:bigwave: Do we have to have evidence of records already disposed, I mean like a sheet that tells when a specific record was destroyed or something like that? I'm asking this because in the company I'm working now the procedure specifies that and I really would like to get rid of that requirement..what do you think?:ko:

BEKY
Ours says we shred all obsolete documents, period. When you look at revision history for a particular document, there's the date you shredded it. JMHO

Hi Beky...

ISO 9001:1994 and 2000 specifies that documented procedures be maintained for disposition of quality records, but does not specify that records be maintained of the disposition of quality records. However it is probably prudent to maintain records of disposal.

Our records retention/disposition system is set up in such a way that a report of records requiring destruction is generated each month for each department. Upon destruction (shredding if hard copy, deletion from the computer if a data file) of the particular records, the person who has responsibility for those records signs off that they were destroyed. This is maintained by the QA Department as evidence of records disposal.

Hope this helps!!

Cheers!

ISO 9001 doesn't but QS-9000 does require you to specify disposal method, as I remember.

Here's the actual way it's written in our Document Revision Control procedure. I also send a document acknowledgement sheet for sign off with the obsolete document returned to me for disposal. Another reason we do that is because people have pulled the wrong page out and trashed it.

5.4.2 Quality documentation surpassed by a revision or replaced with another document shall be returned to the Quality Assurance Department in accordance with Quality Procedure QAP-205-04, Document Administration and Control, and a copy may be retained as a record, if deemed necessary, in an archive in a labeled file to ensure that these documents are secured from use.

5.4.3 Obsolete documents not required for archive purposes shall be immediately destroyed by shredding.:smokin:

That sounds good Energy, I wish I could trust them to do that. :rolleyes:

When we have a controlled document change, either myself or my cohort in crime will personally remove obsolete documents and replace them with the new revision and destroy the old rev. Luckily we have a relatively small shop (150 employees) so this doesn't take too long. On the other hand, when it comes to the Quality Record, I have faith in those people assigned to maintain those files - so when records are disposed of, I know they are done properly.

Cheers!

We are ISO 9002 and have set minimum retention times for all our QMS records. Have had no problem to date. The question is "What does your QMS require of you?"

Thanks for your comments guys, Energy: I have the impression that you are only looking the documentation side of it, what I'm talking about is more of quality recors such as inspection sheets, from 2 years ago for example, that certain department has to dispose every year and maybe (Not sure yet) live evidence of the date those were disposed.. get it?:rolleyes:

Beky,
When I say documentation I refer to all documents. If for some reason, though I don't know why, you say you destroy documentation every two years, of course I would ask the same thing. How do you prove it? Well, if I couldn't see that particular document with a date that exceeds 2 years, what's the problem. Most companies say they retain files for a pre-determined time, so if they are there longer, who cares? I don't understand the requirement or logic. Help me out here!:smokin:

Sometimes it's legal issues at the heart of it, but this is mostly with respect to records as opposed to documents (e.g. procedures). I suspect this is where the confusion comes in within this thread - most folks saw DOCUMENT instead of RECORD in the original post.. I go into some detail about the distinction between 'documents' and 'records' in my Implementing ISO files set.

With either records or 'documents' - if one of your procedures says you're going to keep a specific document (or record) for a specific time and then you will destroy it you are bound by your procedure, not ISO. As I said - I haven't seen this used with documents (destroy by date). It is extremely common with records.

Most companies keep certain records for a certain time. Some records are kept for legal reasons (for example in a transportation, copies of drivers logs are kept for a certain period of time by federal law). I have seen some smaller companies that had 30 or 40 years of records, to the extreme.

Now - why the big deal if you keep it longer than you say you will? It's not a matter of logic. It's a matter of how you wrote your procedure. If you say you'll do this you don't have a choice. You can avoid this if your procedure is worded along the lines of defining a minimum retention time while stating that there is no maximum retention time.

> Do we have to have evidence of records already disposed, I
> mean like a sheet that tells when a specific record was
> destroyed or something like that?

Not that I am aware of.

> it is probably prudent to maintain records of disposal.

This is a good idea in some companies. In others it is vast overkill. If you're a manufacturer of medical devices this is probably more important than if your company injection molds toy dolls for Cracker Jack boxes.

