How to count the number of NCs in an Internal Audit?

S

samsung

#1
I am not sure how to report the number of NCs detected during an audit. e.g.

Case-1: There were 3 different types of problems in a document - it had wrong version details, it wasn't reviewed for adequacy for long and it contained wrong references. Are there 3 NCs in all? How many CARs to be issued?

Case-2 : There are 3 sections under the same process owner (deptt. head) while each maintaining separate sets of documents. In an audit, same problem was detected in all the 3 sections. Do we report 3 NCs?

Case-3 : A new requirement was recently introduced and it was to be implemented (including document change) by all the 20 departments in an organization. Half of the owners ignored it and during their internal audits, all the 10 defaulting deptts. were caught and booked by the auditors for failing to implement this particular requirement. How many NCs to be reported to Top Management?

There may be other similar (real life) scenarios. How Internal Auditors generally report such instances and in what form it is reported to the top?

Valuable thoughts appreciated.

Thanks in advance
 
Elsmar Forum Sponsor

SteelMaiden

Super Moderator
Super Moderator
#2
Re: How to count the number of NCs in an Internal Auidt?

My first question would be: Is each case nonconformances found in one audit? (for example, in case one, you found the 3 problems all in one audit)

Case-1: There were 3 different types of problems in a document - it had wrong version details, it wasn't reviewed for adequacy for long and it contained wrong references. Are there 3 NCs in all? How many CARs to be issued?
I'd probably make this one nonconformance as it is about controlling and reviewing for adequacy prior to approval. (my rationale at the end)

Case-2 : There are 3 sections under the same process owner (deptt. head) while each maintaining separate sets of documents. In an audit, same problem was detected in all the 3 sections. Do we report 3 NCs?
If this is all in one audit, and the problem is identical, I'd probably write it up once. (again, I'll explain later)

Case-3 : A new requirement was recently introduced and it was to be implemented (including document change) by all the 20 departments in an organization. Half of the owners ignored it and during their internal audits, all the 10 defaulting deptts. were caught and booked by the auditors for failing to implement this particular requirement. How many NCs to be reported to Top Management?
If this was my audit, I'd make sure to document exactly which departments were not following the the documented process, and write up one nonconformance. Now, I'll explain why I'd only write it up once for each case. If you start bombarding your people, and your system, with nonconformances you will begin to alienate people, and they will start to look at you and your auditors as the kwality kops. Issue 20 nonconformances, and somebody has to deal with them. Believe me when I tell you that you will not earn any points. Also, please don't use terms like "departments were caught and booked by the auditors". Again, you move away form the partnership that you should be striving to acheive and become the kwality kops that nobody wants to see coming.:2cents:
 
S

samsung

#3
Re: How to count the number of NCs in an Internal Auidt?

SteelMaiden;330791]My first question would be: Is each case nonconformances found in one audit? (for example, in case one, you found the 3 problems all in one audit)
Yes, 3 problems in one audit.

I'd probably make this one nonconformance as it is about controlling and reviewing for adequacy prior to approval. (my rationale at the end)
It was duly approved when first created but not reviewed in line with the procedural requirement.

If this is all in one audit, and the problem is identical, I'd probably write it up once. (again, I'll explain later)
Again, it is the case of one audit.
If you start bombarding your people, and your system, with nonconformances you will begin to alienate people, and they will start to look at you and your auditors as the kwality kops. Issue 20 nonconformances, and somebody has to deal with them. Believe me when I tell you that you will not earn any points. Also, please don't use terms like "departments were caught and booked by the auditors". Again, you move away form the partnership that you should be striving to acheive and become the kwality kops that nobody wants to see coming.::2cents:
Excellent thoughts worth attention. I make a point to keep them alive in my memory and thanks a lot for your nice response.

Regards,
 
E

edelsal

#4
I agree with SteelMaiden’s response…

This is the way I would handle (in fact, that is the way I already handle) internal audit findings.

I find that when I sit down and explain to the managers that this is my way to ensure the overall goal of improving the system through the audit process, it actually compels them to be more cooperative and they will actually even seek out some advise or suggestions on the best approach to corrective action based on their investigations.

They seem to like the approach, and also lets them know that your findings are not just knit-picking!

Edelsal
 
S

samsung

#5
I agree with SteelMaiden’s response…

This is the way I would handle (in fact, that is the way I already handle) internal audit findings.

I find that when I sit down and explain to the managers that this is my way to ensure the overall goal of improving the system through the audit process, it actually compels them to be more cooperative and they will actually even seek out some advise or suggestions on the best approach to corrective action based on their investigations.

