What is the requirement for dealing with an instrument that was sent for annual calibration, but was found out of range?
With regards to the validation studies performed throughout the year, does it negate the temperature studies?
The equipment was used within its calibrated period but the annual calibration found it out of specfic. There are 4 temperatures were measured during the re-calibration. it passed for 65, 100 and 300, but failed at 150. Unfortunately, the validation work hovered between 100 and 150.
I dont this should be an issue. The requirement is that calibrated equiipment be calibrated to acceptable standards and its within its calibratied period. correct?
Does anyone believe all hte validation studies need to be redone.
Think a little more on that statement. Say you went into the hospital and got an overdose of an x-ray then came to find out the x-ray equipment passed all the safety checks; the only problem was the test equipment failed to deliver accurate results even though it was within the calibration period. Would you find that acceptable? The intent is (always) safety. Having calibrated equipment gives a reasonable level of assurance that your equipment is working properly but is not a guarantee that the test results will always be accurate.
So regarding your original question (what has to be done), the first steps need to include a risk assessment and an impact assessment. Did you release product based on results gathered from the (faulty) equipment? If so, could someone be harmed as a result? If that’s the case, you need to take immediate actions to ensure public safety (potentially up to a recall). If there’s no risk to public safety, you may just need to notify whomever has the (potentially faulty) product.
If the equipment was just used during a validation exercise (and product hasn’t been released), then the impact is reduced. I would suggest, at a minimum, that some of the validation exercise be repeated just to prove there were no incorrect conclusions made as a result of the faulty equipment.
Yodon. Thank you for your input. I understand and agree with your point. If I wasn’t clear, there is no product involved. There was no product being manufactured. This only relates to thermal mapping and therefore, there was no product impact. This is related to temperature mapping of the autoclave. The validation studies affected are the requal of the autoclave and couple process qualification.
Since there is no product impact and relating to thermal mapping, would there be a need to include a risk assessment and repeat of all the vlaidation studies?
Ok, good! And just to be clear, there has been no product manufactured using that equipment since the validation and now, right? (The statement about being only thermal mapping and no product impact concerns me.)
The situation is that you have something that calls into question the results so you DO need to take some action to re-establish the validity of the results. If you don’t completely re-do the validation, you need some (documented) basis for limiting the effort. A short risk assessment can help provide the rationale for limiting the scope. If you don’t have the (documented) rationale for limiting the scope, any (good) auditor / inspector will likely ding you for making (seemingly) arbitrary decisions (at best… at worst you could get slapped with the old ‘adulterated product’ line).
[quote=wes77]Yodon. Thank you for your input. I understand and agree with your point. If I wasn’t clear, there is no product involved. There was no product being manufactured. This only relates to thermal mapping and therefore, there was no product impact. This is related to temperature mapping of the autoclave. The validation studies affected are the requal of the autoclave and couple process qualification.
Since there is no product impact and relating to thermal mapping, would there be a need to include a risk assessment and repeat of all the vlaidation studies?[/quote]
I was just reading the article about top 12 audit findings for equipment validation. the #1 was failure to document and investigate discrepancies…
So your calibration was out of specification, there should be some system to document this nonconformance. In this case it is only within the validation, so perhaps it is handled within the validation as a validation deviation? The quality system is a feedback loop, so this nonconformance needs to feed back to some document that identifies impact to product and addresses risk to validation - as Yodon was saying.
Also look at how much the calibration was out of specification. Perhaps it was 0.0000001C from the NIST and your autoclave uniformity / specification is 0.01C. This can be brought into the risk assessment as well to mitigate risk.
It is strange that it failed an intermediate point (150) but passed at 300. Can you verify at a closer temperature to your actual use range? Perhaps more investigation will mitigate risk as well.