Yep absolutely correct Homi ... I was quickly typing - should be "tamper evident" sticker or tape. If it was tamper proof, then the answer to the question would be simple :).
Original Message:
Sent: 19-Jul-2018 19:38
From: Homi Dalal
Subject: Servicing activities
Seems to me we are all looking at different parts of the same elephant and drawing conclusions that are not necessarily contradictory but narrowly focused on specifics, at times missing the bigger picture!
As Dan points out, the blog originator cited the definition of Routine Servicing from Part 803, which certainly includes the 'repairs of an unexpected nature' as a consideration for some sort of correction. Whether this correction escalates the service as a repair, adjustment, modification, etc. requiring field action on one extreme, or whether the service simply requires trending of the service records with no further action on that specific unit, would be determined by the risk of harm posed to users. In between these two extremes, the service records may identify a "deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance" of the released device, which clearly needs to be addressed as a complaint! I believe the 'repairs of an unexpected nature' would imply the device risk management file originally failed to capture this fault or failure mode, thereby requiring further analysis of risks and other considerations, irrespective this results in no action/ complaint recorded/ reporting of malfunction/ recall.
From Ginger's point of view, the statistical analysis for trending of service records to determine the respective action poses practical difficulties for most small manufacturers, so a review of individual service records could be the default. It should also be noted that the very first service record viewed (i.e. before any statistically relevant data set may be compiled) could in theory trigger an appropriate action - complaint/ reportable event/ recall. This is probably what the FDA inspector in Ginger's point #2 was looking for.
This FDA presentation highlights the need for servicing technicians to be trained to identify possible complaints, followed by a review of all service records to identify those that meet the definition of a complaint: https://www.fda.gov/downloads/Training/CDRHLearn/UCM586412.pdf
As Richard states, none of the above is influenced by the presence or absence of the tamper evident warranty void. Richard, please note this seal is intended to be tamper evident (not tamper proof!) to safeguard against liability arising from incorrect or improper servicing.
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Homi Dalal RAC
Regulatory Affairs Leader
Christchurch
New Zealand
Original Message:
Sent: 19-Jul-2018 08:38
From: Ginger Glaser
Subject: Servicing activities
Dan,
I'm not sure that is so "contrary" - in fact, under ISO, I'd argue it is probably an even better approach to managing complex capital systems. However, I suspect there are a couple of practical problems.
1) most small firms, if not all, who make capital, are unlikely to have a lot of reliability data at the individual component level. I've spent a great part of my life working with such companies to collect any such data. And even if they have it, it is unlikely they "trend" the service data at that level to compare it. Groups tend to be too small to be able to do all that, even if the understanding is there.
2) on the occasions where there is such a system, prepare for a big battle with FDA inspectors. I can't begin to count the # of times they have gone through service records one by one and argued that an individual report should have been a complaint. No matter how much reliability data we had, they didn't seem to agree with that viewpoint that it was trending, not an individual event, that determined whether it is a complaint. I'm not sure the hassle is worth whatever benefit you gain from not logging them as complaints. Complaints with known causes that tie back to the reliability and risk analyses are pretty darn easy to investigate and close. Much easier than fighting with FDA inspectors. :-)
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
Original Message:
Sent: 19-Jul-2018 07:44
From: Dan O'Leary
Subject: Servicing activities
I'm going to take a bit of a contrary approach.
The original question is, "If repair work (non-safety related) is performed during routine servicing, does that trigger a complaint process?" The question then goes on to cite part of the definition of routine servicing from the corrections and removal regulation in Part 806. This definition is part of the decision process to determine the need to file a correction or removal report. As such, the definition is not applicable to the complaint decision.
In this case, it is better to stay inside Part 820. In 820.200(b) the manufacturer analyzes service records using appropriate statistical means. In addition, the manufacturer should review each service record to determine if the servicing activity meets the definition of a complaint in 820.3(b).
Ginger suggests, "If, however, the battery you are supposed to replace every 2 years fails in 1 year, it is "unexpected" and thus a complaint." I disagree, because "unexpected" is not part of the complaint definition.
However, there is a very important issue, reliability, for the analysis (using statistical means). Reliability is an attribute of the population, not of the individual items. One battery that fails early is not a reliability issue. However, the statistical analysis should determine the actual life distribution of the battery and compare it against the specification. Presumably, the frequency of battery replacement, in servicing, utilizes the specified life distribution.
If the analysis determines the battery population is not meeting the specified reliability, then it is a complaint. In my courses, I bring up this issue, stating that an internal report prepared by an analyst can be a complaint. Sometimes, people object under the assumption that complaints can only originate externally. This is not a requirement.
An individual premature battery failure could be a complaint because it satisfies another part of the complaint definition.
Evaluate every complaint (individual event or statistical analysis) for potential reportability as an MDR. Make the reportability decision under Part 803.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 17-Jul-2018 23:15
From: Rashmi Pillay
Subject: Servicing activities
Hi,
If repair work ( non-safety related) is performed during routine servicing , does that trigger a complaint process. As per the definition . I assume 'repairs of unexpected nature' are safety related? 'Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing.'
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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