Hi All,

We are a small software company with staff strength of 20. We are now getting prepared to be ISO 9001:2000 Certified by end of November. I was going through the topics in this forum and found them interesting. My interest is to know which of the following is a document, a record or none:

* Master list of Quality Documents - contains the list of controlled documents
* Master list of Quality Records - contains the list of controlled records.
* Task tracking sheet - contains the list of tasks in the project
* Test case Review log - contains the list of test cases documents and their review dates.
* Facility Service log - contains the service requests for various facilities in the office.

Thanks in advance for the time spent to understand my question and answering it.

Sharat .M

Remember, to some extent at least, YOU get to decide the measure of control you exercise over documents. TS wants you to "establish criteria" for that control, which should of course be appropriate to your facility/operation. YOU decide what needs to be controlled, doesn't need to be in order for your quality system to operate effectively. Fer' instance: we define in our document control procedure that normally LOGS are not controlled documents here. We decided that on the basis of how the few logs we use are utilized AND based on our "criteria statement" for deciding whether or not a document should be controlled. But I know in some organizations logs are used differently, and their mis-use or "non-controlled" status would be problematic.

Bottom line: What makes sense for YOU?

Hello Sharat, and welcome to the Cove. :bigwave:

Here is my take:

* Master list of Quality Documents - contains the list of controlled documents -Record.
* Master list of Quality Records - contains the list of controlled records. -Record
* Task tracking sheet - contains the list of tasks in the project - Record
* Test case Review log - contains the list of test cases documents and their review dates. -Record
* Facility Service log - contains the service requests for various facilities in the office. - Record

Steel provided good advice. pay attantion to what she said.

Another thing: Considering what you do for a living I suppose a computer based system would be nice?

/Claes

Added later: Sharat, Since you're going for ISO 9001 I moved this thread to the ISO900X forum. I think you'll get more answers that way.

...Fer' instance: we define in our document control procedure that normally LOGS are not controlled documents here. We decided that on the basis of how the few logs we use are utilized AND based on our "criteria statement" for deciding whether or not a document should be controlled. But I know in some organizations logs are used differently, and their mis-use or "non-controlled" status would be problematic.

Bottom line: What makes sense for YOU?

Good example - we decided to control our log books as records (they are included in our Record Retention List) because they are critical records - especially in the repair end of our business. In addition - a current customer of ours requires us to retain an EDI log in sheet of their RFQ's and retain for one year.

The way I look at it, a document that has not been filled out = a doucument; once it has been completed and information recorded on it, it is now a record. JMHO :)

My take is a little different than that of Claes. Since the master lists of documents and records will be revised from time to time (as you add or change revisions), I would call them a document. Logs are a history, so they would be a record. For the task tracking sheet, I'm not sure. What is it used for? If it is subject to revision, and/or is used to provide instructions, I would call it a document. If it just shows what happened, it would be a record.

* Master list of Quality Documents - document
* Master list of Quality Records - document
* Task tracking sheet - ??????
* Test case Review log - record
* Facility Service log - record

Sharat M.,

I pretty much go along with Howste, but if the log is purely a management tool to know what is happening with the records, then it is not necessarily a record.

doug

My take is a little different than that of Claes. Since the master lists of documents and records will be revised from time to time (as you add or change revisions), I would call them a document. Logs are a history, so they would be a record. For the task tracking sheet, I'm not sure. What is it used for? If it is subject to revision, and/or is used to provide instructions, I would call it a document. If it just shows what happened, it would be a record.

* Master list of Quality Documents - document
* Master list of Quality Records - document
* Task tracking sheet - ??????
* Test case Review log - record
* Facility Service log - record
First a statement:
Records are merely a special form of document, not normally subject to revision because they represent the RECORD (history) of activities.

I agree with Howste to the extent that the two items he lists as documents because they are subject to revision is a fair statement. The last three items are records in my opinion, with this provision:
"as new or additional data is added to a record, it becomes a new record and the old (previous) one is obsolete and should be discarded if it is a paper printout."

Compare this concept to a continuing inspection log on a part which tracks inspections over the entire production period.
Do we make a new revision of the log each time a new set of inspection results is added? (probably not.)
Is a copy of yesterday's log valid if new info has been added today? (probably not and should be discarded.)
In essence, the date of the last entry in the log takes the place of the involved process of creating a new revision with checks and approvals normally required in a document control system.

