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RegisterLean + vendor oversight = no vendor oversight [General Statistics]
Hi again,
Ooooh...
[rant_on] Lean is an interesting concept. Common sense, some would say. In practice however, the combination of Lean and vendor oversight is a nasty cocktail. Sometimes lean is practiced by corpoquacks who have a lot of insight into ways to minimise cost by cutting away the fat but the fat needs to be identified objectively. I am not explicitly saying these guys know spreadsheets better than the real world, but ... An area where fat is, or can be, quite subjective is supplier qualification. No FDA or EU guideline or law says specifically how frequently it has to be done or when and how etc. And this can be toxic, because it often leads to the conclusion that cost can be cut a lot then. I see this in several companies and I have seen the consequences such as studies that are suddenly not of submission quality. Usually discussions around need for supplier audits end up in hopeless argumentation like "But they were inspected by the Finnish authority in 1963", "My uncle knows the head of QC, and he is a really nice guy" or "Show me concrete proof that we need to allocate an audit here".
In the wake of mishaps there will be a lot of finger-pointing because of the cost.
Fortunately, FDA is now starting to be very interested in vendor oversight principles. I am not exactly sure if EU inspectorates go in that direction too for the time being.
[/rant off]
❝ Me too – but what’s wrong with Lean?
Ooooh...
[rant_on] Lean is an interesting concept. Common sense, some would say. In practice however, the combination of Lean and vendor oversight is a nasty cocktail. Sometimes lean is practiced by corpoquacks who have a lot of insight into ways to minimise cost by cutting away the fat but the fat needs to be identified objectively. I am not explicitly saying these guys know spreadsheets better than the real world, but ... An area where fat is, or can be, quite subjective is supplier qualification. No FDA or EU guideline or law says specifically how frequently it has to be done or when and how etc. And this can be toxic, because it often leads to the conclusion that cost can be cut a lot then. I see this in several companies and I have seen the consequences such as studies that are suddenly not of submission quality. Usually discussions around need for supplier audits end up in hopeless argumentation like "But they were inspected by the Finnish authority in 1963", "My uncle knows the head of QC, and he is a really nice guy" or "Show me concrete proof that we need to allocate an audit here".
In the wake of mishaps there will be a lot of finger-pointing because of the cost.
Fortunately, FDA is now starting to be very interested in vendor oversight principles. I am not exactly sure if EU inspectorates go in that direction too for the time being.
[/rant off]
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- 90% CI rana 2012-02-13 07:51
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 90% CI ElMaestro 2012-02-13 08:07
- Benefit/risk Helmut 2012-02-13 14:29
- Benefit/risk ElMaestro 2012-02-13 14:35
- Benefit/risk Helmut 2012-02-13 14:42
- Lean + vendor oversight = no vendor oversightElMaestro 2012-02-13 15:15
- Benefit/risk Helmut 2012-02-13 14:42
- Benefit/risk ElMaestro 2012-02-13 14:35
- Benefit/risk Helmut 2012-02-13 14:29
- Patient’s risk = 5% Helmut 2012-02-13 12:41
- 90% CI ElMaestro 2012-02-13 08:07
Ing. Helmut Schütz