They seem to like the approach, and also lets them know that your findings are not just knit-picking!

Edelsal
Yes, it is the ethical aspect of the audit one is supposed to (& should) adopt in all its entirety & values it grants to the QMS but what I am also interested to learn is the technical aspects per relevant auditing guidelines. Can a question be raised by a CB on the way the findings are written and reported.

Regards,
 

SteelMaiden

Super Moderator
Super Moderator
#6
Can a question be raised by a CB on the way the findings are written and reported.
Of course they could, if you do not satisfy the requirements of the standard, if you have many unanswered corrective action requests, if none of your corrective actions are effective, if you are not auditing the processes, etc.
 

Izoyd

Involved In Discussions
#7
I don't necessarily agree with the responses above. When I issue NC's from an internal audit, I have found that Root Cause Analysis for one department may not be the same for another department, for the same issue. Also the same if there are more than one issue found for one department in the same area; potentially different Root Causes, so therefore potentially different corrective actions needed.

I had found in the past, that if I issued only 1 grouped NC, it became difficult to track multiple responses for multiple departements, and sometimes the true Root Cause was not identified and remedied then, it became muddied as to what needed to be followed-up and verified, and repeat issues would occur.

My management is aware that each NC is an opportunity for us to improve our system. We are a Japanese-based company however, and eternal improvement, or Kaizen, is a highly promoted activity and mind-set. Therefore, the number of NC's issued is not looked upon as a bad thing within my company.

There's my :2cents:.
 

SteelMaiden

Super Moderator
Super Moderator
#8
Izod, I don't think anyone is saying that management views the number of nonconformances as a bad thing, per se, just that numerous nonconformances for the same thing tend to not be viewed the same as one well written one. In our case, it is kind of like the old "this order is hot." "this order is hot", pretty soon all orders are hot, and then hot becomes the new norm. If everything is hot, nothing is hot. That can happen easily when you start to issue 20 corrective action requests for every audit that you do. Pretty soon everyone is drowning in implementing corrections, and none of the depts know or understand what the others are doing.

Now, this all depends on the organization also, and how it operates. You state that if you find the problem in several departments, you would issue the nonconformance for each dept. And I can see that being the case. But, in many instances, it might be preferable to consolidate them into one, handled by a cross functional team and "championed" by one dept/manager. I'm thinking of something like a training issue, you might want all your training handled the same no matter what depts. are doing it wrong or right. Here, we would have the HR supervisor "own" the corrective action (even if he didn't do all the action items himself, or even the investigation) in order to ensure that implementation would be the same across the board.

In the long run, each organization should do what works best for them. Thanks for providing another viewpoint to be considered.
 
D

DsqrdDGD909

#9
I am not sure how to report the number of NCs detected during an audit. e.g.

Case-1: There were 3 different types of problems in a document - it had wrong version details, it wasn't reviewed for adequacy for long and it contained wrong references. Are there 3 NCs in all? How many CARs to be issued?

Case-2 : There are 3 sections under the same process owner (deptt. head) while each maintaining separate sets of documents. In an audit, same problem was detected in all the 3 sections. Do we report 3 NCs?

Case-3 : A new requirement was recently introduced and it was to be implemented (including document change) by all the 20 departments in an organization. Half of the owners ignored it and during their internal audits, all the 10 defaulting deptts. were caught and booked by the auditors for failing to implement this particular requirement. How many NCs to be reported to Top Management?

There may be other similar (real life) scenarios. How Internal Auditors generally report such instances and in what form it is reported to the top?

Valuable thoughts appreciated.

Thanks in advance

IMHO,
Case 1 - 1 NC
Case 2- Don't understand.
Case 3- either 1 NC against upper management or 10 NC's.
 
S

samsung

#10
IMHO,
Case 2- Don't understand.
In all the 3 sections audited, identical problem was encountered. Actual case was that each of the 3 sections (maintaining separate document identity) under one department failed to address one of the newly interpreted requirements of ISO 9001:2008; i.e.; defining control on outsourced activity within their QMS. (Although each of them had defined the controls in respective work orders but the work order itself was not part of the QMS (uncontrolled doc.). If 1 NC is to be written against the 'common' Process Owner, then all the 3 sections need to be referred but separate RCA and CA to be conducted as Izoyd had conveyed in his above post.

Case 3- either 1 NC against upper management or 10 NC's.
10 NC's is OK but why 1 against the upper management if at all ?
 
