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[Company Name]

[Company Group, Division, Location]

Document Title: Development of Design Output Requirements


Document Number: [Document Number]
Document Filename: [Document Filename]

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Revision Revision DCO/ECO Revision


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COMPANY PROPRIETARY AND CONFIDENTIAL


[Company Name] Development of Design Output Requirements
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Table of Contents

1.0 Purpose..........................................................................................................................................................2

2.0 Scope.............................................................................................................................................................2

3.0 Definitions.....................................................................................................................................................2
3.1 Acceptance Criteria............................................................................................................................2
3.2 Executive Management Team (EMT)................................................................................................2
3.3 Customer............................................................................................................................................2
3.4 Design History File (DHF).................................................................................................................2
3.5 Design Input.......................................................................................................................................2
3.6 Design Output....................................................................................................................................2
3.7 Marketing Requirements Document (MRD).....................................................................................2
3.8 Design Validation...............................................................................................................................2
3.9 Device Master Record (DMR)...........................................................................................................2
3.10 Process Validation..............................................................................................................................2
3.11 Product...............................................................................................................................................3
3.12 Product Development.........................................................................................................................3
3.13 Quality................................................................................................................................................3
3.14 Quality System...................................................................................................................................3
3.15 Specification.......................................................................................................................................3
3.16 Validation...........................................................................................................................................3
3.17 Verification.........................................................................................................................................3

4.0 Responsibilities.............................................................................................................................................3
4.1 Executive Management Team (EMT)................................................................................................3
4.2 Product Manager................................................................................................................................3
4.3 Product Development Team (PDT)....................................................................................................3
4.4 Regulatory Affairs/Quality Systems Director....................................................................................4

5.0 References And Applicable Documents........................................................................................................4

6.0 Procedure......................................................................................................................................................4
6.1 Purpose of Design Output..................................................................................................................4
6.2 Types of Design Output......................................................................................................................4
6.2.1 Product Design and manufacturing Process Design Documentation.................................4
6.2.2 Design History Documentation...........................................................................................7
6.3 Form and Content..............................................................................................................................9
6.4 Change Control..................................................................................................................................9

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 1 of 9


[Company Name] Development of Design Output Requirements
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

1.0 Purpose
This procedure defines the guidelines for establishing and documenting the design output resulting
from the development of a product design.

2.0 Scope
This procedure applies to all product development programs funded and managed by [Company Name].

3.0 Definitions

3.1 Acceptance Criteria


Defined limits placed on characteristics, materials, or products.

3.2 Executive Management Team (EMT)


A management team that plans, directs, and manages company activities, including
manufacturing operations and product development. It has the authority and responsibility to
carry out the company’s strategic objectives. The Executive Management Team has the authority
to establish or make changes to the quality policy and quality system.

3.3 Customer
Anyone purchasing, using, operating, or interfacing with a product in any manner.

3.4 Design History File (DHF)


A compilation of records, which describes the design history of a finished product.

3.5 Design Input


The physical and performance requirements of a product used as a basis for product design and
development.

3.6 Design Output


The results of a design effort at each design phase and at the end of the total design effort. The
finished design output is the basis for the Device Master Record. The total finished design output
consists of the product, its packaging and labeling, and the Device Master Record.

3.7 Marketing Requirements Document (MRD)


The Marketing Requirements Document specifies design input requirements used as the basis for
complete product design. It defines what the design is intended to do and details requirements
for functionality, performance, interfacing, etc. as well as system and product development
requirements and goals. Approval of the MRD by the Executive Management Team marks the
end of the research phases (Concept and Feasibility) and the beginning of a development
program.

3.8 Design Validation


Establishing by objective evidence that product specifications conform to user needs and intended
use(s).

3.9 Device Master Record (DMR)


A compilation of records containing the procedures and specifications for a finished product.

3.10 Process Validation


Establishing by objective evidence that a process consistently produces a result or product
meeting its predetermined specifications.

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 2 of 9


[Company Name] Development of Design Output Requirements
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

3.11 Product
Unless otherwise specified, the word “product” in this procedure is used in the more global sense
to refer to components, materials, structures, machines, devices, systems, processes, software, or
services.

