Hello everyone!

Well I've really started to buckle down and start actually writing procedures (based on the ones I have from ISO 9K:1994). Anyway, I am at the part about quality records. Now I know that I don't have to do documented procedures on all of this stuff, but believe me, if you worked here, you might understand why.

I digress. So. I have procedures from my original "Control of Quality Records, Element 16". But quite frankly, they suck large. So, I am hoping that y'all can help me out a little. What exactly do you guys at home include in your record procedures. Do you include where,precisely (blue file cabinet in Bob's office, third drawer up) the records are kept. What constitutes a record? An inspection record? A bill of lading? A raw material certification?

HELP!:frust: :)

THANK YOU!

FG

My suggestion is that don't go into too much details. You will be confused. First, look into your procedures/work instructions and identify what records they generate when you work on procedure/work instruction. A document exists before the fact; a record exists after the fact. Or in other way, a record contains data and information resulting from activity. Then, identify who keeps the record. For example, in our company, Sales keeps the record for quotaion/ customer order copy etc. We do not specify where, drawer detail, Sales keeps record. Then, decide on the retention time of all these records. At the end, decide on disposition of the record.

Hope, this will help.

FG,

Here is a file that might help. I had to do some inserting of recors and such and you might have to work on the formatting a bit but the esscence is there.

I'm currently working on our procedure for Control of Records myself and was working off of the same format as Al has in the attachment. I was thinking that I'd simply create a table that identified the records retention periods and disposition.

I do have a question.....The standard states you have to have a documented procedure that identifies the controls needed for identification, storage, protection, retireval, retention time and disposition of records. With that said.... how would you cover the identification, storage and protection if you don't state where and how they are filed? Wouldn't you need to state that record "Supplier Evaluation" is maintained in the Quality Manager's office in the Vendor History Files indexed by Vendor's Name in alphabetical order? How do you cover the standard without putting to much detail?

I just thought of something and was wondering if anyone had any comments regarding it. What would your opinions be if you said your retention period for a record was "indefinately"? Do you think this would satisfy and auditor?

What would be an example of indefinable? If that is what you put for most of your items I think it would be a flag. Even if it was for a couple items I think I would expect a question from an auditor as to "Why?"

Sorry my fingers got in the way of my typing. I meant to type indefinately.

:vfunny:

Records we would identify with and indefinately retention period would be our Training Records, Sales Orders, Purchase Orders, Receiving Reports, First Article Inspection Report and Tooling Verification Form. Our company is so small and our VP likes to hang on to things. To my knowledge we have never discarded any of these. We have always just boxed them up when necessary and put them in storage. When I asked her for the retention periods that is what she gave me for about 3/4 of the records. Do you have any suggestions to get around such as this?

Opinions anyone?

Jamie & Nav

Right now, things like inspection records and old drawings I keep forever. Even parts that we no longer make. A couple of times, we've had customers ask us to start making parts again that we hadn't made in years! Plus it's nice to have to stuff for reference. Training records, I don't think you need to keep forever. Generally 5 years after they employee has left is sufficient. Some things to do with accounting like PO's, bills of lading etc. I think you have to keep that stuff for at least 7 years from an accounting point of view. Other than that I think it's pretty much up to you.

I like Al's table format too! As for procedures for retrievability, pull the files out of the file cabinet!
:ca: :vfunny:

FG

FG

I agree with keeping stuff for future reference our customer's are bad about doing things like that too.

As far as training records and records relating to financial matters I don't want to be stepping on anyones toes with these retention periods. I was just talking with our HR Manager and she said that from her stand point the retention period from her HR laws for personnel records was in general 3 years and to not discard any records until consultation with your attorney.

Originally posted by Jamie
Records we would identify with and indefinately retention period would be our Training Records, Sales Orders, Purchase Orders, Receiving Reports, First Article Inspection Report and Tooling Verification Form. Our company is so small and our VP likes to hang on to things. To my knowledge we have never discarded any of these. We have always just boxed them up when necessary and put them in storage. When I asked her for the retention periods that is what she gave me for about 3/4 of the records. Do you have any suggestions to get around such as this?

