Sampling Plans - BS6001

StepPCHen

Involved In Discussions
Good morning,

I am hoping someone can help me with a query regarding Incoming Inspections and Sampling Plans. We assemble procedure packs using CE marked products, this is performed in a class 7 cleanroom...

We currently use BS6001 Sampling Plan for performing Incoming Inspections on goods. Also, when these goods are being used in assembly we perform a 100% inspection.

BS6001 is referenced in our procedures and incoming inspection forms, we use the quantity received to perform the process and work out the quantity to be inspected. This is performed before we place the goods into our material tracking software and into stores. Based on BS6001, if i receive X amount of goods, inspect Y amount of goods and reject Z amount, it may be required to reject the total LOT due to "Z". This does not really work as we require the "acceptable" amount for assembling the final product.

Is it possible for me to remove all reference to BS6001 and stop using this process altogether and move to 100% inspection at goods received? Any rejects detected will be placed into quarantine and scrapped or returned to the supplier, all acceptable goods can be placed into stores.

Supplier rejects will be tracked and monitored and a CAPA / SCAR will be raised if a trend is noticed in the rejects.

Thank you, any input or suggestions would be greatly appreciated.
 

Bev D

Heretical Statistician
Leader
Super Moderator
Rejection doesn’t necessarily mean sending the lot back to the supplier. YOU can perform the 100% sort in your facility and then release and use the passing parts…BUT you should charge your supplier for your inspection time and for the failing parts…
 

StepPCHen

Involved In Discussions
Hi Bev,

Thank you for your reply. We always charge the supplier for failing parts :)

I was led to believe by one of my predecessors that if the total LOT had a certain amount of rejects the total LOT had to be rejected, including any good product within the LOT. This is how BS6001 was explained to me
 

chris1price

Trusted Information Resource
I have always taken exceeding the reject limit as failing the inspection process. What happens next (100% sorting, rejection, etc) is up to you.

You need to explain the rationale for statistical techniques used. Using BS6001 or ISO2859 is an one answer for this. If you don't use the standards, consider how you will explain the method used.
 

StepPCHen

Involved In Discussions
Hi Chris, thank you for your reply.

I would justify not using BS6001 by performing 100% inspection as we are doing this anyway. The reason for 100% inspection is because we are using Medical Devices and is risk based
 

Bev D

Heretical Statistician
Leader
Super Moderator
In the language of sampling standards rejection (exceeding the acceptance number, c) results in the entire lot being rejected. But then you get to disposition the lot. Disposition can be return to suppler, have the supplier 100% inspect the lot and sort good from bad in your facility or you can do the 100% inspection and sort. You can also scrap the entire lot or depending on the item you could “use as is” although that generally requires robust justification, Customer and/or Regulatory approval. There is no need to eliminate mention of your sampling standard. They all say the same thing…
 
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