Must We Audit Critical Suppliers? How often?

ugecha

Starting to get Involved
#1
Hello, everyone.

We had MDD audit this year and NB auditor said clearly "you must audit your foreign factory (making class II devices) at least ONCE A YEAR. NB must audit them according to ZLG3.9 B17 if you fail to show clear evidence of good controlling. "

My question is,
1. Is this true? If so, is there any document saying manufacture must audit critical suppliers once a year?

2. Is this just because NB is a German organization? How about other NB like SGS? I am told that other NBs never say such a thing.

3. How often should we conduct an audit for "critical supplier" It is not cheap to go there every once a year. One of critical suppliers is located abroad. How often do your company go and audit?

4. We don't have a staff member who speaks English and full of knowledge on regulations. How do you handle such situation in your company? One person never cover them all, two or three people must go visit suppliers. We can't afford that.

5. We will have an inspection from FDA soon. Are they going to say the same thing?

I appreciate for your help very much.
 
Elsmar Forum Sponsor
#2
Hi ugecha,

ZLG is a German notifying authority performing the recognition and monitoring of testing laboratories and certification bodies in the area of medical devices and in vitro diagnostic medical devices. 3.9 B17 refers to the best practice guide from the European Notified Body Operations Group (NBOG BPG 2010-1) that ZLG just adopted without modifications. So it's nothing to do with your NB being German. Check out article 5 (criteria for audit of a supplier's premises), especially the note on page 5 and the last paragraph of this article. This should give your organization some leeway in decision-making.

Regards, Angelika.
 

Attachments

M

MIREGMGR

#3
5. We will have an inspection from FDA soon. Are they going to say the same thing?
21CFR 820.50 requires that you have component specifications and purchasing controls to assure that those specifications are met; and that you define what controls apply to each supplier, and document your application of those controls.

FDA does not have a specific onsite-audit requirement, or required audit frequency. However, if a supplier is identified by you or by the inspector as critical but you haven't defined more-rigorous controls for that supplier, you can expect the inspector to fault you for that lack of evidence that you have taken 820.50 seriously. An on-site audit program of some frequency, with other controls during periods between audit visits to provide evidence that specifications were continually met, would be one way to demonstrate 820.50 compliance.
 

ugecha

Starting to get Involved
#4
Thank you, Miregmgr for your kind explanation. If you happen to know if other NB like SGS, TUV asks the same thing at audit, will you let me know.
Thank you.
 
S

ssz102

#5
many standards had requires enterprise to control and evalute &verify them supplier qulificaiton and related to information

in this process, need to factory or firm to check on supplier site

like your situation, i think may be authorized certification body help to evaluate supplier, or send product to test body, let them help to validate these product whether are meet your specification or not
 

pkost

Trusted Information Resource
#6
There is no specific requirement for the manufacturer to audit, just to have control. If you do audit, there is no requirement to do it x number of times a year.

As Angelika has said, the new code of practice for notified bodies has tightened the area for control of suppliers, however it is important to note that it still doesnt' require the manufacturer to carry out an audit, or specify how frequently. It also leaves a lot of room for interpretation by the NB as to whether the NB needs to audit the supplier.

That being said, if the NB says "you audit or we will" because that is their criteria for supplier control then that is their decision and if you don't like it you could argue the toss or move to another NB
 

ugecha

Starting to get Involved
#7
Thank you all, so from what I have learned here, we would be better conduct an on-site audit at least once a year for the time being following advice from our NB auditor. He said regulation will be tougher due to PIP case in EU as well.
Also I agree that FDA will be happier if we have periodic audit plan for critical supplier. Can't be too careful. Thank you all again.:thanks:http://elsmar.com/Forums/images/smilies/thankyou.gif
 
C

chandaraasekar

#8
first you should have a supplier evaluation system on a regualr frequency , which includes the supplier QUality , Delivery , Continual imp[rovement and cost performance also include his response to ur queries. Now you can ask the supplier to give a countermeasure for poor scoring elements and let him visit your plant to explain corrective actions.If you still find the supplier is repeating the same complaints then prepare a supplier visit .
On a proactive basis you connduct supplier reassessment on a yearly ( local ) 3 year once for a overseas supplier.
 
