As applicable would of course be in line with the organization’s risk-based thinking.
ISO 9001:2105 - Are OFI or Corrective actions required?
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Randy
Super Moderator
It's very clearly defined by the ISO itself....
correction
action to eliminate a detected nonconformity
People use nonstandard terminology all the time.
Randy
Super Moderator
Maybe so but the OP was referencing 9001. People start getting into trouble when using non-standard terms and trying to define stuff on their own instead of using the actual reference. Is there any reason why when giving guidance or help, one shouldn't try to give actual information and not a guesstimation?....I'm only a User so I'm just asking.
I wasn't trying to give a "guesstimation." On the contrary, I was trying to get clarification from the OP to avoid guessing.
Randy
Super Moderator
What's to clarify? The OP asked..."Are we required to have Corrections or OFI processes / records per ISO 9001:2015? " The question has been answered...."No" to the OFI's and "Yes" to corrections
None of this is helping the OP. I saw ambiguity and asked for clarification. That is all.
I'm with you Jim. I asked a similar question early on!
Wow you all are awesome, thanks so much for all the suggestions.
To clarify a bit. When a problem is found there are different severities of problems. We don't want to go overboard and do a root cause analysis for every minor problem. So if the management team deems a problem not significant enough to warrant a root cause investigation(CAR), then my question was, do we need to have some lesser processes to capture the problem and actions taken. Section 10.2.2 seems to say we do. Although, it leads me to question of what qualifies as a non-conformance? I don't think a day goes by where minor issues don't arise and it's not feasible to document every one of them.
Also to clarify I thought a correction is a situation where something goes wrong but it's deemed not severe enough to warrant a root cause analysis so it is fixed without a root cause being identified. If I'm understanding correctly we need to have a process for corrections where we document every non-conformance(not clear what qualifies as a non-conformance) and actions taken(per section 10.2.2). Section 10.2.1 seems to say it's up to us to determine when a root cause investigation(aka CAR) is needed.
We're a really small company where we all wear lots of hats and we are fairly new to ISO so are trying to create effective processes, but can't afford to go overboard.
To clarify a bit. When a problem is found there are different severities of problems. We don't want to go overboard and do a root cause analysis for every minor problem. So if the management team deems a problem not significant enough to warrant a root cause investigation(CAR), then my question was, do we need to have some lesser processes to capture the problem and actions taken. Section 10.2.2 seems to say we do. Although, it leads me to question of what qualifies as a non-conformance? I don't think a day goes by where minor issues don't arise and it's not feasible to document every one of them.
Also to clarify I thought a correction is a situation where something goes wrong but it's deemed not severe enough to warrant a root cause analysis so it is fixed without a root cause being identified. If I'm understanding correctly we need to have a process for corrections where we document every non-conformance(not clear what qualifies as a non-conformance) and actions taken(per section 10.2.2). Section 10.2.1 seems to say it's up to us to determine when a root cause investigation(aka CAR) is needed.
We're a really small company where we all wear lots of hats and we are fairly new to ISO so are trying to create effective processes, but can't afford to go overboard.
See Randy's earlier quotation from the standard, which defines "correction." It's best not to stray from normative definitions. What you're describing seems to be preventive action and continualous improvement. Whether or not those things should be documented is best determined on a case-by-case basis. If what you do is intended to forestall a nonconformity (failure to meet a requirement), it should be documented in most cases. On the other hand, if the action in question is simply a matter of expedience or convenience, whether or not it should documented depends on whether or not the record created might be useful to someone else in the future. Your call, in other words.
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