Definition Nonconformance - How is this Top Management Definition of Nonconformances?

Is this top management definition of nonconformance ...

  • Pure genius, why didn't I think of that

    Votes: 1 7.1%
  • Seems fine to me

    Votes: 0 0.0%
  • Sketchy, but OK if the auditor has agreed

    Votes: 2 14.3%
  • Not really right, even if the auditor lets it slide

    Votes: 0 0.0%
  • Laughable, misses the fundamental point

    Votes: 11 78.6%

  • Total voters
    14

Jim Wynne

Staff member
Admin
#31
I think that maybe a few important points are being missed, and people are talking past each other here. While I agree with Greg that "the organization" has options with regard to how "NC" is defined, the options might be limited. Pesky little things like customer requirements and international standards might play a part in it, and while it's certainly true that if I run the company I can proclaim that henceforth black is white within the boundaries of my own little bailiwick, if the customer (or the standard) calls for white and I supply black, there's going to be a problem, and it's just the sort of problem that registrars should be on the lookout for.

But let's get back to the OP for a moment, because there's an important inconsistency in it that's been overlooked here thus far. Here's what rd007 says that his management wants to do:
in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station.
In essence this is saying, "We might identify parts as nonconforming at some point before final inspection or the point when they reach the customer, but we're not going to call them that so we don't have to do CA until they reach final inspection (or the customer)." So it's not really a question of how "nonconformance" is defined, because if parts weren't identified as nonconforming in production, we wouldn't be having this conversation now.

As for the rationale--not having to to do CA until the end--what possible difference does it make when CA is done? What is the likelihood that failure to act promptly will result in the ability to identify root causes being compromised?

Then there's this scary bit:
There are a few boxes or racks of parts that are scrap or rework at the workstations, and those are just thrown out or reworked when the operator or supervisor gets to it. They aren't tagged, except when an auditor is around ...
(Ellipsis in the original)

So now we know that not only are there parts which have been recognized as conforming, but they also might not be properly marked or otherwise identified as such (perhaps because the special definition of NC hasn't been applied yet).

So let's summarize: The company is aware that nonconforming parts are being produced, but doesn't want to deal with them on any level until final inspection or until they reach the customer. Management feels that this "strategy" can be justified vis a vis the ISO requirements by simply declaring that parts that have been identified as nonconforming are not actually called nonconforming until it might be too late.

Does any of this actually make sense to anyone?
 
Elsmar Forum Sponsor

RoxaneB

Super Moderator
Super Moderator
#32
So let's summarize: The company is aware that nonconforming parts are being produced, but doesn't want to deal with them on any level until final inspection or until they reach the customer. Management feels that this "strategy" can be justified vis a vis the ISO requirements by simply declaring that parts that have been identified as nonconforming are not actually called nonconforming until it might be too late.

Does any of this actually make sense to anyone?
Does it make sense? No. But if this is how the organization has chosen to deal with nonconforming parts in an effort to prevent delivery to the customer, I think 8.3 is being met. It's those linked elements where the issues will start to crop up.
 

Jim Wynne

Staff member
Admin
#33
Does it make sense? No. But if this is how the organization has chosen to deal with nonconforming parts in an effort to prevent delivery to the customer, I think 8.3 is being met. It's those linked elements where the issues will start to crop up.
I think it's clear that "an effort to prevent delivery to the customer" has nothing to do with the strategy in question. It was clearly stated that the motive was to not call NC "NC" until final inspection or after bad parts reach the customer so as to delay or avoid doing CA.

Added in edit: This thread reminds me of the old story about the two guys who were eaten by a large amphibious reptile while arguing about whether it was an alligator or a crocodile.
 
