Training Production Employees When We Have SOOO Many SOPs

R

repiKS

#1
I work for a mid-sized medical device manufactuer in the US. We have hundreds of documents that employees on the production floor train to. Each employee has a job profile (tied to job title) that lists which documents they need trained to based on daily job duties.

We update 20-40 documents per month, and most affect people on the floor. That creates TON of training for supervisors to give and employees to absorb. Currently, we encourage supervisors to do small group training, but many times I just see the SOP and sign off sheet sitting around for people to read and sign. Thta is problematic for many reasons, including that many of our non-English speakers are signing off on it even though they have not read the document.

Any suggestions on better methods of trianing people on the producton floor?
 
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normzone

Trusted Information Resource
#2
What's driving all those updates to your documentation?

This is easy for me to say, I'm miles away and don't wear your hat. So take it for what it's worth.

If all these updates are happening because they affect processes (and thereby affect product), then if the training is being scamped it would be likely that great masses of substandard product is being produced. I'm going to offer the benefit of the doubt and assume that's not the case.

So then all these updates don't affect process/product? In that case, perhaps the training required is minimal?

I think the first question is why the updates?
 

Michael_M

Trusted Information Resource
#3
What are you using as 'verification' that the training was effective?

We have put training out for everyone to sign on rare occasions but follow it up with some type of verification that they actually read it. For example, asking what was talked about 2-3 days after the notice is taken down.

We do not do this type of training often as it really is not that effective for us, however, it may be more effective at your place.


I don't know anything about the medical field, but are all the SOP's required? Can they be created in a different format, for example, prior to running a job, the SOP comes on a computer screen to be reviewed. If you can, this would have them acknowledge the new SOP without having to constantly be trained. If the same document gets changed 3 times in 3 months, will people remember which SOP is the correct version (or correct information to follow)?
 

Helmut Jilling

Auditor / Consultant
#4
I work for a mid-sized medical device manufactuer in the US. We have hundreds of documents that employees on the production floor train to. Each employee has a job profile (tied to job title) that lists which documents they need trained to based on daily job duties.

We update 20-40 documents per month, and most affect people on the floor. That creates TON of training for supervisors to give and employees to absorb. Currently, we encourage supervisors to do small group training, but many times I just see the SOP and sign off sheet sitting around for people to read and sign. Thta is problematic for many reasons, including that many of our non-English speakers are signing off on it even though they have not read the document.

Any suggestions on better methods of trianing people on the producton floor?
Maybe you have to many SOPs. Do you need them all? Maybe some should be condensed or combined.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Welcome to the Cove! :bigwave:

I would not be surprised if non-English speaking employees were signing off on document changes without reading them - unless the documents are in their own language, how could they read the SOPs?

I also wonder how complex the tasks are, and like others I wonder if all those SOPs are needed. If instructions are very important to get it right, can you use pictures, drawings or models?
 

somashekar

Staff member
Super Moderator
#6
I work for a mid-sized medical device manufactuer in the US. We have hundreds of documents that employees on the production floor train to. Each employee has a job profile (tied to job title) that lists which documents they need trained to based on daily job duties.

We update 20-40 documents per month, and most affect people on the floor. That creates TON of training for supervisors to give and employees to absorb. Currently, we encourage supervisors to do small group training, but many times I just see the SOP and sign off sheet sitting around for people to read and sign. Thta is problematic for many reasons, including that many of our non-English speakers are signing off on it even though they have not read the document.

Any suggestions on better methods of trianing people on the producton floor?
Welcome to the COVE ~~~
You do have some good and sound systems, but misdirected practices.
Perhaps they stem from misunderstanding requirements.
Training is need based, so is documentation.
Documentation need do stem from standards / regulations + your requirements.
So when you filter your documents, you may perhaps find that you can get rid of few.
Then you need guts, self belief and conviction to size your documents volume down to need based requirements.
This may in turn reduce your document updating tasks. However planned and stable processes have few changes, when you look at month on month.
Now the training...
All changes do not need training of user. This is because the user is considered in making the changes, and are not out of the document change process (I hope)
This training is then based on significance of change made, and assessed in your risk management. Perhaps you have to address your training process document as well...
 
#7
I work for a mid-sized medical device manufacturer in the US. We have hundreds of documents that employees on the production floor train to. Each employee has a job profile (tied to job title) that lists which documents they need trained to based on daily job duties.

We update 20-40 documents per month, and most affect people on the floor. That creates TON of training for supervisors to give and employees to absorb. Currently, we encourage supervisors to do small group training, but many times I just see the SOP and sign off sheet sitting around for people to read and sign. Thta is problematic for many reasons, including that many of our non-English speakers are signing off on it even though they have not read the document.

Any suggestions on better methods of training people on the production floor?
I've encountered exactly this situation. It's better to start with defining "competencies" rather than "training". If you define competencies, first, it will take care of 80% of the jobs people are required to do. Then you might want to consider what is being called "training". Training is a skills development process. If people are simply reviewing for understanding purposes, what's written, then that's "awareness", not training. The ISO 9001 requirements help you here, because 6.2.2 is called "Competency, awareness and training"...
 

GStough

Staff member
Super Moderator
#8
I work for a mid-sized medical device manufactuer in the US. We have hundreds of documents that employees on the production floor train to. Each employee has a job profile (tied to job title) that lists which documents they need trained to based on daily job duties.

We update 20-40 documents per month, and most affect people on the floor. That creates TON of training for supervisors to give and employees to absorb. Currently, we encourage supervisors to do small group training, but many times I just see the SOP and sign off sheet sitting around for people to read and sign. Thta is problematic for many reasons, including that many of our non-English speakers are signing off on it even though they have not read the document.

Any suggestions on better methods of trianing people on the producton floor?
I can tell you that if the training is necessary, the method you described would not sit well with an FDA auditor. We just had the pleasure of hosting a visit from them, and they made a comment along the lines of "invest in real training, because reading/acknowledging doesn't prove competency or effectiveness of the training." Also, take a look at all of those SOPs and determine whether they are all necessary or if they can be streamlined into fewer, related documents and make use of technology, if possible, by employing photos, illustrations, flowcharts, etc. This removes (or at least reduces) the language barrier, as well.

Hope this helps. :bigwave:
 

channelr

Starting to get Involved
#9
How do you address extended leave of absence for employees and retraining in your training procedure? I would love to hear your thoughts and appreciate the feedback. Thank you!:bigwave:
 
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