Opinions anyone?

I would spell out in your procedure/matrix how long you will keep them, and if your VP wants to keep them longer, in a nice way suggest that she take them home and store them. That's what I did where I work. The quickly change thier tune when you lay it back on them.

Here is a copy our procedure

To get around holding a Indefinately retention perios could you say something like your retention period is 3 years after which you place them in storage?

At my previous company, we had a coporate Quality Records system (covering several locations + HQ). We had definite retention times for almost everything - the only indefinite retention times were for government-type records (we integrated ISO-14001, so there were some records that required us to keep them forever).

As for the disposition, we only indicated DESTROY or ARCHIVE at the end of our retention times. The auditors had no problem with this, as long as we showed evidence that we were doing so.

As a kind of general information note -

Always state that your retention times are minimum with the stipulation that as long as you are not running out of storage space you will not necessarily destroy the records in question immediately upon expiration of the retention period. You will find that keeping everything indefinitely will 1) not fly with your registrar, 2) create major havoc with storage space.

We have some items that due to traceability we need to maintain per our corporate office as long as we are in business. Those items are basically maintained through the computer system, backed up when current, archived when not. A lot of inspection and test results actually get transferred into computer records for product and you may find that the actual test records may not need to be kept for long periods of time.

I do know of two very large national/international companies that I have been near to and know people at had some major nonconformances way back when because of the retention issues. The first one had done the indefinitely thing and the registrar would not certify them until they set documented storage and retention times. The second was cited with a major during their certification audit because they had stated their retention as X years, and not as a minimum requirement. They auditors found basically every record kept had old records far past their stated retention.

I hope this helps.

It's a Saturday and I was catching up on my reading of new posts because I was pretty busy this week. Basically, everything made for good reading until I came to this thread. Let me get this straight: I can show my document/record retention time as, for example, 6 months minimum , but I can't say "indefintely". That's pure assinine. That's like some chickensh-t auditor questioning once a quarter and every three months. Yes, I know there is a difference, but aren't there bigger fish to fry?:p :ko: :smokin:

energy,

Yes.......and no. I agree that one shouldn't have to be told to clean up the files once in a while, but what I have found in the workplace is that if there is no reason to look at what you've got in the storage room, it's gonna sit there forever taking up space, adding to your cost by buying new file cabinets etc. Sometimes it is the most mundane chores that build up.

Originally posted by SteelMaiden
As a kind of general information note -
You will find that keeping everything indefinitely will 1) not fly with your registrar, 2) create major havoc with storage space.


Steel,

This statement is where I have a problem. If I have the space, and I say indefintely, what does the registrar have to say about it? We've stated our retention time. Maybe this is the type of low hanging fruit that you leave for that type of long tailed auditor.:vfunny: :smokin:

I wish I had unlimited space for records!!!:vfunny:

I think it is more like saying indefinitely does not "define" anything other than the fact that we are not sure how long we will keep them. I have things that corporate says we will keep indefinitely, I just define them as being kept as long as we are doing business, and then they will be sent to the corporate office for disposition. I don't feel that the auditors are so much against keeping things for long periods of time, as they are against not defining retention time.

I am totally against the principal of leaving low hanging fruit, but as I have said in the past, I'm a Virgo and get kind of uptight sometimes.:p I would just hate to tell people, "Yes, indefinitely is ok for record retention." when I some of my buds in other industries have gotten bit in the astroturf by doing it. Just trying to do my part by sharing what I've seen. If you do decide to stick by "indefinitely", I'd really be interested to know how your assessors view it throughout your first complete audit cycle.

Take care! Don't get caught:ca:

In looking over some of the attached procedures a couple of you have posted throughout this thread you've identified person responsible or Retention Responsibility. I may be confusing myself here, but is this the person whom is responsible for identifying the retention period or person responsible for maintaining the file or the person responsible for the final disposition? The reason I ask is because depending on which one, it could be one of three people in my company.