. . .
In essence, the date of the last entry in the log takes the place of the involved process of creating a new revision with checks and approvals normally required in a document control system.I'm not sure I was clear in the "discard" aspect of my post. I referred only to the "copy" of the previous date of the record. In the case of computer entry, the previous material remains, course, as the history of what happened. In a machine shop, for example, the inspection record may be maintained on one sheet of paper, adding new entries at every inspection. Copies of the record through a certain date may have been made for different purposes. Once the new data is added to the record, the previously made copies are obsolete and may be discarded.

Hi All,

We are a small software company with staff strength of 20. We are now getting prepared to be ISO 9001:2000 Certified by end of November. I was going through the topics in this forum and found them interesting. My interest is to know which of the following is a document, a record or none:

* Master list of Quality Documents - contains the list of controlled documents
* Master list of Quality Records - contains the list of controlled records.
* Task tracking sheet - contains the list of tasks in the project
* Test case Review log - contains the list of test cases documents and their review dates.
* Facility Service log - contains the service requests for various facilities in the office.

Thanks in advance for the time spent to understand my question and answering it.

Sharat .M

Like Claes pointed out, looking at your industry, what kind of document control system do you have? Is it primarily electronic? But here's my take...

Master list of Quality Documents
At my organization, our Document Control System is the list Master List of Documents. Controlled documents from external sources and controlled software have their lists maintain via a document (i.e, a work instruction) - listing name, rev#/date, location, person responsible for maintaining it. The Document Control System software can be found on the controlled software listing.

Master list of Quality Records
Within our Document Control System, there is a Records List module. Again, cound on the controlled software listing.

Task tracking sheet, Test case Review log, & Facility Service log
While blank, it a document called a form. Once there is data on it, it becomes a record.

My sincere thanks to all who have taken time to discuss this issue.

To make myself clear on the type of document control system we are following:

* All documents and records are created using MS Word.
Email approvals for documents are maintained.
* The master lists are stored in MS Word format.

Question: The Master list of Quality records get updated almost every day. Since most of you have identified this list as a document, Should there be a review and approval of the Master list everyday?

* The Tracking sheet, logs and registers are stored in seperate MS Excel files. There is no form to store the contents of the log or register. There are columns designated in the MS Excel file to store the form data. Therefore one MS Excel file gets changed/updated almost everyday.

Question: Should the MS Excel file be treated a document with review and approval?

Sharat .M

I expected some differences of opinion here. :D It all depends on how you set your system up.

Sharat, that sounds pretty much like our situation, which is also the reason to why we consider the master lists to be records. We have procedures describing how we handle control of documents and records, but the lists are not in the procedures. Instead they point to databases containing the lists.

Thus we consider each procedure a document and the databases to be records. It works for us, but as a well known Cove dweller says: One size does not fit all.

/Claes

I expected some differences of opinion here. :D It all depends on how you set your system up.

Sharat, that sounds pretty much like our situation, which is also the reason to why we consider the master lists to be records.
. . .
It works for us, but as a well known Cove dweller says: One size does not fit all.
/ClaesClaes has opened my eyes a little.
I wrote:
". . . extent that the two items he lists as documents because they are subject to revision is a fair statement."

Which I now retract, given more of your details. I change my vote to RECORD. I was inserting my own company's use of "Master List" which is different from yours (Nasty habit, that A-S-S-U-M-E.) The way you describe your Master List is like it is one of several hard copy cross-indexes which just describes the content of your files by name, number, title, etc.. Since it is generated electronically, it can therefore be sorted on the various fields, just like any database. To categorize it as a document subject to revision is like saying the directory of your computer is a document subject to revision.

The Master list of Quality records get updated almost every day. Since most of you have identified this list as a document, Should there be a review and approval of the Master list everyday?

I'm a little confused. :confused: Why does your Master List of Quality Records get updated almost daily? Ours has not really changed in well-over one year...excluding our whole fiasco with Sales (but that's a separate story).

But my System may have something simliar to your System. We have Nonconformance Reports generated for everything from poor product quality, unscheduled downtime, Internal/External Audit findings, payroll errors, etc. For every report created, an entry is made into the Nonconformance Log. Unfortunately, there are times that there are additions to the Log on an almost daily basis.

However, the Log's template - the blank version of it - is a form. The Log with the data on it is the record. But no one is required to approve it on a daily basis. The people who use it are trained on how to use it properly...and once a month, I go in an just verify that is being documented as it should be.

Who enters data into, reviews, and approves your Master List of Quality Records? Is it really necessary? If you have multiple people entering information into it, perhaps stating that they are trained on how to properly use the Master List is sufficient? Having the format (i.e., the template) may be all that requires actual approval? JMHO.

