Elsmar Cove Forum Header Graphic The Elsmar Cove Wiki Sitemap More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar Cove Forums Main Page Elsmar Cove Home Page
NQA-USA
Miner's MSA (Measurement Systems Analysis) Blog 
Go Back   The Elsmar Cove Forum > Information Resources - Papers - Articles - Etc. > The Reading Room
Forum Username

Wooden Line

Some Options for Risk Based Auditing - Page 2


Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links

Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
audits and auditing, risk management and analysis
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 1 votes, 5.00 average. Display Modes
  Post Number #9  
Old 17th February 2012, 03:19 PM
Chance

 
 
Total Posts: 506
Re: Some Options for Risk Based Auditing

Jen,

How do you come up with your raw data used in the chart "Audit Scores by Department"?

Sponsored Links
  Post Number #10  
Old 17th February 2012, 07:00 PM
Jennifer Kirley's Avatar
Jennifer Kirley

 
 
Total Posts: 5,585
Re: Some Options for Risk Based Auditing

Quote:
In Reply to Parent Post by Chance View Post

Jen,

How do you come up with your raw data used in the chart "Audit Scores by Department"?
Did you see the spreadsheet attachment in post #8 in this thread? The chart is automatically generated given hypothetical data. Please tell me if you want some scenario examples of what data would be represented with the numbers shown.
Sponsored Links

  Post Number #11  
Old 21st February 2012, 10:28 AM
Chance

 
 
Total Posts: 506
Re: Some Options for Risk Based Auditing

The factors are subjective to me preparing the report. Managers might not agree with my finding classifications. Can you tell us more details what triggers an audit finding to fall in each of the factors?

1. systemic problem
2. Process gap, dysfuction
3. Human performance, not following procedures
4. Procedural gap, need revision
5. Audit readiness issue

Right now, I am trying to summarize in a report our audit findings per year using Process Perfomance Wighted Scores. It is nice. But I have trouble filling out the gray cells.
  Post Number #12  
Old 2nd March 2012, 10:17 PM
Jennifer Kirley's Avatar
Jennifer Kirley

 
 
Total Posts: 5,585
Re: Some Options for Risk Based Auditing

Quote:
In Reply to Parent Post by Chance View Post

The factors are subjective to me preparing the report. Managers might not agree with my finding classifications. Can you tell us more details what triggers an audit finding to fall in each of the factors?

1. systemic problem
2. Process gap, dysfuction
3. Human performance, not following procedures
4. Procedural gap, need revision
5. Audit readiness issue

Right now, I am trying to summarize in a report our audit findings per year using Process Perfomance Wighted Scores. It is nice. But I have trouble filling out the gray cells.
1) Systemic is defined as "affecting or relating to a group or system (such as a body, economy, or market) as a whole, instead of its individual members or parts." We can then consider systemic breakdowns to involve multiple instances or more than one interdependent group. For example: Auditees described that several times last year a manufacturer halted one or more lines due to shortage of critical material because of an inability to accurately forecast what was needed to produce the manufactured goods. Or, the supplier sent repeated shipments of materials/chemicals that failed receipt inspection. This involves both process realization and purchasing element groups.

2) Process gap, dysfunction: a group of employees was hired without identifying or performing training needed to do their work accurately and efficiently. This involves one element group. If this routinely happens or has occurred with a large group of people for whom the organization fails to plan for regulatory training, the issue could be considered to be a systemic one.

3) One or two operators insist on doing things his/her way instead of following procedures. The issue may be one of procedures themselves not being optimum (they are in fact inefficient) or the immediate person makes a choice not to adhere to the procedures on the basis of personal viewpoints or a lack of understanding of how this affects downstream processes. Note that if this is widespread throughout the processes it could be considered to be a systemic problem.

4) A process has been changed but the written procedure has not been updated. Note that if this is widespread throughout the processes it could be considered to be a systemic problem.

5) One or two copies (out of dozens) of a work procedure on the manufacturing floor were out of revision. No impact on product could be found. Note that if this is widespread throughout the processes it could be considered to be a systemic problem.

Of course these are guidelines. Nothing is writ in stone, so to speak. Overall the weight of impact is judged on how widespread the issue it, or its result, or possible result, on what's delivered to the customer (product or service) or regulatory compliance.

I hope this helps!
Thank You to Jennifer Kirley for your informative Post and/or Attachment!
  Post Number #13  
Old 22nd March 2012, 04:37 AM
Raffy's Avatar
Raffy

 
 
Total Posts: 835
I Say... Re: Some Options for Risk Based Auditing

Jen,
I dunno if this question would be appropriate in this reading room. Nevertheless, I would like to make a follow-up question with regard to the new requirements of ISO19011:2011 which somehow I think has a link. How to identify and evaluate audit program risks? Do we need to one by one identify the said guideline and implement it to our system? Please advice.
Thank you very much in advance for the usual kind attention you will give this matter.
Best regards,
Raffy
  Post Number #14  
Old 22nd March 2012, 08:38 AM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,077
Re: Some Options for Risk Based Auditing

Quote:
In Reply to Parent Post by Raffy View Post

Jen,
I dunno if this question would be appropriate in this reading room. Nevertheless, I would like to make a follow-up question with regard to the new requirements of ISO19011:2011 which somehow I think has a link. How to identify and evaluate audit program risks? Do we need to one by one identify the said guideline and implement it to our system? Please advice.
Thank you very much in advance for the usual kind attention you will give this matter.
Best regards,
Raffy
There are no requirements in ISO 19011--it's a guidance document.
  Post Number #15  
Old 20th July 2012, 01:51 AM
dwayne_dhey

 
 
Total Posts: 3
Re: Some Options for Risk Based Auditing

Do you also have some materials on the definition of root cause based on ISO? May I have some of it? I am still hard up in this subject matter since ISO 31000 does not provide.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Information Resources - Papers - Articles - Etc. > The Reading Room

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Evolving QA from 'Compliance-based' to 'Science/Risk-based' approach v9991 US Food and Drug Administration (FDA) 2 27th February 2011 09:21 AM
Risk Based Internal Auditing - Pharmaceutical Plants Ajit Basrur Internal Auditing 3 30th September 2009 10:27 PM
Risk Based Certification sathis ISO 19011 *and* ALL other Auditing Discussions 2 4th January 2007 11:10 AM
Risk Based Audits ocussing on those areas of identified risk eric abbott ISO 19011 *and* ALL other Auditing Discussions 3 28th February 2001 06:17 AM



The time now is 01:26 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".
no new posts