Infrastructure: Equipment, Work Environment and Contamination Control

yodon

Leader
Super Moderator
Why do you think a procedure is needed? The requirement is:

The organization shall document the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product.

(emphasis added)

I just document them as part of the management review minutes (that's easiest for me but may not work well everywhere).

There are certainly elements within those requirements that typically drive procedures (especially when you get into the maintenance activities).
 

duff999

Quite Involved in Discussions
Thank you for the feedback, appreciate it. i was given a project to create for Infrastructure: Equipment, Work Environment and Contamination control, I thought I was in good shape but struggling with the contamination control portion.
 

ragulkumar

Registered
I am looking for a sample of a procedure if available, thanks
if you have any procedure for this infrastructure and work environment topics please share me sir

i am newly joined one of the medical device manufacturing company this one topics only pending on my task
 

Sidney Vianna

Post Responsibly
Leader
Admin
if you have any procedure for this infrastructure and work environment topics please share me sir

i am newly joined one of the medical device manufacturing company this one topics only pending on my task
I would suggest that, instead of continuously begging for others intellectual property, search the attachment section of this website to assist you. And learn the fact that procedures are a component of business processes, which tend to be either unique to an organization, or highly bespoke to the organization’s context. A management system can never be accomplished with a patchwork of documents acquired by copy and paste approach.
 
Top Bottom