ISO 13485: 2016 Lot numbering question

MRBMP

Registered
Hello,
I represent an Injection mold company and had a question about the lot numbering of family molds. For those of you not familiar with this concept, "A family injection mold has more than one cavity cut into the mold, allowing multiple various parts with the same material to be formed in a single cycle." (Rodon group) For this example, we have one mold that produces two 30mL beakers and 2 100 mL beakers. My question is, do these products have to have unique lot numbers although they have different product numbers? When researching the ISO and FDA CFR820 standards, I feel that we are compliant and could quickly identify the specific product produced in a potential nonconforming situation.

Many thanks for considering my request.
Mike
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
Hello,
I represent an Injection mold company and had a question about the lot numbering of family molds. For those of you not familiar with this concept, "A family injection mold has more than one cavity cut into the mold, allowing multiple various parts with the same material to be formed in a single cycle." (Rodon group) For this example, we have one mold that produces two 30mL beakers and 2 100 mL beakers. My question is, do these products have to have unique lot numbers although they have different product numbers? When researching the ISO and FDA CFR820 standards, I feel that we are compliant and could quickly identify the specific product produced in a potential nonconforming situation.

Many thanks for considering my request.
Mike

Good day @MRBMP ;
When you say "do these products...", do you mean...
1- Each individual product type (i.e. 30mL vs 100 mL)?...or....
2- ONE of the 30mL items vs SECOND 30mL item ? (same would apply to 100mL).

In regard to you reference to "lot numbering"...

When you say LOT #. Typically a "lot" is a pre-identified max quantity (example...1000 pcs) or a change point(s) (for example:...during the 1000 pc run, if it is necessary to change to a different container/lot of pellets after 550 pieces. In that example the lot size may be reduced to 560 pieces). These LOT sizes are determined so as to assist your organization by limiting exposure (if something goes wrong), ease in identifying root cause (if something goes wrong), providing material, and/or equipment, and/or operator traceability. Lot numbers continually sequence/change.

Typically the additional identification within the mold is simply a cavity number (e.g. 30mL cavity ONE vs 30mL cavity TWO). This is a fixed number and again assists your organization by limiting exposure and assisting with root cause analysis if something goes wrong.

The first question(s) I would recommend being asked are what identification/traceability do WE (the organization) need. Don't simply do for a standard or an auditor. I can not image a scenario where your ORGANIZATION would not want cavity traceability AND lot number assignment/segregation.


Hope this helps.
Be well.
 

MRBMP

Registered
Good day @MRBMP ;
When you say "do these products...", do you mean...
1- Each individual product type (i.e. 30mL vs 100 mL)?...or....
2- ONE of the 30mL items vs SECOND 30mL item ? (same would apply to 100mL).

In regard to you reference to "lot numbering"...

When you say LOT #. Typically a "lot" is a pre-identified max quantity (example...1000 pcs) or a change point(s) (for example:...during the 1000 pc run, if it is necessary to change to a different container/lot of pellets after 550 pieces. In that example the lot size may be reduced to 560 pieces). These LOT sizes are determined so as to assist your organization by limiting exposure (if something goes wrong), ease in identifying root cause (if something goes wrong), providing material, and/or equipment, and/or operator traceability. Lot numbers continually sequence/change.

Typically the additional identification within the mold is simply a cavity number (e.g. 30mL cavity ONE vs 30mL cavity TWO). This is a fixed number and again assists your organization by limiting exposure and assisting with root cause analysis if something goes wrong.

The first question(s) I would recommend being asked are what identification/traceability do WE (the organization) need. Don't simply do for a standard or an auditor. I can not image a scenario where your ORGANIZATION would not want cavity traceability AND lot number assignment/segregation.


Hope this helps.
Be well.

Hey John,
Thanks for the response and just to clarify on your initial question, each part that is produced has a cavity ID marking, but where the mold produces 2 30mL and 2 100mL beakers, do they need to have different lot numbers? From a documentation perspective, there are two separate packets that go out with the job to record quantities, labels etc.

Thanks,
Mike
 
You mentioned 21CFR820.
(m) Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

If this is a finished device (or part of one), then the different sizes should be different lot numbers.
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
Hey John,
Thanks for the response and just to clarify on your initial question, each part that is produced has a cavity ID marking, but where the mold produces 2 30mL and 2 100mL beakers, do they need to have different lot numbers? From a documentation perspective, there are two separate packets that go out with the job to record quantities, labels etc.

Thanks,
Mike
Thanks for the clarification Mike. I see nothing that would (per the standard) prevent you from maintaining the same lot number across both part numbers. However, I would counsel to consider....is that a good idea for your organization? Will there be any confusion if a lot number is reported ? (i.e. which part number is being referred to?) If a verification or other activity is tallied (quantity) by lot number....will there be confusion as to which part number is being referred to? Will your CUSTOMERS be confused when lot number information is exchanged? Doesn't your organization ever track shipments by LOT number? ... (particularly if/when product needs to be "recalled" or otherwise verified)?

Food for thought.

Hope this helps.
Be well.
 
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