Q110 Quality Program Requirements Subcontractors

User Manual: Q110 Quality Program Requirements Subcontractors

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Q-110 1 rev 7/15/14

Quality Program Requirements for ADTRAN Contract

Manufacturers

Q-110 2 rev 7/15/14

Foreword

ADTRAN designs and manufactures telecommunications equipment that has an enviable

reputation for high reliability and quality content--a reputation that will be maintained

and enhanced. This reputation is due to equipment design, production standards, and

commitment by all management and operating personnel to the quality concept.

The elements contained in this document are those employed by ADTRAN to achieve its

basic quality goals, which are probably best described as good commercial quality

practice and are fundamental to any form of management or quality control. This

document shall serve as both a requirement and a general guide to the extent of quality

control that ADTRAN anticipates from Electronic Manufacture Services/Contract

Manufacturers (CM) Suppliers.

ADTRAN will assist CM Supplier in any reasonable manner to establish an understanding

of and compliance with our contract requirements. The Contract Manufacturer must be

particularly cautioned that no departure from any specification is permitted without a

contract change. Clarification of this or any other ADTRAN document affecting contract

compliance may be obtained through the ADTRAN International Operations

Organization.

__________________________________

George Giles / Manager, SQE-QA-EMS-FQ

__________________________________

Gerry Kelley / Senior Manager,

International Operations/Global Repair Services

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Reference

• IPC-J-STD-033 Standard for Handling, Packing, Shipping and Use of Moisture/Reflow

Sensitive Surface Mount Devices

• IPC/EIA/JEDEC J-STD-002 Solderability Tests for Component Leads, Terminations, Lugs,

Terminals and Wires

• Industry Standard Code 39 Barcode Labels and Printing

• ANSI/ISO/ASQ Q9001-2008: Quality Management Systems (QMS) Requirements

• TL 9000 Quality Management System Requirements

• IPC-A-610 Acceptability of Electronic Assemblies

• IP-CM-770 Guidelines for Printed Board Component Mounting

• ANSI/ESD S20.20 Electrostatic Discharge Control Program Standard

• Q-50 Workmanship Standard

• Q-100 Quality Program Requirements for ADTRAN Suppliers

• ISO 2859 Sampling Procedures for Inspection by Attributes Package

• QA10-16 PCB Impedance Testing

• ISO 14001 Environmental management systems – Requirements

• ISO 18001 Occupational Health and Safety Management System

• ISO 26000 Guidance on Social Responsibility

• ANSI (American National Standards Institute) QS 9000 Requirements

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1.0 GENERAL

1.1 Intent

The intent of this document is best defined as GOOD COMMERCIAL PRACTICE.

When viewed in this context, the requirements herein can be readily and

economically satisfied by competent commercial Contract Manufacturers and

Purchased Assembly Suppliers.

1.2 Scope

When specified in the contract, the requirements contained in this document must be

adhered to by ADTRAN Contract Manufacturers. In the event a Contract Manufacturer

desires an exception to the requirements contained herein, a request delineating the

exception must be submitted for ADTRAN approval prior to acceptance of a contract.

If a conflict exists between the provisions of this document and those of the contract,

the contract shall take precedence.

1.3 CM Qualification

Qualified Contract Manufacturers will be determined by supplier capability and product

evaluations, compliance of procured material with ADTRAN requirements, and the

promptness and effectiveness of corrective action taken. Continued qualification will

be contingent upon continued quality of performance, satisfactory results of Quality

System Audits, and/or external TL9000 audit reports.

1.4 ADTRAN Supplier Capability Assessments (SCA)

Contract Manufacturer facilities and operations may be surveyed either before or after

the placement of contract. The capabilities to meet ADTRAN requirements and to

supply a product of consistent quality will be evaluated. Audits may be scheduled and

conducted if required, to determine compliance with our purchase requirements and

the requirements of this document.

1.5 ADTRAN Source Inspection

ADTRAN reserves the right to Source Inspect product at the Contract Manufacturer’s

facility after reasonable notice of such inspection. Final acceptance of all material will

be made at ADTRAN regardless of the results of Source Inspection.

1.6 Deviations and Substitutions

ADTRAN expects the supplier to comply with the requirements of the

purchase order. No deviations and/or substitutions in material, design,

specifications, or operating performance are permissible unless

documented by a purchase order change. Such changes are permissible

for single lots if approved by the ADTRAN Non-Conforming Material

Report, Waiver or Deviation process.

1.6.1 Operational Change Verification

The supplier shall notify ADTRAN when significant process changes

are made to operations used in the production of a product or

material purchased by ADTRAN. Examples of major process changes

include a new operator, new machine, new technique, materials, and

a change in sub-suppliers.

1. ADTRAN shall be notified prior to the change being made on any ADTRAN

product.

2. A critical examination shall be made of the first unit(s)

processed after the change is implemented.

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3. Notification to ADTRAN may be in the form of a letter or email.

4. The notification shall identify the type of change, date of

change, and impact to ADTRAN.

5. The notification shall be sent to the Purchasing Commodity

Manger, the Purchasing Buyer and/or Supplier Quality Engineer.