Beky - If you're talking ISO, reword your procedure for the disposal of quality records and get on with life. If you are QS the extended requirements take precedence and require that you define a destruction method and timeframe. The sheet is not necessary as evidence. The absence of records beyond the specified time is your proof. However, again I caution you... Each company is different. Make sure what you do is appropriate for YOUR company.

Originally posted by Marc

Now - why the big deal if you keep it longer than you say you will? It's not a matter of logic. It's a matter of how you wrote your procedure. If you say you'll do this you don't have a choice.


I agree with your entire assessment. The logic I was referring to you addressed completely. Why would any one write a procedure requiring disposal in two years if they didn't have to?:smokin:

Thanks guys I think I'll go with specifying minimum retention times, I found out that the record for disposal was implemented because some QS-9000 registrar auditor wanted to see it (about 3 years ago) and noboody challenged that question and since then no other auditor has ask for the same. Actually since this requirement was added to our procedures, nobody here has respected it although they dispose records, that's why I don't want requirements that are not by the standard and make our living harder.:bigwave:

To knowone in particular:

Although I believe most auditors skim over it and write a finding on a glaring hole, record retention could be a ticking time bomb.

On one original compliance audit I was asked if we destroyed records according to procedure. The answer was yes, since the system was in place for only one year and the minimum retention time was 3 years. Total time on record retention: 5 minutes.

What happens in three years? A good record retention and destruction process better be in place. You might ask, can I just revise the procedure on retention times? After awhile you will be shot down.

Say a company notes in a procedure that all records are kept for ten years, sounds like a real "bye week" in football terminology. What is the problem? As an auditor I would think you are trying to work around the system and dig deeper. I might say: Mr. Quality Manager, the procedure says that all SPC records for part #123 are kept for 10 years. I pull out the control plan and see that you are doing a chart every hour. Please show me the SPC record for part #123 that was generated on 5/21/92.

Get the picture?

Although I have been heavily involved in document and record control for many (too) years I'm not trying to be an alarmist, just a realist.

Good day all:bigwave:

Originally posted by Al Dyer
To knowone in particular:

What happens in three years?

Good day all:bigwave:

Al D.

IMHO, nothing happens because I only specify a three year minimum record retention time. You can't make me destroy records because you think it's a good idea that I destroy them after three years. You can only look for something and discover that I destroyed it in less than three years to issue me that beloved N/C.:ko: :smokin:

> You can't make me destroy records because you think it's a
> good idea that I destroy them after three years.

Yes I can! Yes I can! I'll get Jesse Ventura to hold you down until you say Uncle or something similar.... :p

Unless it's QS. Which is not Beky's case. She put it well saying:

> I found out that the record for disposal was implemented
> because some QS-9000 registrar auditor wanted to see it
> (about 3 years ago) and noboody challenged

No one knew enough or had the courage to question the auditor. Believe me - I know that when you're working with both you can get confused. To me it's "...show me where it says I have to do that..." even when I'm the auditor.

Al is right in so far as if you're QS, or if you embed a destruction clause in your system procedure, your system has to include a 'trigger' for someone to dispose of the records at/by the appropriate date. It used to be a once a month task of dumping paper (keeping, for example, a 24 month rolling file for a 2 year retention to destruction cycle) - but it's gotten interesting - electronic records are typically part of the game now. Server and directory setups can complicte the process if not well thought out.

Has anyone in the thread dealt the issue of triggering the destruction of electronic records? :confused:

My Quote:
-------------------------------------------------------------------------------
What happens in three years? A good record retention and destruction process better be in place. You might ask, can I just revise the procedure on retention times? After awhile you will be shot down.
--------------------------------------------------------------------------------

Energy,

I probably painted with too broad a stroke. I did not mean to imply destruction of records does not have a minimum, only that should be a good system to control those records and destroy them when applicable. I have seen too many times where companies ask: where are we going to store all this?

When I said that after awhile you will be shut down, I was not limiting it to auditors or registrars. As noted earlier there are governmental, environmental, safety, and possibly political records that need to be controlled in some manner. I really believe in this society of litigation that records will only become more and more important and can come back and bite is in the but (wanted to say ass but it will be edited out by the software).

