ‘ or ‘minor ‘ o the treatment of major changes and major repairs o the approval of the design of minor changes and minor repairs o continued airworthiness o the configuration control, when airworthiness or environmental
protection is affected o the acceptability of design tasks undertaken by partners or sub-
contractors
Resources o Substantial reduction in number and/or experience of staff
Policy changes which affect their conditions of approval
Change in the conditions of approval given by National, International Bodies and/or Regulatory Authorities.
The notification of the changes shall be done prior to their implementation by means of the following mailbox:
The submitted changes will be assessed by AW to evaluate their impact on the approval status of the supplier. In case the change is considered significant to the showing of compliance or to the airworthiness and environmental protection of the product, as per Part 21.A.247, it will be sent by AW to EASA for approval.
11.3.5 Control of records
Manufacturing documentation shall be made available to AW, and their Customers and Authorities, in support of audit/investigation activities. Article records for Critical Parts shall be kept by the Supplier in accordance with QRS-112, unless previously approved, in writing, by AW. Design data and qualification data shall be retained for the life of the article Records shall be kept for all personnel in particular for those personnel performing final inspection and those personnel authorised to sign the C. of C. These records are to contain evidence of their education, training, skill, experience and competency. All records (article and business related) not related to critical parts, design and qualification data shall be retained from the completion of the Purchase Order,
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unless specified by the Contract, Quality Plan and/or Customer in accordance with QRS-112. Secure storage facilities shall be used to prevent deterioration and ensure ease of retrieval e.g. fire proof safe, back up copy (s) located away from the facility. All data stored by electronic means shall be secured and regularly backed up and audited to verify the integrity of the data. Suppliers that have a computer repository system shall have a disaster recovery procedure that is defined, documented, implemented and regularly audited for compliance.
In the event of insolvency all pertinent records shall be supplied to AW. AW is strongly committed to the respect of the environmental policies and labour safety. This commitment is flown down through its entire Supply Chain. Suppliers are encouraged to have a documented system considering Environmental Policy and Labour safety (e.g. refer to ISO14001 and OHSAS18001). In case of Suppliers not holding an ISO14001 and OHSAS18001 certification, the
Supplier shall implement in its QMS the basic principles as a minimum.
11.3.6 Supplier Commitment
Suppliers to AW shall produce and deliver safe and reliable articles that meet the Purchase Order/Contract and/or Agreement requirements, for quality, cost and on time delivery. Continuous improvement initiatives shall be applied. AW may accept non-conforming Article(s) in exceptional circumstances only with permission from Quality Control Department. Supplier shall ensure that all Articles and Parts are new and unused. Procedures shall exist for the Repair and Overhaul of Articles. Supplier shall ensure that Government surplus Article(s) are not supplied Supplier shall ensure to have in place the necessary controls on its supply chain to avoid the delivery of suspected / counterfeit parts to AW. Based on the Supplier Type, the requirement of the associated documents listed in QRS01A – Associated QRS-01 Documents also be considered and apply.
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11.4 Control
11.4.1 Surveillance
Suppliers will be subject to periodical audits that can be performed by AW and other parties AW decides to involve (e.g. N.A.A., M.O.D., customers, etc.). AW reserves the rights to outsource specific surveillance activities to a Third Party Organization that will be legally bound to AW through a Non-Disclosure Agreement (NDA). In the event AW will recur to this choice, a written communication will be submitted in advance to the audited Supplier. The Supplier will be notified by AW before the performance of audit activities. The duration of the audit (AW, N.A.A., M.O.D., customers, etc.) is established by AW in accordance with the specific needs and it will be at least 1 (one) day.
11.4.1.1 Non conformities management
If, during the audit activity, a Corrective Action Request (C.A.R.) emerges, the Supplier shall complete the form (see Annex A).
The table below represents the deadlines set to define and manage non conformances:
Root Cause Containment Action
Corrective/Preventive Action
Level 1
Identification and implementation within 5 calendar days otherwise communicated by the lead auditor.
Identification and implementation within 5 calendar days otherwise communicated by the lead auditor.
