Recording of First Piece Inspection to meet 21 CFR 820.80e and ISO 13485 7.5.1.1

jkuil

Quite Involved in Discussions
#1
In order to meet 21CFR820.80e and ISO 13485 7.5.1.1 requirements, how would you record the results of a first piece inspection, i.e. an inspection performed at the start of a run to confirm the system suitability for manufacturing (intermediate) products that meet specifications?

a) Record te results of any inspection performed until the system settings are final.

or

b) Only record the result of the last inspection performed upon which the run is started.
 
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Q

Qualqueen

#2
Re: Recording of first piece inspection

In order to meet 21CFR820.80e and ISO 13485 7.5.1.1 requirements, how would you record the results of a first piece inspection, i.e. an inspection performed at the start of a run to confirm the system suitability for manufacturing (intermediate) products that meet specifications?
Are you just looking for an inspection form to enter your data?
 

jkuil

Quite Involved in Discussions
#3
Re: Recording of first piece inspection

I am not looking for a form specifically, however it may answer the question.

The above question was meant to be a multiple choice question with two possible answers. How much data do you need to collect to record a first piece inspection?
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#4
Re: Recording of first piece inspection

In order to meet 21CFR820.80e and ISO 13485 7.5.1.1 requirements, how would you record the results of a first piece inspection, i.e. an inspection performed at the start of a run to confirm the system suitability for manufacturing (intermediate) products that meet specifications?

a) Record the results of any inspection performed until the system settings are final.

or

b) Only record the result of the last inspection performed upon which the run is started.
I vote for 'B' - the rest of the info is 'set-up', and really should be inspected 100% or scrapped, but suspect in any case. You should have a procedure for handling set-up parts, as they are one of the highest cause of rejects from a well controlled system!

This choice is also my vote for the first SPC plotted data point.
 
Q

Qualqueen

#5
Re: Recording of first piece inspection

I am not looking for a form specifically, however it may answer the question.

The above question was meant to be a multiple choice question with two possible answers. How much data do you need to collect to record a first piece inspection?
I'm still not sure I understand but I'll tell you what we do at my shop and have never been questioned by it.

Our 1st piece article is completed and consists of every dimension on the print taken from a sampling of parts prior to production. Once the samples are approved, we have an in-process inspection which consists of any major dimensions or something that we know can change during the run. This can consist of 2-3 or even 15 dimensions depending on the complexity of the part. As our final inspection, we take a handful (marked as final piece) and perform the inprocess inspection stating that it's the final piece and approve or not. Pretty basic but it works.

If you're looking for a multiple choice than I believe you're leaving yourself open for a problem. If it's not documented then there's no proof that it was ever done:

a) Record the results of any inspection performed until the system settings are final and b) Only record the result of the last inspection performed upon which the run is started. I'd take out the word Only .
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#6
Re: Recording of first piece inspection

Our 1st piece article is completed and consists of every dimension on the print taken from a sampling of parts prior to production. Once the samples are approved, we have an in-process inspection which consists of any major dimensions or something that we know can change during the run. This can consist of 2-3 or even 15 dimensions depending on the complexity of the part. As our final inspection, we take a handful (marked as final piece) and perform the inprocess inspection stating that it's the final piece and approve or not. Pretty basic but it works.
:agree1:I agree - this is very typical and a good benchmark. Many will AQL (I guess a little more specific than a handful:tg:) for final and measure all dimensions, too (unless otherwise specified by their customer.) AQL is appropriate for final inspection, and often cited on purchase orders.

If you're looking for a multiple choice than I believe you're leaving yourself open for a problem. If it's not documented then there's no proof that it was ever done:

a) Record the results of any inspection performed until the system settings are final and b) Only record the result of the last inspection performed upon which the run is started. I'd take out the word Only .
How this is done is really a need for a set-up parts procedure. Do all set-up parts need inspected? 100% of the dimensions? All documented? Or only the one affected by the adjustment? What was the problem with the system that it was not yet ready for first piece? It is so tenuous of a part of the process that many folks just scrap them rather than bother with them. It is just too risky.
 
Q

Qualqueen

#7
Re: Recording of first piece inspection

How this is done is really a need for a set-up parts procedure. Do all set-up parts need inspected? 100% of the dimensions? All documented? Or only the one affected by the adjustment? What was the problem with the system that it was not yet ready for first piece? It is so tenuous of a part of the process that many folks just scrap them rather than bother with them. It is just too risky.
I agree. What I was talking is actually a first piece submission of the part by the set-up operator after all adjustments are satisfied. I also agree with measuring all dimensions for final - but we know our jobs so well that we're able to just take the criticals, at a minimum - and yes - that's how we have it written in our procedure. :rolleyes:
 
B

Bunny

#8
Regarding performing 1st article inspections for product ordered by a critical vendor. How do you document the inspection? Do you use a non-specific inspection form and note on it that it is a 1st article inspection? Do you notate anything on the drawing?
 

RCW

Quite Involved in Discussions
#9
Regarding performing 1st article inspections for product ordered by a critical vendor. How do you document the inspection? Do you use a non-specific inspection form and note on it that it is a 1st article inspection? Do you notate anything on the drawing?
One option, among many, is to not reinvent the wheel. You can find FAI (First Article Inspection) forms that meet AS9102 requirements on the web. While these were developed for aerospace, they can be easily used and/or modified to fit other fields.
 
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