Understanding The ISO/TS 16949:2002 Standard 

7.3.3 D & D Outputs  

You shall: 

Provide d & d outputs in a form that enables verification against d & d inputs 

Approve d & d outputs prior to their release  

repare design and development output to: 

a)    meet d & d input requirements 

b)    provide appropriate information (for purchasing, production, and service) 

c)    contain or reference product acceptance criteria 

d)    specify characteristics of the product essential for its safe and proper use 

7.3.3.1 Product design output – supplemental 

Express product design output in terms that can be verified & validated against product design input requirements 

Product design output shall include: 

Þ      Design FMEA, reliability results, 

Þ      Product special characteristics and specifications 

Þ      Product  error-proofing as appropriate 

Þ      Product definition including  drawings and math based data, 

Þ      Product design review results 

Þ      Diagnostic guidelines where applicable 

7.3.3.2 Manufacturing process design output 

Express manufacturing design process output in terms that can be verified & validated against manufacturing design input 

Manufacturing design output shall include:  

Þ     Specifications and drawings 

Þ     Manufacturing process flowchart/layout 

Þ     Manufacturing process FMEA’s 

Þ     Control Plans (7.5.1.1) 

Þ     Work instructions 

Þ     Process approval acceptance criteria 

Þ     Data for quality, reliability, maintainability & measurability 

Þ     Results of error-proofing results, as appropriate 

Þ     Methods for rapid detection and feedback of product/manufacturing process nonconformities.

Key Explanation Points and Tips: 

Þ      Product d & d output may be product or documentation or both. Product may be prototype or finished product and documentation could be in computerized or hardcopy form. A manufacturing d & d output may be a physical manufacturing process as well as documentation. See examples of both in Clauses 7.3.3.1 and 7.3.3.2 above). 

Þ      Check product d & d output against the input requirements specified in 7.3.2, before you use it any further. Express product design output in any or all the forms specified in 7.3.3.1.   

Þ      Provide appropriate information to purchasing (material or service specifications); production (product specifications, special characteristics, drawings, FMEA’s, diagnostics, etc.); service (product specifications; performance reliability and maintenance criteria). Initially, this information may be used for trials and validation, before being firmed up. 

Þ      The product design output should result from a process that includes efforts to simplify, optimize, innovate and reduce waste. The design process should include: 

Þ      Analysis of cost, performance and business risks and trade-offs 

Þ      Appropriate use of geometric dimensioning and tolerancing 

Þ      Design for assembly (DFA); Design for manufacturing (DFM); design of experiments (DOE); quality function deployment (QFD); Value engineering (VE) 

Þ      Tolerance studies and appropriate alternatives 

Þ      Use of Design FMEA’s 

Þ      Use of feedback from testing, production and the field 

Þ      Diagnostic guidelines in clause 7.3.3.1 refers to systems software/equipment for field servicing that requires engineering based data essential to service the vehicle.  

Þ       Manufacturing process ; Check manufacturing process d & d output against input requirements specified in 7.3.2.3. Express manufacturing design output in any or all the forms specified in 7.3.3.2. 

Þ      The manufacturing process design output should result from a process that includes efforts to simplify, optimize, innovate and reduce waste such as lean manufacturing tools that include: 

Þ      ANDON system (line control system) 

Þ      Error proofing; level scheduling; pull system inventory control;  

Þ      Synchronous manufacturing (single-piece flow) 

Þ      Visual controls 

Þ      Workplace organization and layout 

Þ      Many documents are created from the d & d output stage (drawings, FMEA’s, control plans, etc). These documents must be controlled as per clause 4.2.3 of this standard (approval; revision control, distribution, etc). 

Þ      Many sophisticated d & d tools are required to be used as indicated above. You must provide and keep records of appropriate competence and training for functions performing d & d activities.