External Auditor Findings when an Internal Audit found a Nonconformance Yesterday

S

starfish

#1
Hello, its me again:)

Can an external auditor give you the same non conformance as an internal auditor on a certain process? For example a finding given to me today, in an internal audit, can the external auditor give me the same finding tomorrow.:bonk::thanx:
 
Elsmar Forum Sponsor
D

Duke Okes

#2
Theoretically they could, but if your organization has raised a CAR and has a history of effectively addressing NCs I would think it is unlikely. Of course it might depend on the significance of the NC, what impact it has already had, and whether or not containment and remedial action have already been taken.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Can an external auditor give you the same non conformance as an internal auditor on a certain process? For example a finding given to me today, in an internal audit, can the external auditor give me the same finding tomorrow.:bonk::thanx:
We had a long but worthy discussion about this very issue in this thread. I suggest you take the time to go over the pros and cons. Sometimes, there are valid reasons for the external auditor to be "redundant".

You could also ask the same question, from another perspective; such as: if you are already working on a corrective action for your internally reported non-conformity, what is the harm of responding back to the external CAR with the same corrective action?

Too many games played by registrants out there....:mg:
 

Wes Bucey

Quite Involved in Discussions
#5
We had a long but worthy discussion about this very issue in this thread. I suggest you take the time to go over the pros and cons. Sometimes, there are valid reasons for the external auditor to be "redundant".

You could also ask the same question, from another perspective; such as: if you are already working on a corrective action for your internally reported non-conformity, what is the harm of responding back to the external CAR with the same corrective action?

Too many games played by registrants out there
....:mg:
That may be (too many games), but why paint every registrant with the same tar brush?

It seems to me (personal opinion) that if an external auditor comes across a nonconformity which has been previously reported by an internal auditor and the registrant states, "It's being worked on." then the question should move on to the status of the root cause search and corrective action. If the registrant is, indeed, "playing games," that might be the source of a DIFFERENT N/C for the auditor to note, not merely acting like an automaton and redundantly noting the original N/C again.

If, however, the registrant is silent about the initial internal audit N/C, then the external auditor is fully justified in noting it as if it were the only time, since to him it is the only time it's been noted.

The whole crux of the matter is two-way communication during any audit, internal or external. If the registrant stands by, silent, hoping the internal or external auditor won't notice anything, and remains silent when and if either auditor notes an N/C, then it seems foolish to talk to strangers later about an issue which could have been resolved on the spot.

Added in edit:
Sorry, somehow I accidentally deleted a large part of the following paragraph
(restored part in blue)
If, however, the matter is brought up in the closing meeting, "someone" at the auditee has a responsibility to speak up and clarify whether there is, in fact, an active corrective action process or whether it is all just "lip service." Auditees MUST be clear on all the points raised by an auditor. Some auditors are better than others at inviting questions and discussion on the findings throughout the visit because the "guide" or "escort" may not be knowledgeable enough about the big picture to adequately represent the auditee's interest during the actual inspection tour.
 
Last edited:

arios

Your Mexican Amigo
#6
I've faced this situation before and when I review the said CARS or CAPA's it turns that they don't always cover what the auditee claims they do.

If the CAPA or CAR addresses the issue it may not be necessary to issue a new NC, but I have also seen "abuse" of this practice: Many CAPA's and also many gaps in the system at the same time. When that happens I explain that it's Ok that they found the issue recently but the role of my audits is to determine if the QMS is implemented, and if it is effective. Only looking at opened or identified CAPA's instead of implemented requirements says that the QMS is strong on one side and too weak on the other. This scenario could be a potential for a Major NC.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
but why paint every registrant with the same tar brush?
I did not. And, for those who want a well thought out critical analysis of when and why an external auditor should also report an NC, already uncovered during an external audit, read the hyperlinked thread.
 

Wes Bucey

Quite Involved in Discussions
#8
I did not. And, for those who want a well thought out critical analysis of when and why an external auditor should also report an NC, already uncovered during an external audit, read the hyperlinked thread.
The poster mentioned an internal audit [where the previous N/C was noted, and, presumably, a root cause and corrective action were underway], as did I in my post.
(Are we dealing with apples and oranges?)
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
The poster mentioned an internal audit [where the previous N/C was noted, and, presumably, a root cause and corrective action were underway], as did I in my post.
(Are we dealing with apples and oranges?)
My mistake. I meant internal, despite the fact that I wrote external.

