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5.7.3 - Corrective Actions on Non-Conformances

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Posted 01 December 2015 - 03:48 PM

Hello everyone,


High Risk Section 5.7.3 states that "Corrective actions shall be implemented to avoid recurrence of the non-conformance. Actions taken shall be documented."


There are many types of printing/laminating/slitting issues that we label as non-conforming that require reworking or a final disposition. Does every single non-conformance, regardless of severity, require a corrective action? If so, what is the most effective way to address them all?


Thank you for your help!


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Posted 01 December 2015 - 04:22 PM

If you complete a non conformance correctly, you'll have completed a route cause analysis to prevent further incidents?

Although not always possible to find an accurate cause you should ask the 5 why's which may shed more light on what the cause(s) might be.


An easy analogy is a car with flat battery. No good replacing with new one until you know what caused it yes? Next thing you know maybe another flat battery!


Only you can decide if you should record ALL, but makes sense to at least gather data to start with and then work from there?

Once you have the data you might find it happens on the late shift 68% on laminate brand x 78% and between 19:00 and 20:00 42%........the data might surprise you and almost answer the questions!


You could grade severity and decide to prioritise?


Above all decide and AGREE any actions and completion dates and make realistic timescales. Say what you do, do what say. Be hard/ruthless with self too!!

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