1.7 Independent Distributors/Brokers (D/B)

Upon request from ADTRAN the CM may source parts/components from its D/B for use

in an ADTRAN product. The follow requirements shall apply for D/B used by the CM to

supply materials on the behalf of ADTRAN.

1.7.1 The CM shall obtain in writing (email, deviation, etc.) ADTRAN’S approval prior

to initiating a purchase on the behalf of ADTRAN and or using the material in

an ADTRAN product.

1.7.2 The CM shall have a documented program for the selection, approval and

control of Independent Distributors/Brokers.

1. D/B materials shall be subjected to an incoming inspection routine with the

results of the inspection documented and, upon request, available for

review by ADTRAN.

1.8 Raw Material Sales (RMS) to Contract Manufacturer (CM)

ADTRAN may sell raw material to be used in the fabrication of ADTRAN assemblies.

When this is required, the CM will provide a purchase order with an agreed quantity

and price. The purchase order will be entered as an ADTRAN sales order and

processed for shipment.

1.8.1 RMS Material Date Code Requirements

RMS material is NOT subject to date code requirements specified in Q100. Batteries,

epoxies and other perishable items are subject to manufacturer shelf life guidelines.

The use of Aluminum Electrolytic capacitors and Printed Circuit Boards (PCBs) will

follow the below mentioned criteria.

• WVR: Blanket Engineering Waiver, denoted by a purple sticker with the letters

WVR. This applies only to electrolytic capacitors in class codes 3136 & 3137.

o ADTRAN’S Q100 document requires that all electrolytic capacitors be

used within the 18 month DC threshold. However, the managers of

ADTRAN’S Power Supply and Reliability groups have agreed to deviate

from the Q100 requirement and grant a blanket waiver for parts whose

DC falls between 18 and 36 months. No further paperwork needs to be

filed for this material and they can be used in all ADTRAN products and

locations.

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• PCBs

o Hot Air Solder Leveling (HASL) ≤ date code + 24 mo. (without

solderabilty testing)

o Electroless Nickel Immersion Gold (ENIG) ≤ date code + 18 mos.

(without solderabilty testing)

o Immersion Silver (ImAg) ≤ date code + 12 mo. (without solderability

testing)

NOTE: Material outside these limits does not mean its scrap but its use shall be strictly

approved by ADTRAN Engineering via Q100 deviation/waiver process and may require

additional testing.

1.8.2 Non-Conforming RMS Material

All material used on ADTRAN product shall be listed in the ADTRAN Approved Vendors

List (AVL) and be defect free. RMS is material determined to be

wrong/discrepant/damaged upon initial receipt.

1. The CM shall document the finding and report the discrepancy to ADTRAN

International Operations and Supplier Quality (SQ) Engineering. The report

shall include the following information at a minimum:

• ADTRAN PN

• MFR PN

• Quantity received and Quantity defective

• Sales Order and Purchase Order

• Problem description

• Digital images of PN label and any other images helpful to problem

description and root cause

2. The CM will also be responsible for filinga discrepancy report in BaaN session,

“Maintain RMS Discrepancy”, adsfco147m000.

3. If replacement material is NOT required, the purchase order will be credited at

the same unit cost the supplier was invoiced.

1.8.3 Obsolete RMS Material

Obsolete components due to Engineering Change Orders (ECOs), changes in

production schedules or AVL changes may or may not be returned to ADTRAN.

1. If the components can be consumed on other ADTRAN products, then ADTRAN

will issue a purchase order to the CM for the component at the cost paid by the

supplier.

2. If the components cannot be used, the CM will be authorized to scrap the

material and a purchase order will be issued by ADTRAN to cover the cost of

the component.

1.9 Return to Stock Materials

In conjunction with the RMS process ADTRAN may require materials to be returned as

part of a buyback, purge, or ECO change. Appendix 1 provides the process flow for

RTS materials.

1. The process flow is predicated on an ADTRAN representative being at the CM to

approve the shipment of the product.

2. In the absence of an onsite ADTRAN representative the CM shall notify the

ADTRAN Business Unit Manager or the ADTRAN International Operations

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Coordinator of the RTS and provide inspection reports to the ADTRAN Supplier

Quality Engineer for final acceptance of the material.

1.10 First Article Inspection (FAI) Requirements

First Articles are required for all New Product Introduction (NPI) Assemblies,

subassemblies and mechanical and formed part numbers. This may include current

assemblies that incur major changes in Form-Fit-Function.

1.10.1 FAI Compliance

The CM/supplier shall meet the requirements of the Bill of Material (BOM), assembly

drawing(s), engineering specification(s) and Purchase Order. All dimensions are to be

considered critical.

1.10.2 FAI Report

A completed ADTRAN First Article Inspection (FAI) Report form (Q110-1, page 1and 2)

shall accompany all shipments of First Article units (Identify the container or box that

will contain the FAI documentation with a First Article low adhesive label).

1. The FAI report shall provide actual measurements in comparison to the

specifications. A working print of the BOM and all assembly drawings shall be

included in the FAI documentation package.

