Non-Conformances

deepikanegi said:

Interview Question

If you have three non-conformances to deal with. How would you prioritize them? Which one will you work on first?

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By consideration of the following factors:

- Risk to patient or user: Non-conformances that pose a significant risk to the patient or user should be addressed first. This includes unresolved product non-conformances that could lead to recalls if not resolved (FDA QSIT, Purpose/Importance, 160).

- Impact on product quality: Non-conformances that directly affect product quality and compliance with specifications should be prioritized (21 CFR 820.100(a)(2)).

- Recurrence and trends: Non-conformances that are recurring or show a trend of increasing frequency should be addressed promptly to prevent further issues (21 CFR 820.100(a)(1)).

- Regulatory implications: Non-conformances that may result in regulatory actions, such as Warning Letters or enforcement actions, should be prioritized (FDA CP 7382.845, A. QUALITY SYSTEM REGULATORY/ADMINISTRATIVE FOLLOW-UP, 378).

Based on these, prioritize the non-conformances and address the most critical ones first.

You should first prioritize by risk. Then by what action will give you the most bang for your buck. IE least cost and easiest to implement with the greatest reward. Have you ever seen a pick chart? Attached. We use this as a tool to help prioritize PDCA actions related to a corrective action. You can also use a SWOT based RPN style ranking system. We use it for risk analysis and contingency planning / testing. See photo. Hope this helps

Some of the responses in this thread lend very well to a great water cooler discussion- "what is the stupidest/weirdest interview question you were ever asked?" It's so good, I have to give it its space. See water cooler discussions...
Stupid Interview Questions (elsmar.com)

FRA 2 FDA said:

Some of the responses in this thread lend very well to a great water cooler discussion- "what is the stupidest/weirdest interview question you were ever asked?" It's so good, I have to give it its space. See water cooler discussions...

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Not during an interview, but during the online app after my hire was a done deal:

"Have you ever been fired or forced to resign due to committing or threatening an act of violence?"

That should have been a major red flag.

Matt's Quality Handle said:

"Have you ever been fired or forced to resign due to committing or threatening an act of violence?

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Definitely not from the Marines, it was actually a job requirement to be very adept at violence

Randy said:

Definitely not from the Marines, it was actually a job requirement to be very adept at violence

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At this job, I thought I was going to have to physically get between a floor supervisor (Army Iraq Vet) and the QM (Vietnam-era Air Force Vet).

The lack of professionalism I see is discouraging.

Randy said:

Definitely not from the Marines, it was actually a job requirement to be very adept at violence

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Which would make being fired (court martialed) or forced to resign even scarier.

Matt's Quality Handle said:

At this job, I thought I was going to have to physically get between a floor supervisor (Army Iraq Vet) and the QM (Vietnam-era Air Force Vet).

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Yeah, but neither one was actually dangerous or really geared to be scary violent.