SBS - The best value in QMS software

Internal Audit Questionaires - Checklist that is outside the box

#11
maybe this attachment/example can give you an idea.

thanks
This may not work as an internal audit checklist - Any series of questions should follow the 'process' you are auditing, to be of use. The example starts of with sampling document control - which isn't getting to the start of the Purchasing Process, at all! Indeed, in most places if you ask the questions the way they are written here, likely you'll get some strange looks.

There is another thread around here somewhere which asked how to audit a process which isn't documented. My reply should give a good basis for an auditors questions.

Oh, and one more thing - writing any questions down, isn't a substitute for having an auditor who knows something about the process they are going to audit. If anyone has at least half a clue about purchasing, a quick look at their process, or an interview with the manager is all you need to get you investigating the implementation. You don't need any prepared or canned list of 'fixed' questions to ask.
 
Elsmar Forum Sponsor

Doug Tropf

Quite Involved in Discussions
#12
The use of checklists seems to be discouraged in the present "process based" approach to auditing. I find that a well crafted checklist serves as a beneficial tool in conducting process based audits.
 
#13
The use of checklists seems to be discouraged in the present "process based" approach to auditing. I find that a well crafted checklist serves as a beneficial tool in conducting process based audits.
I'd agree, Doug, if they don't support a process approach. IMHO, the examples given here don't do that in a manner that would clearly give the auditor a 'path' to follow. It's not the audit approach that's causing the problem, it's the format of the checklist..........
 
M

Mueller Time

#14
We started with our own Internal Audit Checklist 6 years ago before we became ISO 9001 certified. We have since scrapped that list because following a checklist became a crutch for our auditors and did not give a true picture of our system. We found that our auditors did not follow the processes they were auditing, only the checklist.

We do still use an audit Questionaire, but they are developed for each individual audit (by the Internal Auditors) and are approved by the Lead Auditor prior to use. The Questionaires are just a few simple questions (or notes to look for evidence) related to the processes to be audited, are based on the process, the Standard and past audit results, and are used as a jump off point to help start an audit trail. From there the auditor follows the flow of the process, gathering evidence and making sure it meets our system's requirements.

We found that allowing our Auditors to develop their own questions helped them look closer at the processes that they were auditing, and they ended up taking more interest in our systems.:yes: I've had the same problems finding interested auditors and this seems to have helped us.
 
#15
We started with our own Internal Audit Checklist 6 years ago before we became ISO 9001 certified. We have since scrapped that list because following a checklist became a crutch for our auditors and did not give a true picture of our system. We found that our auditors did not follow the processes they were auditing, only the checklist.

We do still use an audit Questionaire, but they are developed for each individual audit (by the Internal Auditors) and are approved by the Lead Auditor prior to use. The Questionaires are just a few simple questions (or notes to look for evidence) related to the processes to be audited, are based on the process, the Standard and past audit results, and are used as a jump off point to help start an audit trail. From there the auditor follows the flow of the process, gathering evidence and making sure it meets our system's requirements.

We found that allowing our Auditors to develop their own questions helped them look closer at the processes that they were auditing, and they ended up taking more interest in our systems.:yes: I've had the same problems finding interested auditors and this seems to have helped us.
Wow - what a super piece of information! I'm happy to have read that! It supports what I've seen over the years too!
 
E

easttn

#16
You guys are brutal. The guy was just looking for some help, none of your comments are helpful if your just getting started. From now on I'll keep all my comment to myself as the pundits on this forum are well in control. Jeezzze.

I'll continue to lurk as there is a vast amount of knowledge here. Thank you.
 

SteelMaiden

Super Moderator
Super Moderator
#17
Sorry easttn, I did not mean to be brutal to anyone. The question was asked, and I tried to give feedback based on what the standard requires. If you feel that there is any other information I should have provided, please let me know. don't just bow out, because then we all lose in the exchange.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#18
You guys are brutal. The guy was just looking for some help, none of your comments are helpful if your just getting started. From now on I'll keep all my comment to myself as the pundits on this forum are well in control.
People here do tend to be blunt, if that's what you mean by brutal. I've looked over the thread and I'm not sure what the issue is, but if you'll PM me your thoughts, I'll be happy to listen. I prefer not to derail the thread with further discussion about issues within this thread.
 
M

Mueller Time

#19
You guys are brutal. The guy was just looking for some help, none of your comments are helpful if your just getting started. From now on I'll keep all my comment to myself as the pundits on this forum are well in control. Jeezzze.

I'll continue to lurk as there is a vast amount of knowledge here. Thank you.

:truce:Sorry, I wasn't trying to be brutal. I thought the idea was to share info and experiences.
If a checklist is what someone else is looking to do I would recommend it be based on their system, not word for word from the standard. (Basically I believe it should be tailored to focus on finding objective evidence that their system is being followed -- assuming their system follows the Standard). I would also allow for input from each individual auditor at each audit. This allows the auditor to add their own personal contribution to the audit if they so choose.
 
B

Benjamin28

#20
I'm doing my 5th auditing course in as many weeks and I've had about 100 people that I have told the same thing.......If you use a checklist just use it as a tool to start the audit and help take you from the beginning to the end, letting it allow you to get off track and follow those audit trails that present themselves (I use the term Reeses Pieces), and to get back on track; and use the checklist as a memory aid to help reduce your workload as an auditor so you don't have to remember everything you need to look for and look at.

Don't get all wrapped around an axeltrying to get the perfect checklist...it ain't out there.
I agree 100% with Randy on this. The goal should not be to create the ultimate checklist, it should be to create the ultimate auditor. Using a checklist is fine and dandy, but the auditor should not use it as literal questions. The questions should be open ended and should address not only the literal requirement but the periphery of the process as well and the auditor should feel free to follow that course to whatever it reveals, be it reeses pieces, m&ms, or mouse droppings.
 
Thread starter Similar threads Forum Replies Date
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
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 7
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 5
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 1
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
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 10
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 149
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 22
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

Similar threads

Top Bottom