2. FAI documentation and shipment tracking must be forwarded to ADTRAN

electronically to the following email address: FIRST_ARTICLE@ADTRAN.COM.

3. First Article units shall be properly labeled by a First Article low adhesive label.

The First Article label (One per overpack) will need to be placed beside the

blisterpack label. If multiple overpack boxes are used a First Article label will

need to be placed on each overpack box. Each overpack box must be sent with

the proper paperwork to ensure receipt and payment. A minimum of 5 units

will need to be shipped to ADTRAN for first article inspection.

1.10.3 Deviations to Specifications

A request for deviation to a drawing or specification must be submitted and approved

in writing by ADTRAN prior to first article submission. Once approved, the deviation

must be clearly documented and attached to the ADTRAN First Article Inspection

Report.

1.10.4 Review of FAI Submissions

The first articles shall be inspected for workmanship and labels will be scanned to

assure proper barcode printing.

1. ADTRAN will review and approve/reject all First Article submissions. The CM

may be required to re-submit First Articles based on engineering review.

2. The ADTRAN International Operations department will notify the CM of

disposition of all First Articles submissions in documented form (i.e. email, fax,

etc.).

1.11 PCB Impedance Testing

ADTRAN had developed PCBs that will require impedance test verification prior to

production usage. PCBs requiring impedance testing will contain Test points for

Impedance Tolerance verification. The following shall apply for PCBs requiring

impedance test verification.

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1. The CM shall perform impedance test verification prior to production, and the

results of the testing shall be included in the supplier’s weekly quality report.

2. For CMs performing the impedance test verification ADTRAN shall provide the

CM a copy of procedure QA10-16 as a reference procedure.

3. The CM shall be responsible for ensuring that the requirements of QA10.16 are

implemented within their internal testing procedures.

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2.0 OTHER BUSINESS REQUIREMENTS

2.1 Direct Turnkey Suppliers.

Direct Turnkey are suppliers which ADTRAN has authorized the CM to place

purchased orders, and schedule and change material deliveries directly with the

supplier.

2.1.1 The CM is restricted from any interactions with the ADTRAN supplier for on

cost, engineering and process changes, and quality related issues and

improvements.

2.1.2 The CM shall immediately notify ADTRAN International Operations Organization

of Direct Turnkey Supplier issues (delivery, quality, etc.), and include a status

of the issue.

1. Notification may be in the form of a telephone message, email, or fax.

2.2 Full Turnkey Suppliers

Turnkey suppliers are suppliers listed on the ADTRAN AVL, in which the CM is

authorized to purchase and receive parts directly from the supplier for use in an

ADTRAN product.

2.2.1 The CM shall be responsible for addressing quality issues associated with a

turnkey suppler and shall notify ADTRAN of the quality issues. Notification may

be in the form of an email. The CM may be required to report the status of

open turnkey supplier’s issues in a formal report.

2.2.2 When quality issues directly impact ADTRAN production requirements the CM

shall immediately notify ADTRAN, and include a status of the corrective actions.

2.2.3 When quality issues are not addressed in accordance with CM requirements the

CM shall escalated the issue to ADTRAN Supplier Quality Engineering

Organization for final corrective action and resolution of the issue.

2.2.4 Other issues that cannot be satisfactorily resolved between the CM and the

supplier shall be escalated to the ADTRAN International Operations for final

corrective action and resolution of the issue.

2.3 Open Source Suppliers

Open source suppliers are supplier listed on the CM’s AVL and listed as a sub-

supplier to the CM on the ADTRAN AVL. The CM is authorized to use the parts in

the production of an ADTRAN product.

2.3.1 Initial Approval: The CM shall request ADTRAN’S approval to approach a

supplier on providing an ADTRAN commodity. The CM should provide

information on the supplier’s capability to provide the commodity.

1. The CM shall not provide any ADTRAN’S proprietary information

(documents, drawings, etc.) to the supplier without ADTAN’s approval.

2.3.2 Qualification: ADTRAN and the CM shall decide the method of open source

supplier qualification. Qualification criteria shall include:

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1. Supplier Capability Assessment (may be performed by CM and/or ADTRAN).

2. FAI submittal in accordance with Section 1.10.

3. ADTRAN 1st production buy-off (performed at CM and as an incoming

inspection at ADTRAN).

2.3.3 The CM shall be responsible for addressing open source supplier quality issues

identified during production, Finished Goods and in the field.

1. ADTRAN shall be notified of product and customer affecting issues (i.e.,

issues affecting the form fit, or function of a product).

2.4 Direct Fulfillment (DF) Requirements

ADTRAN is committed to offering our customers exceptional quality and service.

To ensure timely shipments to its customers ADTRAN may establish a DF

agreement with the supplier. When this agreement is made the supplier is

ultimately responsible for product quality and safety.

1. The supplier shall ensure that only products that meet the requirements set forth

in the product and this specification will be acceptable for direct fulfillments order.

2. Unless otherwise specified, prior to first DF shipment the product shall be

submitted to ADTRAN in accordance with Section 1.10 “First Article Inspection

Requirements.