Last edited:
G

Greg B

#34
I am in agreement there. 8.3 would be the guiding paragraph.
I feel the 8.2.2 would not apply at this time. The definition of nonconforming is the topic, which reflects, in my opinion, maybe the system is still being developed and/or implemented.
Whether or not something conforms, or is in "conformity" isn't dependent upon the stage of implementation. Something either conforms or it doesn't. The point I think chergh was making is that "conformity" has a specific, normative definition in the standard, and 8.2.2 says,
Redefining "nonconformance" (which is the same thing as "nonconformity") certainly raises rational questions regarding adherence to the clear intent of the standard in this regard.
What does 8.2.2 have to do with Non Conformance as discussed by the OP? 8.2.2 addresses NCs found by the AUDITOR during INTERNAL AUDITS. I must ask why people keep using the word 'Normative Reference'. There is no explanation or definition of what a Non Conformance IS but their are guide lines on what we have to do with them - in the standard. This is like those massive discussions we have on 'Preventative vs Corrective' an endless circle of standard references, dictionary quotes and interpretation. the OP should explain better what he actually wants us to do. Is he just getting something off his chest? Does he want us to pass on similar experiences of Management brutality relating to QA systems or does he want us to offer a solution to his problem?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#35
I must ask why people keep using the word 'Normative Reference'. There is no explanation or definition of what a Non Conformance IS but their are guide lines on what we have to do with them - in the standard.
I hope you will agree that ISO 9001 invokes ISO 9000 as a NORMATIVE REFERENCE. Because it does. If you agree that non conformance equates to nonconformity, then the definition of nonconformity in ISO 9000, and already posted, applies in the context of ISO 9001 implementation.
And to refer to ISO 9001 as a guideline is wrong. ISO 9001 contains requirements. The requirements contained therein require interpretations to be applied in the different contexts. But, unless the requirements can be excluded, due to the nature of the business, one can not pick and choose the requirements and still meaningfully declare compliant to the Standard.
 
G

Greg B

#36
I hope you will agree that ISO 9001 invokes ISO 9000 as a NORMATIVE REFERENCE. Because it does. If you agree that non conformance equates to nonconformity, then the definition of nonconformity in ISO 9000, and already posted, applies in the context of ISO 9001 implementation.
And to refer to ISO 9001 as a guideline is wrong. ISO 9001 contains requirements. The requirements contained therein require interpretations to be applied in the different contexts. But, unless the requirements can be excluded, due to the nature of the business, one can not pick and choose the requirements and still meaningfully declare compliant to the Standard.
Sidney, my point is that the definition does still NOT tell you what a Non conformance is. The company and its customers MUST work that out themselves. I DO posses copies of the standard and this does nothing to help anyone IMO.
As stated in ISO 9000:2000
3.6.1: CONFORMITY: Fulfillment of a requirement (3.1.2)
3.6.2: NON CONFORMITY: Non fulfillment of a requirement (3.1.2)
3.1.2: REQUIREMENT: need or expectation that is stated, generally implied or obligated

This is like saying DEAD: Not living or ALIVE: Not Dead. My point in my original reply to this thread is that the company MUST define what an NC is to THEM. They MUST document WHAT their REQUIREMENTS ARE!!! Did anyone actually read my original reply or was it once again glossed over by the international dateline:mad:

The OP MUST define what a NC is otherwise it defeats the purpose of having a procedure on what do do with them AFTER they have been discovered - be it in process or at final inspection. If the operators do not know what their internal parameters (3.2.1 requirements) are then they CANNOT put the procedure for remedial action in place!
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#37
Re: How is this Definition of Nonconformances?

The OP MUST define what a NC is otherwise it defeats the purpose of having a procedure on what do do with them AFTER they have been discovered
Greg, the OP questioned if the upper management definition of a NC as
Top management has told me that "in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station."
would fly.
You responded
If that statement works for YOUR company then USE IT! but I personaly don't agree with it.
I think many Covers and the poll results state that the suggested definition would not be accepted during an external audit, so most respondents, through their posts, tried to dissuade the OP from using it. So, the OP knows now that they have to find ANOTHER definition of NC. And, I hope whatever they come up with does not contradict "the non-fulfillment of a requirement" .
 
G

Greg B

#38
Re: How is this Definition of Nonconformances?

Actually Sidney, THIS is what I posted first up. I told them their response was lame and offered ours as an EXAMPLE. These are OUR REQUIREMENTS for a NC and an explanation on why we have them!!

