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Written by Zina Bulbuc - Validation Engineer, QPharma
Complaints System
Complaints, complaints, complaints….
Everybody gets them: from friends and family members, from customers and business partners, from bosses and co-workers. How do we handle them to keep everybody happy?
I will start with customer product quality complaints and later, we may extrapolate the model for other types of product complaints (Adverse Events, Medical Device Reports) or even for complaints in other areas of our lives (but that will be part of another blog…)
All marketed products (drugs, medical devices or combination products), will sooner or later generate a number of complaints. Handled correctly, complaints can be used by the manufacturer and others, in a constructive way.
While the number and content of complaints may vary for each product, they all have something in common: they have to be acknowledged, investigated, resolved, reviewed, and where applicable, reported. We must have a system in place that will handle them in a timely and organized manner.
Complaints Defined
Q: How do we define drug complaints? 21 CFR 210.3 does not have a definition for complaints.
A: This is true, 21CFR 210.3 does not explicitly define ‘complaints’. We have a guidance of what the Agency considers a drug complaint through 21CFR 211.198(a) which states: … Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of its specifications…
In the mean time, we have a clear definition for complaints for medical device in 21CFR 820.3(b); … any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.
Since the medical device complaints definition is more comprehensive and includes “identity, quality, … safety, effectiveness or performance” one can equally apply it to drugs.
Q: Are dissatisfaction about price or availability considered complaints? They do not meet the definition of a complaint as per the 21CFR.
A: FDA does not include these in their ‘complaints’ definition because they do not pose any direct risk for the patient / user (although, the indirect effects of such complaints can be disputed). The difference here is the investigating entity and the corrective action’s target. Do we want to treat them as ‘regular’ complaints? The answer is ‘yes, absolutely’! But, they should be labeled as ‘non product-quality’ complaints (or a similar term), to draw a regulatory distinction between them and those other ‘complaints’ that we are specifically required by regulation to maintain files for. This way, we satisfy the strict legal obligations for complaint handling (keeping the lawyers happy), while continuing to capture and act on customer satisfaction issues (keeping the product managers happy).
Q: Are Service Calls (for medical devices) complaints?
A: This is a hot topic in medical device companies; due to the number of incoming service calls, risking overload to the complaints system. First, service calls are “allegations of … performance” and fit the definition of a (quality) complaint. You may argue that in some cases, the allegations are about an ‘error message’ that is in line with the instrument’s specifications. The regulations cover the ‘failure to meet specifications’ in the definition of an MDR, but not so in the definition of a (quality) complaint. Second, these are calls that require an investigation and a corrective action, so they do not fall in the ‘inquiries’ category. And third, sometimes it is hard to delimitate where a ‘service call’ ends and a ‘complaint’ begins. The safest way is to have them handled as complaints. And make sure to have them clearly identified for trending purposes (also required by 21 CFR 820.200 Servicing and 21 CFR 820.250 Statistical Techniques).
Complaints, complaints, complaints….
Everybody gets them: from friends and family members, from customers and business partners, from bosses and co-workers. How do we handle them to keep everybody happy?
I will start with customer product quality complaints and later, we may extrapolate the model for other types of product complaints (Adverse Events, Medical Device Reports) or even for complaints in other areas of our lives (but that will be part of another blog…)
All marketed products (drugs, medical devices or combination products), will sooner or later generate a number of complaints. Handled correctly, complaints can be used by the manufacturer and others, in a constructive way.
While the number and content of complaints may vary for each product, they all have something in common: they have to be acknowledged, investigated, resolved, reviewed, and where applicable, reported. We must have a system in place that will handle them in a timely and organized manner.
What do we expect from a complaints system?
- First, we want to make sure it is compliant with the CFR requirements.
- Second, it has to be a good feedback tool for the manufacturer: on the product’s design, on the product’s efficiency or efficacy and on users’ satisfaction.
- And third, the complaints system should be user friendly and economical to run.
When creating a complaints system we are faced with two - often opposing - decisions: business and compliance. The first one will guide us to spend the least possible amount of money and resources and the second, to invest as much as necessary to ensure a thorough and safe handling of complaints.
The main steps to follow in creating a complaints system are:
- Define complaints (CFR provides different definitions for different types of complaints);
- Decide how you can assure a complete and consistent collection of complaints;
- Decide how you will keep track and monitor complaints: will you use an electronic log, or a paper based system? Do you have an electronic system in place to handle them (TrackWise, Oracle)?
- Designate a quality group / quality unit to handle complaints;
- Define the content of a complete complaint file;
- Define the time frame to close a complaint and retention time for complaint files.
Now, that we have a overview of what is expected from a complaint handling system, let’s get to answering some of the most frequent questions on this subject.
Complaints Defined
Q: How do we define drug complaints? 21 CFR 210.3 does not have a definition for complaints.
A: This is true, 21CFR 210.3 does not explicitly define ‘complaints’. We have a guidance of what the Agency considers a drug complaint through 21CFR 211.198(a) which states: … Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of its specifications…
In the mean time, we have a clear definition for complaints for medical device in 21CFR 820.3(b); … any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.
Since the medical device complaints definition is more comprehensive and includes “identity, quality, … safety, effectiveness or performance” one can equally apply it to drugs.
Q: Are dissatisfaction about price or availability considered complaints? They do not meet the definition of a complaint as per the 21CFR.
A: FDA does not include these in their ‘complaints’ definition because they do not pose any direct risk for the patient / user (although, the indirect effects of such complaints can be disputed). The difference here is the investigating entity and the corrective action’s target. Do we want to treat them as ‘regular’ complaints? The answer is ‘yes, absolutely’! But, they should be labeled as ‘non product-quality’ complaints (or a similar term), to draw a regulatory distinction between them and those other ‘complaints’ that we are specifically required by regulation to maintain files for. This way, we satisfy the strict legal obligations for complaint handling (keeping the lawyers happy), while continuing to capture and act on customer satisfaction issues (keeping the product managers happy).
Q: Are Service Calls (for medical devices) complaints?
A: This is a hot topic in medical device companies; due to the number of incoming service calls, risking overload to the complaints system. First, service calls are “allegations of … performance” and fit the definition of a (quality) complaint. You may argue that in some cases, the allegations are about an ‘error message’ that is in line with the instrument’s specifications. The regulations cover the ‘failure to meet specifications’ in the definition of an MDR, but not so in the definition of a (quality) complaint. Second, these are calls that require an investigation and a corrective action, so they do not fall in the ‘inquiries’ category. And third, sometimes it is hard to delimitate where a ‘service call’ ends and a ‘complaint’ begins. The safest way is to have them handled as complaints. And make sure to have them clearly identified for trending purposes (also required by 21 CFR 820.200 Servicing and 21 CFR 820.250 Statistical Techniques).
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