Critical Action Limits (CAL) for All Internal and External Audit Findings

B

bigup1ca

My company is implementing a new NC/CAPA software solution where ALL NCs will be input into the system, including those from Internal Audits. I am part of a team tasked to come up with a CAL for audit findings that can be utilized in multiple divisions and provide a signal to our corporate office.

Anybody ever here of a CAL being set for audit findings? If so, could you forward an example? Appreciate it.
 

Stijloor

Leader
Super Moderator
My company is implementing a new NC/CAPA software solution where ALL NCs will be input into the system, including those from Internal Audits. I am part of a team tasked to come up with a CAL for audit findings that can be utilized in multiple divisions and provide a signal to our corporate office.

Anybody ever here of a CAL being set for audit findings? If so, could you forward an example? Appreciate it.

Any suggestions?

Thank you!

Stijloor.
 

Ajit Basrur

Leader
Admin
My company is implementing a new NC/CAPA software solution where ALL NCs will be input into the system, including those from Internal Audits. I am part of a team tasked to come up with a CAL for audit findings that can be utilized in multiple divisions and provide a signal to our corporate office.

Anybody ever here of a CAL being set for audit findings? If so, could you forward an example? Appreciate it.

I use a simple Excel spreadsheet and found it very useful :)
 

Bev D

Heretical Statistician
Leader
Super Moderator
It would be helpful if we had more information on what the OP is asking for.
What do you mean by 'Action"? will you be issuing a Corrective Action?
you can set an action limit based on severity (cost, quality delivery) or number of repeats of the same non-conformity...
 

Stijloor

Leader
Super Moderator
It would be helpful if we had more information on what the OP is asking for.
What do you mean by 'Action"? will you be issuing a Corrective Action?
you can set an action limit based on severity (cost, quality delivery) or number of repeats of the same non-conformity...

Thank you Bev. Yes, I think (but I'm not quite sure :confused:) that the OP is asking about a standardized set of nonconformity evaluation criteria that will be used to decide on the type of action to take.

Stijloor.
 
S

Sorin

Anybody ever here of a CAL being set for audit findings? If so, could you forward an example? Appreciate it.

Did not heard (yet) but it should be pretty simple (you don't want a multi-ramifications nightmare I assume).

Is it critical for process/product/etc?
Short, Medium, Long Term...

Another idea would be to develop a reverse Ishikawa and apply it for every major finding.

Just ideas...
 

Bev D

Heretical Statistician
Leader
Super Moderator
Thank you Bev. Yes, I think (but I'm not quite sure :confused:) that the OP is asking about a standardized set of nonconformity evaluation criteria that will be used to decide on the type of action to take.

Stijloor.

good points. I'm not sure either. although he is saying something about a "signal to corporate". to *me* that means a signal regarding the state of nonconformances and further action as opposed to action regarding individual 'findings'

to the OP: can you clarify what you're looking for?
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
I've developed an audit tracking tool using Excel that has been getting refinements over time to provide meaningful audit data. I've attached its various iterations in the Cove - here is the latest one. It is meant to incorporate risk analysis of audit findings. Those risk levels may provide the "Critical action limits" you are asking about.

I've also started up a "Risk Based Auditing" thread where corrective action expectations change according to potential impacts of the issue.

The Tracking Log has drop down menus in columns such as "Functional Areas" that are set up in the Database sheet. With this method, your organization can decide on its own root cause types by changing the entries in the peach colored cells in Column AE. They are currently set to record:
  • Not following specs or SOP's
  • Procedures/SOPs were inadequate/ nonexistent
  • Failure to Comply with Regulations
  • Equipment Failure
  • Improper Equipment Installation
  • Improper tools/equipment used for the task
  • Equipment inadequate for needs
  • Other
The Functional Areas cells can be changed to represent the various types of audits: Customer visits, registrar, internal audits, etc. You might even decide to combine safety, environmental and quality audits in this single tool. Find this group of cells is in the Database page, colored yellow in Column Z:
  • Administration
  • Design
  • Human Resources
  • Design & Test Engineering
  • Information Systems
  • Manufacturing
  • Plant Engineering & Maint
  • Process Engineering
  • Procurement
  • Quality Assurance

This particular tracking log is set up to count findings against TS16949 elements - see column AG. You can reset those also.

The Database is set up to automatically update the drop down menus according to what's entered in the database. It will also keep track of and chart everything within the past 12 running months. If you want to change the time frame, the formulas for that are in the Database sheet, column C. The charts may be useful for reporting to management.

I hope this helps!

P.S. Please let me know if there is a problem in the tool, and I will fix it.
 

Attachments

  • Global audit tracking log.xlsx
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Last edited:

Ajit Basrur

Leader
Admin
Great tool Jennifer. Thanks :agree1:

I was just wondering how this ties in to the Balance Score Card worksheet which is towards the end ?
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Great tool Jennifer. Thanks :agree1:

I was just wondering how this ties in to the Balance Score Card worksheet which is towards the end ?
Thanks Ajit... Audit results are just one of the system measures in a good balanced scorecard dashboard like the one I put in there. The page has some other suggested measures. I will see about doing some more with that and editing the attachment.
 
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