Regulatory Open Forum

I infer the context is ISO 13485:2016 clause 6.2 which requires three activities:

• Determine the necessary competence for personnel performing work affecting product quality
• Provide training or take other actions to achieve or maintain the necessary competence
• Evaluate the effectiveness of the actions taken

The standard doesn't make a distinction between personnel who directly affect product quality and those who indirectly affect product quality.

I also infer that the question relates to evaluating training effectiveness, not determining the need for training. Employees need to be competent on the basis of appropriate education, training, skills, and experience. You must have a process to establish competence; the most common way is a job description that includes the required training to perform that job. A gap analysis between the required training and a given person's actual training (based on the training records), identifies needed training.

It is usually easy to provide the training, but this leaves open the training effectiveness question.

The newly published ISO 13485:2016 Handbook offers some methods to "evaluate [training] effectiveness based on the risks associated with the work for which the training or other action is being provided:

• Surveying the trained personnel to assess whether he or she feels they have learned the required information
• Testing or questioning the trained personnel to assess their competence using objective criteria
• Evaluating the work performance of the trained personnel
• Reviewing the trainer assessment of training effectiveness

ISO 10015:1999 Quality management – Guidelines for training provides a comprehensive system that works well. Clause 4.5.1 says, "The purpose of the evaluation is to confirm that both organizational and training objectives have been met, i.e., training has been effective." It recommends evaluation on both a short-term and a long-term basis. In the short-term, use trainee feedback information on the training methods, resources used, and knowledge and skills gained as a result of the training. In the long-term, assess trainee job performance and productivity improvement. In addition, Table A.4 provides suggestions on the inputs, process, outputs, and records for evaluating training outcomes.

I infer the context is ISO 13485:2016 clause 6.2 which requires three activities:

• Determine the necessary competence for personnel performing work affecting product quality
• Provide training or take other actions to achieve or maintain the necessary competence
• Evaluate the effectiveness of the actions taken

The standard doesn't make a distinction between personnel who directly affect product quality and those who indirectly affect product quality.

I also infer that the question relates to evaluating training effectiveness, not determining the need for training. Employees need to be competent on the basis of appropriate education, training, skills, and experience. You must have a process to establish competence; the most common way is a job description that includes the required training to perform that job. A gap analysis between the required training and a given person's actual training (based on the training records), identifies needed training.

It is usually easy to provide the training, but this leaves open the training effectiveness question.

The newly published ISO 13485:2016 Handbook offers some methods to "evaluate [training] effectiveness based on the risks associated with the work for which the training or other action is being provided:

• Surveying the trained personnel to assess whether he or she feels they have learned the required information
• Testing or questioning the trained personnel to assess their competence using objective criteria
• Evaluating the work performance of the trained personnel
• Reviewing the trainer assessment of training effectiveness

ISO 10015:1999 Quality management – Guidelines for training provides a comprehensive system that works well. Clause 4.5.1 says, "The purpose of the evaluation is to confirm that both organizational and training objectives have been met, i.e., training has been effective." It recommends evaluation on both a short-term and a long-term basis. In the short-term, use trainee feedback information on the training methods, resources used, and knowledge and skills gained as a result of the training. In the long-term, assess trainee job performance and productivity improvement. In addition, Table A.4 provides suggestions on the inputs, process, outputs, and records for evaluating training outcomes.

I think you have raised a second issue.

The first is training effectiveness, in which one is trying to determine if people learned things from the training that would maintain or improve skills, performance, etc.

The second is individual effectiveness. This question is independent of, but perhaps influenced by, training effectiveness. For example, I could have a job for which I attend training to maintain a skill or knowledge. Perhaps it is annual QMS refresher training. If the trainer were to do a poor job, and I don't learn anything, I could still be effective at the job. On the other hand, if the trainer were to do a good job, I still might not learn anything new. I am already effective at my job and the training reinforced what I already know.

As often happens in these cases, there are four possible states for any given person and training. The training is effective, Yes/No. The person is effective, Yes/No.

The usual tool for a person's effectiveness is the performance review. In an earlier post, I described some tools for training effectiveness.

I think you have raised a second issue.

The first is training effectiveness, in which one is trying to determine if people learned things from the training that would maintain or improve skills, performance, etc.

The second is individual effectiveness. This question is independent of, but perhaps influenced by, training effectiveness. For example, I could have a job for which I attend training to maintain a skill or knowledge. Perhaps it is annual QMS refresher training. If the trainer were to do a poor job, and I don't learn anything, I could still be effective at the job. On the other hand, if the trainer were to do a good job, I still might not learn anything new. I am already effective at my job and the training reinforced what I already know.

As often happens in these cases, there are four possible states for any given person and training. The training is effective, Yes/No. The person is effective, Yes/No.

The usual tool for a person's effectiveness is the performance review. In an earlier post, I described some tools for training effectiveness.

I infer the context is ISO 13485:2016 clause 6.2 which requires three activities:

• Determine the necessary competence for personnel performing work affecting product quality
• Provide training or take other actions to achieve or maintain the necessary competence
• Evaluate the effectiveness of the actions taken

The standard doesn't make a distinction between personnel who directly affect product quality and those who indirectly affect product quality.

I also infer that the question relates to evaluating training effectiveness, not determining the need for training. Employees need to be competent on the basis of appropriate education, training, skills, and experience. You must have a process to establish competence; the most common way is a job description that includes the required training to perform that job. A gap analysis between the required training and a given person's actual training (based on the training records), identifies needed training.

It is usually easy to provide the training, but this leaves open the training effectiveness question.

The newly published ISO 13485:2016 Handbook offers some methods to "evaluate [training] effectiveness based on the risks associated with the work for which the training or other action is being provided:

• Surveying the trained personnel to assess whether he or she feels they have learned the required information
• Testing or questioning the trained personnel to assess their competence using objective criteria
• Evaluating the work performance of the trained personnel
• Reviewing the trainer assessment of training effectiveness

ISO 10015:1999 Quality management – Guidelines for training provides a comprehensive system that works well. Clause 4.5.1 says, "The purpose of the evaluation is to confirm that both organizational and training objectives have been met, i.e., training has been effective." It recommends evaluation on both a short-term and a long-term basis. In the short-term, use trainee feedback information on the training methods, resources used, and knowledge and skills gained as a result of the training. In the long-term, assess trainee job performance and productivity improvement. In addition, Table A.4 provides suggestions on the inputs, process, outputs, and records for evaluating training outcomes.