AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work.

[lorenambrose]

I am looking for a bit of help with the required procedure for controlling nonconformances as defined in section 8.7 fo the AS9100 standard.

Our organization if fairly unique in that we outsource almost ALL of chapter 8.

1. We outsource the vast majority of Design & Development
2. We outsource ALL of Manufacturing (purchasing of raw materials, production, testing, final acceptance, packaging, etc...)
3. We outsource logistics (inventory control, stocking, order aggregation and fulfillment, shipping)
4. We outsource sales and customer account management.

Each of the above is a SEPARATE external supplier. In essence, we operate like a giant Program Management Office.

So as you can see We do not deal with product in-house. Section 8.7 only deals with PRODUCT and the control of identified nonconformances. How could I capture this in the required procedure?

Would it be acceptable to include the requirements for control of nonconformances in our Supplier Quality Assurance Requirements Manual?

 

[Eredhel]

Do you inspect any of the purchased parts you sell?

 

[lorenambrose]

They never come to us. They go directly from the PMA manufacturer to our logistics provider who would be responsible for inspection.

 

[John Predmore]

You said section 8.7 only applies to PRODUCT. AS9100D says [emphasis mine]
"8.7 Control of Nonconforming Outputs
8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.
NOTE: The term “nonconforming outputs” includes nonconforming product or service generated internally, received from an external provider, or identified by a customer."

If there was any doubt, section 8.4.1 requires
"The organization shall determine the controls to be applied to externally provided processes, products, and services when: ...
b. products and services are provided directly to the customer(s) by external providers on behalf of the organization; "

Annex A section A.2 further explains outputs is products and services.

 

[lorenambrose]

So my point is since we do not manufacture, process or deliver our product or the service it uses directly, what is the best method to comply? We contract almost all of chapter 8.0.

In this case, would it be appropriate to cover the requirements for nonconforming outputs via our Supplier Quality Requirements Manual? There seems to be no need for an internal documented process for how we (the internal employees) will handle this issue. We will not be doing anything accept flowing down requirements and auditing to those requirements. This can be included in the Quality Assurance Manual.

I do understand that my process for controlling external providers will need to be MUCH more robust than what is typical as our compliance to AS9100D requirements in chapter 8.0 will be completely dependant on the compliance of my supply chain.

 

[Eredhel]

Are you AS9100D certified or just trying to be compliant? What would you do if one of the products you broker was found to be non conforming after delivery to your customer?

 

[lorenambrose]

We are trying to become compliant then certified. I have many years under AS9100C but this is my first D certification process.

We are not brokers. These are our products. We outsource most customer service but handle warranty processing in house. We just outsource the actual repair activity.

Post delivery nonconformance is a quality system breakdown and is addressed in section 10.2. Section 8.7 does not apply to these types of nonconformances. I wish they would use different terminology in both sections.

I still believe this section is ONLY addressing things like receiving inspection nonconformances, in-processes manufacturing nonconformances, Material Review Board, etc... This section used to be Control of Nonconforming Product. They seemed to have changed the name but not any of the content. Using "outputs" was an attempt to include the idea of "services" in my opinion.

Still........................... Does anyone think since I will not be performing ANY of these activities by ANY of my company's employees that we could address these requirements in a Supplier Quality Assurance Requirement Manual instead of a stand-alone internal procedure?

 

[Sidney Vianna]

I still believe this section is ONLY addressing things like receiving inspection nonconformances, in-processes manufacturing nonconformances, Material Review Board, etc... This section used to be Control of Nonconforming Product. They seemed to have changed the name but not any of the content. Using "outputs" was an attempt to include the idea of "services" in my opinion. ?

I think you are mistaken. Outputs is much broader. For example, you say sales is outsourced. What if, the output of the sales process is incorrect, such as quantity, configuration of the part, delivery dates, etc...? A nonconforming sales order is a nonconforming output.

Your situation is very complex and I doubt you will get the breath and depth of the assistance you need, for free, here. But I wish you good luck.

 

[Eredhel]

Whether you put things in a quality manual or a stand alone procedure is up to your organization, the standard doesn't get that specific. But I also don't think not doing an activity will help you fulfill the requirements of the standard. I'll second Sidney about the intricacies of what you're trying to do.

 

[Big Jim]

You might already be doing what you need, or most of it. Yes, you need a written procedure for 8.7 "The organization's nonconformity control process shall be maintained as documented information . . . " It goes on and specifies some of the topics that need to be covered in the procedure.

As you have clearly pointed out, you outsource most if not all of that. Outsourcing falls under purchasing in element 8.4 where it provides details about those controls. You cannot simply outsource and not maintain control. 8.4.2a "The organization shall . . . ensure that externally provided processes remain within the control of its quality management system . . . "

If you have a written procedure for purchasing is should include how you control everything you outsource, and if you do it may already cover what is needed for 8.7 or you could craft it so it does. 8.7 calls for a written procedure, but it doesn't say it needs to stand by itself. It could be included with other written procedures. This was clearer in AS9100C, but 9100D doesn't say you can't.

If your current documentation for purchasing doesn't cover how you handle junk a vendor creates then you likely don't have adequate control. I'll bet you do though. I'll bet that you get reports about the problems and that you review them in some fashion.