Any comments?

Just a couple of thoughts.

I always recommend that a procedure on Q records basically says the record retention is defined in the associated procedure, flowchart, or work instruction. Each procedure, flowchart, or work instruction then specifically states what record, where and for how long. Saves rewriting the record retention policy each time you add a record, and lets the person following the specific document know what, where, and how long.

With regard to record retention times I usually recommend a minimum time. If you decide to keep it longer, fine. Example, if you retain records on supplier approval for a minimum of five years after the supplier is no longer an active supplier, you don't have to worry about clearing out files because some zealous auditor thinks a five year retention policy means you have to dispose of then at five years and one day.

Regards,

Rick

As far as 'retention", I wrote this in the procedure to try to cover this point:
" Minimum retention periods are determined by the departments responsible for the collection and storage of the Quality Records....The minimum retention periods for Quality Records are shown in Table 1. Records may be retained longer than the minimum time without formal justification.....Quality Records should be appropriately disposed of as soon as practical following the completion of the minimum retention period....Disposition may be to discard or destroy the Quality Records, or it may be to move the records to a long-term storage solution such as off-site archival or CD format....."

I envision a general "cleaning house" annually for all depts. probably during the slow Christmas period for the records that hit their "minimum" retention times during that year. That means that some records were obviously held for 3 years 11 months, etc. And the end of the year is the most "practical" I can think of!

mmmmmm. What is a record?

For me you have a document and data is added to that document, this is the record.

I have a simple procedure for records that states what we will do to ensure identification, storage, protection, etc.

All other procedures document that records and retention times within them.

We also use an Excel Spreadsheet as a records register which lists every record and who is responsible for them. This can be sorted by Department, Aplhabetically, Procedure Name, etc.

Don't worry about placing things like in the 2nd cupboard behind the pool table on the top floor of building three! What will happne then is you will find that you are changing documents daily because someone moves a filing cabinet or whatever.

We just state that such and such is retained in the client's file for a period of ???? and then destroyed. Simple as that.

But then again, the level of control is appropriate to the level of security you need, but I doubt if you need to go to specifics.

Just to through in my two cents, most department managers should know the required retention periods for legal documents (employee records, purchase orders, etc.). The way we handle the issue is by stating minimums. For example, inspection records are maintained for a minimum of 3 years unless otherwise required by the customer. In the past we had finite retention periods and would either get nailed by an auditor for having records retained for longer than then the specified period or every January each department would get tied up for two weeks purging documents. By defining retention periods with a minimum, one gains the flexibility to purge over time without exposing yourself to a potential non-conformance. Obviously the fun part is always establishing a system meets the requirements of the standard and is still manageable for your departments..

Greg,

I agree entirely, in fact in the past I have documented a qu recs. procedure not dissimilar to the one outline in you post!

I also adopted the same control method!

Spooky!!



:thedeal::agree:

I apologise if I am going over old ground here, but why would an auditor have a problem with records retained for longer than the specified retention period ?

I can understand that there would be a problem if they were destroyed before the specified retention period, but where is the problem with keeping them longer ?

Has anyone ever been given an explanation for this ?

Having just caught up with this thread, there seems to be a worrying absence of reference to what your stakeholders require of you. The debate all seems to centre on satisfying auditors. We are finding that the principal way to do this is to demonstrate we are doing things logically to satisfy our customers.

We run some GMP manufactures which generally require records retained for 7 years (and boy there is quite an archive of them). This is what our "procedures" state - we use the devolved 'define retention in individual procedures' (which is my favourite). But it makes some of our customers warm and fuzzy to know that we never throw out records related to them. Staff know not to throw out the records related to this customer, because we've spent some time discussing the whole issue of satisfying customers - not because we've proceduralised it.

Another thought - how many staff ever read a Procedure on the Control of Quality Records.

Finally we're heading as much as possible to electronic records. These are backed up and archived - for ever so far.

