What evidence to I need to supply as a remote location in relation to manufacturing sites?

DariusPlumdon

Starting to get Involved
#1
I work for a company that has recently successfully been re-certified against IATF16949, we have been 16949 accredited for many years.
With our new auditor a question was raised in passing that we want to prepare for (should it come up next year).

We are based in Europe, we have 3 separate offices (Birmingham, Madrid & Warsaw). We have many (around 10) separate manufacturing sites in the Far East, each of these sites has it's own separate IATF16949 certificate, each of these certificates clearly states/lists the 3 European sites as a remote location with a scope of supporting 'Sales', 'Marketing' & 'Product Development'.

1) Can the auditor ask us to provide evidence of this (I am assuming this is a fair question - although we have never been asked this before), &
2) If they do ask us then what are examples of evidence that would be acceptable to an auditor for
- Sales
- Marketing
- Product Development

With Product Development the reality is that each of our European design centers supply data to the central HQ design center in the Far East, and it is this central HQ design center that uses/consolidate this design data & adds there own design input before the central HQ design center the supplies data to the 10 manufacturing sites for them to manufacture items.

I believe our certificate scope is honest and correct, I am just not sure what we need to prove (if anything) and how we prove it in a simple effective way.

Any thoughts/advice please.

PLEASE do not reply with 'ask your auditor', as the reality is this will lead to a theoretical answer & could open a can of worms for no reason! :)
 
Elsmar Forum Sponsor

Sebastian

Trusted Information Resource
#2
First, do not ask auditor. :vfunny::vfunny::vfunny:

Part of preparation for audit of manufacturing site with remote supporting function is audit of supporting site.
There are two options, manufacturing site certification body does it by themselves or use audit report of remote supporting site performed by other certification body.
In case of product design and development it has to be done annually.
Other functions, maybe once per certification cycle is enough, but I am not sure.
Your certification body should be contacted by certification body of manufacturing sites you support and asked to audit your supporting functions. You said, their certificates list your plant as remote supporting function, so I do not see reason why there were no questions about it during your audit. Maybe someone else was asked, not you?

It can look like this:
-Hey, you were identified by quality manual of site A as remote supporting function.
They say, you support them in product development.
Could you show me example of this activity from last 12 months?
- There were cases of product development, but all of them were done for purpose of our own needs.
- Ok, finish.
So, then in report can appear something like this "Remote supporting function Site A - Product development. No cases for last 12 months."
If there were any, it would be audited in similar way to products yo have developed for needs of own manufacturing site.

I do not see related way you have organized designing sites with central HQ design center.
Your plant is listed on manufacturing sites certificates, so you have to be audited, not HQ design center.
If HQ design center is listed too, so both you and HQ have to be audited.

We have here active 3rd party auditors, so they will correct me, if needed.
Summary - do not ask auditor, as it can result in "can of worms", but be prepared one will ask for it someday.
 

DariusPlumdon

Starting to get Involved
#3
Hi Sebastian,

I appreciate your comments, but can I clarify what I am looking for help with (& also what I am not looking for) :)

We have an effective full internal and external audit program, there is no problem with out understanding, or application.

What I/we are struggling with as a remote location is IF ASKED what are examples of evidence that would be acceptable to an auditor for us to demonstrate
- Sales
- Marketing
- Product Development

I was not joking about not asking our auditor. Even the best auditors have our strengths and weaknesses, our current auditor is young, has a fantastic knowledge of the IATF standard, but they do not have much real world experience on how to interpret the standard ... hence I am asking the forum for ideas :)
 

Daniel O.

Starting to get Involved
#4
Hello Darius,

I work in a IATF accredited company, we have technical centers in Spain and China and manufacturing locations in Europe, America and China and this is how we evidence the support during audits in different processes:

- Desing and development: During the audit in the supporting site, the auditors go through different projects and they try to see every year projects that are developed in HQ for different locations. For example they see different material tests, all the APQP documents and how is the project transferred to the manufacturing plant, the evidences of the R&R performed, how HQ validates the project in its final location...
- Sales: Same as Design and development, they audit different projects that are managed in HQ for the other plants, the cost calculation, the relationship with customer...

