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  • 1.  Quality Management System Glossary

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2022 13:50
    This message was posted by a user wishing to remain anonymous

    Do you have it in your company? 
    Do you use a dedicated SOP for Quality Management System Glossary?
    How do you manage it to support\cover multiple jurisdictions?

    Many thanks,



  • 2.  RE: Quality Management System Glossary

    Posted 25-Jan-2022 16:07
    I have seen it done a variety of ways:
    1) Include relevant acronyms and definitions in each SOP 
    2) Have the glossary as a stand-alone document
    3) Have the glossary as an Appendix in the Quality Manual
    4) A hybrid of 1 and 2 or 1 and 3 where the general definitions are in the glossary and definitions specific to jurisdiction are in the applicable SOP. 
    My preferred method is option 2​, but there are drawbacks to each, and you can choose what works best for you - for option 1, it is possible to have 2 different definitions in 2 different SOPs. People don't set that up on purpose, but you can imagine that one person revises document #1 and then another person revises document #2 at some other point in time and the definitions drift apart from each other. Ideally, information in a QMS shouldn't be repeated in multiple places for this reason.
    In scenario 2 and 3, you may find yourself revising two documents every time you add a new definition​ - the SOP that uses the word and the glossary. Although this is potentially more work, it is also offers the best control of the definitions.
    In scenario 4 you might have to spend some time hunting for the definition because it could be in any one SOP. And, you might also have the same issue as in scenario #1 with drift between revisions. 

    ​

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    Erica Livingston
    Carlsbad CA
    United States
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    Original Message


  • 3.  RE: Quality Management System Glossary

    Posted 25-Jan-2022 21:07
    Covering multiple jurisdictions is tricky. The cleanest approach might be to include an explanation that the terms as defined in the glossary are the terms used by the company, noting that some terms may have differing definitions in different places. Then within the relevant SOPs, maybe in an end note, you can point out the differences in definition and explain how you're meeting the requirements of any jurisdiction where the terminology may lead to ambiguity.

    You need the QMS to make sense to and be usable by the people at your company, every day. And you also need it to make sense somehow to inspectors from each relevant jurisdiction, so they can follow how you're meeting their specific requirements.

    It's a little easier if the various jurisdictions use different languages!

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    Anne LeBlanc
    United States
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    Original Message


  • 4.  RE: Quality Management System Glossary

    Posted 26-Jan-2022 03:59
    Hello,

    I have to support what Erica and Anne have said already supporting there are many different ways this could be done.  Personally, I like to have the acronyms or definitions in the SOP/work instruction/procedure itself because referencing back to a single glossary document may not be helpful.  Unless you have a nice eQMS system where the user can easily click on a link to get to the glossary or even have embedded in the document itself "pop-up" windows of the terms.  As Anne said, be cautious of the different jurisdictions or regulated regions because while the word/terms may be the same, sometimes the definitions are different.  So in a single glossary document, defining Adverse Event once may not be sufficient for multiple regions.  I have seen glossaries used all the time in medical device quality system either in the procedure or a single document - in fact I would say it is quite a normal "good documentation practice" today.  Ask your internal users, see how external users interact with your procedures (auditors), and what documentation control system you have to develop what works for your organisation.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Quality Management System Glossary

    Posted 29-Jan-2022 02:44
    I am a big believer in having a centralized quality system glossary connected to the Quality Manual (Level 1). In doing so, Level 2 quality system procedures can simply refer to the glossary document for "Definitions" and need not repeat the definitions within the procedure - that is the entire point of having a separate glossary. Too many times I have seen disparate and incorrect definitions scattered throughout procedures. 

    In my experience, most of the definitions should be derived from applicable regulations, standards, or guidance documents. I am a strong believer in citing the source of each definition.

    Here are the references I am currently citing in my glossary.

    REFERENCES

    Identification

    Document Title

    Canada SOR/98-282

    Medical Devices Regulations

    EN 62304:2006+A1:2015

    Medical device software - Software life-cycle processes (IEC 62304:2006+A1:2015)

    EN 62366-1:2015+A1:2020

    Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015+A1:2020)

    EN ISO 11139:2018

    Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139 :2018)

    EN ISO 13485:2016

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    EN ISO 14155:2020

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

    EN ISO 14971:2019

    Medical devices - Application of risk management to medical devices (ISO 14971:2019)

    EN ISO 9000:2015

    Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)

    Europe Regulation 2017/745
    (Europe MDR):M1+C1,C2

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

    Europe MEDDEV 2.12-1 Rev. 8

    Guidelines on a Medical Devices Vigilance System

    GHTF/SG3/N99-10:2004

    Quality Management Systems - Process Validation Guidance

    IMDRF/WG/N10FINAL:2013

    Software as a Medical Device (SaMD): Key Definitions

    USA 21 CFR Part 7

    Enforcement Policy, Subpart C - Recalls

    USA 21 CFR Part 11

    Electronic Records; Electronic Signatures

    USA 21 CFR Part 801

    Medical Devices - Labeling

    USA 21 CFR Part 803

    Medical Device Reporting

    USA 21 CFR Part 806

    Medical Devices; Reports of Corrections and Removals

    USA 21 CFR Part 807

    Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

    USA 21 CFR Part 810

    Medical Device Recall Authority

    USA 21 CFR Part 812

    Investigational Device Exemptions

    USA 21 CFR Part 820

    Medical Devices; Quality System Regulation

    USA 21 CFR Part 860

    Medical Device Classification Procedures

    USA FDC Act

    Federal Food, Drug and Cosmetic Act, as amended, Title 21 US Code



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    Sam Lazzara
    Medical Device Quality Consultant
    San Francisco Bay Area, California USA
    www.mdqc.com
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    Original Message


  • 6.  RE: Quality Management System Glossary

    Posted 29-Jan-2022 20:20
    Edited by Kevin Randall 29-Jan-2022 20:24

    I prefer to have jurisdiction-specific, policy-level (Tier 1) lists of general overarching definitions in the Quality Manual, especially where adjacent jurisdictions use the same words, but have different definitions.  For example, each jurisdiction's competing definitions for "manufacturer" and "distributor".  And also jurisdiction-specific policy-level terms like "European Union", "CE Mark", "component", "finished device", etc.  This approach is required if you have an ISO 13485 quality management system.  Also for ISO 13485 systems we must in addition reconcile ISO 9000's and ISO 13485's own definitions with the jurisdictional definitions.

    Then I put operating-level (e.g., Tier 2 &3) definitions in their appropriate operating contexts in the SOPs or WIs where they are more likely to be noticed and used.  Having the operational definitions living remotely in a Quality Manual glossary tends to cause them to be overlooked and not used.  It's already pretty hard to get folks to read the SOPs and WIs let alone when we require them to also filter through the Quality Manual each time they use/read an SOP.  And many of those definitions are too important, complicated, or otherwise nuanced to burden users with the task of trying to decide which from amongst a list of hundreds in the Quality Manual are to be used for the user's context of the moment.  Examples include but are not limited to words like "complaint", "recall", "correction", "incident", "nonconformity", "validation", "reasonably suggests", etc.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


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