The requirements here are probably confusing to many readers - What are the differences in these three activities? And what shall be done exactly for each activity?
Design and Development Validation
Let's first take a look at design and development validation. In ISO9000:2015, validation is defined as "confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled". ISO9001:2015 says, as cited from Clause 8.3.4, the purpose of validation is to ensure the resulting products and services meet the requirements for the specified application or intended use. From these statements in ISO9000 and ISO9001, several points can be extracted:
1. Validation is done on the resulting product, so it should be done on the real product, not just the ideas of the product.
2. Validation must be done with objective evidences. So it involves a process of obtaining objective evidences. This process can be inspection, testing, and so on.
3. Validation is to confirm the resulting product meet the requirements. So it involves a judgment or a decision making process.
As a summary, design and development validation involves analysis (e.g. inspection, testing, etc.) on a real product and a judgement based on the analysis result whether the product actually meets the requirements of the intended use or application.
Design and Development Verification
Now let's look at the design and development verification. In ISO9000:2015, verification is defined as "confirmation, through the provision of objective evidence that specified requirements have been fulfilled". ISO9001 says the purpose of verification is to ensure that the design and development outputs meet the input requirements. So the key points here are:
1. Verification is done on design and development outputs. The design and development outputs are the design concepts or ideas of the product, e.g. what materials to be used, what structure to look like. It is not talking about a real product. This is the key difference between verification and validation. In terms of time sequence, verification is done before validation, as design concepts are generated before a real product is manufactured.
2. Verification must be done with objective evidences. So same as validation, it also involves a process of obtaining objective evidences. This process can be calculation, simulation, experiment and so on.
3. Verification is to confirm that design and development outs meet the input requirements. So same as validation, it involves a judgement or a decision making process as well.
As a summary, design and development verification involves analysis (e.g. calculation, simulation, experiment, etc) on the design concepts and a judgement based on the analysis result whether the design concepts meets the input requirements. Please be noted that as there's no real product yet during the verification stage.
Design and Development Review
So how about design and development review? ISO9000:2015 defines "review" as "determination of the suitability, adequacy or effectiveness of an object to achieve established objectives". ISO9001:2015 says the purpose of review is to evaluate the ability of results of design and development to meet the requirements. Based on these statements, it is important to notice that
1. Review is done on the results of design and development. Here the results of design and development can be anything generated from the design and development process, including the design and development plan, the feasibility study, the risk analysis, the design concept of the product, the verification results, the validation results, and even an individual document such as the process flow chart.
2. Unlike verification and validation, review can be done with or without objective evidences. For example, when a material is proposed for the designed product, there's probably no objective evidence available at this point yet to prove that the material is suitable, but when reviewing the design proposal, a decision can still be made whether or not to approve this material. Review can done through meetings, emails or any other ways of communication. For example, if a document needs to be reviewed before its release, it can just be done through email by individual person, and if a design concept needs to be reviewed before its finalization, a meeting can be held.
3. Review is to confirm that results of design and development to meet the requirements, so same as validation and verification, it involves a judgement or a decision making process.
As a summary, review is a decision making process, during which the evaluation can be done with or without objective evidences. And it can be done during any stage of the whole design and development process. As mentioned before, verification is done before validation, but review has no such time sequence in relative to verification and validation.
Summary
The table below is a summary of the above discussion, which compares what to be reviewed, verified and validated, when they should be done and how they are done:
Review
|
Verification
|
Validation
|
|
What
|
Almost everything
|
Design concepts
|
Real products
|
When
|
Any time
|
Before the design concepts are
finalized
|
After real products are made
|
How
|
Meetings, emails,
|
Calculation, simulation, experiment
|
Testing, inspection
|
No comments:
Post a Comment