CAPA (Corrective Action) For A Typo?

Hi Everyone,
I am a brand new quality manager and just had my first audit, I had one NC for a typo on my calibration log. I typed an asset number for a high voltage power supply as 6005 and it should have been 6007. My question is what is a good CAPA for a typo? Any ideas will be greatly appreciated

Re: CAPA For A Typo?

BarbaraMc said:

My question is what is a good CAPA for a typo?

Click to expand...

That would depend on the consequences of a typo in your process.

If a typo is dangerous or costly, then you may need to modify your process to detect typos before they are released, or to be more tolerant of typos.

Corrective actions to minimize typos might include substituting human data capture with electronic data acquisition or bar-code readers. Or you could double enter everything, or simply proof-read. CAs to make your process more tolerant of typos might include having dictionaries, checksums, lookups, etc.

Else, if the typo would have little consequence, then a simple correction of the typo is all you need. For example, if the first one to look up the bad entry is likely to notice that the asset doesn't correspond to the number, then just correct it and move on. No need for CA.

Re: CAPA For A Typo?

BarbaraMc said:

My question is what is a good CAPA for a typo? Any ideas will be greatly appreciated

Click to expand...

Fire the auditor who wrote the Nonconformity for lack of common sense should be a perfectly fine corrective action. Or do, as Pancho suggested, limit the issue to a correction and no corrective action is required. Typos WILL re-occur, as it is impossible to guarantee perfection.

Re: CAPA For A Typo?

I'm with Sidney, but less elegant, it's a horse$hit nonconformity , and I'd be embarrassed to write one....And if it was a team audit and I was the Lead, it wouldn't happen either.

That fruit is so low hanging it's rotted in the dirt

Re: CAPA For A Typo?

You probably need only a correction, not a corrective action.

When a NC is found, you need to take immediate action (being a correction, rework, etc.). Then you need to evaluate the root cause and verify if there?s need for a corrective action.

In this case (as is in the case of typos in general), it seems that you only need to correct the problem.

You should also make the auditor aware that writing this as an NC (which it is anyway) is not common audit practice, unless several of them were noted. If an internal auditor, maybe you need a retraining on the correct concepts.

Fire the auditor who wrote the Nonconformity for lack of common sense

Click to expand...

Sure, that?s the best way to treat someone who made a mistake or anyone with lack of common sense. Just fire him!

Re: CAPA For A Typo?

I'm disappointed with this auditor. If it was me I would expand my sample after finding the first one, to understand if there's a true problem. If there's only one little typo out of a large sample I would find a vague way to word an OFI so as to signal to you that this thing has been noticed and will be again.

Re: CAPA For A Typo?

Barbara,

Unless typos of this type are common or have serious consequences, correct it and move on.

The auditor should've investigated the extent and seriousness but you do not mention this.

Perhaps the auditor did not have time. In any case you'll investigate to determine if correction is all you need to do.

Should you see cost benefits of removing the root causes (aka corrective action) then you may need the help of IT to configure the form not to accept the wrong number. In other words mistake-proof the electronic form.

You are not obliged to take corrective action for every nonconformity.

John

Re: CAPA For A Typo?

Though I agree with all posts I'd like to stress a more formal point: If the content of a document is incorrect then you have a non-conformity. If this is found by an employee then you follow your NC procedure (and this typically should result just in a correction in such a case). If, however this is found during an audit you have a finding and if your system tells you to treat all audit findings via your CAPA system then what can you do other then open a CAPA?

Re: CAPA For A Typo?

here is the rub: typos in a hand written or electrically handwritten system WILL occur. Why? because they can. We can implement all kinds of manual inxpections but they will only bog the system, be ineffectivea nd introduce new opportunities for error.

the only way to prevent "typos" is to have a computer system with barcode entry and internal checking of allowed values and earlier entries. Coupled with intelligent numbering/naming systems. These are expensive.

Re: CAPA For A Typo?

TWA said:

If, however this is found during an audit you have a finding and if your system tells you to treat all audit findings via your CAPA system then what can you do other then open a CAPA?

Click to expand...

Actually, instead of CAPA, we should be using CAR for corrective action request.

Let's remember that ISO 9001 does not require a corrective action for each and every system, process, product, etc. nonconformity, as clearly exemplified in this case.

If the process of issuing a CAR would fix each and every problem known to Man, we would have eliminated hunger around the World and conquered net-positive energy nuclear fusion.