TRAINING ON SOP'S FOR SUPERVISORY STAFF

[Randy]

T=$ and wasted T doing stupid things wastes even more $.

 

[Mikey324]

That is the way the former HR Manager had set-up the training matrix in the QMS software that we are using. I'm not sure what the cost would be (trying to find out) to "reprogram" the software. We have been using the software since 2017 after have a cumbersome paper system. Since the matrix includes the supervisors, we'll have to see how big of a change it will be and how much.

If your software is that rigid, it can be difficult to keep up with the everchanging world. You need to be able to make modification and improvements when its needed. If you need to pay to make changes to your own training plan, it might be time to look into new software that gives you freedom of control, or create your own internal system. A training matrix is great, and a review now and then doesn't hurt anything, but if the matrix doesn't work for your organization then you are just checking the boxes with no real value added.

 

[Renea Koski QAM]

I came to this thread because of the same question. Does management need to be "trained" on a SOP? Another question is for QM documents (we are ISO 13485.) Since top management aided in the creation of the documents, do they really need to "trained" on them?

For those managers/supervisors who are hands-on, I feel that they do need to be trained on the SOP for production. I even have the creator or "trainer" of the SOP sign-off as being trained. As far as the reviews--YES, the SOPs need to be reviewed. If you have ever worked in manufacturing you know that variations can form in a process from person to person. Having to review the SOP can help to alleviate that variation and also bring to light any revisions that need to be made to reflect the current "variations" that have worked better than in the SOP. (In a perfect world, everyone would follow the SOP word for word; but we all know-- they read it once then 3 months later, they have created their own way of doing it.)

For Dan Watson-- who is using an old software program. I have found that QT9 has worked really well. It is very inexpensive in relation to other eQMS software. It is cloud based and validated. Has great modules for ISO. Let me know if you want me to contact you with my guy at QT9. (plus, it has unlimited users in its Employee Portal--where document trainings are done.)

 

[Golfman25]

I came to this thread because of the same question. Does management need to be "trained" on a SOP? Another question is for QM documents (we are ISO 13485.) Since top management aided in the creation of the documents, do they really need to "trained" on them?

For those managers/supervisors who are hands-on, I feel that they do need to be trained on the SOP for production. I even have the creator or "trainer" of the SOP sign-off as being trained. As far as the reviews--YES, the SOPs need to be reviewed. If you have ever worked in manufacturing you know that variations can form in a process from person to person. Having to review the SOP can help to alleviate that variation and also bring to light any revisions that need to be made to reflect the current "variations" that have worked better than in the SOP. (In a perfect world, everyone would follow the SOP word for word; but we all know-- they read it once then 3 months later, they have created their own way of doing it.)

For Dan Watson-- who is using an old software program. I have found that QT9 has worked really well. It is very inexpensive in relation to other eQMS software. It is cloud based and validated. Has great modules for ISO. Let me know if you want me to contact you with my guy at QT9. (plus, it has unlimited users in its Employee Portal--where document trainings are done.)

We are a small company. We combine development of the SOP and training at the same time. If we get together and work on the SOP, there is no need for a separate "training" other than to placate some auditor. The only people who get separate training are those who didn't participate in the development of the SOP, which is very rare in our company.

 

[Renea Koski QAM]

We are a small company. We combine development of the SOP and training at the same time. If we get together and work on the SOP, there is no need for a separate "training" other than to placate some auditor. The only people who get separate training are those who didn't participate in the development of the SOP, which is very rare in our company.

Yes, we do as well. We might have a "classroom" training session where everyone signs an attendance form (then I upload the training to my eQMS software.) But for the revisions of SOPs to support the skills training, we have our employees go to the Employee Portal to "sign-off" on the document training with a skill attached to it. I have been hit hard over the years from auditors for the training process-- that I am covering my bases, your bases and everyone else's bases. lol. Thanks for the response.

 

[FRA 2 FDA]

Our SOPs and work instructions define in them who should be trained and for what purpose. Our production WIs say that the production manager needs to be competent to a level that allows them to support carrying out of the instructions. So our current production manager couldn't go in and sit at a sewing machine and make a perfect part like our sewing people can, but she knows what goes into the process and can ensure that the process can be carried out as specified. And since she approves all changes and signs the DCN form, there is the proof of her awareness training.