3. Products approved for DF shall be subjected to internal supplier Out-of-Box audits.

4. To ensure that products are being shipped in accordance with ADTRAN

specifications to the customer, all products are subject to audit at the supplier’s

location.

3.0 ADTRAN SUPPLIER CORRECTIVE ACTION REQUIREMENTS

When it has been determined that corrective action is required from a supplier, an

External Supplier Corrective Action Request (ECAR) will be submitted to the responsible

supplier.

3.1 Supplier ECAR Actions:

3.1.1 The supplier shall use the (10 – 20 Rule) for addressing an ECAR. (See Note

1).

 10 business days from the receipt of the ECAR to provide immediate actions for

correcting the nonconformance.

 20 business days for submitting a final corrective action plan.

Note 1: Based on the severity of issue, the response time may change. For a customer

impacting condition, the response time is 5 Business days.

3.1.2 If final root cause cannot be provided by the response due date, at a minimum

the corrective action should be completed and submitted to Purchasing.

3.1.3 The final corrective action response shall include the following information:

 The initial actions taken to contain the problem

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 A description of the root cause of the problem

 The proposed corrective action or solution to the problem

 The actual or planned implementation date of the corrective action

 The plans for verifying that the corrective action was effective, and

 The actual or planned date of the verification of effectiveness

3.1.4 Inadequate and/or untimely responses to ECAR will result in additional actions

on the behalf of ADTRAN. Actions may include demerits to supplier

performance rating, probation, and/or disqualification.

4.0 SUPPLIER QUALITY MANAGEMENT SYSTEM

ADTRAN suppliers should have an established-documented and maintained Quality

Management System (QMS) which complies with the requirements of an accredited QMS

such as:

• ANSI (American National Standards Institute) QS 9000 Requirements

• ISO (International Organization of Standards) 9001 QMS Requirements

• TL (Telecommunications) 9000 QMS Requirements

ADTRAN is an ISO 9001/TL9001 registered company. The ADTRAN Quality Policy may be

viewed at: ADTRAN Company Web site - Quality Policy.

4.1 Supplier Quality and System Certifications

The supplier shall provide ADTRAN copies of its quality and other system

registered certifications.

4.1.1 At a minimum the latest version of the suppler certificates shall be provided

when an update or release of the certificate is made.

5.0 SUPPLIER ENVIRONMENTAL & HEALTH AND SAFETY MANAGEMENT SYSTEM

ADTRAN suppliers should have an established-documented and maintained Environmental

Management System (EMS). In addition to having an established EMS the supplier should

have an established Corporate Social Responsibility (CSR) Program. The EMS and CSR

program should comply with the requirements of an accredited standard such as:

• ISO 14001 Environmental management systems – Requirements

• ISO 18001 Occupational Health and Safety Management System

• ISO 26000 Guidance on Social Responsibility

ADTRAN is an ISO 14001 company, and has established a CSR program that focused on

the “Sustainability” aspects of an environmental and sociability system. ADTRAN

Environmental Policy and Sustainability commitment may be viewed at: ADTRAN

Company Web site - Environmental Policy-Sustainability.

5.1 Supplier Environmental, Health, and Safety (EH&S) Certifications

The supplier shall provide ADTRAN copies of its EH&S system registered

certifications.

1. At a minimum the latest version of the suppler certificates shall be provided

when an update or release of the certificate is made.

6.0 SUPPLIER CAPABILITY ASSESSMENT ELEMENTS

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ADTRAN has established 25 business element requirements for procurement and for ensuring

that purchased items and supplier processes conform to the product/material drawing,

specification, and procurement requirements.

Note: Some business elements may not be applicable to a supplier; for example Section 6.10

“Moisture Sensitive Devices/materials” may not be applicable to a metal supplier.

6.1 Quality System and Management Responsibility

• The supplier shall have a documented quality system procedure to ensure product

conformance. The supplier shall establish and maintain documented procedures for

planning and implementing internal quality audits to verify quality activities and the

effectiveness of the quality system. The internal audit shall be conducted at

prescribed intervals with results reported at the management review.

• Resources for the implementation of a Quality Management System will be required

from the supplier.

• Internal Quality audits must be formally planned, performed at pre-specified

intervals and communicated to management during management reviews. The

supplier must also perform formal procedure reviews at a pre-determined frequency

to ensure that the documentation is current and relevant.

6.2 Development and Design

• The supplier should establish and maintain a documented product development

procedure to control the design process from the initial product conception to the

final product release. This procedure should include a flow chart overview of the

design cycle, and the design review documentation templates.

• For each individual design project, a milestone plan detailing the development

phases and their duration and design review dates should be created and agreed

upon with the customer. Any modifications to this plan after the initial release must

have the customer’s approval.

• The initial design phase should include detailed customer specifications, including all

applicable standards (those defined by the customer and those which are

considered mandatory for the product given its intended use – Compliance Marking

(CE), Network Equipment Building System (NEBS), etc.) and target costs. Both the

supplier design manager and the customer representative should sign off. These

specifications should be available to all members of the design team.

6.3 Document and Data Control

• The supplier shall establish and maintain a documented procedure to control all

documents related to the requirements of the supplier’s quality system. The

procedure shall not only address the control of the supplier’s documents, but also

the control of customer supplied documents.

