@Dan O'Leary states you should be following 21 CFR 820. 25 b). But as the Proposed QMSR is expected to be released in December according to FDA, perhaps you should be moving to the more modern requirements in ISO 13485 6.2 for "a) determine the necessary competence..." and "b) provide training or take other actions to achieve or maintain the necessary competence."
@Naveen Agarwal also states, perhaps reflecting on the differences between the CFR and 13485, "Training is only one aspect of competence". He goes on to say, correctly, [Training] does not mean they (those trained) are competent in specific risk management activities.
The position of the ISO TC 210 JWG1 technical committee on ISO 14971 is reflected in ISO TR 24971:2020 4.3 where we discuss: Note Risk Management tasks can be performed by representatives of several functions, each contributing their specialist knowledge. In our discussion in the technical committee we felt that those "representatives of several functions" did not need to know everything about all of risk management, but rather should be competent in the contributions from their specialist knowledge.
So the bottom line is that those performing risk management activities need to know their responsibilities in sufficient depth to perform those responsibilities in risk management. To know how their contributions fit in the process, then some training on the complete process may be required. But you need to identify the necessary competence as required in ISO 13485 6.2 a).
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Edwin Bills
Edwin Bills Consultant
ASQ Fellow CQE, CQA, CQM/OE, RAPS RAC
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 21-Jun-2023 10:52
From: Dan O'Leary
Subject: Risk Management SOP
Yes. People who participate in a QMS activity should be trained on your company's SOP. Consider, for example, a risk management system that follows ISO 14971:2019. It provides the steps but leaves the details up to the company. For example, the risk matrix is usually specific to a company based on the risk management policy.
FDA QSR 820.25(b) asks each manufacturer to, "establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities".<o:p></o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 20-Jun-2023 16:44
From: Nawal Tiouri
Subject: Risk Management SOP
Are we supposed to have all participants in the hazard analysis thoroughly trained in risk management SOP ? I have the SOP, but the employees have not been trained on it.
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Nawal Tiouri
Quality & Regulatory Engineer
Ypsilanti MI
United States
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