ISO 9001:2105 - Are OFI or Corrective actions required?

Hi All,

Our continual improvement processes cover our Corrective Action processes/records, but we have no processes in regards to Corrections or OFI (Opportunities For Improvement). We're a small company with limited resources and are relatively new to ISO so are trying to walk before we run... Are we required to have Corrections or OFI processes / records per ISO 9001:2015?

Is there a particular section from the standard you're looking into?

Don’t bother with OFIs but you may find that your colleagues would welcome a means of suggesting improvements to the system that is meant help them to do good work or even better work.

Corrections need not be recorded (they may happen as a result on monitoring a process) unless they are an essential step in corrective action.

embedded said:

Are we required to have Corrections or OFI processes / records per ISO 9001:2015?

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I'm guessing you have a copy of the standard? Can you find this stated anywhere? Can I ask what motivated this question?

As a friendly challenge study 10.2.2 of the 9001:2015 standard and ask yourself...Do we need to keep a record?

John Broomfield said:

Corrections need not be recorded

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If you don't, at what point do you determine they are a) too common and b) aren't working?

Indeed, process corrections that don't work may eventually be reported and shared as a process nonconformity worthy of corrective action. And too common process corrections may indicate the need for system improvement but then the person knowing this will suggest an improvement perhaps to have it addressed across the organization.

Otherwise these ineffective process corrections may result in service or product nonconformity.

If this is too risky or ineffective then keep a record of the corrections provided the records are reviewed for necessary improvements.

The point at which process corrections are recorded may depend on the magnitude of the potential service or product nonconformity.

John Broomfield said:

Don’t bother with OFIs but you may find that your colleagues would welcome a means of suggesting improvements to the system that is meant help them to do good work or even better work.

Corrections need not be recorded (they may happen as a result on monitoring a process) unless they are an essential step in corrective action.

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How do you explain this?
10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.

Randy said:

How do you explain this?
10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.

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I don't think it's clear at this point what was meant by "corrections" in the original post. It's possible to "correct" something before a nonconformity happens. This is somewhat at odds with common terminology, but it would be good if the OP could explain what was meant.

embedded said:

Hi All,

Our continual improvement processes cover our Corrective Action processes/records, but we have no processes in regards to Corrections or OFI (Opportunities For Improvement). We're a small company with limited resources and are relatively new to ISO so are trying to walk before we run... Are we required to have Corrections or OFI processes / records per ISO 9001:2015?

Click to expand...

Further to Randy's comment, per 10.2.1 you must "as applicable" take action to control and correct non-conformities, and deal with their consequences. It is hard to imagine a case where you'd want to deliver (or your customer would want to receive) non-conforming product, so, yes, you should, at least, have corrections. And though the standard doesn't require it, it is good practice to record your NCs as they happen. Such record allows for better control, correction and dealing with the consequences.

NCs are valuable. They show you where your system is weak. They ARE opportunities for improvement. We use issue-handling software to record them along with other OFIs. It works great.