Inspection Reports Required? Records are kept in a different country

[Sam4Quality]

Originally Posted by jkuil

Sam,

The idea is that the 'manufacturer' is the legal entity who puts the product on the market under his name irrespective if he performs the manufacturing himself or outsources it. If he outsources it, he remains responsible for the manufacturing process and must define the method and extend the monitoring and control of the outsourced process in its Quality Manual.

Just to clarify, my first statement in my previous post here, was not in reply to your comments. It was for the OP's query itself. The interesting part was the OP's query itself and the way he's put it, needs more clarification.

I totally agree with you here regarding a manufacturer's responsibility for the manufacture of a product, irrespective of whether he does it in-house or outsources it. However, the current known fact is the OP's company is designing and releasing the product in the market. Its unclear whether its outsourcing the production to the Chinese company, as a manufacturing company.

Also, based on Hari's previous post...

Originally Posted by harinandu2003

......For production we are depending on this company in China. They are not a part of us and I belive fall under the Subcontractor category.

Does this make Hari's company a manufacturing company, subcontracting only the production part?

Let the OP step in.

Ciao.

__________________________
Sincerely, SAM
"To achieve the impossible, it is precisely the unthinkable that must be thought!"

 

[harinandu2003]

Hello Sam,

The Product is designed by us, and the chinese company is just a contract manufacturer for us, they will make the products based on the manufacturing and assembly instructions, test plans sent by us and will ship the products to the destination as requried by us. The final product will have no identification of the subcontracting company and all the labels will bear our name being the ODM.

So now I feel that the manufacturing ofcourse should be part of our scope and cannot be excluded. But my greatest concern is that the chinese company has translated the inspection reports to Chinese.inspection reports to Chinese and they are keeping it. I found it unlogical to have them send all the inspection reports to us ( in thousands) back to us and keeping it here. Our Engineers are always witnessing the production. But still, I am not sure how will I substantiate the Clause (8.2.4) to the Auditor ( Evidence of conformity with the acceptance criteria shall be maintained).

Thanks,
Harish

 

[harry]

But still, I am not sure how will I substantiate the Clause (8.2.4) to the Auditor ( Evidence of conformity with the acceptance criteria shall be maintained).

1. Lets forget about whether manufacturing should be included in your scope or not first.

2. If you are doing design only or your scope covers design only, you are providing a service and clause 8 is also applicable in the service environment.

3. Per Cl 8.2.4, you will need to ensure that all the monitoring and measurement are conducted at significant stages of service realization (design) process.

4. Evidence of conformity with the acceptance criteria - Aren't the design input/output, verification and validation evidence of these?

 

[harinandu2003]

Harry,

Design and Development verification and validation records are being kept, but not the Production inspection reports. I would have agreed with you if were responsible for design only and were just like a design service provider, but we are an Original Equipment Manufacturer for the complete product ranging from Hardware , Embedded Software, Application Software etc, we are integrating these diverse designs to finally deliver the solution. I understand that production just being one among them cannot be excluded from our scope and we are ultimately responsible for product quality, we will answerable to quality for any issues.

So there is no question that Production is not under our scope and it has to be in our scope. But should we keep the entire inspection reports for the units being manufactured for us, in our office location and whether keeping those at the outsourced facility would suffice is my question?, I can bring some samples of the test reports but bringing thousands of them and keeping it here doesn;t seem to be practical.

We have defined in our Product Quality Plan the processes/ test stages which have to be done by the Subcontractor.But the thing I am not sure about is whether the compliance records should be kept at our facility or not?

 

[Sam4Quality]

Originally Posted by harinandu2003

Harry,

Design and Development verification and validation records are being kept, but not the Production inspection reports. I would have agreed with you if were responsible for design only and were just like a design service provider, but we are an Original Equipment Manufacturer for the complete product ranging from Hardware , Embedded Software, Application Software etc, we are integrating these diverse designs to finally deliver the solution. I understand that production just being one among them cannot be excluded from our scope and we are ultimately responsible for product quality, we will answerable to quality for any issues.

So there is no question that Production is not under our scope and it has to be in our scope. But should we keep the entire inspection reports for the units being manufactured for us, in our office location and whether keeping those at the outsourced facility would suffice is my question?, I can bring some samples of the test reports but bringing thousands of them and keeping it here doesn;t seem to be practical.

We have defined in our Product Quality Plan the processes/ test stages which have to be done by the Subcontractor.But the thing I am not sure about is whether the compliance records should be kept at our facility or not?

So, now its clear that you ARE an OEM, having subcontracted/outsourced your production to the Chinese company, with YOUR specifications, YOUR product quality plan. Hence, this makes you completely responsible for the quality of the product. And this definitely makes you responsible for the production process at the Chiness facility.

Now, coming to your original query! While you do agree to take complete responsibility of your manufactured product (which you should!), including the production part of it, and would like to maintain inspection records to provide evidence of conformity to requirements, this however has nothing to do with an auditor auditing your organization, strictly from the Audit point of view.
Why?

Because, the auditor will only audit the SCOPE. And currently your scope is 'Design of Wireless Products', for which you are maintaining all relevant records in line with the standards requirements including Clause 8.2.4. The auditor has NO RIGHT to go any further trying to audit your production process. No question of that!

Agreed that you should include production within your scope (and I believe the auditor may suggest you this) in order to gain adequate control over your processes, and ensure sustained product/service quality. I also agree that there should be some methodology to maintain inspection reports of the products being manufactured (not neccesarily bringing down all the hard copies of the reports!). As in the rare event that your product, which is already in the market, has a defect, the root cause can be traced down to the inspection reports for the product.

But, currently based on your scope, you do not have to worry about the audit as Ted, Harry, jkuil and I have mentioned, unless ofcourse there are other issues related to the QMS.