The underlying issue is that there is no adequate SINGLE answer that fits all scenarios for this question.

For anyone who is semi-knowledgeable about registrar audits and the games played by some of the registrants to infer that 3[sup]rd[/sup] party auditors should never "duplicate" an internally originated non-conformity, is wrong.

I find very telling that nobody attempted to answer my previous question, reversing the perspective on the issue:
if you are already working on a corrective action for your internally reported non-conformity, what is the harm of responding back to the external CAR with the same corrective action?
 
Thread starter Similar threads Forum Replies Date
K External Auditor asking for other Audit Findings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
B Internal and external auditor competency to CSR's IATF 16949 - Automotive Quality Systems Standard 20
A OHSAS 18001 external auditor finding personal interpretation? Occupational Health & Safety Management Standards 5
A External Auditor issue with Internal Audits Internal Auditing 7
S ISO9001:2015 Clause 9.1 - What the external auditor will look at? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Risk Approach doesn't address External Issues (Auditor's Comment) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
K EMS Manual - External auditor expectations Miscellaneous Environmental Standards and EMS Related Discussions 5
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
W Hiring an External Auditor to perform our AS9100 Compliance Audits AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
N Corporate direction - External Auditor Influenced by Corporate Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
F VDA 6.3 Level C Certificate Requirements for External Auditor VDA Standards - Germany's Automotive Standards 3
E Help needed on the TS 16949 External Auditor Exam IATF 16949 - Automotive Quality Systems Standard 8
J Can An External Auditor Also Write The Same Non-Conformance As An Internal Auditor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Changing External Auditor Service General Auditing Discussions 13
D Is our external auditor acting within the rules? General Auditing Discussions 9
K Can I join External or Online Internal Auditor Courses Apart from my Company...? Training - Internal, External, Online and Distance Learning 4
P How to Qualify as External Auditor in ISO Quality Systems General Auditing Discussions 2
J Repeat Visits By Same External Auditor for the Last 10 Years General Auditing Discussions 22
B Incompetent External Auditor - Is the Auditor Liable or the CB? General Auditing Discussions 25
D Advised by external auditor to change all QMS?s procedures to Flow charts Document Control Systems, Procedures, Forms and Templates 16
Z Interviewing an External Auditor? Choose a Registrar for ISO 9001 Registration Registrars and Notified Bodies 30
B External Auditor Confidentiality Agreement General Auditing Discussions 8
J Verifying the Effectiveness of Corrective Action - Challenge with an external auditor Nonconformance and Corrective Action 16
P External Contract Auditor for Internal Quality Audit Internal Auditing 18
B Keeping an External Auditor on because he's "useless"... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 55
H External Auditor asked that we Improve in 4 Areas - ISO9001 - help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
W External Consultant as Internal Auditor - Can NC be issued by TS Auditor? Internal Auditing 18
D Can an external ISO Auditor view FDA inspection results General Auditing Discussions 9
W Conflict with External Auditor in ISO 9001- Number of Fire extinguishers General Auditing Discussions 48
B Internal Auditor Training - Shadowing external auditor? Internal Auditing 18
M Need input - Potential poor external auditor? My first ISO 14001 registration audit ISO 14001:2015 Specific Discussions 4
K 7.5.5 Identification of Stored Product - External auditor identified storage problem ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
L External auditor agenda General Auditing Discussions 17
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 4
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
I What kind of wine best complements the Friday that you close out your external audit findings? Opinions are welcome. Coffee Break and Water Cooler Discussions 12
B How to apply external voltage to SIP/SOP IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Qualifying commercial off the shelf (COTS) external suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 1
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Reduction of software class based on multiple external risk controls IEC 62304 - Medical Device Software Life Cycle Processes 5
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
C External Laboratories and OEM Calibration IATF 16949 - Automotive Quality Systems Standard 0
Q AS9120B flow down to external providers: Records Retention AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
Casana IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration IATF 16949 - Automotive Quality Systems Standard 8
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
C ISO 17025 2017, Requirement 6.6.3 - Communicate requirements to external providers ISO 17025 related Discussions 4
C Determining if Maintenance Contractor is an External Service subject to ISO 9001 Clause 8.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
Similar threads


















































Top Bottom