Course Code: ELM-117-11

CAPA Basics: Non-Systemic Issues

It may help to illustrate the differences by discussing what a non-systemic issue is and providing a few examples.

‘Non-Systemic Issue’ Defined

A non-systemic issue is often a “one-time” occurrence. Note that it may occur more than once but unless the likelihood to continue to recur is high, it still may not be a systemic issue. In manufacturing, processes generally have limits.

Fall-Out

Some fall-out may be expected and so if your fall-out is within limits, it may just be a result of the process capability. We’ll talk about data collection later but suffice to say for now that unless the issue is likely to recur (which can be indicated by trends or frequency), it may not be systemic.

Assessment and Actions Required

We should also note that if you have a non-systemic nonconformity, you are still required to take actions. All non-conformities must be assessed to determine disposition and all non-conformities need to be assessed for trends (to determine if it is, indeed, systemic).

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group