ADTRAN Quality Management System (QMS) Manual page 9

Documented approval is required for each phase of the design, ensuring all deliverables are complete before
progressing to the next phase. (GEN05.5)
Test Planning
Engineering develops documented test plans for all products. The results of these tests are maintained as quality
records by the organization performing the test. (EN07, EN10, PQ01, TE01, TE09, SL15,)
Integration Planning
The responsible engineer develops a plan for integrating software components into the product. The plan includes
methods and documented procedures to insure that the software component function as designed. (EN10)
Migration Planning
Engineering, Product Management, and Marketing are responsible for planning the system or software migration from
an old to a new environment. These requirements are documented and analyzed. Then a migration plan is developed
and executed. (SL15, EN02)
Design and Development Process Quality Measurement
Appropriate design and development measurements are reported as suitable to the project. (Gen 4.4 and EN02)
Regression Test Planning
When performed, regression tests, features and functions are identified on the test plans. (PQ01)
Inputs
There are numerous sources that provide input for the design specifications, features, and decisions. The range of
sources include original new ideas, input from our OEM activities, continual improvement and evolution of existing
products, results from customer field trials, customer input from Sales, Marketing, Product Management, feedback
from Technical Services, Outsource Manufacturing, competitive evaluation, benchmarking, manufacturability, and
quality reviews. Design reviews are used to determine compliance with design and program objectives and to provide
independent assessment of design methology. (EN02,EN11, and SL15)
The responsible engineer documents design and development requirements in product specifications and other product
related documents. These requirements include, but are not limited to functional and performance requirements,
software requirements, applicable statutory and regulatory, information derived from similar designs, and other
requirements essential for design and development. (EN11)
Outputs
The results of an engineering product design are evidenced in successive releases, i.e., Engineering Prototype,
Production Planning, Limited Production and Full Production. A comprehensive checklist of required items to
accomplish each release includes attention to Bill of Material entries, Piece Part Drawings, PCB Artwork, Test Set and
Documentation, Design Verification Testing, Acceptance Test Procedure etc. The entire set of ADTRAN policies and
procedures is intended to influence the quality of designs, reduce the length and cost of the development cycle, and to
meet the requirements of our customers. (GEN04.4, GEN05.5, EN02, EN10, and EN11)
Software outputs include specifications, source code, executable files, and user documentation.
Design Review
Processes for conducting design reviews have been established to ensure that, at appropriate stages of design, it is
reviewed to assure that planned activities have been conducted. Participants involved are those required for the specific
stage of design and determined by the responsible engineer. Engineering holds design reviews and maintains records
of these reviews. (GEN09.3, EN02, PQ01)
Design reviews and design verification tests are conducted by Design Engineering during the development of a
product. The culmination of the design phase results in a formal documentation release meeting to facilitate first
production. (EN10 and GEN05.5)
Document Q101, Revision W (Printout Uncontrolled) Page 9 of 23