• The supplier shall maintain a master list, identifying the current revision status of all

controlled documents.

• Pertinent and current issues of appropriate documents shall be available at the

locations where the operations that impact quality are being performed.

• The supplier shall establish and maintain a documented procedure for the

identification, collection, indexing, access, filing, storage, maintenance, and disposal

of quality records.

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6.4 Change Management

• The supplier shall establish and maintain a formal documented procedure to control

elements related to the requirements of a formal change control system. The

procedure shall not only address the control of the supplier’s documents, but also

the control of customer supplied documents (such as drawings, Specifications, etc.).

The procedure shall describe the review, approval, release, distribution and revision

of change documents in a timely and controlled manner.

• Engineering Change Orders (ECO) whether design / procedural, issued on a

temporary or permanent basis must be adequately controlled and communicated to

all affected organizations.

• Records of the changes and the results of the review of changes including any

necessary actions shall be maintained.

• The supplier must have an internal process capable of transmitting applicable

change (ECO) requirements from a customer to all downstream suppliers in an

effective and timely manner.

6.5 Supply Chain Management (Purchasing)

• The supplier shall ensure the adequacy of specified purchase requirements prior to

communicating with the supplier. The documented purchasing procedure shall

include product requirement definition.

• The supplier shall establish and implement the inspection or other activities

necessary for ensuring that purchased product meets specified purchase

requirements.

• The supplier shall establish criteria for selecting suppliers including the quality

system and specified quality assurance requirements.

• The supplier shall have a documented procedure for generating purchase orders.

Purchasing information shall describe the product to be purchased, including the

appropriate requirements needed for approval of product. Suppliers must also

ensure compliance to special instructions that are requested by ADTRAN and be

capable of flowing down ADTRAN requirements to second tier Suppliers.

• The supplier must be able to demonstrate an effective Purchase Order (PO)/material

requirement process.

• The supplier must have a defined process on escalating delivery requirements with

their downstream suppliers. The process must define the appropriate times to

escalate and establish the steps involved.

6.6 Supplier Management

• The supplier shall establish and maintain a formal documented process to qualify

vendors. This procedure shall define the criteria for the qualification/disqualification

of a vendor.

• The supplier shall have a documented procedure to evaluate risk analysis and

maintain the ability to communicate to management the risk within the supply

chain.

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• The supplier shall have a documented process for corrective action that provides

feedback to suppliers on all quality and performance issues.

6.7 Receiving

• The supplier shall have a documented procedure to ensure that incoming material

conforms to specified requirements prior to its usage. If incoming inspection is not

required, the supplier must demonstrate adequate controls and justification in place

to ensure that the qualities of the material received are acceptable.

• The supplier shall establish and maintain a specific area that clearly segregates

incoming material from material already received.

• The supplier shall ensure that there is a documented process to accurately label

crates, boxes, shipping containers, etc.

• The supplier must establish a process that tracks the recall and replacement of non-

conforming material that is in current production.

6.8 Demand and Production Planning

• The supplier shall establish and maintain a forecasting procedure that is capable of

handling the requirements placed by ADTRAN. This procedure shall define the

prescribed interval to update the accuracy of the forecast.

• The supplier shall have a Material Requirements Planning (MRP) system. The MRP

system shall have the ability to feed into the purchasing of materials, synchronize

demand and supply.

• The supplier must have a procedure to track delivery performance on a weekly basis

and maintain a feedback system on performance for its customers.

• The supplier shall have a process for capacity planning.

• The supplier must have an effective process that handles material shortages and

helps prioritize and expedite a recovery effort to bring back production up to speed.

6.9 Inventory Management

• The supplier should have a documented inventory management process that

addresses access control of the warehouse, the provisioning of materials that are

impacted by engineering change, and excess/obsolete inventory review process.

• The supplier shall establish an inventory monitoring and management system.

Whenever appropriate, the inventory items should be categorized based on their

value and/or lead-time. The inventory items should be properly identified with their

part number.

• The supplier should establish a mechanism to monitor the materials in their supply

chain. In case of materials shortage, a proper escalation process should be in place

to resolve the key shortage issue including a notification to ADTRAN.

6.10 Moisture Sensitive Devices/materials (MSD)

• The supplier shall establish a documented program as to how its handle MSD

materials in accordance with the JEDEC requirements (J-STD-033).

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• The supplier shall have procedures and facilities for opening, inspecting, sealing and

storing packages containing MSDs in accordance with JEDEC requirements.

• Some method of dry storage facilities (dry nitrogen, dry air, and desiccant) shall be

available as required in the component storage area, manufacturing assembly

areas, and repair areas.

6.11 Process Control

• The supplier shall establish documented procedures defining all manufacturing steps

for a product.

• A formal sign-off process is required prior to placing new equipment into

manufacturing operations. Records for all process change and equipment must be

maintained.

• The supplier shall establish and maintain a documented procedure to promptly

advise the customer prior to transferring work to another location than that

described in the quality plan or otherwise initially agreed to with the customer.

