I have been asked to revise the training procedure for employees that are only here a few days (we hire everyone through a temp service). Current procedure calls for the training file to be started asap(820.25b- training identified) but there is one area that we have high turnover for several reasons of which I won't go into. It is a highly supervised job and all work is reviewed by the lead and a final inspection by QC. One day we could have 8 temps working and the next day only two show up and we start over. One job is counting up to 25 and packaging the product. They are given the job and materials by a lead and don't make decisions themselves.
Management wants a revision that allows for a training record to start once the employee seems like they are going to stay with us. 13485 or FDA guidelines do not specifically state when we need training to be documented so I are we safe revising it to fit our needs? Could we identify the training needs for the department instead of each person? There is quality training as well which they want to hold off until later.
Thanks,
Bridget

I have been asked to revise the training procedure for employees that are only here a few days (we hire everyone through a temp service). Current procedure calls for the training file to be started asap(820.25b- training identified) but there is one area that we have high turnover for several reasons of which I won't go into. It is a highly supervised job and all work is reviewed by the lead and a final inspection by QC. One day we could have 8 temps working and the next day only two show up and we start over. One job is counting up to 25 and packaging the product. They are given the job and materials by a lead and don't make decisions themselves.
Management wants a revision that allows for a training record to start once the employee seems like they are going to stay with us. 13485 or FDA guidelines do not specifically state when we need training to be documented so I are we safe revising it to fit our needs? Could we identify the training needs for the department instead of each person? There is quality training as well which they want to hold off until later.
Thanks,
Bridget


Hello Bridget,

It appears that you have a serious problem here....
Neither party (management and the temps) is willing to make a commitment to one and other. As a result a revolving door, and constant training and re-training. Very frustrating and very risky.

You may want to get the Temp Agency involved. Is there some basic training that can be provided by them? Could this be part of "supplier development?" They should do more than just sending you "warm bodies" possibly lacking basic work place skills. Management should assess this situation, and perform a risk analysis on this particular process.

I am not a medical devices expert, but I do know a lot about training and what it takes to make training a success. It starts with commitment from Management and more clearly defined expections for your Temp Agency.

Hope this helps.

Stijloor.

It sounds like all they really need in this case is a warm body that is able to count. If all they are doing is manual labor with no decision-making and the supervisor oversees and checks all work, there may be little need for formal training.

820.25b requires that you identify training needs, and "ensure that all personnel are trained to adequately perform their assigned responsibilities." It also requires that "personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs."

A quick orientation (with records) should be able to suffice for these requirements if the supervisor is ensuring the work outputs are correct. For those who stay long enough to get more responsibility, or to work without direct supervision, more formal training should be provided.

Thanks howste & Stijloor:
You both had different points of view and I appreciate the feedback. What has disrupted our system is two things, one a new production manager who challenges the current training proc and the other the growth of the company to require the additional packaging dept. We have two other packaging departments but the owner wanted product made by us to be packaged in the production department to speed things up. We took a seasoned employee and made her a lead over the new dept. We are in a small city and the temp service has them read our employee handbook to save time once they get to us. Our procedure states that upon hire we start their training log (one form) and highlight their initial job (training needs) as well as read the quality training booklet. The new manager does not want to do this paperwork until he knows they are a sure thing and management seems to be backing him up on this. This is stupid for a mature quality system to be messed up by a man who's last job was not with medical devices and management will back him up because they hired him.
I will be auditing training this month and I am sure I will find current employees that do not have forms on file so I am anxious to see what happens.
I am willing to revise the procedure and that a form might not be needed asap. The training needs could be identified by a matrix but the quality training is needed before they start and if they have the quality training that would require a sign off on a form somewhere. If I give this to the temp office I imagine they could have someone sign it off and send the document to me to file. If anyone else has anything to offer please let me know.It is the value gained from this forum that will give me enough to make a valid point to management.
Thanks to all,
Bridget

Bridget, the supervisor can do the initial training on-the-job and record this in the training log.

Al:
Thanks, the issue is the manager/supervisor does not want to start the training record until the person becomes full time perm with us(after 90 days). There is no one else who handles the training in that area. The previous manager had the same issue so I have been trying to think how to revise the proc to fit their needs and still be compliant. If I have misunderstood your post please explain further.
Bridget

Al:
Thanks, the issue is the manager/supervisor does not want to start the training record until the person becomes full time perm with us(after 90 days). There is no one else who handles the training in that area. The previous manager had the same issue so I have been trying to think how to revise the proc to fit their needs and still be compliant. If I have misunderstood your post please explain further.
BridgetYou can't not have a record of the training. Look at it from a risk point of view to sell them. What if you had a serious problem that led to an injury and there was no evidence that the employee was trained? The lawyers would have a field day! Rather than sell them something based on the regulation use $$$$.

