Questions About Exclusions in ISO 9001 - Clause 7.5 Production and Service provision

Here's one I haven't run across before. In 7.5, Production and Service provision, does a company specifically have to state that it excludes "service", if the management team says that they do not service the product they sell? They typically replace it, but will occasionally repair it. The repair is done at the manufacturing site. There is a document that defines the repair activity.

Other one -- what are your thoughts about a company excluding 7.5.2, process validation? I know the traditional processes that fall under this clause -- like soldering, welding, etc. Do you think painting metals and plastics are "special" processes? I guess I am a proponent of process validation because it makes good engineering sense. Other thoughts?

--QG

Hi,

We have to differentiate the words "servicing" and "service". Servicing as in the 1994 standard clause 4.19 is not the same as what is covered in 7.5.1. The only link is in 7.5.1 f) for post delivery activities. I believe that this element should not be excluded since this clause includes all the services that you may provide, such as design, repair, etc...

With regards to process validation, soldering or painting should be validated if it has to be performed to specific requirements. If you are painting and it is just for aesthetic purposes, validation does not apply.


Danny K

You cna only exclude 7.3 in TS16949.

Bob Ablond1

qualitygoddess said:

Other one -- what are your thoughts about a company excluding 7.5.2, process validation? I know the traditional processes that fall under this clause -- like soldering, welding, etc. Do you think painting metals and plastics are "special" processes? I guess I am a proponent of process validation because it makes good engineering sense. Other thoughts?

--QG

Click to expand...

We have recently discussed this issue here
http://elsmar.com/Forums/showthread.php?t=11268 and the general comnclusion is yes, you can exclude and there are companies that have.

qualitygoddess said:

Here's one I haven't run across before. In 7.5, Production and Service provision, does a company specifically have to state that it excludes "service", if the management team says that they do not service the product they sell? They typically replace it, but will occasionally repair it. The repair is done at the manufacturing site. There is a document that defines the repair activity.

Click to expand...

We make a specific statement to the effect that we exclude the "service" aspect of 7.5 and that doing so does not adverserly impact our ability to meet the needs of our Customers. The concepts of replacing it or fixing it are dealt with under Customer satisfaction and nonconforming product (for us).

qualitygoddess said:

Other one -- what are your thoughts about a company excluding 7.5.2, process validation? I know the traditional processes that fall under this clause -- like soldering, welding, etc. Do you think painting metals and plastics are "special" processes? I guess I am a proponent of process validation because it makes good engineering sense. Other thoughts?

Click to expand...

As was already said, if the painting process is for looks only, I'm not sure how validation comes into play - unless colour matching is vital. But for some organizations (e.g., I used to work for a manufacturer of city transit buses), the painting process includes verifying/validating the thickness of the paintcoat.

Exclusion of Servicing

Our scope of "Processing of orders for new equipment" was approved by our registrar. However, the auditor says we have to include the service side of our business, which we planned to add to our scope next year, because we do service after the sale. So here I am wondering why the registrar approved the scope, knowing about our plans for the future. Any ideas? Oh yeah our audits are this week!

Re: Exclusion of Servicing

MarilynJ6354 said:

Our scope of "Processing of orders for new equipment" was approved by our registrar. However, the auditor says we have to include the service side of our business, which we planned to add to our scope next year, because we do service after the sale. So here I am wondering why the registrar approved the scope, knowing about our plans for the future. Any ideas? Oh yeah our audits are this week!

Click to expand...

In ISO 9001, you do not have to include all aspects of your business. There can be certain types that can be excluded, but it must be clear in the scope. IE: we certify the manufacturing business, but not the distribution division.

In TS, this is not an option, unless the excluded divisions are non-automotive.

Re: Questions About Exclusions in ISO 9001 - Clause 7.5 Production and Service provis

Forgive me if I have missed the thread that deals with excluding "Service Provision" from 7.5. I have spent a couple of hours reading through the various threads that touch on the 7.5 requirements, and exclusions, but I have not found an answer to what I am looking for from the Cove.

Situation: I have been with this company for more than 2 years. I helped the company through the Revision C Changes to AS9100. During my last surveillance audit from the registrar, it was brought to my attention that the exclusions in the Quality System Manual [QSM] are not the same as those on the Certificates [ISO:9001 & AS9100]. I went along with the recommendations from the Registrar Auditor, but when the new certificates arrived - I re-read the QSM Scope along with the Exclusions on the Certificates and I still felt that they did not jive. So, the Registrar called to talk with me about my observations and he presented a concept that I am not sure if I should follow or not.

Questionable Concept: Just because you are a contract manufacturer you are not to make a general exclusion to "Service Provision". That supposedly it is understood by your scope statement of being a "contract manufacturer". The Registrar caller stated that I must be thinking pre-2000 version of ISO 9001 where service was thought to be a post delivery activity.

Now what I have stated is not necessarily word for word, thus no quotation marks, but I believe it does represent the concept that I want confirmed by my knowledgable friends here at the Cove. I went back to the obsolete 2008 revision of the company's QSM and it made a general exclusion to "Service Provision" in 7.5. So do I go with the guidance from my registrar or keep the general exclusion to "Service Provision" in 7.5. In the QSM "Service Provision" is absent in the Main Clauses of 7.5, 7.5.1, and 7.5.2.

Thanks for Your Feedback!
Doug

Re: Questions About Exclusions in ISO 9001 - Clause 7.5 Production and Service provis

Hi Doug...
Your registrar is so correct.

exclusions in the Quality System Manual [QSM] are not the same as those on the Certificates [ISO:9001 & AS9100].

Click to expand...

Perfectly said

Just because you are a contract manufacturer you are not to make a general exclusion to "Service Provision". That supposedly it is understood by your scope statement of being a "contract manufacturer".

Click to expand...

Perfectly said
The product realization consists of Products that you can touch and feel as well as services which are considered products. So in the providing of products (Goods or services) controls required, Validations required are very much necessary.
The after sales service of any goods is an other process, that you may or may not have in your scope.

Re: Questions About Exclusions in ISO 9001 - Clause 7.5 Production and Service provis

You may find some help from the IAQG Clarifications on AS9100C.

http://www.sae.org/iaqg/projects/9100clarify2009.pdf

7.5.1.4 Question
If a company does not provide service to products
after the part is delivered to a customer, can they
take exclusion to clause 7.5.1.4?

Response
Delivery Support, is applicable when servicing of your product is performed
after initial delivery. The location of the service is irrelevant no matter whether the servicing is taking place at your facility or in the field.
If an organization provides any post delivery support activities (such as
warranty work), clause 7.5.1.4 cannot be excluded in its entirety. At a minimum, 7.5.1.4b would be applicable. Product that is found to be
nonconforming after delivery to the customer require actions to be taken, including investigation and reporting; therefore 7.5.1.4b is applicable. The organization may utilize the Clause 8.3 d and e, Control of Nonconformiing Product process and Clause 8.5.2, Corrective Action process as the method for implementing Clause 7.5.1.4b; however Clause 7.5.1.4b would not be excluded.


There is also guidance from TC-176 on the related ISO 9001:2008 7.5.1 that may have some bearing on this thread:

http://www.iso.org/iso/01_guidance_on_iso_9001_2008_sub-clause_1.2_application.pdf

Near the end of Example 7 we find:

Note also that subclause 7.5.1 only requires control of post-delivery activities
?as applicable?, making a formal exclusion unnecessary.