Reliable performance is a must in any industry but no more so than connected with the production of Life Science Products such as pharmaceuticals and medical devices.
Poka-Yoke, the Japanese term used in Lean operations refers to the process of mistake proofing or providing a fail safe mechanism that will assure reliable operation. Eliminating defects or preventing operational mistakes can have a major effect on process capability, product specifications and operational efficiency, just to mention a few areas of advantage, so it must be given a much higher priority in our industry than currently is often the case. In our experience we could quote case histories for the following examples which are by no means uncommon or unrepresentative of the types of issues that require attention:
1. An absence of a mechanism between harvest and drain valving arrangement which have seen operators flushing millions of dollars of product down the drain. Use of an interlocking valve system, valves of different sizes or even different connectors might solve this issue.
2. Failure systems that did not fail closed results in loss of product or contamination of product.
3. Mix ups in products due to transfer of product dust as a result of improper air flows between adjacent pressurized rooms.
4. Double mechanical agitator seals installed incorrectly in bioreactors causing lost batches due to contamination problems.
5. Steam traps on sterilized systems connected incorrectly or not opening at all leading to contamination issues.
6. Flow values installed backwards.
7. In QC laboratories, analysis errors due to the analysis being started prior to the system meeting stable system suitability requirements.
8. Inappropriate use of dispensers in media preparation for bioreactors resulting in X10 components added to the media or buffer solution damaging the yield of the production batch.
Clearly these examples are all avoidable provided a comprehensive Poka-Yoke program is included as part of an overall Lean strategy. Hopefully companies will begin to appreciate the importance of such programs.