Sampling processes - Who must define the AQL level?

invitro_spain

Involved In Discussions
#1
Hello Folks,

Please, give me your opinion about the following thought about Statistical techniques and sampling methods:

Who must define the AQL level in a medical device company QA or QC in QC processes?

What is your opinion?

P.D. QA: Quality Assurance, QC: quality control engineers

Thanks
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#3
What is the label claim?
for characteristics nor covered by label claim, what is the budget for service or return or Customer Experience?

and by the way, the more important parameter of QC testing is the RQL, not the AQL...
 

indubioush

Quite Involved in Discussions
#4
The risk management process is a team effort between different functions: engineering, quality, clinical affairs, regulatory, etc. The results of the risk management process should dictate your AQL for QC. As you gain more knowledge of your process, you update your risk management documentation and can update your AQL. Does that help or do you need more info?
 

Ronen E

Problem Solver
Staff member
Moderator
#5
AQL (or similar) is first and foremost a marketing decision. It affects the overall quality image of the device/brand/manufacturer. So Marketing / BD (voice of the customer) must have an input on it.
 

somashekar

Staff member
Super Moderator
#6
Please also look inwards into your own process capability and controls. What has been the quality levels attained. Your AQL must not end up challenging your process nor it should let bad parts slip out to customer.... again as said above, what is the RISK (confidence level)
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#8
Statistically speaking, both the AQL and the RQL are supposed to ‘come from the Customer’ not the manufacturer (producer). The confidence level (1-alpha) embodies the producer’s risk. The producer’s risk is defined as the probability of rejecting a lot that meets - or beats - the AQL/RQL. The consumer’s risk (1-Beta) is the probability that a lot that exceeds the AQL/RQL will be accepted and shipped to the field.

For manufacturers that sell directly to a true ‘consumer’ who doesn’t specify a defect rate except through their loyalty and purchasing behavior, the AQL and RQL need to come from either the regulatory agency approved claim (this is in a medical device forum) OR from an informed assessment of the user base and the harm that could occur (this is loosely referred to as ‘risk assessment’ or hazard assessment in some quality standards). As such the QC organization should not be the one to determine the AQL/RQL levels. maybe QA should if they are involved in an appropriate assessment of the true needs of the user base form a severity and acceptable occurence rate. One can also believe that legal, regulatory and product owner groups should also be involved.

It would also be highly recommended that those individuals actually understand how acceptance sampling works. And most inspection standards including the ANSI versions of the mil-stds are pale versions of teh reality of acceptance sampling. Just because it’s written in a standard doesn’t mean it is correct or even particularly useful...
 

invitro_spain

Involved In Discussions
#9
your customer?
your risk management process?
I agree. I think you must define what is critical or not and in this case, the Risk management Process is vital. In addition, you can also use the Customer feedback. However, Who would be the internal process proprietary?
 

invitro_spain

Involved In Discussions
#10
The risk management process is a team effort between different functions: engineering, quality, clinical affairs, regulatory, etc. The results of the risk management process should dictate your AQL for QC. As you gain more knowledge of your process, you update your risk management documentation and can update your AQL. Does that help or do you need more info?
Yes, absolutely. I think the process must be changed. As you said, the AQL would be an output of the Risk management process. So, it is not easy to assure that all the people involved will agree.
 
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