System Trouble Reports


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We have a System Trouble Reports (STR) procedure which is used to record and report system level issues that need further resolution. Resolution of the issue is not required for the STR closure, only disposition. Engineering related STRs involve issues pertaining to software/hardware requirements, design requirements, and testing documentation. Manufacturing related STRs involve issues pertaining to the manufacturing documentation or process.

A System Level Issue is defined as any issue that is considered an anomaly at a system level, which includes subsystem level or higher assembly levels. This can occur during testing or manufacturing.

My question is, would you say that this specific procedure falls under the scope of post delivery activities or nonconforming output? The reason I ask is because on our internal audit schedule it is listed in the post-delivery activities section 8.5.5. However, the process steps seem more related to control of nonconforming outputs.

Any help?

Big Jim

It could fall under either or both depending on circumstances. Each incident needs to be evaluated to see where it fits.
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