Complaint Fun Facts
Where is our new investigation space?
Mundelein
The customer reports that a product is missing a label. What should you request first?
Sample or photo
A common diagram used to find a root cause (hint: fish-shaped)
Fishbone diagram
What software do we use to work our complaints?
SAP
True or False: Quality is only the responsibility of the QA department?
False- it's a cross-functional effort!
Name one KPI that quality tracks related to complaints?
closure time or number of complaints
A customer reports a "chemical smell" coming from one of our products. Which team will you go to first to assist?
Manufacturing, R&D, or regulatory.
What does a cause code indicate in SAP?
The root cause of the reported defect.
Before closing a complaint, the investigator must send this to the customer.
A closing response with detailed investigation findings
What is the name of the main quality management system used by Medline?
ETQ reliance
Who does our team report up to?
Sam Brandell
You find multiple complaints for the same item with the same lot number. What is the most likely next step?
What does SCAR stand for?
Supplier corrective action request
Something that investigators look for when multiple complaints reference the same issue over a certain period of time
a trend
Small, continuous improvements made every day are part of this quality philosophy.
Kaizen
How many people are currently on the complaint team?
40
A clinic says its gauze sponges seem thinner. What do you compare the complaint sample to?
A control sample from stock
If a product is defective because of someone missing a step in the process, this type of cause is likely...?
Humar error
What happens when there is an injury associated with a quality complaint?
Reported to the FDA (MDR)
What are the two main regulatory bodies that make up quality standards today?
FDA and ISO
What is the division with the highest complaint volume and how many complaints do you think they get a month?
DME- about 1400 complaints a month
A complaint claims that a walker arrived with uneven legs, causing instability. The product sample shows correct assembly. What is your next step?
Review an inspection checklist or supplier records
If you needed to add or delete cause/defect codes in SAP, what document would you fill out?
SOP-00228-F-00001
What type of document do we send to suppliers when there is a supplier-confirmed issue? Bonus points if you get the exact SOP number
SOP-00031
A core benefit of complaint investigations is strengthening cross-functional WHAT?
Collaboration/relationships!