Process for closing complaint records after a period of inactivity?

Mark Meer

Trusted Information Resource
#1
Another thread to throw out there for discussion...

Going through our complaint records, I've realized that many of them have been open for some time, pending response and/or decision from the customer.

As such, I'd like to revise our complaint-handling system procedure to provide allowance for closing these records if customers become unresponsive.

So, open to discussion:
  1. Is this acceptable in the medical device industry? I know it's common practice in a lot of general consumer-product companies, but I'm concerned that closing out records simply due to customer unresponsiveness may be inappropriate for medical devices. Regulations (ISO13485, FDA QSR), don't seem to indicate either way...
  2. If practiced, what is an appropriate length of time to wait? I'm thinking wording something like: "if no response from customer within 4-weeks, in which period attempts were made to contact the customer, then the complaint record can be closed." (though in general consumer companies, I've seen this period be a low as 72 hours)

Love to hear how others handle this... :read:
 
Elsmar Forum Sponsor

NikkiQSM

Quite Involved in Discussions
#2
Another thread to throw out there for discussion...

Going through our complaint records, I've realized that many of them have been open for some time, pending response and/or decision from the customer.

As such, I'd like to revise our complaint-handling system procedure to provide allowance for closing these records if customers become unresponsive.

So, open to discussion:
  1. Is this acceptable in the medical device industry? I know it's common practice in a lot of general consumer-product companies, but I'm concerned that closing out records simply due to customer unresponsiveness may be inappropriate for medical devices. Regulations (ISO13485, FDA QSR), don't seem to indicate either way...
  2. If practiced, what is an appropriate length of time to wait? I'm thinking wording something like: "if no response from customer within 4-weeks, in which period attempts were made to contact the customer, then the complaint record can be closed." (though in general consumer companies, I've seen this period be a low as 72 hours)

Love to hear how others handle this... :read:
I work for a company that supplies plastic for medical device manufacturers.

This is just my opinion based on my experience, but I see no problem with closing complaints after a period of time where there is no actions. In fact, I have had to close out complaints for that reason before.

Why keep following up over and over and wasting your time tracking a potentially "dead" complaint?

I use a time frame of 30 days. If I dont hear anything for that amount of time, the complaint gets closed out and scanned into our system.

If the customer suddenly decides to further the investigation / complaint, simply re-open the complaint.

Just my :2cents:
 

Mark Meer

Trusted Information Resource
#3
Why keep following up over and over and wasting your time tracking a potentially "dead" complaint?
I guess my concern has to do with the implications for regulatory reporting, and product NC records.

I could easily foresee an email correspondence as follows:
CUSTOMER: "The device we bought 2 years ago fell off the table during a session and broke."
COMPANY: "How did it happen? Was it secured properly? What is the serial number? Was anyone hurt? The warranty is expired, so we'd have to charge for servicing."
CUSTOMER: (no reply...)

In this example, we'd just have to use our "best guess" as to reportability determination, and have insufficient details to make any determination as to product non-conformance.

I agree, that it makes no sense to keep records open indefinitely if customers become unresponsive.

But open to discussion is: What is the (generally) expected level of diligence you should document in terms of trying to pry details from the customer? (e.g. 1 week with no attempts, 30 days with one attempt, 2 months with multiple attempts....etc.?)
 
Thread starter Similar threads Forum Replies Date
A Closing CARs (Corrective Action Requests) due to Process Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P ISO 11607-2 Process Specification Other Medical Device Related Standards 1
Q Best off presentation of process flows Process Maps, Process Mapping and Turtle Diagrams 10
Q Logistics process flow ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Process FMEA for Laser Cutting/Press Brake/Welding FMEA and Control Plans 2
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
F Is this misuse of the MRB process? Manufacturing and Related Processes 7
L Product and process Deviation procedure Manufacturing and Related Processes 1
Ch00Ch00 How to evaluate a process ? Document Control Systems, Procedures, Forms and Templates 3
M Implants made by Additive Manufacturing process approved by USFDA Other Medical Device and Orthopedic Related Topics 1
Q Process Key figures and reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Ch00Ch00 Evaluate a process - Issue number Lean in Manufacturing and Service Industries 7
F Rules of process outsourcing in China China Medical Device Regulations 1
B Process / Procedure - Radiographic (X-Ray) Non-Film Document Control Systems, Procedures, Forms and Templates 0
P Certification process for registered device China Medical Device Regulations 12
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Melissa Process Validation of Rotary Heat Sealer Speeds Design and Development of Products and Processes 4
C Validation of process for releasing the UDI EU Medical Device Regulations 4
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 10
C Validation of process for production and servicing 5.7.1.5 API Spec Q1, 9th Edition Oil and Gas Industry Standards and Regulations 9
Z IA Construction Procurement Process Internal Auditing 3
H Risk Management Plan in agile process ISO 14971 - Medical Device Risk Management 14
DuncanGibbons Process flow & PFMEA for production planning and simulation activities? Process Maps, Process Mapping and Turtle Diagrams 7
N Help with understanding Process Controls Manufacturing and Related Processes 7
M VDA 6.3 – Workshop for Certified Process Auditor VDA Standards - Germany's Automotive Standards 4
C Process Consistency Manufacturing and Related Processes 5
I PFD (Process Flow Diagram) approach. Setup details as part of PFD? APQP and PPAP 5
K Business Process Flowchart Process Maps, Process Mapping and Turtle Diagrams 2
L Looking for Control Plan and FMEA Stamping process FMEA and Control Plans 2
J License renewal process in Iran Other Medical Device Regulations World-Wide 0
J Definition Outsourced process - Clear definition - 13485 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
S IS0 13485 process flows ISO 13485:2016 - Medical Device Quality Management Systems 2
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
C Revalidation of Process Equipment for Equipment Transfered to New Facility. ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Process map Evaluation and Analysis Method Process Maps, Process Mapping and Turtle Diagrams 5
S In process inspection Manufacturing and Related Processes 2
S Brexit 100% inspection during in process inspection Manufacturing and Related Processes 11
A Complaint review as part of the complaint handling process? ISO 13485:2016 - Medical Device Quality Management Systems 3
mustomutlu Process Validation Final Report Other Medical Device and Orthopedic Related Topics 2
Q Process Matrix_Audit Matrix Quality Management System (QMS) Manuals 4
Q Process description for outsourced processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Process matrix examples of ISO 9001 & 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
A When someone refuses to follow a process.... Misc. Quality Assurance and Business Systems Related Topics 30
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
R AS5553 Clause 3.1.7 f - "Implement a returns process....." AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
normhowe "The Problem with Quality Management: Process orientation, controllability and zero-defect processes as modern myths" Book, Video, Blog and Web Site Reviews and Recommendations 2
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
B SOP for CNC turret punching machine for sheet metal process Manufacturing and Related Processes 0
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 5

Similar threads

Top Bottom