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Design Transfer关于设计移交的介绍

Table of Contents

1.0Purpose (2)

2.0Scope (2)

3.0Definitions (2)

3.1Design History File (DHF) (2)

3.2Design Input (2)

3.3Design Output (2)

3.4Design Validation (2)

3.5Device Master Record (DMR) (2)

3.6Final Product Development Review (2)

3.7Pilot Production (2)

3.8Product (2)

3.9Production Specifications (2)

3.10Product Development (2)

3.11Quality (3)

3.12Quality System (3)

3.13Specification (3)

3.14Validation (3)

3.15Verification (3)

4.0Responsibilities and Requirements (3)

4.1Executive Management Team (EMT) (3)

4.2Product Manager (3)

4.3Regulatory Affairs/Quality Systems Director (3)

5.0References (3)

6.0Procedure (4)

6.1Objective of Design Transfer (4)

6.2Number of Final Product Development Reviews (4)

6.3Conducting Final Product Development Reviews (4)

6.4Documenting Design Transfer (4)

1.0 Purpose

This procedure defines the process for ensuring that the product design is correctly translated into

Production Specifications and properly transferred to Manufacturing.

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 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.

3.4 Design Validation

Establishing by objective evidence that product specifications conform to user needs and intended

use(s).

3.5 Device Master Record (DMR)

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

3.6 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.

3.7 Pilot Production

Initial trial production run(s) made under full-scale production conditions after installation of the

complete manufacturing process.

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.

3.11 Quality

The totality of features and characteristics that bears on the ability of a product to satisfy fitness-

for-use, including safety and performance.

3.12 Quality System

The organizational structure, responsibilities, procedures, processes, and resources for

implementing quality management.

3.13 Specification

Any requirement to which a product must conform.

3.14 Validation

Confirmation by examination and provision of objective evidence that the particular requirements

for a specific intended use can be consistently fulfilled.

3.15 Verification

Confirmation by examination and provision of objective evidence that specified requirements have

been fulfilled.

4.0 Responsibilities and Requirements

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 transfer.

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.

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 the Final Product Development Review, the

Product Manager determines the type and scope of the review, selects the individual reviewers, and

conducts the review. The Product Manager assures proper execution of design transfer throughout

the development cycle.

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

Design Review

6.0 Procedure

6.1 Objective of Design Transfer

Design Transfer is the process of transferring product design information (Production

Specifications) to Manufacturing for the purposes of manufacturing the product. This transfer

does not occur at a single time but takes place throughout the design process in the form of

documentation, training, and possibly personnel. However, Design Transfer is formalized in one

or more Final Product Development Reviews following completion of all verification and

validation activities and a pilot production run to determine the adequacy of full-scale

manufacturing.

The essential objective of Design Transfer is to ensure that the product can be repeatedly and

reliably manufactured within product and process capabilities using the Production Specifications

as transferred to Manufacturing. Although Design Transfer occurs throughout the design

development process, reviewers must address the following elements at the Final Product

Development Review.

?Accomplish a qualitative assessment of the completeness and adequacy of the Production Specifications.

?Verify the proper verification and validation of all design input requirements.

?Verify the approval of all Production Specifications.

?Verify the Production Release of all Production Specifications.

?Verify the completion of all statutory and regulatory approval requirements.

?Verify attainment of the development program's objectives.

6.2 Number of Final Product Development Reviews

The number of Final Product Development Reviews may vary depending on the complexity of the

product and the extent of the design requirements. The Product Manager 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.

6.3 Conducting Final Product Development Reviews

The Product Manager plans, schedules, conducts, and documents each Final Product Development

Review. The Product Manager selects reviewers, prepares for the review, conducts the review,

and implements corrective actions in accordance with the Design Review procedure.

6.4 Documenting Design Transfer

The Product Manager prepares minutes for each Final Product Development Review detailing the

topics, the date, the reviewers, a synopsis of the discussion and conclusions, and the identified

problems with their corresponding disposition. The reviewers approve the minutes and the

Product Manager documents the minutes in the Design History File.

The Product Manager also prepares a Release to Full Production and Support approved by the

Executive Management Team and documented in the Design History File.

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