On Practical Uses of ISO Standards: Two Case Studies

Abstract

Statistical ISO-standards such as ISO 2859-1 and ISO 3951-1 are still used in many organizations for many different purposes, from incoming control to release of final product. In the current era of optimization everywhere there is, however, a new focus on sampling and use of resources. In many organizations new technologies like Lean, Six Sigma, etc. are widely used, and hence the sample sizes proposed by the ISO standards are often challenged with the purpose of reducing sampling to reduce cost both directly in terms of fewer samples but also indirectly in terms of saved costs in the labs.In this paper I will present two very different examples from the pharmaceutical world. The first example is an algorithm to lower the sample size in In-Process Control (IPC). In this case, we wanted to do some testing in real time as IPC controls, to be able to react in time if these parameters show a trend or go out of control. These plans are based on ISO standards in the sense that we retain the Consumer Risk Quality (CRQ) at the levels of the standard, but we then reduce the sample size to save costs and reduce the workload of sampling and analyzing samples in production.The second case study is from the other end of the spectrum. In this case we look at a vision system that enables us to do 100% control for many parameters. We also retain the CRQ from ISO, but we rewrite the acceptance criterion to allow for 100% control of outgoing batches.