For all our plants except the ones in China we use the same certification body and this is what they do. For our plants in China we have a different CB, so we just send the plants there our audit report and the nncc closing evidences so they can prove the relationship with us during their audit.

But if you ask me (since im an internal auditor)... just follow the standard ;)
 

John C. Abnet

Teacher, sensei, kennari
Staff member
Super Moderator
#5
Good day @DariusPlumdon -
Let's take a look at what the requirements state.

First....within IATF 16949, the terms in question are defined as follow...

3.1 Terms and definitions-
Support Function
:
Non-production activity (conducted on-site or remote location) that supports one (or more) manufacturing sites of the same organization.

Remote Location:
Location that supports manufacturing sites and at which non-production processes occur.

Rules 5th edition-
5.5 Supporting activities
"...initial stage 2 audit, at least once during surveillance cycle...at recertification audit"


I'm not sure what you mean by "evidence".
1- Evidence at/of remote support function-
As you can see, whether one of the "other" (assuming multiple across your organization) certification bodies is auditing the support locations and then the local manufacturing site cert holders are using that audit result, the individual certification holders will be held accountable (their individual certs depend on it), for the audit results of the support functions. So the audits at the support functions will indicate (should) if those support functions are performing compliant with IATF within the scope of services they provide, including if internal audits of the support function are performed and effective.

2- Evidence at/of manufacturing site (cert holder)-
If you are referring the "evidence" at the manufacturing site, the auditor will likely (should) be following the bread crumbs and looking for evidence of the support information (e.g. product design drawings), flowing into the cert holder manufacturing site..; how that information is controlled/managed (e.g. special characteristics flowing to the point of work, regulatory/statutory information flowing to suppliers, rev level design change point control, etc..etc...). Likewise for sales information, etc...).

Does this address your question?

Hope this helps
Be well.
 

DariusPlumdon

Starting to get Involved
#6
Hello Darius,

I work in a IATF accredited company, we have technical centers in Spain and China and manufacturing locations in Europe, America and China and this is how we evidence the support during audits in different processes:

- Desing and development: During the audit in the supporting site, the auditors go through different projects and they try to see every year projects that are developed in HQ for different locations. For example they see different material tests, all the APQP documents and how is the project transferred to the manufacturing plant, the evidences of the R&R performed, how HQ validates the project in its final location...
- Sales: Same as Design and development, they audit different projects that are managed in HQ for the other plants, the cost calculation, the relationship with customer...

For all our plants except the ones in China we use the same certification body and this is what they do. For our plants in China we have a different CB, so we just send the plants there our audit report and the nncc closing evidences so they can prove the relationship with us during their audit.

But if you ask me (since im an internal auditor)... just follow the standard ;)
Thank you Daniel, that helps :) I am also an internal auditor of many years, we have the same (single) certification body for all sites around the world
 

DariusPlumdon

Starting to get Involved
#7
Good day @DariusPlumdon -
Let's take a look at what the requirements state.

First....within IATF 16949, the terms in question are defined as follow...

3.1 Terms and definitions-
Support Function
:
Non-production activity (conducted on-site or remote location) that supports one (or more) manufacturing sites of the same organization.

Remote Location:
Location that supports manufacturing sites and at which non-production processes occur.

Rules 5th edition-
5.5 Supporting activities
"...initial stage 2 audit, at least once during surveillance cycle...at recertification audit"


I'm not sure what you mean by "evidence".
1- Evidence at/of remote support function-
As you can see, whether one of the "other" (assuming multiple across your organization) certification bodies is auditing the support locations and then the local manufacturing site cert holders are using that audit result, the individual certification holders will be held accountable (their individual certs depend on it), for the audit results of the support functions. So the audits at the support functions will indicate (should) if those support functions are performing compliant with IATF within the scope of services they provide, including if internal audits of the support function are performed and effective.

2- Evidence at/of manufacturing site (cert holder)-
If you are referring the "evidence" at the manufacturing site, the auditor will likely (should) be following the bread crumbs and looking for evidence of the support information (e.g. product design drawings), flowing into the cert holder manufacturing site..; how that information is controlled/managed (e.g. special characteristics flowing to the point of work, regulatory/statutory information flowing to suppliers, rev level design change point control, etc..etc...). Likewise for sales information, etc...).

