An Internal Audit Challenge - Audit of the Quality System Effectiveness

C

cjssag

#1
(The Grouch is back!)

Your boss, the Audit Leader, hands you a new assignment. You are to conduct an audit of the quality system's effectiveness. Your report is due in 15 minutes. Only one of two findings will be acceptable. 1. The quality management system is effective and here is the objective evidence. OR
2. The quality management system is not effective and here is the objective evidence.
How will you conduct the audit? What will be your criteria?
 
Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#2
Re: An Internal Audit Challenge

(The Grouch is back!)

Your boss, the Audit Leader, hands you a new assignment. You are to conduct an audit of the quality system's effectiveness. Your report is due in 15 minutes. Only one of two findings will be acceptable. 1. The quality management system is effective and here is the objective evidence. OR
2. The quality management system is not effective and here is the objective evidence.
How will you conduct the audit? What will be your criteria?
I'm not being "flip," but if he/she was an effective leader, you would (even if you were brand new that day) merely look to retrieve the results of the most recent internal audit, saying, "Here is the snapshot you prepared on [date], let's see if any NC points are unresolved."

If you (and he) are unable to retrieve such report within the 15 minute time limit, the answer is, "Sorry, the system is not effective, the objective evidence is the inability to retrieve a key part of any QMS, the periodic internal audit."

Obviously, my colleagues here in the Cove will be quick to point out there are many organizations with "pristine" internal audit reports that are totally fraudulent. Dealing with fraud is a whole different kettle of fish. Even those of us who are very experienced have been taken in by fraudulent paperwork, but the proof is always in the personal eyewitness and interview of personnel to determine the deed meets the plan.
 
#3
(The Grouch is back!)

Your boss, the Audit Leader, hands you a new assignment. You are to conduct an audit of the quality system's effectiveness. Your report is due in 15 minutes. Only one of two findings will be acceptable. 1. The quality management system is effective and here is the objective evidence. OR
2. The quality management system is not effective and here is the objective evidence.
How will you conduct the audit? What will be your criteria?
If I read it correctly, it's an impossible task to audit the system in 15 minutes. As Wes appears to point out, a review/compilation of the audit findings could be done. However, it's often a stretch to have sufficiently robust audits that you could gain that level of knowledge about the system - it is so dependent on so many factors.

If there were a practical timeframe, a system wide audit of the processes of the organization, conducted against the system description including the stated objectives etc. would be the way to go.

From merely looking at audit findings? In 15 minutes? - your boss is a cruel tryrant:lol:
 
C

cjssag

#4
"Ars longa, vita brevis, occasio praeceps, experimentum periculosum, iudicium difficile"
Thanks Wes and Andy for your inputs. I'd like others to chime in here, too.

One interpretation of Andy's tag line is :"It takes a long time to acquire and perfect one's expertise (in, say, auditing) and one has but a short time in which to do it"

Very appropriate to the question, yes?

I am not suggesting there is any one right solution to the challenge nor am I ready to give you my 2 cents worth. But I posted it in an effort to focus attention away from the trees and back onto the forest, where it belongs. While MGM (or whomever) can claim they live by "Ars gratia Artis" (art for the sake of art) we should not allow ourselves to succumb to auditing for the sake of auditing.

Who wishes to argue that one must conduct a regimen of internal audits in order to have or demonstrate that they have an effective quality management system? (To do so, IMHO, would be to hold that the tool is more important than the product.)

Challenge Clue: What is/should be the function of any quality management system and what has greater status and importance than that?

Let's hear from others please.
 
C

cjssag

#6
Easy. Show them the minutes of the last management review.
Great!

1. What exactly would you be looking for in those minutes to demonstrate system effectiveness?

2. What if they did not conduct a management review? Can their QMS still be effective and how could you tell?

Challenge Clue #2. Whose QMS is it anyway?
 
C

curryassassin

#7
Great!

1. What exactly would you be looking for in those minutes to demonstrate system effectiveness?

2. What if they did not conduct a management review? Can their QMS still be effective and how could you tell?

Challenge Clue #2. Whose QMS is it anyway?
Ooh. What fun !!!

1. You would be looking for current performance in all areas against target/objective eg. audit performance data, training data, customer satisfaction (order completion, complaints, returns/reworks/recalls), CAPA performance, process performance, recommendations for improvement etc).

2. Yeah, similar to above and in response to your second clue, who are the stakeholders in the QMS? Management, staff, customers, board, shareholders, investors, regulators, local community, environment? So measurements that these are satisfied. Is it increase in sales, profits, share price, market share?
 
#8
Easy. Show them the minutes of the last management review.
My CurryCompanion!

Most Management go to a Managent Review with no clue why they're there or what to get from the time spent.........:mg: Well, apart from the fact that 'ISO-says-So'.......:lol:

:topic:
(How's the water level in Oxford..........?)
 
C

curryassassin

#9
My CurryCompanion!

Most Management go to a Managent Review with no clue why they're there or what to get from the time spent.........:mg: Well, apart from the fact that 'ISO-says-So'.......:lol:

:topic:
(How's the water level in Oxford..........?)
I know this is the case in some orgs.

Now in the drying out/pleading with insurers phase.....
 
C

curryassassin

#10
My CurryCompanion!

Most Management go to a Managent Review with no clue why they're there or what to get from the time spent.........:mg: Well, apart from the fact that 'ISO-says-So'.......:lol:

:topic:
(How's the water level in Oxford..........?)
Must run. You guys carry on. I'll ctach up later.
 
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