View Full Version : Identification of Quality Records (ISO9001:2000 - 4.2.4) - How?
Rachel 23rd February 2004, 11:18 AM Hi all...
Okay, likely thinking too much about this again...what have you all put in your procedures for the *identification* of records? How do you uniformly identify all of your records when they can exist in different media? Is this as simple as a master list? Are there better ways to do it?
It's too early on a Monday to be stumped. :rolleyes:
Cheers,
-R.
Tom W 23rd February 2004, 11:23 AM I use a master list - however this can be done many different ways. I do not believe there is a right or wrong answer here as long as you identify them in some method. :bigwave:
If you do a search on this you might get a number of ideas. Or maybe one of the Gurus can point you to a specific thread.
Rachel 23rd February 2004, 11:45 AM Thanks, Tom.
I'm a little concerned with the feasibility of keeping this master list up to date. Each department is responsible for its own records - it seems like I'd be shooting myself in the foot if I asked them to update the master list as well. Internal records would be easy to standardize - it's the ones that originate externally (i.e., supplier C of A) that are stumping me.
Claes Gefvenberg 23rd February 2004, 11:54 AM I use a master list - however this can be done many different ways. I do not believe there is a right or wrong answer here as long as you identify them in some method.
I fully agree. Mine is a database btw.
If you do a search on this you might get a number of ideas. Or maybe one of the Gurus can point you to a specific thread.
I wouldn't know about the gurus, but I can suggest a few links:
Identifying Quality Documents and Records from Non-Quality (http://elsmar.com/Forums/showthread.php?t=7811&highlight=4.2.4)
Definition: Quality Record (http://elsmar.com/Forums/showthread.php?t=7532&highlight=4.2.4)
Record Retention (http://elsmar.com/Forums/showthread.php?t=3128&highlight=4.2.4)
Quality Records - Retention and Required Controls (http://elsmar.com/Forums/showthread.php?t=7286&highlight=record+master+list)
/Claes
Rachel 23rd February 2004, 11:57 AM Sorry, folks - I obviously am terribly irresponsible this morning, as I *completely* forgot about the search option.
Feel free to can this thread...
Cheers,
-R.
CarolX 23rd February 2004, 12:03 PM Hi Rachel,
My creed is always...KEEP IT SIMPLE
This is basically my procedure for records
1.0 ALL RECORDS RELATED TO QUALITY FUNCTIONS SHALL BE MAINTAINED FOR A MINIMUM OF ONE YEAR UNLESS OTHERWISE SPECIFIED BY THE CUSTOMER.
2.0 ALL DOCUMENTS CONTAINED IN A JOB PACKET SHALL BE STORED TOGETHER UNDER THE JOB NUMBER.<O:p
3.0 THE FOLLOWING DOCUMENTS ARE STORED IN THE QUALITY AREA:<O:p
· CALIBRATION RECORDS
· FIRST ARTICLE REPORTS
· ECO’S (INCLUDING PREVENTATIVE ACTION ECO'S)
· NON-CONFORMING MATERIAL REPORTS
· CORRECTIVE ACTION REPORTS<O:p</O:p
· AUDIT REPORTS
· MANAGEMENT REVIEW REPORTS
· HARD COPIES OF ALL ISO RELATED PROCEDURES
· APPROVAL OF ALL ISO RELATED PROCEDURES
· OBSOLETE PROCEDURES AND DOCUMENTS
· CUSTOMER TOOLING INVENTORY
4.0 THE FOLLOWING DOCUMENTS ARE STORED IN ENGINEERING
· CUSTOMER DRAWINGS
· ALL JOB PACKET DOCUMENTS
· ROUTING SEQUENCE
· CUTTING LIST
· PRINT
· SET-UP SHEETS
· INSPECTION RECORDS
· ANY OTHER DOCUMENT CONTAINED IN THE PART FILE SYSTEM OR ENGINEERING MASTER FILE.
· CONTRACT REVIEW
5.0 THE FOLLOWING DOCUMENTS ARE STORED IN PURCHASING
· PURCHASE ORDERS
· VENDOR HISTORY FILE
· APPROVED SUPPLIER LIST
6.0 THE FOLLOWING DOCUMENTS ARE STORED IN HUMAN RESOURCES
<O:p
· PERSONNEL RECORDS
· TRAINING RECORDS
· SAFETY RECORDS
<O:p
This is a 2 page procedure. Short and sweet!!
