Is it a Finding if all Internal Auditors are from the Quality Department?

SGquality

Quite Involved in Discussions
#1
In my organization, we have a list of Internal Auditors and all are from different roles in the Quality Department. I feel this is not good. Is this acceptable and would it be a finding in the ISO Certification audit ?
 
Elsmar Forum Sponsor

dsanabria

Quite Involved in Discussions
#2
Re: Is it a finding if all Internal Auditors are from Quality ?

In my organization, we have a list of Internal Auditors and all are from different roles in the Quality Department. I feel this is not good. Is this acceptable and would it be a finding in the ISO Certification audit ?

Short answer NO!

The only requirement is:

"The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work."

... and the logic of that is - can you imagine that their own area never receives an NCR and they are so perfect....:sarcasm:

Hope this helps
 

Randy

Super Moderator
#3
Re: Is it a finding if all Internal Auditors are from Quality ?

Short answer NO!

The only requirement is:

"The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work."

... and the logic of that is - can you imagine that their own area never receives an NCR and they are so perfect....:sarcasm:

Hope this helps
Can you imagine if they are so honest to actually identify NC's

Anyway the question is about to become moot because the restriction is being done away with in the 2015 revision
 

QAengineer13

Quite Involved in Discussions
#4
Re: Is it a finding if all Internal Auditors are from Quality ?

In addition to dsanabria comments, 820.22 states that " Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited" with that being said ensure that the 820.25 Personnel training certificates/ experience pertaining to them being trained as Internal auditor is maintained in their training files.
 
#5
Re: Is it a finding if all Internal Auditors are from Quality ?

In my organization, we have a list of Internal Auditors and all are from different roles in the Quality Department. I feel this is not good. Is this acceptable and would it be a finding in the ISO Certification audit ?
Why would it be "not good"? What you should be seeking is objective, impartial, competent auditors, not worrying about what department they're from...

It could be, for example, that you don't have ANY candidates in QA who fit the bill!:popcorn:
 

insect warfare

QA=Question Authority
Trusted Information Resource
#6
Re: Is it a finding if all Internal Auditors are from Quality ?

In addition to dsanabria comments, 820.22 states that " Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited" with that being said ensure that the 820.25 Personnel training certificates/ experience pertaining to them being trained as Internal auditor is maintained in their training files.
This is true for FDA and medical devices, but keep in mind that the OP has posted in the ISO 19011 forum, and thus the requirements may be applied somewhat differently (e.g. demonstrating competency of auditors vs. having training records).

Brian :rolleyes:
 
A

arkyhog

#7
Re: Is it a finding if all Internal Auditors are from Quality ?

I like to select accountants for new internal auditor candidates they are sticklers for compliance and they tend to dig real deep.
 
#8
Re: Is it a finding if all Internal Auditors are from Quality ?

I like to select accountants for new internal auditor candidates they are sticklers for compliance and they tend to dig real deep.
Welcome. Do you think an accountant would be good to audit a welding process and its controls, in that case? Or a jet engine design process?
 
A

arkyhog

#9
Absolutely! Taking some one that is not a subject matter expert or thinks they are one; is the best way I have found for asking questions. You essentially you could get a 5-why to a simple audit question if the auditor has no prior subject matter experience. The only pre requisite is the subject matter material to review. The less you know the more questions you will ask if you take what you?re doing serious. I have yet to meet many accountants that joke around the water cooler most if the day. ;)
 
#10
Absolutely! Taking some one that is not a subject matter expert or thinks they are one; is the best way I have found for asking questions. You essentially you could get a 5-why to a simple audit question if the auditor has no prior subject matter experience. The only pre requisite is the subject matter material to review. The less you know the more questions you will ask if you take what you?re doing serious. I have yet to meet many accountants that joke around the water cooler most if the day. ;)
Interesting reply. So, based on this, why do you think being a Lead Auditor requires many years of experience, in related industries and passing an accredited course with an exam, if it's simply a case of asking questions?
 
