Definition Document vs. Record in ISO 9001 Procedure - Differences between and Definition

Jim Wynne

Staff member
Admin
#11
Re: Difference between "Document " and " Record" in ISO Procedure

I agree. Databases that often are used as "records" are changed as additional information becomes available. For example, a training (records) database is changed when a person receives additional training or when a time based training certificate expires.

Stijloor.
Just to be clear, the thing that seems to confuse most people about this subject is the idea of changing records such that history is being misrepresented or falsified, which shouldn't be done, and in some cases might even be illegal. Nonetheless, not only should it be considered okay to correct or amend records such that they represent what actually happened (if necessary), in most cases it's the responsible thing to do.
When changing a record in this fashion, there should be a trail--you should be able to ascertain who changed the record, when it was changed, and why it was changed.
 
Elsmar Forum Sponsor
#12
Re: Difference between "Document " and " Record" in ISO 9001 Procedure

Sitting here, reading through this thread - I must have nothing else better to do, since we've hashed this over time and again - and it occurs to me that some have to shift their paradigms in thinking about documentation.

In my early days in QA, learning as I went from two US Military Lieutenant Colonels, it occurs to me that part of our documentation was a lengthy test procedure/instruction/process which was also a form for recording results obtained at each step.

Indeed, the NATO peoples' advice was to do it that way since it could be reviewed easily for the target spec (also included), the process for testing and the result. It had never entered my head to consider the elegance of such documentation until recently, when I went rooting through a box of old stuff in the basement.

It throws a wrench into the much vaunted 'pyramid' of documentation, doesn't it? 3 rolled into 1...
 
Last edited:

Wes Bucey

Quite Involved in Discussions
#13
Re: Difference between "Document " and " Record" in ISO 9001 Procedure

Andy's "elegance" and Jim's "trail" are important factors. The point of both men, I think, is that changes to any documents, especially records, should follow a protocol, not willy nilly because some guy "decided" there was an error and erased the original entry in favor of the new one without leaving a trail of the fact a change was made and why it was made. The trail helps prevent silly mistakes as well as intended fraud.

The elegance comes from being able to review the accurate history to help identify opportunities for improvement in processes, designs, material, etc.

An example of how the "trail" helped generate a improvement in an inspection process which eliminated nearly 90% of data entry errors and cut the net inspection time on a product by nearly 70%:

Opportunity: a customer's incoming inspection team was trained to take a random sample of product and compare measured dimensions on the product with specified dimensions on the engineering drawing.

The inspection team went through a period where literally dozens of shipments from different suppliers of different products were put into quarantine because there appeared to be a discrepancy between actual product and drawing specifications.

Oddly, a material review board at the customer cleared all the quarantined product and attributed the wrongful quarantine as "operator error." In the meantime, of course, because of quarantines, product payment was delayed and the cascading effect disgruntled the customer's entire supply chain, especially since none of the products were ultimately found discrepant by the customer's own MRB. There were dark hints the customer was conspiring to stretch out its payments by use of a "suspected" discrepancy. The suppliers were so disgruntled, they formed a committee to face down the customer's top management over the issue.

Three supplier quality managers watched over the shoulders of the customer's incoming inspection team for less than five minutes before one recognized the factor causing all the erroneous data entries:
Other than an engineering drawing, the inspectors had no systematic plan for inspecting any of the products. No two inspectors measured the same part's dimension in the same order. There was frequent switching back and forth between inspection instruments (from micrometer to vernier to hole gage to thread gage and back again.) On some pieces an inspector might pick up the same instrument five times to measure different dimension on the same product. Worst of all, inspectors started with a blank sheet of paper and wrote in the specified dimension and tolerance for each dimension checked and then entered their own reading.

Looking at the accumulated data sheets,it could be seen that inspectors had caught themselves making incorrect entries, diligently put a line through the erroneous entry, added the correct one, and initialed the correction.

The error proofing solution:
each engineering drawing for a product had dimension features individually numbered in the order in which each was to be inspected, so that an inspector would make all vernier caliper readings first, then micrometer readings, then hole gage, then thread gage readings. Each product had a data entry sheet form with the specification and tolerance pre-printed along with the type of instrument to be used for the measurement. The inspector would enter his reading plus there was a space to record the ID number of the actual instrument used by the inspector (for tracking and recall in case the instrument was later learned to be out of calibration.) The system was duplicated at each supplier so everyone was literally on the same page when making an inspection of a product.

Net result:
an inspection process which eliminated nearly 90% of data entry errors and cut the net inspection time on a product by nearly 70%. There were no further quarantines of any suspect products later found to be OK.
 

Jim Wynne

Staff member
Admin
#14
Re: Difference between "Document " and " Record" in ISO 9001 Procedure

The elegance comes from being able to review the accurate history to help identify opportunities for improvement in processes, designs, material, etc.

An example of how the "trail" helped generate a improvement in an inspection process which eliminated nearly 90% of data entry errors and cut the net inspection time on a product by nearly 70%:

Opportunity: a customer's incoming inspection team was trained to take a random sample of product and compare measured dimensions on the product with specified dimensions on the engineering drawing.

The inspection team went through a period where literally dozens of shipments from different suppliers of different products were put into quarantine because there appeared to be a discrepancy between actual product and drawing specifications.