CarolX
Claes Gefvenberg 23rd February 2004, 12:04 PM I *completely* forgot about the search option.
Feel free to can this thread....Nah. Threads are often similar but very seldom exactly the same... Nothing wrong with this one. Besides, if we had canned it we would have missed Carols list. Thank's Carol
/Claes
CarolX 23rd February 2004, 12:10 PM Your welcome, Claes...I try to jump in when I get a minutes.
Rachel...don't sweat it!!
Mike S. 23rd February 2004, 02:42 PM I use a chart in my Q records procedure to list the name of the record, where retained, by who, and retention time . There are only about 15 types of records. But I don't list every single record per se. For example, I might make one category "product test records" and there might be 6 different forms that comprise product test records (i.e. density test records, surface finish test records, dimensional test records, etc.)
Rachel 23rd February 2004, 03:03 PM Sorry folks - I'm really excited - I had to share - I just got my RAB Lead Auditor course results back and I got a 90! :biglaugh: Man, I haven't gotten a top score since high school! (It's funny how I graduated university feeling dumber than when I got there...) Anyway, that's my excitement. Forgive me if it seems braggish - I just had to tell *someone*...and you guys seemed to fit!
Okay, back to documentation. I think a list is the way to go. We have a horribly inaccurate record retention list right now - maybe this can be fixed up to serve for both the IDs and the times. K.I.S.S., right?
One other question - I talked to our Purchasing manager and he said the bulk of their records are kept electronically. Retention time: "forever". I get what he means...but is this really a feasible answer? Would an auditor accept that?
mshell 23rd February 2004, 03:21 PM This is an example of our record control procedure. It may give you a few ideas.
CONGRATS RACHAEL That is a long course and a tough test. :applause:
Claes Gefvenberg 23rd February 2004, 04:00 PM Sorry folks - I'm really excited - I had to share - I just got my RAB Lead Auditor course results back and I got a 90! ... I just had to tell *someone*...and you guys seemed to fit!Sorry about what? Congratulations... and yes, we fit :D
Okay, back to documentation. I think a list is the way to go. We have a horribly inaccurate record retention list right now - maybe this can be fixed up to serve for both the IDs and the times. K.I.S.S., right? Right :agree1: . That's a common route, as well as a sensible one.
One other question - I talked to our Purchasing manager and he said the bulk of their records are kept electronically. Retention time: "forever". I get what he means...but is this really a feasible answer? Would an auditor accept that? If he can back his claim up with the necessary storage space and convince me that the storage is (reasonably) safe and retreavable: Yes, I would accept that. It may be a good idea to set minimum retention times though. That way you won't be required to scrap data when you pass the time limit.
/Claes
Aaron Lupo 23rd February 2004, 04:18 PM Sorry folks - I'm really excited - I had to share - I just got my RAB Lead Auditor course results back and I got a 90! :biglaugh: Man, I haven't gotten a top score since high school! (It's funny how I graduated university feeling dumber than when I got there...) Anyway, that's my excitement. Forgive me if it seems braggish - I just had to tell *someone*...and you guys seemed to fit!
Okay, back to documentation. I think a list is the way to go. We have a horribly inaccurate record retention list right now - maybe this can be fixed up to serve for both the IDs and the times. K.I.S.S., right?
One other question - I talked to our Purchasing manager and he said the bulk of their records are kept electronically. Retention time: "forever". I get what he means...but is this really a feasible answer? Would an auditor accept that?
90 that is pretty darn good!!! You going to apply for your Provisional Auditor Status?
I agree with what you have said KISS, the Master List is the way to go.
As far as your Purchasing Manager- yes that sounds feasible/reasonable, what I would wonder is why keep them forever? As an auditor to tell you the truth I am not sure if I would accept this or not, I guess it would depend on what they tell me as a rationale. Remember as long as the records are maintained they are auditable they may want to re-think keeping them forever.
Rachel 23rd February 2004, 04:40 PM Thanks for the congrats, all. No big deal - but I can be pretty unsure of myself at times, and getting news like that helps me realize that I can't be *that* far off base... :)
Not sure about the Provisional Auditor status - it's pricey, considering that it won't actually get me anywhere. I don't have the work experience *or* the auditing experience to get to the "auditor" level, and I don't know how I could get there - seeing as I'm putting this QMS together and that disqualifies me from counting any of the company audits toward my experience (is that right??). Besides, I'm not sure that my company would fork out the cash for me, seeing as it's really of no benefit to them (I can audit for them with or without "Provisional Auditor" status). I'd like to, though - we'll have to see - being in this auditor role at work has opened up a lot of opportunities, that's for sure.
