Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not exist

J

joshubob

#1
What are the steps the auditor should take of a QMS Audit on a potential supplier, from the initial contact the auditor learns that a formal documented QMS does not exist.
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
Re: Supplier QMS Audit

It depends on what your product is and who the supplier is ? If this is one of the many suppliers in that commodity, search another one but if it is like a monopolistic supplier and you have no alternative but to take this supplier onboard, work with them for developing the qms.
 

qusys

Trusted Information Resource
#3
Re: Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not e

What are the steps the auditor should take of a QMS Audit on a potential supplier, from the initial contact the auditor learns that a formal documented QMS does not exist.
You can establish some criteria in advance with your potential supplier, before visiting them on their premises for a second party auidt.
You can send them a check list , requesting general info , among which the kind of certification they possess.
if you need other info, plas contact the covers:bigwave:
 

somashekar

Staff member
Super Moderator
#4
Re: Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not e

What are the steps the auditor should take of a QMS Audit on a potential supplier, from the initial contact the auditor learns that a formal documented QMS does not exist.
It looks to me that your selection criteria for a potential supplier does not include being certified to a recognized QMS, typically the ISO9001.
So how can you plan an audit of QMS, when for sure you know he is yet to establish a formal documented QMS ?
You may have to approach with a process and production audit plan to check how his process can consistantly meet your parts quality and quantity requirements. Taking forward a supplier quality program, you can agree for a timeplan from the supplier to be certified to ISO9001 QMS. Further to that, it is your call to decide about you conducting a supplier QMS audit.
 

Colin

Quite Involved in Discussions
#5
Re: Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not e

Just audit them against the clauses of the standard. They will have processes in place to do things like buying stuff and how they take on new work, it probably just won't be formally documented.

Of course there will be some gaps, especially when it comes to documented procedures and they probably won't do things like internal audits but they will have many informal systems in place.
 

Chennaiite

Never-say-die
Trusted Information Resource
#6
Re: Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not e

We consciously use the term 'evaluation' rather than 'audit' for prospective suppliers. It's more of evaluating the capability of the Supplier fraternity to raise the bar to expected level.
Sometimes, we enjoy cost advantage in case of such 'up-gradable' Suppliers.
 
J

JaneB

#7
Re: Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not e

What are the steps the auditor should take of a QMS Audit on a potential supplier, from the initial contact the auditor learns that a formal documented QMS does not exist.
You absolutely should determine the scope of the audit, the procedure and the benchmark - ie, what you will audit against - before you go there.

It just isn't fair, let alone effective, to do an audit without that. I speak having seen the other side of such "audits" done on where no one was clear about what the audit was against, and the results were enormously time-wasting. For example, at one company I saw an audit report by some so-called 'auditors' which was almost unintelligible and I doubt its accuracy. It kept saying 'no quality manual exists' and virtually refused to look at anything else, giving ultimately a somewhat biassed and incorrect view of the operations there, which did have a number of controls built into the computer system, but which the auditors didn't appear to consider.

The suggestion to audit against the Standard's requirements is a sound one - it's a recognisable and respected benchmark. You could always leave out a clause or three if they aren't relevant. And yes, you could also call it an evaluation, which may go down better.
 
A

amanbhai

#8
Re: Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not e

We can audit them if this audit is agreed between you and your supplier and that it has been agreed prior.
You can agree with your supplier on the following clauses:
Non conformances procedure, corrective actions, purchasing, contract review and amendments, and whether they have certification place.
Make initial contact with them and even if you don't visit them, you can still send them self evaluation checklist.
 

jasonb067

Quite Involved in Discussions
#9
Re: Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not e

Unless you have some requirements from your customer or industry I urge you to focus on the processes and parts not the documents or documented procedures.

Are there current or similar processes capable, stable, in control and producing good parts? Do they have the staff to understand the processes and products? How do they let the process speak to them which will let them respond correctly to trends, variation etc.

Do they have means to manage the execptions and have they demonstrated responses to past exceptions?

Focus more on what they are doing. Otherwise you are selling yourself and your company short because of a non-valid reason.

You can sit in a conference room all day long with the best QMS ever drafted presented to you in paper format and never understand what the conditions of the products your potential supplier are making...

Unless you are buying a Quality Management System from them do not focus your audits or reviews or whatever you want to call them on the QMS.
 
J

Jason PCSwitches

#10
Re: Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not e

You also need to review the requirements flown-down to your organization from your customer. They may have requirements for sub-tier suppliers that you may need to take into consideration. Often you may be required to use only sub-tier suppliers they have approved. If this is the case you will need to get your customer to approve them as a source, if not already approved by them.
 
