3. Related Procedures and Other Documents

[Company Name] / Procedure Number
QSP 7.3-1
QUALITY SYSTEM PROCEDURE / Page
1 of 8
Subject: / Date Issued
10/01/02
DESIGN AND DEVELOPMENT CONTROL / Supersedes
None
Written by:Approved by: / Review/Approved Date

1. Purpose:

The purpose of this procedure is to define the responsibilities and steps [Company Name] follows for design control and review (verification/validation) of new products or major modifications of existing products.

This procedure is also used, with special considerations, in the planning, development, verification and validation of the processes required for new or significantly modified products – see also Advanced Product Quality Planning QSP 7.1-1.

2. Scope:

This procedure applies to all personnel involved in major design projects, including new products and processes and/or significant improvements of existing products and processes.

This procedure applies to clauses 7.1, 7.3 and 7.5.2 in ISO/TS 16949 and Sections 7.1, 7.3 and 7.5.2 in [Company Name]'s QMS Manual.

3. Related Procedures and Other Documents:

Procedure No.Description of Procedure

QSP 4.2-3Control of Records

QSP 5.6-1Management Review

QSP 7.1-1Advanced Product Quality Planning

QSP 7.3-2Engineering Change Request and Notice

QSP 8.3-1Control of Nonconforming Product

QSP 8.5-1Corrective Action

Supersedes
None / Date Issued
10/01/02 / Page
1 of 8 / Procedure No.
QSP 7.3-1

4. Procedure:

PROJECT INITIATION

4.1Any employee identifies and communicates a request for a new product or process design or a major design change to an existing product or process by contacting the VP of Engineering (or designee).

NOTE 1:This need is often identified by the following areas:

SALES: Customer requests, competitor developments, market requirements, field reports, etc.

MANUFACTURING: Process changes, manufacturing cost reductions, new technologies, value analysis, etc.

MANAGEMENT: New strategic directions or product opportunities.

4.2The VP of Engineering (or designee) reviews the merits of the request, consulting with Engineering staff, Quality Assurance, and upper management as appropriate.

4.2.1If the project is approved, then go to step 4.4.

4.3The VP of Engineering (or designee) informs the person making the request that the request was not approved.

END OF PROCEDURE.

4.4The VP of Engineering (or designee) uses Engineering staff to estimate the time and cost of the project and to document the results, while the Manager of Quality Assurance initiates Advanced Product Quality Planning QSP 7.1-1.

4.4.1If the project size is classified as a major project, then go to step 4.6.

NOTE 2:A project is typically classified as “major” if the product is significantly different from previous product offerings, if a new manufacturing process must be utilized, and/or if the project requires more than 40 hours of engineering work.

4.5The VP of Engineering (or designee) initiates Engineering Change Request and Notice QSP 7.3-2.

END OF PROCEDURE.

DESIGN INPUT

4.6The VP of Engineering (or designee) assigns a product engineer or inter-departmental team to:

collect and document all required design input information (functional and performance requirements, statutory and regulatory requirements, relevant information from previous projects, and other requirements essential to the project),
resolve any incomplete, ambiguous, or conflicting requirements with those responsible for imposing these requirements,
gather and use any relevant information from previous design projects to avoid repeating problems or expedite the design process, and
ensure the confidentiality of information and knowledge of any customer-related products and processes under design and development.

NOTE 3:Product design and development inputs include customer and contract/order review requirements, including special characteristics, identification, traceability and packaging, and targets for product quality, life, reliability, durability, maintainability, timing and cost.

NOTE 4:Process design and development inputs include product design output data, targets for productivity, process capability and cost, and customers’ requirements, including special characteristics.

NOTE 5:[Company Name] uses a relational database; categorized files of records; quality function deployment; studies of cost, performance and risk; competitor analysis; supplier feedback; internal input; and field data to deploy information gained from previous design projects to current and future projects of a similar nature.

NOTE 6:CAD/CAE systems are used by [Company Name] as a means of integrating the design input information into the design process.

DESIGN PLANNING & ORGANIZATIONAL AND TECHNICAL INTERFACES

4.7The Product Engineer/Team establishes updated cost estimates and a realistic time schedule, including stages of the design process; review, verification and validation activities appropriate to each design stage; and responsibilities / authorities for each design stage.

NOTE 7:[Company Name] uses PERT and Gantt charts in the development and documentation of the design plan and the identification of organizational and technical interfaces providing input to the design process. These charts and related design plans are updated, as appropriate, as the design evolves.

NOTE 8:Measurements such as quality risks, costs, lead-times, critical paths, etc., are included in the design plan, as appropriate. Results of these measurements are included in the design reviews (see NOTE 9) and summary results are provided as an input to Management Review QSP 5.6-1.

DESIGN REVIEW - PROJECT APPROVAL

4.8The VP of Engineering (or designee) conducts a design review addressing the design inputs, the cost estimates, and the time schedule that jointly define the project, and signs the documentation as evidence of review once an approval stage is reached.

4.9The VP of Engineering (or designee) schedules a formal, documented, upper management review of the project as appropriate.

4.9.1If upper management approves the project as defined, then go to step 4.11.

NOTE 9:Records of design reviews are in the form of meeting minutes, which include how the review was conducted, who was involved, what factors were considered, what decisions were made, and what actions were taken. The design inputs, cost estimates, time schedule, and other requirements (product performance, delivery, safety, legal, regulatory and value) that jointly define the project are updated by the Project Engineer/Team as the design evolves, often after design reviews.

4.10The VP of Engineering determines whether to close out the project and file the documentation (according to Control of Records QSP 4.2-3), or to revise the project based on upper management's feedback.

4.10.1If the project parameters are to be revised, then go to step 4.7. Otherwise,

END OF PROCEDURE.

DESIGN OUTPUT

4.11The Product Engineer/Team develop the design outputs.

NOTE 10:Product design outputs include Design FMEA and reliability results; product special characteristics and specifications; product error-proofing (as appropriate); product definition including drawings or mathematically based data; product design review results; and diagnostic guidelines (where applicable).

NOTE 11:Process design outputs include specifications and drawings; manufacturing process flowchart/layout; Process FMEA; control plans; work instructions; process approval acceptance criteria; data for quality, reliability, maintainability and measurability; results of error-proofing methods (as appropriate); and methods of rapid detection and feedback of product / manufacturing process nonconformities.

NOTE 12:The following strategies/tools are used in the process to generate design outputs, as appropriate:

Efforts to simplify, optimize, innovate, and reduce waste (e.g., QFD, DFM/DFA, VE, DOE, tolerance studies, and response surface methodology)
Utilization of geometric dimensioning and tolerancing
Analysis of cost/performance/risk trade-offs
Use of feedback from testing, production and the field
Use of design / process FMEAs

NOTE 13:The design outputs must meet the input requirements; provide appropriate information for purchasing, production and service operations; indicate or reference appropriate product acceptance criteria, and identify the critical characteristics of the product that are essential to its safe and proper use. All design output documents used in defining and controlling production steps are designated with customers’ or [Company Name]’s equivalent special characteristic symbols or notations to indicate process steps that affect those special characteristics. Attribute sampling plans in all cases have acceptance criteria of zero defects (C=0).

DESIGN VERIFICATION

4.12Prior to release of single or groups of design output documents (to manufacturing and other departments), the Product Engineer/Team performs design verifications according to other output means (such as performing alternative calculations, comparing the new design with other similar proven designs, conducting component tests, and so forth) to ensure that design stage output meets the design stage input requirements.

NOTE 14:Prior to release, the Product Engineer/Team stamps (or initials) and dates prints and other documents to indicate review and approval. Results of any other design verification measures and necessary follow-up actions are recorded and included in the design file.

4.13If required by the customer or [Company Name] management, the Product Engineer/Team develops a prototype of the new/modified product to assist in the verification of the design.

NOTE 15:Wherever possible, the same suppliers, tooling and manufacturing processes are used in prototype development that will be used in production. The Product Engineer / Team is also responsible for performing product performance, life, reliability, durability, and other qualification tests, as appropriate, and tracking the testing to ensure timely completion and conformance to requirements.

DESIGN REVIEWS - PROJECT EVOLUTION

4.14At appropriate stages of the design process (i.e., defined milestones in the project schedule including Concept, Definition, Design, Fabrication & Assembly, Testing & Verification, and “Lessons Learned”), the Product Engineer/Team schedules design reviews with qualified personnel and other designated specialists to ensure that the design project and results are meeting all defined requirements and to identify problems and propose follow-up actions (see NOTE 9).

4.14.1If the design review shows that the project is meeting the defined requirements, then go to step 4.16.

4.15The Product Engineer/Team makes the necessary revisions to the project or product in order to meet the defined input requirements, or gets documented concessions as appropriate to revise the input requirements.

NOTE 16:The Product Engineer/Team is responsible for addressing questions and problems which develop during manufacturing and assembly, and using Control of Nonconforming Product QSP 8.3-1 when defects are generated. Revisions to design output documents (part and assembly drawings, bills of materials, etc.) are then made according to Engineering Change Request and Notice QSP 7.3-2.

DESIGN VALIDATION

4.16The Product Engineer/Team coordinates with the Assembly and Customer Service Departments (and the customer) to conduct functional and reliability tests on individual modules and/or the final product under both start-up and production conditions as a means to ensure that the product and/or process conforms to user needs and/or requirements.

NOTE 17:[Company Name] uses the AIAG Production Part Approval Process Reference Manual as a guide for performing design validation to ensure that all customer engineering design and specification requirements are properly met by the products produced on the new/modified process. This process is also applied to suppliers.

NOTE 18:Design validation is performed in conjunction with customer program timing requirements.

4.17The Product Engineer / Team records the results of the design validation activities and necessary follow-up actions in the design file.

4.17.1If the product does not have a major failure in principle during testing, then go to step 4.19.

4.18The Product Engineer/Team establishes a new project or redefines the existing project. Go to step 4.6.

NOTE 19:Corrective Action QSP 8.5-1 is initiated to address design validation failures.

4.19The Product Engineer/Team uses Engineering Change Request and Notice QSP 7.3-2, if appropriate, to initiate revisions to design output documents (part and assembly drawings, bills of materials, etc.) as a means to make minor revisions to improve the final product or process.

DESIGN REVIEW – LESSONS LEARNED

4.20The Product Engineer/Team schedules a lessons learned design review with Engineering staff and other qualified personnel to compare actual project results against defined plans and goals in order to identify ways to improve the planning and execution of future design projects at [Company Name] (See NOTE 9).

4.21The VP of Engineering (or designee) reviews the results, forwards them to upper management as appropriate, and maintains all documentation related to the design process in Engineering according to Control of Records QSP 4.2-3.

END OF PROCEDURE.