8.2.2 Internal audit

A

Andrews

#1
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
N

noboxwine

#2
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 !!!
 
D

D.Scott

#3
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.

Dave
 

SteelMaiden

Super Moderator
Super Moderator
#4
Greetings

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!
 

gpainter

Quite Involved in Discussions
#5
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.
 
R

Randy Stewart

#6
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?
:thedeal:
 
#7
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
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 6
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
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
S Internal audit discrepancy - We missed a few audits that were scheduled Internal Auditing 12
Raffy ISO 14001 9.2.2 Internal Audit Programme Content Internal Auditing 9
N Internal Audit Schedule – Who gets to set the schedule? Internal Auditing 16
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
G Non Conformance During ISO 9001 Audit - Not All Internal Audits Completed General Auditing Discussions 19
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
T Internal Audit Schedule when Hiring Out Internal Auditing 7
D ISO 9001:2015 Internal Audit Training Advice Internal Auditing 10
M Internal audit consultant ISO 13485 (English speaker) Consultants and Consulting 3
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
F Internal Audit - Procedure example Internal Auditing 5
C Internal Audit - Process Clause Matrix / Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 7
CPhelan Internal audit - Combine similar nonconformities in one or keep separate? Internal Auditing 6
M Internal Audit Plan in Retail Internal Auditing 10
D Management of NC after internal system audit IATF 16949 - Automotive Quality Systems Standard 7
A Purchasing - Internal Audit Questions Internal Auditing 8
N Comprehensive Compliance Matrix for Internal Audit Checklist Other Medical Device Regulations World-Wide 1
W Where to begin with an ISO 9001:2015 internal audit Internal Auditing 13
D Internal audit forms or checklists for a medical/veterinary laboratory General Auditing Discussions 5
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 146
E ISO 9001:2015 - Internal Audit Plan Clauses General Auditing Discussions 8
S Internal Audit Checklist for Application/Software development IEC 27001 - Information Security Management Systems (ISMS) 1
S Internal Audit - Risk and Opportunity (ISO 9001:2015 ) Internal Auditing 1
F API Spec Q1 9th Edition Surveillance Audit - Questions about internal audits. Oil and Gas Industry Standards and Regulations 23
Ashland78 IATF 16949 Internal Audit Checklist Manufacturing and Related Processes 11
Ed Panek Root Cause CAPAs from internal audit ISO 13485:2016 - Medical Device Quality Management Systems 16
K Student wanting Case Study about Internal Audit Report Internal Auditing 1
R How far apart can you schedule separate areas or departments in your internal audit? Internal Auditing 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
A API Spec Q1 9th Edition - 12 month Internal Audit Schedule Audit Nonconformance Oil and Gas Industry Standards and Regulations 10
J Microsoft Teams to manage Internal Audit System? Internal Auditing 3
tony s An organization's Internal Audit Office certified to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
Tagin Does ISO 9001:2015 require a full internal audit annually? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
S GM/VP softgrading internal audit finding - need feedback from an audit guru! General Auditing Discussions 11
M Internal Audit Assessment Criteria - ISO 13485:2016 Internal Auditing 21
V Process and Internal Audit Criteria matrix wanted Internal Auditing 8
S Internal Audit Completion Memorandum Internal Auditing 2
T Example wanted - Template for internal audit IATF 16949 IATF 16949 - Automotive Quality Systems Standard 1
a_bardi Is it possible to exclude internal audit from qms scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28

Similar threads

Top Bottom