I think one reason the auditors are getting hung up on the retention times is because of the QS9000 standard. In this standard it is mandated that retention times be established and recorded, and the records disposed of when the retention time is up. Although it does state that all retention times will be considered "minimums" (4.16.1), I think that the purpose of enforcing this disposal of records was to facilitate a 5S philosophy (ensure things are organized and disposed of when no longer needed). Basically, it was just another way for the Big 3 to show more control over their suppliers, by making them throw away documents when they normally did not do so (they also mandate what retention times you will use for certain documents).

Personally, I think you should set retention times for documents, and dispose of them when no longer required. To set a time of 'indefinitely' for everything shows that you didn't put much thought into it and took the easy way out. By setting retention times and dispositions, it helps keep your records organized. Yes there are some that you need to keep indefinitely, but there are many records (checklists, inspection sheets) that just take up space and increase the chance of current records being misplaced. JMO.

Originally posted by Dean P.
I think one reason the auditors are getting hung up on the retention times is because of the QS9000 standard. In this standard it is mandated that retention times be established and recorded, and the records disposed of when the retention time is up.
*****
To set a time of 'indefinitely' for everything shows that you didn't put much thought into it and took the easy way out

Not withstanding the requirements of QS 9000, we are striving for ISO9001-2000, the use of the term "Indefinitely" does not indicate that you took the easy way out. To the contrary, you must have every record the auditor asks for and be able to retrieve them efficiently. Over the years, and they are many, I have "purged" my files of data that I had for years because I wanted to tidy up. Within a short period of time, someone invariably comes up and asks about a particular situation where I had retained the documents, only to have to tell them that they are gone. You cannot sort through every document and decide when you may or not need it. Another situation was a new General Manager seeing transfiles in a warehouse asked, "How often do you have to use these records?" I told him that rarely, but we have had to search for records because the Customer needed "history" data. He marked boxes of records with a marker and said to get rid of them. We did. The Customer (USN) requested prototype records showing how the equipment was originally validated. 15 years hence. They were destroyed. You say, well someone should have known. No. You'd have to be able to see into the future. Again, one more time, if we have the room and choose to keep records indefintely, that's what we do. We say what we do and do it. Right? That's are decision. Our business. The standard wants you state retention times. No minimums. No maximums. The reason that an auditor may have heartburn with it is because he/she can forget about citing you for keeping records to long or dumping them early. They have to swing their club somewhere else. JMHO:ko: :smokin:

but there are many records (checklists, inspection sheets) that just take up space and increase the chance of current records being misplaced. JMO.

I agree Dean. In fact, the procedures that I write are not completely formal and I often give an explanation of "why" we are doing something. In the part of my Control of Records procedure that deals with disposition, I say " the purpose of disposition is to free up filing space, both for hardcopy files and network data files. It also makes it easier to locate current material that may need to be referenced."

The warehouseman mentioned to me on Monday that we are out of storage space in the warehouse for any more boxes of records and we haven't even stored the 2001 stuff yet. He wants to know what he's supposed to do. The boxes go back for 7 years.

In the new procedure (which we haven't issued yet) I defined "disposition" to include longterm offsite storage, or CD archiving. In a sense this is keeping things "indefinitely", but it still gets the stuff out of our way.

Keeping things in paper format in boxes "indefinitely" uses office or warehouse space that costs the org money to own and operate. It is a fire hazard, and provides habitat for pests. It is much better management of physical resources to get the cr@p out of there when its purpose has been served.

Energy,

Consider scanning all these records you want to toss but are afraid to (because of past experience of needing them later). Save the info on CD. Then do as I did and define "disposition" as performing this act.

This keeps the shelf clean, allows you to keep things "indefinitely", and satisfies an auditor also.

The standard doesn't have to use the modifying terms "minimum" and "maximum". It is black and white that you define the retention time. Saying "indefinitely" doesn't cut it, because that is not a "time". You need to show management of the records.

Originally posted by Lucinda
It is black and white that you define the retention time. Saying "indefinitely" doesn't cut it, because that is not a "time". You need to show management of the records.

