Internal Audits in a tiny Dx Company

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Carol2015

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#1
I work for a tiny Dx Company and there's only two of us in Quality, I am a Certified Lead Auditor my employee is not . We don't have money to hire an auditor to conduct internal audits for us. How can I have my employee audit the processes I'm responsible for (e.g., CAPAs, design controls, etc.)? My company has fewer than 15 people and while we got a CE Mark last year, we don't have product in the market.
 
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indubioush

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#2
There are some lower cost auditor training programs online. You might even find a free one. You could train your employee to the ISO standard you follow and also ISO 19011. Your employee can audit any process in which he/she is not responsible. Also, are you sure you can't afford an auditor consultant? If you could get someone just for one day, it would be very beneficial. You might even be able to find someone on here who could give you a deal.
 

Carol2015

Starting to get Involved
#3
"Am I sure I can't afford an auditor?" Yes, I wouldn't be asking otherwise. I went through great pains explaining we're a tiny Dx, we have no money, etc.

"You could train your employee to the ISO standard you follow"
Yes, my idea is to train the employee in the process, but I will have to be the Lead Auditor since she's not and she has all but one year experience in the department, none of which has been in auditing. Honestly, with her level of experience, it would be lame to cram an auditor training in a week. Plus, my company has no money for it.

"If you could get someone just for one day"
Again, that's not a choice. Why would you think I have not considered this? We're struggling in the post-Covid world, there is NO money. We might get money later on, but I don't want to wait 'til October to see IF we get it because by then it would be too late to start the internal audit process.

I guess I'll just have to write a memo explaining our hardship and swing for the fences. This audit exercise will provide good training to the employee, but it would be done over the next 5 months, not 1 week. Thanks!
 

Randy

Super Moderator
#4
What do you mean by Certified Lead Auditor, that you hold a 3rd party certification or just passed a training course....2 entirely different things

Look, there is no absolute requirement that you use external people to audit, the primary concern is objectivity and impartiality of the process, and an outside, paid person is no guarantee of that, I'm an outside, external or whatever you want to call it, CB auditor and there's no absolute guarantee of my objectivity and impartiality except through my personal ethics and performance.

People get all wrapped around the axle and go all crazy on this subject, don't you do it, you're a small organization with limited resources, so just be honest with you audit process, and do it following a sound ethical pathway.

Read the attached, it backs up what I've said and can help give you a bit of guidance.
 

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Cari Spears

Super Moderator
Staff member
Super Moderator
#5
Our company's owner also owns another company that we do work with - we consider each other sister companies. Their Quality Manager and I audit a few processes for each other.

Do you have a relationship with another company that might want to work out auditing certain processes for each other?
 

indubioush

Quite Involved in Discussions
#6
Nobody here is treating you like an idiot. We are all trying to help. I think in your situation, it is acceptable for you to audit your coworker and for her to audit you. You can write a memo in each audit explaining that your company does not have the resources to hire a fully independent individual. Doing this would be better than not doing an audit.

I addition, it may be a signal to you to find a new job if your company cannot afford an auditor.
 

Randy

Super Moderator
#7
Sorry about that you asked and answers were provided. I've run into 100 people that stated they're certified this and certified that only to find out that passing a Lead course doesn't make them certified as as such, professional certification by an accredited organization takes more than a certificate.

Outside auditors are not a guarantee of objectivity and impartiality, even in my case. All I am is an outside auditor, that's it, no training, no consulting, nothing but 3rd party auditing and over 60 days of that this year alone. The only assurance of my objectivity and impartiality are the ethics I adhere to and my personal integrity.

Independence isn't objectivity and impartiality, independence is freedom from unfair influence and control. I can be totally and absolutely independent (as I am now) but I can absolutely and totally slant my audit with my objective evidence to either trash or hold up as excellent the MS and organization I'm looking at....Either way, good or bad.........and you'd not know it.

Other than for a few exceptions certification of a person to do internal audits isn't necessary, the IA only needs to be competent and you're the decider on how that happens..

I did a slight edit on the previous post, I accept that straightforward language is seldom appreciated today
 

yodon

Staff member
Super Moderator
#8
In the "maybe better than nothing" category, consider reaching out to the local ASQ chapter to see if they have anyone in the Audit SIG that might consider doing an audit for you (for free) to get audit hours needed for re-certification. (Of course, you'd want to be selective to ensure they are sufficiently qualified to audit your organization.)
 

Carol2015

Starting to get Involved
#9
"Nobody here is treating you like an idiot. We are all trying to help. I think in your situation, it is acceptable for you to audit your coworker and for her to audit you. You can write a memo in each audit explaining that your company does not have the resources to hire a fully independent individual. Doing this would be better than not doing an audit."
Thanks, now this is helpful. Sorry if I snapped, but I'm overworked and someone asking me if I knew the difference between being certified and taking a course came across as an insult.

"I addition, it may be a signal to you to find a new job if your company cannot afford an auditor"
Last time I checked, as in 5 min ago, planet earth is going through a global pandemic and many US companies are laying people off. Many more are advertising for positions that are "frozen" and won't start hiring until the economy normalizes somewhat. Many of my friends are faced with this as of right now. I'm lucky to still be employed and that my company has managed to stay afloat despite being a startup while more "established" companies like LinkedIn is laying off 1000 of its employees.
 

Carol2015

Starting to get Involved
#10
Sorry about that you asked and answers were provided. I've run into 100 people that stated they're certified this and certified that only to find out that passing a Lead course doesn't make them certified as as such, professional certification by an accredited organization takes more than a certificate.

Outside auditors are not a guarantee of objectivity and impartiality, even in my case. All I am is an outside auditor, that's it, no training, no consulting, nothing but 3rd party auditing and over 60 days of that this year alone. The only assurance of my objectivity and impartiality are the ethics I adhere to and my personal integrity.

Independence isn't objectivity and impartiality, independence is freedom from unfair influence and control. I can be totally and absolutely independent (as I am now) but I can absolutely and totally slant my audit with my objective evidence to either trash or hold up as excellent the MS and organization I'm looking at....Either way, good or bad.........and you'd not know it.

Other than for a few exceptions certification of a person to do internal audits isn't necessary, the IA only needs to be competent and you're the decider on how that happens..

I did a slight edit on the previous post, I accept that straightforward language is seldom appreciated today
Randy, the problem is not "straightforward language," but rather the fact you keep repeating yourself over and over about things that are obvious to most people with industry experience. Most people posting questions are not looking for a lecture, but rather a concise solution to their situation. Your suggestion about the memo reinforced what I initially had in mind and that was very helpful. The fact that someone out there thinks it's a viable way to explain things makes me feel reassured.
 
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