How do you handle a pushy auditor?

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#41
Hello,

We are a software medical device manufacturer and we had an FDA inspection in September and we are going to have and ISO audit in November. I know that the ISO 13485 auditor can request to see internal audit reports, can they also see external audit reports?

Anticipating a "pushy" auditor . . .

Thank you in advance for you're assistance.

Anne
I have answered your question in the thread Can an external ISO Auditor view FDA inspection results. It usually isn't necessary to ask a question in different threads. This forum is pretty responsive.
 
Last edited:
Elsmar Forum Sponsor

Randy

Super Moderator
#42
I encountered the same thing with my registrar. They were a very large company with hired consultants and each consultant seemed to have a different opinion on things. I asked the same questions as you. Initially, the two big guns they sent in on the registration audit seemed to get caught up in sematics. I eventually fired them and went with a smaller company. They are not easy but they are not as inconsistent nor rigid on verbiage as the first registrar.

As a matter of fact, we almost fired the registrar prior to exiting the initial opening meeting because we were in the conference room for over 3 hours arguing over manual verbiage. They seemed to change their tune when they saw we were not going to back down.

Don't be afraid of standing up to them if you feel you are right.
Dante......registrars don't use consultants they use auditors....big difference!

I will stop here.
 

Wes Bucey

Quite Involved in Discussions
#43
I encountered the same thing with my registrar. They were a very large company with hired consultants and each consultant seemed to have a different opinion on things. I asked the same questions as you. Initially, the two big guns they sent in on the registration audit seemed to get caught up in sematics. I eventually fired them and went with a smaller company. They are not easy but they are not as inconsistent nor rigid on verbiage as the first registrar.

As a matter of fact, we almost fired the registrar prior to exiting the initial opening meeting because we were in the conference room for over 3 hours arguing over manual verbiage. They seemed to change their tune when they saw we were not going to back down.

Don't be afraid of standing up to them if you feel you are right.
I'm sure you mean "hired independent contractors as auditors" (versus having each auditor on the payroll as a full-time employee.)

You'll find the nomenclature for individuals performing third party audits is very particular about keeping a dividing line between auditing and consulting.
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#44
Re: Can an ISO Auditor request to view FDA audit findings

Anticipating a "pushy" auditor . . .:lol:
Hi, Anne -

I wouldn't "anticipate" anything - give the auditor a chance to get in there and then react. It's been my experience that most auditors are very open minded and listen to their clients.
 

Helmut Jilling

Auditor / Consultant
#45
I encountered the same thing with my registrar. They were a very large company with hired consultants and each consultant seemed to have a different opinion on things. I asked the same questions as you. Initially, the two big guns they sent in on the registration audit seemed to get caught up in sematics. I eventually fired them and went with a smaller company. They are not easy but they are not as inconsistent nor rigid on verbiage as the first registrar.

As a matter of fact, we almost fired the registrar prior to exiting the initial opening meeting because we were in the conference room for over 3 hours arguing over manual verbiage. They seemed to change their tune when they saw we were not going to back down.

Don't be afraid of standing up to them if you feel you are right.

It should not take 3 hours to discuss verbiage in the manual.

It is not beneficial to either party to argue for 3 hours. Good auditors are there to be value added. Poor auditors may not understand what that means. But, please be sure that you are not compounding the problems. I have had a few clients who made things worse, but did not understand that they did not know the requirements.
 
D

dcsmith1001

#46
Re: How do you handle an arrogant auditor?

How would you handle an auditor who is arbitrary in application of the requirements in many cases making interpretations outside of the cope of the standard, and at one instance accepts the quality system as adequate and then 4 months later identifies multiple non-conformances when the system itself is unchaged?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#47
Re: How do you handle an arrogant auditor?

How would you handle an auditor who is arbitrary in application of the requirements in many cases making interpretations outside of the cope of the standard, and at one instance accepts the quality system as adequate and then 4 months later identifies multiple non-conformances when the system itself is unchaged?
Are you being charged extra for his/her multiple personalities? :lmao:

On a more serious note, the recurring advice applies. Keep your auditor honest by forcing him/her to stick to requirements. If s/he doesn't, appeal in writing to their superiors since CB's are required to have an appeal process. But keep in mind that the auditor could be correct in both instances. Or wrong in both audits. Time and time again people come here expecting to find a mob ready to bash auditors, but sometimes, when details are provided, one finds out that the auditor was doing their job correctly, and the problem lies with the auditee's perception and expectations. So, if you really would like to have more meaningful feedback, you need to provide more information.
 
Last edited:

Stijloor

Staff member
Super Moderator
#48
Friends,

I believe that it is appropriate to "push back" (in a professional manner) when auditors bring up issues that are not really requirements. Regretfully, the auditees do not always have a clear understanding of the applicable Standard and interpretation of the requirements, let alone their own! What's even worse is when managers start contradicting each other during an audit... Before we "beat up" on the auditors, let's first get our own (quality management system) house in order. :2cents:

Stijloor.
 

Helmut Jilling

Auditor / Consultant
#49
Re: How do you handle an arrogant auditor?

