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nonconformance report (ncr), nonconformances, operator error
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  Post Number #1  
Old 12th March 2018, 06:38 PM
Mark Meer

 
 
Total Posts: 891
Question User Errors and Product Nonconformances

Wondering: Is a product failing to meet a requirement still considered non-conforming if its failure to meet the requirement was due to actions of the user?

For example, consider the following sequence of events:
  1. Product requirement is "sensor responds correctly to user movement".
  2. Complaint is received that "sensor is all out of wack", and they want to return the device. Device is returned.
  3. Device received and checked, and indeed sensor appears to not be working correctly. Product NCR filed.
  4. As part of NC investigation it is determined that there is actually nothing wrong with the sensor. The customer (undisclosed) had simply recalibrated the device incorrectly.
In this example, is this actually a product non-conformance? When reported, the device was clearly failing to meet the requirement. But on further inspection it was actually behaving exactly as you'd expect given the user's misuse (error?) of the device.

Curious to know what you think...
MM.

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  Post Number #2  
Old 12th March 2018, 06:48 PM
Golfman25

 
 
Total Posts: 1,463
Re: User Errors and Product Nonconformances

I wouldn't call the product defective. But maybe the calibration process needs a look. How hard is it?
  Post Number #3  
Old 12th March 2018, 06:56 PM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,660
Yin Yang Re: User Errors and Product Nonconformances

Quote:
In Reply to Parent Post by Mark Meer View Post

Wondering: Is a product failing to meet a requirement still considered non-conforming if its failure to meet the requirement was due to actions of the user?

For example, consider the following sequence of events:
  1. Product requirement is "sensor responds correctly to user movement".
  2. Complaint is received that "sensor is all out of wack", and they want to return the device. Device is returned.
  3. Device received and checked, and indeed sensor appears to not be working correctly. Product NCR filed.
  4. As part of NC investigation it is determined that there is actually nothing wrong with the sensor. The customer (undisclosed) had simply recalibrated the device incorrectly.
In this example, is this actually a product non-conformance? When reported, the device was clearly failing to meet the requirement. But on further inspection it was actually behaving exactly as you'd expect given the user's misuse (error?) of the device.

Curious to know what you think...
MM.
Mark,

It seems to me that you are not done yet.

Two possible causes flowing from your investigation of this nonconformity:

1. The calibration instructions failed to meet the requirements of the customer.

2. The device needs mistake-proofing so the customer cannot use it incorrectly.

Or, you may just have a service or business opportunity to train customers in their proper calibration and use of the device.

John
  Post Number #4  
Old 12th March 2018, 06:58 PM
Mark Meer

 
 
Total Posts: 891
Re: User Errors and Product Nonconformances

The calibration process is a relatively obscure feature, intended only for over-the-phone troubleshooting. As I say, not disclosed in this case.

...but really it's just an example. I'm more interested in the principle, and categorization (documentation) practices in such cases. If a product non-conformance is defined as simply not meeting a requirement or specification, is product not meeting a requirement due to the actions of a user still considered "non-conforming"?

You use the word "defective". Would you say this is synonymous with "non-conforming"?

Perhaps the requirements specifications need to just be more specific, to specifically exclude cases where user action is the cause.
  Post Number #5  
Old 13th March 2018, 06:10 AM
Bev D's Avatar
Bev D

 
 
Total Posts: 3,630
Re: User Errors and Product Nonconformances

Interesting question.

To my way of thinking, “defective” is not synonymous with “non-conforming”. If the requirements - or specifications - are wrong, a product may be defective and stilll conforming. It may also be non-conforming and still quite able to function as intended. From a legal standpoint, the two terms are also quite different. For example, a latent defect may not be apparent until some stress has uncovered it. So a part can be defective yet meet requirements for some time.

As to your original question, this is more of a gray area. A product that is altered by the Customer and then returned may in fact be non-conforming and require control to prevent shipping it back out in a non-conforming state regardless of the source of non-conformance. Once you accept it back it is now your responsibility. Further investigation would be required to determine how the Customer would have altered the product. While we can’t necessarily control malicious alterations, we can control misguided or “incompetent” alterations through error-proofing. We can also determine what caused the Customer to believe that they had to alter the product in some way - adn then take action against that. Typically these two actions are based on how frequently this occurs. If there are only a very few occurrences it may not be worth a lot of effort. If it is fairly frequent then it may be teh right thing to do to maintain Custoerm loyalty.
Thanks to Bev D for your informative Post and/or Attachment!
  Post Number #6  
Old 13th March 2018, 08:08 AM
Mike S.

 
 
Total Posts: 2,270
Re: User Errors and Product Nonconformances

Quote:
In Reply to Parent Post by Mark Meer View Post

In this example, is this actually a product non-conformance? When reported, the device was clearly failing to meet the requirement. But on further inspection it was actually behaving exactly as you'd expect given the user's misuse (error?) of the device.

Curious to know what you think...
MM.
The key here to me is if the user indeed "misused" the device, and knew, or should have known, not to do that. For example, if you have an easily accessed screw that says "calibration" and no prominent instruction not to touch it, or it is not covered by a tamper-resistant cover, etc. then you might expect a user to fiddle with it, and I'd say you are inviting trouble.

If a user destroyed a tamper-resistant cover to fiddle with the screw, I'd say the user is totally at fault.
  Post Number #7  
Old 13th March 2018, 11:33 AM
mlee97's Avatar
mlee97

 
 
Total Posts: 32
Re: User Errors and Product Nonconformances

If the customer's perception is that it is defective, then your product has failed to meet the customer's requirements. It might meet yours, but you're not the purchaser.

If you plan to stay in the business of producing this product, then there is a clear need to improve your product's sensor calibration or what-ever.

The quality system standards of today are geared toward making a business better and stronger by staying relevant to stakeholder requirements and addressing risks. The problem of having dissatisfied customers is definitely a risk to your company.

So in a nutshell, I would say yes the part is a non-conformance as its design or its instructions do not meet customer expectation.

Last edited by mlee97; 13th March 2018 at 11:42 AM. Reason: adding answer
Thanks to mlee97 for your informative Post and/or Attachment!
  Post Number #8  
Old 13th March 2018, 04:13 PM
Mark Meer

 
 
Total Posts: 891
Re: User Errors and Product Nonconformances

Quote:
In Reply to Parent Post by mlee97 View Post

So in a nutshell, I would say yes the part is a non-conformance as its design or its instructions do not meet customer expectation.
I'm a bit wary to tie the QMS non-conforming product process to something so subjective. Ideally, the requirements/specifications would be clearly documented so that the decision to issue an NCR is clear. If not meeting customer expectations is grounds for product NC, then pretty much every single complaint would spin out an NCR, no?

Consider: If a customer called in a complaint and said simply "I don't like the product", would you consider this a product non-conformance as it "[did] not meet customer expectation"?
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