Supplier Audit (Desktop) Issues

H

htquality

I am currently performing an audit of one of our suppliers. The supplier is one of our logistics provider (warehousing/distribution) and the audit is conducted remotely. They have provided me with a lot of information to answer my queries, and they summarized processes for me, but they are unwilling to provide me with copies of any of their procedures or their quality manual. They keep saying that they can't provide me with any document related to QMS due to privacy disclosure (we do have a CDA with them) and legal issues; and that their QMS was assessed and validated by an independant reviewer as part of their ISO 9001 certification. I usually get copies of pretty much every relevant QMS document (sometimes with blacked out information), and have never faced a situation like this. Any recommendation/feedback would be greatly appreciated!
 
K

keres

The good practice is to be audited only this part of supplier activity that is related to your activity. And do not get copies from supplier's QMS documentation.
 
S

Sorin

I am currently performing an audit of one of our suppliers. The supplier is one of our logistics provider (warehousing/distribution) and the audit is conducted remotely. They have provided me with a lot of information to answer my queries, and they summarized processes for me, but they are unwilling to provide me with copies of any of their procedures or their quality manual. They keep saying that they can't provide me with any document related to QMS due to privacy disclosure (we do have a CDA with them) and legal issues; and that their QMS was assessed and validated by an independant reviewer as part of their ISO 9001 certification. I usually get copies of pretty much every relevant QMS document (sometimes with blacked out information), and have never faced a situation like this. Any recommendation/feedback would be greatly appreciated!

That's fishy...usually, the Quality Manual is a public document that can/could be handed in the street. As for the procedures related to the quality system they should be able (and willing) to distribute them to anyone.

Send them this link

http://metalcraft.net/

All, I mean ALL, their quality system douments are on-line. Including job descriptions and and work instructions.
 
S

Sorin

1.The good practice is to be audited only this part of supplier activity that is related to your activity.

2.And do not get copies from supplier's QMS documentation.

1.Uhmmm....nope. If I audit a supplier I need to see (read audit) how their processes are controlled and monitored, how the contract review is performed, how they are controlling their purchasing, etc. And that means auditing all their QMS.

2.How else I am supposed to do an audit. I may get compelled (through an NDA) to sent them back or destroy them, but that's another story.
 
S

silentrunning

Our company is an open book to any customer that wants to come and audit us, but no controlled documents leave the premesis. I have never had a customer balk at this arrangement.
 
S

Sorin

Our company is an open book to any customer that wants to come and audit us, but no controlled documents leave the premesis. I have never had a customer balk at this arrangement.

And there is the key word....how about an uncontrolled copy?
 

qusys

Trusted Information Resource
I am currently performing an audit of one of our suppliers. The supplier is one of our logistics provider (warehousing/distribution) and the audit is conducted remotely. They have provided me with a lot of information to answer my queries, and they summarized processes for me, but they are unwilling to provide me with copies of any of their procedures or their quality manual. They keep saying that they can't provide me with any document related to QMS due to privacy disclosure (we do have a CDA with them) and legal issues; and that their QMS was assessed and validated by an independant reviewer as part of their ISO 9001 certification. I usually get copies of pretty much every relevant QMS document (sometimes with blacked out information), and have never faced a situation like this. Any recommendation/feedback would be greatly appreciated!

Quality manual is a sort of "visiting card" of a company , so it is done to show how the QMS of an organization works. It is very strange that they do not want to show to you, it could means that they want to hide something.
To avoid this situation , we can go directly on their premises with an audit plan , checking if the requirement you should have agreed with them for the provided service are met or not.
In the planning phase of a supplier audit we can send them before a sort of check list ( questionaire) where they shall provide response you can successively check on their premises, a sort of self scoring that then you can confirm or not.
In my opinion , desk audit for suppliers are not so usefull. You should combine different input and verify them on the place. One of these input could be if they are still open action for corrective action with you and verify the related status of the action.:bigwave:
 
K

keres

1.Uhmmm....nope. If I audit a supplier I need to see (read audit) how their processes are controlled and monitored, how the contract review is performed, how they are controlling their purchasing, etc. And that means auditing all their QMS.

2.How else I am supposed to do an audit. I may get compelled (through an NDA) to sent them back or destroy them, but that's another story.

1. If you are my client I will not permit you to see any other information if it is not related to our contract and conducting of orders. In other case you will have access to information about other my clients wich is not good for them... and for me.

2. Watch, take interviews and review of documents.
 
S

Sorin

1. If you are my client I will not permit you to see any other information if it is not related to our contract and conducting of orders. In other case you will have access to information about other my clients wich is not good for them... and for me.

2. Watch, take interviews and review of documents.


1.Assume I am the customer.

a)I am sending you a PO. You review the PO and acknowledge that you are able to perform as per requirements that are explicit (and implicit) in the PO.

Up to this point I need to see how you are reviewing PO's (contracts, your control of internal and external documents (as well as statutory and regulatory standards) including drawings.

b)Schedule of my parts
I need to see your planning and risk management.

c)Start of manufacturing.
I need to see how you control and monitor your processes, calibration of equipments used to control and monitor, purchase and control upon reception of raw materials and services (including calibration), inspection and verification (in process and final), training of personnel that can affect the quality of the parts in process and upon inspection.

d)Shipping
I need to see how do you control the process of verication that all aspects detailed in my PO were verified and how do you ensure that the final product complies with them.

