[Company Name]

[Company Group, Division, Location]

Document Title: Design Review

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COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] Design Review
[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 Design History File (DHF).................................................................................................................2
3.2 Design Input.......................................................................................................................................2
3.3 Design Input Reviews........................................................................................................................2
3.4 Design Output....................................................................................................................................2
3.5 Design Validation...............................................................................................................................2
3.6 Manufacturing Process Design Reviews............................................................................................2
3.7 Process Validation..............................................................................................................................2
3.8 Product...............................................................................................................................................2
3.9 Production Specifications...................................................................................................................2
3.10 Product Development.........................................................................................................................3
3.11 Product Development Reviews..........................................................................................................3
3.12 Quality................................................................................................................................................3
3.13 Quality System...................................................................................................................................3
3.14 System Design Reviews.....................................................................................................................3
3.15 Technical Design Reviews.................................................................................................................3
3.16 Validation...........................................................................................................................................3
3.17 Verification.........................................................................................................................................3

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

5.0 References.....................................................................................................................................................4

6.0 Procedure......................................................................................................................................................4
6.1 Definition of Design Review..............................................................................................................4
6.2 Purpose of Design Reviews................................................................................................................4
6.3 Informal Reviews...............................................................................................................................4
6.4 Number of Design Reviews................................................................................................................5
6.5 Types of Design Reviews...................................................................................................................5
6.6 Selecting Reviewers...........................................................................................................................6
6.7 Conducting Design Reviews..............................................................................................................6
6.8 Documenting Design Reviews...........................................................................................................7
6.9 Auditing the Results of Design Reviews...........................................................................................7

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[Company Name] Design Review
[Company Group, Division, Location] [Document Number]
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1.0 Purpose
This procedure defines the process for conducting and documenting formal design reviews during 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 Design History File (DHF)

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

3.2 Design Input

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

3.3 Design Input Reviews

A series of reviews conducted by the Product Manager to ensure the product design requirements
are adequate, appropriate, and address the intended use of the product, including the needs of the
user and customer.

3.4 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.

3.5 Design Validation

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

3.6 Manufacturing Process Design Reviews

A series of reviews conducted by the Product Manager to validate manufacturing processes and
the manufacturing process design. These reviews confirm with objective evidence that a process
consistently produces a result or product meeting its predetermined specifications.

3.7 Process Validation

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

3.8 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.

3.9 Production Specifications

A compilation of documents such as assembly drawings, component specifications,
manufacturing instructions, test specifications, workmanship standards, etc., or any other equally
acceptable means, written and unwritten, to communicate and convey design information to
Manufacturing for the purpose of repeatedly and reliably manufacturing a product.

3.10 Product Development

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

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[Company Name] Design Review
[Company Group, Division, Location] [Document Number]
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3.11 Product Development Reviews

A series of reviews conducted by the Product Manager at the end of each phase of the Product
Development Cycle to verify attainment of objectives for that particular phase and to authorize
continuation into the next phase. The objective of the reviews is a comprehensive, systematic
examination of the design to evaluate the adequacy of the design requirements, to evaluate the
capability of the design to meet the requirements, and to identify problems.

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

3.13 Quality System

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

3.14 System Design Reviews

A series of reviews conducted by the Product Manager to verify and validate the product design
based on the results of verification testing and validation testing. These reviews confirm with
objective evidence that the product design output meets the design input requirements and that
product specifications conform to user needs and intended use(s).

3.15 Technical Design Reviews

A series of reviews conducted by the Product Manager to verify the product design based on the
results of verification testing. These reviews confirm with objective evidence that the product
design output meets the design input requirements. The Product Manager may conduct design
reviews for distinctive functional disciplines (mechanical, software, etc.) or for components,
subsystems, and others as required.

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
have 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 Executive Management Team may not exactly
follow this procedure, but must still apply the essential elements of effective and systematic design
review.

4.1 Executive Management Team (EMT)

The Executive Management Team has comprehensive responsibility and authority to plan, direct,
and manage all activities and deliverables of a development program and to carry out the
strategic objectives of Executive Management. The EMT assures proper review of design results
throughout the development cycle.

4.2 Product Manager

The Product Manager bears overall responsibility for management of the development program
and is responsible for leading and facilitating the efforts of the Product Development Team. In
addition to planning, scheduling, and documenting each review, the Product Manager determines
the type and scope of each design review, selects the individual reviewers, and conducts the
review.

