Release of New or Revised Procedures

[Marc]

Scenario:

Company X has written a new procedure or revised an existing procedure (policy or whatever).
Employee training on it is required.

A "test" is given to each employee (takes test using their computer).
Employees who fail have to re-take the "test".

My Question: When is the procedure (policy or whatever) released for use? Must all employees who the procedure is applicable to pass the "test" prior to release?

 

[Coury Ferguson]

Interesting Scenario Marc.

I would think that the most important thing would be: have the employees been trained in their new procedure and are they able to access it without hesitation.

In my history, I was more concerned that the employees had access and knew exactly where it was. I never expected the employees to memorize any procedure or take a test, unless it was testing like Internal Auditing or such to show competency.

Just show evidence that they were trained by a sign in sheet for the training.

 

[Marc]

Yeah - I have seen it done both ways - Everyone has to be "trained" on it prior to release vs. Release and then immediately training. It has depended upon the industry and criticality.

I'm just trying to get some "across the board" feedback.

I know the ideal is train then release.

This is for a "software solution" situation. No paper records. Training is online - Company intranet.

 

[Candi1024]

Well, it depends... LOL!

Documents that directly relate to manufacturing such as work instructions on the floor, it is required that everyone is trained. We could write exemptions for employees out on leave or for other reasons.

Other documents allow 28 days for everyone to train, but do not require everyone to be trained for release. It is the employees job to ensure they are trained to the most recent document before engaging in whatever process the document describes. When fulfilling CAPA requirements and the such, we consider these type of documents "trained enough" lol, at 80%.

ETA: We use a training software so it is all on the company intranet, and people are notified via email that there is new training required.

 

[Project Man]

I say the document can be released as soon as it is signed off and it can be used by employees who are trained to it. Otherwise, If employee A, B & C are the applicable users but employee A is on vacation, does that mean employee B & C have to wait until employee A is back from vacation to use the released procedure?

 

[Pancho]

We release the moment the procedure is done. At the process owner's request, affected personnel must acknowledge in the CA record.

Operators that do not use a computer in their daily work are trained in the new document asap, usually at the next start of shift.