[QUOTE=Bridget;203877] ..........Management wants a revision that allows for a training record to start once the employee seems like they are going to stay with us. 13485 or FDA guidelines do not specifically state when we need training to be documented so I are we safe revising it to fit our needs? [QUOTE]

Hi Bridget,

FDA is very serious regards to training. If you refer the QSR Manual, http://www.fda.gov/cdrh/qsr/05prsnl.html it gives a detailed info on Management commitment for training, training needs and training methods.

It is always a pre-requiste that the person must be trained before he embarks on any new operation.

You can refer this link also which stresses lot on training. http://www.fda.gov/ora/inspect_ref/fmd/fmd101.htm I am also attaching a CDER procedure on thier employee training which is worth a look. :cool:

Thanks to everyone for their feedback. I printed this post and finally had a chance to quietly bring it into a conversation with the owner of the company and he was very upset that a newcomer was trying to mess with with the training process. He put out a memo asap advising everyone to comply then I had a meeting with the managers (including the problem one). Up to the last minute the problem manager was pushing for some of the training to be done by the temp service before the employee started but he lost out.
Since the meeting I have audited the training records 100% and found that we are finally back on track.
:applause::applause::applause:
Bridget

Thanks to everyone for their feedback. I printed this post and finally had a chance to quietly bring it into a conversation with the owner of the company and he was very upset that a newcomer was trying to mess with with the training process. He put out a memo asap advising everyone to comply then I had a meeting with the managers (including the problem one). Up to the last minute the problem manager was pushing for some of the training to be done by the temp service before the employee started but he lost out.
Since the meeting I have audited the training records 100% and found that we are finally back on track.
:applause::applause::applause:
BridgetCongratulations and now watch your back.

AAAAHHHHHHH!!!! The power of the cove. Way to stick to your guns Bridget. And now like Al said, is the time to grow eyes in the back of your head.

I see a more important problem than when to conduct and document the training of staff. It involves management controls in general because top management (i.e. management with executive responsibility) have dropped the ball regarding your quality system.

Yes, the QSR training sections are small in scheme, but not in importance. Training is involved in every QSR operation (be it internal auditing, design controls, CAPA, MDR's, process validation, manufacturing, labeling, etc.).

When I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena, and now as a contract international medical device consultant, I have seen many instances where improper/lack of training of staff have led to product and process non-conformances (not only causing marketing/sales/profitabilty headaches, but also major costs to firm management and staff as well- even closure or product discontinuance).

I believe your firm management have to rethink the "temp" approach if there are problems in this area (i.e. not having enough qualified personnel, etc.). Even if operations are automated, one has to take into consideration the people factor (even when conducting process validations/revalidations).

Three ideologies that I always tell management/staff are:
1. Quality has to be built into the system, not the product.
2. There is someone worse than the FDA investigator or Notified Body auditor. It is the customer's attorney (especially in the US).
3. Would you be comfortable having a family member use your product?

Could it be that top management have put quality on the back burner as compared to achieving profits or having variable costs decreased (thus the use of temps)? If top management do not want to buy into quality, then how could lower managers and staff buy into it as well?

This philosophy needs to be fixed first. It may even cause the elimination of temp staff in QSR operations (such as by changing staff from one operation/ department to another). If management wants to use temps (to save on expenses, insurance, benefits, etc.), maybe they can be used in administrative or other non-QSR operations?

As far as training is concerned, incoming employees usually undergo basic training on the first day of hire (administrative, safety, basic firm operations, etc.) with more advanced training (SOP's, QSR, etc.) in the upcoming days and weeks. If everything is thrown to a new employee all at once, he/she may forget to conduct critical operations (especially if these operations involve many task oriented manufacturing operations). If there is no training, employees can interpret operations (and written instructions, if not detailed) anyway they choose. Thus, quality problems can occur.

I hope this helps. :D

As 820.25 is the topic here, I have a question in regards to part (b)

#1: "As part of their training, personnal shall be made aware of dvice defects which may occur from the improper performance of their specific jobs"

We were told that a simple statement in the training manual is not adequate - that we should incorporate risk analysis and cause and effect (if this, then this...). Any suggestions?

As 820.25 is the topic here, I have a question in regards to part (b)

#1: "As part of their training, personnal shall be made aware of dvice defects which may occur from the improper performance of their specific jobs"

We were told that a simple statement in the training manual is not adequate - that we should incorporate risk analysis and cause and effect (if this, then this...). Any suggestions?

Assuming a QMS has been implemented for medical devices, it is often the case that compliance with both the ISO 13485 standard and FDA QSR is relevant.

In terms of the situation described above, it is useful to have on-going training regarding findings from the CAPA and auditing efforts to create awareness of non-conformances. Provide the primary effect, root cause, corrective/preventive action, and status to the associates in each department to make the learnings relevant. Also, save samples or pictures of non-conformances with these bulletin board items.