As a quality system auditor, I often see confusion in the meaning and use of the terms 'correction', 'corrective action', 'preventive action'. I think the reason is that the way they are used in 9001 is not wholly in line with the way they are used generally. But, no matter why, they are often used wrongly.
To quote from the ISO 9000 standard:
Briefly, a correction is to fix a fault in a product (or service).
A corrective action is (for example) to make a change to the way things are done, or a change to test plans – such a change being an attempt to avoid similar nonconformances happening again.
Preventive action is an action to avoid nonconformances. It is not to remove nonconformances, so (for example) design review is not preventive action (generally). The most likely example of preventive action in the average firm is a risk analysis carried out at the start of a project.
So how does this relate to the clauses of ISO 9001:2008?
In 8.2.2 (internal audit) we read "...any necessary corrections and corrective actions are taken … to eliminate detected nonconformities and their causes". Thus, the correction is to eliminate nonconformity (ie: to fix the product), and the corrective action is to eliminate the cause (ie: to stop it happening again).
In 8.2.3 (monitoring and measurement of processes) we read that we are to check processes to ensure they achieve planned results, and "...when planned results are not achieved, correction and corrective action shall be taken...". So again, if we find things are wrong (not achieving planned results) we have to fix any problems in product (ie: correction) and in processes (ie: corrective action).
In 8.3 (control of nonconforming product) there are four types of action which might arise. First is "...action to eliminate the detected nonconformity..."; this is correction. Fourth is "...action appropriate to the effects, or potential effects of the nonconformity...". That is: we should consider whether there any effects arising from having put the faulty product into use. If there are then an appropriate action might be a product recall, or a planned upgrade programme.
In 8.4 (analysis of data) we are required to analyse data on products and processes to seek opportunities to make improvements. That includes the possibility of implementing some preventive action. This would need to be more than simply tightening up product-testing (for example). It might be, for example, adding a new item to a design checklist.
In 8.5.1 (continual improvement), we see that we "...shall continually improve the effectiveness of the ... system..." through using corrective action (ie: by improving the system) and by using preventive action (ie: by implementing preventive actions to avoid faults occurring). However, it is not immediately obvious how preventive action on its own can effect continual improvement (any addition or change to preventive action would be achieved by means of a corrective action).
8.5.2 (corrective action) gives chapter and verse. In essence, for all nonconformities (ie: faults found): find out what their cause was (easier said then done sometimes); decide how to avoid them; do it; check on whether what you did was effective. At all times do what is proportionate.
Likewise 8.5.3 (preventive action) requires that you consider all potential nonconformities. Then, in a proportionate way, decide on and implement appropriate actions, and check whether what you did was effective. In this context the appropriate actions may be checklists (for risk analysis) or failure mode analysis or design checklists. You might implement more stringent materials testing as a preventive measure.
At the margins, the distinction between corrective and preventive action is a nice one; it rather depends on whether you are responding to a fault you've found (then you'll be carrying out corrective action) or a fault that you think you might have (then you'll be carrying out preventive action). The actions could be the same, but their labels would be different.
last updated by Gordon Kirk on 25 February 2010 |
© copyright: Gordon Kirk 2010