Should there be a incident/deviation for breakdown or missed calibration date?

[v9991]

should a incident or deviation be initiated in following two cases.
1) breakdown of equipment (preventive maintenance schedule)
2) a calibration date being missed. (delay in initiating & completion of calibration activity)

there are two situations,
1) where equipment is not used (after breakdown or delay in calibration)
2) where equipment is used; but no apparent effect on previous analysis.

now the option we are weighing is that,
A)
in case of breakdown:- is it adequate to include steps for impact-assessment in the breakdown-analysis/report (if impacted, then trigger an incident)

in case of calibration :- is it adequate to include steps for "not use the equipment" before completion of calibration. (if used, then trigger an incident)

B) or should an incident be triggered, just because there was a break down or delay in calibration schedule.


note :- this is for FDA/CGMP regulated laboratory/manufacturing unit

 

[Marc]

Do you mean a nonconformance report? I don't think a deviation would apply to equipment breakdown or missed calibration. Depending on how you define "Incident Report", that might be appropriate.

As to missing a calibration date it really depends a lot on the specifics of the situation. For example, what measurement instrument and what are the potential effects and risks if the instrument in question is found to be out of calibration when it is calibrated.

There is also the aspect of whether the event is a recurrence or not.

Other than those thoughts, I can't help much. Hopefully others here will chime in on this one.

 

[silentrunning]

Towards the end of 2008 it became apparent that we were not going to be able to do our scheduled shop wide tool calibration of measuring tools. We held a managers meeting and noted in the minutes that we would be 30 days late on our calibration. Each employee received a letter explaining that the date on the calibration sticker was extended by 30 days. The employees initialed it and returned it to management. When I presented this to our auditor I showed that we have not had a reject in the last 8 years due to a defective measuring tool. He said OK and we moved on.
I don't know if this was the correct way to handle this problem, but the end result was good.

 

[Stijloor]

Towards the end of 2008 it became apparent that we were not going to be able to do our scheduled shop wide tool calibration of measuring tools. We held a managers meeting and noted in the minutes that we would be 30 days late on our calibration. Each employee received a letter explaining that the date on the calibration sticker was extended by 30 days. The employees initialed it and returned it to management. When I presented this to our auditor I showed that we have not had a reject in the last 8 years due to a defective measuring tool. He said OK and we moved on.
I don't know if this was the correct way to handle this problem, but the end result was good.

Based on the fact that you did not produce nonconforming product, you could have extended the calibration interval permanently. Saving time and cost.

Stijloor.

 

[Marc]

Indefinite Calibration Interval

Towards the end of 2008 it became apparent that we were not going to be able to do our scheduled shop wide tool calibration of measuring tools. We held a managers meeting and noted in the minutes that we would be 30 days late on our calibration. Each employee received a letter explaining that the date on the calibration sticker was extended by 30 days. The employees initialed it and returned it to management. When I presented this to our auditor I showed that we have not had a reject in the last 8 years due to a defective measuring tool. He said OK and we moved on.
I don't know if this was the correct way to handle this problem, but the end result was good.

What you did was show that you were aware of the issue, all affected employees were aware of the issue and were addressing it, rather than "Oops! I wonder how THAT happened..." during the audit.

Based on the fact that you did not produce nonconforming product, you could have extended the calibration interval permanently. Saving time and cost.

Stijloor.

I'm not sure what you mean. Are you suggesting establishing an indefinite calibration period for measurement equipment (eliminate calibration of M&TE)? I.e.: Since there haven't been any nonconformances in 8 years the company can essentially eliminate calibration? (Note: I'm easy to confuse... ).

OR - Are you saying they should just set a new calibration interval based upon production non-conformances instead of basing calibration intervals on the calibration record of the individual measurement instruments (not to mention environment it is used in, etc.)?

 

[Stijloor]

Re: Indefinite Calibration Interval

I'm not sure what you mean. Are you suggesting establishing an indefinite calibration period for measurement equipment (eliminate calibration of M&TE)? I.e.: Since there haven't been any nonconformances in 8 years the company can essentially eliminate calibration? (Note: I'm easy to confuse... ).

