Understanding The ISO/TS 16949:2002 Standard 

7.3.6.2 Prototype program  

When required by the customer, you shall have a prototype program & control plan.  

Wherever possible, use the same suppliers, tooling and manufacturing processes as in production 

Monitor all performance testing for timely completion & conformance to requirements 

Be responsible for, control and show technical leadership for any outsourced design services 

Key Explanation Points and Tips:

Þ      Your d & d project plan must include your prototype program. Use a prototype control plan to manage the development of a specific product. Use existing approved suppliers, tooling and manufacturing processes to save time and risk. Review specific requirements for prototype programs at OEM customer or IATF websites. 

Þ      Monitor internal and supplier activities to both your d & D project plan as well as your prototype control plan.  

Þ      You must have a process for outsourcing activities (e.g. tooling). You must include this process as part of your QMS (see clause 4.1).  

7.3.6.3   Product Approval Process 

You shall: 

Use and conform to the customer approved product & manufacturing process approval procedure (e.g., PPAP Manual). 

Apply the same approved procedure to your suppliers 

Note:   Product approval should follow the verification of the manufacturing process 

Key Explanation Points and Tips: 

Þ      Use the customer provided or recognized procedure provided procedure if one exists, otherwise use the appropriate OEM PPAP reference manual. Review specific requirements for PPAP at OEM customer or IATF websites. 

Þ      Make your suppliers use the same procedures or manual as you do. If supplier PPAP’s are done by your purchasing function that is located off-site, make sure that both the offsite purchasing process as well as the PPAP process is identified in your QMS processes (see clause 4.1). 

7.3.7 Control of D & D Changes 

You shall: 

Identify and maintain records of changes 

Review, verify, and validate the changes (as appropriate)

Approve the changes before implementation 

Evaluate effect of changes on constituent parts and product already delivered 

Maintain records of the results of such reviews and any necessary actions 

Note:  D & D changes include all changes during the product program life (see 7.1.4) 

Key Explanation Points and Tips:

Þ      Make sure your process for d & d changes follow appropriate steps of clause 7.3 (define plan, have inputs and outputs, verify and validate) to the extent necessary to meet customer requirements and control product, quality and business risks. 

Þ      Changes may come from internal, customer or regulatory sources. Get all requests for product or manufacturing process design changes in writing from your customer! Review specific requirements for design changes at OEM customer or IATF websites. 

Þ      Impact of the change must be evaluated on – materials used; design process; manufacturing process; characteristics and use of developed product; regulatory compliance; cost; etc. 

Þ      Closely linked clauses include 4.2.3.1 and 7.3.6.3