Guidelines on record retention of obsoleted calibration procedures (Revision History)

Hi,

I'm new here, so please no raspberries yet...

I haven't been able to find any guidelines on record retention of calibration procedures. Some people archive their old procedures, but I don't see any real requirement in 17025 to do so. I've never heard an auditor ask about an old procedure either.

Any thoughts?

It's just a document/data control issue. I'm not that familiar with 17025, but from QS/TS/ISO perspective the organization determines how they control their documents and their own record retention guidelines. It's fairly common to maintain obsoleted procedures, at least for some period of time, as reference and, in some systems, as the record of what was changed. Whether or not 17025 specifically calls it out it's probably a good idea to retain them for a time anyway. At the LEAST maybe just retain the previous version until the current one is updated AGAIN, always having at least the LAST version prior to THIS one.

We maintain our obsoleted procedures and I will say I've referred to them on many occasions. Things come up, in audits and in every day conversation, where I need to remind myself what we did in regard to a particular point in a procedure, or why we did it. The obsoleted procedures are a nice point of reference then.

CalDog,

You are correct, ISO/IEC 17025 does not specifically require retention of obsolete calibration procedures. However.....

Section 4.3.2.2.d does require that any obsolete documents that are retained are suitably marked. Perhaps more importantly thought:

Section 5.4.1 does require the laboratory to have and use instructions (read procedure here) on the use and operation of relevant equipment. Put another way, a sharp assessor may ask to see whether the new copy of the procedure you actually addresses the item that is under immediate scrutiny. If it does, and the obsolete versions are "protected against unintentional use" per section 4.3.2.2.c, then you are OK. However, if the obsolete document does not cover the item in question, and you do not have one that does, then you may well receive a CAR.

One other point is that retention time of documents and records must be established. the requirement is actually under the quality records section, 4.12.1.2, but does apply to the entire document control system. That then means obsolete documents. You get to establish when and how to dispose of such things, but the quality manual or other procedures must specify it.

My personal suggestion (my thoughts only, not IAS', as that would be consultancy) is that it is prudent to maintain the manual and/or calibration procedure for every piece of equipment you have, until it is retired. Then there is no question. Of course, if you have a lot of items, that can mean a lot of space!

Hershal

Caldog - you didn't state what industry you're dealing with, and that is an important variable in my experience. My experience includes being a tier 2 supplier to the aircraft industry, as well as running an ISO Guide 25 accredited lab embedded within the QS-9000 certified quality system of a steel mill, which was a tier 1 supplier to 2 of the big 3. As a tier 2 to the aircraft industry, our chem lab was ISO Guide 25 certified. At that time minimum retention for anything was 25 years, and basically was really for the life of the plant. If/when an aircraft went down for mechanical failure of an engine, it was expected that the engine manufaturer would trace the turbine blades back to the raw materials, one of which (high purity vacuum grade chromium) we could have supplied.

For the steel mill, the standard QS-9000 retention times built into that system were deemed acceptable by our registrar. (We piggy backed the A2LA system on top of the QS-9000 system after deciding to become QS registered. The A2LA registration for ISO Guide 25 for all in plant labs preceded the decision to register the mill to ISO 9001:94, then QS-9000.) If I remember correctly, our retention times for obsolete procedures, including calibration procedures, was in the range of 7 to 10 years.

I was running the lab for 5 & 1/2 years, and never had an assessor ask for a copy of one of our old procedures. I did have testing procedures gone over with a fine tooth comb by our assessor to verify that we were following the ASTM testing procedures to the "T".

I think of archiving old procedures, as an insurance policy against customers coming back years later with a claim/complaint regarding test results. A lot depends on the industry you serve, and what their archive requirements passed on to suppliers are. Just my $.02 wortj.

In a past life I was a Quality Manager for a QS-9000 company and when it came to record retension make sure you go over you P.O.. One of our customers to whom we were tier 1 mandated that record be kept for a specific time frame then destroyed. They wanted no records kept beyond that specified time frame. On an off the record conversation I had with one company offical they explained that liabilty wasthe reasoning behind this. As for calibration my lab was also A2LA ceritified and we documented calibration record will be maintained for a period of 7 years in our Lab Manual.

CalDog said:

... guidelines on record retention of calibration procedures. Some people archive their old procedures, but I don't see any real requirement in 17025 to do so ...

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CalDog,

I am working with an in-house calibration lab in the airline industry. The lab is registered to ISO 9001:2000 but is not accredited. Their quality management system (which I helped develop) addresses calibration procedure development this way:

• If a calibration procedure is revised or replaced, the minimum retention period is the longer of: one year or until all items calibrated by that procedure are recalibrated under the new version.
• Service manuals or operating manuals for customer's equipment are retained for at least the longer of: one year after the last applicable item is disposed of, or until the calibrations of all of those items expire.
• If either of the above are for measurement standards, then the minimum retention period is the longer of: one year, or until all calibrations performed using that standard have expired.
• If customer requirements (currently none) mandate a longer retention period then that is used instead.
• Printed documents that are replaced but retained are marked and placed in a separate file cabinet. Electronic documents that are replaced but retained are moved to a limited-access folder on the server.

The purpose of retaining calibration procedures is to be able to, if necessary, exactly repeat the calibration procedure that was last used. I have never had a need to do that but I suppose it could be asked for by someone sometime for some reason I can't think of.

(One thing you do not want to say is that documents are retained "forever". If you say that then some smart-*** auditor might ask how you are going to protect them when the Sun goes nova in 15 billion years or so ... )

Kevin H said:

Caldog - you didn't state what industry you're dealing with, and that is an important variable in my experience.

