Consultant Participation in Registration Audit

C

CliffK

#1
In an earlier thread here, many people opined that consultants can represent a company in internal audits. e.g. "you can outsource the whole quality system"

I agree with this position.

Unfortunately, I now need some support and references.

First, pointers to registrars that do not exclude consultants from registration audits. Please name names, as I will be contacting them.

Second, official statements that support this position. These could be pronouncements from ISO, ANAB, courts in the USA (I hate to go this far, but this is an important issue and IIRC it has actually been litigated).

Ironically, the auditor that wants to ban me from the audit has been consulting like crazy during the audit.

Thanks ever so...
Cliff Kachinske
 
Elsmar Forum Sponsor
#2
Re: Consultant participation in audit - help, please

Cliff:
I feel your pain.

Two registrars I have personal experience of in such a situation are LRQA and VCA. As far as I'm aware it's only TS that specifically mandates the exclusion (in the rules). Since you're ISO 9000, the registrar has no business excluding you if you've done the audits. I'm guessing that you haven't 'got in the mix' in other areas of the audit, to be seen to fend for the auditee.

Hey, if consultants were excluded, Excel Partnership Inc. would never have been registered by BVQI!
 

Randy

Super Moderator
#3
Re: Consultant participation in audit - help, please

I work for a minor:)lol:) registrar and we do not exclude consultants.

Check out my favorite website and you'll see who I'm referring to.
 

Stijloor

Staff member
Super Moderator
#4
Re: Consultant participation in audit - help, please

In an earlier thread here, many people opined that consultants can represent a company in internal audits. e.g. "you can outsource the whole quality system"

I agree with this position.

Unfortunately, I now need some support and references.

First, pointers to registrars that do not exclude consultants from registration audits. Please name names, as I will be contacting them.

Second, official statements that support this position. These could be pronouncements from ISO, ANAB, courts in the USA (I hate to go this far, but this is an important issue and IIRC it has actually been litigated).

Ironically, the auditor that wants to ban me from the audit has been consulting like crazy during the audit.

Thanks ever so...
Cliff Kachinske
Hello Cliff,

What is your Client's position in all this? If they hire you to guide the QMS development and implementation process, including supporting them during the audit, then your Client should step up to the plate and make their position clear to the Auditor and the Registrar s/he represents. It looks more like a turf war to me.... Not good and nobody wins. Andy is correct in stating that only IATF rules forbid consultants to be present during the audit.

Other Covers will respond I'm sure.

Stijloor.
 
C

CliffK

#5
Re: Consultant participation in audit - help, please

Hello Cliff,

What is your Client's position in all this? If they hire you to guide the QMS development and implementation process, including supporting them during the audit, then your Client should step up to the plate and make their position clear to the Auditor and the Registrar s/he represents. It looks more like a turf war to me.... Not good and nobody wins. Andy is correct in stating that only IATF rules forbid consultants to be present during the audit.
Stijloor.
Ouch, turf war. That one could leave a mark.

Okay, I can see how it would seem like that. Actually, though, I have been hired in great part because a majority of the company's management team feels like the auditor is trying to run the company. I see their point completely.

Part of the problem is this auditor has them somewhat cowed. Peers at the management rep over glasses perched on the end of his nose, drums his fingers on the table while they talk, clarifies his questions by repeating the same words again - stuff like that.
 
Last edited by a moderator:
C

CliffK

#6
Re: Consultant participation in audit - help, please

Cliff:
I feel your pain.

Two registrars I have personal experience of in such a situation are LRQA and VCA. As far as I'm aware it's only TS that specifically mandates the exclusion (in the rules). Since you're ISO 9000, the registrar has no business excluding you if you've done the audits. I'm guessing that you haven't 'got in the mix' in other areas of the audit, to be seen to fend for the auditee.

Hey, if consultants were excluded, Excel Partnership Inc. would never have been registered by BVQI!
Well, I feel my pain, too. :tg: But thanks for the empathy.

Actually, I have gotten in the mix, as you will see in my reply to Stijloor.
 
C

CliffK

#7
Re: Consultant participation in audit - help, please

I work for a minor:)lol:) registrar and we do not exclude consultants.

Check out my favorite website and you'll see who I'm referring to.
Good chance I'll be in touch.

It's the chemical industry. I forget the SIC right off hand. Manufacture of additives for plastic and rubber.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Re: Consultant participation in audit - help, please

If a CB were to demand a consultant to leave the premises (outside of a TS audit) they would be inviting a lawsuit for restriction of trade. It has happened.
On the other hand, it is accepted protocol that, during the course of a management system audit, if a consultant is present, s/he should not interfere with the audit, by, e.g., answering questions on behalf of the auditee. Good consultants understand and realize that the organization must have ownership of the system, so they refrain from active participation in an audit, unless they are working in a capacity that is part of the system being audited, for example, being the management representative, an internal auditor, the CEO, etc...
 
C

CliffK

#9
Re: Consultant participation in audit - help, please

If a CB were to demand a consultant to leave the premises (outside of a TS audit) they would be inviting a lawsuit for restriction of trade. It has happened.
On the other hand, it is accepted protocol that, during the course of a management system audit, if a consultant is present, s/he should not interfere with the audit, by, e.g., answering questions on behalf of the auditee. Good consultants understand and realize that the organization must have ownership of the system, so they refrain from active participation in an audit, unless they are working in a capacity that is part of the system being audited, for example, being the management representative, an internal auditor, the CEO, etc...
Your tag line says it all - organizational dysfunction.

