Design verification plan

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. 

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 ... 

RFQ Request For Quotation DVP R Design Verification Plan and Report ° PV Process Validation EDI Electronic Data Interchange ° PFMEA Process Failure Modes and Effects Analysis SPC Statistical Process Control MSDS Material Safety Data Sheet DVP Design Verification Plan CFMEA Concept Failure Modes and Effect Analysis DFMEA Design Failure Modes ans Effect Analysis. 

The verification plan needs to cover some or all of the following details as appropriate A definition of the product design standard which is being verified. 

As part of the verification plan, you should include an activity plan that lists all the planned activities in the sequence they are to be conducted and use this plan to record completion and conformance progressively. The activity plan should make provision for planned and actual dates for each activity and for recording comments such as recovery plans when the program does not proceed exactly as planned. It is also good practice to conduct test reviews before and after each series of tests so that corrective measures can be taken before continuing with abortive tests (see also under Design validation). ... 

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... 

Verification of some characteristics may only be possible by calculation rather than by test, inspection, or demonstration. In such cases the design calculations should be checked either by being repeated by someone else or by performing the calculations by an alternative method. When this form of verification is used the margins of error permitted should be specified in the verification plan. 

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

Design verification is assigned to the [research and development department] and is planned, established, and documented. 

During design verification, the detailed design is verified, tested, and refined (if necessary). This phase starts after the detailed design is completed and the complete documentation, including technical drawing, machine control files, and productimi plans, for the product is finished (Pahl and Beitz 1996). 

The hardware design lifecycle processes are defined. o o Hardware Verification Plan 10.1.4 HC2 HC2 HC2 HC2... 

The means of compliance of the hardware design assurance objectives, including strategies identified using guidance in Section 2.3.4, are proposed to the certification authority. o o Hardware Verification Plan 10.1.4 HC2 HC2 HC2 HC2... 

Section 3.7 Design Verification. Includes a description of the approach and methods planned to verify that the design architecture, established from synthesis, is both upward and downward traceable to the functional architecture and satisfies the requirements of the validated requirements baseline and supports baseline of configurations and specifications (including the human engineering, manpower, personnel, safety, and training specification). 

Design verification test plan, protocols, and reports... 

As noted above, the basic R D work, to prove the feasibility and practicality, has been completed, some supplementary testing, to support the detailed design, is planned, and "component"-related tests and a large-scale integrated system test, for final verification before start of construction, are envisaged for the future. 

Scope of remediation works to be undertaken and any design details required to inform the verification plan Yes D/No ... 

In general, the DIR is adequate if the design verification and validation test plans can be written and risk-management activities can be completed. Hence, if the product was developed exactly as described in the DIR, the overall residual risk would be acceptable. 

Note that by making the above checklist as part of the verification plan we have arrived at a checklist that can be related back to the conceptual design phase. 

Vee model This model is used to visualize the systems engineering efforts. It highlights the need to define verification plans during requirements development, the need for continuous validation with stakeholders, and the importance of continuous risk and opportunity assessment. The left side of the Vee shows the evolution of the system baseline from requirements to detailed design. The right side of the Vee illustrates the evolution of system testing. 

Establish Verification Procedures. Verification can be performed independently by the manufacturer and the regulatory agency to determine that the HACCP system within the plant is in compliance with the HACCP plan as designed. 

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