• The supplier shall develop a planned preventive maintenance system requiring

procedures, predicative maintenance and replacement schedules.

• In case of components or materials that are MSD or Electrostatic Sensitive Devices

(ESD ), procedures must clearly indicate the process for handling, storage,

packaging, transportation and review of these materials.

• Traceability for all materials must be clearly identified. This requirement includes all

raw material, Work-In-Progress (WIP) and finished goods. The processes should be

established in accordance with Industry procedures such as IPC-A-610, IP-PA-770,

and ANSI 20.20.

• Production materials that are build up as a kit for an aggregate assembly must be

tracked and controlled to ensure accuracy and completeness prior to issuance to the

production floor. Verification of the work instructions, identification and part

shortage issues for kits must be clearly defined.

• All points to be soldered (terminal, leads, stranded wire, etc.) shall meet the

solderabilty requirements defined in IPC ANSI / J-STD-002 - 4.2 and 4.3.

6.12 Corrective Action and Non-Conforming Processes

• The supplier shall establish and document a system to control product that does not

conform to specified requirements and ensure that the problem is contained, root

cause is determined and preventive measures are established. The system should

provide for identification, evaluation, and disposition of non-conforming product.

• Adequate facilities should be provided to analyze the root cause of non-conforming

product. The throughput period should be agreed upon with the customer –

normally two weeks. For products that have failed external to the supplier’s

manufacturing facility.

• A full Failure Mode Analysis (FMA) must be carried out. The quality organization

must be responsible for determining the failure mode, the root cause analysis and

the corrective/preventive actions taken to prevent a reoccurrence. Subsequent to

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this, a detailed failure analysis report should be issued to the customer for each

failure mode.

• All corrective action results must be made available at internal management reviews

and available to the customer upon request.

• The supplier shall establish a documented Return Material Authorization (RMA)

process for customer returned material.

6.13 Process Improvement Program

• The supplier shall establish and maintain a documented Quality Improvement

Program to improve the quality and reliability of the processes/product. The

program shall be active and contain a prioritized list of scheduled quality/reliability

issues being addressed.

6.14 Inspection and Testing

• Test plans shall be documented (including a flow diagram for all inspection points)

and all results must be recorded. The test plan should also include acceptance

criteria for the tests and inspections.

• Inspection and testing results shall be recorded and analyzed using control charts or

a similar technique as appropriate for the purpose of identifying problem areas and

monitoring the effectiveness of the quality system.

• Repair or rework product shall be inspected in accordance with the defined quality

plan. Repair and return products shall also be subjected to the appropriate test(s)

to ensure conformance to product specification.

• Records shall be maintained to provide evidence that the inspection and testing

have been completed. All inspection or testing activity shall have detailed

documentation, status identification and be available for inspection personnel.

• Product should not be shipped until all inspecting and testing activities have been

completed and verified as conforming to specific requirements. ADTRAN requires

an out of box audit of product using an approved sampling plan per ISO 2859 –

International Standards: “Sampling Procedures”. All products must have a

documented test plan.

6.15 Inspection, Measuring and Test Equipment

• The supplier shall establish processes to ensure that the measurement and test

equipment is acceptable for use, maintained to suitable accuracy and protected

from damage and deterioration during handling and storage.

• All applicable equipment in the calibration program shall be clearly identified with

necessary information to enable calibration, traceability and status.

• Measurement and test equipment shall be verified at specified intervals, or prior to

use, against measurement standards traceable to international or national

measurement standards.

• Any out of calibration measurement or test equipment shall be documented and the

status shall be clearly identified. The supplier shall have a procedure to address

active equipment found to be out of calibration.

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• Any contracted calibration services or labs shall be accredited to the appropriate

national or international standards within the industry.

• The supplier shall have a defined and effective Preventive Maintenance program

that addresses all production and non-production related services and equipment

that could impact the product received by ADTRAN.

6.16 Field Quality and Customer Returns

• The supplier shall establish a documented procedure to address the return and

repair process. This procedure should include the movement (steps taken) of

material through all operations.

• The supplier shall have the capability to track field turnaround time.

• Failure analysis should be conducted for each ADTRAN complaint and a documented

FMA process must be available.

• For No-Trouble-Found (NTF) cases, ADTRAN should be notified in an appropriate

manner. For cases that have been confirmed as a quality issue, a formal corrective

action process should be applied to each complaint/return, and ADTRAN should be

notified of the result of the FMA and corrective action plan.

• Customer returns and complaints must be recorded, and proper statistic techniques

should be applied to monitor ADTRAN’S return rate.

6.17 Customer Support and Satisfaction

• The supplier must have a documented procedure for Customer Support. The

procedure must include elements or sections that describe technical support, points

of contact, dedicated account managers (where applicable), forms/duration of

support, geographical region of support (where applicable) and a customer

complaint system.

• An effective Customer Satisfaction process must be in place with well-defined

metrics that quantifies customer satisfaction surveys and customer complaint

response times. Suppliers must have a formal and effective customer complaint

system.

• The Customer Satisfaction process must define clearly the interface with the

Management Review process. Metrics such as number of complaints, response times

and survey results must also be used to communicate the effectiveness of the

customer satisfaction process at the Management Review.