The dysfunction in question is that the organization does not have ownership of the system. They are trying very hard to wrest ownership away from this auditor.

The first meeting with this company, the CEO asked if I was the hit man, come to put them out of their ISO misery.

However, you raise a good point. It probably would have been better to formalize/document our relationship. Thank you very much. Assuming this organization stays with this registrar, we'll have that particular duck in its row.
 

Helmut Jilling

Auditor / Consultant
#10
Re: Consultant participation in audit - help, please

Hello Cliff,

What is your Client's position in all this? If they hire you to guide the QMS development and implementation process, including supporting them during the audit, then your Client should step up to the plate and make their position clear to the Auditor and the Registrar s/he represents. It looks more like a turf war to me.... Not good and nobody wins. Andy is correct in stating that only IATF rules forbid consultants to be present during the audit.

Other Covers will respond I'm sure.

Stijloor.

Let's clarify the above comment. IATF Rules say

" 4.1 - Consultants to the organization cannot participate in the audit." However, they may be present to observe, and frequently are.

Sidney explained it well. They should allow the organization to answer the questions. There is no harm in them being an observer, however. There is no need or benefit to create a hostile environment - we are all working for the same goals, after all.
 
Thread starter Similar threads Forum Replies Date
qualprod Can a consultant be audited instead of QMS responsible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Supplier Qualification for Engineering Consultant? Supplier Quality Assurance and other Supplier Issues 3
chris1price EtO Sterilisation Consultant Wanted Job Openings, Consulting and Employment Opportunities 0
normhowe Seeking a De Novo Consultant Paid Consulting, Training and Services 7
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 10
K ISO 50001 Consultant wanted Paid Consulting, Training and Services 0
E Consultant with Office 365 experience Consultants and Consulting 2
D Automotive Hospitality Consultant Career and Occupation Discussions 11
L AS 9100 D consultant in Delhi, India AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D ISO 9001 & AS9100 Certificate issued by a consultant for a Distributor Registrars and Notified Bodies 11
S MDR consultants - in search of recommendations for a consultant for MDR transition. Paid Consulting, Training and Services 7
A ISMS - Seeking VAPT Consultant Food Safety - ISO 22000, HACCP (21 CFR 120) 1
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
H Looking for Tips on finding an IATF consultant Consultants and Consulting 6
L ISO 13485 5.5.2 - Can a consultant be our Management Representative ISO 13485:2016 - Medical Device Quality Management Systems 5
D Clinical Evaluation Report - Consultant Recommendations Consultants and Consulting 9
M Internal audit consultant ISO 13485 (English speaker) Consultants and Consulting 3
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
N Is consultant prohibited in ISO9001 audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
N Is ISO14001 consultant allowed to attend ISO14001 audit? ISO 14001:2015 Specific Discussions 17
S ISO 13485 Consultant Question - The company has 5 part time employees ISO 13485:2016 - Medical Device Quality Management Systems 1
C Specification Developer or Consultant? Definitions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Who here is Using a Consultant for ISO 9001 Transition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Setting up an LLC as a Consultant Paid Consulting, Training and Services 27
K Sister Company Moving to AS - First time "consultant" - Help? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
S Can anyone share a Consultant Proposal for QMS Remediation? Consultants and Consulting 5
T IATF Certified Auditor/Consultant Wanted in the Evansville, Indiana Area Consultants and Consulting 0
M Can a Consultant be the main contact for a Medical Device Company? Other Medical Device and Orthopedic Related Topics 6
F Cost of hiring ISO 17025 Consultant to Build Laboratory From Scratch ISO 17025 related Discussions 6
J Is getting a UDI Consultant a good idea? Other Medical Device Regulations World-Wide 4
E Consultant Person who implemented ALSO the Registrar Auditor? Consultants and Consulting 17
H How to find a good ISO 9001 Implementation Consultant in Calgary, Canada? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P How to deal with a Recruitment Consultant Career and Occupation Discussions 3
A Creative ways to access Expert Information when you can't afford a top $ Consultant Misc. Quality Assurance and Business Systems Related Topics 7
S Design and Development Document evidence for Engineering Consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P FDA QSR Inspection Consultant Recommendations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
L Mock Audit by External Consultant (ISO 13485) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S GDPMD MALAYSIA Consultant and what they teach Other Medical Device Regulations World-Wide 14
Jen Kirley This international consultant thing sure is a ride! Career and Occupation Discussions 13
R Ethical Aspects while being Consultant and Certifier within same Organization. Consultants and Consulting 6
M Can an Auditor introduce a Consultant to help fix NCs after the audit? General Auditing Discussions 12
G Has anyone used shlomo Aviv-lean consultant? Lean in Manufacturing and Service Industries 1
E What are the major difficulties when working as a consultant in your industry? Consultants and Consulting 20
S Advice on becoming an ISO Management Systems Consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
C Medical Device Regulatory Consultant in Mexico Other Medical Device Regulations World-Wide 3
P Can an outside consultant audit all the AS9100 requirements including Internal Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
R ISO 17025 Accreditation - Need for consultant? ISO 17025 related Discussions 10
JoCam Reputable, UK based Consultant for the Health & Safety standard OHSAS 18001 Consultants and Consulting 14
I How to measure the performance of ISO 9001 Consultant? Consultants and Consulting 9
R Charge (Fair Prices) by a Consultant for a traditional 510k Review Other US Medical Device Regulations 2

Similar threads

Top Bottom