Justification for Month End Calibration Date

[Scubabiker03]

I know this is an old thread but I'm wondering if anyone ever came up with a way to do this. I'm currently stuck in the same situation.

 

[Mike S.]

If you have a situation like the OP I would ask the auditor politely to "show me the shall". If someone is writing a NC the first thing to do is to list the requirement, aka "the shall".

 

[Scubabiker03]

Unfortunately Our company works a little different, our internal auditors are requesting (Demanding) this and no matter how we try it seems not good enough. I've ran this system at multiple companies and have never had to justify this. They're wanting an individual asset by line item assessment. I'm hoping someone out there has come up with a way to justify it by not doing individual assessments. Thanks for any help you can give me.

 

[Ninja]

Are your internal auditors company employees? Or are they outside the company hired in for the job?

If employees...have management push them back. (ie. swing the bat)
If outside...document the input, write your defense as to why it is inappropriate and find someone else to audit from now on...

 

[Mike S.]

I would definitely take this to a higher authority. No auditor worthy of the title will demand something or write a NC for something that is not required. With no requirement (shall) there is no NC. If there is a requirement, let the auditor specify the requirement, that is part of their job. Without the requirement, how can you develop a compliant system via corrective action?

"Auditors" like this give auditing a bad name.

 

[Scubabiker03]

Well Mike S, I agree with you on all points but unfortunately this is an internal auditor and I can't tell them that. Our auditors require Justifications for everything they do not understand, which unfortunately most people do not understand calibration. They want me to show that the additional days won't make a difference. I tried going the confidence route but that didn't give them the warm happy feeling their looking for, I don't have the time to do a real study so if anyone has a something they pulled off the information would be extremely helpful, our auditors didn't bring up their concerns until after we made schedule changes.

 

[Sidney Vianna]

Well Mike S, I agree with you on all points but unfortunately this is an internal auditor and I can't tell them that. Our auditors require Justifications for everything they do not understand, which unfortunately most people do not understand calibration.

You have the other way around. The auditee can not be responsible for educating the auditor on each and every issue they don't understand. As already mentioned, it is the auditor's responsibility to identify the requirement not being complied with. If there is no explicit requirement being violated, at best, the auditor identified some "risk". Who determines if the risk is acceptable or not should be the people with the understanding of the situation.

Measurement devices don't go bad the day after the calibration date expires. Frequency of calibration determination, when well executed, takes into account several parameters such as device calibration stability, frequency of use, storage, usage and handling conditions, criticality of the measurements being undertaken, etc.

If you allow auditors, internal or external, to dictate risk management decisions they are not equipped to make, you are doing your organization a huge disservice.

 

[Mike S.]

Scubabiker03, maybe I am reading this wrong, but you may be inexperienced and/or a bit intimidated. If so, we have all been there. But between Ninja, Sidney, and myself you probably have well over 70 years worth of experience advising you. This kind of thing will go on until someone puts a stop to it. If the Lead Internal Auditor won't step in and stop this BS, I strongly suggest you raise it to the next level of Management. JMHO.

 

[Ninja]

20 yrs here...so I think the total is higher than 70yrs.
FWIW, I come from the "getting audited" side of things...and I've had to push back hard on some auditors who were out of line.

My first audit was extremely intimidating, and I laid down and took it because I didn't know any better.
When I had learned better, I realized that I didn't have to be intimidated...these "should be" people who are trying to help your company by finding what's broken so you can fix it.
No one likes being told they did it wrong (especially if you haven't done it wrong)...you have to keep your brain engaged and reality check any potential finding...NEVER just lay down and take it...learn, or teach, or learn together using only the standard (which includes your internal docs by reference).

 

[Scubabiker03]

Mike, I actually have been in the business for 35 years, but I was informed by my leadership that this is an internal requirement, not external, so I must do this. It makes no sense to me but I don't have a choice in this matter.