Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I have been asked to investigate and establish complaint alert levels with the idea that we would trigger a CAPA if we met our alert level. What is your company's complaint alert level? Is there an industry standard for this?

Thanks!

GHTF/SG2/N36R7:2003, "Manufacturer's Trend Reporting of Adverse Events" (found here: http://www.imdrf.org/documents/doc-ghtf-sg2.asp) may be of interest.  The guidance document does not specify action limits; however, section 5 does provide guidance on statistical methods for doing so.

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Christopher Erwin
Scottsdale AZ
United States
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Original Message:
Sent: 08-Sep-2021 16:05
From: Anonymous Member
Subject: Complaint Percentage

This message was posted by a user wishing to remain anonymous

Hello,

I have been asked to investigate and establish complaint alert levels with the idea that we would trigger a CAPA if we met our alert level. What is your company's complaint alert level? Is there an industry standard for this?

Thanks!

First, complete a proper ISO 14971 risk analysis that analyzes the hazards, hazardous situations, sequences of events, and harms (or lack thereof) that are reasonably foreseeable for the subject device.

Thereafter, consider the risk analysis's predicted probabilities and also the actual observed frequencies of occurrence of harm (or lack thereof) along with the associated risk acceptance criteria from the risk management plan to set alert and action limits for screening complaints and/or complaint trends for the need for CAPA.

If an alert limit is reached, then perform further evaluation or investigation to decide the need for preventive action.

If an action limit is reached, then that is typically an automatic corrective action.

If there is no precedent in the risk analysis for the issue observed in a complaint, then update the risk analysis accordingly to integrate the observed issue and use that risk assessment (factoring in any "as-observed" adjustments) to make the CAPA decision.


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

Original Message:
Sent: 08-Sep-2021 16:05
From: Anonymous Member
Subject: Complaint Percentage

This message was posted by a user wishing to remain anonymous

Hello,

I have been asked to investigate and establish complaint alert levels with the idea that we would trigger a CAPA if we met our alert level. What is your company's complaint alert level? Is there an industry standard for this?

Thanks!

This is a good point, it will be necessary to establish alert limits and monitoring processes to detect where a specific instance goes above a limit, as well as where complaint/incident reportabilty based on trending is necessary. 21 CFR 803.3 as well as the MDR and IVDR discuss trending as a factoring in reporting; depending on the markets your company has entered or intends to enter, this should be a consideration. For example, depending on the risk associated with the device and volume distributed, a sustained increase observations above an established baseline may warrant further investigation as mentioned. This planned approach may be included within an SOP, but certainly should be referenced/explained within the post-production activities in the risk management plan.

------------------------------
Christopher Erwin
Scottsdale AZ
United States
------------------------------

Original Message:
Sent: 09-Sep-2021 17:56
From: Kevin Randall
Subject: Complaint Percentage

First, complete a proper ISO 14971 risk analysis that analyzes the hazards, hazardous situations, sequences of events, and harms (or lack thereof) that are reasonably foreseeable for the subject device.

Thereafter, consider the risk analysis's predicted probabilities and also the actual observed frequencies of occurrence of harm (or lack thereof) along with the associated risk acceptance criteria from the risk management plan to set alert and action limits for screening complaints and/or complaint trends for the need for CAPA.

If an alert limit is reached, then perform further evaluation or investigation to decide the need for preventive action.

If an action limit is reached, then that is typically an automatic corrective action.

If there is no precedent in the risk analysis for the issue observed in a complaint, then update the risk analysis accordingly to integrate the observed issue and use that risk assessment (factoring in any "as-observed" adjustments) to make the CAPA decision.


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

Original Message:
Sent: 08-Sep-2021 16:05
From: Anonymous Member
Subject: Complaint Percentage

This message was posted by a user wishing to remain anonymous

Hello,

I have been asked to investigate and establish complaint alert levels with the idea that we would trigger a CAPA if we met our alert level. What is your company's complaint alert level? Is there an industry standard for this?

Thanks!

Since the GHTF document Christopher cited, GHTF/SG2/N36R7:2003, was released, a lot has gone on, and there are more references you should review.  ISO 13485:2016 and ISO 14971:2019 (cited by Kevin) postmarket processes were each revised based on GHTF/SG3/N18:2010, the GHTF CAPA guidance, and finally the postmarket processes in both of these standards (Clause 8 in ISO 13485:2016 and Clause 10 in ISO 14971:2019) were connected together with the regulatory postmarket surveillance processes in ISO TR 20416:2020.  Annex B in ISO TR 20416, for example, discusses Data Analysis methods for the postmarket processes and refers to ISO TR 10017 on statistical techniques for analysis and evaluation.  ISO TR 20416 has lots of important information that should be reviewed in setting up your postmarket processes

ISO TR 20416 also points our that simply setting action and alert levels for complaints is only part of a complete postmarket surveillance process that also, as Kevin discusses, includes the product safety processes of risk management and the Corrective Action and Preventive Action processes of the quality system.

