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Record Falsification - What clause to raise a non-conformity?

B

Bill Pflanz

#11
Jim Howe said:
So ok where is the line in the sand? ... Now, aside from the waste of time and lack of planning by the planners, was fraud committed? You tell me! :frust:
Jim,

Now you have raised a different issue than lying. The workers are being asked to do something that may not be value added but is required by management. If the control cards are not used for anything than what difference does it make how efficiently they are signed? Were inspectors verifying something or were they just signing off.

I have written up observations (not non-conformances) where I noted that no review was taking place but only a sign off. In the post-audit meeting I would note that the requirement was being met but it was ineffective and suggested that the requirement include what is to be reviewed and how objective evidence was collected to verify the review. Almost every time, the decision was made to drop the requirement.

This is where internal policies and procedures can get in the way of an effective management system.

Bill Pflanz
 
J

Jim Howe

#12
Bill Pflanz said:
Jim,

Now you have raised a different issue than lying. The workers are being asked to do something that may not be value added but is required by management. If the control cards are not used for anything than what difference does it make how efficiently they are signed? Were inspectors verifying something or were they just signing off.

I have written up observations (not non-conformances) where I noted that no review was taking place but only a sign off. In the post-audit meeting I would note that the requirement was being met but it was ineffective and suggested that the requirement include what is to be reviewed and how objective evidence was collected to verify the review. Almost every time, the decision was made to drop the requirement.

This is where internal policies and procedures can get in the way of an effective management system.

Bill Pflanz
Process control cards were verifiable evidence that a process was performed correctly and found to be compliant by inspection. In those days most operations were 100% inspected by the inspector, followed by 100% DCAS inspection, followed by 100% Customer inspected.
As I recall the process dealt with Torpedoe Warhead Exploders, timing devices I believe. You can imagine what might happen if a torpedoe blew up prematurely!
Now we now that the inspection was done as the first lot control card inspection stamp testified to. The fact that we now wanted to send these parts to the next level of process as individuals rather than as a huge lot is what prompted the photography. Yet the Inspector had a point how did she know they were moving the parts she inspected.
 
#13
Masculinie said:
How I wish ISO Standards have a direct clause to deal with record fabrication or falsification....
Well, the scope of ISO 9001:2000 is reasonably clear in one respect:
ISO 9001:2000 said:
1.1 General



This International Standard specifies requirements for a quality management system where an organization


a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.


1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
At least we are not supposed to stray outside the boundaries of the law.​

/Claes​
 
B

Bill Pflanz

#14
Jim Howe said:
As I recall the process dealt with Torpedoe Warhead Exploders, timing devices I believe. You can imagine what might happen if a torpedoe blew up prematurely!

Okay, now we have established that the quality inspection was for something important. Does that mean that if all the cards were signed appropriately that their is no risk of a premature explosion? On the other hand, will an explosion occur for any of the inspected parts that were not properly signed? The cards won't answer either question. Correlating the signing of the cards with the number of defects is mathematically possible but not statistically valid.

Experience without theory teaches nothing. - W. Edwards Deming
At this point, we are on shaky ground about whether following a written standard will result in better quality. I remember someone asking Juran at a conference about the ISO standards. He was not a supporter of them. Your story indicates the possible danger of meeting the requirements but failing to prevent the defects.

With the new information provided, I would probably question how signing the cards prevents defects. Again, I must complement the Covers for an interesting thread. The line in the sand is not always easy to draw.

Bill Pflanz
 
J

Jim Howe

#15
Bill, the signing of the cards was necessary in order for product to continue to next step of process. The card is a process control card and yes even back in the 80's we controlled processes.
Could the torpedoe still blow up prematurely? Of course, look at the shuttle! But would you not agree that by taking the necessary steps (controlling process) we can reduce that possibility?
Isn't that what it is all about? Control the process and you control product quality.
Although I agree with your "shaky ground" hypothesis :agree1: what other course do we have?
In your opinion was "fraud" commited?
Good thread!
 
B

Bill Pflanz

#16
Jim Howe said:
Although I agree with your "shaky ground" hypothesis :agree1: what other course do we have?
In your opinion was "fraud" commited? Good thread!
IMHO, fraud was committed in the way the card was signed but it may or may not have been fraud in whether the process for controlling defects was followed.

If a defect occurred (worst case scenario is a premature explosion) then looking to see whether the process card was signed would not tell you anything about the root cause of the problem.

I fully realize that I am nitpicking on the value of the process cards and am willing to call a truce. :truce:

Bill Pflanz
 
J

Jim Howe

#17
Bill Pflanz said:
IMHO, fraud was committed in the way the card was signed but it may or may not have been fraud in whether the process for controlling defects was followed.

If a defect occurred (worst case scenario is a premature explosion) then looking to see whether the process card was signed would not tell you anything about the root cause of the problem.

I fully realize that I am nitpicking on the value of the process cards and am willing to call a truce. :truce:

Bill Pflanz
OK truce it is! :truce: But the discussion IMO needs a few more points.
Suppose the card was NOT signed or stamped would that not conjure up the impression that maybe, just maybe, that operation was not performed? Or how about during the course of the investigation the stamp on the card was found to be a photographic image?
I guess my point is that in those days even the ink used to stamp the cards was a special ink (acid etching) and highly controlled so that we could tell if the stamp was a forgery.

This ink was so potent that on one occassion when I was the QAE for MRB and was missing a PCB from the scrap pile (we had finished the paper work and stamped a big red "R" (scrap stamp) on the board) we called it a day with full intentions of destroying the PCB in the morning. When morning came the board was missing.

After several weeks of investigation I received a tip that a technician had rescued the board from the scrap pile and intended to perform experimental work with it.

Long story made short I found the board (white wired) in a computer bank that was up an running test for delivery to the US Air Force. The Big RED "R" was not visable on the board. I threw the switch, terminating the mission. I pulled the board from the rack and destroyed it on site.

I was being severally criticized for my actions. In response I gathered up the pieces and took them to a black light booth and Bingo there gleamed the etched "R", which was a little bit of info the tech didn't know about. :bonk:

In closing I will state that Mil-Q-9858A had a lot going for it!
 

CindyG

Involved In Discussions
#18
Ok, I'll bite. How about and The use of falsified data would negate the possibility to carry those requrements out, wouldn't it? Mind you, I would not call it record falsification.... I would have to prove that the data is incorrect, and would settle with that.


/Claes
Great!
And...what clause would this be same as in IS0 9001-2015?!
 

Al Rosen

Staff member
Super Moderator
#19
There are 2 that might fit.

7.5.3.2 For the control of documented information, the organization shall address the following
activities, as applicable:
...
....
Documented information retained as evidence of conformity shall be protected from unintended
alterations.


or

8.5.2 Identification and traceability
The organization shall use suitable means to identify outputs when it is necessary to ensure the
conformity of products and services.

The organization shall identify the status of outputs with respect to monitoring and measurement
requirements throughout production and service provision.


The organization shall control the unique identification of the outputs when traceability is a
requirement, and shall retain the documented information necessary to enable traceability.
 
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