Training and Distribution of new edition SOPs (paper based system)

Hi all,

We had been audited by a client and was found the following deviation:
“When SOPs are approved is applicable to carry out a training session. But, there is assigned a period from approval to get into force, this period is based on the number of areas (e.g. Manufacturing area, QC area, etc) that have to be distributed the SOP. This sstem does not assure that its staff will be trained before of the entry into force of the procedure.”

So, it is related on to questions:

  1. how you assure that all the implied personnel will be trained, before the new edition effective date?
  2. you have an approved SOP, but it is not current because you have a period of time that some people will be executing one edition of SOP and some the newer.

Have you any idea on how you can establish a better system? Have you the same problem!? Can you help me!!!



Hi Sterile,
It was almost similar situation and we were caught off guard during such training implementations.
We took some measures
-We divided each training session depending up on Department.
-All training SOP’s will be different and will be named in a Master Training SOP.Different training will have different Annexures, where we have a start date & completion date one after the other based up on deperment completion and evaluation.
-Once a depratment is completed that particular annexure was implemented.
-We wrote another sop for such an annexure implementation.
It happened to us 4 years back and we had no choice except to follow such procedure.

thanks a lot!!!

Designing A Results-Oriented Training Program for Cleanroom Operators

The Elements of Training

Most definitions of training involve the goal of controlling or modifying behavior. The goal of the trainee is to acquire the knowledge or skills that lead to behavioral changes.
One of the challenges that trainers face is how to take information and convey it to people in a manner that permanently modifies their behavior.

There are several potential approaches for accomplishing this task, but the primary elements of any successful training program are:

Clarify the message
•Engage the trainee
•Reinforce the behavior
•Clarify the message

A comprehensive contamination control training program should also include the following subjects, delivered in a clear, easily understood manner:

•Basic microbiology (what are we trying to kill/control and why?)
•Cleaning and disinfectant chemistry (what are we using and how does it work?)
•Industry standard practices (what procedures do the Food and Drug Administration and other regulatory inspectors view as benchmarks?)
•cGMP compliance (what are the repercussions to my business if I fail to comply?)
•Safety (what are the hazards of working with these products and how do I work safely?)

For more tactical subjects, such as SOPs for cleaning the manufacturing area, have the attendees prepare a videotape showing the proper steps. This way, they are starring in their own movie and learning by doing, a highly effective principle of learning. This technique also includes another important principle of training—repetition. Attendees repeat the activities by rehearsing for the video; then, after the video tape is prepared, the operators can view themselves properly executing the SOP. This tape may then be used to address procedural questions or as part of a formal operator training program.