How to define R & D Receiving (Incoming) Inspection Plan

lisawxf80

Involved In Discussions
#1
Dear All,

I am in medical device line in R & D center. For our current new product development, my boss ask me to define a incoming inspection procedure or plan.

As what I know, the incoming inspection plan is the outcome of design output, I am not sure how to define upfront.

According to boss, the plan shall include inspection criteria, AQL, etc.

Can anyone advise me how should I draft this document.

Thanks!

Lisa
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#2
I assume this is for incoming inspection of raw material or components that will be used in the development and/or prototype builds?

In which case the R&D team may not yet know all of the important factors and their specifications but they will know some and will probaby have identified others through their design efforts even if they are not yet quite right. In thsi case the incoming material can be inspected for compliance of those factors to the specified tolerance limits.

In general, the incoming inspection can be based on the number of passing and failing units in the sample. (categorical or attributes data) Even if the actual insection is done by measurement (continuous or 'variables' data).

These plans work by specifying an AQL level (Acceptable Quality Level) or by specifying a RQL (Rejectable Quality Level) or both a AQL and RQL. In either case, R&D folks will benefit from having the continuous data of each unit inspected so that they know where the units lie in the specification range...there is probably more value in this data than in the simple inspection for pass/fail itself.

You can check out this spreadsheet to determine sampling plans based on RQL or AQL and RQL.
 

somashekar

Staff member
Super Moderator
#3
Dear All,

I am in medical device line in R & D center. For our current new product development, my boss ask me to define a incoming inspection procedure or plan.

As what I know, the incoming inspection plan is the outcome of design output, I am not sure how to define upfront.

According to boss, the plan shall include inspection criteria, AQL, etc.

Can anyone advise me how should I draft this document.

Thanks!

Lisa
What is your role in the R&D center.
What ever it be, your broad understanding about inspection is pretty clear.
Your boss seems to be not in control of the current new product development.
Inspection criteria can be defined, however AQL is no business at R&D level.
In the various design review meetings, where bill of the materials are discussed, you may question each item about what is / are critical to product requirement and make your notes, to then include them into the specification. Prior to this, you will be good if you do some homework on getting to know more about each item in the BOM in relation to the selection for the new product, more so the custom design parts. You must even know about some regulatory requirements, RoHS if it applies, Safety mark on some components., and more. You must also get trained about materials, selection and application and be able to question them with the design team.
Good luck anyway Lisa ~~~
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#4
A clarifying question: are you developing the incoming inspection plan for when the new product launches into production or is this for materials that will be used during development?

Also what type of materials will bd indpected? discrete parts or batches of liquids or powders? The sampling plan will be different for discrete units than for batches...
 

lisawxf80

Involved In Discussions
#5
I assume this is for incoming inspection of raw material or components that will be used in the development and/or prototype builds?

In which case the R&D team may not yet know all of the important factors and their specifications but they will know some and will probaby have identified others through their design efforts even if they are not yet quite right. In thsi case the incoming material can be inspected for compliance of those factors to the specified tolerance limits.

In general, the incoming inspection can be based on the number of passing and failing units in the sample. (categorical or attributes data) Even if the actual insection is done by measurement (continuous or 'variables' data).

These plans work by specifying an AQL level (Acceptable Quality Level) or by specifying a RQL (Rejectable Quality Level) or both a AQL and RQL. In either case, R&D folks will benefit from having the continuous data of each unit inspected so that they know where the units lie in the specification range...there is probably more value in this data than in the simple inspection for pass/fail itself.

You can check out this spreadsheet to determine sampling plans based on RQL or AQL and RQL.
Thanks for the advise. Would like to clarify whether you are saying we should have to check each units for the raw material during development phase to gain enough data and then decide on AQL OR RQL? As of now, our raw materials come into different quantities, sometimes 50pcs, or 100pcs, my boss said that our incoming guy is not able to perform 100% check. However, I think we should do thorough study during R & D phase, as we do not know anything at this stage, should access in different ways. Am I right to say that.

Thanks & Regards,

Lisa
 

lisawxf80

Involved In Discussions
#6
A clarifying question: are you developing the incoming inspection plan for when the new product launches into production or is this for materials that will be used during development?

Also what type of materials will bd indpected? discrete parts or batches of liquids or powders? The sampling plan will be different for discrete units than for batches...
This is the materials that will be used during development. Mostly are discrete parts without batch identification. Basically they were used for study purpose, as we are in the prototype stage.
 

lisawxf80

Involved In Discussions
#7
What is your role in the R&D center.
What ever it be, your broad understanding about inspection is pretty clear.
Your boss seems to be not in control of the current new product development.
Inspection criteria can be defined, however AQL is no business at R&D level.
In the various design review meetings, where bill of the materials are discussed, you may question each item about what is / are critical to product requirement and make your notes, to then include them into the specification. Prior to this, you will be good if you do some homework on getting to know more about each item in the BOM in relation to the selection for the new product, more so the custom design parts. You must even know about some regulatory requirements, RoHS if it applies, Safety mark on some components., and more. You must also get trained about materials, selection and application and be able to question them with the design team.
Good luck anyway Lisa ~~~
I am QA in R&D, not sure whether I should take the role to define this, as I have not enough knowledge on how to define the critical features of each materials. I agree with you that AQL is no business in design phase, what if we need to define in future production phase? my boss was asking the R & D guys will not know how to define AQL as design output.
 

somashekar

Staff member
Super Moderator
#8
I am QA in R&D, not sure whether I should take the role to define this, as I have not enough knowledge on how to define the critical features of each materials. I agree with you that AQL is no business in design phase, what if we need to define in future production phase? my boss was asking the R & D guys will not know how to define AQL as design output.
Who ever told AQL is a design output ...
At R&D stage you define requirements. It is upto the purchaser and supplier to determine what AQL can be agreed at.
AQL is a statistical term and gets applied after process capability estimation and organization's requirement for a particular part.
You are QA in R&D... I guess everyone in R&D must be a QA.
I am still wondering why your boss is stuck with AQL.
 
I

ISAN16

#9
U can refer to AQL sampling plan, in AP 5442. draft in simple way by attaching the table as appendix. ( Eg. Table S-4, 1.0 %)
 
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