18 replies to this topic

[Zeeshan]

Hi to all!

I am living with a confusion while performing "document and record control activities" since start of my career as management system developer. I want to share it with professionals, experts and thinkers on the forum so that if some body have a good idea or better practice, persons like me get benefit of it.

Lets understand the confusion with the help of an example:

I have made a format (form) for standardizing the documentation of product specification. Whenever I need to document the specification of existing or future products, I have a set format which guide me what to document.

Format has a control number and issue number so that it can be identified. Also changes to the format can be controlled. Specifications of different products are identified with unique reference numbers. Whenever a specification of a particular product is changed (that is content of the format or in other words records of specification as it is generated by filling out the form format) , it is controllable through revision numbers. Whenever a particular specification is changed, its revision number is changed (not issue number as format is not changed). Whenever the format of specification document is changed, its issue number is changed.

Now I want to ask some questions/ideas/suggestions corresponding to following points:

1- First of all, whether the above practice is valid as per management system practices?

2- What should I do with the old copy of withdrawn record? Can I stamp it as "Withdrawn" just like as I stamped old copy of a document as "Obsolete"?

3- Whether it is right to stamp on such records as "Record under revision control".


I have drawn justification of point 3 from the definition of RECORDS in ISO9000:2000 (Fundamentals of quality management system; Page 15) which states that generally records need not be under revision control. It means, a record may controlled through revision control techniques if a need arises.

Help me in solving this long lasting drilling problem.

Regards:

[Abdul Qudoos]

Hi to all!

I am living with a confusion while performing "document and record control activities" since start of my career as management system developer. I want to share it with professionals, experts and thinkers on the forum so that if some body have a good idea or better practice, persons like me get benefit of it.

Lets understand the confusion with the help of an example:

I have made a format (form) for standardizing the documentation of product specification. Whenever I need to document the specification of existing or future products, I have a set format which guide me what to document.

Format has a control number and issue number so that it can be identified. Also changes to the format can be controlled. Specifications of different products are identified with unique reference numbers. Whenever a specification of a particular product is changed (that is content of the format or in other words records of specification as it is generated by filling out the form format) , it is controllable through revision numbers. Whenever a particular specification is changed, its revision number is changed (not issue number as format is not changed). Whenever the format of specification document is changed, its issue number is changed.

Now I want to ask some questions/ideas/suggestions corresponding to following points:

1- First of all, whether the above practice is valid as per management system practices?

2- What should I do with the old copy of withdrawn record? Can I stamp it as "Withdrawn" just like as I stamped old copy of a document as "Obsolete"?

3- Whether it is right to stamp on such records as "Record under revision control".


I have drawn justification of point 3 from the definition of RECORDS in ISO9000:2000 (Fundamentals of quality management system; Page 15) which states that generally records need not be under revision control. It means, a record may controlled through revision control techniques if a need arises.

Help me in solving this long lasting drilling problem.

Regards:

My simple suggestion is:

Whatever changes required in specification or document amend it as applicable with new revision no. & effective date, signed it, stamp it as master copy and followed by controlled document stamp for copies, for older or existing documents (for which changes has been made) put it as obsolete stamp and maintain in obsolete folder for future references, make a list of obsolete documents with document no, name, revision date, changes made and changed by, etc. and maintain it, this will help your system effectiveness...

[Zeeshan]

Dear Abdul Qudoos, AOA.

Thanks for your reply.

Unfortunately I felt I have not well conveyed my problem.

Actually the problem is some thing else:

Let me explain it with some other example:

I have made a form for specifying job descriptions of employees. Now I have filled two forms for two different employees. What that two documents called - "Controlled Documents" or "Records"? In my opinion, the two documents should be tagged as RECORDS as they are generated after filling some data or information for different positions or jobs. If I called the two job descriptions as controlled documents, I have to give them some unique identification and puts all the controls of controlled documents on them.

Hopefully, now the question became clear.

Regards:

[Charles.C]

dear Zeeshan,

Not an ISO 9000 expert but if I understand yr question correct, you are debating whether records are controlled documents. Hv seen such confusions before in forums elsewhere. maybe the enclosed upload from a book will help ?? There is more info folllowing the enclosed clip and i can probably tell you how to google this book on the net if the information is relevant ? if not relevant, please come back again.

 iso_9000_records.jpg   65.56KB   129 downloads

Rgds / Charles.C

added - I looked a bit more and I can see that this subject is not quite so black and white as i first thought (as usual). The next enclosure offers some further detail / option perhaps.

 record_and_controlled_document.jpg   77.71KB   127 downloads

I can see why people get confused. Thank you ISO 9000.