OR - Are you saying they should just set a new calibration interval based upon production non-conformances instead of basing calibration intervals on the calibration record of the individual measurement instruments (not to mention environment it is used in, etc.)?

No, :mg: I would not set an indefinite calibration period based on "waiting until nonconforming product is produced." But yes, a new extended calibration interval could be set based on the robustness of the measurement system and the performance of the individual measurement instruments. If no nonconforming product is produced over an 8 year time period due to faulty equipment, the system must be pretty robust, but I would not take that as the sole criterion.

Hope this clarifies.

Stijloor.

 

[Marc]

Re: Indefinite Calibration Interval

Jan,

OK - I get it. I'm sort of a calibration freak in that when I did implementations that was typically (almost always) a weak area which wasn't always supported, for example, by a manager (who was often *really* calibration knowledge limited to top things off).

Now - Don't get me wrong... I'm not a calibration expert. There are others here who are much more knowledgeable than I. I don't even have any of the current standards and I certainly never worked in a calibration environment. I can only say I learned the "basics" years ago during my military manufacturing days. The company I worked for had a calibration lab you had to walk through a double door room, don a smock, and then enter the lab. Some standards were kept in liquid solutions at a specified temperature.

That said, I was knowledge hungry back in those days. I was essentially a new QE working in a high reliability electronics manufacturer. One thing I came out with was a pretty good understanding of setting calibration intervals. In fact (as I blow my own horn) going back about 20 years I did the local ASQ CQE prep calibration tutorial (a donate your time thing) for several years.

When I read silentrunning's post (number 3 in this thread) I looked at it from a *competent* auditor's viewpoint and was impressed. I would have let it go and moved on, too. The actions silentrunning took were appropriate and, from my experience, rare. It is almost *always* an "Oops! How did THAT happen?" answer from the auditee.

Many companies scrimp on calibration. In some cases (e.g.: the manufacture of rubber duckies for kids to play with in the bathtub) calibration is typically not a big deal. On the opposite side of the fence, such as high reliability products, calibration can be critical.

 

[v9991]

should a incident or deviation be initiated in following two cases.
1) breakdown of equipment (preventive maintenance schedule)
2) a calibration date being missed. (delay in initiating & completion of calibration activity)

there are two situations,
1) where equipment is not used (after breakdown or delay in calibration)
2) where equipment is used; but no apparent effect on previous analysis.

now the option we are weighing is that,
A)
in case of breakdown:- is it adequate to include steps for impact-assessment in the breakdown-analysis/report (if impacted, then trigger an incident)

in case of calibration :- is it adequate to include steps for "not use the equipment" before completion of calibration. (if used, then trigger an incident)

B) or should an incident be triggered, just because there was a break down or delay in calibration schedule.


note :- this is for FDA/CGMP regulated laboratory/manufacturing unit

an extension of the question is that.,
in the event of breakdown, suitable maintenance/servicing is followed through with 'performance verification / calibration' ;
so question is that ., should this calibration be treated as additional step(1); VS should we re-cast the calibration schedule from the current date of calibration (2)?

in scenario 1 :- we would have additional calibration...( particularly debated in case of annual & external calibrations involving cost - time tec)

in scenario 2:- difficult to justify the extension of the next calibration from current date ... (particularly debatable as inadequate data/surity for next failure-rate, and calibration date would be 1 year from current date, and often the activities are related to re-qualibration! (not re-qualification))

 

[khamid1963]

You need to have an in-house SOP that spells out what test need to be done after certain repairs. An example:
a calibrated HPLC lost pressure due to bad pump seals. If the instrument is still in calibration, all you need to do after repair is to verify flow rate and pressure stability.

 

[dwperron]

"If the instrument is still in calibration, all you need to do after repair is to verify flow rate and pressure stability."

"Still in calibration" is meaningless. The due date on the calibration label does not guarantee that the unit is operating within specifications.

If you want to know if you are still getting accurate results after a repair you need to do some sort of verification test.