3.12 Product Development


The systematic development process for optimizing a product’s time to market, cost,
performance, quality, customer satisfaction, and risk management. A product development
simultaneously integrates all product knowledge and expertise from concept, through
manufacturing and customer satisfaction, to the end of the product’s life.

3.13 Quality
The totality of features and characteristics that bears on the ability of a product to satisfy fitness-
for-use, including safety and performance.

3.14 Quality System


The organizational structure, responsibilities, procedures, processes, and resources for
implementing quality management.

3.15 Specification
Any requirement to which a product must conform.

3.16 Validation
Confirmation by examination and provision of objective evidence that the particular requirements
for a specific intended use can be consistently fulfilled.

3.17 Verification
Confirmation by examination and provision of objective evidence that specified requirements has
been fulfilled.

4.0 Responsibilities
This procedure is intended as a guide. Depending on the complexity of the product and the extent of
the design requirements, the Product Manager and the Product Development Team may not exactly
follow this procedure, but must still apply the essential elements of effective and systematic
development of design output.

4.1 Executive Management Team (EMT)


The Executive Management Team has comprehensive responsibility and authority to plan, direct,
and manage the business and strategic objectives of product development programs. The EMT
approves the Marketing Requirements Document to initiate a product development program.

4.2 Product Manager


The Product Manager bears overall responsibility for successful management of the development
program and is responsible for leading and facilitating the efforts of the Product Development
Team. As the leader of the Product Development Team, the Product Manager is responsible for
coordinating and integrating their activities and acting as liaison with the Business Management
Team.

4.3 Product Development Team (PDT)


The Product Development Team has collective responsibility and authority to plan, direct, and
manage the technical activities and deliverables of a development program and to carry out the
objectives of the Business Management Team. The PDT is responsible for development of design
output.

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 3 of 9


[Company Name] Development of Design Output Requirements
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

4.4 Regulatory Affairs/Quality Systems Director


The Director of Regulatory Affairs/Quality Systems is responsible for assuring the quality of the
product design process, the Manufacturing Process, the product, and all phases of the Product
Development Cycle.

5.0 References And Applicable Documents


“Design Control Guidance for Medical Device Manufacturers”, FDA Center for Devices and
Radiological Health, March 11, 1997
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Kimberly
Trautman, ASQ Quality Press
The Product Development Cycle

6.0 Procedure

6.1 Purpose of Design Output


Throughout the design process, developers generate design output. The Executive Management
Team, Product Manager, Product Development Team, Team leaders, and every other developer
must assure design output meets the design input requirements and is both adequate and suitable
for its purpose. There are three (3) primary functions of design output.

 Document conformance to design input requirements as confirmed during design verification


and validation and assured during design review.
 Document or reference acceptance criteria for determination of product conformance.
 Identify and document the characteristics of the design essential to the safe and proper
functioning of the product, including documentation needed to produce the product and
maintain it throughout its life cycle.

6.2 Types of Design Output


Design output must be comprehensive to be effective. An item is design output if it is the product
or deliverable of a task detailed in the Product Development Plan and it defines, describes, or
elaborates an element of design implementation. Design output in one development phase is
often part of the design input in subsequent phases.

6.2.1 Product Design and manufacturing Process Design


Documentation
This is all the product and process design output documentation used to procure
materials and components, fabricate, produce, test, inspect, install, service, and maintain
the product throughout its life cycle. It includes details on packaging and labeling, and
instructions for use, installation, and servicing of the product. It also includes
documentation on product structure and configuration such as process flow charts and
product trees. The product and manufacturing process design output documentation
provides the basis for the Device Master Record (DMR).

The Product Development Team must assure the proper development, form, and content
of the following examples of product and process design output technical information.

6.2.1.1 Artwork
A graphic rendering of the product, subsystem, or component containing
additional information not included on other drawings.

6.2.1.2 Assembly and Detail Drawings


Drawing of the product, subsystem, or component identifying the
characteristics of the design essential to safe and proper functioning.

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[Company Name] Development of Design Output Requirements
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

6.2.1.3 Component Specification


Specifies critical functionality and performance design criteria essential to
the safety and proper functioning of the component.

6.2.1.4 Inspection Instruction


Specifies the required procedure and equipment to assure a product,
subsystem, or component meets its specifications.

