Generic or Specific Checklists for Internal Audits

#11
Checklists

First of all Richard, I apologize for waiting so long to respond. I have been spending quality time with my best friend (my fishin’ pole). I’m back now, and feeling fully refreshed (thank you very much).

Now to the question at hand (if Martin and Jim will allow): Auditing IS REQUIRED! (even if it is done through our “met via normal management processes” as Jim mentioned – aren’t we playing semantics here) To get the most of your QMS (or EMS) your checklists should include both the standard-based requirements and the organizational documentation.

My recommendation is to begin with a canned set of checklists. I know Marc has at least one set available. Add to that questions based on your own processes and procedures. For each step in the process ask yourself three questions:

1) What activity is being performed?
2) Who is performing the activity?
3) What evidence would show the activity is being done correctly?

I think this is a good start, at least for most organizations?
 
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#12
Required Checklists

Quote:

But wouldn't you agree that:
a) those three questions aren't required to be answered by 9001/8.2.2
I think if you actually read the standard, you will find they are required! No I'm lying! :bonk: In this case they are not covered by a “shall”. No checklist is required. However, I believe that auditing (and checklists) should be tools that allow the organization to see the level of compliance and uncover any possible improvement targets. The three questions allow the auditor to have a better understanding of the process and can assist in the audit process.

Quote:

b) a lot more needs to be done to meet the requirements of 9001/8.2.2?
Oh yes! But this thread is about checklists (which are not required). If asking my three questions about process steps is followed throughout each process, I think both 8.2.2 a) and b) will be addressed.

Hope this clears things up.
 
J

Jimmy Olson

#13
Okay, so ISO 9001 doesn't require us to audit procedures, but wouldn't that be an easy way to do the audit? Most processes have procedures to define them. If the process has a procedure that is part of the quality system, why not use the procedure as your reference for your internal audit of that process?

I am still new to all this and am terribly confused. :confused: :confused: :confused:
 

Randy

Super Moderator
#14
Do what is easiest and works best for you. it may take some trial and error. So what? That's what continual improvement, & C&P action are for and about.

Just be sure that you can verify the implementation, effectiveness and the conformance of your system.
 
#15
Jim,
I agree with your position for the auditing process. The focus of ISO9000 is on auditing processes, even though there are documented procedures required for implementation.
A process is typically described by written word, flow diagrams and/or process maps. When we describe a process by word, we tend to be drawn back into that procedure mentality. We should be focusing on the process as described by the procedure.

A process is defined by three basic steps: inputs, activities, outputs. Questions I would ask during an audit;
- What is your job?
- How do you know that what you are doing is right?
- Have you had training?
- Who is your customer?
- What are their requirements?

Of course the determination of an acceptable process is only evident by verification of an acceptable product.

And as usual these comments are just MHO

:bigwave:
 
#16
Losing sight?

We must be careful not to lose sight of the original question in regards to checklists. ISO wants us to think “process” and ONE WAY to audit the process is to see how the process is being performed. The "HOW" you perform a process IS THE procedure, written or not. When developing a checklist based on HOW the process is performed, the three questions I use is ONE way to determine the process performance. The “what we have achieved” vs the “what we are doing” issue is only valid in mature systems. If you can’t meet the “doing” part, the “achieving” part can never occur. As systems mature, then there needs to be a natural migration from compliance to performance. You can’t feed a newborn steak, and a healthy adult should be beyond babyfood.

To add a fourth question: “How can the process be improved?”, can add some benefit, but unless handled properly, it might alienate process operators (“Are you telling me how to do my job?”). If the auditor asked the question directly to the auditee, that situation may be avoided.
 
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