ISRAEL AEROSPACE INDUSTRIES LTD.
MILITARY AIRCRAFT GROUP, LAHAV DIVISION
LAHAV 9001
QUALITY REQUIREMENTS
From Category 12 and 13 Vendors
CORRESPONDS TO THE RELEVANT PARAGRAPHS IN
AS9100 STANDARD REVISION C
Date: 05 July 2015
Authorized by: M. Gershburg - Quality Management Manager, Lahav
Revision: J
Table of Contents
1. GENERAL 4
2. OBJECTIVE 4
3. DEFINITIONS 4
4. CONTROL OF DOCUMENTS AND RECORDS (4.2.3/4.2.4) 5
5. QUALITY ASSURANCE SYSTEM REQUIREMENTS (4/5.5.2) 5
5.1. Responsibility and Authority 5
5.2. Quality Management System 6
5.3. Management Review (5.6) 6
5.4. Training (6.2) 6
5.5. Order Receipt 6
5.6. Contract Review (7.2.2) 7
5.7. Configuration Management (CM) (7.1.3) 7
5.8. Design Control (7.3) 7
5.9. Purchasing (7.4) 7
6. VENDOR RESPONSIBILITY AND SUPPLIERS CONTROL 8
6.1. Procurement Control 8
6.2. Flow Down of QA Requirements to Vendor's Subcontractors 8
6.3. Verification of a Purchased Product (7.4.3) 8
6.4. Changes in Vendor Work or Processes 9
6.5. Vendor Authorization 9
6.6. Accessibility to Lahav's Representatives and Lahav's Customers (7.4.2) 9
7. SPECIAL PROCESSES (7.5.2) 10
7.1. Special Processes Performance 10
7.2. IAI's Special Processes 10
7.3. Training (6.2.2) 10
7.4. List of Special Processes 11
7.5. Special Processes - Boeing Products 12
7.6. Special Processes - Lockheed Martin Aeronautics Products 12
8. PROCESS CONTROL 13
8.1. Process Control Performance (7.5.1) 13
8.2. Inspection and Testing (7.5.1.1) 13
8.3. Status of Inspections and Tests 16
8.4. Certificate of Conformance 16
8.5. Control of Lahav Furnished Equipment (7.5.4) 16
8.6. Preservation of Product (7.5.5) 17
8.7. Control of Inspection, Measuring, and Testing Equipment (7.6) 17
8.8. Internal Quality Audits (8.2.2) 17
8.9. Statistical Techniques (8.2.4) 17
8.10. Control of Nonconforming Product (8.3) 17
8.11. Corrective and Preventive Actions (8.5.2/8.5.3) 17
9. Avoidance of Counterfeit Components 19
10. Accompanying Documents 19
11. Environmental Protection and Safety 19
Appendix A Control of Documents and Records 20
Appendix B First Article Inspection (FAI) 29
Appendix C Certificate of Conformance 33
Appendix D Handling of a Nonconforming Product 35
1. GENERAL
This document defines the requirements for Lahav's vendors including the relevant Lahav's procedures for obtaining Lahav's approval for the supply of products to the company.
This document is an addition to and constitutes an inseparable part of the designated Quality Assurance requirements detailed in the Agreement/Purchase Order for the project. Lahav's Vendor/Subcontractor Manager is responsible for providing to Vendor/Subcontractor the updated designated Quality Assurance requirements.
The numbers written in parenthesis in this document correspond to the paragraphs in the AS9100 standard.
2. OBJECTIVE
To define the quality assurance requirements that Lahav's Category 12 and 13 Vendors must meet.
3. DEFINITIONS
(a) Product – Material, component, part, refurbished item, process and/or technology intended for Lahav's products, as well as auxiliary material that Lahav uses for its processes of manufacture/inspection/experimentation/ storage and manufacturing services, including engineering design.
(b) Vendor – A person or corporation supplying products, in accordance with conditions determined in a contract or in a purchase order.
(c) Manufacturer – A vendor who manufactures products in accordance with his own engineering design or accepted standard specifications.
(d) Subcontractor – A vendor who manufactures products in accordance with Lahav's and/or subcontractor's engineering design and/or designs/develops products in accordance with Lahav's and/or subcontractor's engineering specifications.
(e) Qualification Audit – Evaluation of the quality assurance capabilities of the vendor to act within the framework of the contract specifications, or defined quality standard specifications.
(f) Rating – Methods for evaluating vendor performance during a specified period, based on quality criteria and the meeting of delivery dates.
(g) Category 12 Vendor – A vendor who operates a quality management system at his facility and is able to provide documented proof of the performance of inspection actions complying with the specifications of major standards, not including engineering functions (manufacturing subcontractor only - Build To Print).
