FDA Part 820 Quality System Regulation - 820.198 Complaint files

R

Richard Main

#1
820.198 Complaint files

The requirement states in part, "Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of PART 820 QUALITY SYSTEM REGULATIONS".

At what point does a Customer's call into a Service Department become a Complaint.

Does it only become a complaint if the issue being raised has caused Death, Serious Injury or the potential of Death, Serious Injury?

Or

If the Customer calls the Service Department for clarification or to schedule equipment repair or preventive maintenance, does this register as a complaint and if not does it have to be recorded?

:confused:
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
Re: Fda Part 820 Quality System Regulation

At what point does a Customer's call into a Service Department become a Complaint.

:confused:
Probably at the point when it becomes evident that the call is not being made to compliment or make positive comments? Just a guess of course.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
Re: Fda Part 820 Quality System Regulation

At what point does a Customer's call into a Service Department become a Complaint.
According to this,

COMPLAINT DEFINITION
A consumer complaint is notification that a product in commercial distribution:
1. May be in violation of the laws or regulations administered by the FDA.
2. May have caused an illness, injury, or death.
3. Is alleged to have caused problems not covered by the above.
 
J

jgossett

#5
I can't remember exactly where-it may be in the QSR or the Device Advice Compliance Guide, but all negative or potential problem questions or statements should initially be recorded. A justification for dismissing it as a complaint should be documented. The value comes from trending these issues to see if you have a pattern indicating a problem, or one that could be addressed in improved instructions for use, or revisiting the risk analysis to assess the effectiveness of controls or....

I would not consider a normal repair or service a complaint.
 
A

Aaron Lupo

#6
820.198 Complaint files

The requirement states in part, "Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of PART 820 QUALITY SYSTEM REGULATIONS".

At what point does a Customer's call into a Service Department become a Complaint.

Does it only become a complaint if the issue being raised has caused Death, Serious Injury or the potential of Death, Serious Injury?

Or

If the Customer calls the Service Department for clarification or to schedule equipment repair or preventive maintenance, does this register as a complaint and if not does it have to be recorded?

:confused:
It becomes a reportable event if the issue raised caused a death, serious injury.....

Any allegation (written or oral) of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance after the product has been released for distribution should be recorded as a potential complaint and investigated.

What the FDA expects is that manufactures classify the information as it relates to the inadequate performance of the device as a possible complaint.
 
P

phaswell

#7
If you look in Section 820.3 - Definitions, you'll see FDA's definition of a complaint:

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.

This is virtually identical to the ISO 13485 definition:

Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market
 
G

Gerry Quinn

#8
Phasewell has correctly identified the rule.

The key clause is "...after it is released for distribution...".

A 'complaint' is an alleged or real non-conformance that is discovered after release for distribution. All complaints must be tracked and dispositioned. Allegedly non-conforming product needs to be recovered and analyzed. Some complaints based on severity are reportable to the FDA.

My definition of 'released for distribution' is the point where you complete your final inspection and will no longer perform any more evaluations on the product. Most business folks don't like this one, they want it to be the point where you actually ship it to the customer.

Following that logic, you could actually ship it through several distribution centers before it goes to the customer.
 
R

rose24m03

#9
If service data (e.g. service call, service repair data) that fits FDA definition of a Complaint (i.e. "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."), the Agency expects 820.198 be followed. (There were warning letters and some 483s issued on firms failing to process these types of service data in their complaint handling.)



I can't remember exactly where-it may be in the QSR or the Device Advice Compliance Guide, but all negative or potential problem questions or statements should initially be recorded. A justification for dismissing it as a complaint should be documented. The value comes from trending these issues to see if you have a pattern indicating a problem, or one that could be addressed in improved instructions for use, or revisiting the risk analysis to assess the effectiveness of controls or....

I would not consider a normal repair or service a complaint.
 
