Design verification

The purpose of the criticaUty rating is to provide guidance as to which failure modes require resolution. However, critical modes of failure resulting in unsafe operation should be given special attention, and design/verification actions should be taken to ensure that they never occur. 

Do the design controls ensure that design reviews and design verification and validation are recorded and demonstrate the product meets the design input and user requirements ... 

Is design verification and validation performed using the same subcontractors, tooling, and processes as will be used in production ... 

Performing product design verification and validation (clauses 4.4.7 and 4.4.8.1) Reviewing product design changes (clause 4.4.9.1)... 

The techniques of design verification identified in clause 4.4.7 can be used to verify that the design output meets the design input requirements. However, design verification is often an iterative process. As features are determined, their compliance with the require-... 

A schedule of design reviews should be established for each product/service being developed. In some cases there will need to be only one design review after completion of all design verification activities. However, depending on the complexity of the design... 

The standard requires that at appropriate stages of design, design verification shall be performed to ensure that the design stage output meets the design stage input requirements. 

The standard creates a distinction between design verification and design validation. There are two types of verification those verification activities performed during design and on the component parts to verify conformance to specification and those verification activities performed on the completed design to verify performance but more on this later. 

The standard does not state when design verification is to be performed although appropriate stages implies that verification of the design after launch of product into production would not be appropriate. 

The standard requires design verification measures to be recorded. 

The design verification plan should be constructed so that every design requirement is verified and the simplest way of confirming this is to produce a verification matrix of requirement against verification methods. You need to cover all the requirements, those that can be verified by test, by inspection, by analysis, by simulation or demonstration, or simply by validation of product records. For those requirements to be verified by test, a test specification will need to be produced. The test specification should specify which characteristics are to be measured in terms of parameters and limits and the conditions under which they are to be measured. 

The verification plan should be approved by the designers and those performing the verification activities. Following approval the document should be brought under document control. Design verification is often a very costly activity and so any changes in the... 

Prepare procedures for the conduct of design verification activities. 

How do you control subcontracted design and design verification activities ... 

Under what circumstances would design verification by similarity be valid ... 

Do allow for designs to fail design verification in your development plans - never assume designs can be produced right first time. 

To accomplish this, you need to specify either in the quality plan or the documented procedures, the inspections and tests you intend to carry out to verify that the product meets specified requirements. In Part 2 Chapter 4 there is a description of a Design Verification Plan and this includes a specification of the tests and inspections to be performed on each production item as a means of ensuring that the qualified design standard is being maintained. This requires that you produce something like an Acceptance Test Plan which contains, as appropriate, some or all of the following ... 

Devices that you use for product verification at all stages in the quality loop need to be controlled and this includes devices used for inspection and test on receipt of product, in-process, and final acceptance before release to the customer. It also includes devices used during design and development for determining product characteristics and for design verification. Some characteristics cannot be determined by calculation and need to be derived by experiment. In such cases the accuracy of devices you use must be con-... 

Design verification measures (clause 4.4.7) Design validation records (clause 4.4.8.2)... 

Design Verification Testing of the prototype to see if it meets design input requirements... 

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