Process Audit Checklist Example - Feedback Please

#11
Andy,

I've been looking at your process football. If I audit my processes, management responsibilities through preventive action, it seems I will have audited document control and record control. I will have seen that the correct documents have been used and were available. I will have seen the records that are created by each process. I will have seen where the documents and records are stored. This being said, I believe I will have indirectly audited document and record control. I wouldn't need a separate audit of these two processes. Is this acceptable?

If there were findings relating to document or record control in any of the audits, that could trigger an audit of that process.
YOU'VE GOT IT! You fully understand what I'm trying to convey. Thanks!
 
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ehoqa

#12
YOU'VE GOT IT! You fully understand what I'm trying to convey. Thanks!
Hi Andy,

Does the same thing apply to other areas like Control of Nonconforming Product, Calibration, and Corrective/Preventive Action? Say when I audit the production department and I ask about nonconforming material during the production process, will I have covered the requirement to audit the nonconforming material element? And when I touch upon calibrated instruments used in production, would I have covered calibration? Thanks in advance. :)
 
#13
Hi Andy,

Does the same thing apply to other areas like Control of Nonconforming Product, Calibration, and Corrective/Preventive Action? Say when I audit the production department and I ask about nonconforming material during the production process, will I have covered the requirement to audit the nonconforming material element? And when I touch upon calibrated instruments used in production, would I have covered calibration? Thanks in advance. :)
You've certainly covered the implementation of those aspects. Now, if you detect that the process isn't being implemented as intended, then it may indicate a need to audit that process as the next audit. Let's say you see a number of non-conforming products in an area, and you look at the reasons recorded. You discover that they are all the same basic reason, you discover (and you've seen it personally) that this has been going on for some time - you might make the analysis and use of nc product data and how it links to corrective action the scope of the next audit. That way you can use the results of one audit to feed the focus of another instead of just mindlessly sticking to some arbitrary calendar...
 
G

gadimustafa

#14
am always using the process approach for conducting the audits as follows:
  1. process input ( material or information)
  2. the infrastructure
  3. the work environment( including the safety requirements)
  4. the document needed(procedures, method statements, workinstructions) for the process
  5. the training of the persons that performing the work
  6. the calibration of measuring and testing equipments
  7. the customer feed back( internal and or external customers)
  8. the output of the process( non conformity)
  9. the process effectiveness
 
T

TeeQ1

#16
I'm working on something similar for my company but was taking a different tack.
-I am trying to create a checklist that is more generic for the process being audited so we can use it as a template.​
-I try to avoid yes/no questions​
-I have a worksheet for different auditees (for example, one for the process owner, and one for a process operator, etc.)​
-I have space for an auditor to include "custom" questions based on previous findings or areas of interest.​
 
#17
Oddly enough, I have the answers to all of these questions in my head and understand what I would do to answer them in an interview. However, I see that the checklist is lacking in many regards. Looks like I will continue on without the checklist.
You can never replace the fact that a competent auditor "knows" their stuff. Filling up a sheet with all types of questions - some of which have nothing to do with the QMS of the organization - isn't going to make an effective audit!

This is one area of a CB audit which, paradoxically, internal audits rarely replicate - using auditors who know the process(es) - CB auditors usually have significant experience in a sector of industry. Internal auditors are "from another department so they are independent"...:rolleyes:
 
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