It works on the understanding that is not possible to guarantee high-quality and consistent products or services by only inspecting at random stages or by only inspecting the final result. It is necessary to create a product or service that is effective, safe and of high quality to begin with.
The entire process of manufacturing is moderated and organized in such a way that the end result complies with all the necessary characteristics. In relation to the quality of a product, manufacturing process qualification states that the performance of a product does not differ regardless of the amount of batches involved, but remains consistent.
There are three stages of implementing manufacturing process qualification: process design, process qualification and continued process verification. The first stage, process design, is when the process is outlined due to the data that is acquired during various activities leading up to it. Process qualification refers to the evaluation of the design outlined in stage one in order to assess whether the process has the capability required. Stage three, continued process verification, implies the continuous assertion is a norm due to the standards of production, which are constantly monitored.
Manufacturing process qualification shows whether or not the process that has been created can handle reproducing consistent manufacturing. There are two key attributes involved with process qualification. The first is the design of the processes and the types of tools used. The second is the procedure used to validate the performances. It is necessary to undergo manufacturing process qualification before a product or service is made available to the public.
If all goes well then the products that are a result of the manufacturing process are accepted for distribution. The qualification shows that the tools that are required are able to perform the job and will help reach the performance level that is required. Qualification of the various tools typically includes appropriate selection, confirmation that they are built for their intended purposes, risk assessment, confirmation that they can perform in the conditions required, comparing various tool options and performing a variety of tests and studies.
Shruti Bhat PHD MBA Certified Lean Six Sigma Black Belt is an Enterprise Strategist and Business Process Improvement Mastermind.
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