Responding to Audit Findings - Procedures not being followed to the letter

Stijloor

Staff member
Super Moderator
#11
Oh they know:cool:, I've been doing it for 10 years. Its become a bit of a game :lmao:

Basically, If I raise an NC and they don't react, the penny has finally dropped, they can expect to see it in the next external assesment, so they tend to take more notice now;)

Cxx
Chrissie,

If you need "extrinsic" forces to get things fixed/corrected, then there's something wrong with Top Management commitment. Has your CB auditor raised that issue?

Stijloor.
 
Elsmar Forum Sponsor
C

ChrissieO

#12
Chrissie,

If you need "extrinsic" forces to get things fixed/corrected, then there's something wrong with Top Management commitment. Has your CB auditor raised that issue?

Stijloor.
Yes and things have improved over the last 3 years.

Cxx
 
F

fionanm

#15
Thank you for all the replies, its helped me think it through more completely and respond to the auditor. Hopefully they will find it acceptable.

I understand why auditors would get tougher as time goes by, but this was a big jump that I wasn't expecting.
 
#16
Thank you for all the replies, its helped me think it through more completely and respond to the auditor. Hopefully they will find it acceptable.

I understand why auditors would get tougher as time goes by, but this was a big jump that I wasn't expecting.
And it's put them in a difficult situation (well, some of them) to have to tell a client; "We haven't been doing it correctly, we're going to be more rigorous from now on"...
 
J

John Martinez

#18
Re: Responding to audit findings

It's true to say that over the past few years, the accreditation bodies have brought some weight to bear on the CB's grading of ncs. As a result, observations have been issued as minors etc.

It's all too easy to pick on some part of a job and say 'the procedure isn't being followed'. What's missing in this story is the effectiveness of what's being done! I make a cup of tea on a regular basis (I like tea) but I don't follow the process that my grandmother taught me! Is the result effective - you bet! Time to write down something different? Possibly.

Trouble is, your auditor didn't indicate if the results were any good - lazy auditor!
Hi, Andy:
I don't think we have enough information, not to mention one side of the story to determine if the auditor was lazy or not. Like I said before, before we jump to conclusions, the posters should give us facts, like the actual NC as written would be helpful.
 
#19
Re: Responding to audit findings

Hi, Andy:
I don't think we have enough information, not to mention one side of the story to determine if the auditor was lazy or not. Like I said before, before we jump to conclusions, the posters should give us facts, like the actual NC as written would be helpful.
Maybe, but simply reporting that 'procedures weren't followed' is only part of the story. Auditors who haven't, by now learned to look for the results of 'not following procedures' are either incompetent or lazy. Since ISO/IEC 17021 requires the CB to determine and so competence, the auditor must be lazy!:notme:
 
J

John Martinez

#20
As a third party auditor, I tell all my clients, that if they wish to retain me as their auditor (and I hope they do), then they can expect the bar to be raised every time I come in.

I'm not stating that I'm going to impose upon them requirements over and above the Standard I'm auditing. I am stating that "continuous improvement" will be taken a step up with each visit.

Where I may overlook a "not to the letter" one visit, I probably will the next, especially if we are two years into the certificate and no changes have been made to this document within that two year period. No, I'm not suggesting changing for changing sake, but if I found something, and no changes have been made, then I'm going to write it.

While I may suspect their internal auditing system is lacking and may have to pursue that, I CAN NOT fall into the trap of trying to write the NC on the perceived root cause by myself. I must write the NC based upon the FACTS and it is then up to the client to TELL ME what the root cause is.

Andy is correct, Certification Bodies have been hammered for accepting root cause analysis that is anything except an excuse.

It was also stated by someone else in this thread. While training as subsequent to a process or document change is part of the action, “re-train the employee” in and of itself is rarely accepted.

After all, it's the client system. If they are not following it, then whose fault is it? Certainly not the auditor's!:frust:
 
Thread starter Similar threads Forum Replies Date
J Time Frame for Responding to a Major Nonconformance - Registrar Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Responding to ISO9001 Audit NCR?s/Observations - ?Top Management? ? Clause 5.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
B Responding to ISO9001 or TS16949 Audit NCR?s/Observations. Nonconformance and Corrective Action 5
D Overwhelmed, next audit around the corner - Responding to Nonconformances Identified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
J Supplier not responding to PPAP request APQP and PPAP 5
N Responding to NADCAP nonconformance - Control of External Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Technical Documentation Review: Responding to a Nonconformity ISO 13485:2016 - Medical Device Quality Management Systems 14
K Suppliers not responding to Supplier Corrective Action Requests (SCAR) Supplier Quality Assurance and other Supplier Issues 12
W Responding to an FDA FOIA Request US Food and Drug Administration (FDA) 5
R Responding to a Customer Identified Nonconformance caused by Human Error Nonconformance and Corrective Action 22
M Operator Mistakes (Errors) and responding to CAR (Corrective Action Requests) Nonconformance and Corrective Action 20
N Is there a standard length of time to track down non-responding customers w recalls? Misc. Quality Assurance and Business Systems Related Topics 2
AnaMariaVR2 Strategic Priorities: Responding to the Public Health Challenges of the 21st Century US Food and Drug Administration (FDA) 0
Q Not responding all the NCR?s Nonconformance and Corrective Action 10
M Responding to customers upon receipt of an alleged medical device deficiency Customer Complaints 6
M Workmanship Related Failures - Responding to a customer CAR Nonconformance and Corrective Action 12
ScottK Responding to calls for references, how do you handle it? Career and Occupation Discussions 5
M Responding to external communciation - In particular 4.4.3 b) - Dinged Miscellaneous Environmental Standards and EMS Related Discussions 6
S The Unreasonable Customer - Responding to 3 or more Customer Concerns a Day Customer and Company Specific Requirements 26
B Request: Suggestions / Tips for Responding to CAR for Late Deliveries Nonconformance and Corrective Action 14
I Corrective Action Time Line When Responding to a Major from a Registrar IATF 16949 - Automotive Quality Systems Standard 8
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Supplier audit Medical Device and FDA Regulations and Standards News 2
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 7
B Remote IATF 16949 audit preparation General Auditing Discussions 10
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
I Do I need to sign off my annual audit calendar? Internal Auditing 2
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Nice and simple invitation email to an audit kickoff meeting Internal Auditing 1
M IATF 16949 - Audit of Remote Location/Support Site and IT IATF 16949 - Automotive Quality Systems Standard 4
Q IATF audit - Root Cause Analysis results IATF 16949 - Automotive Quality Systems Standard 5
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
xfngrs NIOSH Audit for N95 respirators US Food and Drug Administration (FDA) 1
Sidney Vianna IATF 16949 News Risked Based Audit Day Calculation IATF 16949 - Automotive Quality Systems Standard 2
T AS9100 audit due to facility move AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B SAP Audit trail Periodic Review EU Medical Device Regulations 1
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
R Gap Audit Aerospsace and Rail QMS Quality Manager and Management Related Issues 0
salaheddine96 Internal audit planning Internal Auditing 2
A MDSAP Audit Questionnaire Medical Device and FDA Regulations and Standards News 7

Similar threads

Top Bottom