Understanding The ISO/TS 16949:2002 Standard 

7.3     Design & Development Planning  

7.3.1 Product design and development (d & d) planning 

You shall plan and control the design and development of product 

During design and development planning, determine:  

a)    design and development stages  

b)    appropriate review, verification, and validation at each stage 

c)    responsibilities and authorities 

Manage the interfaces between the different groups involved to ensure: 

Þ     effective communication  

Þ     clear assignment of responsibility 

Update the planning output as needed, as the d & d activity progresses 

Note :  Clause 7.3 applies to both product and manufacturing d & d and focuses on error      prevention rather than detection 

7.3.1.1 Multidisciplinary approach 

You shall use a multidisciplinary approach to develop, monitor & review:  

- Special characteristics,  

- FMEA’s, including actions to reduce potential risks  

- Control plans 

Note:    A multidisciplinary approach may include design; manufacturing; engineering; quality; production, etc.  

Key Explanation Points and Tips: 

Þ      Clause 7.3 must include the d & d of both the product as well as the manufacturing process and extends throughout the product program life.  

Þ      The scope of your d & d activity must consider all aspects of the product and product realization processes to ensure its conformity to requirements. This includes product identification, handling, packaging, storage and protection during internal processing and delivery to the customer. 

Þ      Product d & d sometimes results in new manufacturing processes or changes to existing manufacturing processes. This clause is equally applicable for designing and developing manufacturing processes.   

Þ      Planning must focus on error prevention rather than detection in product as well as manufacturing d & d. 

Þ      You must have an overall plan for your design project. Your plan must specify the design and development stages, activities and tasks; responsibilities; timeline and resources; specific tests, validations, and reviews; and outcomes. There are many tools available for planning ranging from a simple checklist to complex software. Use your customer-specific manuals for APQP as a good starting point. 

Þ      The degree and details of planning may vary according to size and length of contract or project, complexity, risk, product life, customer and regulatory requirements, past experience with similar product, etc. You have flexibility in determining the scope of the stages, review, verification and validation required for your product d & d projects.    

Þ      Your plan must be dynamic and updated as requirements and circumstances change. You must track progress against your plan at regular intervals or project milestones and update the plan as activity progresses. 

Þ      You must use a multi-disciplinary approach, that includes as needed, other functions (besides design) such as quality, engineering, purchasing, sales, tooling, production, etc.. Your plan must clearly identify these other functions and their specific role and responsibilities regarding the project. Consider including customer and supplier personnel at appropriate stages to do work and review results or progress. Consideration must also be given to the methods of communication and interaction. Inclusion of these controls in your d & d plan is one of many effective ways to achieve this.   

Þ      A multi-disciplinary approach has the benefit of applying collective and relevant knowledge and skills of these different functions to carry out or review d & d activities 

Þ      You must use the multi-disciplinary approach for specific activities such as determination of special characteristics, conducting FMEA’s, developing control plans, and plant and facility planning, etc. Review specific requirements for multi-disciplinary approach at OEM customer or IATF websites. 

Þ      The d & d project plan serves as both a document and a record as it is updated for completion for various activities. 

Þ      Where some or all of the design responsibility is subcontracted or done off-site, then you must ensure that  your organization and the subcontractor or off-site location collectively address all the requirements of clause 7.3 with particular coverage of the interfaces between them 

Þ      You must review all input requirements; review d & d progress; verify product design and validate developed product at various stages of your d & d process. The nature, frequency and scope of these controls must be defined in your d & d plan or other document. You must carry out these controls according to your plan and keep appropriate records (see record requirements in clauses 7.3.4; 7.3.5; 7.3.6 and 7.3.7). 

Þ      Clause 7.3 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production activities (see clause 4.2.1d). These documents may include – contracts; technical drawings and specifications; a documented plan for d & d; work instructions; a documented procedure; etc., combined with unwritten practices, procedures and methods.  

Þ      Look at the risks related to your product, processes and resources in determining the nature and extent of documented controls you need to have (also see clause 4.2.1 notes). Many organizations use various software tools to document their product or process d & d plans. 

Þ      Performance indicators (to measure the effectiveness of design and development processes in meeting requirements and achieving quality objectives) should focus on reducing variation in and improving these p rocesses and related use of resources. Indicators may include reduction in – design cycle time; development cycle time; specification errors, omissions; changes; d & d costs; etc., as well as measurable improvements in products developed.