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[Company Name] Design Review
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4.3 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
“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
Development of Design Output

6.0 Procedure

6.1 Definition of Design Review

The term "design review" designates a documented, comprehensive, systematic examination of a
design and its development to evaluate the adequacy of the design input requirements, evaluate
the capability of the design to meet those requirements, and identify problems in the design or
development program.

6.2 Purpose of Design Reviews

Throughout the design process, developers generate design output. The formal design review
process is a means for the Business Management Team, Product Manager, Product Development
Team, Team Leaders, and every other developer to assess the design output. There are four (4)
primary functions of design reviews.

 Provide a systematic assessment of design results, including the product design and the
associated design for manufacturing and product support.
 Provide feedback to designers on existing or emerging problems.
 Assess progress of the development program.
 Provide confirmation that the development program is ready to move to the next phase of
development.

6.3 Informal Reviews

Throughout the Product Development Cycle, developers and task teams may conduct or
participate in many informal reviews for assessing a design and design output. These reviews are
known by various names such as supervisory review, peer review, technical assessment,
preliminary review, etc. Generally, these reviews are verification activities and not formal design
reviews as described in this procedure. They lack the comprehensive, definitive, cross-functional
scope of a formal design review. Their purpose is to confirm that design output satisfies design
input requirements detailed in the Marketing Requirements Document. Task team leaders and
developers are encouraged to conduct these reviews when needed and, as always, document the
meetings with written minutes. These review activities typically add to the design output and are
themselves subject to subsequent design review.

Task team leaders and developers also conduct many routine meetings during the development
process to discuss issues, coordinate activities, assess progress, resolve problems, etc. Again,
these do not conform to the definition of a formal design review. All such meetings should be
documented in written minutes.

6.4 Number of Design Reviews

During the Planning Phase, the Product Manager and Executive Management Team plan
appropriate design reviews at pertinent points in the Product Development Cycle and specify the
type and time of each review in the Product Development Plan. The Product Manager should

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assume the reviews would detect some problems and allot adequate time to implement corrective
actions following each review.

Specific types of reviews occur during distinct phases of design and development. However, the
number of reviews of the same type may vary depending on the complexity of the product and the
extent of the design requirements. For instance, a particularly complex product design may
require several Technical Design Reviews to complete a review of verification activities and
design output for all subsystems and technical disciplines. The Product Manager and the
Executive Management Team must exercise care to limit the scope of an individual review to
something reasonably manageable within the allocated time. Reviews that are overly long
become self-defeating.

6.5 Types of Design Reviews

There are several specific types of formal design reviews. The type of a particular review is
dependent on its purpose and phase in the Product Development Cycle.

6.5.1 Design Input Review

A review or series of reviews conducted by the Product Manager to ensure the product
design requirements are adequate, appropriate, and address the intended use of the
product, including the needs of the user and customer.

6.5.2 Technical Design Reviews

A review or series of reviews conducted by the Product Manager of the product design
based on the results of verification testing. These reviews confirm with objective
evidence that the product design output meets the design input requirements detailed in
the Marketing Requirements Document. The Product Manager may conduct design
reviews for distinctive functional disciplines (mechanical, systems, software, etc.) or for
components, subsystems, and others as required.

6.5.3 System Design Reviews

A review or series of reviews conducted by the Product Manager for design verification
and validation of the product design based on the results of verification testing and
validation testing. These reviews confirm with objective evidence that the product
design output meets the design input requirements detailed in the Marketing
Requirements Document and that product specifications conform to user needs and
intended use(s).

6.5.4 Manufacturing Process Design Reviews

A review or series of reviews conducted by the Product Manager for validation of
manufacturing processes and the manufacturing process design. These reviews confirm
with objective evidence that a process consistently produces a result or product meeting
its predetermined specifications.

6.5.5 Product Development Reviews

A series of reviews conducted by the Product Manager at the end of each phase of the
Product Development Cycle to verify attainment of objectives for that particular phase
and to authorize continuation into the next phase. The objective of these design reviews
is a comprehensive, systematic examination of the design to evaluate the adequacy of the
design requirements, to evaluate the capability of the design to meet the requirements,
and to identify problems.

6.5.6 Final Product Development Review

The Product Development Review(s) conducted by the Product Manager at the end of
the Pilot Production Phase to verify attainment of objectives for the development
program, to ensure the product is correctly translated into Production Specifications, and
to transfer the product design to Full Production and Support.

