Understanding The ISO/TS 16949:2002 Standard 

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.