[Zeeshan]

Thanks Charles,

I am happy to see you after so long and thankful to you for joining this discussion.

I will, definitely, come back after reviewing the attached material.

By-the-way, after posting this question, I have encountered some other associated issues. I will also put forward those issues along with comments on attached material.

Thanks and Regards:

[Zeeshan]

Dear Charles!

I have gone through the material provided by you. The attachments are with information very much relevant to my query. Would you please tell me the name of the book(s) the extract of which you have attached?

Also, I think you have not fully disclosed your own ideas with respect to my original post (queries) probably because of first confirming the understanding of of queries (Not blaming you for not correctly understanding my query. Rather its my fault not to portray the actual problem correctly
.)

Regards.

[Simon]

Dear Abdul Qudoos, AOA.

Thanks for your reply.

Unfortunately I felt I have not well conveyed my problem.

Actually the problem is some thing else:

Let me explain it with some other example:

I have made a form for specifying job descriptions of employees. Now I have filled two forms for two different employees. What that two documents called - "Controlled Documents" or "Records"? In my opinion, the two documents should be tagged as RECORDS as they are generated after filling some data or information for different positions or jobs. If I called the two job descriptions as controlled documents, I have to give them some unique identification and puts all the controls of controlled documents on them.

Hopefully, now the question became clear.

Regards:

In answer to your original question Zeeshan you could consider the document template for the job description a controlled document and then if you complete 100 documents for employees they would be records. So I agree with you. Unless of course their job descriptions changed regularly then you may want to consider controlling them by revision.

Regards,
Simon

[Zeeshan]

In answer to your original question Zeeshan you could consider the document template for the job description a controlled document and then if you complete 100 documents for employees they would be records.

(Zeeshan @ Jul 2 2009, 09:43 AM)

3- Whether it is right to stamp on such records as "Record under revision control".

I have drawn justification of point 3 from the definition of RECORDS in ISO9000:2000 (Fundamentals of quality management system; Page 15) which states that generally records need not be under revision control. It means, a record may controlled through revision control techniques if a need arises.

Dear Simon,
Keeping above references in mind, I have had a full length discussion with three QMS Auditors, but they are not agree with this point that "records can be revised". Since English is not our primary language, would you please elaborate the statement given in ISO9000:2000 as under:

"Generally records need not be under revision control". What does it mean?

Does it mean that in special cases, records can be revised -or-
it mean that as a rule, records can not be revised?

In this connection I have also made a diagram that depicts a system (as a suggestion) with can control and trace any change to a document or a record.

Any type of comment is welcome!!!

 Document_Record.gif   142.44KB   114 downloads

Regards:

[Simon]

Dear Simon,
Keeping above references in mind, I have had a full length discussion with three QMS Auditors, but they are not agree with this point that "records can be revised". Since English is not our primary language, would you please elaborate the statement given in ISO9000:2000 as under:

"Generally records need not be under revision control". What does it mean?

Does it mean that in special cases, records can be revised -or-
it mean that as a rule, records can not be revised?

In this connection I have also made a diagram that depicts a system (as a suggestion) with can control and trace any change to a document or a record.

Any type of comment is welcome!!!

 Document_Record.gif   142.44KB   114 downloads

Regards:

Zeeshan, I like diagrams, I can normally understand visuals more than words, but I find it too complicated - sorry. I'm a great believer in keeping it simple because if you don't it is unlikely that your objective will be done. As specified. All of the time.

I personally take the statement:

"Generally records need not be under revision control".

to mean exactly what it says. That records generally do not need to be under revision control, unless YOU feel it is prudent to do so. It does not say NEVER.

So you need to be able to explain to an auditor why or why not any document or record does or does not need to be under revision control.

Does this help?

Regards,
Simon

[Charles.C]

Dear Zeeshan,

Sorry delay in answering yr earlier requesy for route to my extracts.

Will give 2 routes, 1st is my original (recommended), 2nd probably works if 1st fails (maybe you hv different browser, non-default setup, etc)

1.google "iso records are not controlled documents"
look on 1st page for title (iso 9000 quality systems handbook) by david hoyle, 4th down for me.
similarly on (for me) 2nd page / 5 down look for title (iso 9000 quality systems applications in food and technology) by debby L. newslow
Just click on the title in each case and should go to same page (or close) to one as I extracted (as shown in my picture)

2.google "google books"
> advanced book search on 1st or second item (almost certain locations), can then enter the titles and /or authors above. The page numbers perhaps might not work though since i think sometimes only a random limited preview is offered unlike method1 which is keyed to the search link.

