Yes, absolutely you need a level of competence to review the work. The tricky parts are in sorting out how much competence and how to document it.
You don't have to have expertise in all the work you hire outside experts to do for you, but you have to have some understanding of what they're doing and why. And you have to be able to read their reports, which isn't a trivial thing.
I have seen cases where project managers checked the box saying yes the electrical safety test reports or the sterilization test reports have arrived, so the product is ready to launch - without noticing that the reports indicated test failures.
The simple default method of documenting competence is a training record, even if it isn't the most meaningful. Imagine, for example, that you ask employees to read your risk management procedure and then take a five-question, multiple-choice quiz to show their understanding. One of the employees is an entry-level project coordinator with an AA degree, one is an engineer with ten years of medical device development experience, and one was a member of the ISO 14971 development committee. Each one who passes the quiz shows some level of understanding, but they're not equivalent.
I don't know a really good way to demonstrate competence on a standard. They're complex enough that, while basic training can help, a level of competence develops with experience. A degree in mechanical engineering, electrical engineering, or microbiology is a helpful starting place, but neither necessary nor sufficient. Reading the standard cover to cover is also helpful, though not always necessary. Attending introductory trainings or webinars can help, but usually is not enough. A checklist of what to look for when reading a report might be useful for someone without much experience, but wouldn't suffice for someone without any relevant background knowledge.
------------------------------
Anne LeBlanc
United States
------------------------------
Original Message:
Sent: 31-Mar-2023 11:10
From: Peter Reijntjes
Subject: Training Competence
Hi Anon,
I completely agree with Victor on this.
If a medical device is tested against e.g., IEC 60601, it needs to be designed and developed according to the requirements of that standard to prevent failing the tests. And that means that in your organization knowledge is needed to understand and use that standard. Or any other standard for that matter.
ISO 13485 pays attention to that by stating in 7.3.3 (Design and Development Input) that you have to determine which standards are used as input for product requirements and in 7.3.2 (Design and development planning) one needs to identify and document resources needed, including necessary competence of personnel.
------------------------------
Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
Original Message:
Sent: 31-Mar-2023 09:02
From: Victor Mencarelli
Subject: Training Competence
Hi Anon.
I can't speak competently to the question regarding IEC standards as I don't have any experience with these but I know several other members of the community are very knowledgeable in this area and are regularly willing to provide information, context and assistance so I will leave that issue completely to the experts!
However, I think you do need to train your personnel who are performing any activity that might impact the quality or safety of the product to ensure that they are performing the assignment properly and in compliance with your internal (and external) requirements. So for sterility and batch record review, I would say you need to have the proper training in place by someone who is actually qualified to train the individual(s) involved in order to maintain your compliance to the regulations, the standards and your SOPs.
I have always been a proponent of the theory that "if a job requires specialized knowledge or insight, then the job requires a training program to ensure compliance". What that really means is when you have a job that the documentation does not make sense to a 5th grader then you really need to train and qualify your employee(s) to perform that job. This also ensures continuity and consistency between different people, different locations or just different days.
------------------------------
Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
Original Message:
Sent: 30-Mar-2023 16:36
From: Anonymous Member
Subject: Training Competence
This message was posted by a user wishing to remain anonymous
Testing to IEC 60601 is typically contracted to test laboratories whose core competency includes 60601 and ideally, they are accredited for providing such services and testing to the standard. <o:p></o:p>
Is it necessary for the manufacturer to be appropriately trained in the requirements of the standard in order to approve and accept test reports, given that the tests and reports were generated from an accredited test laboratory?<o:p></o:p>
Similar question with respect to sterilization and the approval of batch records. Does the manufacturer need to have personnel appropriately trained and qualified to do so?<o:p></o:p>
My take this that they do, in order to be compliant with ISO 13485 "Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills, and experience". <o:p></o:p>
Trying to put a rationale together to support training requests in these areas!<o:p></o:p>
Thanks in advance.<o:p></o:p>