Understanding The ISO/TS 16949:2002 Standard 

TS 16949 7.3.2   Design & Development Inputs  

Determine inputs to product requirements that include: 

a)    functional and performance requirements 

b)    applicable statutory and regulatory requirements 

c)    applicable information from previous similar designs 

d)    Other requirements essential for d & d 

Review the inputs for adequacy 

Shall be complete, unambiguous, and not in conflict with each other 

Note: Special characteristics shall be included in this requirement (see 7.2.1.1). 

TS 16949  7.3.2.1 Product Design Input 

 Identify, document & review inputs relating to: 

Customer requirements (contract review) such as special characteristics, identification, traceability, packaging, etc,. 

Use of information - have a process to deploy information gained from various sources 

Targets for product quality, life, reliability, durability, maintainability, timing and cost 

TS 16949  7.3.2.2 Manufacturing process design input 

Identify, document & review mfg process design inputs relating to: 

• Product design output data; 
• Targets for productivity; process capability and cost; 
• Customer requirements if any; 
• Experience from previous developments 

Note: Use of error proofing methods in manufacturing process design                       appropriate to magnitude of problems experienced and risks encountered 

TS 16949  7.3.2.3 Special Characteristics 

Identify special characteristics in Control Plan (CP) and:  

- Use customer specified definitions & symbols on CP’s, drawings, FMEA’s, operator instructions  

- Or use company symbols on above 

Note:   SC’s may include product characteristics or process parameters 

TS 16949  Key Explanation Points and Tips: 

Þ      Use your customer specified APQP reference manual as a good tool for d & d planning and control. 

Þ      Product d & d is only applicable if you are designated as being design-responsible. Determine (in writing) from your OEM customer if you are designated as being design responsible. You must apply all relevant requirements of clause 7.3 for manufacturing process d & d. 

Þ      You must identify, document and review design inputs requirements for function, performance, safety, regulatory, quality, reliability, durability, life, timing,  maintainability, cost, identification, traceability, packaging, special or safety characteristics (from the customer or regulatory body), and other requirements essential to the product.   

Þ      You must have a process to deploy (identify, document, review and use) design input information coming from various sources such as - customer contracts, drawings and specifications; your own organization’s database of previous d & d projects; competitor analysis; industry standards; feedback from suppliers; field data.  

Þ       You must identify, document and review manufacturing process design input that include – product design output data; targets for productivity; process capability and cost; customer requirements for manufacturing, if any; and experience from past d & d projects and manufacturing activities; and the use of error-proofing methods appropriate to the size of problems and risks experienced.  

Þ      You must have a process to deploy (identify, document, review and use) manufacturing process design input information coming from various sources. 

Þ       You must identify and include all special and safety characteristics (using the customer’s or your own equivalent symbol or notation) in your process control documents such as - control plan; FMEA’s drawings; operator instructions and other documents used to make or verify product. Note that special characteristics can also include process parameters such as temperature, timing, concentrations, etc. Review specific requirements for special characteristics at OEM customer or IATF websites. 

Þ      Not all products or processes necessarily have special characteristics. You may define them as appropriate and include them in the documents mentioned above. Guidance in determining special characteristics, comes from customer requirements; regulatory requirements and analysis of previous concerns 

Þ      You must review all input requirements for adequacy and completeness. You must ensure that requirements are complete, clear and consistent with each other. 

Þ      Clause 7.3.2 is closely associated with clause 7.2.1 and 7.2.2 – determining and reviewing customer requirements.. Accordingly, you must keep appropriate records of identification, documentation and review of input data.