S

sfkevin

#10
How would a contract manufacture handle a complaint for medical products in regards to the fact that the product is not shipped to the end customer but the designer of the product?
The contract manufacturer would only deal with the complaints from our customer the designer and not the end customer?
 
Thread starter Similar threads Forum Replies Date
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
N Change Control - Compliance with FDA 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
S Does FDA expect suppliers to be independently assessed to 21 CFR Part 820 ? US Food and Drug Administration (FDA) 4
T Can I approve my own Documentation per FDA QSR 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 1
A Does any one have FDA 21 CFR Part 820 QSR training material? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
A Question about FDA 21 CFR Part 820.90 Nonconforming Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B FDA 21 CFR Part 820 Medical Device Audit Criteria US Food and Drug Administration (FDA) 5
Q Books that have a combination of ISO 13485 and FDA Title 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 9
P FDA Part 820 Clause 820.100 Corrective and Preventive Action 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Chinese Version of FDA Code 21 CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Matrix for Documented Procedures (US FDA Part 820, ISO 13485 and ISO 9001) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q FDA 21 CFR part 820.22 - Reaudit schedule necessary? Internal Auditing 6
S FDA part 820 Software Validation - Can software be retrospectively validated? Qualification and Validation (including 21 CFR Part 11) 10
S FDA Part 820 Audit vs. ISO 9001 - Anything I should be aware of as an auditor? Various Other Specifications, Standards, and related Requirements 13
S Documents / Following Procedures - FDA 21 CFR Part 820 Quality System Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
C Definition Finished Medical Device - Definition of - FDA 21 CFR Part 820.1 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 13
J ISO 13485 vs. FDA QSR (21 CFR Part 820) - Differences - Includes Spreadsheets ISO 13485:2016 - Medical Device Quality Management Systems 64
G FDA QSRs and ISO 9001:2000 - CFR 21 Part 820 and CFR 21 Part 58 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
QIE FDA 21 CFR Part 11 "Meaning of Signature" Other US Medical Device Regulations 6
M Informational FDA Qualifies First Biomarker Test as Part of Medical Device Development Tools (MDDT) Program Medical Device and FDA Regulations and Standards News 0
M Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant) Qualification and Validation (including 21 CFR Part 11) 12
V Data Quality and Data Integrity - Audit Trail - Part 11 - WHO - FDA - MHRA - PDA US Food and Drug Administration (FDA) 6
V Development Data - Part 11 for report compilations excerpts of which filed to FDA Qualification and Validation (including 21 CFR Part 11) 1
B Has FDA amended any standards in the 21 CFR Part 800 series? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D Compliance to 21 CFR Part 11 Require Registration to FDA? Qualification and Validation (including 21 CFR Part 11) 9
S Our device as part of another company?s device ? FDA liability? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A FDA Labeling Regulations - 21 CFR part 801.109(c) vs (d): Prescription Labeling Other US Medical Device Regulations 5
S FDA Device Listing Question - "Each Device" Definition - 21 CFR Part 807 Other US Medical Device Regulations 4
D FDA 21 CFR Part 11 Compliant Digital (electronic) Signatures Document Control Systems, Procedures, Forms and Templates 7
L FDA GMP requirement: Avoid Non contact with floor? 21 CFR Part 110 US Food and Drug Administration (FDA) 1
P Any one know about FDA's GMP, 21 CFR Part 111 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 14
D Affordable electronic CAPA system (compliant to FDA 21 CFR Part 11) ISO 13485:2016 - Medical Device Quality Management Systems 1
S FDA CFR Part 56,58,812,809 checklist General Auditing Discussions 0
C Software recommendations for CAPA that will meet the FDA QSR & Part 11 Quality Assurance and Compliance Software Tools and Solutions 4
L Medical Devices FDA 510k third part review? Class II Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
C Rework Requirements - ISO13485 Part 8.3 vs. FDA QSR ISO 13485:2016 - Medical Device Quality Management Systems 9
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 0
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12

Similar threads

Top Bottom