8.2.2 Internal audit



8.2.2 Internal audit says "The management responsible for the area being audited shall ensure that actions are taken without UNDUE DELAY to eliminate detected non-conformities".What does UNDUE DELAY mean.If some corrective actions takes 2 months to implement does it mean it is a non-conforming situation.
What will happen if some of the internal audit NCR's are still open during the routine surveillance audit by the cerifying body?
Elsmar Forum Sponsor


Dare I use this in the Quality Field: Here goes. Just use some simple common sense. There is no definition for undue delay. Don't read too much into this. If an audit finding is essential enough to require a C/A, that will in turn add cost effective value, just have it scheduled with the respective dept and get it done when it is feasible. Agree that it needs to happen before you officially document it. Dont be a policeman just writing tickets. The ongoing open items that you speak of that can drag on for months and months and then are fabricated to close out usually were issued without discussion and werent important enough to start with. If it is a 2 month projet, that's O.K. The most important part IMHO is to use common sense when you document the actions, so that you dont create a giant listing of them to look "good" at audit time and then feel the pressure just to close them out on paper for the scumbag 3rd party auditors. Get the buy in that this is an improvement tool and you're not just out there to find stuff wrong. Good luck !!!


IMHO there is nothing wrong with corrective actions being open as long as they are being actively worked on. I have seen some companies trap themselves into a corner by stating in a procedure that the C/A must be closed within 60 or 90 days only to find it is impossible to complete the permanent corrective action in that time.

To my thinking, UNDUE DELAY would be doing nothing about the issue for any period over a week or so. If you do the investigation and root cause determination, implement an interim corrective action but have to order a piece of equipment that will take 6 months to arrive, you can't determine any "undue" delay. If on the other hand, you waited 2 months before starting the C/A, that probably is "undue" delay.

Whenever a subjective requirement is made, there will be different interpretations of what it means. AIAG "clarified" the term "timely" by stating this meant "days, not weeks". The difficulty comes when judging when the clock starts ticking.

My opinion is that if you are doing what you reasonably can to close your C/As, not dragging your heels, and keeping your customer (internal or external) up-to-date - you will have no problem with your registrar.



Super Moderator
Trusted Information Resource

I gotta go with the flow here, there is nothing that says that corrective actions cannot take months to finish. My advice to you is to be very thorough in you CA system when you schedule corrective actions.

Point one: do not confuse corrective actions with root cause analysis or managing problems, nonconformances. I have found that a lot of people don't fully understand the whole process. I think that ISO would do the world a service if they talked about problem/issue management instead of corrective and preventive actions.

Point two: If a corrective action is truly needed, make sure you are specific in scheduling and assigning activities. Don't say "Joe will fix it" Each step should be assigned and scheduled. 1) purchasing agent will issue a PO for the Whatchamaycallit. Lead time is 3 weeks. Delivery due on 7/31/02. 2) Whatchamaycallit will be set up by maintenance. Task time is 1 week. Action due date is 8/7/02. 3) Newly installed Whatchamaycallit will be trialed, and operators trained. Equipment and process capabilities will be assessed. Training will take approximately 3 weeks and will be done at the same time the equipment is trialed. Capability assessments will take aproximately 3 more weeks. Action due date is 9/30/02.

If you set up each action and follow up on it soon after the due date, you will be able to adjust schedules for any unforeseen problems. (like the barge that ran aground last nite :biglaugh: )

Not only have you provided evidence of corrective and/or preventive actions, but you can also use these as part of the quality planning process when applicable. I have been involved in corrective actions that took 2 years to complete. Of course there were many interim actions that were taken to minimize risk until new lines could be purchased, fabricated and installed. Just make sure you can show you have a schedule, you are on top of it, and making progress!

Good luck!


Quite Involved in Discussions
Common sense applies. Action - as a part of CA containment must be done without undue delays. So IMO containment is the immediate (undue) action as a part of the CA process. When I find an N/C during an audit containment is done immediately as well as when a N/C is detected by other methods.

Randy Stewart

No Undue Delay to me would be putting in place whatever it took to protect the customer from receiving bad product (containment). The closure of the CAR would come when you can prove out the preventive action (no directed time frame).

All of us agreeing on basically the same thing!!!!! Is it a Friday the 13th or something?? What's up with that?
I agree with 'SteelMaiden' (Wonderful name!). Corrective action should, where appropriate, be accompanied by an action time line. The progress can be then tracked against the timeline. Un-due delay then would be, not adhering to the time line wiithout a valid reason.
Thread starter Similar threads Forum Replies Date
T AS9100D Risk-Based Internal Audit Schedule AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
S Minimum Retention Time for Records of internal audit results as per AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
B Establishing topics for IATF internal audit processes Internal Auditing 9
T Robust internal audit program AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
Q AS9100:D Counterfeit internal audit questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Documenting internal audit of customer specific requirements IATF 16949 - Automotive Quality Systems Standard 10
R Looking for ISO 13485 Internal Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 8
G During internal audit - finding poor action plans ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
G Opening meeting - internal audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Mr Roo Discovered dishonesty after performing an internal audit General Auditing Discussions 5
W IATF Internal Audit how to determine risk IATF 16949 - Automotive Quality Systems Standard 12
X Looking for 17025 auditor to perform internal audit on IT software testing laboratory ISO 17025 related Discussions 3
J 9001 Internal Audit of Client Onboarding process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Internal audit checklist Internal Auditing 5
V Internal Audit Software IATF 16949 - Automotive Quality Systems Standard 5
J Internal Audit Schedule IATF Internal Auditing 4
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
D Number of people to be interviewed during an internal audit? Internal Auditing 10
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
armani Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
C API Q1 internal audit report Internal Auditing 3
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 2
J Internal audit random sampling methodology Internal Auditing 2
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
W How do you phrase your internal audit questions? Internal Auditing 3
M IATF - Internal Audit 3 year span Internal Auditing 4
Q ISO 9001-2015 Internal audit finding Internal Auditing 14
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
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 20
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 8
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
salaheddine96 Internal audit planning Internal Auditing 2
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
E MDR internal audit Internal Auditing 4
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
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 12
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3

Similar threads

Top Bottom