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[Company Name] Design Review
[Company Group, Division, Location] [Document Number]
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6.6 Selecting Reviewers

The Product Manager plans and schedules each review and also selects the reviewers. In
determining the participants for a particular review, the Product Manager considers individual
qualifications, the types of expertise required to adequately assess the design under review, and
the independence of the reviewers.

6.6.1 Qualifications
The Product Manager selects individuals to conduct the review who have technical
competence and experience at least comparable to the developers. It is also essential
that representative developers attend the review. It is mandatory that a representative
from Quality Systems participate in each review.

6.6.2 Expertise
Adequate assessment of a particular design may involve a number of disciplines such as
optics, electronics, mechanics, software, etc. as well as manufacturing and customer
considerations affecting the design. The Product Manager must exercise care to limit
the extent of an individual review to a manageable scope but still allow comprehensive
assessment of the design. Based on the scope of the review, the Product Manager should
prudently consider which interests and expertise to designate for a specific formal design
review. This is important because subtle differences in perspective may dramatically
affect design quality.

6.6.3 Independence
In each design review, the Product Manager will include at least one individual without
direct responsibility for the design or phase under review. This individual must also
have the appropriate technical competence and experience.

6.7 Conducting Design Reviews

The Product Manager plans, schedules, conducts, and documents each formal design review.

6.7.1 Preparation
Before the review, the Product Manager prepares an agenda. The agenda aids everyone
involved in the review to focus on the issues, to manage discussion time, and to ensure
coverage of all pertinent topics. The agenda must exactly detail the scope of the review
and explicitly state the goals and ground rules for conducting the design review. The
agenda is documented in the Design History File.

At least two (2) working days prior to the review, the Product Manager also distributes
or makes available to the reviewers the material to be presented in the review.
Reviewers must prepare with as much prior knowledge as possible to prevent the review
from becoming a training session.

6.7.2 Design Evaluation

Designers make presentations explaining design implementation, verification activities,
validation results, etc. Reviewers may ask for clarification or additional information on
any topic or issue. The Product Manager must encourage the designers and reviewers to
work together toward a systematic exploration of problems and discovery of solutions.
They must ask relevant questions, avoid making assumptions, and think critically. This
evaluation portion of the review focuses on identifying problems and potential problems,
not solutions.

6.7.3 Resolution
The reviewers decide on an appropriate disposition for each valid problem or potential
problem raised in the evaluation portion of the review. Depending on the problem and
its disposition, the Product Manager, the Product Development Team, or the Executive
Management Team make the appropriate decisions and commitment of resources to

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resolve the problem. If there are unresolved issues, the Product Manager is responsible
for resolving differences and determining an appropriate disposition.

6.7.4 Implementation
In deciding an appropriate disposition for a problem, the reviewers may decide to take
no action (issue is erroneous or immaterial), to make a change in the Marketing
Requirements Document, to make a design change, or to further study the issue.
Changes to requirements or design are subject to company change control procedures.
The Product Manager is responsible for tracking and ensuring disposition of issues
requiring further study. Normally, resolution of these issues occurs as a result of
continued development and reexamination at future reviews. Document the completion
of any implementation plans resulting from a design review in the Design History File.

6.8 Documenting Design Reviews

The Product Manager is also responsible for documenting the review. In addition to the agenda
discussed previously, prepare minutes for each review detailing the design topic, the date, the
reviewers, a synopsis of the discussion and conclusions, and the identified problems with their
corresponding disposition. The reviewers must approve the minutes. Document the minutes in
the Design History File.

For Product Development Reviews, the Product Manager also prepares an Authorization to
Continue Development approved by the Business Management Team. For the Final Product
Development Review, the Product Manager prepares a Release to Full Production and Support
approved by the Business Management Team. Document both in the Design History File.

6.9 Auditing the Results of Design Reviews

After the review, the Product Manager and the Executive Management Team audit the results of
the evaluation and corresponding dispositions and implementation plans to determine if they
satisfied the requirements and goals of the design review. If they determine the review did not
meet its requirements and goals, the Product Manager is responsible for corrective action. For
example, the review could result in plans to implement extensive design changes. The Business
Management Team, due to the scale and nature of the changes, may reject continuation to the
next stage or phase of development until the changes are verified, validated, and undergo another
formal design review. The Product Manager documents all such changes in the Design History
File and Product Development Plan.

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