Process of validating a will
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.
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.