Telephonic supplier audits!

roneljdsilva

Involved In Discussions
#1
Hey Guys.. and Marc :bigwave: ,
Firstly I'd like to show my gratitude for all that the cove has helped me with.Thanks all of you! You guys are awesome... and i genuinely mean it.
I've recently graduated and had trained in the QMS for three months in a startup machine shop/fabrication facility complying to ISO ( We are planning on obtaining API Q1 (we have a few API monograms)) after which my Quality Manager resigned and I was assigned a lot of his duties. I have a lot on my plate and I am understanding bits of the standard one piece at a time and it's going great! This is also a reason you'll are going to be seeing a lot of my posts in coming times :notme:
Now regarding supplier audits.. I work in Kuwait and most of my supplies, especially critical, come from Dubai.. So as per API Q1, do I really need to conduct a supplier audit for supplier qualification? If yes, can it be telephonic?
I do not have much experience and have no info backing me up, everything from here on now is just fresh food on my plate and boy, am I hungry! HELP!
 
Elsmar Forum Sponsor
L

lk2012

#2
hello,
well done on your new role.
Nothing replaces seeing the supplier's site for yourself and making your own judgement.
I'd strongly recommend doing the supplier audits, preferably as a visit to their site at least for their first time you're taking them on. After that, you could either ask them to provide a self-assessment (you may use tools like the MMOG/LE for example) or perhaps run a spot check on a few things in a teleconference.
If there's something not quite right, another visit may be on the cards.
Hope this helps
 

roneljdsilva

Involved In Discussions
#3
It does help,
I understand the need to have an on-site visit and will push my management to fly my team there but we have a lot of ground to cover and since we are a start-up I just want to know if it is a mandatory requirement.. I think it is. Or wait let me pull this one out..
I quote API Q1 Clause 5.6.1.2
b) assessment of the supplier to ensure its capability to meet the organization's purchasing requirements by:
i) performing an on-site evaluation of relevant activities, or
ii) performing first article inspection to ensure conformance to stated requirements, or
iii) identifying how the supplied product conforms to stated requirements when limited by proprietary, legal, and/or contractual arrangements.


* Now the fact that they connected these three point with "or" confuses me on whether an on-site audit is mandatory. Please advice.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#4
Welcome to the Cove!

Let us consider risk. You describe these parts as critical. Can you discern the supplier's reputation for performance and customer service in another way? If the supplied parts are not good, would you be able to notice right away or would product failure only be apparent once it gets to the customer?

If the cost of getting it wrong is high, a visit to their site could be a good investment. Being ISO 9001 registered is supposed to be enough, but in my experience it is not always. You have the prerogative to decide.

Since you are intent on maintaining conformance with the standard, it is not too soon to begin thinking in terms of risk because the 2015 revision of ISO 9001 will be centralized on managing risk. Supplier control is an excellent place to begin applying the critical thinking principles and recording the basis of your decision for the sake of future reconsideration and reporting to management as needed.

Once having established a good relationship with suppliers and gaining confidence that the parts are good, it is possible to evaluate continued supplier performance via their supplied products and/or services alone.

I hope this helps!
 

roneljdsilva

Involved In Discussions
#5
I just quoted a section of the API Q1 manual regarding this. What do you make of it? Again, I'm stating I understand a field visit is crucial but as of now I just want to know if it is madatory. We have been using the suppliers for a year now and nothing has come up.. plus in the middle east, I must say the supplier aren't overly impressive with their systems.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#6
I just quoted a section of the API Q1 manual regarding this. What do you make of it? Again, I'm stating I understand a field visit is crucial but as of now I just want to know if it is madatory. We have been using the suppliers for a year now and nothing has come up.. plus in the middle east, I must say the supplier aren't overly impressive with their systems.
API Q1 provides a range of choices of allowable means for supplier evaluation, consider the word "or" following lines i) and ii). The question thereafter becomes one of effectiveness, which your site is expected to periodically evaluate and respond to based on data analysis. Since you have described your own sense of the need to in-person visit as crucial as a business case, it appears your decision is made and the intent of API Q1 is satisfied. As time progresses you may decide, based on the parts' condition when you receive them and the supplier's otherwise performance (on time delivery, responsiveness to queries etc.) you may decide to apply choices ii) or iii) unless something happens to change your mind.
 