(h) Category 13 Vendor – A category 12 vendor who operates a quality management system that complies with the principles of standards specifications, including engineering functions (design and manufacturing subcontractor - build to specification).
(i) Q.M. – Quality Management.
4. CONTROL OF DOCUMENTS AND RECORDS (4.2.3/4.2.4)
The vendor will control documents and records in accordance with the AS 9100 standard.
In accordance with the type of record, the length of time that the record must be retained at the vendor's premises will be as defined in Appendix A to this document. The vendor must obtain prior authorization from Lahav Quality Administration before disposing of records relating to Lahav agreements/purchase orders.
5. QUALITY ASSURANCE SYSTEM REQUIREMENTS (4/5.5.2)
5.1. Responsibility and Authority
5.1.1. The vendor will run an AS 9100 standard quality assurance system, as well as additional requirements as defined in this document.
5.1.2. The vendor will submit to Lahav a copy of certification for its Quality Assurance System approval, valid for the relevant period of the agreement.
5.1.3. The vendor shall notify Lahav immediately upon any change in its AS9100 and/or ISO 9001 approval.
5.1.4. In accordance with Lahav's requirements, the vendor will submit a report detailing the status of the quality assurance system and will present failure analysis reports.
5.1.5. The vendor's Quality Assurance Manager will serve as the Focal Point for position holders in the Lahav Quality Management Administration.
5.2. Quality Management System
5.2.1. The vendor will manage the quality management system in accordance with the AS 9100 standard, the Quality Manual (4.2.2) and the requirements of this document.
5.2.2. Upon request, the vendor will submit the following documents to Lahav for authorization: Quality Assurance Program, Quality Assurance procedures, any other document.
5.3. Management Review (5.6)
The vendor will carry out a management review at least once a year, in accordance with the AS 9100 standard.
This review will cover the following issues:
· Customer satisfaction
· Customer complaints
· Internal quality audits
· Status of non-conforming products
· Continuous improvement in the level of quality
5.4. Training (6.2)
The vendor will train and qualify his workers in accordance with the AS 9100 standard and Lahav requirements.
5.5. Order Receipt
5.5.1. Upon receipt of an order, the vendor must ensure that the following data are clearly defined (as required):
(a) The name of the product or other clear identification, applicable version numbers of specifications, blueprints, process specifications, inspection instructions, and other relevant technical data.
(b) Specifications for the authorization of the product, procedures, equipment, tools.
5.5.2. The vendor must immediately inform Lahav's Quality Management Director (in writing) when he receives an order from Lahav that deviates from his current authorization.
5.6. Contract Review (7.2.2)
The contract will be reviewed in accordance with the AS 9100 standard and the requirements of this document.
5.7. Configuration Management (CM) (7.1.3)
The vendor will maintain a Configuration Management (CM) system that meets AS9100 requirements. The vendor will carry out the CM control for all the applicable engineering documents and changes relating to the work produced for Lahav under the order/agreement, including control of up-to-date and full release of documents and controlled distribution.
5.8. Design Control (7.3)
The vendor will carry out design control in accordance with the AS 9100 standard and the requirements of this document.
For purchase orders that include design, the following will be specified, as required (not including off the shelf products):
· Specifications for design, testing, and inspection and instructions for acceptance by the vendor
· Test samples specifications (including: manufacturing methods, number of samples, storage conditions, additional specifications) for the authorization of the design, inspection, investigation, or review.
· Specify, as applicable, any critical items, including any Key characteristics, for these items.
5.9. Purchasing (7.4)
5.9.1. The vendor will carry out the purchasing process in accordance with the AS 9100 standard and the requirements of this document.
5.9.2. The vendor will purchase the materials, processes, and services that are not supplied by Lahav, only from sources that IAI has authorized in advance.
6. VENDOR RESPONSIBILITY AND SUPPLIERS CONTROL
6.1. Procurement Control
6.1.1. The vendor is responsible for effective control of his sources of procurement and for the compliance with quality specifications of all the products/services supplied within the framework of the purchase order. The vendor will exercise control over his purchasing documents and will ensure the incorporation of all the applicable requirements, including quality assurance requirements.
6.2. Flow Down of QA Requirements to Vendor's Subcontractors
6.2.1. The vendor will pass all the applicable of quality assurance requirements defined in this document (flow down) to his subcontractors, including the designated Quality Assurance requirements document detailed in the order/agreement for the project.
