Modifying an old printed record? ISO 9001

[QAMTY]

Hi all

Recently we ran an audit and a NC was raised because in two paper printed records several fields were not filled up and some others were not so legible.
Due to that NC, a CA was registered in the System.
but one plan was to correct such records.
But I started to doubt about that, because I think a record is a snapshot of certain time and if such records are modified, then the records really are not reliable.
What is your opinion ?

Other point, is about an electronic record, how can we be sure about the reliability, because is changing dinamically (database, not a pdf file), and is not possible to go backwards and show the record at certian date/time.

Your insights are welcomed.

 

[Marc]

A record is a snapshot of a specific instance.

1. Two records out of how many total records? While noted, it doesn't sound like a recurring and/or wide spread problem.

Changing a record is definitely not advisable - In my opinion it is never allowed with the possible exception of a single line mark through an inaccurate entry, and initial, date and reason. In some industries, it is illegal to alter a record. In fact, some countries have banned or restricted the sale of correction fluid (aka "white-out") to prevent changes to records.

Correction_fluid

If it is an old record and currently you use electronic records it could be argued that the nonconformance is not valid because your record keeping system/method has changed. In addition, has there been a previous finding of incomplete records and/or incorrectly completed or illegible records which you have done a corrective action for?

When an auditor finds an old record, beware. How far back in time is the auditor going? Add in that if your system has changed, which it sounds like it has, you can not do a non-conformance on a system which is no longer in use.

2. Records do not change, electronic or paper. If a database is changing records you have a serious problem.

Document vs. Report vs. Record - What are the differences?

Form vs. Record - What is the Difference between a Form and a Record

 

[AMIT BALLAL]

Correcting the record won't be a good idea. And it is old, therefore is also not relevant. Instead of this action, you can check what information was missed, whether it had any impact on customer / product / service. This can be the temporary action for closure of nonconformity.

 

[Mike S.]

CORRECTING a record is perfectly fine.

CHANGING a record can get you in trouble, even jail time, depending on what it is.

You should have a procedure for CORRECTING errors in records. Ours basically involves lining through the original entry so it is still visible as to what it originally read, and correcting it beside that, and signing and dating the correction. Depending, you may also wanna attach an in-depth explanation.

 

[Claes Gefvenberg]

Ours basically involves lining through the original entry so it is still visible as to what it originally read, and correcting it beside that, and signing and dating the correction.

That would be my approach as well. Our paper based records are few and far between, but that makes no difference.

 

[PaulJSmith]

Lining through as Mike suggested is an acceptable practice, even in the tightly controlled world of the aerospace industry.

Another practice we occasionally engaged in while I was in that industry is to "recreate" the questionable document as a new, legible copy, mark it as such and explain the reason for it's existence, and attach the original to it. You gain a complete or legible document, yet still retain the unaltered original as well.

 

[Marc]

Lining through as Mike suggested is an acceptable practice, even in the tightly controlled world of the aerospace industry....

Yeah - I mentioned that as well in my post. But on OLD records my opinion is it would be more questionable. And, as I said, it really needs an initial (at the least vs. a signature), a date and preferably a reason stated somewhere if not on the document.

EDIT: Ninja'd by Mike, too.

 

[Ajit Basrur]

I would approach slightly differently. Since the CAPA is already initiated, and as part of "Correction",

review if the missing data on the record impacts the product or the disposition of the product. If it does, this would roll into a bigger Impact Analysis. If the missing data has no impact on the product and is a low risk, try to collect all the supporting data to fill the missing gaps. Also check if there were any additional records that could be impacted.

Correction to old records is acceptable but all corrections should refer the CAPA number and all people involved may have to re-sign. Also look out if customer has to be informed.

QAMTY, could you let us know what these two records were ?

 

[PaulJSmith]

Yeah - I mentioned that as well in my post. But on OLD records my opinion is it would be more questionable. And, as I said, it really needs an initial (at the least vs. a signature), a date and preferably a reason stated somewhere if not on the document.

EDIT: Ninja'd by Mike, too.

Yeah, on older records, it's probably best just left alone, especially if, as also alluded to above, it's from an older system that is no longer in use. If that's the case, it kind of smacks of an unnecessary NC.

If the decision is made to correct, then I am a strong proponent of the single line though / initials / date method. A traceable quality stamp and date would be even better. It was a rare occasion when we would recreate a document, but it did happen.

 

[Marc]

Yeah - I think we all pretty much agree. I'm just a bit of a stickler on recording the reason for the "change" somewhere (even in today's electronic world). Sticks with me from my DoD paper days. No pencils, black ink only entries, single line-through, no white-out, a traceable responsibility (had to be a person, not a department or position), a date and the reason for the change.