How to link skill matrix / competence matrix to risk management?

[erkid89]

the company I am currently working was just ISO 13485 certified, however, we do not have a product on the market yet since we are still at Validation and Verification stage.

Since we do not have a product on the market yet, we provide ONLY Read and Understand trainings for the moment. These are driven by the training matrix (it is a Job Description based, this means the JD will define the list of trainings required for each employee),these are tracked on our eQMS. The auditors were happy with that.

We are getting ready for manufacturing, hence I am currently working on a Competence Matrix (CM, which) that will have the names of the employee, not JD, with different levels of competency 1 (new employee),2 (fully independent),3 (train the trainer). The CM will cover the trainings required to achieve the competence required to complete Manufacturing and QC activities.

I was thinking to link the CM to the risk management (pFMEA), because I would like to include in the CM ONLY high risk work instructions, not ALL the manufacturing work instructions.

Do you have any recommendations on how to to link pFMEA to the CM? Or in other words, do you have any recommendations on triggering CM/skill matrix with a risk based approach?

Then, based on the difference levels required by the CM, different trainings effectiveness check will be done (Read and understand + on the job demo to get level 1, quiz + record review to get level 2, quiz + interview to get a level 3)

Thank you!

 

[d_addams]

the company I am currently working was just ISO 13485 certified, however, we do not have a product on the market yet since we are still at Validation and Verification stage.

Since we do not have a product on the market yet, we provide ONLY Read and Understand trainings for the moment. These are driven by the training matrix (it is a Job Description based, this means the JD will define the list of trainings required for each employee),these are tracked on our eQMS. The auditors were happy with that.

We are getting ready for manufacturing, hence I am currently working on a Competence Matrix (CM, which) that will have the names of the employee, not JD, with different levels of competency 1 (new employee),2 (fully independent),3 (train the trainer). The CM will cover the trainings required to achieve the competence required to complete Manufacturing and QC activities.

I was thinking to link the CM to the risk management (pFMEA), because I would like to include in the CM ONLY high risk work instructions, not ALL the manufacturing work instructions.

Do you have any recommendations on how to to link pFMEA to the CM? Or in other words, do you have any recommendations on triggering CM/skill matrix with a risk based approach?

Then, based on the difference levels required by the CM, different trainings effectiveness check will be done (Read and understand + on the job demo to get level 1, quiz + record review to get level 2, quiz + interview to get a level 3)

Thank you!

I've never seen training/qualifications require assessment of competence or demonstration other than for operators on the manufacturing floor demonstrating competence to conduct some operations.

From the compliance standpoint, either someone is qualified to conduct the work or they are not. Assigning a relative level of competence such as 'just learning' to 'highly skilled' has no value when demonstrating someone was qualified to complete the work they did within the product realization process.

Most systems I've been part of would consider demonstration of qualification (competence) has two elements; their CV and internal training. Their CV demonstrates they posses the qualifications to fulfill their role as laid out in the Job Description. The training system contains records they are trained to execute the various QMS elements they are responsible for executing in accordance with company policy and procedures. For your example of pFMEA, their CV demonstrates they have the competence to understand the technology and processes which would be necessary to conduct pFMEA and their QMS training indicates they understand your specific pFMEA execution requirements. If you feel the pFMEA process is so critical more than just R&A is appropriate, then you implement that (quizzes, in person training, in person training with quizzes/demonstration). What you are referring to as a 'Competence Matrix' I would say only has value to keep track of 'who's qualified to do what', but from all non-operator roles (where you may want to track who's qualified to do what operations for workforce planning), its generally expected all engineers and technicians are qualified to do all relevant QMS processes at all times (as long as they are up to date on their training). Dont apply the same system to track operator training as you do for engineers.

 

[Bev D]

Training and Training effectiveness is NOT, repeat NOT objective evidence of competence. I’ve trained tons of people who still cannot or will not perform the job as required. People lie on their CVs and operators do not have CVs. A training record only provides evidence that he person was present and awake long enough to sign their name on a record - or respond “here” when their names is called. Quizzes are also only some evidence that the training stuck long enough to take the quiz.

Observation of someone doing the work correctly and inspection test results are objective evidence that the person is competent to perfrom the job. Boy I hope the airplane welders don’t gain their competence certificate from just a written test…oh, wait. Boing