This is my opinion, and I think others may not agree.
The QSR preamble, section 190, says, “Section 820.198(b) discusses the initial review and evaluation of the complaints in order to determine if complaints are “valid.” It is important to note that this evaluation is not the same as a complaint investigation. The evaluation is performed to determine whether the information is truly a complaint or not and to determine whether the complaint needs to be investigated or not.”
The question then is whether the information about these older products constitutes a valid complaint. A complaint is an allegation of a deficiency in reliability or durability (and other characteristics). Does the information receive constitute an allegation of a deficiency?
I divide the life cycle into three periods separated by the end of the warranty period and the end of the “design and expected life”.
In the warranty period, the report is a valid compliant and needs investigation; there are a number of Warning Letters to that effect. In the expected life period (after warranty), it is probably a valid complaint and may or may not require an investigation. After the expected life, it is hard to see how the information could allege a deficiency in reliability or durability, i.e., it hard to see how these could be a valid complaint.
I note however, that IEC 60601-1, 3.28 defines expected service life as the time period specified by the manufacturer during which the ME equipment or ME system is expected to remain safe for use (i.e., maintain basic safety and essential performance).
NOTE Maintenance can be necessary during the expected service life.
If you defined an “expected service life” that is longer than the “design and expected life”, then the longer period should govern.
Whether or not you classify these activities as complaints, they are still servicing under §820.200 and need analysis using appropriate statistical techniques. To be clear, some service activities are not complaints.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 06-Jul-2016 09:49
From: Diane Arpino
Subject: Complaints...how long?
Community,
How long after the end of the last sale of a new device do you continue to process complaints? My firm continues to process and trend service reports for products that have not been actively sold for 4-10 years. All this effort reveals is that these are aging products needing routine parts replacement (the products are durable medical equipment). We are way beyond identifying a latent design flaw or missed product requirement. Can anyone share a rational used to end processing complaints into infinity? Thanks, in advance.
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[Diane] [Arpino] [MPH]
[Director, Quality Ops and RA]
[Mindray DS USA, Inc.]
Mahwah NJ
United States
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