Backorders and delayed packages complaints?



Hello everyone!

First time posting, but long time Elsmar viewer. I've just recently taken a role where I am responsible for overhauling a companies complaint handling processes. Problem is, I've no experience with complaint handling and no one in the company knows anything about complaints. They have a BSI finding that needs to be resolved so that's why I am here.

I'm excited for the learning opportunity but and have made quite a bit of progress. In review of our complaint trending and assessment of our case types, I've been asked if 'backorders' and 'delayed packages' meet the definition of a complaint.

We define a complaint as:
Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, usability, effectiveness, or performance of a device after it is released for distribution. The following criteria applies:
• Returns are generally considered to be complaints. However, obvious handling damage or abuse beyond normal handling or wear & tear is not considered to be a complaint.
• User error is considered to be a complaint.
• Packaging or labeling errors are considered to be complaints.
• Customer activities that are conducted prior to distribution, such as ordering errors, are not considered complaints.

I don't feel that a backorders or delayed packages (in most cases) would qualify as complaints, but given my lack of experience in this arena, can you please provide some insight?


Elsmar Forum Sponsor


Change Agent and Data Storyteller
Super Moderator
I don't see the source of the written, electronic, or oral communication cited within your definition, so it's difficult to answer if backorders or delayed packages would qualify as a complaint.

From my own experience, a delayed package would be considered a nonconformance. It only escalates/evolves to the complaint status if a customer calls in about the delay.

For improvement purposes, I'd look to see a decrease in delayed packages overall and the ratio of delayed packages that had been escalated up to complaints.

Sidney Vianna

Post Responsibly
Problem is, I've no experience with complaint handling and no one in the company knows anything about complaints. They have a BSI finding that needs to be resolved so that's why I am here.
I was a co-developer of a complaint handling assessment protocol against the previous version of ISO 10002. I highly recommend you acquainting yourself with that guidance standard, as it contains a lot of wisdom on complaint handling as part of the customer satisfaction spectrum.

As for your question, the way I would address is: irrespective of how back orders and delayed deliveries should be formally categorized they are important components of what you really should be focusing on: customer satisfaction. If your organization is truly (not just lip service) committed to continually satisfy customers, those items need to be quantified and, as necessary, addressed.

Good luck.
Last edited:


I agree, wholeheartedly that from a customer satisfaction standpoint, it is important to assess and remediate backorder and delayed package issues.

However, the company I am working for is severely limited on resources and their biggest concern is in their ability to sustain a robust complaint handling process. We've had the management responsibility conversations, and they know they need to invest in additional resources. Our main concern at the moment is to ensure we are not including in our requirements for documenting complaint investigations and root cause determinations anything that does need to be in accordance with the QSR (820.3) definition for a 'complaint' (which is the definition we use, and I previously provided in my post). Our definition provides additional input because literally no one except me and the Quality Manager has any kind of quality understanding so we try to 'dumb it down' as much as we can.

This company is in a really tough place being that they are in an industry that has been regulated for quite some time, but the regulating bodies simply haven't done their jobs in enforcing the regs in this industry.

I don't want to give too many details, but it's a tough situation for them to be in after being in business for decades, to all of a sudden have all these new rules to abide by and need to rebuild their entire QMS in less than one year in order to adhere to MDSAP and ISO 13485:2016.

That's not my concern though, my concern is to ensure we are effective system that ultimately ensures patient safety. While customer satisfaction is (very) important, if I have to choose between patient safety and either more or less customer satisfaction, I will choose a sustainable patient safety, less customer satisfaction focused program every single day.

I appreciate your responses and I will certainly look into that ISO standard as I hadn't heard of it before. :)


I forgot to mention that we trend anything that is classified as a non-complaint and handle those through our CAPA system is an adverse trend presents itself (much like it would in the case of excessive backorders, etc.). I just need to understand if it's industry standard to considered these as 'complaints' according to FDA. :)


Looking for Reality
Trusted Information Resource
Sounds like you need to divide and conquer. Right up my alley...I love the overly complex jobs no one else wants...

If you have a backlog you are working through, I would do this:

1. Separate and define "Complaint" as a customer contacting you regarding dissatisfaction.
2. Separate returns as a specific type of complaint...but a complaint none-the-less (they wouldn't return it if nothing was is a customer contact).
3. Late shipments are an OFI.

Kill off (handle) the outstanding complaints...and set up the system for handling them. Complaints are the biggest ding to your business. Returns hurt the handle them first. Why? What was wrong? How do you make a complaining customer happy again.

Then handle the other complaints...maybe through the same complaint system, maybe you need to broaden it.

