Are internally found Medical Device Software "Bugs" Complaints?

#1
Hi Folks,

I have a question regarding how companies have interpreted the FDA regs (and ISO) relating to Complaints. We are trying to determine whether any software bug that might be found internally should fall into the Complaints process as if it had been reported by a customer? For example, when testing as part of development of a new release we may sometimes uncover an obscure bug which exists in a previously distributed product, but which has never been found or reported by a customer.
Should this be classified as a Complaint? If not, under what process would you capture and review it?
Thanks
thejbster
 
Elsmar Forum Sponsor

NicoleinFlorida

Inactive Registered Visitor
#2
I am not familiar with software devices. But I think the "Bugs" identified internally are not Complaints. They can be "nonconformities", therefore, I think you may want to handle the "Bugs" through Nonconforming Product Control and CAPA if an investigation is required.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
I agree with Nicole. Complaints are negative feedback from outside the organisation.

In my understanding a software bug is a situation where a software process doesn't perform as specified to (or as expected to, as an indirect result of a specification), thus it would be a NC. Your situation is not different in essence from one where a physical flaw is realised internally in a physical device already on the market. The exception would be where the discovery is not a clear deviation from a specification or a requirement, but more of a realisation of a way to do things better. In that case I would use the Design Control processes to initiate a review and decision regarding implementing an improvement (a design change).

Cheers,
Ronen.
 
U

uhohraggy

#4
Interesting question. I disagree with the previous posts.
Via the FDA 820.3
(b) Complaint means 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.

It's probably not a huge deal, but technically it should be logged as a complaint if the product is on the market.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
C Can You Internally Audit a Process You Own? Internal Auditing 25
C Method of Monitoring our Internally Produced Non-Conforming Products Quality Tools, Improvement and Analysis 7
D Sharing ISO Standards internally on company computers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Internally powered ME with non-conductive applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Isolation of Internally Powered (3.3 Vdc) ME Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Single Fault Condition for Internally Powered Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S Should Client Controlled Procedures be Controlled Internally by us as well? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R Referencing and Controlling Labels & Stickers used internally throughout Production Document Control Systems, Procedures, Forms and Templates 1
H How do we use AS9101D internally? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
A Internally Powered Medical Device and Dielectric Strength IEC 60601 - Medical Electrical Equipment Safety Standards Series 17
D Means Of Protection of the Video OUT of an Internally powered device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M All Internally Generated Documents ? Required to be Controlled or Not All? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
C How will I Internally Audit my BPO Center for ISO 9001:2000 Internal Auditing 8
J What PPM (Parts Per Million) targets do you use internally? Quality Tools, Improvement and Analysis 9
B Calibration of "Z" class ring gauges internally using a CMM General Measurement Device and Calibration Topics 5
B Can I calibrate Optical Comparators internally? General Measurement Device and Calibration Topics 22
K Requirements for 2nd languages? I can't even audit them internally IATF 16949 - Automotive Quality Systems Standard 59
A Gauges on pressure tank - What is the best way to calibrate a psi gauge internally? General Measurement Device and Calibration Topics 6
L Posting portion of standards internally? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Why internally audit ISO clauses for ISO 9001:2000? (Small company) General Auditing Discussions 16
E Wall Internal Auditor Training - Done internally Training - Internal, External, Online and Distance Learning 7
S ISO 9001 7.1.5.2 - Actions Taken When Measuring Equipment is Found to be Unfit for Use General Measurement Device and Calibration Topics 9
G Correction fluid found on documents that are reviewed Qualification and Validation (including 21 CFR Part 11) 11
Ed Panek ISOTECH TTI-10 found out of calibration - Calibration house was wrong? General Measurement Device and Calibration Topics 7
supadrai Just found out the hard way that only one registration per manufacturer is allowed in Yemen, regardless of OEM or private label arrangement. Other Medical Device Regulations World-Wide 0
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
M Can we change the ProCode if a better one is found? Other US Medical Device Regulations 3
GStough Pushback on a Nonconformance Found in a Supplier Audit General Auditing Discussions 22
S Recapture Program for Measurement Devices found Out of Calibration General Measurement Device and Calibration Topics 8
GStough Nonconformance Found Outside the Audit Scope - Supplier Audit General Auditing Discussions 16
A Defect Rate for asking for an RMA - Company wants an RMA for every defect found Supplier Quality Assurance and other Supplier Issues 10
Stijloor Inmate-Produced Combat Helmets Found Defective Supplier Quality Assurance and other Supplier Issues 4
C Calibration Certificate "As Found" condition - TS16949 Section 7.6.2 General Measurement Device and Calibration Topics 7
T What to do if parameters are found to be Outside of Control Limits Document Control Systems, Procedures, Forms and Templates 5
A Does anybody know in which Standard can this attached Alarm Symbol be found? Other Medical Device Related Standards 3
B Nonconforming Parts found by our Service Department Nonconformance and Corrective Action 3
D As Found Condition - In or out of tolerance? General Measurement Device and Calibration Topics 4
J Customer found Nonconforming Product Metrics ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Internal Audit Cancellation when Nonconformances are Found Quality Manager and Management Related Issues 13
D "As Found" Condition and Calibration Interval Changes Calibration Frequency (Interval) 5
N What Would You Do If You Found Treasure - But it's not yours... Coffee Break and Water Cooler Discussions 17
D What is "As Found" in Calibration of a Measurement Device? General Measurement Device and Calibration Topics 8
R "As Found" Calibration Results for HPLCs General Measurement Device and Calibration Topics 22
Q Auditor found Form with Identical Contents but different Format - is this an NC? Document Control Systems, Procedures, Forms and Templates 28
D What should the QMS Auditor do if a Major Nonconformity is found during an Audit? Internal Auditing 11
C National/International Standard For Calibration "As Found" Readings General Measurement Device and Calibration Topics 4
Marc So, I woke up this morning and found this tree growing... Coffee Break and Water Cooler Discussions 4
Y What if the Root Cause can't be found? Nonconformance and Corrective Action 6
R Information found missing in a Medical Device Record Other US Medical Device Regulations 4
Hami812 Predicting the outcome using high No Trouble Found Rate Statistical Analysis Tools, Techniques and SPC 4
Similar threads


















































Top Bottom