I'm a little confused. :confused: Why does your Master List of Quality Records get updated almost daily?

An example:

We have project that has tasks that complete almost every day. These tasks under testing. Each tested task has a Test case execution report. This report is a record. Therefore, the Master List of Records needs to be updated by adding this report into the list.

This will be a tedious task if the Master list requires review and approval every day.

Sharat .M

My Goodness! My take on "Master Lists" is they show all of the TYPES of records, instructions, procedures, etc. that you utilize, NOT every INDIVIDUAL record or report.

If you must keep a running tab on each report, that in itself would be a log, or running record; not subject to the same controls as a "master list".

My Goodness! My take on "Master Lists" is they show all of the TYPES of records, instructions, procedures, etc. that you utilize, NOT every INDIVIDUAL record or report.

If you must keep a running tab on each report, that in itself would be a log, or running record; not subject to the same controls as a "master list".

This is what I was thinking also. Our Record Retention List states the name and document number of the form. For example: Our form for final inspection is denoted on the list and it states where and how they are maintained. I do not add "Job #123 Final Inspection Report" to the list every time we generate a final inspection report. For the type of records that do not have document numbers the list simply says "Outside Calibration Certs" or "Customer Requirements Correspondance".

My take is that documents are used as inputs to the job. That is why they must be controlled, to ensure the information is valid. Records are an output of a job, and hence, are usually not subject to change. In many cases one activity's record becomes another activity's document.

In the case of a Master List, we begin by looking at its function. I use the Master List to ensure my document is valid. Because I use the Master List, it is a document. The Master List also contains a historical record of my documents. Therefore, it is also a record. Because document control is more critical than record control, then the Master List would be treated as a document.

My Goodness! My take on "Master Lists" is they show all of the TYPES of records, instructions, procedures, etc. that you utilize, NOT every INDIVIDUAL record or report.

This is good news for me. I feel this is more sensible. Therefore for each log of records maintained, an entry for each log requires to be updated in the Master list of records.

Sharat .M

My Goodness! My take on "Master Lists" is they show all of the TYPES of records, instructions, procedures, etc. that you utilize, NOT every INDIVIDUAL record or report.

Yep. Same here.

/Claes

An example:

We have project that has tasks that complete almost every day. These tasks under testing. Each tested task has a Test case execution report. This report is a record. Therefore, the Master List of Records needs to be updated by adding this report into the list.

This will be a tedious task if the Master list requires review and approval every day.

Sharat .M
Why do you update your master list of records? If Your master list of records is a general list that indicates that the "Test Case Execution Reports" are maintained in a location, by whom and for how long you shouldn't have to update it and review and approve it unless there is a change. Each individual "Test Case Execution Report" would be dated and signed by the individual generating the report (record). The report would be maintained without change. If the report is actually a log of the test(s) performed, an entry would be made to the log but the master list would still remain unchanged.

I believe other people in this thread have described similar scenarios. Perhaps you should review what you are doing since it may be more than you have to.

Hi,

Thanks for clarifying my doubts. I have decided to treat the documents and records as follows:

* Master list of Quality Documents - a document
* Master list of Quality Records - a document
* Task tracking sheet - a record
* Test case Review log - a record
* Facility Service log - a record

Also, the Master list of Quality records will contain the type of record and the folder in which the records will be stored.

This was a great forum and I plan to contribute my knowledge to help others.

Thanks again,
Regards,
Sharat .M

An example:

We have project that has tasks that complete almost every day. These tasks under testing. Each tested task has a Test case execution report. This report is a record. Therefore, the Master List of Records needs to be updated by adding this report into the list.


Sharat .M

I'm joining a little bit late, but we are going through the same definition these days in my company.

I was wondering whehter you need to upgrade your master list of record every day since I am guessing that the test report you are refering to is a template to complete. Do you keep a track of EVERY record generated in every project? Is that neccesary?

What we are implementing is a list of every document (i.e. role assigments, meeting minute, etc) but the way we manage our recors is establish in a methodology, so we don't nee to have a track of EVERY record generated which will insume too many resources.

this thread was very helpfull since it was a bit hard to me to understand what "documents requiered by the QSM meant.

Regards from down south

Martin

We decided to keep the records in seperate folders depending on the type of record. Example MOM (Minutes of the Meeting) , PSR (Project status reports) etc. These folder names along with the full path is mentioned in the Master list of records.

One-off records are kept in their respective folders. Example: Technical review for DESIGN is kept in the DESIGN folder. These individual records names and the path is identified in the master list of records individually.


Sharat . M