Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

For temporary employees like contractors used for the design and development work of a regulated device, what QMS training is typically required for these type employees?

​Hi Anon.

Unfortunately I think that the answer to this question is, once again, "it depends".  It really needs to be reviewed in relation to the work that they will perform, what, if any, internal supervision will be put in place, what, if any, responsibility will internal personnel take for the overall outcome of the project, and how will the answers to these questions comport with your internal QMS. 

While QMS is relatively similar in many ways across companies within the industry, each QMS is distinct in many potentially important and rather specific contexts.  That said, it is going to be something that you need to review what you expect these people to be doing and what access to information or facilities and even rooms that the contract employees might have.  All of your training decisions should be based on essentially the answer to the question "What controls must be in place for someone to access _______" where the blank could be a facility, a room, a document, a server, etc.  Only then can you really understand the potential impact of untrained personnel getting into an area and what that might mean for quality, safety and efficacy of the product(s) involved.  Then you develop the training modules that you expect contractors to complete based on that information.

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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 05-Sep-2018 12:52
From: Anonymous Member
Subject: Temp Employee Training to QMS

This message was posted by a user wishing to remain anonymous

Hi All,

For temporary employees like contractors used for the design and development work of a regulated device, what QMS training is typically required for these type employees?

I agree totally with Victor, but would just add that design is a very tricky area because in future you may want to make what you design available in other jurisdictions. For example, software is often written by contractors but in a later abbreviated or special 510[k], or EU Tech File Essential Requirements, compliance statement you may want to state that all software has been developed in a controlled design environment under ISO 13485 / IEC 62304 / ISO 14971 etc. Suddenly you find you have no evidence of any/adequate training and either have to "re-engineer" core software or treat it as SOUP. Almost whatever you do, in a few years you may regret not having done more!

Good luck!

Neil

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Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough United Kingdom
and Kilkenny Ireland
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Original Message:
Sent: 05-Sep-2018 16:18
From: Victor Mencarelli
Subject: Temp Employee Training to QMS

​Hi Anon.

Unfortunately I think that the answer to this question is, once again, "it depends".  It really needs to be reviewed in relation to the work that they will perform, what, if any, internal supervision will be put in place, what, if any, responsibility will internal personnel take for the overall outcome of the project, and how will the answers to these questions comport with your internal QMS.

While QMS is relatively similar in many ways across companies within the industry, each QMS is distinct in many potentially important and rather specific contexts.  That said, it is going to be something that you need to review what you expect these people to be doing and what access to information or facilities and even rooms that the contract employees might have.  All of your training decisions should be based on essentially the answer to the question "What controls must be in place for someone to access _______" where the blank could be a facility, a room, a document, a server, etc.  Only then can you really understand the potential impact of untrained personnel getting into an area and what that might mean for quality, safety and efficacy of the product(s) involved.  Then you develop the training modules that you expect contractors to complete based on that information.

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 05-Sep-2018 12:52
From: Anonymous Member
Subject: Temp Employee Training to QMS

This message was posted by a user wishing to remain anonymous

Hi All,

For temporary employees like contractors used for the design and development work of a regulated device, what QMS training is typically required for these type employees?

This depends on what they are going to be doing specifically. Generally, it is always a good idea to have their resume on file, to establish qualifications. It is generally good to have them go through your basic Quality System training as well. Beyond that, focus on the tasks. Are they going to be doing product design? then train on your deisgn and development procedures, work instructions etc (much as you would an internal employee doing the same work). Are they going to be doing change orders - either creating or signing off? Then train them on your change controls processes. If they have a CAPA project, train them on your CAPA process.

If you keep in mind "they should be trained on the process before they do the task" you will end up in a good spot.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 05-Sep-2018 12:52
From: Anonymous Member
Subject: Temp Employee Training to QMS

This message was posted by a user wishing to remain anonymous

Hi All,

For temporary employees like contractors used for the design and development work of a regulated device, what QMS training is typically required for these type employees?

The paradigm case is a full time employee with a specific job. You will have followed your process to establish competence and produced a job description covering the attributes: education, training, skills, and experience. For any given person, you will have evaluated the need for action to establish or maintain that competence.

 

The process extends. Part-time employees follow the same process.

 

Temporary employees follow the same process. Often companies use a temp-to-hire method. During the temp phase the person is not an employee, but in terms of daily work, consider they are an employee. If the person doesn't work out, this often makes the termination decision easier than a probationary term.

 

Contractors follow the same process. A contractor is an employee of another company, usually brought in for a fixed term to add capacity. They typically perform a job similar to a full time employee.

 

In some cases, the contractor may have special skills for which there isn't a full time job. However, the same process applies. In this case, develop the competency requirements before selecting the person. They will require training in your procedures.

------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 05-Sep-2018 12:52
From: Anonymous Member
Subject: Temp Employee Training to QMS

This message was posted by a user wishing to remain anonymous

Hi All,

For temporary employees like contractors used for the design and development work of a regulated device, what QMS training is typically required for these type employees?