Remember that, with respect to FDA medical device regulation, 21 CFR 820.25(b), entitled 'Training', requires that we establish procedures for identifying training needs to ensure personnel are adequately trained. Remember also that a fundamental premise of FDA's Quality System Regulation (QS Reg) is its flexibility. Indeed, when promulgating the QS Reg, FDA in the preamble stated that, "…the new regulation is less prescriptive and gives the manufacturer the flexibility to determine the controls that are necessary commensurate with risk. The burden is on the manufacturer, however, to describe the types and degree of controls and how those controls were decided upon. Such determinations are made in accordance with standard operating procedures (SOP's) established by the manufacturer..."
Accordingly, there is no direct statutory or regulatory premise prohibiting a firm from utilizing "read and understand" / "self-certify" training methods. For example, we see evidence of this in FDA's old Small Entity Compliance Guide, which permitted employee training to be achieved by many methods, including reading GMP/QA manuals.
But make no mistake, FDA investigators will most certainly scrutinize a firm's training processes and the adequacy of personnel training (as measured by things like completion of planned/promised training and by observing evidence of competence). There has repeatedly been Warning Letter citations for failure to complete training and for FDA-perceived incompetence. Indeed, FDA's QSIT guide notes how FDA investigators may consider various facts and then form ideas about whether the training being provided is "sufficient". And in the QS Reg preamble, FDA states, "…During inspections, FDA will assess whether a manufacturer has established procedures and followed requirements that are appropriate to a given device under the current state-of-the-art manufacturing for that specific device…"
A 2008 Warning Letter citation noted in a 2009 issue of "The Silver Sheet" recites how a firm was in fact cited for utilizing "read and understand" training instead of relying on demonstrated competency. The citation stated, "…Your firm's retraining (re-qualification) of employees includes only a review of the written procedure and does not require actual demonstration of adequate manual bonding by the employees…" So there is definitely Warning Letter precedent for FDA objections to "read and understand" training. But as mentioned above, there is no direct statutory/regulatory premise for that. Instead, FDA likely weighed the associated risk of the particular scenario and then concluded that "read and understand" training was insufficient to assure public health in that case.
To help avoid similar FDA citations involving FDA's specific 820.25(b) "training" regulations, firms should establish (define, document, and implement) procedures for development of risk-based training plans structured by job title and/or where appropriate, by job task. In each plan, prescribe and justify the type and degree of training and competence evaluation needed (be it "read and understand", on-the-job, external course, written exams, and so on and so forth.). If the firm has a reasonable risk-based rationale for its training methods and can thus reasonably assert that such methods will guard the public health, then corresponding FDA 483s and/or Warning Letters are unlikely.
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com© Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 27-Sep-2019 10:27
From: Andrea Chamblee
Subject: Is "Read and Understand" an adequate training plan?
After the FDA webpage redesign, Warning letters older than 2018 have been removed from the site (!). I am looking for any FDA WLs or statements about the adequacy of "training plans" that require staff to "read and understand" without any tests for competency. Is anyone familiar with Best Practices, GDPs, or other issues related to the adequacy of training plans and SOP updates that merely request or "require" "read and understand"? Thank you.
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Andrea Chamblee Esq., RAC, FRAPS
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.
Silver Spring MD
United States
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