6.2.1.5 Manuals
Written documents for the user, customer, technician, etc. providing
instructions, technical descriptions, procedures, etc. for using, installing,
servicing, and/or maintaining the product, e.g., User’s Guide, Technical
Manual, etc.

6.2.1.6 Manufacturing Instructions (Assembly Instruction)


Specifies the required procedure and equipment to perform a specific
assembly operation in the manufacturing of a product. Includes packaging,
labeling, and all other required manufacturing operations.

6.2.1.7 Manufacturing Process Flow Chart


Specifies the sequence of work centers and operations within the work
centers required to manufacture a product. In final form, the flow chart may
also identify the materials, components, documentation, tools, and equipment
required for each operation. The operations include testing, inspection, and
quality assurance.

6.2.1.8 Manufacturing Process Procedure


Specifies the required procedure and equipment to perform a general
manufacturing process within production, e.g., soldering, welding, bonding,
etc.

6.2.1.9 Material Specification


Specifies critical functionality and performance design criteria essential to
the safety and proper function of the material.

6.2.1.10 Parts List


Specifies the material resource necessary to manufacture, assemble, or
fabricate a part, component, subsystem, or product.

6.2.1.11 Process Specification


Specifies critical functionality and performance design criteria essential to
the safety and proper functioning of an operation performed on a product or
material, e.g., anodizing, heat treating, welding, bonding, curing, etc.

6.2.1.12 Product Specification


Specifies critical functionality and performance design criteria essential to
the safety and proper functioning of a product, subsystem, or component.
Includes packaging, labeling, and all other required product or subsystem
specifications.

6.2.1.13 Product Tree


A graphical representation of the product specifying the bill of material
structure as the product is to be manufactured. The Manufacturing Process
Flow chart is the corresponding process document.

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[Company Name] Development of Design Output Requirements
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

6.2.1.14 Product Use Procedure


Specifies the required procedure and equipment to use a product in its system
configuration. Product use procedures are engineering documents providing
more technical information and detail than manuals for customer and users.

6.2.1.15 Quality Assurance Procedure


Specifies the required procedure and equipment to perform a specific quality
assurance operation to assure a product, subsystem, or component conforms
to its specifications.

6.2.1.16 Schematic
A graphical representation of the connections and functions of an electrical
circuit without regard to the actual physical size, shape, or location of the
component devices or parts.

6.2.1.17 Software Release


An electronic file required to create a new software item. Examples include
image files or executable files used as items on parts lists.

6.2.1.18 Source code


A set of one or more electronic files containing computer instructions and
data definitions expressed in a form suitable for input to an assembler,
compiler, or other translator.

6.2.1.19 Test Procedure


Specifies the required procedure and equipment to perform a specific testing
operation to assure a product, subsystem, or component meets its
specifications during manufacturing, maintenance, or service.

6.2.1.20 Test Specification


Specifies critical functionality and performance design criteria essential to
the safety and proper functioning of the product, subsystem, or component.
Used as a standard in a test procedure.

6.2.1.21 Traveler
A document accompanying the product and tracking its progression through
the entirety of the manufacturing process, upon which pertinent data and
signatures are recorded. It defines the sequence of work centers, operations,
testing, etc. and corresponding man-hours necessary to manufacture a
product.

6.2.1.22 Wire List


A textual description of a schematic or wiring interconnection diagram.

6.2.1.23 Wiring Interconnection Diagram


A graphical representation of the electrical connections between an installed
product and its component devices. It may cover external connections,
internal connections, or both. It is a form of a wiring schematic showing
external connections between unit assemblies or equipment.

6.2.1.24 Workmanship Standard


A graphical illustration of the workmanship resulting from manufacturing
operations and processes. A workmanship standard illustrates the possible
results in acceptability classes of “best”, “acceptable”, or “unacceptable”
where “best” is the outcome of a properly executed procedure.

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 6 of 9


[Company Name] Development of Design Output Requirements
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

6.2.2 Design History Documentation


This is the documentation necessary to establish the conformance of design output to
design input requirements. This design output is the total of documentation resulting
from product design verification and validation activities. The design history output
documentation provides the basis for the Design History File (DHF).

The Product Development Team must assure the proper development, form, and content
of the following examples of design history output documentation.

6.2.2.1 Authorization to Continue Development


Document generated after a successful Product Development Review
authorizing continuation to the next development phase.