Thread starter Similar threads Forum Replies Date
A Supplier File info for large (Microsoft) companies. Medical Device and FDA Regulations and Standards News 2
J Revamping Supplier Qualification, Re-evaluation, and Monitoring Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
J Outsourced Purchasing for Contract Manufacturing vs more typical/simple Supplier Management ISO 13485:2016 - Medical Device Quality Management Systems 2
D "FAI" Requirements/Process for New Supplier Materials Design and Development of Products and Processes 3
T Stellantis supplier quality manual Supplier Quality Assurance and other Supplier Issues 5
G Use of Supplier's Corrective Action Form vs. Corporate Form Supplier Quality Assurance and other Supplier Issues 4
Stefan Mundt AS9100D Engineering sample purchases - Supplier not approved AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
G Audit & Agreements for "Test Laboratory" Supplier? US Medical Device Regulations 4
S Supplier performance required to be reported to supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P Homologation responsibilities as OEM supplier Manufacturing and Related Processes 0
S Non-approved supplier? Supplier Quality Assurance and other Supplier Issues 3
Q 8.4.2.4 supplier monitoring IATF 16949 - Automotive Quality Systems Standard 3
Q IATF 16949 8.4.2.4 Supplier Monitoring IATF 16949 - Automotive Quality Systems Standard 2
G Control of Approved Supplier List (ASL) When Employees Make Purchases Supplier Quality Assurance and other Supplier Issues 6
V Prototype for chemical supplier IATF 16949 - Automotive Quality Systems Standard 0
Sortinghat Locating Customer Supplier Manuals Customer and Company Specific Requirements 5
Q BMW Supplied Parts Quality Management -> Is there any new supplier quality manual? Customer and Company Specific Requirements 0
M Supplier Control for Unique Product ISO 13485:2016 - Medical Device Quality Management Systems 6
C Process owner for Supplier Controls ISO 13485:2016 - Medical Device Quality Management Systems 11
L Unique Supplier Control Issue AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
D Supplier OTD Slip Due to Shipping Delays or Natural Disaster AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Re-labeler - audit the supplier EU Medical Device Regulations 2
Evelyn7E The fastest way to get supplier to ship good parts to you Supplier Quality Assurance and other Supplier Issues 10
J Verification of purchased product / supplier questionnaires ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question on Supplier Quality (SCAR) ISO 13485:2016 - Medical Device Quality Management Systems 6
Z REACH: contradictory statement from supplier? REACH and RoHS Conversations 4
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
R Select the 1 Supplier based on the Parts Durability from 6 Supplier Samples using Minitab Using Minitab Software 11
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3
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
S IATF 16949 Supplier selection criteria 8.4.1.2 IATF 16949 - Automotive Quality Systems Standard 5
M Supplier approved list - Notified body, regulatory body Supply Chain Security Management Systems 4
N Making improvements in supplier relationship last? Supplier Quality Assurance and other Supplier Issues 6
K Supplier Qualification for Engineering Consultant? Supplier Quality Assurance and other Supplier Issues 3
M Supplier evaluation Supplier Quality Assurance and other Supplier Issues 5
briteme4 ASL - AS9100 / Supplier Survey Supplier Quality Assurance and other Supplier Issues 3
A System for Supplier Documents Quality Assurance and Compliance Software Tools and Solutions 7
T IMDS submission without supplier's input? RoHS, REACH, ELV, IMDS and Restricted Substances 5
J Supplier not responding to PPAP request APQP and PPAP 5
D Supplier audit Medical Device and FDA Regulations and Standards News 2
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
S Distinction between a critical supplier and a Virtual manufacturer EU Medical Device Regulations 3
R AS9102 FAI Change in Material / Process Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
John Broomfield Five ways to botch your supplier management program Misc. Quality Assurance and Business Systems Related Topics 7
C Supplier survey - 200 to 250 duppliers Supplier Quality Assurance and other Supplier Issues 3
J Where is the definition of a critical supplier? ISO 13485:2016 - Medical Device Quality Management Systems 5
U Approved Vendor (supplier) List Supplier Quality Assurance and other Supplier Issues 8
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
P Training department ideas and development for automotive supplier Training - Internal, External, Online and Distance Learning 6

Similar threads

Top Bottom