Complaint alert levels - Industry standards pertaining to alert levels for complaints

ASteel

Starting to get Involved
#1
The company I work for has established complaint alert levels and I have been tasked with the inquiry of industry standards. All I have been able to find are levels regarding bioburden. Question to the fellow Quality members of the forum is...are you familiar with any industry standards pertaining to alert levels for complaints. Thanks for your help!

Are current levels are as follows:
Triggers by Absolute Numbers:
  • Other Complaint Types > 1/1,000 (0.1%)
  • Potential Adverse Events > 1/10,000 (0.01%)
    • Children’s Potential Adverse Events > 1/10,000 (0.01%)
Triggers by Rate:
  • Other Complaint Types > 2 Standard Deviation above the Average
  • Potential Adverse Events > 2 Standard Deviation above the Average
    • Children’s Potential Adverse Events > 2 Standard Deviation above the Average
 
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indubioush

Quite Involved in Discussions
#2
Do you work for a medical device company? Are the alert levels assigned only for low risk complaints? What happens when the alert limit is reached? All complaints need to be assessed according to a previously performed risk analysis. Are you doing that? If you answer the questions, maybe we can help you further.
 

ASteel

Starting to get Involved
#3
Do you work for a medical device company? Are the alert levels assigned only for low risk complaints? What happens when the alert limit is reached? All complaints need to be assessed according to a previously performed risk analysis. Are you doing that? If you answer the questions, maybe we can help you further.
Yes, it is a medical device company. The alert levels are separated into Other, which are low risk complaints, and Potential Adverse and Children's
Potential Adverse,
which are higher risk (e.g., efficacy, safety, etc.). We perform an investigation for all complaints (e.g., batch record review); however, when an alert level is reached, we perform a more in-depth investigation (e.g., HHE). Please clarify what you mean when you say "assessed according to a previously performed risk analysis". During the investigation of every complaint we currently ensure that the complaint has been established within our risk management and document if the risk hazard index is in need of adjustment.
 

indubioush

Quite Involved in Discussions
#4
When I say assessed according to a previously performed risk analysis, I mean you go back and ensure the hazardous situation that occurred for the complaint is recorded in your hazard analysis and that the risk level is correct. It seems as though you are doing this.

As for having complaint alert levels, I am not aware of any standards that pertain to alert levels. The only thing I can think of that may be related is trend reporting per MEDDEV 2.12-1. However, I don't believe this is what you are taking about. Also, I do not fully understand the what this does for your organization. You should be performing a review on a regular basis to meet the requirements of ISO 14971 production and post production information. To do this review, you need to look at way more info than occurrence levels.

I hope someone else can chime in and provide additional insight into the idea of alert levels for complaints.
 

ASteel

Starting to get Involved
#5
Our alert levels are a way of noticing an upward trend in certain types of complaints. This analysis, among others, is included in a quarterly feedback report. I wouldn't think that we are revolutionary in our setting alert levels for complaints, so hopefully someone else can give some more insight.

Thank you for your input.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
I would strongly caution against using 2 SD. by the rule of the formula for the standard deviation, there will be ~5% false alarms. Real control charts are much better for alert levels if you are simply trying to see real upward trends.

For high severity failures I recommend using a severity based approach. Higher severity failures will have lower limits for the number or proportion of complaints. For example, we have a limit of one complaint for any power supply that smokes or catches on fire.
 
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