I am a firm believer that a company must determine their own systems, but that those systems must be robust and fit within goals and plans of the company.

As always, Respect!

Al D.

Not too broad a stroke. As Marc has said, there are obvious requirements in QS. What's QS?:biglaugh:

Our records would only fill a small dumpster. Why? Because we haven't determined what out "records" are yet!!:confused: :eek:

Keep up the good work. Man, are you posting lately or what?:ko: :smokin:

Energy,

Yeh, I'm very regenerated.

By mutual agreement, I have left Ohio and am back at home. 16 months of commuting from Lapeer, MI to Wooster, OH (250 miles) was taking its toll on me mentally and physically.

I will be returning there as a consultant 2-3 days a month and they are holding my apartment.

I'll be home with the kids (16B & 11G) 90% of the time and still make a little money on consulting and customer visits.

Great to be home and never felt better!:bigwave:

Originally posted by Marc

Unless it's QS. Which is not Beky's case.

Has anyone in the thread dealt the issue of triggering the destruction of electronic records? :confused:First of all: YES :D we're QS certified (sorry if I didn't specify) :o

Second: Same as Marc, I also would like to know how everybody else pushes the departments to comply with their record's disposition times...anybody? Ideas? :confused:

Beky,

Internal audit works for me. But don't limit youself to a yearly schedule that we all keep. Go out once a week or month and verify that record retention requirements are being met. If they are not, consider a corrective action.

An internal audit schedule is only a minimum. The objective of real internal audit is to continuously monitor the effectiveness of the system.

Heck, don't tell them your coming if you don't want to. All people need to be aware of the major systems and recognize when the system is malfunctioning just by a quick walk through.

Ask yourself the the first important act and auditor performs. Plant walk through to get a first impression.

Good Luck!

> Same as Marc, I also would like to know how everybody else
> pushes the departments to comply with their record's
> disposition times...anybody? Ideas?

Embed it in the applicable procedure, train the appropriate employees on the revision and expect them to do it. I hate that word 'push'. I was thinking more in the area of an example system. I got to thinking about how we did it back when QS was popular and I was doing implementations. I mentioned the paper method but I can't remember addressing computer records. Documentation updates and control - yes - but not electronic records. I guess you could write a script to search a certain directory on a disk and delete every file older than XXXXXX days. Not much control there though - a lot of faith in the script.

Yeah - if you're QS you don't have a choice.

Originally posted by Marc
Has anyone in the thread dealt the issue of triggering the destruction of electronic records? :confused:

Marc,

Please clarify "trigger". I have an Access database established for all our Quality Records. Each record has a retention code which corresponds with either a monthly, quarterly, semi-annual or annual destruction trigger. The Departmental Quality Records Retention Chart lists the retention period for that department's quality records (for example - a 5 year retention period would be "5Y" which equates to "Current calendar year plus 5 complete calendar years". Anything beyond the 5 calendar years would be destroyed at the end of the year. A "3M" would equate to "Current month plus 3 complete months", so anything older than 5 months would not be held. This works for either electronic or hard copy files.

I hope I haven't confused anyone == or I may be confused myself - that is entirely possible. :biglaugh:

Cheers!!

That would do it. Thanks for the info / idea!

Make use of Access as you have done, with it you can "connect" the start-up of a computer in the morning to generate a report that youn can work with for record/document/gage activitesis, etc....

Let the software work for you!!

And to throw a little more into the mix.....

Originally posted by Marc
I suspect this is where the confusion comes in within this thread - most folks saw DOCUMENT instead of RECORD in the original post.. I go into some detail about the distinction between 'documents' and 'records' in my Implementing ISO files set.

With either records or 'documents' - if one of your procedures says you're going to keep a specific document (or record) for a specific time and then you will destroy it you are bound by your procedure, not ISO. As I said - I haven't seen this used with documents (destroy by date). It is extremely common with records.I have always condsidered my quality procedures as records. Why...because these documents have recorded how our system is to operate. I know it may be overkill....but it has always worked for me.

Any thoughts from the group?

CarolX

> I have always condsidered my quality procedures as records.

