What is Production Process Verification?
The AS 9100 standard requires that production processes are "verified" to ensure they are fully capable of meeting the intended result, and the activities used to arrive at this conclusion are documented. The types of activity used to draw these conclusions will vary by type of manufacturing process, but let's take the example of a machine shop to explain this concept high level...
Production Process Verification for Machining Example:
- Objective analysis of cycle times and available hours is undertaken to verify the machining set up is capable of producing parts within the desired lead time.
- Assuming statistical control is used within the machine shop - capability studies are undertaken to determine the ability of the machines to consistently produce parts that are within specification limits.
Completion of the above steps would give you (and your customer) confidence that the machining process should be able to regularly produce a conforming product within a predictable lead time. This is just one simple theoretical example, but I hope it illustrates the concept for you.
Chances are you may already be doing these things, but ensuring these activities are properly documented is an essential element of AS 9100 Revision D. On-time delivery and right first time is a top priority for Aerospace / Space / Defence customers, so it will be necessary to demonstrate through objective means that elements affecting these two variables are under control in your manufacturing process.
What is First Article Inspection?
The AS 9100 Revision D standard also requires that when a new product is being manufactured for the customer, a representative first example is taken and checked to confirm the production process is working as intended. This is similar to the concept explained above, but with more focus on conformity of a specific product rather than the manufacturing process in general.
Within the Aerospace / Space / Defence industries this activity is commonly known as First Article Inspection (FAI).
The way in which to properly conduct and document an FAI has been standardised through the AS 9102/B standard, and this will often be stated as a customer requirement. You can read more about how to document an AS 9102/B compliant First Article Inspection report through this really useful article I found here:
In basic terms, an FAI is created by tracking through the manufacturing process and verifying that all necessary activities have been completed as planned, with the anticipated outputs observed. Using our Machine Shop example for earlier, the type of information typically used to create an FAI report for a machined part would likely include but is not limited to:
- Measurement results for all characteristics stated on the drawing.
- Copies of mill certificates for any material used.
- Copies of purchase orders placed for any material used.
- Traceability to any special processes (e.g. hardening) used either as part of the process in house or sub-contracted out. I.e. reference to specifications and resulting certificates of conformity.
Evidence supporting above bullet points would provide us confidence that the first production run has been capable of building a conforming product that meets design intent.
Quality Management System Considerations
So, production process verification activities and initial FAI reports for your new product line have been completed - job done, right?
There is a requirement to complete FAI (full or partial) again if there are changes in the design of the product or production process itself. For organisations working in compliance with AS 9102/B this would also be necessary if there has been a break of more than 2 years in production of the part.
Here are some considerations for controls you may need in the Quality Management System to help manage this:
- Who is responsible for completing FAI reports and what training do they require?
- How is the need to complete an FAI going to be flagged up? Particularly for changes that are less obvious such as a change of a material supplier or change of tooling.
- How will breaks in production of >2 years be identified?
- Where will FAI reports be stored and who requires access to them?
As you can clearly see, having a robust Quality Management System will save you a lot of time and make it easier to keep track of FAI reports, especially if your customer requires you to provide them.
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