How would you handle an auditor who is arbitrary in application of the requirements in many cases making interpretations outside of the cope of the standard, and at one instance accepts the quality system as adequate and then 4 months later identifies multiple non-conformances when the system itself is unchaged?
I don't have an answer for the first part of your question. But the second part - even good auditors can see definitely different results from audit to audit. It is largely dependent on what items he happens to look at from audit to audit.
 
Thread starter Similar threads Forum Replies Date
K Different Indications for Use in Different Countries -- how to handle IFU? Other Medical Device Regulations World-Wide 4
K How to handle GTINs for different configurations of one device with one part number? Other Medical Device Related Standards 0
I How to handle pending FSN when incident happens? EU Medical Device Regulations 1
Jimmy123 Process disturbances and the repair - How do you handle this risk in your company? FMEA and Control Plans 18
GoSpeedRacer How to handle operator involvement in the non conformance ISO 13485:2016 - Medical Device Quality Management Systems 5
A How to Handle Documented Information in an online database for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
O How will you handle Clause 6.1 - Risks and Opportunities for AS9100 Rev. D Auditors? Risk Management Principles and Generic Guidelines 22
V Systems to Handle Development and Batch Analysis in same Laboratory Qualification and Validation (including 21 CFR Part 11) 3
dubrizo How do you handle damaged IM&TE in your organization? General Measurement Device and Calibration Topics 3
D MDD Classification of Bone Saw Handle ISO 13485:2016 - Medical Device Quality Management Systems 1
1 How to handle Nononformances in Clincal Manufacturing ? Nonconformance and Corrective Action 2
R How do we handle Training during transition and overlap from one system to other ? Training - Internal, External, Online and Distance Learning 4
Q How to handle different voltages for different countries Document Control Systems, Procedures, Forms and Templates 1
A How to handle complaints after end of specified medical device life-time ISO 13485:2016 - Medical Device Quality Management Systems 5
M How does Australia handle products that are EU PPE, but Australia Medical Devices? Other Medical Device Regulations World-Wide 7
C How to handle this Inspection conflict? Second Shift Inspector? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T How to handle Demo Units during an ISO 9001 Audit General Auditing Discussions 3
C ISO 9001 Nonconformances an how to handle them ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D How to handle a blood stained GMP document ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
T How to handle 510(K) submisison in 2014 when the Fees were paid in FY13 ? US Food and Drug Administration (FDA) 3
C How to handle Action Results in a new FMEA Review once we have a new RPN? FMEA and Control Plans 1
Mikishots How to handle CAR (Corrective Action Request) Scope vs. Timely Response Nonconformance and Corrective Action 9
J Quality Procedure to handle some standard Medical Device Processes Document Control Systems, Procedures, Forms and Templates 1
L How to handle a Business Shutdown - Business Dissolution 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Plan & Procedure to handle a Product that's being Withdrawn from the Market 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Can you handle passivated parts without wearing gloves? Manufacturing and Related Processes 5
A How to handle the various Document Revisions Document Control Systems, Procedures, Forms and Templates 2
N How to handle Quality and Safety Deficiencies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Client that refuses to help - How to handle ? Misc. Quality Assurance and Business Systems Related Topics 5
C How to handle Outsourcing with Same Site - Separate Cert ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B How to handle Medical Device Emergency Software Releases Software Quality Assurance 4
B How to handle/follow supervisor and department head with different supervisory style? Quality Manager and Management Related Issues 7
Z If this is a Nonconforming Product (Service) under clause 8.3? How do we handle it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Responsibility of Distributor for Customer Complaints - How should we handle this Customer Complaints 5
R How to Handle 'Scrap and Replace' of Non-Conforming Products Nonconformance and Corrective Action 9
B Upper Management makes changes to a report - How do I handle this? Six Sigma 12
J SOP for How to Handle an Investigation wanted Document Control Systems, Procedures, Forms and Templates 1
J AS9100 C - 7.5.1.3 - How do you handle Production Equipment Maintenance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
J Seeking advice on how to handle a Special Process Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
M How to handle the task of Organizing a Regulatory File Room Document Control Systems, Procedures, Forms and Templates 2
V ISO 26262 - How to handle OEM ASIL A (Automotive Software Integrity Requirements) Other ISO and International Standards and European Regulations 4
M How to handle Rejections of a Internal NCR event Nonconformance and Corrective Action 7
G Manufacturing Process Subcontracted - How do I handle Cl. 7.5? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
P How to handle Out of Tolerance during Calibrations and exceeded Alert Action Limits Quality Manager and Management Related Issues 4
M The importance of Document Control? How do you handle your Document Control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R How do you handle 'Contaminated Wood Pallets'? US Food and Drug Administration (FDA) 16
L Quality Objectives - How various device companies handle "Quality Objectives" ISO 13485:2016 - Medical Device Quality Management Systems 9
A How does your registrar handle 2 certificates, one for AS9100 and one for ISO9001? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
Le Chiffre Great article on how to handle continuous improvement Quality Manager and Management Related Issues 3

Similar threads

Top Bottom