6.2.2. The vendor will submit to Lahav full information regarding the qualifications of his subcontractors.
6.3. Verification of a Purchased Product (7.4.3)
6.3.1. The vendor will carry out verification actions on a product purchased by him from his vendors. These actions are likely to include:
(a) Obtaining proof of the quality of the product from the vendors (such as: accompanying documentation, compliance certificates, test reports, statistical records, process control)
(b) Inspection and compliance inspection at the vendor's facilities
(c) Inspection of required documentation
(d) Inspection of the products upon their receipt
The purchased product will be handed over for use or for the performance of processes only after having been certified as complying with the defined purchase specification requirements.
6.3.2. When the vendor relies on test reports for the verification of the product purchased, the data in these reports must comply with applicable specifications. From time to time, the vendor will check the validity of the test reports of the raw materials.
6.3.3. Frequency and sampling plan for laboratory testing of incoming products purchased at the vendor's facilities will be per IAI Process Standards PS 850110 (fasteners) and PS 850100 (raw materials).
Note: A vender who has a "Framework Agreement" with IAI (1E Type Supplier) will inspect and test the product purchased, in accordance with the Quality Assurance plan. Supplier (1E) certification is under the responsibility of IAI's central authorization.
6.4. Changes in Vendor Work or Processes
6.4.1. The vendor is required to notify Lahav prior to any transfer of significant work to a new facility, and/or change of vendor's work or processes concerning the Purchase Order, and/or change of ownership of the company.
6.5. Vendor Authorization
6.5.1. Lahav reserves the right to rescind the authorization of the vendor at any time, partially or wholly. The ongoing validity of an authorization depends on proof of compliance with the specifications stipulated above and the proper quality of the products.
6.6. Accessibility to Lahav's Representatives and Lahav's Customers (7.4.2)
6.6.1. Lahav and/or Lahav's customers, government, and the official authorities, shall be entitled to have their representative, granted access to all areas at vendor's premises or at vendor's lower tiers suppliers, in which work on Lahav's order is being performed, to evaluate, validate, inspect and observe the tests and as well as the applicable documentation of all products to be supplied by vendor under Lahav's order and to verify their quality.
7. SPECIAL PROCESSES (7.5.2)
7.1. Special Processes Performance
7.1.1. The vendor will ensure that he and/or his sub-tier suppliers carry out the special processes at vendors who are authorized by IAI / the customer.
7.2. IAI's Special Processes
7.2.1. A vendor or vendor's subcontractor carrying out special processes in accordance with the specifications of Israel Aerospace Industries (IAI) must perform these processes using only approved vendors that appear in the IAI approved vendor list. The vendor is required to use the latest revision of IAI's process standard, which can be obtained from IAI's website: http://www.iai.co.il. From the main menu select "Suppliers net"; "My site"; type the user name & password; then select "Information"; "Eng document List"; "IAI PS".
7.2.2. Any special process carried out in accordance with IAIs' specifications will be subject to a review by IAI's qualification entity of the engineering company and will require its approval.
7.3. Training (6.2.2)
7.3.1. The employees of a vendor who are involved in special/critical processes will be trained and qualified to relevant standards by a qualified trainer.
7.3.2. Electronic industry workers will be trained in accordance with the following standards:
(1) IPC-A-610, Class 3 - “Accepting of Electronic Assemblies”
(2) J-STD-001 - “Requirements of Soldering of Electrical and Electronic Assemblies”
7.4. List of Special Processes
7.4.1. Special processes are defined in the specification and require vendor's certification. Following are examples of the special processes:
(1) Mechanical and Thermo - Mechanical Processes:
· Screws and threads by rolling
· Shot peening and forming
· Heat forming
· Hot dimpling
(2) Thermal and Chemical Processes:
· Chemical milling
· Heat treatment
· Surface and coating treatment
· Laminated structures
· Adhesive bonding
· Electro-chemical processing
(3) Metallurgical Processes
· Castings and forgings
· Welding, soldering and brazing
(4) Computer Based Processes:
· Digital Product Definition (DPD) (Lahav Procedure 300.26.07)
(5) Electronic Industry Processes:
· Soldering
· Manufacture and assembly of printed circuit boards
· Conformal coating of printed circuit boards
· Operation of an ESD system
(6) Tests:
· Non destructive testing
· Electrical conductivity testing
7.5. Special Processes - Boeing Products
7.5.1. Special/critical processes that are carried out for orders/agreements from Boeing must be approved by Boeing. The approved special processors appear on the Boeing D1-4426 public website at: http://www.boeingsuppliers.com/d14426/.
7.5.2. Vendor when required to use D1-4426 approved special processors, must contain a D1-4426 compliant Certificate of Conformance along with a screen print from the Boeing D1-4426 Public Web site to provide objective evidence of their D14426 approval. It is the Vendor's responsibility to monitor and assure only D14426 approved special processors are used for applicable Boeing assemblies/products/hardware. Immediate notification must be sent to Lahav when compliance to these requirements is not met.