Does this address your question?

Hope this helps
Be well.
Hi, Regarding point 1 your info helps, I 100% agree, and we basically do exactly as you suggest. For point 2 I was referring to 'evidence' at 'my' European sites .. the remote locations. But from your reply (and the previous one) I think I am overcomplicating it ... we will continue to follow the standard as we have done in Europe, and let the manufacturing sites worry about the 'links' to our locations & the evidence. :)
 

Sebastian

Trusted Information Resource
#8
In my opinion auditing product developed for external manufacturing site does not differ from auditing product developed for own manufacturing site. So evidences are same in both cases.
Problem area are as always interfaces. When inputs from and communication with with own manufacturing site are defined, so it can be different in case of external manufacturing site, while it should not be.

Previously I was working for manufacturing site, which had often problems with getting DFMEA from HQ design center. Maybe it was personnel resistanceto share it when asked or maybe sometimes HQ was not doing it at all. Audit of remote supporting function is opportunity to identify such cases. But you know, when audit sample is defined by auditee instead of auditor, you may never find problematic cases. So manufacturing site stays alone without proper support.
 

DariusPlumdon

Starting to get Involved
#9
In my opinion auditing product developed for external manufacturing site does not differ from auditing product developed for own manufacturing site. So evidences are same in both cases.
Problem area are as always interfaces. When inputs from and communication with with own manufacturing site are defined, so it can be different in case of external manufacturing site, while it should not be.

Previously I was working for manufacturing site, which had often problems with getting DFMEA from HQ design center. Maybe it was personnel resistanceto share it when asked or maybe sometimes HQ was not doing it at all. Audit of remote supporting function is opportunity to identify such cases. But you know, when audit sample is defined by auditee instead of auditor, you may never find problematic cases. So manufacturing site stays alone without proper support.
Hi Seb,

I understand exactly what you are saying, but our set-up is slightly more complex:
1) We are a remote design site with no manufacturing on site,
2) We supply data/input to a central HQ design site (again no manufacturing)
3) At the same time other different remote locations with no manufacturing also supply inputs/data to the central HQ
4) The central HQ the choose the inputs/data from all the remote sites and produces the design for the chip
5) The central HQ sends this consolidated package to the manufacturing site(s) for manufacture

So we at the remote location have no direct 1-2-1 relationship of even a traceability matrix with the manufacturing site who hold the IATF certification & list us as a remote location!

I stress we are working to our process to meet IATF standard requirements, it is how we prove this that is the nightmare! :)

If we had a 1-2-1 relationship directly with the manufacturing site as most do, and is how the standard is written we would have no issue :)
 

Sebastian

Trusted Information Resource
#10
I've presented a scene. Now I would change it.
-Hey, you were identified by quality manual of site A as remote supporting function.
They say, you support them in product development.
Could you show me example of this activity from last 12 months?
- We don't know what site we develop product for.
It is managed by our design HQ.
If you give us product number for this site, we can present related activities, we had implemented.
Do you know it?
- No, I don't know.
Please show me anything from last 12 months.

Then same product should be followed during audit of design HQ and preferably manufacturing site.

You are not IATF certified. HQ too.
Manufacturing sites are certified only.
You are audited per IAFT only because manufacturing site has mentioned you in their quality manual.
I am sure auditor was not fishing during audit, so he spend time on verification of evidences, that you properly support manufacturing sites, even you don't know which one it is.
You are doing well.

HQ should have someone who knows IATF and is able to prepare with manufacturing sites matrix.
Matrix listing system processes divided on:
1. processes performed by manufacturing site
2. processes performed by remote supported functions
a) HQ
b) other sites, e.g. you.
then matching it with standard clauses and giving clear guidelines to you: Hey boys, requirements of following IATF 16949 sections are applicable to you. Read it and consider during preparation of internal procedures, or, here are ready procedures for you and follow them. All of them address requirements of IATF 16949 clauses, so no worry.