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Excellent point. Usually the liability aspect affects retention whether in calibration or other system procedure. The lower the liability aspect, the less stringent the requirement to keep copies of obsoleted procedures.

When I started in quality it was in military manufacturing of electronics assemblies. There was a department called document control and it did, literally, keep copies of all revisions going back something like 10 years - The department controlled ALL procedures. You wanted a procedure, it had to go through the document control department. The company was at one time AVCO and there were procedures there in the 1980's from back in the 1950's from AVCO.

In today's world, saving electronic copies of obsoleted documents should not be a big issue. As Graeme pointed out - Simply move them to a protected directory.

Kevin and Marc,

You bring up a good point, and it helps in understanding the overall context, and in providing the best answer. I agree with you both.

Please do allow me to point out that ISO/IEC 17025 is not industry specific, and so the original question - as asked - does not depend on industry.

Not to disagree, only to clarify that industry requirements are often beyond the requirements of 17025, and usually rightly so, as each industry has its own needs.

Hershal

Thank you

Thanks to all of you for some great information. I don't think you can help more than you have, but if you're interested in more specifics, read on...

I work for a defense contractor, where the requirements aren't as strict as those in the automotive or pharmaceutical industries.

Document retention is a problem for me due to the following:

1. We have thousands of procedures.

2. Most of our procedures are Microsoft Word documents, stapled on top of OEM or government documents. Scanning these into Adobe creates large files, often about 1MB.

3. Even with the large file size, I tested an Adobe in our laboratory management software program. I protected the document from editing, but when it's pulled up in our management program, the protection is disabled! I can't protect the server, because it needs to be accessed by multiple computers ... unless they can allow access, but not editing (that's a thought).

4. I'd just archive hard copies, but many of the second-source procedures we use are updated. For example, we'll receive half-a-dozen replacement pages. So I can't archive the whole document, only the replaced pages! And then a few months later some different pages will be updated.

So this is a difficult problem to work with. I appreciate all of your thoughts. This is a wonderful forum; I'll have to explore further.

CD

I love the smell of white paste glue in the morning!

CalDog said:

2. Most of our procedures are Microsoft Word documents, stapled on top of OEM or government documents. Scanning these into Adobe creates large files, often about 1MB.

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Is that 1 MB figure for an entire multi-page document? Considering that a sheet of paper is scanned as a picture, that seems closer to the size I would expect for a single page.

I agree that scanning documents does make sizeable files, but all things are relative. The first computer hard drives I ever sold were 5 MB - that was huge in 1979. A few weeks ago I was buying a new external drive for my laptop and about the smallest I could find was 100 GB -- 20,000 times larger!

CalDog said:

3. Even with the large file size, I tested an Adobe in our laboratory management software program. I protected the document from editing, but when it's pulled up in our management program, the protection is disabled! I can't protect the server, because it needs to be accessed by multiple computers ... unless they can allow access, but not editing (that's a thought).

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Wow! I have never heard of an application that could break and remove Adobe's file security all by itself! While we almost certainly use different lab software, I just checked a cal procedure in mine (logged in as a user instead of as an administrator) and the PDF file came up with the security, encryption, protections and digital signature all intact. If your application is breaking the security, that tells me it is probably manipulating all files somehow instead of just storing them. That makes me wonder ... what else it it doing that we can't see?

• What version of Acrobat are you using? (I am most familiar with versions 5 and 6 but I have used older ones as well.)
• How are you turning the protection on? (I go from Acrobat's FILE menu, choose DOCUMENT SECURITY, and then select the security options in the dialog box. After saving it that way, then I put a digital signature on it just to be extra sure.)

On a server, a standard permissions setting is read-only. It is also routine for permissions to be managed by user groups. For example, people in the USER group would have read only access; people in the ADMINISTRATOR group can do anything, and people in the GUEST group can't even see the directory.

CalDog said:

4. I'd just archive hard copies, but many of the second-source procedures we use are updated. For example, we'll receive half-a-dozen replacement pages. So I can't archive the whole document, only the replaced pages! And then a few months later some different pages will be updated.

Click to expand...

I agree that can be a problem, and one even the Governemnt has trouble with. Many of the documents I get from the DAPS ASSIST web site consist of the base document and then several updates, all in separate PDF files. But also in many cases they merge the document for you -- I think the key is if all of the source documents are in electronic format. They do have a limited number of "historical" copies online as well, but not as many as some would like. In that respect, the GIDEP database for calibration and reliability information is better -- they have a lot of old as well as current versions.

I have not bothered to move our old paper documents out of the filing cabinets. Most of them are old test and measurement equipment manuals that the manufacturers do not update. Others are aircraft manufacturer drawings, and for those we can always get the latest version from their online database. In each case they will slowly disappear as the equipment does. I also fairly often check the web sites of the major test equipment manufacturers to find updated manuals for models in out workload and download any new ones. (Many are in electronic format now.) I am also slowly re-writnig calibration procedures in electronic form.

IF a document and its revised pages are both in PDF documents, and they are not protected (or you can turn it off) then you can actually merge the changed pages yourself. In the Acrobat DOCUMENT menu there are choices to insert, delete, merge and replace pages between documents. I would suggest:

• Make a new copy that will contain the changes, and a new copy of the changes. Close the old copies. (Reason - to reduce the risk of accidentally doing something that can't be undone.)
• With the new copy and the new change document both open, use Acrobat to delete and old page and replace it with a changed page.
• Protect and save the changed copy as the new revision. (At that point you will have files of the new version and the previous version, and two copies of the change pages - one of which can be deleted.)

Very occasionally I do get flashbacks of hours spent cutting changed lines or paragraphs from the transmittal message and pasting them into the publications ... just goes to show that not everything in the Marines was fun.