Auditing Tier 2 Vendors (Suppliers) - What to look for?

M

Machelleh2

#1
Auditing Vendors

I have recently been put in charge of all our Teir II vendors. My first goal is to update all vendor audits. I have done one and I wasn't sure really what to look for. :confused: There is alot of training for internal auditors, but does anyone know of training that is for just external audits?

Thanks,

Machelle :bigwave:
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
My 1st question is: Are you a trained auditor?

You perform your audit to obtain objective evidence of conforming or complying with whatever the requirements are.

Identify the requirements your Tier ll's have to meet and audit to them.

As for external auditor training....half the people that contribute to this forum provide that (including me).
 
M

Machelleh2

#3
I am a trained auditor just by observing other auditors. I understand auditing the processes, It's just if they follow that procedure. For the vendor audit, I looked at there process, but I don't know what to look at in addition. Just because they have the procedures, doesn't mean they follow them. I guess I am wondering what else I should be observing to make sure thay are a suitable vendor. :confused:

Thanks,
Machelle
 

howste

Thaumaturge
Super Moderator
#4
What quality system requirements do you have for your suppliers? I agree with Randy. If you haven't defined and communicated these, then it really is tough to audit them. When you do an audit, you are really looking to see that they are meeting the defined requirements and that their quality system has been effectively implemented and maintained.

Auditing internal vs. external is not very different, and there are many training courses available. Most training courses are going to cover the guidance in ISO 19011 (or 10011) as well as whatever quality or environmental system standard you are interested in (9001/14001/16949/AS9100/etc.).
 

Randy

Super Moderator
#5
Machelleh2 said:
Just because they have the procedures, doesn't mean they follow them. :confused:

Thanks,
Machelle
Then they're WRONG!!!!! DUH!!!!!!!!!!!!!

I honestly don't mean to be critical, but if you don't know what you are doing, or don't know how...tell the powers to be. We can give you little tid bits of info but you have to bring something yourself and just watching others in the past ain't gonna cut it. If this "auditing" you are supposed to be doing is tied to any type of QMS or a registration certificate it is not acceptable because you are not a "trained and competent" auditor based upon you own admission. If you were trained you would know how to develop a checklist, an audit plan, and all the other neat stuff auditors know how to do.

This has DOOM written all over it.
 
A

Aaron Lupo

#6
Randy said:
Then they're WRONG!!!!! DUH!!!!!!!!!!!!!

I honestly don't mean to be critical, but if you don't know what you are doing, or don't know how...tell the powers to be. We can give you little tid bits of info but you have to bring something yourself and just watching others in the past ain't gonna cut it. If this "auditing" you are supposed to be doing is tied to any type of QMS or a registration certificate it is not acceptable because you are not a "trained and competent" auditor based upon you own admission. If you were trained you would know how to develop a checklist, an audit plan, and all the other neat stuff auditors know how to do.

This has DOOM written all over it.
I was reading this post and started pounding my head on my desk! Not to be mean but it sounds as if she has no clue what she is doing. I agree with Randy you need to let your boss know, maybe they can help you. The other question I have is why are you auditing your suppliers there is no requirement that you have to, you need to evaluate them and that can be done without an audit. Look at your process and see if that needs to be revised. JMHO
 
R

Randy Stewart

#7
A little knowledge is a dangerous thing.
I took a course a few years ago that was called "QS-9000 Supplier Auditor" given by AIAG. I don't know if they have updated the course for 9K2K or 16949.
If you are not an auditor you may cause more damage than good. Even "qualified" auditors cause problems with their own personnalized interpretations so be very careful.
I have been working with supplier development now for 4 years and it is a very touchy situation. The negative impact you can have on your company can hit hard. I strongly suggest that you get some training in auditing and on the standard.
You'll see a lot of messages here on good and bad auditors and how people feel about being audited. Auditing is not for everyone and it's not easy. It's not just knowing what the standard or requirements are, it's in how they are applied - spirit of the law not the letter of the law.
 