If that statement works for YOUR company then USE IT! but I personaly don't agree with it. This is the definition that I use:

NON CONFORMANCE
"To meet our customers’ needs and expectations, 'Our companys' products must conform to agreed requirements that include chemical, physical and sizing specifications, as well as packaging and delivery specifications."

A NON CONFORMANCE is caused when:
  • Product does not meet Specifications,
  • Product/Packaging/Delivery/Qty etc does not meet the order, and/or,
  • A process is not adhered to as laid down in the Quality, Safety, Environment, Human Resources or Administration Systems.
This is word for word from our training package. We tell them why we need to avert a NC and what a NC is. We then go on to explain how we can prevent a NC

How can we prevent Non -Conformance & Contamination?
  • Be Vigilant,
  • Follow, Review and Update Work Instructions,
  • Check Documentation for errors,
  • Husbandry – Clean as you go,
  • Identify Change (Process),
  • Training,
  • If in Doubt ASK!
Finally we tell them what the ramifications can be:

What are the Ramifications of a Non Conformance &/Or Contamination?
  • Increased Costs,
  • Disgruntled Customers,
  • Loss of Sales/Revenue,
  • Discipline,
  • Rework, Rehandle, Retest, and
  • Investigate (CAR Raised).
The Original Post DID NOT DEFINE what an Non-Conformance IS. It just stated what to do with them once they were found. How can you detect them if you first don't state what constitutes a NC. This has been my point from the beginning and I really think too many people defend the standard and what it may require first rather than give an alternative or understand what the actual issue is. In his statement from Top Management he never tells us that "a non conformance is non conforming parts...." what is a NC and what constityutes NC parts. This MUST be established for the statement to work.
 
Last edited by a moderator:

Jim Wynne

Staff member
Admin
#39
Re: How is this Definition of Nonconformances?

The Original Post DID NOT DEFINE what an Non-Conformance IS. It just stated what to do with them once they were found. How can you detect them if you first don't state what constitutes a NC...This MUST be established for the statement to work.
Nowhere in any of this is there any suggestion that the OP's company was struggling with the definition of nonconformance. In fact the OP's management must have defined what it means, otherwise why would the question even be asked? Why would they be trying to weasel their way around the definition if they didn't know what the definition was?
 
G

Greg B

#40
Re: How is this Definition of Nonconformances?

I'm in a new job, and the ISO audit is coming up next month. I've got to get your input on this item, because it's very important to us ...

Top management has told me that "in our quality system we have defined nonconformances as nonconforming parts found at final inspection or the customer, that way we only have to track and provide corrective actions on nonconformances that are discovered at final inspection, not at the work station." There are a few boxes or racks of parts that are scrap or rework at the workstations, and those are just thrown out or reworked when the operator or supervisor gets to it. They aren't tagged, except when an auditor is around ...

So, I created a poll to get your educated opinons :) Tell me what you think.

Thanks.
Nowhere in any of this is there any suggestion that the OP's company was struggling with the definition of nonconformance.
Jim (and others), The TITLE of the post is "How is this DEFINITION of NONCONFORMACE?" and his opening line is "Top management has told me that in our quality system we have defined nonconformances as..."
This is NOT a definition of a what constitutes a NC!!!! The company IS "struggling " to define what a Non Conformance IS!

In fact the OP's management must have defined what it means, otherwise why would the question even be asked? Why would they be trying to weasel their way around the definition if they didn't know what the definition was?
In 'FACT' This IS their 'definition' (as stated in the title) and I am saying it isn't good enough AS a definition. This is what they do AFTER they find a NC! They are not trying to 'weasel' around the definition. They are trying to 'weasel' around the fact that they have in process issues that they do not want to deal with until final inspection. if they want to do it this way then that is their prerogative but I was offering a solution to the term 'DEFINITION' not their procedure for dealing with NCs
 
