Q110 Quality Program Requirements Subcontractors

User Manual: Q110 Quality Program Requirements Subcontractors

Open the PDF directly: View PDF PDF.
Page Count: 24

Q-110 1 rev 7/15/14
Quality Program Requirements for ADTRAN Contract
Q-110 2 rev 7/15/14
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
George Giles / Manager, SQE-QA-EMS-FQ
Gerry Kelley / Senior Manager,
International Operations/Global Repair Services
Q-110 3 rev 7/15/14
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
Q-110 4 rev 7/15/14
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
2. A critical examination shall be made of the first unit(s)
processed after the change is implemented.
Q-110 5 rev 7/15/14
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
Q-110 6 rev 7/15/14
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
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:
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
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
Q-110 7 rev 7/15/14
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
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,
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.
Q-110 8 rev 7/15/14
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.
Q-110 9 rev 7/15/14
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
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
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:
Q-110 10 rev 7/15/14
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
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
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
3.1 Supplier ECAR Actions:
3.1.1 The supplier shall use the (1020 Rule) for addressing an ECAR. (See Note
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
Q-110 11 rev 7/15/14
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.
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.
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
1. At a minimum the latest version of the suppler certificates shall be provided
when an update or release of the certificate is made.
Q-110 12 rev 7/15/14
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.
Q-110 13 rev 7/15/14
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
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
Q-110 14 rev 7/15/14
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).
Q-110 15 rev 7/15/14
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
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
Q-110 16 rev 7/15/14
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.
Q-110 17 rev 7/15/14
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
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
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
Quality records shall be maintained to demonstrate conformance to specified
requirements (reference throughout the quality elements where a "Record" is
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
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
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
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
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.
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.
A. Gurrero
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.
G. Giles
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.
M. Davis/
G. Giles
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
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
Q-110 24 rev 7/15/14
Assembly Drawing
Dimension or BOM note
Measured Actual
Dimension, enter V for
visual verification
Test Result
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No
Yes No

Navigation menu