Understanding TS 16949

                                   Chapter 10
                    Understanding TS 16949:2002

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 processes 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.

7.3.2   D & D 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).

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

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

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

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.

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
• Prepare 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.

ÞThe 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.

7.3.4 D & D Review
You shall:
• Perform systematic review of d & d at suitable stages as per your plan (see 7.3.1) to:
a) Evaluate the ability of d & d results to meet requirements
b) Identify any problems and propose actions

Include representatives of functions concerned with the d & d stages being reviewed

• Maintain records of such reviews and any actions arising from them

Note: These reviews are normally coordinated with the design phases and include manufacturing process d & d.

7.3.4.1 Monitoring
You shall define, analyze and report (in summary) measurements at specified stages of d & d, as an input for management review

Note: These measurements include quality risks, lead times, critical paths and others as appropriate.

Key Explanation Points and Tips:
Þ Do design reviews at one or more milestones of the d & d project, depending on customer requirements, the size, complexity and risks involved. The purpose of these reviews is to evaluate results to requirements, check project progress and costs to plan (see 7.3.1) and take actions on any problems encountered. Review specific review requirements at OEM customer or IATF websites.

Þ You must take multi-disciplinary approach for doing these reviews and keep appropriate records of issues discussed, actions to be taken, responsibilities and timeline for completion.

Þ All d & d reviews must be included in your d & d plan.

Þ The summary of measurements at specific stages of d & d must be added to the management review agenda (see clause 5.6.2). You will notice this is not listed there.

7.3.5 D & D Verification
• Perform verification in accordance with planned arrangements (see 7.3.1) to ensure that d
   & d outputs satisfy d & d input requirements.
• Maintain records of the results of verification and any necessary actions

7.3.6 D & D Validation
• Perform validation in accordance with plans ( see 7.3.1)
• Ensure that the product meets requirements for the specified application or intended use,
where known
• Complete validation before delivery or implementation (wherever practical)
• Maintain records of the results of validation and any necessary actions

Note 1 The validation process normally includes an analysis of field reports for similar products

Note 2 Verification (7.3.5) & validation (7.3.6) apply to both product d & d as well as manufacturing process d & d.

7.3.6.1 D & D Validation- supplemental
Perform validation in accordance to customer requirements including program timing.

Key Explanation Points and Tips:
Þ Product design Verification includes - design reviews (see 7.3.4); comparing the new design to a similar proven design if available; performing alternate calculations; performing tests and simulations; reviewing the design documents before release, etc.

Þ Verification is checking product or process to input requirements, whereas validation is checking product or process is suitable for it’s intended use - does it perform/function in the way intended by your customer or your organization.

Þ Manufacturing process design verification include - design review (see 7.3.4); process capability studies; testing various process parameters; performing tests and trials; reviewing the manufacturing process design documents before release, etc.

Þ Product and manufacturing process validation includes - design reviews; comparison between customer requirements and internal development plans; d & d validation against customer requirements and d & D input requirements; corrective action and lessons learned from documented process failures and product nonconformities. Review specific verification and validation requirements at OEM customer or IATF websites.

Þ You must keep records for both verification and validation activities.

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