External Audit CAR when Internal Audit CAR is in process?

Helmut Jilling

Auditor / Consultant
#11
I have a non conformity which i have riased in the internal audit, but in the external assessment the lead auditor has riased CAR when we were already working on it.
My question is "is it technically justifiable to riase CAR when it has already been riased in the internal audit & work has already been started on that?

I am not aware of any formal guidance in this area. We auditors have to use judgement. Usually, I will reference the internal CA in my report. If it is a significant issue, I may ask to receive a copy for closure when the CA is complete. In rare cases, when a CA was initiated, but is not being handled properly, I will still write it up as an external CA. It depends on the particular situation.
 
Elsmar Forum Sponsor
S

skappesser

#12
Randy -:topic:

Not sure - my yankee dad and all his yankee brothers were cops (lifers, senior sergeants) in New York, 3 of them State Troopers and 1 of them a homicide det. in the city. I don't remember a lot of donut eating among them. They liked a lot of beer though.:notme: I think the donuts is more of a "Hollywood" thing more than a "Yankee" thing. :lol: How about fritter? Do cops in Dixie eat fritters? My mother in law in Lafe, Arkansas makes real good fritters!
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#13
First, given that the original post is in this thread, I make the assumption that this is an accrediting body assessor, working ISO/IEC 17025 or ISO/IEC 17020.....

If so, and if they are recognized (signatory status in a MRA such as ILAC), then the AB may document any non-conformance observed, even if there is an internal CA.....this is not an ILAC/APLAC requirement, but some ABs do follow the practice.....

Randy may be correct, it may be low hanging fruit, but it must still be documented.....though the exact way to document it can vary some.....
 
A

Al Dyer

#15
AMANBHAI,

The external auditor looks for the system to be in compliance. If there is an open internal CAR on the system it is broken (to some degree) and the proposed corrective action has not been implemented and/or verified.I don't want to go into major or minor but you are probably well on your way to closing the CAR and submitting the verification to the auditor. In the larger scheme of things it seems to be an ant hill as nonconformances go. Both you and the auditor know the problem and the fix so it seems to be a matter of documenting and verifying your actions then submitting it to the auditor so he can close the CAR.

A question---How many nonconformances do you know of that are in the system that the external auditor did not find?:notme:

I may be too layed back but I would rather fight the bigger problems that are sure to arise over time.

Al...
 

Raffy

Quite Involved in Discussions
#16
Hi Guys,
I think I also have the same situation. Four weeks ago, we have a Pre-Assessment Audit against the TS16949 Requirements for Internal Audit. Then, during our Internal Audit, I caught some problems on the unclosed or what we call, CAR that was not been closed for about 3 years, there are some CAR that was been Open and have recurred for so many times. :frust: It was been escalated for so many times, but the TOP Management at that time, don't bother to answer these CAR, that's why it was still Open at the time when I joined the company last January.
Now, during the Pre-Assessment, it was been called out by the Auditor that this CAR that was not been closed for quite come time now, he recommend that we can cancel the CAR, so that we can start a new Internal Audit cycle, for TS Requirements. BTW, this CAR was from ISO9001:2000 requirements.
My concern are the following:
1. Can we really cancelled all unclosed CAR? Please ADVICE. :frust:
2. If we are going to cancelled all CAR, what could be our justification in which a CB Auditor would buy? :frust:
3. If we cannot cancelled all of it, what would you guys recommend? Please advice.
Thank you very much in advance.
Best regards,
Raffy :cool:
 

Helmut Jilling

Auditor / Consultant
#17
Hi Guys,
I think I also have the same situation. Four weeks ago, we have a Pre-Assessment Audit against the TS16949 Requirements for Internal Audit. Then, during our Internal Audit, I caught some problems on the unclosed or what we call, CAR that was not been closed for about 3 years, there are some CAR that was been Open and have recurred for so many times. :frust: It was been escalated for so many times, but the TOP Management at that time, don't bother to answer these CAR, that's why it was still Open at the time when I joined the company last January.
Now, during the Pre-Assessment, it was been called out by the Auditor that this CAR that was not been closed for quite come time now, he recommend that we can cancel the CAR, so that we can start a new Internal Audit cycle, for TS Requirements. BTW, this CAR was from ISO9001:2000 requirements.
My concern are the following:
1. Can we really cancelled all unclosed CAR? Please ADVICE. :frust:
2. If we are going to cancelled all CAR, what could be our justification in which a CB Auditor would buy? :frust:
3. If we cannot cancelled all of it, what would you guys recommend? Please advice.
Thank you very much in advance.
Best regards,
Raffy :cool:
Would it be better to cancel it as irrelevant, and reissue a similar CAR?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#18
This post is unclear.
My concern are the following:
1. Can we really cancelled all unclosed CAR? Please ADVICE.
Can you? Or should you? No, you shouldn't. Why would you want to close/cancel CARs (assuming they are legitimate issues) without implementation of effective corrective actions? Why let top management off the hook so easily? Why wouldn't you use this as leverage to improve your system?
2. If we are going to cancelled all CAR, what could be our justification in which a CB Auditor would buy?
Most professional auditors would not buy any stinking excuses because what you described shows that the system is not working.
3. If we cannot cancelled all of it, what would you guys recommend? Please advice.
My recommendation is for you to show the external auditor the system as you have it. Hopefully, the auditor will deny TS certification and (who knows?) your top management might get serious about their responsibility.
 
