Do you hear what I hear?
Be Prepared!
Performance
Quality System
Regulate Me
100
Ask questions.
What is a good listening skill?
100
1/2 day - 1 day, 1 day = 2 days
What is the time for preparing for the audit?
100
“Experience is not what happens to a man; it is what a man does with what happens to him.”
What is an audit plan.
100
Don't lag behind!
What is complaint information or other lagging indicators?
100
QSR is to MDD is to IVDD.
What are regulations?
200
Be still my heart.
What is non-verbal body posture indicating stress.
200
Don't cross that line says the sister to her little brother.
What is establishing boundaries for the audit.
200
Not "Pulp Fiction".
What is fact?
200
Suitability & effectiveness.
What are the main outputs of Management Review?
200
Notified body, external consultants, contract sterilizers.
What are critical suppliers?
300
Snuffaluffagus.
What are non-verbal gestures demonstrated during an audit?
300
A negotiator, "the Terminator"!
What is a lead auditor?
300
Forming, storming, norming, performing
What is team development?
300
The proof of the compatibility of the marriage of the design & the process.
What is Process Validation?
300
Fulfill vs. consistently fulfill.
What is verification vs. validation.
400
I remember when I turned 2 years old, it was a Thursday, 78 degrees and sunny outside.
What is "too good of a memory"?
400
How many team members does it take to screw in a light bulb, perform an audit?
What is 1 - 4?
400
Eeny, meeny, miny, moe, catch a tiger ....
What is a sample plan?
400
Input to output to verify, to validate, to transfer wrapped in review.
What is Design Control?
400
We have reached consensus.
What are ISO standards recognized by FDA.
500
I came, I saw, I went..........(Receipt of samples, testing of samples, accountability of samples, .....)
What is the receiving process for samples to be tested?
500
The opposite of the collective, the borg!
What is independence?
500
How bad is bad.
What is ranking of the audit findings?
500
"The review of the vital few vs. the trivial many".
What is Management Review?
500
To audit, or not to audit: that is the question: Whether 'tis nobler in the mind to suffer The slings and arrows of outrageous findings, Or to take arms against a sea of troubles, And by opposing end them?
What is a form of an audit policy.
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