Matters being audited, independence, participation and direct responsibility

[lyobovnik]

Background:
I am a QA Manager at a small business (~20 employees) that is a contract manufacturer for a very large MDM. I have completed no degree higher than a high school diploma, did not go to school for this, started at the lowest position here and basically fought to carve my path here every step of the way. I'm a big supporter of higher education, it just wasn't an opportunity for me.

Anyway... Occasionally I develop a view that disagrees with my VP.

I'm not interested in alienating the one who does my performance appraisal, of course(!), but he has also consistently told me never to let him "screw up." I committed to doing my best there.

So, of course, I try to exercise discernment and not voice every piddly thing... but when I don't think he's right on something major, I believe it's due diligence to find a way to communicate it. I'd hate to see anything bad happen that I could have prevented.

Today's Context:
Without getting into causes, let me say that lately we are very short-staffed in Production and have a ridiculous turnover rate. So much so, that to stuff something in this bleeding hole, Top Management reallocated half of my Quality technicians there "indefinitely" to work as Production operators instead.

Now I am even being told that I and rest of the audit team should also go out to Production and work there as well. As much as possible.

(I'm starving... oh wait... I can eat my eyeballs!)

Feeding auditors to this fire confuses me the most, and nevermind the "how will any QA work get done"... Rather - how can it even work per 21CFR820.22?
I don't see how we aren't each "directly responsible" for our actions, and from that I can't see how someone using a process is not directly responsible for the same. On those grounds I can't think that any process users can count as "individuals who do not have direct responsibility for the matters being audited" when the process is what's audited. E.g., it would not occur to me to have a "Production operator" audit Product Realization. I suggested to my VP that any auditor so assigned should lose qualification for auditing Product Realization, but I was shot down. Apparently, "as long as the auditor avoids using in audits any records that show their involvement, they are not 'auditing their own work' and therefore there is no significant conflict of interest." I trust my VP means well and I'm sure it's not intentional, but the FDA may not agree. I'm concerned they could see it as shifting samples to hide a nonconformance. I do not think shifting samples until you get one that doesn't show the issue works in Inspection, I don't see how it works in auditing, and I still believe it is no substitute for an independent audit.
Question:
Am I missing or misunderstanding anything significant with the regulation?

 

[John Broomfield]

From 21CFR820.22:

“Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.“

Who audits your work?

This means that you need at least two individuals who are competent to audit. All the work you do should be subject to audit too.

If your organization works one shift, with two auditors you should be able to schedule independent audits. Two shifts may require three competent auditors.

In a small organization all of the auditors will do other work which is subject to audit.

John

 

[Ninja]

Another thought to consider...

As a 20 person company serving a "very large MDM"...what % of your business is for them? All?

If that single MDM accounts for >75% or so of your business...I'll bet they audit you.
Consider how you could use their (the customer's) audit of you to also satisfy your internal requirement.

My thinking: If that customer accounts for the vast majority of your company being in business...it's pretty low risk to show some more skin and have that customer who is NOT short staffed help in this area...especially if they are coming to audit you already anyway.

Good reading for your described situation..."Never Split the Difference" by Chris Voss

 

[shimonv]

My thoughts:

1. Your understanding of the regulation is correct.

2. Your company is going through hard times and are they are forced to compromise in several different areas. Your VP probably knows that you are correct; he is in a tougher spot than you are.

3. I suspect that in a serious external audit this won't be the only issue and perhaps even the least of your concerns.

4. My advise: (i) you voiced your opinion; (ii) you are not a member of senior management; (iii) do what you can to support the organisation with hopes that you will raise above it; (iv) be thankful that production is still going on. Hopefully when things get better you could renegotiate your auditors qualifications.

-Shimon