Thread starter Similar threads Forum Replies Date
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
J Customer VDA Audit - We must provide refresher training? VDA Standards - Germany's Automotive Standards 4
J Any diverging opinions regarding audit findings or conclusions must be resolved no later than the closing meeting ISO 13485:2016 - Medical Device Quality Management Systems 13
Q IATF 16949 - Product audit - Must each product be audited? IATF 16949 - Automotive Quality Systems Standard 6
W Product Audit - It must be a separate and distinct activity (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 4
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
C AS9100C Audit must include FAA Part 145 (FAA Repair Station)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G How much time must pass after the first Certification Audit for us to appear in OASIS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
S Must *All* Procedures Be Documented for ISO 9001 Internal Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
B Must I agree to an IATF Witness Audit? Registrars and Notified Bodies 16
V AS9100B Time Limit? Time between your audit and when your CARs must be accepted AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
E What documentation must I provide during a 2nd party audit? General Auditing Discussions 10
A Audit day - Production Planning - Must we be producing product? General Auditing Discussions 14
J Is it a must to run EMS for 3 months before initial external audit Miscellaneous Environmental Standards and EMS Related Discussions 7
G Internal Audit Nonconformances must be Closed prior to Registration? Internal Auditing 28
A ISO 14001 Clause 4.5.4 - Internal Audit - Must a company perform internal audits? ISO 14001:2015 Specific Discussions 5
D Must we have FMEA for ALL the products by the registration audit? FMEA and Control Plans 3
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet Must COPQ always be quantified as a monetary ($) amount? IATF 16949 - Automotive Quality Systems Standard 2
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
A Read instruction manual - What Graphic Symbol must I use? US Food and Drug Administration (FDA) 7
M What kind of instrument that must be calibrated? General Measurement Device and Calibration Topics 3
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
M Which documents must be updated upon product validation? Document Control Systems, Procedures, Forms and Templates 1
G From an ISO 17025 auditor perspective must micrometer calibration check anvil flatness? General Measurement Device and Calibration Topics 4
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
T Must all Disposable Medical Devices be DEHP Free for MDR? EU Medical Device Regulations 1
S Record Retention - How long must a company keep the following records? Records and Data - Quality, Legal and Other Evidence 17
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
A ISO 9001:2015 Clause 9.3.2 - Management Review Inputs must be Documented? Management Review Meetings and related Processes 15
N Must Bioburden Sampling Procedures be Documented? Other Medical Device Related Standards 5
M Contacting a "Must Use" (aka Sole Source) Supplier's Registrar Supplier Quality Assurance and other Supplier Issues 6
T Auditor states my Oven Thermocouples must be Calibrated General Measurement Device and Calibration Topics 18
K Must I update the Quality Policy? (ISO 9001:2008) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
B Must a Design Outsourcing Company have ISO13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
U Must every procedure be proceeded by a policy? Document Control Systems, Procedures, Forms and Templates 2
P Must all parts of a product be RoHS compliant? EU Medical Device Regulations 5
N Must electrodes for Rx/prescription stimulators be Rx only? Other US Medical Device Regulations 2
V Is there an approach to define the "must 'or' should" in supplier audits? US Food and Drug Administration (FDA) 2
F Electronic Signatures (21CFR Part 11) - Must They Appear on Printed Documents Document Control Systems, Procedures, Forms and Templates 9
R What are the "Must Have" Specs and Standards for AS9100 Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
L Must we do Receiving Inspection for everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
U Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited labs? ISO 17025 related Discussions 8
C Must we identify steps taken to identify the Root Cause of a failure Nonconformance and Corrective Action 15
Y Must every Process have a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
L Must the Signature on a Quality Record be Legible? Records and Data - Quality, Legal and Other Evidence 33
N Must Employees Be Evaluated Annually? Training - Internal, External, Online and Distance Learning 19
A Calibration system must meet ISO 10012, ISO 17025 or ANSI/NCSL Z540? ISO 17025 related Discussions 38

Similar threads

Top Bottom