Summary
In short
- A manufacturing first article inspection is an inspection used in KnowQuality that inspects the first part or pack off a setup against every specified characteristic before the run continues. It is built against ISO 9001 cl.8.5 and forms part of the Statistical Process Control programme.
- Run at every setup and changeover. Completed by quality.
- The template holds 50 fields across 6 sections, with characteristics checked repeating for each entry.
- Scoring is pass rate, where high is good.
- ISO 9001 is quality management systems. The international standard for consistently meeting customer and regulatory requirements. Certifiable.
- It connects to the rest of the library: links Changeover, Process control.
What it is
What it is
What is a manufacturing first article inspection?
A manufacturing first article inspection is an inspection used in KnowQuality that inspects the first part or pack off a setup against every specified characteristic before the run continues. It is built against ISO 9001 cl.8.5 and forms part of the Statistical Process Control programme.
When is a manufacturing first article inspection completed?
A manufacturing first article inspection is completed on the inspection frequency set in your programme, and again after any change to the asset or area. Run at every setup and changeover.
When to use it
When to use it, and when not to
This inspection is one step in a larger programme. Using it for work that belongs to a neighbouring template produces records that are hard to report on later.
Use it for
- The event or activity this inspection covers has occurred, or is about to
- The workspace is being set up, or the register needs an entry added or retired
- You are running the Statistical Process Control programme and this is one of its steps
- A linked record needs this one to exist: links changeover, process control
Not for
- Statistical Process Control Chart Review, which reviews control charts for a characteristic to see whether the process is stable and capable, not merely in specification.
- Statistical Process Capability Study, which establishes whether a process can consistently hold the tolerance it is asked to hold.
- Gauge Repeatability and Reproducibility Study, which measures how much of the observed variation comes from the measurement system rather than the process.
- Anything outside KnowQuality, which belongs in the workspace that owns that process
Standards
What it is built against
ISO 9001Quality management systems
The international standard for consistently meeting customer and regulatory requirements. Certifiable.
ISOInternational Organization for Standardization
A voluntary international standard. Widely adopted, often required by customers, and certifiable where a management system standard.
FAQ
Frequently asked questions
What is the manufacturing first article inspection template based on?+
It is built against ISO 9001 cl.8.5. ISO 9001 is quality management systems. The international standard for consistently meeting customer and regulatory requirements. Certifiable. ISO is international Organization for Standardization. A voluntary international standard. Widely adopted, often required by customers, and certifiable where a management system standard.
What sections does the manufacturing first article inspection contain?+
There are 6 sections: header, setup verification, characteristics checked, decision, related records, result. Together they hold 50 fields, 39 of which are required.
How many manufacturing first article inspection records should we have?+
This is a singleton. One record per workspace, set up once and maintained, rather than one per event. Other templates refer back to it.
Which programme does the manufacturing first article inspection belong to?+
It is part of Statistical Process Control. Processes judged in control before they are judged capable, with the gauge ruled out first.
How is a manufacturing first article inspection scored?+
Scoring is pass rate. High is good. Scores exist to make the form tell you something, not to produce a percentage for its own sake.
Can the manufacturing first article inspection template be changed?+
Yes. Every field, option, score and conditional rule is editable, and the links to other templates come with it. Most teams install it as it is, run it for a cycle, then adjust.
The agents
What the agents do with it
The form is the easy part. Keeping it current, routing it to the right owner and holding the evidence together is the work that actually slips.
Holds the manufacturing first article inspection library against your registers, routes each record to its owner, and keeps the evidence trail together.
Coordinates the crew, rolls completion and exceptions into one view, and holds every write for your approval before it touches a record.
This template lives in KnowQuality — quality and food safety. HACCP, nonconformance, traceability, laboratory and customer complaints.
Sources
Sources
- ISO 9001 — Quality management systems
- ISO — International Organization for Standardization