Thread starter Similar threads Forum Replies Date
M How to count the number of employees? Other Medical Device and Orthopedic Related Topics 4
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
A AQL - How to count samples with defects for each defect class AQL - Acceptable Quality Level 17
M Viable count Measurement ISO Standard Other Medical Device Related Standards 1
supadrai How does the FDA count violations of, for example, misbranding? (Medical Devices) Other US Medical Device Regulations 1
M ISO 14644 Airborne Particle Count Testing Requirements Miscellaneous Environmental Standards and EMS Related Discussions 6
A Difference between Discrimination and Least Count IATF 16949 - Automotive Quality Systems Standard 2
W Legality of selling parts by count - Counting Scales Quality Manager and Management Related Issues 6
C Do Emails count as a Document/Record Document Control Systems, Procedures, Forms and Templates 6
S Head Count for Employees and Contract Workers Misc. Quality Assurance and Business Systems Related Topics 6
C What is an acceptable bioburden level or count when working in cleanroom ISO class7 ISO 13485:2016 - Medical Device Quality Management Systems 1
R Count NDC from Graphik Sample Range vs R chart Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
F Excel I want to use the count I get in another formula Excel .xls Spreadsheet Templates and Tools 13
N Requirements for the Classification of Cleanrooms other than the Particle Count Other ISO and International Standards and European Regulations 5
D Pls hlep me understand the "Total Anaerobic Plate Count" Food Safety - ISO 22000, HACCP (21 CFR 120) 1
T Significance Test for Count Data Statistical Analysis Tools, Techniques and SPC 8
M Setting Solid Dose Drug Fill Count Ranges Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
S Do Medical Sterile Drapes count as MOPP? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
I Bioburden Count Question - Bioburden is above the alert limit >1 CFU/component avg. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L GB15980-2003 Bioburden Count Trend on Operator Hands Other ISO and International Standards and European Regulations 1
S Count (Bolts and Nuts) Scale - Class of Calibration Weights Calibration and Metrology Software and Hardware 3
K Preventing Shortage of Product Quantity - Hand Count and Scale Count Manufacturing and Related Processes 13
D 510K Approval Guidelines and Marketing in the US - CD4 Count Reagent 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R While Measuring Filter Face, Why We Count From Dead Area? HEPA Filter Related Manufacturing and Related Processes 3
Y Environmental Monitoring - Setting for Particulate Count ISO 13485:2016 - Medical Device Quality Management Systems 3
L Labeling and Count/Part Reconciliation Manufacturing and Related Processes 8
B Does this count as a 510(k) Medical Device Modification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
M Devices with Measuring Function - Do rulers and calipers count? EU Medical Device Regulations 7
B Minitab Gage R&R using Defect Count per Unit Area Using Minitab Software 1
L Do "Informal" Internal Audits count? Internal Auditing 18
smryan Count by weight statistical analysis Quality Tools, Improvement and Analysis 24
C Do Newsletter articles count towards recertification? Professional Certifications and Degrees 1
T Does a years worth of prototype manufacturing "count" for TS 16949? IATF 16949 - Automotive Quality Systems Standard 6
A Class 8 100,00 Cleanroom - Airborne Microbial Count ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Latest count of ISO 9001 Registration Certificates world wide ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
S The Logic behind Tolerance vs. Least Count 1/10 Ratio General Measurement Device and Calibration Topics 11
N Auditing Inventory Levels - Computer Count vs. Physical Inventory ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
B R&R Study in Microbiological Testing - Aerobic Plate Count, Coliform, and Salmonella Food Safety - ISO 22000, HACCP (21 CFR 120) 4
Jim Wynne Vista Deathwatch - Is the new Microsoft OS down for the count? World News 30
Jen Kirley How to count two criteria at once in Excel Excel .xls Spreadsheet Templates and Tools 17
G Count By Weight Scale - Calibration within specification, but not linear General Measurement Device and Calibration Topics 8
Manix MTTF Prediction for Customer Requirements - Parts-count MTTF prediction for the part Reliability Analysis - Predictions, Testing and Standards 2
V Minitab Pareto - Trying to plot a relation of Count and Cycle Time Using Minitab Software 5
J Cumulative Count of Conforming Control Chart (CCC) - Calculating UCL and LCL Statistical Analysis Tools, Techniques and SPC 8
S Attribute GRR - Cross tab - Kappa - What does "Expected Count" mean? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
M Can multiple procedures count as one? Different aspects of document control system Document Control Systems, Procedures, Forms and Templates 6
T 3rd party audit time - Does working lunch count as audit time? General Auditing Discussions 66
Wes Bucey At the end of the day, only votes count! World News 5
D Gage R&R on a delta measurement - Particle measurement count tool Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
C Least count thumb rule - Stone walling SPC Statistical Analysis Tools, Techniques and SPC 7

Similar threads

Top Bottom