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Read & Understand

  • 1.  Read & Understand

    Posted 19-Feb-2018 09:09

    In another discussion thread there were some comments about using read and understand as a training method for (at least) internal documents. Some comments suggested this is not a good approach. Since I think it is appropriate in some circumstances, I'd like to understand the issue.

    On the positive side, if there is, say, a procedure to move a part from the stockroom to production, I would think read and understand is appropriate. However, there are some cases, such as operating a validated process, that would require different training.

     The objections I hear are usually blanket statements ranging from "the FDA doesn't allow it" to "it never works".

     As a corollary, I heard that the only acceptable training is face-to-face instructor led. (I suppose that a live training from a remote location using a tool such as WebEx would count.)

     I'm working a project involving competency and would like to better understand this issue of training as an element of competency.

    Dan O'Leary
    Swanzey NH
    United States

  • 2.  RE: Read & Understand

    Posted 19-Feb-2018 14:27
    Jobs, competency and training (including verification of effectiveness of training) are under the domain of Human Factors Engineering. There are several ways and techniques to verify training, most related to task analysis.

    I've made several comments and showed some examples in these links:

    What are some ways to demonstrate Effectiveness of Training?

    Update of SOPs for ISO 13485:2016 / MDSAP

    Marcelo Antunes
    Regulatory Strategy Consultant
    São Paulo

  • 3.  RE: Read & Understand

    Posted 19-Feb-2018 14:35
    You can also take a look at Instructional System Design models, such as ADDIE (which I use) :

    Marcelo Antunes
    Regulatory Strategy Consultant
    São Paulo

  • 4.  RE: Read & Understand

    Posted 19-Feb-2018 15:27
    ​​While I am always happy to see people read, and even happier to see evidence that they understood what they read, "training" is an activity that is done by a trainer, not by a trainee.  An author is not a trainer, a reader is not a trainee, and reading is not training, no matter how well the reader understands what they read.

    Can someone perform a task based solely on reading and understanding what they read?  Of course.  Any untrained consumer who has ever put together a "some assembly required" product is proof of that.  Are they then someone who has now been "trained" in the assembly of whatever product it was?  I don't think so.  I think they managed to complete the task without having been trained to do it.  This is quite possible with relatively simple tasks, and with a fair amount of flexibility on expectations for the quality of the outcome.

    In practice, whatever someone can or cannot become competent at, based on reading and understanding, the approach is most commonly used to avoid investment in actual training.  I would guess it is those who have seen the truth of this first hand (and its consequences) that are most adamantly opposed to the approach altogether.  Including FDA, perhaps.

    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)

  • 5.  RE: Read & Understand

    Posted 20-Feb-2018 07:25

    You present a circular argument.  If the author is not a trainer, then who is the "original" trainer.  The author, as the individual who constructed the original subject matter of the training, would have to be the trainer and best able to respond to questions as to how the subject should be addressed.  While the author is obviously not infallible, they would be the holder of the original scope and intent of the subject matter.

    Quite honestly, I find that much of the "training" that is out there is merely a collection of the presenter's experiences and opinions.  These experiences and opinions, while valuable, does not render a trainee more enlightened than read and understand.


  • 6.  RE: Read & Understand

    Posted 20-Feb-2018 08:24
    Demonstrating to the FDA that an individual is trained versus demonstrating they are competent is quite different.

    Before moving into the medical device industry, I taught clinical courses at a university. Training and competency were two different events. First you would teach a student how to do something - this may involve reading a document or textbook, PowerPoint presentations, or hands on learning in a lab.

    Competency was assessed separately. If I trained a student on how to do a chest x-ray, they would practice the skill under my supervision a few times, and then would demonstrate competency on a patient. This competency was assessed through specific pre-determined criteria. It is possible to train someone to a skill or task (sometimes repeatedly), but have failure in competency based on their level of understanding of the training and the method used to train. Competency is the assurance that the training was clearly understood and can be executed as intended.

    I wish you all the best in implementing a strong training and competency program.

    Angela Scurlock
    Quality Management System Deployment, Clinical Specialist
    Highland Heights OH
    United States

  • 7.  RE: Read & Understand

    Posted 20-Feb-2018 08:47

    The issue of competence is complicated in a QMS.

    In QSR, the requirement, 820.25(a), is, "Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed." I takes this as competence with four elements.

    In ISO 13485:2016, 6.2, the requirement is, "Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience." Here competence has four elements, but they are not the same four as in QSR.

    In ISO 9000:2015, 3.10.4 (a normative reference for ISO 13485:2016), competence is defined as "ability to apply knowledge and skills to achieve intended results".

    One problem that I'm working on is, what seems to me, a confusion between competence and training. A common argument is that competence can only be achieved by training. (I don't agree.)

    However, training is an important aspect of competence, and is one the ways ISO 13485:2016 suggests when it says that the manufacturer should "provide training or take other actions to achieve or maintain the necessary competence". People may not notice the "other actions".

    For training, there are multiple methods. I'm concerned with an apparent dichotomy in which procedures should be clear, understandable, etc. to support work, but those same procedures may not be adequate in a "read & understand" setting.