As for the records debate - I just don't like how "forever" sounds. We're not that old or big of a company, but "forever" seems so abstract. I like concrete stuff, set limits, so on. That's why I'm an enginerd. :lol: His argument is that the network is backed up daily, and as long as we have those backups we have "forever-style" records. I don't know, though...still smells fishy to me. But whatever - we'll see. The "minimum" retention time sounds good, though...
Mike S. 23rd February 2004, 05:43 PM I agree with the minimum retention time. There are some records I may keep "forever" -- as long as I am here at least, but I don't want to be "officially" responsible for them or have an auditor pick something 5 years old that I have to go after for no other good reason. So, I simply state that records may be kept longer than the minimim retention time.
Bruce Hostetler 8th April 2004, 05:35 PM I too have had good luck using a master list, although, it is a bear to maintain. Our record updates usually occur either before or durring an internal audit.
The area that I am struggling with is legibility and protection of written records.
Any suggestions?
The Taz! 8th April 2004, 06:30 PM Sorry folks -
One other question - I talked to our Purchasing manager and he said the bulk of their records are kept electronically. Retention time: "forever". I get what he means...but is this really a feasible answer? Would an auditor accept that?
TS has a clause that includes "disposition" of the records. Depending on what your corporate headquarters (or financial Guru's) and customer requires, and State and Federal requirements are, you "should" look at archiving the records after an appropriate amount of time has elapsed. Of course, your IS group may want to keep buying bigger hard drives. . . CD's and tapes don't take up much space.
At some point, all records become useless or obsolete.
Suggest you 'coach" the Purchasing Manager that an auditor might not like that answer. If he means "forever", then, IMHO, I think he might have to show some justification for it. Besides. .. who will be there forever ???
Rachel 12th April 2004, 11:21 AM At some point, all records become useless or obsolete.
Yes and no. In terms of Purchasing, yes, I'd agree. However, I don't think management will ever budge on the R&D records. We have a complete library of all of our reserach efforts from the company's creation in the late seventies, to now. Everything is filed. It's all hard copies, unfortunately, but they're never going to toss that stuff. The intellectual property is too valuable - and, honestly, is referenced quite a bit. It's all of our product history!
We're making up our retention list only for paper copies - any other records are stored indefinitely on the network (backups, CDs, etc.). Is this fair enough?
Bruce, as for your dilemma ("The area that I am struggling with is legibility and protection of written records...Any suggestions?")...what exactly are you struggling with? What's the situation? I just don't know your business - what kind of volume of records are we talking? Are the bulk of your records in hard copy form? Are there measures in place to restore/protect records in case of fire/flood/etc.? Are your records stored in sealed cabinets? Are they legible - as in, can you read the writing? Are they legible - as in, can you read the language? I had a trainer tell me once that he audited a high-tech firm in Ottawa (my hometown! Go Sens!) where they had two sets of procedures - one in English and one in Mandarin - because there were so many Chinese employees that legibility became a problem. I know that's control of documents, but you get my point...
I don't know if that helps at all...hopefully it does.
Cheers,
-R.
The Taz! 12th April 2004, 02:18 PM Yes and no. In terms of Purchasing, yes, I'd agree. However, I don't think management will ever budge on the R&D records. We have a complete library of all of our reserach efforts from the company's creation in the late seventies, to now. Everything is filed. It's all hard copies, unfortunately, but they're never going to toss that stuff. The intellectual property is too valuable - and, honestly, is referenced quite a bit. It's all of our product history!
Sounds like the "records" have become a reference library. . . and not SHOWING VERITY of an action any more. I believe you have a company archive.
We're making up our retention list only for paper copies - any other records are stored indefinitely on the network (backups, CDs, etc.). Is this fair enough?
Are they stored or archived?? Are they used to show evidence of an action being performed? . . or just "stored"?
cheimmie23 15th June 2005, 04:23 AM hello there..
Ma'am Carol.
Would youm ine giving a sample copy of your document control proceures for i will be revising some procedures here and i have difficulty to do this... if you can be of help... thank you.
my name is lea from philippines.
RCBeyette 15th June 2005, 12:18 PM Hi, Lea and welcome to the Cove! :agree1: While I am not Carol, I hope you do not mind me attempting to help you out. :)
I suggest you do a search in the Cove using the 'search function' located towards the top of the screen. Do a search for "document control" or "record control" and a lot will come up.
