Good day Anon,
You might want to seek some expert advice delving more into your incoming receiving and inspection process. Depending on the finished device and the materials being received there are ways to reduce the sampling or remove inspection all together. In fact, the ISO 13485 standard speaks about using a risk-based approach for materials purchasing, receiving, and inspection, which companies can adopt methods such as "Dock to Stock" or DTS where the identity is confirmed and then moved to inventory.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 14-Nov-2023 09:41
From: Dan O'Leary
Subject: Incoming Materials Testing
You didn't describe the system, so I infer it uses attribute lot acceptance sampling. In the US the most common methods are Z1.4 and c=0. (ASQ published the sixth edition in May 2023.)
Both methods use switching rules that automatically adjust the sample size based on history. A good history can switch to reduced sampling reducing the sample size and the cost. If you are using Z1.4, then double sampling will also reduce cost.
Instead of reduced sampling, consider switching to skip lot sampling. This will also reduce cost because you don't inspect every lot. Skip lot sampling also has automatic adjustments to skip more lots when there is a record of good quality.<o:p></o:p>
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 14-Nov-2023 07:34
From: Anonymous Member
Subject: Incoming Materials Testing
This message was posted by a user wishing to remain anonymous
Dear All <o:p></o:p>
We are a manufacturer of medical devices with a market in US and EU.<o:p></o:p>
We would like to challenge our system for test of the raw materials that is set up today on 1 year and is very costly.<o:p></o:p>
Can somebody advice on the minimal number of batches and frequency used of the test on incoming?<o:p></o:p>
Thank you in advance<o:p></o:p>