I hope this has helped you and your organization rethink your responsibilities towards your product, and take appropriate measures accordingly.


Ciao.

Note: I realized from Harish's first post that they are going for ISO 9001 certification.

 

[harry]

The current scope of our QMS is Design of Wireless Electronic Products. We are planning to introduce Industrial Automation design also into our scope.But we are not planning for Production to be in the scope for the time being.

This is what you posted in post #3. Assuming you can change as you like it and include manufacturing in your scope, then manufacturing becomes an 'out-sourced process'. The controls can be as simple as an initial requirement such as ISO 9001 certified plus incoming goods inspection to more complex requirements depending on risk involved. We don't know about that, only you do and you need to make that decision and justify it.

Two recent threads on the same subject are informative and should give you the answers:

How Can We Show Control Over Outsourced Processes?

Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 DIS

 

[Big Jim]

Back to the original question.

No, you do not need to keep the inspection records of your Chinese supplier. If they are ISO certified then they will need to do so for themselves to satisfy their auditor.

What you do need, though, is an explanation of how you control your supplier and the products they produce for you and records showing that you have control of them and those products.

It could be as simple as explaining that details about the product to be made are detailed on the purchase order or referenced contracts, you have approved your supplier by survey, site visit (supplier audit), trial buy, or an appropriate combination of the three, and that you confirm the product is made to your specifications by requiring a C of C, by incoming inspection, or by a combination of the two.

 

[harinandu2003]

Hi Jim,

That was very helpful.

Harish

 

[jelly1921]

Hello,
We are an electronics design firm, and we our products are being manufactured in a firm in China, We are goinf for ISO 9001 certification.
The problem is that the inspection reports of the units that we have produced are kept in China and the reports are maintained in Mandarin. For ISO certification would this be a problem. Should I go ahead and ask our supplier in China to ship all the documents even though in Chinese as evidence of conformity to product specs. and requirements.
Regards,
Harish

Harish:
After reading all of the commends for your question, the first thing you should make sure is that who is the customer of your QMS, and what is the product to your customer.
If you limited your QMS scope to the design and development, then QMS's customer should be internal one within your company, and the products of QMS should be the outputs of your designs. There is nothing to do with production of REAL products you are selling into the market.
ISO/TC 176 has a example in its interpretations that had almost the same situation like yours, the conclusion is that you can be ceritificated but meaningless, because you cannot make a statement to your REAL customer.
Reference---Document: ISO/TC 176/SC 2/N 524R6

10.2 Manufacturing Centre (MC)
Situation:
MC receives orders from headquarters and delivers products to the distribution centre. It has established its QMS guided by, and in conformity with, the quality policy of GTV. All aspects of quality management required by ISO 9001:2008 are performed within the MC, with the sole exception of product design and development. The MC decided to exclude Sub-Clause 7.3 Design and development from the scope of its QMS since it performs no design activities. The MC does include a statement and justification in its quality manual that it is excluding the product design and development process and further indicates that a) its customer is Global TV headquarters who provide orders to the manufacturing plant, and b) Global TV headquarters is responsible for ensuring the Design Centre conforms to ISO 9001:2008.
Issue(s):
Can the MC exclude Sub-Clause 7.3 Design and development from its QMS and claim conformity with ISO 9001:2008?

Analysis and Conclusion:
The exclusion of Sub-Clause 7.3 Design and development is justified, since Global TV Headquarters (the customer) orders product to be manufactured in accordance with the design provided to the MC by the Design Centre. Global TV headquarters is responsible for ensuring that the Design Centre’s quality management system conforms to ISO 9001:2008 requirements. The manufacturing centre properly justified the exclusion by specifying that its customer is Global TV Headquarters. As such, any certificate of conformity for the GTV MC will reference the internal customer and will be of no direct value to the external customer of GTV, the end user customer who buys their TVs.

Jelly

Hello Sam,

The Product is designed by us, and the chinese company is just a contract manufacturer for us, they will make the products based on the manufacturing and assembly instructions, test plans sent by us and will ship the products to the destination as requried by us. The final product will have no identification of the subcontracting company and all the labels will bear our name being the ODM.

So now I feel that the manufacturing ofcourse should be part of our scope and cannot be excluded. But my greatest concern is that the chinese company has translated the inspection reports to Chinese.inspection reports to Chinese and they are keeping it. I found it unlogical to have them send all the inspection reports to us ( in thousands) back to us and keeping it here. Our Engineers are always witnessing the production. But still, I am not sure how will I substantiate the Clause (8.2.4) to the Auditor ( Evidence of conformity with the acceptance criteria shall be maintained).

Thanks,
Harish

If you want to expand your QMS to the real circumstance like mentioned above, your entire QMS will be re-set up, because the customer and product of QMS are changed. eg. from internal customer to real customer; from the design to produtct designing, manufacturing and sales. All processes and relevant responsibilities, procedures, documents and records have to be re-defined.

In addition, for the inspction records in Chinese language, you don't need copy all of them and retain them in your office. The Chinese manufacturer is your out-sourcing sub-contractor, you need to control it with 4.1 and 7.4. What you need is to do is like this:
1. according to 7.4.1, to evaluate its ability to supply product in accordance with your requirements, the only thing you need is the timely summary the inspection records, using control chart for example, to control the variabilities of out-sourcing processes --- manufacturing, in order to demonstrate its abilities.
2. according to 7.4.2, to clearify your requests, which have beed made in your contract with your Chinese supplier.
3. according to 7.4.3, to verify the product shipped to you from China. For each individual product, there must be a final inspection report accompained with prodcut shipped to you, what you need to do is to make an arrangement or procedure to get copies of the reports by sampling at planned intervals.

Jelly