As an ISO 9001:2015 and ISO 13485:2016 certified thermoform packaging manufacturer, Dordan is committed to delivering quality, consistency, and compliance—especially for customers in highly regulated markets like medical devices and automotive.
To meet diverse customer requirements and project scopes, Dordan implements a tiered quality control (QC) system, offering several levels of inspection and validation protocols. These ensure that every package meets critical dimensional, functional, and regulatory benchmarks.
First Article Inspection (FAI): Dimensional Conformance
What it is: 
FAI is a baseline inspection performed at the start of production to ensure that formed parts match the approved design specifications.
Key features:
-
Five random samples are measured and reviewed
-
Standard dimensions assessed include length, width, and depth
-
Dordan maintains a ±0.070" flange tolerance (at a CPK of 1.333)
-
Any customer-specified dimensions are also inspected and documented
This inspection is included with all packaging projects.
First Article Validation (FAV): Dimensional Consistency
What it is:
An enhanced version of FAI that incorporates statistical analysis to evaluate consistency across a larger sample size—commonly used for cleanroom and regulated packaging.
FAV includes:
-
Installation Qualification (IQ): Verifies that equipment is installed according to manufacturer specs
-
Dimensional Analysis: 30–60 samples measured across all tool cavities to assess variation in key features such as height, thickness, cavity ID, and more
-
Final Report: Delivered to the customer, includes validation summary, Certificate of Compliance (COC), and final part drawing
FAV is standard for cleanroom jobs and available upon request for general production.
IQ/OQ/PQ Process Validation: Performance and Repeatability
What it is:
A three-stage validation process used for regulated or sterile barrier packaging, ensuring that the thermoforming process is stable, capable, and repeatable.
Stages include:
-
IQ (Installation Qualification): Equipment checks
- OQ (Operational Qualification): Process parameter testing (temp, vacuum, pressure) using multiple sample runs
-
PQ (Performance Qualification): Full production runs assessed for real-world performance and part conformity
-
Each phase involves large sample sizes, customer approvals, and detailed documentation to validate ongoing process control.
PPAP (Production Part Approval Process): Proven Production Capability
What it is:
A formal approval process—common in the automotive and regulated industries—used to confirm that Dordan understands your design and can consistently manufacture to spec.
Dordan offers PPAP Levels 1–3:
-
Level 1: Basic warrant only
-
Level 2: Warrant + parts + limited data
-
Level 3: Full warrant + samples + complete supporting data
PPAP documentation may include Design & Process FMEAs, Control Plans, Inspection Reports, and Material Records.
Choosing the Right QC Protocol
Dordan works closely with each customer to determine which quality control approach aligns with project needs, balancing regulatory expectations, production risk, and cost-efficiency.
|
Control Level |
Ensures |
Application |
|
FAI |
Dimensional conformance |
All packaging projects |
|
FAV |
Dimensional consistency |
Cleanroom and high-precision applications |
|
IQ/OQ/PQ |
Process capability and control |
Regulated and sterile barrier packaging |
|
PPAP |
Total production reliability |
Automotive and regulated industries |
By offering structured and transparent quality protocols, Dordan helps customers make informed decisions during the packaging development process—ensuring that form, fit, function, and compliance are met at every stage.
Click here to download our Cleanroom and QC Fact Sheet to learn more about Dordan's quality control!