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  • 1.  Reviews in relation to 21CFR or ISO 13485.

    Posted 08-Feb-2024 03:53
    Edited by Daniela Juric 08-Feb-2024 03:54

    Hi to all.  There is something I would like to hear your opinion about:

    - Company A established its quality system 5 years ago. This year's production was double that of 5 years ago. Six months ago they installed an ethylene oxide sterilization chamber and started distributing sterile devices. Several sterilization lots have failed. They perform management reviews annually.

    Is an annual management review sufficient? Yes or No. How to justify  answer based on understanding  reviews in relation to 21CFR or ISO 13485 and  what do you think the company should do -in your opinion based on the standard requirements.






  • 2.  RE: Reviews in relation to 21CFR or ISO 13485.

    This message was posted by a user wishing to remain anonymous
    Posted 08-Feb-2024 09:22
    This message was posted by a user wishing to remain anonymous

    So, have the past 4 or 5 management reviews found the quality system effective? Does it seem effective to you? Was there a good quality plan in place for the addition of the sterilization process? Have the sterilization lot failures been appropriately investigated and resolved? 




  • 3.  RE: Reviews in relation to 21CFR or ISO 13485.

    Posted 08-Feb-2024 18:20

    Yes, the question you need to ask yourself if the QMS is effective.  Then you could justify that the MR take place only once a year.  However, just the one issue regarding the product problem will not allow to justify that your QMS is sufficient.  I would like to suggest to have the MR on a quarterly basis.  



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    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armin.beck@suntrixmedical.com
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  • 4.  RE: Reviews in relation to 21CFR or ISO 13485.

    Posted 09-Feb-2024 02:49

    Hello Daniela,

    My thoughts are the installation of the ethylene oxide steriliser and subsequent lot failures might not be connected to specifically to management review.  Meaning, they could have had management review once a month or once a week, but that does not mean the sterilisation process would have been prevented from failing.  Also, if there are issues with the sterilisation process this would be handled by other processes in the quality management system like validation and corrective action.  If not having sufficient management reviews, only having once a year, was preventing the management team from seeing many underlying issues in the quality system, then maybe once a year was not enough.  Though not being there in the meetings could not say more, but maybe the management reviews even once a year were not effective themselves.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Consultant
    Oriel STAT A MATRIX - ENTERPRISE
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  • 5.  RE: Reviews in relation to 21CFR or ISO 13485.

    Posted 09-Feb-2024 10:37

    Agreed with Armin and Richard.

    I'll add that there is no specific rule for the number and frequency of management reviews.  An unscheduled additional management review would generally only be appropriate if a nonconformity(s) reasonably indicate that the QMS itself is or may be holistically ineffective or unsuitable. While an emergent quality problem might make it necessary to do additional management review(s), I would say that most times, it will not (building on what I think Anon above is probing about).  The only related rule is that the management review frequency needs to be sufficient commensurate with risk and in accordance with what your management review SOP requires and in accordance with the fundamental purpose of management review.

    In other words, a general expectation is that management review frequency be increased only as needed to meet the fundamental intent for management review, which purpose is NOT generally for attending to emerging quality problems.  Instead, management review is a holistic exercise aimed at (FDA) assessing the overall suitability and effectiveness of the quality system to ensure the quality system satisfies 21 CFR Part 820 and the firm's quality policy and objectives, and (ISO 13485) to ensure the quality management system's (QMS's) continuing suitability, adequacy, and effectiveness, including, but not limited to, the need for changes to the QMS, quality policy, and quality objectives (ISO 13485). Again, these assessments are intended as executive summary assessments, not necessarily granular assessments of a single quality event.

    Neither 21 CFR Part 820 nor ISO 13485 require a QMS to operate flawlessly. And nonconformity doesn't necessarily immediately mean that the QMS is as a whole ineffective.  This reality is primarily why FDA and ISO require ongoing monitoring (e.g., day-to-day, week-to-week, month-to-month, etc.) to detect the inevitable emergent quality issues and nonconformity and then, where necessary, take improvement action.  Nonconformity (e.g., a single inadequate Quality Plan, single inadequate process validation, etc.) doesn't automatically mean a new management review is needed.  On the other hand, a single quality event can indeed implicate an inadequate QMS. Thus, we need to employ these general principles to decide if an additional management review is needed.



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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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  • 6.  RE: Reviews in relation to 21CFR or ISO 13485.

    Posted 10-Feb-2024 02:57

    Hi Richard,

    Thank you a lot for your replay and such a great explanation. This helps me a lot to clarify my thoughts about the question.



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    Daniela Juric
    Dornach
    Switzerland
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  • 7.  RE: Reviews in relation to 21CFR or ISO 13485.

    Posted 10-Feb-2024 02:53

    Thank you a lot for your replay. 



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    Daniela Juric
    Dornach
    Switzerland
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  • 8.  RE: Reviews in relation to 21CFR or ISO 13485.

    This message was posted by a user wishing to remain anonymous
    Posted 12-Feb-2024 09:05
    This message was posted by a user wishing to remain anonymous

    Hello Daniela,

    I agree with Richard's opinion that installation of the EO sterilizer and lot failures might not be connected to management reviews. Before coming to the conclusion if management reviews are effective or not, it is critical to understand following related to sterilized products:

    1) The lots that failed the sterilization, were they ever sent out to the customer, or were they contained before distribution? If they were never sent to the customer, then it would indicate their QMS has effective controls over not releasing non-conforming products. One would expect that they have CAPAs open to investigate the issue that are being periodically reviewed outside of management reviews (internal audits, periodic quality reviews). Such controls and reviews would be indicative of an effective QMS. In this case an annual MR may still be sufficient.

    2) If they were released to the customer, that is a huge issue and certainly a major non-conformance for such a critical process. Effectiveness of QMS should be the least of the worries (think recalls, FDA inspections, loss of customer confidence). It may be indicative of multiple underlying issues - training, equipment maintenance, resources... to name a few.

    So, the conclusion of their MR frequency and it being effective or not, depends on the scenarios above. If it is case # 2, increasing the frequency of MRs will do little if the root cause of the issue has not been identified or being addressed.

    Hope this helps.