Thread starter Similar threads Forum Replies Date
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Supplier Quality Standard vs Senior Management Direction Supplier Quality Assurance and other Supplier Issues 2
S Supplier Control - Supplier quality management certificates (ISO, etc) ISO 13485:2016 - Medical Device Quality Management Systems 2
J Support and guidance with supplier quality management system Supplier Quality Assurance and other Supplier Issues 1
J IATF 16949 Cl. 8.4.2.3 - Supplier Quality Management System Development IATF 16949 - Automotive Quality Systems Standard 59
S SQM (Supplier Quality Management) - Centralized or divided per Business Group Benchmarking 0
Q Supplier Quality Management Development IATF 16949 - Automotive Quality Systems Standard 10
L Courses in Supplier quality management - Sydney or NSW Supplier Quality Assurance and other Supplier Issues 6
F What are the Performance Indicators for Supplier Quality Management Department Supplier Quality Assurance and other Supplier Issues 11
A Supplier Quality Management Strategies - Semiconductor Assembly and Test Services Supplier Quality Assurance and other Supplier Issues 6
Sidney Vianna SI 5 06 - ISO/TS 169494:2002 7.4.1.2 Supplier quality management system development IATF 16949 - Automotive Quality Systems Standard 42
P TS16949 vs. AS90001 - 7.4.1.2 Supplier Quality Management System Development IATF 16949 - Automotive Quality Systems Standard 7
J Automotive makers strategy and benchmarking on supplier quality management Supplier Quality Assurance and other Supplier Issues 2
D Supplier Quality Management including Supplier performance evaluation methods Supplier Quality Assurance and other Supplier Issues 2
T 7.4.1.2 Supplier quality management system development Supplier Quality Assurance and other Supplier Issues 3
Ajit Basrur Quality Agreement with supplier covering medical devices and consumer requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
Jen Kirley Moving on - I accepted an offer to be a Supplier Quality Engineer at GE Healthcare Coffee Break and Water Cooler Discussions 42
Tagin Measuring supplier quality with small quantities Statistical Analysis Tools, Techniques and SPC 10
A Critical Supplier/Quality Agreement Procedure ISO 13485:2016 - Medical Device Quality Management Systems 8
GStough Have You Had to Write a NC Against a Quality Manual in a Supplier Audit? General Auditing Discussions 12
P ASQ Certified Supplier Quality Professional is the certification worth it? Supplier Quality Assurance and other Supplier Issues 1
T ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements ISO 13485:2016 - Medical Device Quality Management Systems 11
L Supplier Approval Process – Should the Quality Department be Excluded? Misc. Quality Assurance and Business Systems Related Topics 7
I Difference between ASQR (Aerospace Supplier Quality Requirements) and AS9100 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 20
K NPI (New Product Introduction) Quality Plan Outsourced Manufacturer/Supplier APQP and PPAP 3
B Measuring Supplier Quality Performance Supplier Quality Assurance and other Supplier Issues 10
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
S Supplier Quality with Prototyping Parts with no Part Number or Drawings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Can you help me on manpower planning for Supplier Quality Engineers ? Misc. Quality Assurance and Business Systems Related Topics 4
V Quality Roadmap from Voice of the Customer way down to Supplier Quality Manager and Management Related Issues 4
G Supplier Quality Questionnaire - Asking who our customers are Quality Manager and Management Related Issues 10
D What's the future of supplier quality engineer for your worklife? Supplier Quality Assurance and other Supplier Issues 3
V Supplier Service Level Agreements (Supplier Quality Development) APQP and PPAP 2
F Supplier Quality Engineer Beginner - Potential Interview Questions Supplier Quality Assurance and other Supplier Issues 3
O Vendor (Supplier) Responsibility - Re: Quality Audits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Does someone has experience with a Supplier "Quality Watch" Supplier Quality Assurance and other Supplier Issues 3
T World Class Supplier Quality Alert System CAR/SCAR By Email Quality Assurance and Compliance Software Tools and Solutions 2
J Quality Manager's role in Customer and Supplier Complaints Customer Complaints 10
J Implementing a Supplier Quality Portal Misc. Quality Assurance and Business Systems Related Topics 2
T Senior SQE (Supplier Quality Engineer) Specific Roles and Responsibilities Career and Occupation Discussions 5
P What is the last revision of Toyota SQAM (Supplier Quality Assurance Manual)? Customer and Company Specific Requirements 3
S SQE (Supplier Quality Engineer) Job Interview Questions Benchmarking 4
D Aftermarket Supplier Quality Requirements IATF 16949 - Automotive Quality Systems Standard 6
T Recommended Books for SQE (Supplier Quality Engineering) Book, Video, Blog and Web Site Reviews and Recommendations 20
L Avoiding Recurrence of the Supplier?s Quality Problems Supplier Quality Assurance and other Supplier Issues 5
N Using a Vendor's (Supplier's) Quality System ISO 13485:2016 - Medical Device Quality Management Systems 7
optomist1 Definition Supplier Quality Assurance vs. Supplier Development vs. Field Quality Engineering Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
Q Vendor (Supplier) Quality Plan vs. Our QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Medical Device Supplier Quality Agreement example wanted Supplier Quality Assurance and other Supplier Issues 2
T Integration of Supplier Quality Assurance within Plant Engineering Supplier Quality Assurance and other Supplier Issues 5
Similar threads


















































Top Bottom