6.18 Reliability Program

• The supplier must establish and maintain a design reliability program to predict and

measure the reliability of new or modified products. As necessary the program must

include the review of software reliability and reliability testing on work in process to

ensure compliance. The program must also ensure that if the results do not meet

ADTRAN expectations, corrective actions must be implemented. As part of this

program, the product’s life cycle should be determined with both the early life,

Mean Time Between Failure (MTBF) and steady state failure rates defined.

• The supplier must ensure that all sub-components meet the reliability requirements

specified for the products intended use. There should be documented criteria

Q-110 18 rev 7/15/14

regarding the selection process for commercial, industrial and military grade

components.

• The design change procedure shall specify the reliability levels required for the

individual products. When an ECO is introduced, and if ADTRAN or the supplier

reliability manager deems it necessary, the reliability level should be re-assessed.

6.19 Disaster Planning and Security

• The supplier shall ensure that copies of Quality records / data / software are stored

either off-site or within fireproof storage on-site. The supplier must also ensure that

disaster recovery and contingency plans are documented and available for review

by ADTRAN.

• Quality records shall be maintained to demonstrate conformance to specified

requirements (reference throughout the quality elements where a "Record" is

required).

• Emergency action plans that are approved, tested and reviewed for (fire, flood,

hurricane, tornado, terrorist, etc.) must be clearly defined and in place.

• Security policies governing an employee/non-employee’s access to

buildings/facilities shall be clearly defined and enforced.

• The supplier shall assure that adequate security protocols (i.e., security guards,

card-access, photo identification, visitor’s badges, etc.) are in place for all

buildings/facilities.

• Procedures shall be in place to notify Customs authorities if the supplier notes

anomalies in shipments or illegal imports.

• The supplier shall ensure that policies are in place to control the following

Information Technology (IT) applications: Firewall access, encryption, phone and

voicemail, e-mail and virus protection. IT servers shall be backed up regularly and

overall IT disaster contingency and recovery plans shall be well defined.

6.20 Environmental Health and Safety (EH&S)

• The supplier should have an effective system in place for assuring compliance to

applicable (supplier and customer) legal requirements.

• The facility should have a management process, with clearly defined roles and

responsibilities for managing Environmental, Health and Safety issues.

• ADTRAN customer contracts may require or encourage suppliers to establish

environmental management systems, preferably certified by an accredited external

registrar.

• The facility should have established health and safety programs to ensure the well-

being of personnel and property.

6.20.1 Corporate Social Responsibility (CSR)

• The supplier should have agreed on a program, and communicated an

explicit commitment to CSR.

• The supplier should have a common definition of CSR as it relates to their

company, their sector and broader societal trends.

Q-110 19 rev 7/15/14

• The supplier should conduct regularly review progress on the company’s

performance against CSR goals, objectives and targets.

6.21 Training (Human Resources)

• The supplier shall establish and maintain a documented procedure for identifying

and training all personnel (including temporary personnel) performing activities

affecting quality.

• Appropriate records of training shall be maintained for all employees performing

activities affecting quality, and will include an employee training plan, training

status, continuous improvement training, re-certification status (as applicable),

problem solving training and customer satisfaction training.

• The supplier shall determine the personnel resources and capabilities required, prior

to accepting a customer's order or committing to a customer delivery. The supplier

shall provide adequate and capable personnel resources for management,

performance of work, and verification activities to satisfy order requirements.

• The supplier must have a policy that requires a background check on employees,

contractors or interns.

6.22 ESD Sensitive Materials

• Ownership of the ESD process is essential and reflects on the level of management

commitment. It is imperative that all employees who come in direct contact with

ESD sensitive components undergo formal ESD training and re-training in order to

raise ESD awareness.

• The supplier shall establish and maintain a formal documented ESD program. ESD

audits at a pre-determined frequency should be performed to ensure compliance to

the program. External ESD audits must be performed where necessary to ensure

supplier compliance.

6.23 Order Management and Logistics

• In terms of the supply base, delivery performance must be available for feedback

on supplier performance. In terms of the customers, delivery performance must be

current, maintained and available for review upon demand.

• The supplier shall have an effective process for conducting root cause analysis,

corrective and preventive action on missed shipments/ delivery.

• The supplier shall establish an effective process for analyzing commitments and

customer notifications on customer orders when there is a change in a supply

constraint.

• The supplier shall establish an effective process for notifying the customer of missed

commitments when product is sourced to multiple facilities (locations).

• The supplier shall establish a process to provide a timely response to informal

customer delivery requests based on priority. The same tools used in the

commitment process should be used.

• ADTRAN and the supplier will communicate all critical order management, shipping

and invoicing information via Electronic Data Interchange (EDI) unless otherwise

agreed upon.

Q-110 20 rev 7/15/14

6.24 New Product Introduction (NPI) & Transfer Process

• The New Product Introduction process must be formalized and should establish clear

guidelines on product development, testing requirements, prototype launch and

production hand-off. The process shall also establish the planning involvement by

the senior management team.

