What does 1st piece (1st Article) mean to a lay person like myself?

D

dbulak

#1
Not having dealt with this before, what does 1st piece(1st Article) mean to a lay person like myself? Any explanation would be appreciated.
 
Elsmar Forum Sponsor

Al Rosen

Staff member
Super Moderator
#2
dbulak said:
Not having dealt with this before, what does 1st piece(1st Article) mean to a lay person like myself? Any explanation would be appreciated.
It's a detailed inspection of the first production piece. It includes every characteristic and design requirement of the specification, engineering drawing and manufacturing process.
 

Jim Wynne

Staff member
Admin
#4
dbulak said:
Where would I get this information from?
The source.

Not much of an answer, but you didn't ask much of a question, either:D .
If you can provide more detail as to what you're trying to find out, I'm sure someone can provide the information you're looking for.
 
H

H. Majhenich

#5
H. Majhenich

A first article will cover every single item on the blueprint(s). NOTHING is excluded, including notes, any generic tolerance listed for unspecified dimensions in the tolerance box, any processes done on the part, everything measurable or identifiable or provable on the part. Not to forget anything not listed on the blueprint included in your purchase order that specifies any dimension, tolerance, or process on the part. Usually, if you provide a part that's incomplete per customer request, the customer wants you to even list tolerances and processes that you didn't do, (that are on the blueprint) and list N/A on your first article. Be very, very thorough.

Did I miss anything? Of course, the heading would have to list part number, purchase order number, customer name, and revision.

Sorry, there might be more, but I just finished another twelve hour work day.
 

Wes Bucey

Quite Involved in Discussions
#6
We are probably talking about "First Article Inspection," which in my experience means checking EVERY dimension and attribute of a part made on the exact production machinery which will be used to continue producing the part. Technically, the First Article is usually not the very first piece, but, in fact, the first piece once the machinery is tweaked, but before actual production is authorized.

In a Control Plan, in my further experience, producers generally include the following steps:
  • First Article Inspection (often redundantly approved by a customer before production can begin if it is a custom part. FAI may be performed under laboratory conditions. The First Article is almost always tagged and reserved for future reference.)
  • an inspection plan to take consecutive samples of the production run at predetermined intervals. (in process) These samples are often only inspected for critical characteristics. Almost always, these inspections are performed by the operators at the machine or by inspectors coming to the machine. (Critical characteristics may be crucial fit or function ones or they may be "process critical" ones which flag when a tool may need to be changed because of wear.)
  • a plan to use the readings from the inspections in statistical analysis (SPC, Cpk, etc.)
I don't think it is good practice to use the term "first piece" in written correspondence - typically it is verbal shorthand for "First Article."
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Two separate things in my experience.

Wes Bucey said:
I don't think it is good practice to use the term "first piece" in written correspondence - typically it is verbal shorthand for "First Article."
Wes pretty much exhausted the explanation about First Article, a very typical figure in the Aerospace Sector. Actually, First Article Inspection is the object of an SAE AS Standard: AS9102.

First piece is a term that I have seen being used in organizations involved with high volume, automated processes, such as, for example, plastic injected molded parts or CNC machined parts. The operators, after setting up the equipment, does a very thorough "first piece" inspection to ensure that the part is in conformance with the specification and "let the machine run". Ensuring that the first piece conforms to the requirements prevents scrapping hundreds/thousands of parts produced afterwards
 
Last edited:

Jim Wynne

Staff member
Admin
#8
Wes Bucey said:
I don't think it is good practice to use the term "first piece" in written correspondence - typically it is verbal shorthand for "First Article."
Not so; the two terms are universally interchangeable and understood to mean the same thing. The only exception might be in synchronizing terminology with a customer, but even then, either term might be used.
 

Wes Bucey

Quite Involved in Discussions
#9
First Article vs. First Piece

First Article vs. First Piece
I admit the distinction came into my ken about 35 years ago. At the time, OEM organizations were VERY finicky about terminology and nomenclature and the term "Production Part Approval Process" (if it even existed) hadn't entered my sphere of experience.

Production bosses were prone to sneer at "first piece" as the actual first piece that went through the entire production process, but before final finishing, deburring, plating, polishing, etc. First Article was reserved for the completely finished item (as it would be delivered to a customer) and would include outsourced processes like plating and/or heat treating.

A quick google of the two terms:
  • first article inspection
  • first piece inspection
will show a scattering of OEM's using the term "piece" while the overwhelming majority will use "article"

My advice is simply to make sure everyone (at customer and supplier) is on the same page about whichever term you use, especially whether the concept is
  • first from a specific production process
    or
  • first after all processes and ready to deliver to customer
 
Thread starter Similar threads Forum Replies Date
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 0
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
H How does a gas turbine work on diesel fuel? Oil and Gas Industry Standards and Regulations 12
G What does performance specification include? US Food and Drug Administration (FDA) 1
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How long does it take to register a product with MHRA? UK Medical Device Regulations 3
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Watchcat Does "Similar Device" = "Predicate"? EU Medical Device Regulations 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Definition Open Audit - What does an Open Audit mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
P What does UPH/m² mean? Quality Tools, Improvement and Analysis 3

Similar threads

Top Bottom