Are inputs to the nonconformance process required to be identified?

jmech

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#11
How will explicitly identifying the inputs (presumably in the quality manual or NCR procedure, or the beloved turtle diagram) improve the effectiveness of the QMS?
If anything, this creates a new potential finding on the next audit for not following the company's written requirements, either for not using all identified inputs on an NCR (because some weren't necessary for this NCR) or for using a non-identified input.
I don't see the value in this and I don't think offering it as a suggestion or writing it as an opportunity for improvement is helpful to anyone.
 
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Marc

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#12
How will explicitly identifying the inputs (presumably in the quality manual or NCR procedure, or the beloved turtle diagram) improve the effectiveness of the QMS?
If anything, this creates a new potential finding on the next audit for not following the company's written requirements, either for not using all identified inputs on an NCR (because some weren't necessary for this NCR) or for using a non-identified input.
I don't see the value in this and I don't think offering it as a suggestion or writing it as an opportunity for improvement is helpful to anyone.
I disagree with you.

Identifying inputs to a system, in this case the nonconformance system, is a way of defining responsibilities/requirements for actions/inputs. Improvement comes from defining responsibilities/requirements/inputs assuming inputs, or few inputs, were initially defined. With few or no responsibilities/required inputs defined, theoretically the nonconformance system would be of little or no value.

As to "...not following the company's written requirements...", how could an audit finding be a problem? If employees are not following requirements/procedures there is no control. Not to mention, what value is a requirement/procedure if employees do not follow requirements/procedures? Are you suggesting that to reduce audit findings a company should reduce or eliminate requirements?
 

jmech

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#13
I disagree with you.

Identifying inputs to a system, in this case the nonconformance system, is a way of defining responsibilities/requirements for actions/inputs. Improvement comes from defining responsibilities/requirements/inputs assuming inputs, or few inputs, were initially defined. With few or no responsibilities/required inputs defined, theoretically the nonconformance system would be of little or no value.

As to "...not following the company's written requirements...", how could an audit finding be a problem? If employees are not following requirements/procedures there is no control. Not to mention, what value is a requirement/procedure if employees do not follow requirements/procedures? Are you suggesting that to reduce audit findings a company should reduce or eliminate requirements?
Let's try to work out our disagreement.

The nonconformance process is part of the quality system. Inputs do not equal responsibilities/requirements and identifying inputs does not necessarily identify any responsibilities/requirements. Identifying responsibilities (such as, "the employee who finds the nonconformity is responsible to report it to his/her supervisor or QA manager", "the supervisor or QA manager is responsible to investigate any nonconformance which has been reported to him/her", etc.) is of value.

There is one essential input to the nonconformance process: the (perceived) nonconformance itself (such as, "out of tolerance dimension on part"). I do not see value in writing this in the QMS, as it seems very obvious and not helpful, but perhaps this is not obvious to some people and would help them. Aside from the nonconformance itself, what other inputs would you suggest for the nonconformance process?

I fully agree that employees should follow requirements/procedures. I am suggesting that a company should not write requirements into their QMS if these requirements do not add value to their QMS and are not required by the standard to which they will be audited.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
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#14
I said "...Identifying inputs to a system, in this case the nonconformance system, is a way of defining responsibilities/requirements for actions/inputs...".

I did not say "...Inputs equal responsibilities/requirements...".

In addition, identifying inputs does necessarily define/identify responsibilities/requirements for each input.

Procedures, etc., define responsibilities and requirements for inputs and what those inputs are. The more a company defines what inputs are required, and who is responsible for those inputs, the more control they have.

"...a company should not write requirements into their QMS if these requirements do not add value to their QMS and are not required by the standard to which they will be audited...." is pretty much a general no-brainer statement which holds true even when a company does not limit the applicability to the QMS. A company is much more than its QMS. Better said "...a company should not write requirements which do not add value to their company and/or are not required by an applicable standard...".
 

jmech

Trusted Information Resource
#15
Consider the following statement: "An input to the nonconformance process is the nonconformance itself."

The above statement identifies an input without defining/identifying responsibilities/requirements for the input, so I don't understand how "identifying inputs does necessarily define/identify responsibilities/requirements for each input."

