SBS - The best value in QMS software

When audit NC requires only correction

Jane's

Involved In Discussions
#1
I was wondering how unusual is it to provide just a correction and no corrective action to an audit NC. The audit NC is minor and it is one of its kind, so there is no trend or multiple occurrences to establish a defined root cause.

TIA for your replies.
 
Elsmar Forum Sponsor

Jane's

Involved In Discussions
#3
Will do:)

Meanwhile it would be nice to know that other ppl have done that too. I should add that risk was calculated as low and our current process allows for this (it's just that we have never used that for an audit NC).
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Sure - it's up to the auditor and his organization's policies.

It's still pretty standard practice that if a one-off finding is corrected by the time of the closing meeting it won't count as a finding... whether the auditor makes you follow the full corrective action process is up to them and they would likely make that judgement base on potential risk.

If it's really super simple, like a page missing from a printed document where the pdf version is whole, I would let that go with just a correction... unless I saw a second instance.
 

Jane's

Involved In Discussions
#6
The NC is minor by definition and calculated risk is low due to low occurrence and high detection, but the issue itself is maybe not minor per se. My problem is that:

  1. there is no other occurrence of a similar NC,
  2. the NC precedes me (the content which contains an error was written by the former staff), and
  3. we already have a mechanism in place to prevent this from happening again - compliance with applicable standards and regulatory requirements is required throughout our processes. The NC was that retention time for certain records was set to be shorter than that required by the EU regs.
Any additional thoughts much appreciated.
 

Marcelo

Inactive Registered Visitor
#7
The NC was that retention time for certain records was set to be shorter than that required by the EU regs.
I'm not sure how this is a minor NC. Your company is already required, including by applicable regulations, to comply with regulations. If you are not complying, this is a very serious NC. Why did this happen? Why were your system not complying with something. It should? Did anyone check compliance with all applicable regulatory requirements? If so, why the person did not note this? How many more regulatory requirements is the company not complying with?

we already have a mechanism in place to prevent this from happening again - compliance with applicable standards and regulatory requirements is required throughout our processes.
Doing something that you should already be doing (as mentioned, this is already required by the standard and by the applicable regulations) is not something that controls the risk, and I don't see how it will prevent this from happening again as the NC itself already is a case of this not happening.
 
#8
I was wondering how unusual is it to provide just a correction and no corrective action to an audit NC. The audit NC is minor and it is one of its kind, so there is no trend or multiple occurrences to establish a defined root cause.

TIA for your replies.
What type of audit is it? External? Internal? When people answer, without knowing this information, it becomes very difficult to provide an accurate, "quality" answer.
 

Jane's

Involved In Discussions
#9
I'm not sure how this is a minor NC. Your company is already required, including by applicable regulations, to comply with regulations. If you are not complying, this is a very serious NC. Why did this happen? Why were your system not complying with something. It should? Did anyone check compliance with all applicable regulatory requirements? If so, why the person did not note this? How many more regulatory requirements is the company not complying with?
I agree with you that severity of the NC is high and that is how we evaluated it too, but this is still a minor NC. For all I know, that could have been a typo showing 3 where it should have been 5 in the table which specifies the records retention time. As i said, this was established by former staff, so i can't ask them what happened or re-train them or whathave you.

Note that a major NC/QMS breakdown would be not having any requirement for records retention. How do we know other EU req's are met? We completed the essential requirements checklist, Annex I (we are class II, so self-declared).

Doing something that you should already be doing (as mentioned, this is already required by the standard and by the applicable regulations) is not something that controls the risk, and I don't see how it will prevent this from happening again as the NC itself already is a case of this not happening.
I am not sure I understand what you are saying in this paragraph, but I appreciate the effort.

@AndyN: It's an external. I know, i'm feeling pretty brave just talking about it:)
 
Last edited:
#10
Most external auditors look at things as if they are an "iceberg" - by which I mean the auditor thinks "If I found it, it must be that there's much more below the surface". That's instead of them taking time to understand how systemic the issue is. So, they treat everything as if root cause is needed instead of allowing things to be corrected...
 
Thread starter Similar threads Forum Replies Date
marmotte Malaysia - Auditor Requires an Updated Audit Report Other Medical Device Regulations World-Wide 5
A Client requires to witness an Internal Audit of our Sub-Contractor Internal Auditing 4
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 3
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
S Quality Audit Training Activities Quality Manager and Management Related Issues 3
G IATF Rules for COVID 5th revision - Re-certification audit timing IATF 16949 - Automotive Quality Systems Standard 3
E MDR internal audit Medical Device and FDA Regulations and Standards News 0
Ed Panek Remote Audit GOTOMEETING thoughts Coffee Break and Water Cooler Discussions 22
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 7
M Audit Criteria Training Materials Internal Auditing 1
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
S Complexity Rating - CB adding another audit day for "high complexity" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
K MDSAP Audit Approach 2020 for Brazil Other Medical Device Regulations World-Wide 1
K MDSAP Audit Approach 2020 ISO 13485:2016 - Medical Device Quality Management Systems 3
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
T COVID, Furlough and ISO9001 Surveillance Audit Coffee Break and Water Cooler Discussions 2
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
Dean Bell Implementation of Controls as per SOA for Stage 2 Audit IEC 27001 - Information Security Management Systems (ISMS) 0
G Logistic organization and controls - IATF/ISO 9001 audit Nonconformance and Corrective Action 2
Geoff Cotton Performing a Delta Audit General Auditing Discussions 12
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G MSA check list to audit IATF 16949 - Automotive Quality Systems Standard 8
L Open Positions During AS9100 Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F Who can sit in/perform an API audit? Oil and Gas Industry Standards and Regulations 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 6
G Self Assessment Audit from a new potential customer General Auditing Discussions 3
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 3
Ooi Yew Jin Customer E audit preparation Quality Manager and Management Related Issues 2
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
J Remote Audit Experiences - June 2020 General Auditing Discussions 32
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
M Supplier Audit Report - Template for second party audit wanted Lean in Manufacturing and Service Industries 1
Stefan Mundt AS9100D Major nonconformity due to recurrence of a NC during a subsequent CB audit. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1

Similar threads

Top Bottom