I was just wondering if people still tend to collect hard copies of objective evidence found in audits?. Personally I have always tended to record serial no's, PO no's or anything that will allow anyone looking at the audit report to go back and find the item, hardocopies are pretty much a last resort for me.

As an auditor, you technically *shouldn't* be collecting hard copies of anything. Evidence is not yours to keep - it belongs to the auditee and should stay that way. Furthermore, if an external auditor tried to walk out the door with a copy of one of our CARs, for example, our management would be screaming bloody murder - there's a confidentiality aspect there that cannot be understated. For internals, confidentiality may not be as much of an issue (depending on what processes you're auditing, and what your business function is)...but still - what would be the need?

What's the need for you to keep hard copies of anything? If your traceability system is robust, then all you need are the form numbers.

Wouldn't be a bad way to audit traceability and control of records, actually -go back to previous audits, check for references to evidence, and then see if the record retention policy is being followed for those pieces of evidence.

The question was really in respect to internal audits, wouldn't allow an external audit to take hard copies, so should have put that in the question. :bonk:

My company is currently working towards ISO 9001 registration and to help us along a little we got a consultant in to help us work through some of the audits. When he came back from each of his audits he had a pile of paper as objective evidence.

I know that when I am conducting internal audits I may occasionally grab a hard copy of an emailbut 99 times out of a 100 I only have ID's that can be used to locate the evidence I found. Was just curious if many people, like our consultant, took hard copies.

sometimes the only way to get management to understand (or believe) is to take a copy of the offending evidence to see for themselves. you can tell them a million times, that such and such document shows the nonconformity, but unless you take them right to it, well......

one thing i must say to qualify that statement is that usually this gets better as the system matures, management starts to believe/understand what you are saying in the reports. i think it is a simple learning/growing process.

As far as external auditors, no they should leave all those things behind, but I, as a management rep, do keep whatever they bring to me in the audit file.

The question was really in respect to internal audits, wouldn't allow an external audit to take hard copies, so should have put that in the question. :bonk:

My company is currently working towards ISO 9001 registration and to help us along a little we got a consultant in to help us work through some of the audits. When he came back from each of his audits he had a pile of paper as objective evidence.

I know that when I am conducting internal audits I may occasionally grab a hard copy of an emailbut 99 times out of a 100 I only have ID's that can be used to locate the evidence I found. Was just curious if many people, like our consultant, took hard copies.
YES, during internal audits I collect (copies) of objective evidence. The plant supervisor is made aware of my intention (always). The objective evidence conforming and/or nonconforming becomes part of the audit record.

The audit record, which includes copy of objective evidence is often brought to table at management review.

This same objective evidence which is included in the audit record, is offered (if asked) to our Registrar Auditor for review only, during surveillance audits.

Our consultant and registrar has not (to date) asked to take hard copies of anything from our facilities. They ask to see them but always return them.

On the other hand our regulatory authority can seize records. This has not happened to us...but they do have that power.

Hope this helps! :)

I was just wondering if people still tend to collect hard copies of objective evidence found in audits?I do use softcopy a lot (Digital Camera).

/Claes

On the other hand our regulatory authority can seize records. This has not happened to us...but they do have that power.Ours always takes hard evidence.

I do use softcopy a lot (Digital Camera).

/Claes

Interesting that you mention use of soft copy. It's in my plan to have my Digital Camera with me at next audit. :agree1: Further implementation of my KISS plan.

Thanks for the reminder Claes! :)

We of course don't use cameras. During audits hard copies may be used but they never leave the site. Occasionally I may obtain a "sanitized" vesion of something that is really neat to use as an example in a training course, but only after the organization has allowed it. More and more everything is electronic, even records and the real problem now is accessing the stuff and the folks that stumble through the process blindly.

I was just wondering if people still tend to collect hard copies of objective evidence found in audits?. Personally I have always tended to record serial no's, PO no's or anything that will allow anyone looking at the audit report to go back and find the item, hardocopies are pretty much a last resort for me.
Well, yes most of us use hard copies as a promary evidence. But i do beleive that as technology progress more & more organization would use electronic docs/ soft copies.
Considerations should be given to changes in technolgy.

We use a digital camera and create an annotated Powerpoint walk through of the area. This is used in the closing meeting and is very effective. It get's attention.

It is also nice to show improvements made from the last audit. It creates a nice visual history.

We print control plans, procedures and work instructions and mark them up heavily (and neatly) during the audit. We then scan and pdf all hard copy evidence and attach it to the audit to support the findings and CARs.

The entire audit file is electronic, there is no paper.

The question was really in respect to internal audits, wouldn't allow an external audit to take hard copies, so should have put that in the question. :bonk:

My company is currently working towards ISO 9001 registration and to help us along a little we got a consultant in to help us work through some of the audits. When he came back from each of his audits he had a pile of paper as objective evidence.

I know that when I am conducting internal audits I may occasionally grab a hard copy of an emailbut 99 times out of a 100 I only have ID's that can be used to locate the evidence I found. Was just curious if many people, like our consultant, took hard copies.
I added the word "internal" to your poll to make your intention clear.
My internal auditors were like "boy scouts" on a hike - take nothing but pictures or notes, leave nothing but footprints.
'
I'd like to echo Randy in that they looked for "good" stuff, too, which might be valuable as part of "improvement."