Okay,

Scanning is a great idea. We just increase the head count and copy everything. The 1994 version allowed you to keep uncontrolled documents for "historical" purposes. Why's that you think? That appears to be missing from the new version. Maybe because it was a useful clause.

So, (just having a little fun here-our little sea devil) How about:
All Records are retained from January 30, 2002 for a minimim of 50 years, or a 100 years. Is that "time" defined for you? :bonk: Geez!:ko: :smokin:

If your system is like ours...for Reference Documents that have no known shelf life or records we cannot set actual timelines for we use 99 months. The problem with the database setup I use is that I want the field to be a number field not text, so I must assign a number.

Example: Certification Records - we actually want to keep them for the length of employee service +5 yrs. Since we have no way of knowing how long the employee will work here this is an intangible number (indefinate)

The footer of my Report includes "99 Months = Refer to reference document. Very long time or indefinate." This is the best way I've found to quantify it.

Would like to hear what others are doing if they have similar needs.
Eileen

Ok - Can't wait to see how many different opinions will be set forth on this one.

We also struggled a bit with the "how do we set a controlled retention time & even a disposition method - for some information when we had no idea how long they would be VALID/USED.

Wrote into our 9002:94 procedures and our Quality Records list under:
Retention time: "As determined by the Custodian" AND/Or - For life of contract.

Disposition: Destroy/Remove upon decision of Executive management"

We intend to take the same approach with the new version - UNTIL an external auditor tells us differently- so far this has not been an issue.

We did however have a minor written concerning "how often" preventative machine maintanence was scheduled/preformed - because the 94 version did not specify we actually put a date on these items.. we left it open - we simply recorded when and what was done. - indicated the specific machine's records would be disposed of when the Manager in charge determined they were no longer of valid use.

Because this thread discusses several times what an Auditor may do, I'm curious about an Auditor actually does when it comes to determining if retention times are adhered to. Is their problem with the document control procedure statement about retention times? Do they say "Where are your records kept?" Do they then start sifting through the records to see if there are any records there that are "outside" the retention times you state? Are they driven to a record because of the procedure they are auditing? Considering that records may be in different places, do they ask to see all the record holding areas and begin their search? I'm just curious. I know that there are auditors in the forum, I love you all:vfunny:, so maybe I can get an example how this record thing actually plays out. As an internal auditor here, I ask to see the record mentioned in the procedure only. Should I be rooting around the file cabinet looking at any records stored there. As I have indefinitely as our retention time, for now, it's not an issue. But if you can scare me with the actual audit tactics, I can always amend the procedures. As Eileen has mentioned, we can do that anytime. So audit me. Assume that I have 5 years retention times in our procedures. Any takers?:ko: :smokin:

I think I would laugh my head off if an auditor mentioned that I have a six year old record in my archive where my retention period is stated as only 5 years.

Then I would kindly show them the door and never use their services again.

The purpose of stating a retention period is so that you keep the record for long enough, not so that you dont keep it for too long !

As for 'indeterminate' I would accept that as a defined period of time, it may be endless but it is defined. If an organisation chooses to keep a record for ever that is their look out.

Originally posted by M Greenaway
As for 'indeterminate' I would accept that as a defined period of time, it may be endless but it is defined. If an organisation chooses to keep a record for ever that is their look out.

My thesaurus has for the term "indeterminate" the following:
undefined, undetermined, indefinite, unfixed, imprecise, uncertain, vague, unspecified. That lends credence to Lucinda's point that indefinite is not a specified time. As for asking the auditor to leave, does he take my certificate with him?:biglaugh: :ko: :smokin:

As for asking the auditor to leave, does he take my certificate with him.....

Gladly, probably rolled up tightly and shoved up his ar....

Well to explain a bit further - for the curious minds out there -

In our case yes - when (1994 version) 4.16 was audited - the auditor quietly went around and looked for a large sampling - as I recall - 10 record samples - that were on the master listing - until he found one showing an older version of the record and a newer version (updated revision) of the same record.