That's up to you if you consider them synonymous, but technically they're significantly different - including the requirements for each. Without knowing the specifics of your system, company size, etc., I can't say whether it's overkill (in your specific case) or not.

Marc,

No, I don't consider them synonymous, but that policy is kinda a carryover from my old DoD/FAA days. Fortunately, I don't have volumes and volumes of procedures, since we are a small company, and maintaining the old revisions is not too much trouble....but I may want to reconsider my thoughts on this. Thanks.

Regards,
CarolX

I agree with Barb, in regards to the old days, that it is not too much trouble as long as you are careful with what you "call records". Just important stuff!

I'm more concerned with the electronic records. While we do not appear to have a time frame imposed by ISO for destruction of records, does the storing of electronic "records" take up room on you server? Marc, help me here.:ko:
Will it require adding to the system to accomodate all the records,
just the important stuff? Maybe it's not a problem. If so, I would set a limit, set by our MIS guy, to purge records when you reach that level.:smokin:

Hi Energy...

I may be misinterpreting your post, but I think it is more important to purge records based on content rather than storage capacity. Some records have mandatory retention periods stipulated by legal/accounting regulations, others by a CYA factor.

If you have a lot of electronic files that have mandatory retention periods, wouldn't it behoove you to expand the storage capacity rather than start purging files? :confused:

Cheers!!

M.T.

Being a pack rat, I would increase the storage capacity. Content, records, etc., have not been determined yet. Our ISO effort is reduced to a crawl, due to other business related matters. I just visit all the topics, offer advice as how I see it and learn more than I give. Only by sifting through the various posts can you see the differing opinions on any subject. From here, I make my determination as how I WILL proceed. The powers to be are impressed with what I offered so far, compliments of the Cove. That's one of the reasons we are proceeding slowly. It's a resource problem and a lot of things have to get done. Good advice.:smokin:

Hi Energy...

That's cool! I too have gotten a great deal from the Cove to impress those in the big chairs... and I have gotten a lot out of your posts.

My wife claims I'm a pack rat too... *laff* I just can't see throwing all those good things away. I swear - I can make something out of the old vacuum cleaner... :p

Have a good one!

I agree that each company must be careful in how they describe how to handle record retention and disposal. Our level 2 OP describes minimum retention times for each type of document, allows for exceptions, and establishes that the minimum retention time is identified on each form/record. We say that we may retain records past the minimum retention time, and that records shall be disposed of in the most appropriate manner. Paper records are normally recycled.

We have a WI that defines how we store "boxes" of records and maintain a "box" record log.

Simple, but so far effective. Our biggest issue becomes apparent when the record storage area becomes full, and we know it's time to have a recycling party. The disposition of boxes of records are dutifully entered onto the box log.

In regards to documents that are not records. We really weren't sure when we implemented our QS, but we anticipated that there would be a need to understand how "we used to do it". We decided to maintain obsolete docs as records. Based on internal customer's requests this turned out to be an invaluable resource.

CM

This is precisely why I said each company has to look at themselves and determine what are and are not 'quality' records.

I personally don't consider obsolete procedures, work instructions and the like records per se, but I see no harm in using the word as long as everyone understands the definition within the context of your specific company and system(s).

Hi Guys

In my company , we set the "Record preserving rule " from 3 inputs.
A. The government Regulation,
B. Customer Requirement
C. The Other Supplier's rule.
Once the records are over the keeping date requirement . They can be scrapped. I think it will be no problem if there is a clear rule for the disposition.

Jack Leu

Hope this is not too little too late:

Not too late part 2

Originally posted by beky
Second: Same as Marc, I also would like to know how everybody else pushes the departments to comply with their record's disposition times...anybody? Ideas? :confused:

Hi Beky,

At the beginning of each month, I print out a report from Access that lists what departments have records that are scheduled for destruction, and a listing of those records. I give this report to each department head and provide a deadline when they must have the records listed on the report destroyed. Upon destruction, they are to initial off by each record listed and return the report to me.

This places the responsibility for records disposal squarely where it belongs (with the department managers) and provides the documentation that I like to see as evidence of compliance. To ensure records disposal is actually accomplished, I make it an informal check when conducting internal audits.

So far this system has worked out pretty well.

Hope this helps.

Cheers!!