Warning letter addresses lack of training/education

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M

mad_casual

#13
Mad casual - it's up to the firm to define requirements for any position. If respiration and pulse are all that's required by the job description, then that's the minimum. The CFR makes general statements about suitable level of education/experience for those responsible for product acceptance and other functions, and in those cases FDA would have a good argument for more robust requirements in the job description, but it's still up to the firm to define.
So it's entirely plausible that the outcome of this warning letter (or at least this portion) was some paperwork, looser job specifications, the same or lower product quality, and more profits?

Sorry, IMO, this thread quickly degenerated to a quality self-hugging session. As science is the methodological observation of reality (natural phenomenon), to me, quality becomes abstract bureaucracy when quality personnel regurgitate 'Do as you say and say as you do.' and 'Science has nothing to do with it.' Don't the design control guidances say things like quality starts during the earliest design phases? If CFR isn't empowering quality professionals to judge competence and suitability, isn't it just checking if people are current on their paperwork?

Again I only ask because I work in a place where dollars will be spent and procedures re-written around a machine that automates a formerly manual process, but performs the task slower than a human and requires near-constant maintenance/monitoring. After which, what quality professionals we have, will be told to validate it.
 
K

KilgoreTrout

#14
MC - the issue is that the OP misread the warning letter and made a broad generalization based on that incorrect reading. Given the wide scope of that WL, the firm had a very rough series of inspections. FDA was in their shorts. Calling the firm out for not following its own procedures - even basic stuff like satisfying their own internal job descriptions - speaks to a systemic breakdown. The items listed in the WL are examples of where the firm's quality system - required by law - fails to do its job. It is not intended to be an exhaustive list of issues, just what FDA has observed.

I'm an engineer and I don't know what you mean by degenerating into self-hugging, but the issue I have with this thread is its title. This isn't some groundbreaking WL that points the finger at non-technical personnel. Nowhere does it insinuate that a QA manager or a regulatory professional has to be a Ph.D. chemist or some other scientific type. That was the OP injecting his/her own misguided reading of one bit of the WL taken out of context and making a specious statement.

Would firms be wise to require technical degrees and experience for QA and RA functions? You bet. But if someone can get the job done correctly with a BA or some other non-technical background (IOW, their experience makes up for lack of a tech degree) who is the FDA to say that such a person is not qualified? It's up to the firm to staff its positions.
 
G

gar4guv

#15
I believe Kilgore is right in that this is nothing new or groundbreaking. Part of a standard QSIT inspection is to look at the qualifications and training of personnel. It is up to the firm to determine those needs. Normally inspectors would look at someone on the manufacturing floor and QC first (like the calibration coordinator that was mentioned). But if they found problems in another area (say the CAPA system), they would look at who oversees that area.

With a little imagination, you can kind of see a pattern of what the inspector(s) asked for. There were problems in QC so they asked to see if the QC manager was qualified. There were problems with CAPAs not being closed out so they asked to see the qualifications of the person in charge of those. My guess is that was the RA manager. Neither one met the job descriptions, so they asked to see the qualifications of their boss, the Director of QS. This is just what I got out of it. :2cents:

Of course one can't tell for sure what happened without an inspection report. Warning letter are a great source of information but they never tell the full story.
 
A

arios

#16
A quick look at the FDA's warning letters site led me to this:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219001.htm

A warning letter to Abbott Diabetes Care, Inc. from 7/2/10


Any thoughts or comments?
Competence matters!

As a matter of fact, there are certain roles for which there are pre-established background requirements.

Take for example the following paragraph from FDA's program 7382.845:

"However, if the firm's investigation does not change the alleged association between the device and the death, the event must be submitted as an MDR report. In addition, if the firm's investigation produces information that would cause a person who is qualified to make a medical judgment to reach a reasonable conclusion that the device did not cause or contribute to a reportable MDR event - no report is required. Translation - if a firm decides NOT to report an apparent device-related death, serious injury or malfunction - this decision must be made by a person that the regulation recognizes as qualified to make a medical judgment, i.e., a physician, nurse, risk manager, or biomedical engineer"
 
K

KilgoreTrout

#18
Competence matters!

As a matter of fact, there are certain roles for which there are pre-established background requirements.

Take for example the following paragraph from FDA's program 7382.845:

"However, if the firm's investigation does not change the alleged association between the device and the death, the event must be submitted as an MDR report. In addition, if the firm's investigation produces information that would cause a person who is qualified to make a medical judgment to reach a reasonable conclusion that the device did not cause or contribute to a reportable MDR event - no report is required. Translation - if a firm decides NOT to report an apparent device-related death, serious injury or malfunction - this decision must be made by a person that the regulation recognizes as qualified to make a medical judgment, i.e., a physician, nurse, risk manager, or biomedical engineer"
But that is not at all what the WL in the OP is addressing. Yet another statement taken out of context.:notme:
 
G

gar4guv

#20
an interesting side note to this thread,

There are now job openings for the Director of Quality Systems and the Manager for CAPA systems at this facility; along with Director of Complaint Handling, Manager of Complaint Investigations, and Manager of Doc control.

Looks like someone was none too pleased with the quality department after receiving that warning letter.
 
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