Now...are there aspects of your QMS that are not mentioned? Could be...but I did it just to show you that an audit from any customer could easily encompass all your QMS.

2.Keep in mind that are talking about your QMS, not about proprietary information.
 
T

treesei

An existing customer auditor can easily cover every aspect of a QMS and review documents from quality manual down to details records. A big part of a quality audit is to see if your practice comply with your procedures (do what you say, say what you do).

A potential customer may have restricted access to certain info, but the quality manual and many general secondary procedures are accessible.

To both existing and potential customers, documents (and areas if applicable) that are associated with another customer, for example, the process SOP or drawing of a product you build for another customer) are confidential.

Some other documents, for example, your AVL, can be confidential.

But the quality manual and many secondary procedures are always available to any auditor.
 
Thread starter Similar threads Forum Replies Date
G MDR critical supplier audit checklist EU Medical Device Regulations 0
D Critical Supplier will not allow us to audit Plant floor US Food and Drug Administration (FDA) 12
S AS9100 Supplier Audit Checklist example AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
GStough Audit Nonconformances (?) for Suppliers Not Registered to ISO and No Supplier Quality Agreement Exists General Auditing Discussions 24
C Supplier Audit - Looking for a quality audit checklist General Auditing Discussions 3
G Audit & Agreements for "Test Laboratory" Supplier? US Medical Device Regulations 4
D Re-labeler - audit the supplier EU Medical Device Regulations 2
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
D Special IATF audit of sub-supplier IATF 16949 - Automotive Quality Systems Standard 18
D Supplier audit Medical Device and FDA Regulations and Standards News 2
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
M Supplier Audit Report - Template for second party audit wanted Lean in Manufacturing and Service Industries 1
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
shimonv Rigid rules for handling supplier audit findings ISO 13485:2016 - Medical Device Quality Management Systems 11
Q Supplier audit question cataloque VDA Standards - Germany's Automotive Standards 0
G ISO 22442 Supplier Audit Checklist - Medical devices utilizing animal tissues General Auditing Discussions 0
Genofear Customer wants to audit our supplier audits - seems inappropriate General Auditing Discussions 16
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
A Supplier Audit Results - when do you prepare? General Auditing Discussions 10
P IATF checklist for External Supplier Audit IATF 16949 - Automotive Quality Systems Standard 9
H 8.4.2.4.1 Supplier Audit - Supplier with IATF certified loss IATF 16949 - Automotive Quality Systems Standard 4
S Supplier Audit Assessment / Evaluation Forms IATF 16949 - Automotive Quality Systems Standard 1
Pmarszal Supplier Auditing Services (Audit Needed?) General Auditing Discussions 4
GStough Pushback on a Nonconformance Found in a Supplier Audit General Auditing Discussions 22
GStough Have You Had to Write a NC Against a Quality Manual in a Supplier Audit? General Auditing Discussions 12
GStough Nonconformance Found Outside the Audit Scope - Supplier Audit General Auditing Discussions 16
K Audit a sole supplier? Supplier Quality Assurance and other Supplier Issues 9
R Vertical Supplier Audit Plan Supplier Quality Assurance and other Supplier Issues 4
A Supplier Audit Request - Made be laugh ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Performing an ISO 9001 based Supplier Audit - Multiple Supplier Facilities Supplier Quality Assurance and other Supplier Issues 4
G Supplier Significant Environmental Aspects - Audit Finding ISO 14001:2015 Specific Discussions 21
GStough Template for Supplier Notification of Audit Supplier Quality Assurance and other Supplier Issues 5
M Supplier Audit Form for Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 2
L Sourcing Audit Schedule for Supplier Audits IATF 16949 - Automotive Quality Systems Standard 3
S Supplier Audits - What to Audit when a Supplier is not Certified Supplier Quality Assurance and other Supplier Issues 11
Q Supplier Audit Corrective Action Request Responses Supplier Quality Assurance and other Supplier Issues 4
R Can our Supplier's Quality Mgr. conduct Supplier Audit on behalf of manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Going Rate for Performing a Supplier Audit? Consultants and Consulting 1
T Contacting the Supplier's CB vs a Supplier Audit - Nonconformance Problems AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
E Do I need to audit the supplier supplying mop heads for our Clean Room ? ISO 13485:2016 - Medical Device Quality Management Systems 8
F Tips, Guidelines and Checklist to conduct Audit of Supplier & Subcontractor Document Control Systems, Procedures, Forms and Templates 5
Marc Definition ASAS-P - Alliance Supplier Audit Standard - P for Production Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
M Free supplier audit webinar Book, Video, Blog and Web Site Reviews and Recommendations 0
B Is there an FDA requirement for a Supplier Audit Schedule US Food and Drug Administration (FDA) 22
GURU SDI VDA 6.3 Audit for different Parts from the same Supplier VDA Standards - Germany's Automotive Standards 5
S Need Supplier Audit Form to Audit Supplier or Factory Supplier Quality Assurance and other Supplier Issues 3
P Should I send survey questionnaire prior to Supplier EMS Audit? Miscellaneous Environmental Standards and EMS Related Discussions 14
S Supplier Audit Questionnaire for aerospace product suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
F Supplier Audit Training Course Suggestions Training - Internal, External, Online and Distance Learning 4
K System Audit for New Supplier Qualification Supplier Quality Assurance and other Supplier Issues 6

Similar threads

Top Bottom