ISO 9001:2000 Interpretations: RFI's #16 and 17 - Clause 8.3

Sidney Vianna

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OK Folks,

TC 176 has released more official interpretations. Two that I personally have a strong concern are RFI's #16 and 17

Request: ISO 9001:2000 Clause(s) 8.3
When an organization detects, after delivery or after use has started, a product which does not conform to one of the “requirements specified by the customer” (Clause 7.2.1 a)), does the standard require that the organization inform the customer of the nonconforming product?
Interpretation: No
Rationale: The last paragraph of Clause 8.3 specifies that it is the organization’s responsibility to take appropriate action regarding the nonconforming product.
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Request: ISO 9001:2000 Clause(s) 8.3
When an organization detects, after delivery or after use has started, a product which does not conform to one of the “requirements specified by the customer” (Clause 7.2.1 c)), does the standard require that the organization inform the competent authority of the nonconforming product?
Interpretation: No
Rationale: The last paragraph of Clause 8.3 specifies that it is the organization’s responsibility to take appropriate action regarding the nonconforming product.
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My question is: wouldn't it be a VERY appropriate action to communicate with your customers and applicable competent authorities (especially in case of a regulated product) when you discover that a shipped product was out of spec? :bonk:

What say you? I can't think of an instance in which it would not be appropriate to (AT LEAST) advise the customer and authorities when a non-conforming product was shipped. Very interested to hear opinions on this.
 
Last edited:
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Topic Split and My 2 cents

This was split off of:

https://elsmar.com/elsmarqualityforum/threads/7577/

My own comment is that simple common sense tells us to advise customers (and authorities when appropriate) when it is known that non-conforming product was shipped.

Business sense tells us otherwise. I've attended too many meetings in my life which were focused on how to hide shipped defectives. :2cents:
 
Sidney Vianna said:
Request: ISO 9001:2000 Clause(s) 8.3
When an organization detects, after delivery or after use has started, a product which does not conform to one of the “requirements specified by the customer” (Clause 7.2.1 a)), does the standard require that the organization inform the customer of the nonconforming product?
Interpretation: No
Rationale: The last paragraph of Clause 8.3 specifies that it is the organization’s responsibility to take appropriate action regarding the nonconforming product.
No..? NO?! :mg: That is not the way I interpret things at all.

Sidney Vianna said:
My question is: wouldn't it be a VERY appropriate action to communicate with your customers and applicable competent authorities (especially in case of a regulated product) when you discover that a shipped product was out of spec? :bonk:
I'll say it would. I know very well how true Marc's description of the pains taken to cover things up is, but: Surely, the proper action to take is to alert the customer, and if need be recall the product. No, I do not agree with that rationale...

/Claes
 
Sidney Vianna said:
My question is: wouldn't it be a VERY appropriate action to communicate with your customers and applicable competent authorities (especially in case of a regulated product) when you discover that a shipped product was out of spec? :bonk:

What say you? I can't think of an instance in which it would not be appropriate to (AT LEAST) advise the customer and authorities when a non-conforming product was shipped. Very interested to hear opinions on this.

From an ethical standpoint, I agree with you Sidney. My company, for example, has on occasion made components for brake pedals. If we were to find out after shipment that our product did not truly make spec, from legal and safety standpoints, the appropriate action to take would be to let the Customer know.

However, define "appropriate". It isn't black and white.
 
Defining "Appropriate"

RCBeyette said:
However, define "appropriate". It isn't black and white.
Other that general guidelines, "Appropriate" can only be determined when an incident arises in most cases because the specifics of each 'event' will differ. Thus - the meeting in many cases to determine how to handle a situation. This is why I mentioned 'meetings' above. Rationalization is an interesting phenomena to watch - especially as a 'disinterested' party.
 
The implication is there in ISO9K2K; the expressed statement is included in ISO/TS-16949:2002:

"8.3.3 Customer information. Customers shall be informed promptly in the event that nonconforming product has been shipped.
 
ISO 9001 allows us to take action that is appropriate based on the effects (or potential effects) of the nonconformity. But I can't imagine a situation where I would be willing to not at least notify the customer and let them make the call as to the products acceptability.

I guess after over 17 years of being told that knowingly shipping nonconforming product to the government (or not notifying them of a products nonconformity) is considered fraud and is subject to fine and prison, has tainted my subjectivity.
:biglaugh:
 
Lemme see if I have this right: If you detect a nonconformity before shipment to the customer, ISO says you must contact the customer for permission (waiver, deviation, etc.) to ship the nonconforming product (or else not ship it). But, if you detect the nonconformance after shipment you do not have to notify the customer. :eek:

So, if you detect it before shipment, you are not allowed to interpret what is appropriate, ISO tells you what is appropriate -- notifying the customer or not shipping. But if you detect it after shipment, ISO lets you decide what is appropriate. :mg: :bonk:

WOW! Mr. Spock apparently is not on TC176! What stupidity.

This gives unethical organizations another easy out -- just say you never detected the problem until after shipment. Hey, let's reduce pre-shipment inspection! :frust:

Can anyone defend this???
 
TS16949 closes this loophole in 8.3.3 Customer Information: "Customers shall be informed promptly in the event that nonconforming product has been shipped." someone must have noticed the ISO issue you pointed out.
 
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