My name is Phuong Vy and I am a quality engineer. I am seeking information about first article inspection and examples (procedure/forms). I am tasked to create a procedure for this process and would love any insights on how FAI benefits multiple industries. Textbooks, articles, videos, websites..anything is appreciated.
Please let me know if there are any questions.
One suggestion is SAE AS9102 "Aerospace First Article Inspection Requirement". It includes procedure, instructions, and an inspection form. I have successfully used it for medical device companies.
I greatly appreciate you sharing this, I will look into that.
The industry that I am in is Biotech. Majority of raw material are reagents that do variety of things such as purification, amplification, marking/staining, storage, formulation, etc. I want to start off first by recognizing value that FAI brings in and tailor the details from there.
Biotech is broad industry (and rapidly changing) industry, so it is important to be aware of 'current' industry practices (since likely cGLP, cGMP, etc.), and not just regulations, requirements, and specifications. There are industry trade organizations (research, clinical, CROs, cGLP, cGMP, etc.) which should have already written guidances for you. This is an industry in which you typically do not 'develop' a first article system, but implement a industry standard. "Sampling/ Handling plans and rules" apply to first articles in this industry.
There are many types of First Article Inspection systems (the term can be loosely used). First Article may refer to:
- A design prototype to validate or verify a design (but article needs to be verified itself before the verification or validation).
- The first batch of material from a supplier, to approve the supplier as a vendor.
- The first batch of material from a supplier, to approve the material (from an already existing supplier). Common usage of term.
- First items of the production line (either for process verification or quality control checks).
- First items delivered to customer, for validation or verification.
Each is a different system
Thinking the value of a first article inspections is: most issues (design issues or manufacturing issues; special cause or normal cause) can be caught by checking the first items produced by the process.
From your reply, sounds like you are considering First Article Inspections for supplier raw materials which your facility will use for testing, manufacturing or processing.
If a lab, thinking I have only seen labs control reagents by just purchasing from ILAC accredited ISO17034 producers, no additional checks (other than routine testing 'quality checks'/ILC/PTs).
If manufacturing (or processing), then thinking it will be based on your (e.g. ISO14971) risk assessments or CFRs/industry requirements, as opposed to 'value added' or 'quality improvement' initiatives.
If in a niche industry, you may want to consider contacting a competitor and ask for advice. I have had good results. (Their motivation: it is one thing 'to be wrong', it is another thing to 'be wrong in good company').
You may be able to get advice from your suppliers. They often serve other customers, thus may have some insights.