Thread starter Similar threads Forum Replies Date
A External Audit CAR on Record Control? General Measurement Device and Calibration Topics 6
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 13
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
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 Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
qualprod The Perfect audit? External Audit causes a significant negative impact in a company General Auditing Discussions 9
B How to reply NCR on ineffectiveness of corrective action during IATF external audit? This is repeated issue whereby some mistake was done. IATF 16949 - Automotive Quality Systems Standard 7
B IATF 16949 7.1.5.3.2 FAQ #7 Audit Finding - External Calibration Laboratory IATF 16949 - Automotive Quality Systems Standard 7
P IATF checklist for External Supplier Audit IATF 16949 - Automotive Quality Systems Standard 9
J Ignoring a Failed Gage R&R and upcoming external audit IATF 16949 - Automotive Quality Systems Standard 22
B Integrating ISO 9001/27001 External Audits - Audit Time Reduced? Discounts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Corrective Action for External Audit NCMR (Procedure Not Followed) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Effectiveness Plan for CAPA initiated from External Audit US Food and Drug Administration (FDA) 3
P Is Internal and external audit of Account Department applicable to any ISO standard Internal Auditing 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
R Root Cause for "Simple" External Audit Findings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Internal Audit finding versus External Audit finding General Auditing Discussions 2
drgnrider Control of External Audit Notes and Documents Document Control Systems, Procedures, Forms and Templates 8
L Mock Audit by External Consultant (ISO 13485) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R External Audit Attendees - Surveillance Audit Quality Manager and Management Related Issues 27
Q External ISO 14001 Audit in a Distribution Center ISO 14001:2015 Specific Discussions 3
R QMS changes before Annual External Audit Quality Manager and Management Related Issues 8
M External Audit Findings - TS 16949 IATF 16949 - Automotive Quality Systems Standard 3
B Audit of equipment after certified external calibration... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M What to do during a Stage 1 External Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Having trouble with corrective action on external audit nonconformance Nonconformance and Corrective Action 8
V Most Common Internal/External Audit Observations on Risk Management ISO 14971 - Medical Device Risk Management 4
S Internal and External Audit Programme Implementation Internal Auditing 6
C No findings from External Audit - Should I be worried? General Auditing Discussions 7
K External Auditor asking for other Audit Findings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
S Dreading an Ineffective External Audit and the impact it will have on staff General Auditing Discussions 1
Chennaiite External Audit re-defined Imported Legacy Blogs 4
A Need to Audit an External Calibration Laboratory? - Customer Audit Finding Other Medical Device Regulations World-Wide 5
J Withdraw NCR Request - External QMS Audit is In Progress General Auditing Discussions 23
S Customer Audit needs to see External Supplier Management Procedure Supplier Quality Assurance and other Supplier Issues 7
B Critical Action Limits (CAL) for All Internal and External Audit Findings General Auditing Discussions 17
S External Audit Non-Conformance - Control Plan and Inspection Issues IATF 16949 - Automotive Quality Systems Standard 1
S External Auditor Findings when an Internal Audit found a Nonconformance Yesterday Document Control Systems, Procedures, Forms and Templates 11
Chennaiite Questions on the Scope of Remote Locations for the ISO/TS External Audit IATF 16949 - Automotive Quality Systems Standard 7
R ISO 9001 Internal Quality Audit by Consultants (External agency) Internal Auditing 5
A What happens if an External Audit NC (Nonconformance) is not closed in 90 days? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Escalation of an External Audit Nonconformance Nonconformance and Corrective Action 13
M Giving copy of external audit report to customer General Auditing Discussions 20
S External Audit - Nonconformance Root causes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
L Human Resources Officer is absent during an ISO 9001 External Audit General Auditing Discussions 17
P ISO 13485 Audit - EN 62366:2008 not in External Document File IEC 62366 - Medical Device Usability Engineering 1
E First external audit coming up, do I need to have performed Internal Audits already? Internal Auditing 15
L How to check for validity of registration scope during ISO9001:2008 external audit Quality Manager and Management Related Issues 3
L Preparation for the second year external audit. General Auditing Discussions 8

Similar threads

Top Bottom