R & D is remote, in Japan. Do I have to perform a remote "internal" audit?

[Nikki Will]

Our R & D is in Japan, and we are in the States. It is included in our QMS and is in our Quality manual. The person in this position before me was only asking for and saving a copy of our remote, support sites' IATF audit reports. Is this sufficient, or do I need to figure out some way to audit them remotely? Our Quality manual says:

Sections 8.3.1., 8.3.2, 8.3.2.1, 8.3.2.2, 8.3.2.3, 8.3.3, 8.3.3.1, 8.3.4.1, 8.3.4.4, 8.3.5.1 from Design and Development of Products and Services Section of IATF/ISO Standards have been determined applicable to ***My site***, because product design and development functions are performed by both the Customer and ***Remote R & D***.

Any help is greatly appreciated. I've only been in this position a little over a year.

Thank you!

 

[Ashland78]

What does your process say within your organization? Ours says that I have include in my audit plan the applicable support processes (at remote locations). When you get certified it will show good practice if you did, as it will prepare for when they are externally audited. #IWorkforGM

 

[Watton1440]

For IATF, we did internal audit our Japan R&D. Us and most auditors we've had agree that our Japan facility was within the scope of our Audit.

 

[Nikki Will]

For IATF, we did internal audit our Japan R&D. Us and most auditors we've had agree that our Japan facility was within the scope of our Audit.

Thank you for your response. I feel that it is too, as it's listed in the scope of our QMS. Uggh. Now to figure out how to schedule this.

 

[Nikki Will]

What does your process say within your organization? Ours says that I have include in my audit plan the applicable support processes (at remote locations). When you get certified it will show good practice if you did, as it will prepare for when they are externally audited. #IWorkforGM

Thank you for your response. I'm going to go ahead and try to get an actual internal audit scheduled.

 

[Ashland78]

Keep in mind you can do this audit virtually, depending on what your organization procedure specifies.

 

[Sebastian]

Short answer: "Yes". Without any "but". Gray area is, we didn't perform that for years and unfortunatelly, it was not audited by 3rd party, so we had not get "major" for this.
Control over "remotes" is weak point of standard and rules and in my opinion deserves stronger coverage.

 

[larry006]

Our R & D is in Japan, and we are in the States. It is included in our QMS and is in our Quality manual. The person in this position before me was only asking for and saving a copy of our remote, support sites' IATF audit reports. Is this sufficient, or do I need to figure out some way to audit them remotely? Our Quality manual says:

Sections 8.3.1., 8.3.2, 8.3.2.1, 8.3.2.2, 8.3.2.3, 8.3.3, 8.3.3.1, 8.3.4.1, 8.3.4.4, 8.3.5.1 from Design and Development of Products and Services Section of IATF/ISO Standards have been determined applicable to ***My site***, because product design and development functions are performed by both the Customer and ***Remote R & D***.

Any help is greatly appreciated. I've only been in this position a little over a year.

Thank you!

If your Japan R&D site is included in your QMS and performs design-related activities, then keeping only their IATF audit reports is not enough. You are required to show active oversight, which means doing some form of remote internal audit or documented monitoring of their design and development work. The goal is to prove you control the remote site’s contribution to your QMS, not just file their reports.

 

[qusys]

Our R & D is in Japan, and we are in the States. It is included in our QMS and is in our Quality manual. The person in this position before me was only asking for and saving a copy of our remote, support sites' IATF audit reports. Is this sufficient, or do I need to figure out some way to audit them remotely? Our Quality manual says:

Sections 8.3.1., 8.3.2, 8.3.2.1, 8.3.2.2, 8.3.2.3, 8.3.3, 8.3.3.1, 8.3.4.1, 8.3.4.4, 8.3.5.1 from Design and Development of Products and Services Section of IATF/ISO Standards have been determined applicable to ***My site***, because product design and development functions are performed by both the Customer and ***Remote R & D***.

Any help is greatly appreciated. I've only been in this position a little over a year.

Thank you!

Yes, of course. Question: Has R&D been included in your QMS process? I think so, also with communication channel.
QMS of R&D in Japan is the same , it is unique. They shall also demonstrate to perform Design FMEA, Problem Solving , 8D and all pertinent quality tool with trained personnel.
They shall also have their KPI and they shall be included in the management review. R&D in Japan cannot be considered apart and stand alone, based on what reported in the manual.

 

[Imans]

Our R & D is in Japan, and we are in the States. It is included in our QMS and is in our Quality manual. The person in this position before me was only asking for and saving a copy of our remote, support sites' IATF audit reports. Is this sufficient, or do I need to figure out some way to audit them remotely? Our Quality manual says:

Sections 8.3.1., 8.3.2, 8.3.2.1, 8.3.2.2, 8.3.2.3, 8.3.3, 8.3.3.1, 8.3.4.1, 8.3.4.4, 8.3.5.1 from Design and Development of Products and Services Section of IATF/ISO Standards have been determined applicable to ***My site***, because product design and development functions are performed by both the Customer and ***Remote R & D***.

Any help is greatly appreciated. I've only been in this position a little over a year.

Thank you!

You don't need to conduct audit/internal audit of Japan R&D Dept if following condition are satisfied:
1. Japan R&D and your company are in same group of company.
2. Japan R&D is mentioned in your Bussiness Process Mapping (process interaction) as remote support location.
3. You mention in you Quality Manual that you receive support from Remote Support Location Japan R&D. You also need to mention what kind of support you received from Japan R&D, for example : Product Design, Process Design, etc.
4. In Japan R&D Quality Manual also mention that Japan R&D provide support to your company with same name of support processes (Product Design, Process Design, etc.)
5. Japan R&D are certified for IATF. In their IATF audit plan and report, mention that you company as Receiving Support Location with same name of supported processes.

If that condition not satisfied, you need to do audit to Japan R&D.
If Japan R&D and your company are not in same group of company, it shall be considered as outsources process.

You may check IATF 6th Rule for detail.