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Determining if Maintenance Contractor is an External Service subject to ISO 9001 Clause 8.4

#31
….Is the maintenance contractor company considered an external provider subject to clause 8.4?
He was VERY CLEAR in his question. I think it is incumbent on people engaging on the thread to understand the question and provide feedback accordingly.
To the OP: As per 8.4, if you want to exclude them, you could justify it.

The way I understand the standard, it's up to the organization and it's context if you want to consider an external provider subject to clause 8.4.

To Sidney, I hope I am VERY CLEAR in my new response!

:)
 

Sidney Vianna

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#32
The way I understand the standard, it's up to the organization and it's context if you want to consider an external provider subject to clause 8.4.
It is the other way around. Any external source that provides product, processes and services that DIRECTLY affect the product conformity HAVE TO BE subjected to the requirements of 8.4. That's the minimum requirement.

Other providers that DON'T HAVE to be subjected to 8.4 can be, at the discretion of the organization.
 

tony s

Information Seeker
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#34
is the maintenance contractor company considered an external provider subject to clause 8.4?
What's in 8.4 that we deemed not applicable to control the maintenance contractor to "ensure that externally provided processes, products and services conform to requirements."?
 

tony s

Information Seeker
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#35
control the municipality that provides them with roads to deliver products, the Internet Service Provider, etc...As I said, the slippery slope can get ludicrous. FAST.
I don't think organizations will get as ludicrous as we think of them. If I control my production equipment maintenance contractor as per 8.4, would you expect me to do the same with local/national government? I don't think so.

Going back to the OP's concern about their maintenance contractor. My question is: What's in 8.4 that we deemed not applicable to the maintenance contractor to "ensure that externally provided processes, products and services conform to requirements"? The reason we debate of subjecting or not subjecting the maintenance contractor to 8.4.
 

Sidney Vianna

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#36
Please make the case to demonstrate that maintenance services
Going back to the OP's concern about their maintenance contractor. My question is: What's in 8.4 that we deemed not applicable to the maintenance contractor to "ensure that externally provided processes, products and services conform to requirements"? The reason we debate of subjecting or not subjecting the maintenance contractor to 8.4.
It is a philosophical debate. If you believe that the maintenance contractor needs to be subjected to the requirements of 8.4, so should the manufacturers of the production equipment an organization purchases in order to make their products. And then, the producers/distributors of the grease, lubrication oil and coolants used in production machinery. And then you can also subject Amazon Business to the controls of 8.4, because the organization buys spares from Amazon Business. And then......slippery slope warning....:blowup:

In my view, the services performed by an outside maintenance contractor do not DIRECTLY affect product conformity and customer satisfaction, in most typical cases. Obviously, a louzy maintenance job can impact a machine uptime, can lead to more frequent out of control runs, etc...but, and again, in most typical manufacturing contexts, their services do not directly impact product quality and delivery performance. I have never seen a customer imposing specific maintenance service specifications towards suppliers as this would typically be a significant micromanagement approach of suppliers.

You offered the example of a golf course and the importance of a properly qualified lawn mower provider. That's a good example of the importance of context assessment.

On this thread, I am focusing on the typical chemical processing plant, the context of the OP. In other scenarios, the assessment could lead to another conclusion.
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#37
Another question - "Could a customer complaint somehow be tied to the performance of this supplier?"
 
#38
Another question - "Could a customer complaint somehow be tied to the performance of this supplier?"
Yes. this case is very common.
When the monitoring of suppliers is performed, input data is its performance (OTD, rejects, support) and additionally if a customer complaint is in some way related to the supplier, is also considered "tied".
Is this what you mean?
 

tony s

Information Seeker
Trusted
#39
And then, the producers/distributors of the grease, lubrication oil and coolants used in production machinery. And then you can also subject Amazon Business to the controls of 8.4, because the organization buys spares from Amazon Business. And then......slippery slope warning....:blowup:
Organizations, I believe, have the ability to discern whether they are going to slip in such slippery slope. I will never recommend to subject Amazon to 8.4. There's no value in it. But maintenance service provider of production equipment, in my view, should be controlled. Provision of maintenance services to an organization's production equipment is not a one-time engagement and, usually, build long-term relationship for both parties. One way of ensuring the contractor deserves that relationship is through monitoring of their performance (an 8.4 control). If an organization need to look for another contractor, they need to subject the prospective contractor to their selection/evaluation process (again another 8.4 control).

You mentioned:
Obviously, a louzy maintenance job can impact a machine uptime, can lead to more frequent out of control runs, etc...but, and again, in most typical manufacturing contexts, their services do not directly impact product quality and delivery performance.
This is your view, but can be viewed differently by others. Others might have experiences of lousy maintenance job that resulted to quality and delivery problems. So, it pays to subject maintenance contractors to controls. Obviously, they will do this because organizations need to "ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers" (8.4.2). Why would an organization deem 8.4 is not applicable to maintenance services provider for production equipment when they are already fulfilling it.
 

Sidney Vianna

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#40
I am trying to understand the logic. If you want to make a case that the maintenance provider of a lathe has to be subjected to 8.4, then YOU MUST mandate that the manufacturer of the lather is also subject to 8.4. Your logic DEMANDS that view, because the lathe is an "externally provided product" that can adversely affect the organization's ability to consistently deliver conforming product. Otherwise, there is no logic. You just devised a totally arbitrary line, to include maintenance providers, but not the manufacturer of the equipment that will be maintained, which, there is nothing wrong with it, but NOT SUPPORTED by 8.4, in my assessment.

The maintenance service of production equipment does not even 'touch" the intended product, so, I do not agree with your assessment that it falls under "ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers" .

A coating service, such as anodizing, for example, etc... TOUCHES THE PRODUCT, and directly affects product conformity. Not the same with a maintenance service.

So, just to be clear: there is nothing wrong in having your (production equipment) maintenance service providers subjected to 8.4, but in my assessment, it is not a requirement of ISO 9001, for the typical manufacturing organization.
 
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