Identification within 5 calendar days and implementation within 21 calendar days otherwise communicated by the lead auditor.
Level 2
Identification within 30 calendar days, implementation within 90 calendar days since the audit
Identification within 30 calendar days, implementation within 90 calendar days since the audit
Identification within 30 calendar days, implementation within 90 calendar days since the audit
Level 3 Not requested
Identification within 30 days, implementation within 90 days since the audit
Not requested
Preventive Not requested Not requested Identification within
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action only 30 calendar days, implementation within 90 calendar days since the audit
In case of a Level 1 non-conformance the supplier shall provide AW SQA a technical report identifying, through structured root cause analysis, all causes that have or may have generated or contributed to the undesirable condition, situation, nonconformity or failure, then select the most critical ones that require to be addressed. Some tools must be used to enable problems to be defined, data to be collected and analysed, such as
Fishbone (Ishikawa Diagram)
5 Whys
FMEA
FTA (Failure Tree Analysis).
Root Cause Chain Regardless of the level of non-conformity issued, in the case of significant non conformity having an impact on the AW production in terms of quality and on time delivery, AW will issue a feedback in the IAQG OASIS against the Certification Body
of the Supplier and, for information, to the Supplier concerned. AW SQA will ensure that the appropriate course of actions is implemented. Actions to be considered :
suspension of delivery to AW;
suspension or withdrawal of the AW Supplier Approval;
reduced timescales for supplier response to CAR issued by AW;
containment action;
corrective action;
preventive action; Where a Supplier does not respond to the request for corrective action in the planned times, an "escalation process" will be initiated by AW.
11.4.1.2 Suspension of AW Approval
If the assessments and verifications, and the consequent result of corrective actions do not solve the persistence of a critical situation such as: production process that does not guarantee repetitiveness (realization of conforming
parts constantly in time); manufactured parts not traceable
incorrect measurements made
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increase of defects on AW critical parts before delivery to the Customer repetitive reports from Customers of defects on critical parts / non-critical parts AW may suspend the approval granted to the interested Supplier. The Supplier shall submit a detailed plan of actions to remove the causes that have generated anomalies and provide evidence of its implementation. The suspension period is defined by AW on a case by case basis.
11.4.1.3 Withdrawal of AW Approval
Approved Suppliers without any AW Contracts / Purchase Orders in the last four consecutive years will have their approval withdrawn and shall be therefore considered as new Supplier in case of new business activities with AW. Other circumstances eligible for a possible AW approval withdrawal are (not limited to): Persistence of problematic performances linked to the quality and delivery of the
received parts; Conscious disregard of the AW requirements expressed in this document or deviation
without prior agreement with AW; Fraudulent or harmful behaviour towards AW; Loss of third Other Party accreditation, MoD certification, NAA certification upon
which the AW approval was based; Lack of ethical or safety behaviour by the Supplier; Any particular behaviour that is considered not consistent with AW policy expressed in
this document and in AW rules.
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12 Annexes
Annex A – CORRECTIVE ACTION REQUEST (C.A.R.) FORM SAMPLE
13 Appendixes
APPENDIX A – QRS-01A
Annex A - Corrective Action Request (C.A.R.) Form sample
Annex A - Corrective Action Request (C.A.R.) Form - Box content description
Box 1:
The auditor identifies the level of the Non Conformity raised
Box 2: The supplier shall identify the cause that took to the non-conformity raised.
Box 3: The supplier shall identify the immediate actions to be taken in order to avoid the same problem on the parts under production until the permanent action is in place.
Box 4: The supplier shall propose a consistent action to avoid the problem can emerge again.
Box 5: The supplier shall identify the planned completion date of the corrective action.
Box 6: Supplier Representative Name
Box 7: Supplier Representative Signature
Box 8: Date of definition of the root cause, containment action and corrective action.
Box 9: Supplier Representative Name
Box 10: Supplier Representative Signature
Box 11: Date of implementation of the corrective action. Note 9 – 10 – 11 shall be signed by the supplier after the completion of the corrective action.