Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

What is the recommended training policy (over QMS SOPs)? 
Does this one make sense: 
Employees will be trained on their SOPs for each: 
1. Minor changes - Read and understand 
2. Major change - frontal training or short video and training effectiveness 
3. If not 1 and 2 - at least annually 

My concern is that by this policy I am creating too much training that is not necessarily required.

That does seem to be alot. SOP training is read and understand and once that is complete, the trainee is good until the next revision. We had periodic reviews of SOPs set for every 3 years unless a revision was required prior to that date. If an SOP was particularly complicated, then additional training was performed.  We had been through several inspections with no comments on our training program.

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Annemarie Woodland RAC
Sr. VP Regulatory Affairs & Quality Assurance
Boxford MA
United States
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Original Message:
Sent: 24-Nov-2021 18:08
From: Anonymous Member
Subject: QMS SOP Training

This message was posted by a user wishing to remain anonymous

What is the recommended training policy (over QMS SOPs)?
Does this one make sense:
Employees will be trained on their SOPs for each:
1. Minor changes - Read and understand
2. Major change - frontal training or short video and training effectiveness
3. If not 1 and 2 - at least annually

My concern is that by this policy I am creating too much training that is not necessarily required.

Hello Anon,

To me this sounds reasonable, but depends on a few factors such as maturity of the quality system, type of product being manufactured and sold, the support of upper management, and how viewed by an external auditor/inspector.  I have personally seen a number of training processes implemented where most changes to SOPs are a "read and understand" where the employee enters in a training record or an electronic system they have "self-trained" to the revision of the procedure.  I have even seen "read and understand" on any type of change including major changes to SOPs.  It does also depend on what type of SOPs or work instructions because if these are more instructions, a one-to-one or group training may be needed versus an SOP which is more at a policy level.  I also have not really seen an annual training specifically, though again depends on the company and structure.  Just wanted to make a couple notes on this topic, whatever is determined for the training programme, just make sure it is clear and followed by employees.  Training area is unfortunately still one of those low-hanging fruit observation areas because the process is not followed.  The second comment is training is much more now than just read and understand - there is the competency and effectiveness which needs to be considered as well.  So even if you have a read and understand process in place, how are employees then competent?  And how do you ensure a read and understand process is effective?  There are many different ways this could be done which would be too much for this forum post, but consider how these apply to your training programme as well.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 24-Nov-2021 18:08
From: Anonymous Member
Subject: QMS SOP Training

This message was posted by a user wishing to remain anonymous

What is the recommended training policy (over QMS SOPs)?
Does this one make sense:
Employees will be trained on their SOPs for each:
1. Minor changes - Read and understand
2. Major change - frontal training or short video and training effectiveness
3. If not 1 and 2 - at least annually

My concern is that by this policy I am creating too much training that is not necessarily required.

An SOP is a procedure that describes how to perform a process. The people who perfordure need to understand what the SOP says.

There could be minor changes that involve typos and don't require additional training, the procedure hasn't changed. In some system the revision level uses a letter. For these changes I add a number, indicating that there is a new revision that doesn't require training.

Other changes change the way to perform the process, so employees need to be away. Unless it is a major change, such as using a different piece of equipment that requires a different set-up, then reading the changes using highlighting or some other way to identify the change, will work.

If the procedure covers a validated process, then there are special training requirements. A good approach uses three steps: observe a trained operator, perform the process while being observed, and perform the process solo.

Training does not deteriorate or drift, so periodic training is not necessary. Instead, use audits and nonconformances to determine if the operator follows the procedure. If the procedure is correct, that may indicate a training need. However, don't fall into the trap of "retrain the operator" as the solution to a large number of nonconformances.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 24-Nov-2021 18:08
From: Anonymous Member
Subject: QMS SOP Training

This message was posted by a user wishing to remain anonymous

What is the recommended training policy (over QMS SOPs)?
Does this one make sense:
Employees will be trained on their SOPs for each:
1. Minor changes - Read and understand
2. Major change - frontal training or short video and training effectiveness
3. If not 1 and 2 - at least annually

My concern is that by this policy I am creating too much training that is not necessarily required.