At every point, the auditors asked,

"Does the actual activity follow the plan?"
If yes, they asked personnel, "Do you have any ideas that would make this process work better (more efficiently?)"
If no, they asked, "Why?" (perhaps the personnel thought there was a better way? some other reason? too complicated? no supplies? not enough time? forgot? etc.)
Auditors only stepped in to stop a process if there was a suspicion of life, health, safety concerns. They were empowered to do this. Otherwise, they went to a department head immediately to report a suspected non-conformance. Department head might make immediate change or refer matter to the Material Review Board for confirmation. At this point, the primary question became whether a nonconforming process resulted in nonconforming product. Auditors did not make decisions about whether product was nonconforming, only whether the activity was proceeding according to plan as they understood it.

I want to stress auditors did not make a DECISION a process was "nonconforming" - they made a decision that there was a "suspicion." If the suspicion affected life, health, safety, we operated under the premise, "Better safe than sorry."

Interesting poll. I'm eager to see more explanations.

I was just wondering if people still tend to collect hard copies of objective evidence found in audits?. Personally I have always tended to record serial no's, PO no's or anything that will allow anyone looking at the audit report to go back and find the item, hardocopies are pretty much a last resort for me.


When I first started auditing, I probably did collect some hard copies of objective evidence but it was really to help explain nonconformances. The more audits you do, the less useful and more time consuming it becomes to collect hard copies.

I did keep hard or electronic copies of auditor notes that I took during the audit with information on who and what I audited, which systems appeared to be working and enough identification of a nonconformance so that the auditee could find it and do corrective action.

Personally, I see no value in collecting the hardcopies and it was never questioned by a registrar although they did review my audit notes.

Bill Pflanz

I'm coming around to the idea of keeping little or none of the hardcopy evidence of an audit, outside of the auditors notes. Our new system will keep these electronically. We may ask for hardcopies during the audit for reference in writing notes, findings, or final reports, but I'm no longer sure we need them in the files, just a reference to them in the notes or reports. We still get hard copies of everything in dock audits, along with pictures of the products as they are being loaded for shipment. That will be going electronic as well.

I can't ever recall our registrar keeping hard copies of any evidence (nor would we let them) during audits, so why do I need to?

There should be no need to collect hard copies of evidence. If the auditee (or anyone else) agrees at the time that a non conformity exists, that should be enough. There is no mileage in collecting pieces of paper to prove to senior managers that you have found a non conformity exists in their system. The auditing technique should be robust enough to prevent misunderstanding or the need to present evidence at closing meetings.

There are times when a hard copy is the only evidence left behind. I can think of times when customer-supplied documents cannot be stored or tracked electronically and a hard copy is the only evidence available.

When I have had to keep a hard copy I try to keep a photocopy in order to leave th original where it ought to stay.

Jaime

Our group of Internal Auditors are trained on the basis that their audit notes should be able to stand up on their own. No copies of Objective Evidence are maintained with the audit report. If I looked at FCD-0123 (Rev.5) Title "blah blah blah", I will record that along with relevent record information so that should I need to go back to see that OE, I can do so. But our notes will support whether compliance was determined, or non-compliance or opportunity for improvement or N/A. Certainly makes for an easily managed audit report!

I ask for copies of documents during external audits and internal audits if I want a document to refer to when I am writing my report. If you will give me the document, I'll take it. If not, not big deal. My reports have enough detail to stand on their own.

There should be no need to collect hard copies of evidence. If the auditee (or anyone else) agrees at the time that a non conformity exists, that should be enough. There is no mileage in collecting pieces of paper to prove to senior managers that you have found a non conformity exists in their system. The auditing technique should be robust enough to prevent misunderstanding or the need to present evidence at closing meetings.

You are correct up to a point. Some evidence can be documented in enough detail that copies are unecessary. Some evidence, after all, is verbal. But if there is any question about being able to show enough evidence that the investigator of the CAR can easily find information to find the root cause, I'd rather make sure he has a copy to see.

Unfortunately, especially in new systems, if management is say, less than 100% knowledgeable, they may demand to see copies of what you are citing. I'll even qualify that statement with another: a lot of managers really don't want to have the same level of knowledge as an auditor, and why should they? That is what they have auditors and management reps for. I've found that it is easier to snag a copy for that purpose than to have to go back to an area with 1 or more managers later, especially if your plant is really large. Most of the time, as long as we clearly identify the record/date/whatever identifier we need, we can bring the information up on any computer, but not all businesses are quite so lucky.

You are correct up to a point. Some evidence can be documented in enough detail that copies are unecessary. Some evidence, after all, is verbal. But if there is any question about being able to show enough evidence that the investigator of the CAR can easily find information to find the root cause, I'd rather make sure he has a copy to see.

Unfortunately, especially in new systems, if management is say, less than 100% knowledgeable, they may demand to see copies of what you are citing. I'll even qualify that statement with another: a lot of managers really don't want to have the same level of knowledge as an auditor, and why should they? That is what they have auditors and management reps for. I've found that it is easier to snag a copy for that purpose than to have to go back to an area with 1 or more managers later, especially if your plant is really large. Most of the time, as long as we clearly identify the record/date/whatever identifier we need, we can bring the information up on any computer, but not all businesses are quite so lucky.
There's nothing wrong with saving documentation if it serves a purpose. The purpose might be mnemonic, serving to help the auditor remember something, or it might be to provide exemplary samples--something that was done particularly well or not so well, so that others can benefit.

I always make photocopies as objective evidence, or take digital pictures. Maybe it's not necessary, but I'm relatively lazy, so if I need to refer back to something, I prefer to be able to grab it from the audit files in my desk, rather than having to go back to the department and pulling up Form ABC from the 2nd week in April.

Yes, I could just take super-good notes and the copy would be unnecessary, but if a picture is worth a thousand words then a photocopy must be worth a thousand words worth of notes, right?