    I'm also looking at ISO 10015:1999 Quality Management – Guidelines for Training and ISO 10018:2012 Quality Management – Guidelines on People Involvement and Competence.

    Dan O'Leary
    Swanzey NH
    United States

  • 8.  RE: Read & Understand

    Posted 20-Feb-2018 09:20
    I tend to agree with Dan. It seems that too often, the full definitions are ignored in the interest of finding a "one size fits all" way of showing employee competence.  Well written procedures are part of it. Experience and education are part of it. Training is part of it. Mentoring should be part of it. etc.

    For instance, if I hire someone to process and manage complaints who has never done it before, "read and understand" probably isn't enough. They certainly will need mentoring (to answer questions that arise) and potentially internal or external training classes (or both). On the other hand, if I hire a nurse with 15 years experience processing complaints, probably "read and understand" of the specifics of how my company handles complaints (who does returned product analysis, what forms we use, where data is stored etc) is sufficient for s/he to do a good job. Unfortunately, to pass audits it often ends up being all about a read and understand or a class - rather than other elements that drive competence - in fact, I would argue are more indicative of competence than either of the "commonly used" methods.

    Going to a class on PMAs did NOT make me a competent PMA writer. Reading guidance, mentoring and experience did. I am sure the same is true for most of the rest of us.


    Ginger Glaser RAC
    Chief Technology Officer

  • 9.  RE: Read & Understand

    Posted 20-Feb-2018 10:32
    People need to recognize the shift toward the need for competence (not just training). Similar to what is said in other comments, I would say that providing training does not necessarily lead to competent people. After all, that is what everyone you know that your people know how to do their job. This is the reason to focus on competence, not training.

    I would add to this we need to take a look at  the note at the end of 6.2 in ISO 13485:2016:
    "NOTE The methodology used to check effectiveness is proportionate to the risk associated with the work for which the
    training or other action is being provided."

    There is a methodology that I have put forth several times on checking effectiveness (this answers the question: "is the person competent follow the training or other action?")

    We need to change the thinking here to follow a risk-based approach:

    First, for low risk processes (or low risk changes): instead of "read and acknowledge" or "read and understand", we can shift the thinking to "read and self-assess" or simply "self-assess". By doing this for low risk areas, we set up that a person can self-assess their ability to do that work. There are low risk areas we can implement this thinking and be effective that takes in all the elements of competence.

    Next, for those areas of medium risk, we can outline an approach such as taking a quiz, simply performing the action or otherwise having another person do a limited assessment of the person's ability to do the work. Then provide a simple statement that records that was completed.

    For higher risk areas (final product release, specialized processes, etc.) you can have a performance requirement with another competent person assessing that they are competent (the training or other action is effective).

    Finally, you should periodically (in accordance with the risk of someone not maintaining competence) have someone (say a manager or supervisor) perform an assessment of the person's competence (do they know how to do the job to meet requirements-paraphrase of 9001 requirement). After all, that should be a competence of a manager or supervisor (their ability to assess competence of others that work for them). This should close the loop and meet the requirements of both ISO 13485:2016 and the applicable regulatory requirements.

    Hope this helps! Cheers!

    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States

  • 10.  RE: Read & Understand

    Posted 25-Jun-2018 13:19
    Hi Dan,
    Interesting topic - here is the key for success we have used for a very small company and that passed BSI's regulatory audit for certification:

    The person responsible for regulatory compliance would state each person possession of the competences required, substantiating the statement by levering a mixture of documented evidences and "live examination during the job".

    Below you can dive in the schematic thought process and approach scalability.

    Thank you,

    Thought process:
    I want to claim competency of person X to be responsible for activity Y and accountable for activity Z
    In order to substantiate this claim I will

    identify skills, knowledge and experience required for each Y and Z
    identify skills, knowledge and experience owned by X
    identify the gap

    A planning document was defined for the resource X and it would identify a matrix correlating each activity to its characteristics (the "required" of above) and these to the form in which X was allowed to perform them (autonomy, with supervision, not allowed). 
    This plan would be updated, by procedure requirement, quarterly.
    Attached to this plan the evidences of the resource characteristics (the "owned") of above. These evidences where all sorts, including reference to Audit report, test records, etc.

    The person responsible for regulatory compliance (PRRC) of the product was signing off the plan after having added statements of competence validation confirmation where applicable and signing of.

    I realize that a bigger company might struggle managing this approach, because tailored to the singular resource and creating a bottle neck at the PRRC desk; plus our PRRC was the CEO, founder and technical director too... 

    Nevertheless I guess it could be scaled, implementing it as is for the first line and, at lower levels, substituting the person X with the functional team X or the role X, and delegate the plan approval to the proper middle management level.

    The advantage would be
    • a transparent, harmonic and clear representation of accountability and substantiation at all level of the organization
    • a workaround to "paper as only evidence", in fact the PRRC (or equivalent, when scaling) is taking the responsibility and accountability of validating the statement, with the freedom of providing also "live examination during the job" as rationale.

    Caterina Puddu
    United Kingdom