Closing out an API/ISO QMS Audit Nonconformance - Magnetic Particle Examination

[roneljdsilva]

Hey guys,

it's been a while since I've last posted here and hope you all are keeping well fellow professionals in quality.

I am currently closing out findings from my last API/ISO QMS audit and I am having problems coming up with a solution to as follows:

The QC inspector performing magnetic particle examination (MPI) did not use a light source to ensure light intensity was over 1000 lux while performing the examination. Using a light source is also a requirement of our procedure. Now the question the reviewer is asking is why the procedure hadn't been followed and that corrective action has to include additional controls.

How do you ensure inspectors carry all required equipment prior to performing their examinations?

I've been struggling to come up with a practical control measure to satisfy this requirement and I need my fellow covers expertise.

In advance,


Ron

 

[AMIT BALLAL]

Re: Need help closing out an audit nonconformance!

Hi!

This issue seems of human error. I also faced same issue in past.


Root cause can be:
Although procedure is available which specifies the steps to be followed, it was missed by the inspector to follow some steps. This is because, there is no error proofing available to prevent such incidence due to human error.

Probable corrective action:
Modify the procedure and incorporate the sequence to be followed to make it a SOP. It should specify steps to be followed (Standardized sequence) in detail.

Reason behind that is, if we follow a standardized sequence (Following a SOP) - such problems of missing can be prevented.

If no. of checks to be provide are more, you can also use a checklist thereby preventing missing of any check.

Corrective action to be written:
Standard sequence has been defined and incorporated in SOP i.e. to be followed during magnetic particle inspection. This shall be followed by each inspector performing the test, so that the problem of missing of any check can be prevented.

Or

A checklist has been prepared which specifies checks to be done prior to magnetic particle inspection. This shall be used by each inspector performing the test, so that the problem of missing of any check can be prevented.

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Identify what applies to your organization. This is just an example.

I hope this helps!


Thanks,
Amit

 

[yodon]

Re: Need help closing out an audit nonconformance!

I'd be a bit hesitant in writing new SOPs / WIs, etc., until I understood things better. For example, why didn't they use a proper light source? Is it really necessary? Is it available? Did they know they were supposed to use one and just ignored it? Are they being pressed for time and it takes too long to set up?

I can think of a number of elegant solutions but they may not even be appropriate given the possible circumstances.

 

[Sidney Vianna]

How do you ensure inspectors carry all required equipment prior to performing their examinations?

Your process HAS TO BE user friendly; otherwise it becomes too restricting for the operators. You can not seriously expect the operators to check the light intensity during each inspection. That will make their jobs too slow and inefficient.

The recommended times and frequency for the check of the UV light intensity is to be performed when a new bulb is installed, at startup of the inspection cycle, if a change in intensity is noticed, or every eight hours of continuous use. Regularly checking the intensity of UV lights is very important because bulbs lose intensity over time. In fact, a bulb that is near the end of its operating life will often have an intensity of only 25% of its original output.

Source.

 

[AMIT BALLAL]

If it is a human error such as missing:


Add the checkpoint of lux level (Process characteristics) in your magnetic particle inspection report format, so that same can be checked and chances of missing can be eliminated.


If you can tell us the primary cause, we'll be help you in better way.



Thanks,
Amit

 

[evocube]

Either make the inspector carry a Calibrated light source meter OR what I have done in the past is verify the light source (flashlight) meets the minimum requirements for the code and "certify" the light source for a certain interval. LED (UV and white) lights annually. Mercury vapor/UV 3-6 months depending on if it is field or lab use.