E

energy

#8
Can't be done

Machelleh2 said:
I am a trained auditor just by observing other auditors. I understand auditing the processes, It's just if they follow that procedure. For the vendor audit, I looked at there process, but I don't know what to look at in addition. Just because they have the procedures, doesn't mean they follow them. I guess I am wondering what else I should be observing to make sure thay are a suitable vendor. :confused:
Thanks,
Machelle
Machelle
Your first sentence is where the "flak" is coming from. Nobody can learn Auditing by just watching. It's a thought process you develop by following guidelines and some formalized training.
As for your auditing your Suppliers, if you are receiving the right parts, quantities and their price is right, chances are that they meet the requirements. They have probably been around doing business before you became a "trained" Auditor. Send them a questionaire, let Purchasing discuss any issues and get on with some Training for performing Quality Audits. I'm talking strictly from an ISO viewpoint because I'm not aware of the extra requirements imposed by Automobile Manufacturers. Somehow, I think it can be made as difficult or as simple as you want. :agree: :smokin:
 
M

Machelleh2

#10
I just wanted to start off saying that you guys have made me feel really stupid. :( I have asked to go to a auditor training class, work won't let me. They say that I won't learn anything there that they haven't shown me. The problem with that is they really haven't shown me much. As far as the audits, we are ISO 9002:1994. We have an approved vendor list that needs to be updated. Most of the audits are going out thru mail. But the ones we deal with the most, my bosses want me to visit them and get to know the people there. :ko:
 
Thread starter Similar threads Forum Replies Date
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
J Auditing of Support Function IATF 16949 - Automotive Quality Systems Standard 9
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S Risk based internal auditing Internal Auditing 6
Randy Remote auditing (for disaster, disease, disturbance etc...) during the Neo Coronavirus Pandemic and Social Distancing Registrars and Notified Bodies 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 0
F AS9100D Internal auditing requirements Internal Auditing 3
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
tony s What is the automotive process approach for auditing? IATF 16949 - Automotive Quality Systems Standard 2
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
R I've been auditing for a CB for 18 years General Auditing Discussions 10
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 144
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
N Online Internal Auditing Course for ISO 13485 - Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 8
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
U Internal auditing - Company employees or contract second party Internal Auditing 10
J Recomended Values - Auditing process in a supplier IATF 16949 - Automotive Quality Systems Standard 18
M Canada - Registrars that allow e-auditing for ISO 9001? Registrars and Notified Bodies 4
K Internal Auditing - Umbrella QMS and Multiple Standards Oil and Gas Industry Standards and Regulations 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Ed Panek Supplier Auditing - No purchases from our key suppliers in the last 24 months ISO 13485:2016 - Medical Device Quality Management Systems 5
P Auditing "process validation" process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
qualprod Effective Auditing advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
GStough Auditing Against Criteria Unfamiliar to Auditee - Yea or Nay? General Auditing Discussions 11
qualprod Auditing Product and Services doubts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Auditing support and management processes General Auditing Discussions 7
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
D MSDS / GHS Walk-through / Auditing Occupational Health & Safety Management Standards 6
Pmarszal Supplier Auditing Services (Audit Needed?) General Auditing Discussions 4
S ISO 9001 Audit Observations - Transitioning my career into auditing Career and Occupation Discussions 16
G AS9101 Rev F - Worksheets for internal auditing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
N API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers Oil and Gas Industry Standards and Regulations 5
M Auditing processes followed by employees placed on client's site Internal Auditing 4
S ISO 13485:2016 and MDSAP internal auditing ISO 13485:2016 - Medical Device Quality Management Systems 6
M Auditing a Contractor in EMS and Non Conformity Report General Auditing Discussions 1
Richard Regalado ISMS Auditing Guideline V2 (based from ISO/IEC 27001:2013) IEC 27001 - Information Security Management Systems (ISMS) 7
S ISO 9001:2015 - Internal Auditing - Audit to the Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Auditing Senior Management to determine the Effectiveness of Management Processes IATF 16949 - Automotive Quality Systems Standard 6
R Internal Auditor auditing Internal Audit Procedure (AS9100) Internal Auditing 18

Similar threads

Top Bottom