How to make good Evaluation of Quality Management System of Suppliers

Chennaiite

Never-say-die
Trusted Information Resource
#1
Dear Coves,

How to make good evaluation of Quality Management System of Suppliers ? (Is it really a million dollar question..)
I will put a closed question - Is it possible to make correct evaluation of Supplier QMS without adequate knowledge of the relevant process/product and only through Documents/Records, Observation and interviews? Of course, QMS knowledge is by default.
Thanks.
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: How to make good Evaluation?

No, not really. That's why a site visit and supplier audit are much more effective.

Stijloor.
 
J
#3
Re: How to make good Evaluation?

Dear Coves,

How to make good evaluation of Quality Management System of Suppliers ? (Is it really a million dollar question..)
I will put a closed question - Is it possible to make correct evaluation of Supplier QMS without adequate knowledge of the relevant process/product and only through Documents/Records, Observation and interviews? Of course, QMS knowledge is by default.
Thanks.
One can make a good evaluation of a QMS system without knowledge of the process/product - yes. One is not evaluating the process of manufacture but rather the process of the QMS.
It is helpful and it makes it easier and more thorough perhaps to have knowledge of the process/product but I would say essential.
In fact too detailed knowledge of the process/product risks projecting your own opinions on how things should be done onto the system you are evaluating.

James
 

Chennaiite

Never-say-die
Trusted Information Resource
#4
Re: How to make good Evaluation?

One can make a good evaluation of a QMS system without knowledge of the process/product - yes.
James
Somebody who has worked all his life in Casting and forging may not understand the influence of "dust" in "Screen printing" process. Is it not so?
In which case, how does this evaluator going to confirm that particular QMS is good enough to eliminate or reduce the quality risk?
Thanks.
 

automoto

Involved In Discussions
#5
My purpose would be,

If you want to have benefits from 2nd party audits you should do it on site and focus on manufacturing process. Require control plan from the supplier and check on site if all requirements stated on control plan are implemented. Your interest is to get good parts from suppliers therefore you should check if the supplier performs manufacturing process in the way that was approved through PPAP process. Also check if supplier perform corrective actions that results from claims (if any).
If the supplier has ISO standard then other elements like documents control, internal audits, management review… will be checked thought 3rd party audit. So there is no need to spend time on those elements.

Summarize:
-[FONT=&quot] [/FONT]Check if the supplier perform manufacturing process in the way that ensure good parts for customer
-[FONT=&quot] [/FONT]Do it on site
-[FONT=&quot] [/FONT]Frequency depends on number of claims and how much important parts they deliver
-[FONT=&quot] [/FONT]Make an audit report and require corrective actions

Aleš
 
B

brahmaiah

#6
Dear Coves,

How to make good evaluation of Quality Management System of Suppliers ? (Is it really a million dollar question..)
I will put a closed question - Is it possible to make correct evaluation of Supplier QMS without adequate knowledge of the relevant process/product and only through Documents/Records, Observation and interviews? Of course, QMS knowledge is by default.
Thanks.
If you perform a)QMS audit,b)Process audit at least once in a year and compile c)Supplier rating regulerly you will have a good assessment of a supplier.Again the key here is the format against which you carry out a,b,& c
V.J.Brahmaiah
 
J
#7
Re: How to make good Evaluation?

Somebody who has worked all his life in Casting and forging may not understand the influence of "dust" in "Screen printing" process. Is it not so?
In which case, how does this evaluator going to confirm that particular QMS is good enough to eliminate or reduce the quality risk?
Thanks.
If the evaluator sees a robust and functioning QMS they should see good instructions, well trained employees, low numbers of customer rejections and those rejects should be demonstrably corrected, cleared, and not repeated.
Internal problems should show the same attention to correcting and assuring that mistakes are not repeated.
Any company with low returns, a robust corrective action system and robust overall quality system is very likely to be a good supplier so the Evaluator has confirmed this without specific knowledge of the process.

James
 

Chennaiite

Never-say-die
Trusted Information Resource
#10
I know some ISO certified suppliers that are not very good...;)

Stijloor.
I endorse this statement.
Being ISO Certified does not "always" guarantee good application. It comes from good understandingof the requirements, discipline of the team, Top Management involvement, blaw blaw.
Thanks.
 
Thread starter Similar threads Forum Replies Date
D Supplier Quality Management including Supplier performance evaluation methods Supplier Quality Assurance and other Supplier Issues 2
M Informational US – National Evaluation System for Health Technology Coordinating Center (NESTcc) Solicits Public Comments for Data Quality and Methods Frameworks Medical Device and FDA Regulations and Standards News 0
M ISO 13485 x ICH Q10 Pharmaceutical Quality System - Comparison Evaluation ISO 13485:2016 - Medical Device Quality Management Systems 2
A Quality Assurance System Evaluation Checklist for AAR M-1003 Other ISO and International Standards and European Regulations 14
S Does overdue preventive maintenance require an evaluation on product quality? ISO 13485:2016 - Medical Device Quality Management Systems 5
C Evaluation of Bearing (Effect) of a Deviation on Quality Nonconformance and Corrective Action 10
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 2
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 1
P GSPRs / Clinical Evaluation EU Medical Device Regulations 3
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
M NICE Medical Technology Evaluation Programme - Recommendations Service Industry Specific Topics 0
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 6
S Regular updates of clinical evaluation report EU Medical Device Regulations 6
K Surface finish (Evaluation Length) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M Clinical Evaluation Benchmark vs. Equivalent EU Medical Device Regulations 2
M IVDR and Performance Evaluation Plan CE Marking (Conformité Européene) / CB Scheme 2
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
S Australia TGA Clinical Evaluation Report (CER) Other Medical Device Regulations World-Wide 0
S API Spec. Q1 clause 5.6.1.2 On site evaluation Oil and Gas Industry Standards and Regulations 10
B Biological evaluation plan and report Other Medical Device Related Standards 5
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 12
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
dgrainger Informational MDCG 2020:13 - Clinical evaluation assessment report template EU Medical Device Regulations 0
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 8
M Clinical Evaluation Plan vs. PMCF Plan EU Medical Device Regulations 24
K Biocompatibility evaluation of gas pathways Medical Device and FDA Regulations and Standards News 5
T HF testing / Summative evaluation for MDDS class I necessary? Human Factors and Ergonomics in Engineering 2
N Evaluation of service providers Supplier Quality Assurance and other Supplier Issues 2
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 8
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 16
C Material from outside CER evaluation period CE Marking (Conformité Européene) / CB Scheme 8
DitchDigger IEC 60601-1 subclause 5.1 - Adequate evaluation in lieu of testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
P SOUP anomaly evaluation for MMA (Mobile Medical Application) IEC 62304 clause 7.1.3 IEC 62304 - Medical Device Software Life Cycle Processes 6
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
P IEC 62304 - evaluation of integration and system testing IEC 62304 - Medical Device Software Life Cycle Processes 4
R Supplier evaluation and business needs in the context of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
U Changes to Internal Processes and Risk Evaluation - Mitigations Risk Management Principles and Generic Guidelines 10
M Informational Work in progress at the FDA for biological evaluation – Color Hazard and RISk calculator (CHRIS) Medical Device and FDA Regulations and Standards News 0
M Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities Medical Device and FDA Regulations and Standards News 0
T EU MDR Article 61- Clinical Evaluation EU Medical Device Regulations 2
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
K Supplier re-evaluation (API Q1) Manufacturing and Related Processes 8
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
D Clinical Evaluation Report - Consultant Recommendations Consultants and Consulting 9
qualprod ISO 9001 Clause 9.1 - Monitoring measurement analysis and evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom