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Who should determine the restricted materials in chemical plants? Process or quality?

2011-10-23View Original

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In general chemical plants or pharmaceutical factories, for products that require high quality standards, documents are established specifying which materials are allowed to be used and which ones are prohibited. So who should be responsible for drafting this document? Logically, those in charge of the manufacturing process are familiar with the production procedures as well as the impact of externally supplied materials on the products, but it is the quality control department that should ensure the quality of the products. I’d like to ask everyone how things are going?
Reply #22011-10-23
This should be the responsibility of the process department; the quality department is only responsible for ensuring that the quality of the products manufactured meets the standards. As for the reasons why the products fail to meet those standards, that is the concern of the process department, as it is irregularities in the manufacturing process that lead to poor product quality. The quality department simply needs to provide the parameters indicating that the products do not meet the standards, and the process department will handle the analysis

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