Your Quality Management System (QMS) needs to provide objective evidence (i.e., records) that your staff is trained on procedures they use, and that their training was effective. You must also establish documented requirements for competency. The following examples might help:
- A record of you attending a course is a training record.
- A record of your taking and passing an exam related to that course is a record of training effectiveness.
- A record of you performing a procedure, witnessed by the trainer, is a record of competency. Your resume can also be a record of competency.
Unless a change is trivial in nature, signing a piece of paper that states you read and understood a procedure does not demonstrate training effectiveness. Learning and training are active processes that require engagement and interaction.
In a previous blog (http://bit.ly/12PartSOPTemplate), I described a slightly different procedure structure with some extra sections. There are a number of benefits to that structure, one of which is that the structure facilitates training. The additional sections are referred to in this blog. Whatever template you use, consistency of structure, and presentation across your procedures makes the procedures easier to learn and increases usability.
6 Points to Consider for Effective Training on Medical Device QMS Procedures
- Training requirements. For a new procedure, decide early in your writing which roles require training, what content is needed, and to what level is competency necessary. The example below is a table from a Quality Auditing procedure. The table shows the different requirements for different roles. I prefer to put this information in the procedure document—where it is unlikely to be overlooked or forgotten.
- Open book? For each of the roles listed above, determine whether you need trainees to be able to follow the procedure without the document at hand, or to know the procedure, and be able to find what they need.
- Training method. One-on-one or group? Classroom style, on-job, or remote? This depends on your company, nature of the procedure, and your requirements above.
- PowerPoint or not? My preference is to walk trainees through the procedure, actually have them flipping the pages and writing notes on it. If I use PowerPoint, it’s to clarify the structure and emphasize important points.
- Control of training copies. Paper copies of procedures and forms used for training should be controlled. Your Document Control procedure should allow for clearly marked “Training” copies to be available before the effective date. Make sure your training also reminds trainees where to find the official released a copy of procedures after training is completed.
- Control of training material. Include your slides, training scenarios, quizzes, etc. in your document control system. Review and revise them each time you change a procedure.
Building Consistent Procedures: Questions to Ask and Recommendations
Use a consistent structure for your procedures, then build a consistent training structure around that. The predictability in structure will improve the effectiveness of your training.
- Purpose. Why are we doing this? What is the outcome we are after?
- Scope. When do I use this procedure? When do I not, and what do I do as an alternative?
- References. How does this interface to other procedures? Turtle diagrams or interface maps are useful here
- Definitions. Unfamiliar jargon, and terms that are used in a very specific way in this procedure
- Risk. What risks does this procedure address? How does this affect the design of the procedure – why are we doing it that way? Refer to my earlier blog (http://bit.ly/12PartSOPTemplate) where I explain how to include this in each procedure
- The procedure. Walkthrough the flowchart, explain the accompanying notes, relate the procedure flow to the responsibilities and authorities outlined earlier in the procedure
- Records. What do I do with the completed records from this procedure? Where do I find a copy when I need it?
- Examples. I suggest a training version of the form (which should be available later for reference) with guidance and examples
- Practice. Provide a scenario and a blank form for trainees to work through, individually or in groups
- Testing. Check that the training has been effective. The role competencies that were defined earlier are the basis for the effectiveness criteria for a procedure. This training module may be enough to achieve that level, or a broader training program may be required to ensure operational level competence. See Rob Packard’s blog on training exams for more advice on testing (http://bit.ly/TrainingExams)