Would youm ine giving a sample copy of your document control proceures for i will be revising some procedures here and i have difficulty to do this... if you can be of help... thank you.
If Carol or another Cove member shares their procedure with you, that's great, but it does not truly help you, Lea. What one company does will not necessarily work at your company.
I am curious, though, why are you having difficulty doing this for your own company?
vinaynin 14th October 2005, 09:10 AM we have identified the records in our QMS as follows
record identification is unique no. such as
YY/DC/R-XX
YY Stands for Company Name
DC Stands for Departmental Code
R-XX Stands for Record No.
if media is important you can accomodate in DC like Production, QA etc,
vinay
Hoeyster 12th January 2006, 04:34 PM My customer's supplier quality requirements only states one item to be retained for a period of eleven (11) years, Material Certs. But then further into the procedure it states,copies of records shall be maintained for the life of the document or eleven (11) years or as specified by contract or regulatory authority.
Now how in the heck and I supposed to tell the management of my company how long they are to retain all their documents. I gave them a blanket time of 11 years.
Helmut Jilling 13th January 2006, 03:21 AM My customer's supplier quality requirements only states one item to be retained for a period of eleven (11) years, Material Certs. But then further into the procedure it states,copies of records shall be maintained for the life of the document or eleven (11) years or as specified by contract or regulatory authority.
Now how in the heck and I supposed to tell the management of my company how long they are to retain all their documents. I gave them a blanket time of 11 years.
11 years is way too long for most simple stuff like basic daily production data. You must have shelves full by now. Most of the other stuff doesn't take quite so much space.
You don't name the customer, but the QS-9000 book had a nice list of reasonable retention times, and the Big 3 have continued to adopt those.
Your accountant and attorney can also give you some guidance. And of course, the good ol' IRS.
Helmut Jilling 13th January 2006, 03:26 AM However, I don't think management will ever budge on the R&D records. We have a complete library of all of our reserach efforts from the company's creation in the late seventies, to now. Everything is filed. It's all hard copies, unfortunately, but they're never going to toss that stuff. The intellectual property is too valuable - and, honestly, is referenced quite a bit. It's all of our product history!
If you are getting benefit, there is no reason to discard. Especially intellectual property. I would keep it indefinitely too.
We're making up our retention list only for paper copies - any other records are stored indefinitely on the network (backups, CDs, etc.). Is this fair enough?
Fair enough, but the electronic records should be mentioned on the list as well. They are part of it. But calling them "indefinitely," is OK.
Hoeyster 13th January 2006, 08:57 AM My company has two (2) aerospace customers and one (1) customer whose customer is the government.
I told my management to keep all aerospace records for eleven (11) years. Yes we are going to have reams and reams of records, but I feel I don't dare tell them anything less on aerospace. I couldn't believe it when I read the supplier quality requirements of record retention for 11 years. All those records deal with identification, traceability, costing, etc., so I feel eleven (11) years should be for all.
Coury Ferguson 13th January 2006, 02:56 PM "copies of records shall be maintained for the life of the document or eleven (11) years or as specified by contract or regulatory authority."
Have your records procedures state almost verbatim the above quote. This gives you the option to destroy the records after 11 years unless otherwise specified in the Purchasing Document (PO, Contract). If you do have a requirement that states to maintain the records for 15 years than place them in a separate area from the normal 11 year retention.
This is my opinion and someone may not agree with it.
Coury Ferguson
Program/Contracts Manager
KWalls 26th September 2007, 04:23 PM Hoeyster was saying something about retaining records for an 11 year period... (this is where the quotes weren't working!! idk what happened!?)
We have one customer (aerospace, as well) that requires records be kept for a period of 35 years. Seems like a little much for a company our size, but we have taken the steps to keep electronic files of the documentation and it's updated weekly to a back up drive for safe keeping. We just don't have the space to keep piles and piles of paperwork for 35 years! :bonk:
Logic 26th September 2007, 05:54 PM For those persons storing records on DVD/CD, what happens when that format goes the way of the 5 1/4 floppy disk? Any contingency plans in place?
Raffy 4th February 2008, 10:50 PM Hi Lea,:bigwave:
In what particular part of document control procedure, you are having some problems. Why don’t you attached the said documents to the forum, so that all of us, can add or comment on the specific procedure you want to incorporate.
Best regards,
Raffy :cool:
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