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.comPrincipal Consultant
------------------------------

Original Message:
Sent: 09-Sep-2021 17:56
From: Kevin Randall
Subject: Complaint Percentage

First, complete a proper ISO 14971 risk analysis that analyzes the hazards, hazardous situations, sequences of events, and harms (or lack thereof) that are reasonably foreseeable for the subject device.

Thereafter, consider the risk analysis's predicted probabilities and also the actual observed frequencies of occurrence of harm (or lack thereof) along with the associated risk acceptance criteria from the risk management plan to set alert and action limits for screening complaints and/or complaint trends for the need for CAPA.

If an alert limit is reached, then perform further evaluation or investigation to decide the need for preventive action.

If an action limit is reached, then that is typically an automatic corrective action.

If there is no precedent in the risk analysis for the issue observed in a complaint, then update the risk analysis accordingly to integrate the observed issue and use that risk assessment (factoring in any "as-observed" adjustments) to make the CAPA decision.


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

Original Message:
Sent: 08-Sep-2021 16:05
From: Anonymous Member
Subject: Complaint Percentage

This message was posted by a user wishing to remain anonymous

Hello,

I have been asked to investigate and establish complaint alert levels with the idea that we would trigger a CAPA if we met our alert level. What is your company's complaint alert level? Is there an industry standard for this?

Thanks!

Is the alerts monitoring and subsequent CAPA for follow-up  refer to a medical device ?
Your statement does not specifiy the subject product or drug etc.
If a device -depending on the type of medical device -- FDA may require alerts to be dealt with though non-quotative parameters ripe for alerts are  involved.
Example is with Self monitoring blood glucose devices  and failures with strip inserting into the device etc.



------------------------------
Ram Balani
CEO
FDASmart Inc.
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)
------------------------------

Original Message:
Sent: 08-Sep-2021 16:05
From: Anonymous Member
Subject: Complaint Percentage

This message was posted by a user wishing to remain anonymous

Hello,

I have been asked to investigate and establish complaint alert levels with the idea that we would trigger a CAPA if we met our alert level. What is your company's complaint alert level? Is there an industry standard for this?

Thanks!

Alert levels (and action levels) are not prescribed in any standard or regulation that I know of. It needs to be on a company basis. You first need a good measurement of the complaint rate. I'll base this on FDA QSR, but similar considerations apply to ISO 13485:2016.

Distinguish between two kinds of complaints which I call customer dissatisfaction complaints and regulatory complaints. Regulatory complaints are an allegation of a deficiency in one of -ilities; FDA QSR has the formal definition. Dissatisfaction complaints usually include regulatory complaints as well as other sources of dissatisfaction. For example, late deliveries are dissatisfaction complaints, but not regulatory complaints.

For regulatory complaints distinguish between those related to patient harm which should be covered in the ISO 14971:2018 risk management file and those that are not related to harm. For example, reliability complaints don't usually involve patient harm, since the device should "fail safe".

Use the complaint rate, not the number of complaints. Assume a given complaint type occurs 3 times in every 1,000 uses and is constant. As the installed base grows the rate stays constant, but the number of complaints will increase as the number of uses increases.

To set the alert level, determine the average complaint rate over some period of time, such as two years. This smooths out spikes and other anomalies. In this case, the improvement direction is down. The alert level should be above the historical average. A reasonable multiplier is 1.25 or 1.5. As a sanity check, check the results with management. The alert level should not be higher than, say 1.0%.

For complaints not covered by the risk management file, use the multiplier value as the alert level. For complaints covered by the risk management generate an alert if the frequency of occurrence is above the estimated rate.

Implement the system as part of 820.100(a) data analysis.

If you generate a signal (exceed the alert level) then implement a preventive action following 820.100. Use a corrective action for individual complaint nonconformances.

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

Original Message:
Sent: 08-Sep-2021 16:05
From: Anonymous Member
Subject: Complaint Percentage

This message was posted by a user wishing to remain anonymous

Hello,

I have been asked to investigate and establish complaint alert levels with the idea that we would trigger a CAPA if we met our alert level. What is your company's complaint alert level? Is there an industry standard for this?

Thanks!