“Make GMP Training Stick” – That’s one of the most popular requests from our clients. Of course, there are lots of turn-key, canned GMP training courses, available and for the most part they are OK. Except, that they don’t stick. If you’re not sure, look at your Laboratory OOS and GMP Discrepancy metrics. Now, we know that ‘Human Error” is the most loved “root-cause” for most laboratory and manufacturing investigations. The corrective action seems so easy too -retraining.
This is a weak management response, and it fails. So, on we go, investigating, blaming human error, and retraining. The viscious cycle continues, the investigations do not ebb, and the Quality System fails. Don’t get me wrong, training matters, in fact, without training, one cannot gain new skills and knowledge, and practice those to maintain reliable organizational competencies. 21 CFR 211 – Subpart B talks at length about Qualification and training.
So why do most training programs fail? Because, in most companies, Training program is not effectively integrated in the overall structure of the Quality System. Secondly, there are very few professional resources available internally in most firms, to really do a good job at making Training a success.
The first step then is to start looking at this strategically. Training programs must be developed with care and resources must be allocated to implement those. To learn more, send us an email: email@example.com