His audit question "When- what date was this form/format/record changed within your system. What exact DAY did you go from Rev A to Rev B ?? And how long a retention time did you indicate on your Q records master for this particular record ?? --

His statment was word for word "IF you indicated on the master listing a flat 3 year retention time is used - and if what I have in my hand is 3 years and 24 hours old from the EXACT Date I audit it --- I WILL WRITE IT UP. Also - IF a record format is changed and I find any record being reported on an older version even 24 hours past the identified change date - I will write that up in BOTH element sections 4.5 doc control and 4.16 Records.

Although this statement (as it turned out) was nothing more that a threat at the time - it did lead us to including some very "creative wording" on our Quality Records Master...

But I should also add this for understanding -- - this particular auditor made the statement "more than once" - that he approached every audit in the same manner and intended to "keep digging" on every procedure or record use he audited until he found something to write up...

( I do realize there are auditors out there that do not approach an external in that way but it did and can happen IF the auditor decides it is in the auditees best interest to follow his opinion only.)

Marc mentioned that record retention was a minimum. Sometimes it isn't. I do know that the Blue Oval guys insist on records being destroyed once their expiry date has been reached, I believe the idea is to prevent records clogging up the works and thereby to reduce the cost of maintenance. This requires everyone within Ford to carry out an annual record check and dispose of any records that have come due. I could give a whole load more detail (They call it a Global Information Systems Standard) but I think I'd rather go and watch some paint dry.

Records is such fun!

I seem to recall that at the last place I worked we did have an auditor complain about records that we had had too long. I think their main concern with not keeping them too long is just getting too much stuff! Where do you put it all? Also, it just takes too long too sort thru stuff to find what you are looking for, even if your records are organized.

Anyway, we didn't get a CAR on it, but I think we were given an opportunity for improvement, if I remember correctly. Oh well. Not too often that they don't find something.

Personally, I have kept every report card since kindergarten and every piece of art work I ever did! Needless to say I'm a bit of a pack rat. However, it does get to be a bit much. As far as keeping records indefinitely, it doesn't sound controlled. I might say 'forever'. Indefinitely says to me that we might not ever throw them out, then again, we may throw them out next week! Some things you should probably keep forever- like drawing revisions, etc.. I guess it depends on your company and even more so on who your auditor is! If your auditor is m greenway or energy it won't matter anyway. (LOL) :biglaugh: :vfunny: :biglaugh: :vfunny:

FG

Originally posted by Fire Girl
If your auditor is m greenway or energy it won't matter anyway.
FG

Uh Uh! Not me. Especially in M Greenway's facility. I'm allergic to his certification implantation procedure:eek: :ko: :smokin:

Originally posted by Jim Biz
His statment was word for word "IF you indicated on the master listing a flat 3 year retention time is used - and if what I have in my hand is 3 years and 24 hours old from the EXACT Date I audit it --- I WILL WRITE IT UP. Also - IF a record format is changed and I find any record being reported on an older version even 24 hours past the identified change date - I will write that up in BOTH element sections 4.5 doc control and 4.16 Records.
***************************************************
But I should also add this for understanding -- - this particular auditor made the statement "more than once" - that he approached every audit in the same manner and intended to "keep digging" on every procedure or record use he audited until he found something to write up...



Jim,

Thanks for the rendition. This type of behavior is exactly what I detest about what the system has become. There is no knowing what you are going to get for an auditor. And, more importantly, it adds absolutely no value to your business. I would hope that they send this auditor to m greenway's place of business. :vfunny: He better be wearing steel underwear!:biglaugh: :ko: :smokin:

Jim

Your auditor would definately be carrying his cert out with him as a rectal implant if he took that approach with me.

Seriously though if he cant find that the retention of records has an impact on product quality, or the quality system effectiveness then he cannot (or should not) right you up on it. The trouble with some auditors is that they dont consider the effects ofthe so called non-compliance that they are looking at. I am sure that most potential non-compliances occur due to poorly written procedures, rather than any real impact on quality.

Hopefully ISO9001:2000 will change all that, but thats another thread......