Process of validating a will


02-May-2017 15:54

If there are no expectations set up front, the best approach would be to optimize the molding process.Then, a statistical study would be performed to determine what level of assurance that the “specific process will consistently produce a product that meets its predetermined specifications” can be achieved.If a certain grade is not specified, controlling the process can become a challenge.

Elements of the Injection Molding Process The most important elements that make up the injection molding process include: Machine—The equipment should be in good running condition and be correctly sized for the mold and part.However, as with many regulatory requirements today, the interpretation of how to validate a process can be quite overwhelming.In fact, there are entire books written about the subject. A simple and basic definition for process validation is: Establishing, through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications.The definition, at first, glance seems relatively simple, but the phrase “high degree of assurance” is relative, which leaves the definition subject to interpretation.

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The phrase does not imply a guarantee, so how can one determine when they have reached a high enough degree of assurance?

Likewise, using a material with a high shrink factor or an aggressive material that can contribute to premature mold wear will only compound the problem.



Oct 6, 2016. This is called a product hypothesis because you are testing your assumption whether or not your intended audience will use your product.… continue reading »


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