QMS-100 How to Write GMP Training Materials

Document Owner

Quality Assurance Manager

Affected Parties

All manufacturing colleagues

Purpose

To provide help to employees who are developing training materials of any description.

Scope

This SOP is designed for anyone working within the Manufacturing Division who writes materials for training.

Definition

Related Documents

EHS Statement

Training materials play a vital role in ensuring that staff are fully competent to perform tasks in a manner which minimizes risk to themselves, others, product or company equipment.

Procedure

Responsibility – Author:

The administration side of development of training materials is a similar process to that of writing Standard Operating Procedures (SOPs).  This procedure should be read in conjunction with SOP QMS015, which will explain the procedures.

1.                  Step One:

Contact GMP Training Officer prior to commencing any work in this area to check what resources are available in the way of similar materials already developed or experienced help.  Training officer is be also able to offer a brief training session. Normally, an employee will use the “Training Report Template” (TEM-085).

2.                  Step Two:

Decide what you want the training to cover.  You may need to do some research by looking up any existing relevant materials such as SOPs or related training materials.  If there are no manuals or SOPs already written these may need to be prepared first.

3.                  Step Three:

Decide how the training is to be conducted and complete the session plan using the template, TEM-085.

This template has the following sections:

3.1.             Learning Outcomes:

In here you write what you actually expect the employee to learn.

For example:
At the end of this session/s participants will be able to operate a photocopier to copy, enlarge, reduce, collate and staple documents.

3.2.             Assessment Criteria:

Assessment criteria are a more specific list of the actual things that the learner will be able to do or will know at the end of the session.

For example:

a. Locate and operate the photocopier power switch.

b. Check paper supply and replenish as necessary.

c.  Check toner supply and replace as necessary.

d. Operate the mode and setting keys of the photocopier to correctly select the required modes and settings.

e. Copy documents of varying sizes on-to-one, enlarged and reduced as requested.

f. Operate the collation and stapling options of the photocopier to produce correctly collated and stapled documents.

3.3.             Resources, Training Aids Checklist

List any resources required for the session.  Also, reference any SOPs.

3.4.             Introduction:

Give reasons the training is important.

For example:
I am showing you how to use the photocopier because you will need to use it for….

Try to link to what the trainee already knows.

Outline what will happen during the training as well as after the training i.e. assessment, review activity.

3.5.             Training Points / Methods:

Here you will write down how you plan to actually conduct the session.  For example:

DEMONSTRATE the way to switch the photocopier on.  Have the trainee switch the photocopier on.

You SHOULD NOT write task instructions here, but should reference the relevant SOP and have this handy during the session.

3.6.             Assessment sheet

This sheet lists the specific things the trainee will be able to do as a result of the training, including any performance criteria.  Assessment will not normally take place directly after training.

3.7.             Training Record Sheet
(used where record is required of a formal session, e.g. classroom)

This should be completed to indicate that the trainee has attended training and completed any appropriate review activities.  Upon completion, this should be filed in the trainee’s file.

A Training Practice Log FM-0307 is also available for use to keep track of practice of skills.  After successful assessment this should also be forwarded to the trainee’s file with the assessment sheet.

4.                  Step Four:

Follow SOP QMS-015 to have this documented correctly.
For revisions, please also refer to this SOP.

Summary of Changes