New to this forum but not to quality. Almost 20 years now. I'll be looking through the forums because I have some specific questions regarding visitors, lab coats and uniforms but will also post it here.
I'm new to this company. They bought lab coats that haven't been worn once and are about 8 months old. Would like to hear about [any] risk analyses done that allowed you to not use lab coats. Coats not just for visitors but do you allow non-production personnel to not wear them when they go to the floor? The coats were bought but the previous QAM never set a policy in place nor coached anyone on when to use them and on using an acknowledgement with visitors.
To return to the OP, i deduce the opening query is ^^^^(red)
I, initially, interpret the query as seeking a justification for certain personnel to not require the use of an "over-garment" when entering the Production arena.
It seems to me the answer for (Observing) Visitors, non-Production Personnel (other than Lab/Engineering Personnel) will be "None". (IMEX Engineering Personnel have their own [designated acceptable] uniforms already and Lab personnel have IMEX distinct [designated appropriate] overalls for internal/external lab work ).
The reason for "None" is that IMEX the "usage'" requirement will typically be a Factory Prerequisite Requirement for GMP.
Further, IMO, -
"Over-garments" used for visitors should be separated for this specific activity (or be disposable).
"Over-garments" for non-Production personnel (see above) should also be separated for this specific activity (or be disposable).
As far as the, so-called "lab coats" are concerned, a decision will presumably have to be made as to which of the above functions (if any) are considered suitable for their potential usage based, perhaps, initially on their unknown specific characteristics, eg colour, appearance, buttons, pockets.
In the event that a "usage' possibility is envisaged and since the microbiological condition/history of the, 8-month stored, so-called "lab coats" is afaik indeterminate, I suggest that a preliminary swab test(s) / micro. analysis(es) be carried out to verify that the "cleanliness" of the "lab coats" is adequate.
PS - a possible exception to the above is for non-Observing Visitors such as external maintenance operatives whose activities may demand specific segregational requirements.
Edited by Charles.C, 06 March 2020 - 06:45 AM.