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audits and auditing, calibration procedures and methods, internal audits
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  #1  
Old 18th August 2007, 08:11 AM
Maria Maria is offline
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Please Help! How to Internal Audit the Calibration Process

Can somebody help me how to audit internally calibration for TS 16949?

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  #2  
Old 18th August 2007, 08:34 AM
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Re: Internal audit calibration

Quote:
In Reply to Parent Post by Maria View Post

Can somebody help me how to audit internally calibration for TS 16949?
Hello Maria,

Welcome to the Cove!

I assume that you refer to an internal audit on the calibration process, is that correct? Let's begin with some of the overall "generic" stuff.

Refer to ISO/TS 16949:2002, clause 7.6 and 7.6.2.

Begin by listing all the requirements that apply to the calibration process (ISO/TS, Internal, Customer-specific, other..). (INPUT). This answers the question: "What is the calibration process expected to deliver to the customer?"
Next, evaluate the actual outcome of the calibration process. (OUTPUT) This answers the question: "Did the calibration process deliver the expected outcomes?"

When input requirements meet the output requirements, you can say that the process is effective. This is part of what is known as the "process approach" to auditing.

If there is a difference between what was expected and what actually happened, then the calibration process needs to be further investigated in terms of the contributing elements in the process such as:
  • People
  • Materials
  • Information
  • Environment
  • Equipment
  • Other
You can use a diagram such as a turtle diagram (see examples in the forum) to break down the calibration process in its contributing elements. From there you could develop a list of audit points that you would like to verify.

I'm sure you'll hear from my Fellow Covers.

Hope this helps a little.

Stijloor.

Last edited by Stijloor; 18th August 2007 at 09:21 AM. Reason: Corrected typos
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  #3  
Old 18th August 2007, 11:55 AM
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Re: How to audit the calibration process?

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In Reply to Parent Post by Maria View Post

Can somebody help me how to audit internally calibration for TS 16949?
Hello Maria,

Attached is a very simple Turtle Diagram of a gage calibration process.
Do not interpret this thing as "mandatory, best practice, required, or otherwise." It is meant to be an example of how a process such as calibration could be "pictured" for the benefit of audit preparation. Feel free to customize this thing as you see fit.

Stijloor.
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: ppt Turtle Diagram (Calibration).ppt (40.0 KB, 1925 views)
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  #4  
Old 19th August 2007, 09:20 AM
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Let Me Help You Re: How to audit the calibration process?

Quote:
In Reply to Parent Post by Maria View Post

Can somebody help me how to audit internally calibration for TS 16949?
Maria:

There are going to be a lot of helpers here, but I have a few questions which will help you prepare to audit the calibration sytem, which you should answer first - to get you an appropriate answer..........effective auditing is not just a case of taking someone's checklist or turtle and trying to use it!

Is the person going to audit the calibration system experienced in calibration or not? It's better to have someone who understands calibration to do the audit, otherwise the auditor should have some training on calibration, especially since this is a TS based system. That means the auditor will have to be familiar with the MSA too.

Is this a new calibration system? If you are auditing the calibration system for the first time, then you have a big audit to plan. just taking a simple 'turtle diagram' and expecting it to cover all the requirements is not going to be very effective. The example posted is a simple one and could be used to expand, but without the knowledge of the calibration system, you shouldn't use it on it's own.

If the system is not new, then what area of calibration is causing problems? it's better to audit based on trying to find why problems exist or if there's new equipment etc., to see if the system is being followed.

I know that if you try to answer these questions first you will get a better audit result than just going to do an audit 'blind'.

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Old 19th August 2007, 10:26 AM
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Re: How to audit the calibration process?

Spot on Andy. This piece of good advice should be applicable to all processes that anybody is going to audit.
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  #6  
Old 20th August 2007, 12:06 AM
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Re: How to Internal Audit the Calibration Process

Maria, Stijloor and Andy pretty much covered this. I did want to mention two small things.

I think (correct me if I'm wrong, guys) their suggestions are with a basic assumption that you have competent internal auditors who have had some training.

A core competency in internal auditing should also be a basis here.

Too, both guys are exactly right of having someone who knows about calibration to do the auditing. However, remember to maximize objectivity and impartiality with the auditors.

Yes, that can be a bit challenging, especially in a smaller company; but it can be done.

Oh, and if you want, surf through many of the posts here on setting up calibration labs, calibration failures and followups, etc. The Cove is a pretty good source of knowledge.

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Old 20th August 2007, 04:58 PM
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Re: How to Internal Audit the Calibration Process

Quote:
In Reply to Parent Post by BradM View Post

Maria, Stijloor and Andy pretty much covered this. I did want to mention two small things.

I think (correct me if I'm wrong, guys) their suggestions are with a basic assumption that you have competent internal auditors who have had some training.

A core competency in internal auditing should also be a basis here.

Too, both guys are exactly right of having someone who knows about calibration to do the auditing. However, remember to maximize objectivity and impartiality with the auditors.

Yes, that can be a bit challenging, especially in a smaller company; but it can be done.

Oh, and if you want, surf through many of the posts here on setting up calibration labs, calibration failures and followups, etc. The Cove is a pretty good source of knowledge.
Hello Brad,

Yes, you are right. Andy's concerns are very valid and he raised some excellent points. However, I wrote my response in the context of having competent auditors and a decent audit program in place. That's why I started with how to prepare for such an audit.

Thanks for keeping an eye on us.....

Stijloor.
  #8  
Old 12th November 2012, 02:49 PM
shallowmike shallowmike is offline
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Re: How to Internal Audit the Calibration Process

Hi Brad, can I steal some good advice on a calibration audit coming up. During my pre-audit walk through, all was good. ID stickers in place, data base records cool, however, all four of our scales for weighing and packing final product, erm nearly two months out of calibration. How do I get round this one keeping my bosses happy. We are due a TS visit for recertification. No customer complaints so far regarding short supply of components, but guess that not a get out. If I fail audit how do we continue to supply and verify product in the absence of scales and a way to check, while waiting for calibration engineer. Our recently departed QA manager failed to renew service contract for the scales

Last edited by AndyN; 12th November 2012 at 04:05 PM.
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