• The NPI process must also establish internal “metrics” to track the performance

(and success) of the NPI projects. These metrics must provide one with an overview

of the projects, schedules, and performance and completion rates.

• The Quality Plans established during NPI must be adequate and data collected

during this phase must be maintained.

• The supplier shall establish a well-defined and documented transfer process

(globally and locally), identifying (at a minimum): roles for transfer teams, a

corporate knowledge base, delineation of corporate/local responsibilities and

guidelines for ensuring supply chain continuity for customers.

6.25 Firmware Control

• The supplier shall establish a development environment, configuration management

and change management tools for firmware.

• The supplier shall maintain defects and the defect records should be recorded in a

defect management system and tracked through to closure.

• The supplier shall have documented requirements for the firmware, which have

been reviewed and baseline defined.

• Where appropriate the supplier should evaluate the use of Power on Self-Test

(POST) and Built in Self-Test (BIST) designed into the firmware.

Q-110 21 rev 7/15/14

REVISION HISTORY

Revision

Author

DATE

Description

A

8/12/1997

Release

B

Unknown

9/1/2000

Revised signature line on the “Foreword” to reflect current manager.

Deleted section 1.5, “ADTRAN Outsource Process Engineering

Technician (OPET),” and renumbered remaining sections. In new

section 1.5, removed the word “only.” In section. 2.4, added “IPC-

A-610 and” to 4th paragraph. In section 2.4, 5th para., revised

sentence to reflect only the IPC ANSI/J-STD-002 procedure. Revised

section 2.5, 1st para., to clarify ADTRAN’S and Suppliers’ roles in

calibrating new equipment. Revised section 2.8, 6th para. To reflect

approval of alternate labels.

C

Unknown

4/21/2004

General update to Outsource Manufacturing guidelines. Specifics

include a) Revised signature line on the “Foreword” to reflect current

manager of Outsource Manufacturing. B) Replaced term subcontractor

with Contract Manufacturer. C) Updated Section 2.0 to comply with

new TL9000 requirements. D) Added section 2.2 – Contract

Manufacturer Training.

D

A. Gurrero

1/19/2010

ADD, 1.7 RMS Material requirements for Contract Manufacturers;

ADD, 1.8 First Article requirements for Contract Manufacturers; ADD,

SQE Manager to sign-off ADD, FORM Q110-1, rev A; Change, 2.5

Process Control: “ADTRAN BOM notes or special instructions will

supersede all other criteria.

E

G. Giles

04/18/2012

Document reformat; Added documentation and specification

references; Updated Approvers titles; Sec 1.2 changed title from

applicability to scope; Sec 1.3: extended qualification requirements to

include Purchased Assembly suppliers; Sec 1.4: header from ADTRAN

Quality Audits to SCA; Sec 1.6: added subsection on operational

changes; Sec 1.7: new; Sec 1.9: new; Sec 2.0: new; Sec 3.0: new;

Sec 4.0: total rewrite of QSM elements to include ADTRAN business

requirements; Added Attachment 1 to show RTS process flow; Forms:

corrected document page numbers.

F

M. Davis/

G. Giles

7/15/14

Foreword: removed Purchased Assembly Suppliers and all references

(now defined in specification Q120), changed Outsourced

Manufacturing and Business Operations to International Operations;

Sec 1.8.1: changed requirements for inspection of Electrolytic

Capacitors;. Sec 1.10: changed requirement for first article labeling;

Section 1.11: new (PCB Impedance Testing requirements); Section

2.4: new (Direct Fulfillment requirements); Section 4: new (QMS

requirements); Section 5: new (EMS-CSR requirements); Section 6:

was Section 4, revised element 20 to include CSR requirements.

Q-110 22 rev 7/15/14

Appendix A

CM Return To Stock (RTS) Process

Q-110 23 rev 7/15/14

CM First Article Inspection Report (Q110-1)

Part No. ___________________ Rev. ____ Sheet ____ of ____

Part Name _____________________________________________ Date ____________________

Contract MFR ____________________________ Originator__________________

Work Order No.

Purchase Order No.

(If applicable)

Quantity Shipped:

Test(s) conducted ICT FVT Hi POT Visual Inspection

ADTRAN Assembly DWGs/specification(s) used

First Article unit(s) Serial Number

Remarks

1st Submission 2nd Submission Tooling Rebuilt/Refurbish

Certification Of Compliance

I certify that the parts furnished on the above shipment meet all the necessary Engineering

Instructions, Mechanical Specifications and Necessary Requirements, and that the above parts have

been inspected by this Company. A copy of all working documentation used for verification to include

deviation notices, assembly and label placement drawing(s), BOM and any other written instructions

shall be included with this First Article Shipment.

Quality Manager___________________________ Date_______________

For ADTRAN use only

Disposition: Approved Rejected Conditional Approval

Resubmission of 1st Article Required? YES NO

Remarks

Q-110 24 rev 7/15/14

Reference

Document

Zone

#

BOM

POS#

Assembly Drawing

Dimension or BOM note

Requirement

Measured Actual

Dimension, enter V for

visual verification

Test Result

PASS?

Remarks

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No

DWG

BOM POS

OTHER

Yes No