Oddly, a material review board at the customer cleared all the quarantined product and attributed the wrongful quarantine as "operator error." In the meantime, of course, because of quarantines, product payment was delayed and the cascading effect disgruntled the customer's entire supply chain, especially since none of the products were ultimately found discrepant by the customer's own MRB. There were dark hints the customer was conspiring to stretch out its payments by use of a "suspected" discrepancy. The suppliers were so disgruntled, they formed a committee to face down the customer's top management over the issue.

Three supplier quality managers watched over the shoulders of the customer's incoming inspection team for less than five minutes before one recognized the factor causing all the erroneous data entries:
Other than an engineering drawing, the inspectors had no systematic plan for inspecting any of the products. No two inspectors measured the same part's dimension in the same order. There was frequent switching back and forth between inspection instruments (from micrometer to vernier to hole gage to thread gage and back again.) On some pieces an inspector might pick up the same instrument five times to measure different dimension on the same product. Worst of all, inspectors started with a blank sheet of paper and wrote in the specified dimension and tolerance for each dimension checked and then entered their own reading.

Looking at the accumulated data sheets,it could be seen that inspectors had caught themselves making incorrect entries, diligently put a line through the erroneous entry, added the correct one, and initialed the correction.

The error proofing solution:
each engineering drawing for a product had dimension features individually numbered in the order in which each was to be inspected, so that an inspector would make all vernier caliper readings first, then micrometer readings, then hole gage, then thread gage readings. Each product had a data entry sheet form with the specification and tolerance pre-printed along with the type of instrument to be used for the measurement. The inspector would enter his reading plus there was a space to record the ID number of the actual instrument used by the inspector (for tracking and recall in case the instrument was later learned to be out of calibration.) The system was duplicated at each supplier so everyone was literally on the same page when making an inspection of a product.

Net result:
an inspection process which eliminated nearly 90% of data entry errors and cut the net inspection time on a product by nearly 70%. There were no further quarantines of any suspect products later found to be OK.
This is pure unadulterated fantasy. Even if it were presented as hypothetical it would make no sense because the idea that a situation where disparate suppliers would confederate in a "committee" and march into a common customer's building to watch over the incoming inspection process is patently absurd.

Sometimes records don't reflect what actually happened, and this can happen for a number of reasons, none of which require making up fairy tales to explain. When it does happen, records should be corrected, and there should be a standard method for doing it.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#15
Re: Difference between "Document " and " Record" in ISO 9001 Procedure

Is it a hypothetical example?

I didn't catch the part describing how the three supplier QEs were from different companies. Though it seems unlikely one company would send three QEs... anyway, as I understood it Wes was advocating a methodical way to correct records, which I believe is the point - that it's acceptable to do so if there is a means to make sure previous entries aren't lost.
 

Jim Wynne

Staff member
Admin
#16
Re: Difference between "Document " and " Record" in ISO 9001 Procedure

Is it a hypothetical example?

I didn't catch the part describing how the three supplier QEs were from different companies. Though it seems unlikely one company would send three QEs... anyway, as I understood it Wes was advocating a methodical way to correct records, which I believe is the point - that it's acceptable to do so if there is a means to make sure previous entries aren't lost.
Wes cites an example of how something helped, not how something could help, which indicates something that (allegedly) actually took place:
An example of how the "trail" helped generate a improvement in an inspection process which eliminated nearly 90% of data entry errors and cut the net inspection time on a product by nearly 70%...
Then he refers to suppliers forming a committee, and three supplier quality managers, not supplier QEs.:
Opportunity: a customer's incoming inspection team was trained to take a random sample of product and compare measured dimensions on the product with specified dimensions on the engineering drawing.

The suppliers were so disgruntled, they formed a committee to face down the customer's top management over the issue.

Three supplier quality managers watched over the shoulders of the customer's incoming inspection team for less than five minutes before one ...
As I said, even if it were hypothetical it would make no sense because the premise is so outré.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#17
Re: Difference between "Document " and " Record" in ISO 9001 Procedure

Let's not make too much of it. The example seems okay as a representation of how a record's change is acceptable. That's the impression I got from the post anyway.

To add my own experience, I can share: As a QA Inspector of submarine repairs we were sternly admonished to never scratch out, white-out or otherwise make unavailable the history of what was changed on our inspection record sheets. Changes were allowed, so long as they strictly followed the protocol: a single line through the erroneous information, and the corrector's initials and date to the upper right of the entry. The object was to preserve the record's integrity, but also to preserve the data's integrity. Both can be achieved by following disciplines intended to preserve needed information.
 
C

Craig H.

#18
Re: Difference between "Document " and " Record" in ISO Procedure

I don't think so! A record is the history of the actvity. We don't normally change history, but it may often be amended as new information comes to light. Certain industries, pharmaceutical among them, have strict proscriptions about altering a record.

Just to be clear:
"once completed" means with the data from the activity filled in, NOT a completed blank form ready for data to be entered..
Yes, and if a record is later found to be in error it should still be retained, along with the corrected record.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#20
Unprofessionalism

<snip> This is pure unadulterated fantasy. <snip>
Jim, you have no idea whether Wes' post is 'fantasy' or not. Many of your posts are in the realm of 'fairy tales' as well to some of us. I believe your post was meant to inflame. I suggest that you be more diplomatic and professional in the future in your posts here. Thank you.
 
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