OEM On-Site Calibration issues during Covid19

[al40]

All,
I have a few special instruments that need calibration by the OEM and they will not come on-site till the Covid issue eases up. How do I continue to operate and still be in compliance until the OEM can send someone? Any insights will help.

 

[Sidney Vianna]

Past history of device stability during calibration checks could be used to extend the interval. If data shows such devices have been well within their nominal parameters during PRE-adjustments, the risk of unreliable measurements is very low.
Obviously that assumes the devices recent usage and preservation is adequate.

 

[Kronos147]

How do I continue to operate and still be in compliance until the OEM can send someone? Any insights will help.

1) Review the history of the device, determine if you think this is going to impact product
2) Document the situation in some form (Risk Register, Process Deviation, Management Review) and make sure to document Top Management approval to 'run at risk'
3) Determine if there are any mitigations, implement valid mitigation plans
4) Put a plan in place to get back on track

 

[mattador78]

We have done the above and had no issue in our last audit over the situation

 

[NickV....]

1) Review the history of the device, determine if you think this is going to impact product
2) Document the situation in some form (Risk Register, Process Deviation, Management Review) and make sure to document Top Management approval to 'run at risk'
3) Determine if there are any mitigations, implement valid mitigation plans
4) Put a plan in place to get back on track

If I may add one thing.....make sure your Quality Manual and/or calibration procedures state that an amnesty window can be applied for these types of situations. You'll also want to be sure to list the activities that will be taking place for risk mitigation, the ability to use past calibration history to determine acceptance and the authorization of the amnesty from management once the activities have taken place. Auditors will look for this wording to determine weather you actions were warranted and performed according to your procedures.

 

[Sidney Vianna]

Auditors will look for this wording to determine weather you actions were warranted and performed according to your procedures.

You can NEVER know for sure what auditors will expect, as there is tremendous variation of competence, professionalism, intelligence, common sense, etc among auditors. Just because one auditor state/expect something, it does not mean that all others will follow suit.

For the millionth time ISO 9001 is NOT say-what-you-do-do-what-you-say, as your post implies. COVID-19 Pandemic is obviously, something totally unexpected and to believe that a Quality Manual or procedures have to anticipate something that cannot be anticipated is non sensical.

 

[NickV....]

You can NEVER know for sure what auditors will expect, as there is tremendous variation of competence, professionalism, intelligence, common sense, etc among auditors. Just because one auditor state/expect something, it does not mean that all others will follow suit.

For the millionth time ISO 9001 is NOT say-what-you-do-do-what-you-say, as your post implies. COVID-19 Pandemic is obviously, something totally unexpected and to believe that a Quality Manual or procedures have to anticipate something that cannot be anticipated is non sensical.

I agree with you about the auditor statement and I apologize I didn't see you state that the other 999,999 times but a Quality Manual should have a statement regarding an amnesty window for calibrations. What if the calibrators workload is too great for him to complete on time? Or he/she is the only one performing calibration and they're on holidays? or sick?? It's called risk mitigation.

 

[Jim Wynne]

I agree with you about the auditor statement and I apologize I didn't see you state that the other 999,999 times but a Quality Manual should have a statement regarding an amnesty window for calibrations. What if the calibrators workload is too great for him to complete on time? Or he/she is the only one performing calibration and they're on holidays? or sick?? It's called risk mitigation.

Allowing a reasonable window for calibration is a good thing, but it's irrelevant in this case.

 

[Sidney Vianna]

It's called risk mitigation.

The risk mitigation is done via a meaningful analysis of the calibration data to ensure device stability, not a preemptive statement in the manual and/or procedures. Otherwise, an organization could state that their calibration interval for all devices is 10 years and a CB auditor could say nothing about it. I don't think so.

 

[NickV....]

I see.....I thought that the one couldn't exist without the other. Hence the reason for procedures.....perception is ever changing.