6.2.2.2 Marketing Requirements Document


Specifies design input requirements used as the basis for complete product
design. It defines what the design is intended to do and details requirements
for functionality, performance, interfacing, etc. as well as system and
product development requirements and goals.

6.2.2.3 Design Validation Reports


Technical Reports presenting test procedures, results, and assessment of
results from design validation activities.

6.2.2.4 Design Verification Reports


Technical Reports presenting test procedures, results, and assessment of
results from design verification activities.

6.2.2.5 Development Report


Report summarizing the performance of the product design and compliance
with requirements of the Marketing Requirements Document.

6.2.2.6 Documented Reviews


Reports documenting the results of design reviews and product development
reviews.

6.2.2.7 Error Budget Reports


Technical Reports detailing allocation of allowable error among possible
sources of error to achieve compliance with design requirements.

6.2.2.8 Laboratory Notebooks


Technical notes presenting test procedures, results, assessment, etc. of results
from design and development activities.

6.2.2.9 Manufacturability Report


Report summarizing the performance of the manufacturing process design
and compliance with requirements of the Marketing Requirements
Document.

6.2.2.10 Meeting Minutes


Minutes of task team meetings, coordination meetings, informal discussion,
etc., presenting names of attendees, scheduled activities completed since last
meeting, results of those activities, plans to deal with differences in
scheduled and complete activities, and schedule of action items and activities
before next meeting.

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[Company Name] Development of Design Output Requirements
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

6.2.2.11 Product Support Reports


Technical Reports presenting the results and performance data on reliability,
maintainability, serviceability, modifications, improvement, deficiencies,
safety, customer interfacing, etc. during support of the product in the field.

6.2.2.12 Product Development Plan


Specifies the master schedule and design plan for guiding a particular design
and development program.

6.2.2.13 Release to Production


Document generated after a successful Final Product Development Review
authorizing release of the product to full production.

6.2.2.14 Reliability Test Plan


Written procedures and protocol to conduct reliability and maintainability
testing of the engineering and/or manufacturing prototype.

6.2.2.15 Reliability Test Reports


Technical Reports presenting test procedures, results, and assessment of
results from reliability and maintainability testing.
6.2.2.16 Risk Analysis Reports
Technical Reports presenting the results of an investigation of the product
and available information to identify hazards, estimate their likelihood, and
determine the severity associated with each hazard.

6.2.2.17 Sensitivity Analysis Reports


Technical Reports presenting the results of an investigation of components,
subsystems, and the product to determine output response per unit change of
input.

6.2.2.18 Technical File


A compilation of documents and technical files demonstrating compliance of
a product to the “essential requirements” set forth in Annex I of the Medical
Device Directive, 93/42/EEC.

6.2.2.19 Technical Reports (other)


Technical Reports presenting test procedures, results, and assessment of
results from other research, design, and development activities.

6.2.2.20 Validation Test Plan


Written procedures and protocol to conduct field-testing or clinical trials of
the engineering and/or manufacturing prototype for design validation.

6.2.2.21 Verification Test Plan


The written procedures and protocol to conduct verification testing of a
prototype, subsystem, or component to verify that the design output meets the
design input requirements and confirm compliance with the Marketing
Requirements Document.

6.3 Form and Content


Individual developers and task teams must decide the form and content of design output
necessary to characterize all important aspects of the product design and to allow adequate
verification and validation. Ultimately, the Product Development Team is responsible for
assuring form and content is adequate and suitable. Initially specify the form and content during

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[Company Name] Development of Design Output Requirements
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

the Planning Phase and review it as part of the design verification process as design and
development progresses.

6.4 Change Control


During the product development process, verification and other activities will often uncover
discrepancies, errors, or new information which result in changes to the design output
documentation. The Product Development Team must carefully manage the change control
process to prevent a change that corrects one problem and creates another. Use proper change
control procedures for production documents and insure changes are communicated to developers
who can determine the full impact of the change.

All product design and manufacturing process design documentation (Device Master Record) and
specific design history documentation (Marketing Requirements Document and Product
Development Plan) are subject to company change control procedures for production documents.
The Product Development Team insures these documents are controlled and changed according
to the proper procedures. The Executive Management Team is responsible for tracking,
maintaining, and controlling all other design history documentation and for maintenance of the
Design History File.

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 9 of 9

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