Thread starter Similar threads Forum Replies Date
G During internal audit - finding poor action plans ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
Q ISO 9001-2015 Internal audit finding Internal Auditing 14
S GM/VP softgrading internal audit finding - need feedback from an audit guru! General Auditing Discussions 11
A Writing an Internal Audit Report Finding for Employee Awareness of QMS Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R Can a external auditor raise a finding that is already identified in Internal Audit ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Internal Audit finding versus External Audit finding General Auditing Discussions 2
L Internal Re-audit after Major Finding during ISO 9001 Re-Certification Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K ISO 13485 Audit Finding on Regulatory Issues - Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
S Internal Audit Finding relating to Superseded Documentation Document Control Systems, Procedures, Forms and Templates 36
P Internal Audit Finding - Root Cause Analysis: Auditor or an Auditee Responsibility? Internal Auditing 24
6 Management Review does not highlight Internal Audit Finding - Root Cause Analysis General Auditing Discussions 11
K Scoring Scale for Internal Audits - Please help finding the right terms Internal Auditing 44
G Is this an internal audit finding or not Internal Auditing 8
M Internal Audit finding leading to 'Punishment' (Disciplinary Action) - Your Thoughts? Internal Auditing 79
C How to analyse the internal audit finding in term of discrepancy Internal Auditing 4
J Internal Audit Findings - Major vs. Minor Finding - Defining the differences Internal Auditing 14
S Failure to Close Out an Internal Audit Finding Internal Auditing 20
A Definition Major vs. Minor Nonconformance (Finding) - Internal Audit - Definition & Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 38
Doninina PSUR and main finding of PMCF EU Medical Device Regulations 2
T FAI Finding Prevention AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D ISO 14001 Finding - Missing Safety Data Sheets ISO 14001:2015 Specific Discussions 2
M How to respond to 483 validation finding we disagree with? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 33
E Audit Finding - Measurement of Process - Continuous Improvement - Trend Analysis Oil and Gas Industry Standards and Regulations 22
R Finding Equivalent Material Information Manufacturing and Related Processes 1
C Need help in determining applicable clause for an audit finding (based on AS9120B) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Sidney Vianna Informational Clarification: Finding is NOT synonymous with nonconformity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I Unable to close a finding raised from BSI last year ISO 13485:2016 - Medical Device Quality Management Systems 12
S Audit Finding - Design History File (DHF) Index: few (3 to 4) reports not identified ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Finding Independent License Holder (Medical devices) in Philippines Other Medical Device Regulations World-Wide 1
somashekar Stage 1 Finding. Request views and comments ISO 13485:2016 - Medical Device Quality Management Systems 3
D Finding Optimum Design Parameters using Taguchi method? Using Minitab Software 2
Mikey324 External calibration - Finding in our 3rd party audit General Measurement Device and Calibration Topics 58
M How to answer ISO9001:2015 audit finding of old revisions of documents being used? Document Control Systems, Procedures, Forms and Templates 8
Azaarus Help with CAPA for an IATF finding regarding inspection documentation IATF 16949 - Automotive Quality Systems Standard 10
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 11
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
F Closing a finding before closing meeting General Auditing Discussions 19
J Audit Finding For Not Retaining Test Results ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A OHSAS 18001 external auditor finding personal interpretation? Occupational Health & Safety Management Standards 5
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
Marco Bernardi Finding a flat or not modeling distribution: how to manage it? Capability, Accuracy and Stability - Processes, Machines, etc. 24
H Looking for Tips on finding an IATF consultant Consultants and Consulting 6
D Customer Audit Finding ISO13485:2016 7.6 ISO 13485:2016 - Medical Device Quality Management Systems 7
B PED 2014/68/EU - Is this Traceability audit finding correct? Other ISO and International Standards and European Regulations 4
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
R Major nonformance finding was given during a closing meeting of a ISO9001 certification audit General Auditing Discussions 76
G Audit finding - Components being transferred inter-plant Internal Auditing 3
S Difficulty Finding A Notified Body for CE Marking - No Capacity Registrars and Notified Bodies 5

Similar threads

Top Bottom