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Rapid audit template for plastic parts manufacturing process

#1
Hello everybody,
I'm very honored to have this opportunity to talk with you here.
I'm going to pay a visit to a plastic parts manufacturer, and I plan to conduct a rapid audit during the visit, for quick start sake, would anybody share or guide me to get some template for a rapid audit to such a supplier (such as which part or process need to pay more attention etc.)

Thanks very much!
 
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Mike S.

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#3
And what is it you hope to accomplish during this audit? Is the supplier already approved and you wanna audit a new product? Or is it a new supplier?
 

AgnieszkaSz

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#5
It really depends whether you source standard parts (available from catalogue) or they make parts from your tool on your demand. If you mean injection moulding process, I would start with questions - on which injection moulding machines are the parts in question produced? You would like to know whether the machinery and tools are adequately maintained, so check for maintenance plan and records, machine / tool logbooks if they exist. Then the raw material - if these are standard parts, how much regrind is allowed and if it is allowed at all, ask for documented directions how much regrind can be used. The process itself - who releases the first good piece from production order and how it is recorded? Visual control - do they compare the controlled parts with any reference parts and if so, are these reference parts approved? If part colour is a controlled feature, how do they check that (it can be tricky if they dose and mix the pigment on IMM or, even more tricky, in raw material feeding system). Ask for records of non-compliant parts - it is normal in injection moulding that you get deformed parts in the start-up phase, and then the process can go awry too. If they claim their process produces only good parts - ekhm, that would make me suspicious. This can mean that there is no control during the process. Ask for batch release process. Then check how they make sure each packaging item contains good amount of pieces (can be tricky for small details). Assess whether their packaging procedure protects the item from damage durin transportation, in house and external. You might be interested in their plastic waste management too.
Sorry, I don't have any template. But these are questions you may ask.
 

Tagin

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#6
Since you say "a rapid audit", I would focus your audit on your top priorities.

Think about: Why do you care? Why bother to audit them?

Something like:
  1. Any regulatory/statutory requirements or concerns (e..g., are they subject to FDA? have they had an FDA audit recently?)
  2. Any certification requirements (e..g., ISO 13485)
  3. Any product safety concerns or product safety related processes
  4. Validated (vs. verified) processes
  5. Your documented supplier approval/supplier agreement criteria
  6. Specific focus on areas related to recent quality trends, SCARs, etc.
  7. Any other audit requirements placed on you by your QMS or external supplier audit requirements
 
#7
Welcome,

What is your definition of a "rapid audit"?
Thanks Johnny, "rapid audit" in our organization means an audit within 2 hours including company information understanding and plant tour, and there is no non-conformity items is needed (just a report is enough)

And what is it you hope to accomplish during this audit? Is the supplier already approved and you wanna audit a new product? Or is it a new supplier?
Thanks Mike, actually I hope to accomplish a brief audit report including analysis from different aspects. And the supplier is a new supplier.

Here is what I use when I do a supplier visit. I don't always get to fill all of it out, but as much as I can. Just an idea.
Thanks very much for your sharing, hog, it really helps a lot!

It really depends whether you source standard parts (available from catalogue) or they make parts from your tool on your demand. If you mean injection moulding process, I would start with questions - on which injection moulding machines are the parts in question produced? You would like to know whether the machinery and tools are adequately maintained, so check for maintenance plan and records, machine / tool logbooks if they exist. Then the raw material - if these are standard parts, how much regrind is allowed and if it is allowed at all, ask for documented directions how much regrind can be used. The process itself - who releases the first good piece from production order and how it is recorded? Visual control - do they compare the controlled parts with any reference parts and if so, are these reference parts approved? If part colour is a controlled feature, how do they check that (it can be tricky if they dose and mix the pigment on IMM or, even more tricky, in raw material feeding system). Ask for records of non-compliant parts - it is normal in injection moulding that you get deformed parts in the start-up phase, and then the process can go awry too. If they claim their process produces only good parts - ekhm, that would make me suspicious. This can mean that there is no control during the process. Ask for batch release process. Then check how they make sure each packaging item contains good amount of pieces (can be tricky for small details). Assess whether their packaging procedure protects the item from damage durin transportation, in house and external. You might be interested in their plastic waste management too.
Sorry, I don't have any template. But these are questions you may ask.
Thanks, AgnieszkaSz, your comments helps me a lot, since I don't have any experience in moulding industrials, your sharing helps me to find some idea in my coming visit, thanks!
 

Johnny Quality

Involved In Discussions
#8
It really depends whether you source standard parts (available from catalogue) or they make parts from your tool on your demand. If you mean injection moulding process, I would start with questions - on which injection moulding machines are the parts in question produced? You would like to know whether the machinery and tools are adequately maintained, so check for maintenance plan and records, machine / tool logbooks if they exist. Then the raw material - if these are standard parts, how much regrind is allowed and if it is allowed at all, ask for documented directions how much regrind can be used. The process itself - who releases the first good piece from production order and how it is recorded? Visual control - do they compare the controlled parts with any reference parts and if so, are these reference parts approved? If part colour is a controlled feature, how do they check that (it can be tricky if they dose and mix the pigment on IMM or, even more tricky, in raw material feeding system). Ask for records of non-compliant parts - it is normal in injection moulding that you get deformed parts in the start-up phase, and then the process can go awry too. If they claim their process produces only good parts - ekhm, that would make me suspicious. This can mean that there is no control during the process. Ask for batch release process. Then check how they make sure each packaging item contains good amount of pieces (can be tricky for small details). Assess whether their packaging procedure protects the item from damage durin transportation, in house and external. You might be interested in their plastic waste management too.
Sorry, I don't have any template. But these are questions you may ask.
These are very good questions to ask. I would add questions regarding material conditioning (drying temperature, time), how they keep their moulding conditions and how they document deviations from the process.

If you only have two hours and they're a new supplier I'd follow some part numbers from order received to dispatch. That will give you a good feel of how their system works.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#9
I don't like artificial limits on audit time like 2 hours max. Who picked that, and why? Why not 20 minutes? Why bother at all?
 
#10
I don't like artificial limits on audit time like 2 hours max. Who picked that, and why? Why not 20 minutes? Why bother at all?
Thanks Mike, your opinion is really thoughtful, maybe it's hard to take the action as an audit but our organization called it in this way, and by the way, would you like to share some typical definition of "audit" or its typical characteristic? Thanks for your sharing in advance.
 
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