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Quality Management System and reprocessing

Reprocessing is a frequent case in the production for different branches. For quality management system, this process is a risky process❗, since it is not a standard process.

We defined areas that you should think about in advance to manage risks of reprocessing:
➡️ The reprocessing method should be documented, including, if necessary, environmental requirements, labeling, staff qualification.
➡️ Production records should be kept (for which batch, when, by which method and others)
➡️ The reprocessed lot is usually subject to enhanced #control. A specific  control plan should be defined for the reprocessing process.

The photo shows a fragment of our checklist for supplier audit regarding the reprocessing.

Quality management trainings, risk management, product audits, process audits, consulting services: expert@orexpro.com

07.06.20

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