Thread starter Similar threads Forum Replies Date
N Nadcap AC7101/2 Rev. E Section 3.2 - Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
C NCR (Nonconformance System) Software Nonconformance and Corrective Action 7
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
E When to generate a nonconformance report ISO 13485:2016 - Medical Device Quality Management Systems 6
K Counterfeit parts prevention - Audit Nonconformance - AS9100 8.2.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
qualprod When to write up a nonconformance and require a NCR - We produce labels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
PhilM Nonconformance report, Customer complaint investigations and RMAs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
CPhelan Nonconformance opened as incorrect expiration date placed on received product. Escalate to CAPA? Nonconformance and Corrective Action 4
qualprod Ineffective follow up of people performance - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q AS9120 7.5.3.2 Control of Documented Information - Audit Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
qualprod Criteria to raise a Nonconformance based on KPI values ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 39
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Timing allowed by IATF to close a Remote Site Minor Nonconformance IATF 16949 - Automotive Quality Systems Standard 2
R Visually impacting graphics for Nonconformance status metrics for Management Report Nonconformance and Corrective Action 5
J ISO 13485 Audit Nonconformance written against 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 25
PastorBee13 IATF 16949 Audit Nonconformance Responses per 5.1.1.2 - Format IATF 16949 - Automotive Quality Systems Standard 11
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
S Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness ISO 13485:2016 - Medical Device Quality Management Systems 13
A API Spec Q1 9th Edition - 12 month Internal Audit Schedule Audit Nonconformance Oil and Gas Industry Standards and Regulations 10
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
R ISO 9001:2015 9.3 - Required inputs to the management review - Audit Nonconformance Manufacturing and Related Processes 14
K Which clause would best fit this Nonconformance? (Supplier Related) Internal Auditing 2
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12
J IATF 16949 registration - Major Nonconformance Finding IATF 16949 - Automotive Quality Systems Standard 9
Ajit Basrur Are inputs to the nonconformance process required to be identified? Nonconformance and Corrective Action 21
N Responding to NADCAP nonconformance - Control of External Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Examples of Nonconformance, Corrective Action Requests, and Root Cause Analysis Nonconformance and Corrective Action 2
qualprod Should I initiate CAPA for a nonconformance not recorded? Nonconformance and Corrective Action 25
K Nonconformance on training - Not following own processes (IATF 16949) Internal Auditing 14
J Audit opportunity for improvement raised to nonconformance months after the audit General Auditing Discussions 7
GStough Pushback on a Nonconformance Found in a Supplier Audit General Auditing Discussions 22
K NCR or CA? We're taking any issue we have and saying its a nonconformance Nonconformance and Corrective Action 11
GStough Nonconformance Found Outside the Audit Scope - Supplier Audit General Auditing Discussions 16
R Closing out an API/ISO QMS Audit Nonconformance - Magnetic Particle Examination Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Q Nonconformance Raw Material Treatment in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Recurring Nonconformance - Missing Deadline for Closing a Corrective Action Problem Solving, Root Cause Fault and Failure Analysis 14
N Laboratory Audit Nonconformance - Maintenance of Standards ISO 17025 related Discussions 10
K Internal Auditing a previous Nonconformance? Internal Auditing 19
D Interpretation of new IAQG ruling - Audit duration for nonconformance verification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Q Customer Complaint Vs. Nonconformance - CAPA SYSTEM Customer Complaints 2
D Nonconformance on document control - Unapproved document on production server Document Control Systems, Procedures, Forms and Templates 4
P Ratio of Supplier with a nonconformance vs. Supplier without a nonconfomance Supplier Quality Assurance and other Supplier Issues 10
W Nonconformance Recurrence Response Help General Auditing Discussions 4
dubrizo If Quality Objectives are not known to employees, is it a Nonconformance? General Auditing Discussions 7
xfngrs Automotive Industry Nonconformance Database wanted - Preferably SharePoint based Quality Assurance and Compliance Software Tools and Solutions 5
Gman2 Processes sharing the same nonconformance during an audit General Auditing Discussions 13
T Audit Nonconformance - ISO 9001:2008 Clause 6.2.2 - Competencies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20

Similar threads

Top Bottom