7.3 In - depth analysis of design and development review, verification and validation
Understand the relationship among the three and the starting points for review
In the process of design and development, it is crucial to clearly distinguish the relationships among the three stages of review, verification, and validation and to master how to audit them. We can start with the authoritative standard definitions. First, refer to the definitions of 3.8.4 verification, 3.8.5 validation, and 3.8.7 review in 9000:2000 Fundamentals and Vocabulary. These definitions provide a cornerstone for us to understand the essence of the three. On this basis, by combining the following two detailed comparison tables, we can comprehensively and deeply grasp the differences and connections among them.
Distinguish the three from their main features
In terms of commonalities, design and development reviews, verifications, and validations all revolve around the core objective of checking the quality of design and development. However, there are obvious differences among them in terms of content, methods, etc.
Review
The review mainly assesses the ability of the design results (including stage results) to meet the requirements. It is usually carried out when the necessary stages are completed, and generally more than once. This is because the design process is a step-by-step and continuously improving process, and the design results of different stages need to be strictly reviewed to ensure that they develop in the direction of meeting the requirements. In terms of method, the review usually takes the form of a meeting review. A meeting review can gather functional representatives related to this design stage. Everyone can express their opinions, analyze and evaluate the design results from different professional perspectives, so as to comprehensively examine whether the design has the ability to meet the requirements.
Verify
The focus of verification lies in determining whether the design outputs (including stage outputs) meet the requirements of the design inputs. It will be carried out after each stage is completed and the design is finalized. This is to ensure that the outputs of each stage and the final design output can accurately respond to the expectations of the design inputs. The verification methods are quite diverse, and generally methods such as calculation, experimental demonstration, or document review are adopted. Calculation can verify the rationality of the design output through precise mathematical models and formulas; experimental demonstration visually checks whether the design output can achieve the expected results through actual operations and displays; document review carefully examines various documents of the design output to ensure that their content is accurate, complete, and complies with the provisions of the design inputs.
Confirm
Verification mainly determines whether the designed and developed products meet the specified usage requirements or known intended uses, and it is usually carried out on the final products. This step is directly related to whether the product can perform its due functions in actual usage scenarios. The methods of verification include appraisal and finalization, and confirmation after customer trial use, etc. Appraisal and finalization means that professional institutions or personnel comprehensively evaluate the product according to relevant standards and specifications to determine whether it meets the requirements; confirmation after customer trial use means that the product is tried out by actual users, and it is judged whether the product meets the usage requirements based on the users' feedback and actual usage conditions.
Analyze the differences among the three from multiple aspects
In addition to the differences in the above main features, there are also obvious differences among review, verification, and validation in terms of purpose, object, time, participants, etc.
Purpose differences
The purpose of review is to evaluate the ability of the design results to meet the requirements. It focuses more on assessing the overall planning and direction of the design to see if the design has the potential to meet the established requirements. Verification is to confirm that the design output meets the requirements of the design input, emphasizing the consistency and accuracy between the design output and input. Validation is to confirm that the product meets the specified usage requirements or the requirements of the known intended use, focusing on the applicability and effectiveness of the product in actual use.
The objects are different
The objects of review are the design results at various stages, covering all intermediate products in the design process, so as to discover and correct problems in the design in a timely manner. The objects of verification are the design outputs, such as documents, drawings, samples, etc. These are the specific achievements of the design process, and their quality needs to be ensured through verification. The objects of confirmation are usually the products or samples provided to customers, and the inspection is directly carried out on the final products for the market and users.
Timing selection
Reviews are conducted at appropriate stages of the design. Based on the complexity and characteristics of the design, suitable time nodes are selected to evaluate the design results to ensure the smooth progress of the design. Verification is carried out when the design output is formed, and the design results are inspected in a timely manner to avoid the accumulation of problems until the later stage. As long as it is feasible, validation should be completed before product delivery or production and service implementation to ensure that the products delivered to customers meet the usage requirements.
The participants are different
The review is generally attended by functional representatives related to the design section. They come from different professional fields and can evaluate the design results from multiple perspectives. Verification is usually participated in by the personnel who carry out the design activities, because they have the best understanding of the design process and can accurately judge whether the design output meets the input requirements. Confirmation usually requires the participation of customers or personnel who can represent customers. Their actual needs and usage experiences are the key basis for judging whether the product meets the usage requirements.
Control of design changes
Design changes are an inevitable part of the design and development process, and it is crucial to exercise effective control over them. Reasonable design change control can ensure that necessary adjustments and optimizations are made to the design without affecting the quality of design and development. For relevant control processes and methods, please refer to [Specific link: bbs./frame.php], where you can find detailed guidance and suggestions to ensure the orderly progress of design changes.