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#1 scottaha1

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Posted 13 November 2016 - 01:16 AM

Hello!

 

I have 3 upcoming audits scheduled in Asia -

 

-One Dietary Supplement manufacturer in Japan.  Product is imported to the US

-One Dietary Supplement manufacturer in China.  Product is for the China market

-One food Raw Material supplier (Soy Protein), currently for the China market, with potential for use in US products.

 

Questions:

-Does anyone have any suggestions for an American auditing in Asia?  I will have a company representative with me in both Japan and China for translation.

-What is the best method for document review, as I cannot read the documents?  Just have the translator read everything?

-Any suggestions for auditing RM supplier when the product is not necessarily due for the US, but may be?  I figure that we will need to audit to US standards, based on the potential, but how to justify observations based on US requirements, when the product is not yet bound for US products?

-Aside form the practical audit, how about etiquette?  Anything specific and/or critical to know?

 

Thanks!



#2 Charles.C

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Posted 13 November 2016 - 04:41 AM

Hi scottaha,

I suggest you need to decide on the appropriate audit standard before you go.
If no specific Standard, what is the Objective of the audit ?
IMEX of auditing in "foreign" environments these kind of issues will dictate what extra resources may (or may not) be required, eg what kind of documentation will need to be "evaluated".

I hope you will also be supplied with an intelligible local QA Operative, I predict you will need one. The degree of necessity will depend on the local situation which you encounter.

The number of local surprises you can expect may depend on yr current experience and perhaps the location/condition of the to-be audited facilities.

Some audits are preceded by submitting preliminary questionnaires just to get an idea of the existing set-up but this depends on the situation.


Kind Regards,

 

Charles.C


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#3 SQFconsultant

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Posted 13 November 2016 - 05:17 AM

If you must go, you could commission an auditing company to provide a "local" auditor - you can tag along if needed, but the auditor that is experienced in the areas, customs, etc. will be the point person.

 

Most auditing companies such as TUV USA, have auditors available around the globe.


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#4 Charles.C

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Posted 13 November 2016 - 05:34 AM

If you must go, you could commission an auditing company to provide a "local" auditor - you can tag along if needed, but the auditor that is experienced in the areas, customs, etc. will be the point person.

Most auditing companies such as TUV USA, have auditors available around the globe.

Hi SQFC,

Thks for above.

Indeed I had had a similar thought but I assumed such had already been ruled out for some reason. Scottaha ?

Kind Regards,

 

Charles.C


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#5 scottaha1

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Posted 13 November 2016 - 06:45 PM

Thank you both!

 

I will have a QA Rep from our China office joining, and I have asked her to be the lead on the audits.  The reason I was asked to go is that I have been with the company for 8+ years, and she is new to the company (2 months), though she does have auditing experience.  I will have a technical person in Japan, but I am trying to get a QA person to attend also.  That being said, any recommendations with the working relationship when evaluating with a partner in this manner?  They will be the experts in their local requirements.  Granted, many of the requirements will likely be the same or similar as US requirements, so best to just let the audit run its normal course and interject with specific requirements or differences as they are identified?

 

We did explore a consultant or contracted auditor, but the decision was made for me to attend.  The China audits were planned first, and the Japan one was added since I will already be in the area (kind of...).

 

Thanks again!  



#6 Charles.C

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Posted 13 November 2016 - 09:32 PM

Hi scottaha,

I would anticipate that yr input is going to be ultimately decisive regarding Product viability for US, not the Local opinions.

This would typically be covered by a mutually agreed PRODUCT SPECIFICATION plus yr satisfaction regarding the audited facilities.

Anticipating that typical Chinese/Japanese Quality Specifications will auto-correlate to US norms may be optimistic. Similarly for Process/Environment issues.

On the other hand, you may find that the situation far exceeds yr minimum requirements. Can sometimes happen. Ali Baba's Cave :smile:


Kind Regards,

 

Charles.C


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#7 scottaha1

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Posted 15 November 2016 - 03:03 PM

Hello!

 

We already have specs in place for all products being manufactured in the locations, so that is certainly a useful tool to use during the evaluation.  As all the companies do export to the US, I imagine they will have the appropriate systems in place to support such operations, though I am sure there will also be significant differences.

 

Though my Japan rep will not be QA (unfortunately) I believe he has at least a base level knowledge for assessing facilities due to his background.

 

ON another note, I have never been to dinner with a company that I am auditing, due to potential conflict of interest, but I understand there are different cultural norms.  The company has invited myself and my colleague to dinner after one day of the audit.  Is this typical and/or appropriate in Japan?  I would (and have) decline in the US, no question, but I don't want to offend unnecessarily

 

Thanks! 



#8 Charles.C

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Posted 15 November 2016 - 11:17 PM

Hello!
 
We already have specs in place for all products being manufactured in the locations, so that is certainly a useful tool to use during the evaluation.  As all the companies do export to the US, I imagine they will have the appropriate systems in place to support such operations, though I am sure there will also be significant differences.
 
Though my Japan rep will not be QA (unfortunately) I believe he has at least a base level knowledge for assessing facilities due to his background.
 
ON another note, I have never been to dinner with a company that I am auditing, due to potential conflict of interest, but I understand there are different cultural norms.  The company has invited myself and my colleague to dinner after one day of the audit.  Is this typical and/or appropriate in Japan?  I would (and have) decline in the US, no question, but I don't want to offend unnecessarily

Thanks!


Hi scottaha,

IMEX of Asia and Europe, yr dining info makes USA unique. :smile:

Kind Regards,

 

Charles.C






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