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4.2.4 Control of Records - Registered to ISO9001:2000, ISO 13485 and AS9100

S

silly girl

#1
Hi all-

I am in the middle of an internal audit, and I am having some trouble deciding what to do with a particular finding. Any thoughts would be appreciated.

First, some background. We are registered to ISO9001:2000, ISO 13485 and AS9100. During the last internal audit there was a finding written against 4.2.4, specifically concerned with protection and retrieval. This involves supplier records (C of C and Test data) that are used in an aerospace product. The method of filing makes retrieval difficult (though not impossible), and older records are being stored in a semi trailer (unheated, damp, insect ridden :mg: environment). In the response to the CAR, the responsible person basically said 'This is too expensive to fix, so we won't.' This response was accepted and the CAR closed.

I am auditing our corrective action system, and this CAR closure made my ears perk up. I can accept not changing the filing system, since I do believe that we can find any record we need to, but the 'protection' piece really bothers me. During the last audit there were no records found that were illegible or ruined by moisture, however I am not sure how long records can really stay out there safely. Since our customer has stringent requirements on record retention, we expect those records to stay around for many years...

Opinions wanted - am I overly concerned about this, or is my concern reasonable? Any thoughts on how I should write up findings, or what else I should go look at?

Thanks for input,
SG
 
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B

BadgerMan

#2
The AS9100 standard requires that records be retrievable.......not easily retrievable. It is also pretty vague regarding "protection" of records.

However, you should also be concerned about any customer or regulatory impositions concerning the control of records. Maybe the company can justify the risk from an ISO/AS perspective but that is only one piece of the puzzle.

Historically, I have found our corporate record control requirements to be the most stringent of all with regard to protection from loss or damage and retention times.
 
Last edited by a moderator:

Randy

Super Moderator
#3
Have whoever answer this....

Which is more expensive?

A) Properly maintain records so they can be protected and retrieved, or

B) Possibly pay out million$ from litigation if we can't prove our bona fides.

All records have the potential to have litigation tied to them, either good or bad. Records provide "proof" and without them you just have hot air to verify the past.
 
S

silly girl

#4
Randy said:
Have whoever answer this....

Which is more expensive?

A) Properly maintain records so they can be protected and retrieved, or

B) Possibly pay out million$ from litigation if we can't prove our bona fides.

All records have the potential to have litigation tied to them, either good or bad. Records provide "proof" and without them you just have hot air to verify the past.
Yes, that is exactly my take on the situation. Thanks for the feedback.

SG
 
S

silly girl

#5
An update

Just an update for those interested.

Today I spoke with the management rep. and he has agreed that the CAR was closed inappropriately. As a result, two new CARs are being issued, one for the original issue and one for the corrective action system itself.

SG
 
S

shirly

#7
Control Of Records

Dear silly Girl,

I don't know the volume of your records, but have you considered scanning your records and storing it electronically?

shirly
 
S

silly girl

#8
Scannning records

Yes, that is under consideration. There is a project in place addressing this, but shaking money loose is always a problem so I am a bit sceptical about how long it will be before we have such a system in place. I think it would be wise to manage the risk to the existing records in the interim.

Regards,
SG
 

gard2372

Quite Involved in Discussions
#9
silly girl said:
Yes, that is under consideration. There is a project in place addressing this, but shaking money loose is always a problem so I am a bit sceptical about how long it will be before we have such a system in place. I think it would be wise to manage the risk to the existing records in the interim.

Regards,
SG
A simple cost effective way to store your records electronically is to scan them with a modern printer/copier machine. We do this everyday as certain segments of the projects are completed we gather the paperwork and scan them using our shop floor copy machine and scan them as a pdf file into a predetermined folder ie;

Q:\Engineering\Repair jobs supporting docs\2005\Customer\Component\Frequency testing

It is very easy to maintain and retrieve once the directory is mapped and the folders are maintained. Check with your IT department as it would be very simple for them to implement this and keep daily backups of data for you. As far as the hard copy paperwork goes, our travelers and repair documents are scanned and stored in file cabinets after shipping and receiving processes them.

This is a simple solution, and you've probably already mentioned it to your colleagues, but this is how we maintain our 4.2.4.

Rob
 

Caster

An Early Cover
Trusted Information Resource
#10
A benchmark for you

silly girl said:
silly girl said:

We are registered to ISO9001:2000, ISO 13485 and AS9100. During the last internal audit there was a finding written against 4.2.4, specifically concerned with protection and retrieval. This involves supplier records (C of C and Test data) that are used in an aerospace product. The method of filing makes retrieval difficult (though not impossible), and older records are being stored in a semi trailer (unheated, damp, insect ridden environment). In the response to the CAR, the responsible person basically said 'This is too expensive to fix, so we won't.' This response was accepted and the CAR closed.... but the 'protection' piece really bothers me. During the last audit there were no records found that were illegible or ruined by moisture, however I am not sure how long records can really stay out there safely. Since our customer has stringent requirements on record retention, we expect those records to stay around for many years...Opinions wanted - am I overly concerned about this, or is my concern reasonable? Any thoughts on how I should write up findings, or what else I should go look at?Thanks for input,
SG


SG

Many years ago I did a courtesy audit of a sister plant which was an aerospace foundry. We were Automotive.

When it came time to look at record retention, I was lead to a locked area directly above the main offices.

All records were in heavy duty bankers boxes arranged on shelving. A laser beam passed along the ends of the boxes would just touch them all. They were exactly 2 inches back from the edge of the shelf, exactly 2 inches apart.

All the covers were on and secure. The labels were all exactly 1 inch from the left top and side.

Within each box each individual file folder was snugged up to the left of the box. Within each file folder the records were neatly stacked and they were snugged up to the left within the file folder.

This was starting to creep me out. Every file folder was clearly labelled. All records were in date order within the file.

After I was done pawing through things the doc clerk almost had a heart attack putting thing back to rights.

Overkill? Of course, but this level of detail carried throughout every aspect of the business.

When I commented on the level of detail compared to our records system (biffed into a broken photocopy paper box), I was told, "my family and I fly in airplanes with our parts on them, what would you expect to see here?".

It made me feel better about the flight back home.

I thought automotive was bad for requirements until I saw Aerospace.

BTW, congrats on throwing down on this problem and getting a good result!
 
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