Aside from the nonconformance itself, what other inputs would you suggest for the nonconformance process?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#16
You have to define what, specifically, is a nonconformance to begin with. If you do NOT define what nonconformances are, with specificity, then nothing is nonconforming so there will be no inputs.
 

jmech

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#17
A nonconformance is a non-fulfilment of a requirement. This is the ISO 9000 definition of a nonconformity (= nonconformance). It also matches common understanding of what a nonconformance is. For example, if a part does not fulfill one of the dimensional requirements for the part, this is a nonconformance.

Aside from the nonconformance itself, what other inputs would you suggest for the nonconformance process?
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#18
Good day @ ajit basrur;
As has already been mentioned, the short answer is "no". There is no requirement in the standard specific to your question. However, as in all cases, organizations should first and foremost create a management system that benefits you and your organization. For control of non-conforming product (such a critical process) I prefer to establish the "rule" (procedure) via a flow diagram that identifies potential inputs, decision points, and the required reactions. It is a simple, visual, comprehensive, "one pager" which can easily guide the team using the process.
Hope this helps.
Be well.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#19
A nonconformance is a non-fulfilment of a requirement. <snip>
Precisely. And as I said, requirement(s) have to be defined, with specificity, somewhere in an organizations documentation (which could include customer requirements, product parameters such as dimensions, colour, surface finish, requirements in applicable regulations, etc.) or other places (e.g.: blueprints or local, regional, federal, national or international regulations).

And if you take ISO 9001 alone, as general as it is, the standard its self is nothing more than a list of requirements, and this is probably why you're thinking as you are, the absence (or failure) of which in a company in a compliance to the standard audit results in a nonconformance input. And while ISO 9001 does not state who is responsible for a specific clause in the standard (and typically is a number of different people in various positions).

E.g.: You have a print with a dimension of x inches =/- .01 inch - That requirement defines what is nonconforming (which is a measurement outside of that range).

As I have been saying, you have to define what, specifically, is a nonconformance to begin with. You do this using all the various requirements, regulations, etc. None the less, all the requirements have to be defined, and they define what can be inputs to the nonconformance system.

There is one essential input to the nonconformance process: the (perceived) nonconformance itself (such as, "out of tolerance dimension on part"). I do not see value in writing this in the QMS, as it seems very obvious and not helpful
Well, it's not "one essential input" - Again that is a general statement - there can be hundreds of requirements. Even if a company does (for example) state somewhere that not meeting a requirement requires a nonconformance to be input, it's only one sentence.

In some ways we're saying the same thing. I just see more nuance than you have been expressing - probably because I see a nonconformance system to be a very broad system which is not confined, for example, to products.

Another way to get where I'm coming from: You make a part. You define requirements on a print. By doing that you are defining what will be inputs to the nonconformance system (anything which doesn't meet the requirement(s)). Let's say you define 100 dimensions on a print. That's 100 different potential inputs (each is a specific requirement) to the nonconformance system.
 

jmech

Trusted Information Resource
#20
I also think we mostly agree.

I agree that companies need to define requirements and that there will be many requirements, often of many different types. Defining responsibilities for meeting requirements and/or verifying that requirements have been met is a good idea. Non-fulfilment of any requirement is, by definition, a non-conformance.

I am considering a nonconformance process within the quality management system, whereas you are referring to a nonconformance system. I do consider the process to be applicable to all types of nonconformances (including non-fulfilment of procedures or regulations); I just chose the part example because it is simple.

I do not see all requirements as inputs to the nonconformance process; rather, I see only non-fulfilled requirements as inputs to the nonconformance process. Put another way, all requirements have the potential for non-fulfilment, and thus are potential inputs to the nonconformance process; the actual inputs are the non-fulfilled requirements.

My reasoning for viewing only non-fulfilled requirements as inputs is that the nonconformance process gets initiated when a non-fulfilled requirement is discovered. When an employee notices a non-fulfilled requirement, the nonconformance process should be initiated, with the (perceived) nonconformance as the only required input. If no employee notices a non-fulfilled requirement, the nonconformance process does not get initiated; therefore, the non-fulfilled requirement is the essential input to the nonconformance process.
 
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