You will see that a few million other people are as equally unsure as yourself regarding this issue, ie it is (very) subjective. Probably means that you can make yr own choice as long as you can auditorially validate (I'm only guessing, not a user) ??

Pls revert if search doesn't work

Rgds / Charles.C

[Zeeshan]

Dear Charles!

Thanks for your reply.

I will try as per your guidance and will come back if there would be any problem in finding it out.

Regards:

[Zeeshan]

Dear Simon,

Thanks for your comments: I really appreciate (although there is some sorrowfulness in my heart as that picture took a lot of efforts, thinking and time )

Al right, then, would you please mention the most complicated area? I will try to make it simple and understandable.

I request comments (either positive or negative) from other members also.


Regards:
Zeeshan.

[Zeeshan]

Dear all!

Today I got an idea to illustrate the difference between documents and records. I am sharing it with all of you. Comments and corrections are requested.

Regards:

 Difference_between_Documents___Records.doc   23.5KB   87 downloads

[Simon]

Dear all!

Today I got an idea to illustrate the difference between documents and records. I am sharing it with all of you. Comments and corrections are requested.

Regards:

 Difference_between_Documents___Records.doc   23.5KB   87 downloads

Zeeshan you are far to clever for me. I do not understand it.

[Simon]

Dear all!

Today I got an idea to illustrate the difference between documents and records. I am sharing it with all of you. Comments and corrections are requested.

Regards:

 Difference_between_Documents___Records.doc   23.5KB   87 downloads

Zeeshan you are far to clever for me. I do not understand it.

[Zeeshan]

Dear Simon,

I accept! Its total my fault, not to illustrate it well

I try to elaborate it through following explanation:

As per ISO 9001 (4.2.3) & ISO 22K (4.2.2) statements "Records are special type of documents". It means, records are also documents but have some special features and therefore need some special controls.

If we focus on the definition of document as stated by ISO 9000 (3.7.2) a document is a combination of information and its supporting medium.

We all know that procedures and work instructions have some set formats for any company.

Whenever we add some information (Description of an activity, group of processes or a system) on these formats, they become document.

In a similar manner, when we put some information (outcome of a process or activity) on a format, it become records.

In summary, I want to state that records are also documents but they need some special controls as the information they contained is of special type.

Hope this explanation works!

I have posted this issue so that if I am thinking in a wrong direction, somebody correct me.

Regards:

[Simon]

Dear Simon,

I accept! Its total my fault, not to illustrate it well

I try to elaborate it through following explanation:

As per ISO 9001 (4.2.3) & ISO 22K (4.2.2) statements "Records are special type of documents". It means, records are also documents but have some special features and therefore need some special controls.

If we focus on the definition of document as stated by ISO 9000 (3.7.2) a document is a combination of information and its supporting medium.

We all know that procedures and work instructions have some set formats for any company.

Whenever we add some information (Description of an activity, group of processes or a system) on these formats, they become document.

In a similar manner, when we put some information (outcome of a process or activity) on a format, it become records.

In summary, I want to state that records are also documents but they need some special controls as the information they contained is of special type.

Hope this explanation works!

I have posted this issue so that if I am thinking in a wrong direction, somebody correct me.

Regards:

Thanks Zeeshan I understand the diagram now and agree with your conclusion.

Regards,
Simon

[Zeeshan]

Dear Simon,

Thank you for your feedback .

Regards:

Zeeshan

[Tony-C]

I like diagrams, I can normally understand visuals more than words, but I find it too complicated - sorry. I'm a great believer in keeping it simple because if you don't it is unlikely that your objective will be done. As specified. All of the time.

I personally take the statement:

"Generally records need not be under revision control".

to mean exactly what it says. That records generally do not need to be under revision control, unless YOU feel it is prudent to do so. It does not say NEVER.

So you need to be able to explain to an auditor why or why not any document or record does or does not need to be under revision control.

Regards,
Simon

Absolutely but the 9000 reasoning for this was that if they were changed then a new record is issued. From a practical point of view this is not true.

For example I have a cooking log. Everybody is trained and knows what it is and so I don't want to replace it with a new record when I make a change. Revisions can be quite common on records depending on the level of detail. I like to put limits for the results that are being recorded in the column header so that operators do not need to cross reference with specifications when recording checks. These limits can change from time to time so the record would need to.

Regards,

Tony