What to do with Prior Analysis after instrument was Out Of Calibration (OOC)?

[sharduli_k]

If an instrument is OOC from unknown days before and analyst could not encounter the error as it is much internal and critical to get,what to do with the samples that run on the instrument from some before days?
How one can get the time from when it was out of calibration?

[brahmaiah]

The foolproof method to correct the situation, is :
1)Containment action:
a)Stop production untill you get a correct instrument
b) inspect all the parts available in your custody.
c)Send an express message to your customer to hold all parts available with him
d)Rush to your customer premises and segregate those components.

2)Corrective action:
a)Calibrate the instrument in question and start production.

3)Prevention:
a)Calibrate more frequently
b)Check the instrument before each time it is used as we do in case of hardness testers and micrometers.
c)Introduce a 'Poka Yoke' if possible.

I HOPE THIS IS ENOUGH!.
V.J.Brahmaiah

[trainerbob]

You may never know exactly your intrument went out of calibration. What you must do is move on from this point. I agree with bramiah's procedure. It should take care of your situation. One of the biggest mistakes we know is not letting the customer know what is going on.

[Arena]

Originally Posted by sharduli_k

If an instrument is OOC from unknown days before and analyst could not encounter the error as it is much internal and critical to get,what to do with the samples that run on the instrument from some before days?
How one can get the time from when it was out of calibration?

In our organization, we developed a calendar for internal an external calibrations. It lists all measurement equipment used by production and its calibration frequency (weekly, monthly, quarterly, etc.) Also, each time an equipment is calibrated, we use a label with the calibration date and due date. It has worked for us so far.

Just make sure the equipment listed on the calibration calendar is up to date and try not to run out of labels!

[harry]

Originally Posted by sharduli_k

............ How one can get the time from when it was out of calibration?

What are the 'Risk' involved?

If the risk (or consequential loss or damage) is high, you may want to validate your instrument every day or even every shift. If it is low, you may choose to do it once a week/month or so. In this way, you may be able to contain problems - otherwise, you can't tell by your present practice.

[sharduli_k]

Originally Posted by brahmaiah

The foolproof method to correct the situation, is :
1)Containment action:
a)Stop production untill you get a correct instrument
b) inspect all the parts available in your custody.
c)Send an express message to your customer to hold all parts available with him
d)Rush to your customer premises and segregate those components.

2)Corrective action:
a)Calibrate the instrument in question and start production.

3)Prevention:
a)Calibrate more frequently
b)Check the instrument before each time it is used as we do in case of hardness testers and micrometers.
c)Introduce a 'Poka Yoke' if possible.

I HOPE THIS IS ENOUGH!.
V.J.Brahmaiah

So after this, what about the reports released before? how to correct them?

[sharduli_k]

Originally Posted by trainerbob

You may never know exactly your intrument went out of calibration. What you must do is move on from this point. I agree with bramiah's procedure. It should take care of your situation. One of the biggest mistakes we know is not letting the customer know what is going on.

I agree to you but we have to inform to customers at least when we have failed any batch or we have passed the batch on threshold values

[brahmaiah]

Originally Posted by sharduli_k

So after this, what about the reports released before? how to correct them?

You may release a revision to all related reports stating 'The inspection report No.XXX dt.DD MM YY is invalid due to use of defective measuring instrument.
-VJB