We are setting up a new formulation unit. I wish to know regarding training programme. As I know training SOP is in scope of QA department and conducted by HR Department. But few of my colleagues suggesting that SOP of training will made by HR. Is this ok or QA has to prepare training SOP.
QA and Compliance must prepare training programme SOP, outlay, Modules, Times, Scope of training, Evaluation, Reccomendations after training, Specific training to specified individuals.
The Human rescourse department will take inputs from QA.
[quote=DURGA PRASAD]QA and Compliance must prepare training programme SOP, outlay, Modules, Times, Scope of training, Evaluation, Reccomendations after training, Specific training to specified individuals.
The Human rescourse department will take inputs from QA.[/quote]
I will respectfully disagree. I have not seen anything in regulations or standards that indicates who should (or shall) prepare or deliver training! As with any other role, the individuals performing the task must be competent to perform the duty. You could as easily hire a 3rd-party provider to develop and deliver training.
If your SOPs require that someone performs a job that they are not qualified to do, you have some serious issues with your SOPs!
H.R teams are meant for managing the whole frame work of company and operations. When comes to training the internal core defficiencies and pitfalls are understood better by Quality assurance & Compliance teams. Generally in a company who are a start-up this whole QA group is headed by a senior Manager who shall have experience in handing audits or preapproval inspections. He knows better about planning and training than H.R.
H.R might help him but not directly partcipate in what to training , when and how to train. The core issue is that who understands science and regulatory audits ?
In many companies this particular work is now handled by QA teams as Regulatory awareness and compliance is getting more stringent.
Ofcourse there is a debate going on across companies.There are various theories about pit falls too.
[As per my opinion, if training is of Shop floor SOPs should be prepared by user department and also training should be conducted by the same in co-ordination with QA and HR. Similarly if SOPs are in concern with Health and hygein, staff welfare and pest control, these shuld be prepared by HR in coordination with QA and also training should be given by HR
SOP should be prepared by user department(production,warehouse or engineering) and authorised by QA.If SOP is prepared by QA and it is also applicable for other department(production,warehouse etc.) then QA person will arrange the training for other department.
shopfloor SOP should be prepared by user department and training should be given to all concerned department.