Rebecca,
Conducting training of all employees on quality system requirements is an expectation and can be done minimally without costs and resources - well resources it will take some time. You can utilise the "train the trainer" concept which can then be provided throughout your organisation. There can be one or a few individuals who have targeted training on the EU MDR (and this applies to any other regulation or regulatory requirement as well) through self-training, knowledge, experience, etc. A good method is to have one or few individuals trained by an external organisation. Sometimes I still wonder why someone with many years of experience, expectation of a "certificate of training" is demanded, but here we are today. You can do this internally as well, documenting how an individual has the experience, qualification, and competency in a regulation. Then this one individual (or a few others) would then train everyone else. This could be done a number of ways, but typically you could have a few sessions spread over time or "learning lunches" where each employee attends, concepts of the regulation, maybe an hour targeted sessions. Or you could hold multiple sessions on different topics of the regulation, i.e. technical documentation, clinical evaluation, post market surveillance, etc. Then a nice way to show competency is employees take a quiz on these related topics which become part of their training record. There are even more simple ways to show employees are trained on a regulation such as just self-directed learning where they document on a training record. Bottom line there are different ways to support how (all) employees are trained and competent on regulatory requirements.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 06-Aug-2020 15:11
From: Dan O'Leary
Subject: EU MDR Awareness Training
If I'm reading this correctly, it is as I suspected.
I infer that "ISO Section: 6.2" means ISO 13485:2016 Clause 6.2.
I infer that "Audit Requirements" means something the auditor created for an audit checklist item. In does not cite an internal procedure or an external document that requires this training.
I infer that "Article 1, 10, ALL (EU) 2017/745" means EU-MDR, Article 1 and EU-MDR Article 10. I'm not sure what "ALL" means.
Now, my analysis. ISO 13485:2016, 6.2 does not require training or competence on the EU-MDR or any other regulation. It does require that people "performing work affecting product quality shall be competent on the basis of appropriate education, training, skills, and experience". Consider an example. A person conducting incoming inspection affects quality and needs to be competent. However, that person can be competent without even knowing of the existence of the EU-MDR, QSR, Canadian regulations, etc.
I should note that section 5.5.2.c says that the Management Rep ensures the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization. Also 6.2 requires a documented process for ensuring awareness of personnel.
The audit nonconformance does not address these points. Instead the "audit requirement" invents a requirement for training all employees on EU-MDR overall concepts and requirements and cites failure to conform with the auditor's opinion.
Similarly, neither EU-MDR Article 1 nor Article 10 has a requirement for EU-MDR training on overall concepts and requirements.
In my opinion, this is bad auditing.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 06-Aug-2020 14:16
From: Rebecca Tucek
Subject: EU MDR Awareness Training
Dan, thank you for taking the time to respond; below is the audit finding:
Status: Minor
ISO Section: 6.2
Audit Requirements: Personnel are trained and competent on MDR regulation overall concepts and requirements. All employees have awareness on maintaining and effectiveness of QMS along with product compliance.
Article 1, 10, ALL (EU) 2017/745
Objective Evidence:
The Job Training Plan is not consistently maintained.
Job Training Plan Matrix JTPM, Rev. 4 does not document a requirement to be trained on EU MDR; nor does it include EU MDR awareness training for all employees.
I look forward to your feedback!
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Rebecca Tucek
Melbourne FL
United States
Original Message:
Sent: 06-Aug-2020 14:08
From: Dan O'Leary
Subject: EU MDR Awareness Training
I would very much like to see the text of the audit finding. There is no requirement for company-wide awareness training on the EU-MDR. A correctly written audit non-conformance should cite the requirement, the current state, and the objective evidence. I would like to see the requirement cited in the finding.
It sounds like a case of bad auditing, and it would be a mistake to spend resources on it.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 06-Aug-2020 13:34
From: Rebecca Tucek
Subject: EU MDR Awareness Training
Hello everyone!
We received an audit finding, during our gap assessment, due to not having completed a company-wide awareness training on the EU MDR. Our Compliance/Regulatory Team have completed an official training and have training certificates, and as we update our SOPs as part of our transition, we conduct training on the new SOPs and the section of the regulation that pertains to the changes, etc. I am wondering if anyone has any recommendations for a very general and broad e-learning module/video on the EU MDR that we could have our employees take (perhaps something along the lines of the annual FDA training on GMP for Medical Devices.) I can make a presentation myself, but thought I would check and see if something was already available before duplicating efforts.
Thanks in advance!
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Rebecca Tucek
Melbourne FL
United States
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