Brexit 100% inspection during in process inspection

sharonblon88

Starting to get Involved
#1
Our medical device needs 100% inspection during in process inspection. What's the sample plan we can apply for?
Another question is that for process validation or verification, when it can be proved that it's fully verification without validation? If it needs validation, what parameters related to? (for N95 respirator)
 
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Cthames

Involved In Discussions
#2
It sounds like if you need 100% inspection, you won't be able to use a sampling plans. Sampling plans take a look at a percentage of the total units (lets say 15 out of 100) to make a determination of the acceptability of the lot.
 

chris1price

Trusted Information Resource
#3
Remember if you are doing 100% inspection, you must validate the inspection process to prove that it is suitable, (ie perform Measurement Systems Analysis / Test Method Validation).

Unfortunately, only you can identify the parameters that require validation. Do you have risk assessments or control plans for the process? What are the critical quality attributes for the product, how do you know they are being met in production? If you think about these points, it might lead you to the answer.
 

Cthames

Involved In Discussions
#4
Remember if you are doing 100% inspection, you must validate the inspection process to prove that it is suitable, (ie perform Measurement Systems Analysis / Test Method Validation).

Unfortunately, only you can identify the parameters that require validation. Do you have risk assessments or control plans for the process? What are the critical quality attributes for the product, how do you know they are being met in production? If you think about these points, it might lead you to the answer.
Doesn't 100% inspection alleviate you from validation? I believe the regulation states you must validate all processes which cannot be 100% verified.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#5
We perform 100% inspection of the device in production. We power it on and verify it transmits data and record the event in a human readable log. We have to validate other areas though like tools and equipment.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
Some characteristics can be inspected or tested 100%. (this is verification)
Some cannot and will require process VALIDATION. Process validation is required for those characteristics that can only be tested via a destruct test and therefore 100% inspection is not viable.
 

sharonblon88

Starting to get Involved
#7
Some characteristics can be inspected or tested 100%. (this is verification)
Some cannot and will require process VALIDATION. Process validation is required for those characteristics that can only be tested via a destruct test and therefore 100% inspection is not viable.
Thanks. For the defected in-process products, do we need to maintain a record for different defects? We usually just destroy it and throw into trash can.
 

sharonblon88

Starting to get Involved
#8
We perform 100% inspection of the device in production. We power it on and verify it transmits data and record the event in a human readable log. We have to validate other areas though like tools and equipment.
For 100% inspection, do we need to document inspection finding by characteristics or simply just classify by acceptance or scrapes? We don't reword the device
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#9
I don't know. this is usually either a regulatory requirement and/or a requirement of your QMS.
I would think as a medical device you would want - and most probably need - records so that if an audit, investigation or if a recall were necessary you would be able to show when defects 'began' and 'ended'.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#10
For 100% inspection, do we need to document inspection finding by characteristics or simply just classify by acceptance or scrapes? We don't reword the device
For an audit, it would be expected that the results of the 100% inspection can be reviewed. For us, each device has a serial number that is broadcast with the data that is collected. All of this is exported into an XLS we can add to the DHR. We also record failures of this stage.
 
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