I have big concerns regarding auditing of RSF.
Respecting process approach and auditing RSF before manufacturing site, because it is how things flow is understandable.
But during auditing manufacturing site interesting question to RSF can arise, but there is no opportunity to ask them. Maybe next audit, it means never.
E.g. No DFMEA used during PFMEA preparation. NC for manufacturing site. Period!
But what about, there was no DFMEA for this product? Let's check during RSF audit.
Oh no, impossible, we were there, we have seen example of DFMEA for other product. It was OK, now it is too late.

Maybe someone understands your doubts better than me and give you satisfactory support.
In auditor's opinion you are doing well and probably will do well in future, too.
 
Thread starter Similar threads Forum Replies Date
Ashland78 Need to show evidence in accordance with QR-11012 and SPB-00001-09 Customer and Company Specific Requirements 5
B Sales training for ISO 9001 2000 and What type of training evidence do we need? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
GStough Objective Evidence - Are Interviews Still Considered as Objective Evidence? General Auditing Discussions 15
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
C MDCG 2020-06 Clinical evidence legacy devices EU Medical Device Regulations 3
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
M Informational Critical Thinking and the Process of Evidence-Based Practice Medical Device and FDA Regulations and Standards News 0
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
S Level of Clinical Evidence - MDR EU Medical Device Regulations 3
qualprod Evidence of a talk or phone call in approvals? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Clinical evidence for Class II medical devices in EU and US EU Medical Device Regulations 6
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
N Best practices for capturing audit objective evidence in a practical manner? Internal Auditing 3
M Informational Health Canada – Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing Medical Device and FDA Regulations and Standards News 0
R Timeframe for IATF 16949 certification to accumulate evidence of conformance of systems? IATF 16949 - Automotive Quality Systems Standard 2
M Informational TGA – Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices Medical Device and FDA Regulations and Standards News 0
E ISO 9001:2015 Clause 10.2.2 - Evidence of all nonconformities and actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R 8.1.3 Management of change - Evidence of HIRA and related things Occupational Health & Safety Management Standards 3
Q Evidence of precautions (clinical evaluation report, risk management report) EU Medical Device Regulations 6
S Ways to demonstrate objective evidence that employee is trained and competent ISO 13485:2016 - Medical Device Quality Management Systems 28
mikinnear Evidence - Class IIb Disinfectant Sanitiser EU Medical Device Regulations 2
G FAI Objective Evidence AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Interested parties requirements - Evidence of control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Is evidence of second party audits required for every supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J MDR and Creative Clinical Evidence Other ISO and International Standards and European Regulations 2
B IATF 16949 Cl. 9.2.2.1 - Internal audit program - Types of evidence Internal Auditing 1
E IATF 16949 Cl. 7.1.5.1 - Documented information as evidence of fitness for purpose IATF 16949 - Automotive Quality Systems Standard 3
Q How to provide evidence of Strategic Direction (Easy) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B IATF 16949 Cl. 7.1.6 - Organizational Knowledge - What evidence to have? IATF 16949 - Automotive Quality Systems Standard 1
D No evidence of certain processes on our scope being audited at our remote location IATF 16949 - Automotive Quality Systems Standard 4
R CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence ISO 13485:2016 - Medical Device Quality Management Systems 2
R What kind of Objective Evidence - AS9100 Cl. 7.1.6 - Organizational Knowledge AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Informational Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 82
O ISO 9001:2015 4.4.1 - Providing Evidence of QMS Processes "Shalls" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Type of evidence for Mandatory procedures 4.4.2 A ad 8.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Clinical Evidence - Clinical Evaluation Report for Class I medical devices EU Medical Device Regulations 1
L AIs the R&R study a training evidence considered ? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R What objective evidence can/can't be supplied during a customer audit? General Auditing Discussions 3
W Evidence for Review of Requirements - AS9100 Clause 7.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Audit Ethics and Practices regarding Evidence Internal Auditing 18
S Evidence of Competence, Training and Awareness Training - Internal, External, Online and Distance Learning 5
S Design and Development Document evidence for Engineering Consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Chennaiite Audit Objective Evidence - the holy **** Imported Legacy Blogs 1
J Evidence of ISO Training for all Employees Training - Internal, External, Online and Distance Learning 27
K Evidence for Language Knowledge of Employees Professional Certifications and Degrees 9
S What would be the evidence for trained/competent inspectors? Quality Manager and Management Related Issues 4

Similar threads

Top Bottom