Then, and only then, do you handle late shipments.
Set a "we're OK with this" percentage, and follow up any discrepancy from that.
Late by your definition is not always late by your customer's definition...that's why this one is last. What does "Late" mean?
If the customer was annoyed by late shipment, they would have contacted you...and it would be a complaint.

Take great care drawing reasonable lines between complaint, return (subsection of complaint) and late ship. Put the lines in the right place...and make them vivid. The biggest way you can create work for yourself is to be ambiguous about definitions.

Line it up, prioritize it, and knock-em-down.

When you get down to #3 (late ships) is then time to revisit the "what do we want to be?"...and you may want to engage upper mgmt as to moving the lines between Late, Complaint, Return.

When you have a backlog, late is an OFI.
When you've cleared the backlog...late is a NC.
Cut yourself some slack for your next audit, and set the "acceptable OTD" below where you are now.
Don't even dream of leaving it there long term...but calling it low gives you the time to fix the foundation stuff without fighting with auditors...then put it back up to where upper mgmt wants it.

Thread starter Similar threads Forum Replies Date
Ed Panek Medical Device News MDR Delayed 1 year (Posted 4/2020) EU Medical Device Regulations 9
dinaroxentool Former Class I device that is upscaled to IIa if the MDR is delayed EU Medical Device Regulations 2
Colin ISO 9001:2015 Delayed Release? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Flowcharts of Processes Delayed my Internal Audit Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
R Pantoprazole Enteric Coated, Gastro Resistant & Delayed Release Tablet differences Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
M Delayed PPAP - Supplier has delayed providing PPAP for 2 years APQP and PPAP 25
Crusader ISO 9001 Update Delayed until the Middle of 2009 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Jim Wynne Shuttle Launch Delayed World News 0
P Delayed implementation of a practice & decision on Non Conformance Miscellaneous Environmental Standards and EMS Related Discussions 20
Marc American Chemical Society (ACS) - Delayed Access Plan for their journals online Book, Video, Blog and Web Site Reviews and Recommendations 0
B ISO13485 Standard Documentation Packages ISO 13485:2016 - Medical Device Quality Management Systems 2
S AS9120 Store QMS packages AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
G Regulatory requirements for secondary packages in terms of label content Other Medical Device Regulations World-Wide 2
V ISO 9001:2015 Implementation Packages ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
L Heated Sealed Packages - Sample Size for OQ (Operational Qualification) and PQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
K GHS (global harmonized system) Labeling requirements for Small Packages Occupational Health & Safety Management Standards 2
V GM Lab Packages - Submitting Lab Packages to Lear for Material Laboratory Approval APQP and PPAP 3
K Looking for Ideas to Track Customer Requests and PPAP Data Packages APQP and PPAP 4
G Various ?QMS? packages on the market - Which software package? Quality Assurance and Compliance Software Tools and Solutions 35
K What are some of the best QMS Software Packages available? Quality Tools, Improvement and Analysis 5
A SPC Software Packages - Real Time and can link to Databases including Oracle Statistical Analysis Tools, Techniques and SPC 7
Marc UPS to Require Photo IDs to Ship Packages World News 4
M Decontamination Label on Unit Packages per UL (Underwriters Laboratories) Manufacturing and Related Processes 1
H ISO 9001 Documentation Templates ('Canned' packages) advice Document Control Systems, Procedures, Forms and Templates 4
H 5S Training Packages / materials - recommendations Lean in Manufacturing and Service Industries 8
S Anyone use PDMWorks or Omnify PLM software packages? Quality Assurance and Compliance Software Tools and Solutions 9
C Sampling Plan Software Packages - Implementing ANSI Z1.4 & Z1.9 (or ISO equivalent) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
R Document control of software? Software packages that produce documents Document Control Systems, Procedures, Forms and Templates 4
N Muliti-Language QMS Software Packages Quality Assurance and Compliance Software Tools and Solutions 7
B Calibration Data Packages - CMM - Any way around "As found data?" General Measurement Device and Calibration Topics 17
N Outbound Shipping Quality - Package Contents Sampling Plan - 1,500 Packages an Hour Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
Q Looking for a good PC program for APQP & PPAP packages. Quality Assurance and Compliance Software Tools and Solutions 7
W Internal Auditing Software packages - Seeking Recommendations Quality Assurance and Compliance Software Tools and Solutions 4
C Database for PPAP packages APQP and PPAP 3
B Electronic Doc Control Software Packages Document Control Systems, Procedures, Forms and Templates 3
T Compliance Software Packages QS-9000 - American Automotive Manufacturers Standard 10
Marc ISO/IEC 12119 - Software packages - Quality requirements and testing Software Quality Assurance 3

Similar threads

Top Bottom