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Medical Device Organization (Organization)

  • 1.  Medical Device Organization (Organization)

    This message was posted by a user wishing to remain anonymous
    Posted 21-Sep-2021 13:31
    This message was posted by a user wishing to remain anonymous

    As a small medical device organization, the Quality department maintains the organization chart and releases via change order every time a new employee is hired.  As we have begun to scale in size, this is harder to manage and maintain, as individuals leave or are hired monthly.  How have other organizations solved this?  How do you release your organization charts?  Is it high-level or extremely detailed with every employee listed?  How have auditors responded to either method?


  • 2.  RE: Medical Device Organization (Organization)

    Posted 21-Sep-2021 13:54
    Don't put names on the org chart, only titles.

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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: Medical Device Organization (Organization)

    Posted 21-Sep-2021 15:09

    Without having an organizational chart showing the names of persons in key positions of responsibility and authority, it will be difficult to demonstrate, and perhaps event to maintain, conformity with the fundamental goals of FDA's and ISO 13485's management responsibility requirements related to organizational responsibility and authority.  And in real-world practice, it's important for everyone in the organization to know who, by name, occupies those positions.

    Accordingly, I would highly recommend keeping names on the organizational chart for everyone at the manager level and above.  However, technician and operator names aren't necessarily needed (though such position titles need to remain).


    Without an org chart showing the names of the persons holding key positions of responsibility and authority, I expect that you'll spend more time and effort trying to demonstrate via alternative means (e.g., business cards? hiring paperwork? word of mouth?) who in the organization occupies those seats.  And such an approach may reasonably fail to fulfill the basic goals of FDA's and ISO 13485's management responsibility requirements.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 4.  RE: Medical Device Organization (Organization)

    Posted 22-Sep-2021 05:54
    Hi there,

    What I have done in the past is have two (2) versions of the organisational chart: 1) without names just titles and relationship of positions and 2) with names, titles, reporting structure, in a "form" format.  The first one is the "official" released version which is in the QMS assigned a document number, revision level, referenced in Quality Manual, etc.  The second one is a "form" which is just date controlled, usually managed by QA or HR, so this one can adjust and change when people join and leave.  The second one is still in the quality system, it just does not go through the normal document control change procedure and has a date for the revision.  However, in the organisation roles and responsibilities it clearly indicates a change to the MR, PRRC, or member of management may be considered a significant change and needs to be assessed.  Organisational charts are funny because auditors look at them all different ways, just clearly document how you manage within your own quality system.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Medical Device Organization (Organization)

    Posted 22-Sep-2021 11:41
    My organization uses Kevin's approach with success. In my experience, Dan's approach is not accepted by all regulatory authorities.

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    Pamela Stogsdill
    Regulatory and Quality Specialist
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    Original Message


  • 6.  RE: Medical Device Organization (Organization)

    Posted 24-Sep-2021 10:06

    There is no regulatory requirement to have names on an organization chart. Actually, there is no regulatory requirement to have an organization chart.

    The basic requirement in 820.20(b) is to establish and maintain an adequate organizational structure to ensure that device design and production is in accordance with the requirements of Part 820. The organization chart is the conventional method.

    Because there is no regulatory requirement for the contents of an organization chart, it is the manufacturer's choice. In a growing company, the organizational structure may not change, but the people inside each organizational element may change. Including names makes a non-value-added maintenance problem.

    If an auditor were to tell you that names are a requirement ask her to cite the specific requirement. She cannot write a non-conformance without one. Otherwise, it is just an opinion.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 7.  RE: Medical Device Organization (Organization)

    Posted 24-Sep-2021 10:31
    Goof Morning Dan,

    We have been given a 483 for no organizational chart siting 820.20(b) because the inspector said that is how we establish and maintain organizational structure.

    We have also been given NC for ISO 13485 siting 5.5.1.

    I have participated in many audits/inspections, and every inspector/auditor has asked for an org chart whether it is correct by technical definition or not, and this goes back 30 years.  They are requested, and findings are issued in the real world for some of us.

    I guess it comes down to how much you want to push back against your auditor.

    With kind regards,

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    D Michelle Williams
    VP - Operations
    United States
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    Original Message


  • 8.  RE: Medical Device Organization (Organization)

    Posted 24-Sep-2021 12:06
    Edited by Kevin Randall 24-Sep-2021 12:09
    Dan and Michelle are both correct:  There's no specific regulatory requirement for having names on an organizational chart, or to even have an organizational chart at all.  Yet in the absence of these, nonconformities can reasonably and fairly be issued.

    This comes down to the fundamental intent behind, as well as the letter of, the requirements; specifically, the requirement to, in written form, define and maintain responsibility and authority.  This means assuring proper accountability by certain individuals at certain levels; and this means hierarchically relating those various responsibilities to one another.

    The longstanding worldwide convention in business, and the most efficient, effective way I've ever seen, is to accomplish this via an organizational chart.  Without that, we'll need to reinvent the wheel.  I've not seen that done yet in order to make the gold standard (an organizational chart) obsolete.  But yes, if we need to operate based on regulatory technicalities rather than practicalities, then an organization is certainly free to reinvent the wheel (or even bump along with a square wheel) if that makes sense for that organization.  But I was always taught, and my experience has been, that it usually isn't value added to reinvent the wheel.  This seems to be the case IMHO regarding organizational charts.  No sense kicking against the goads...

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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 9.  RE: Medical Device Organization (Organization)

    Posted 22-Sep-2021 12:16
    As you're growing, it may be a good idea to have the org chart broken down. It's actually similar to FDA. They have a global chart of defining the departments/center at the top (may or may not have names). Then you'd have each of those blocks having their own organizational chart (e.g. Executive Department, Quality Department, etc.).

    Names and titles are important specially as they correspond to responsibilities detailed in the job descriptions. You'd have to be able to point out the players in your organization to an auditor.

    Good luck!

    ------------------------------
    Clarisa Tate
    Medical Devices, Regulatory/Quality/Engineering
    Bay Area, CA
    USA
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    Original Message


  • 10.  RE: Medical Device Organization (Organization)

    Posted 23-Sep-2021 08:23
    Good Day!

    We start off with an org chart (tree/SDL diagram) that purely shows how our company is divided from Board to President to departments to sub-departments with no names.  Then we have a summary that shows how the departments are connected to our QMS.  This goes down to the Associate level but only provides names to the supervisor level and a couple QMS names such as I&T trainer.

    We provide that along with a high level process flow chart which is essentially a data flow chart showing exchanges between our QMS activities at the top and our customers at the bottom with all of our departments in the middle.

    We have used these successfully to pass FDA inspections, ISO certification audits and third-party customer audits.  We have never been asked why every employee is not listed in our charts.

    We currently have about 75 employees and there are 16 names on our chart from President to I&T trainer, including executives, managers, and supervisors.  Currently there are only 2 hourly associate's names on the chart.

    Best of luck,

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    D Michelle Williams
    VP - Operations
    United States
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    Original Message


  • 11.  RE: Medical Device Organization (Organization)

    Posted 23-Sep-2021 10:31
    Clarissa's approach is a good one - I have seen many companies use it.

    As a side (but related) note - if you are growing so fast that keeping up the org chart is really a problem, any good auditor is going to want to dive into how you are managing the growth from a quality standpoint. How good is your training? Are the job descriptions clear as to roles? Do you update other ones when news roles are created? and if so, how are those people trained on the changes? Do they all understand the quality objectives? follow the SOPs closely? etc, etc. Fast growth can be a real challenge from a culture and consistency standpoint, and good auditors know it and will look into the details.

    Ginger



    Original Message


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