If your life sciences manufacturing operation has problems, please call me; I and my team can and do fix those problems whether they are quality, technical, operational, compliance, cultural or all of the above. I have helped fix QMS and manufacturing operations subject to 3 FDA Consent Decrees, 8 Warning Letters, and many 483’s, so we definitely have the experience to help you too.
Example 3: Sometimes figuring out the solution to a chronic multi-million dollar problem takes only a few seconds of eyes-on inspection by someone (like me) who knows exactly what they’re looking at.
Problem: a business with a large R&D and Engineering group operated a testing lab that performed very expensive tests, around $250,000 per set of three tests. These tests could run for hours, days or even weeks. Post-experiment evaluations included a detailed mass analysis of all of the test equipment components. Week after week after week they kept getting invalid test results because the mass balance would not balance - the iron oxide content was always high. Many scientists and engineers worked to figure this out, but none did. Eventually a senior engineer friend of mine asked “Hey, we’re really struggling with this. Would you mind coming with me and just taking a look at the tests and the testing area?” I said sure, and we went to the test area where we were given a grand tour. Our guide was proud of the high-end test area they had built; they had even cleverly saved a lot of time, effort and money by converting pre-existing utility conduits to the new utilities needed for these new tests. He specifically pointed out the natural gas lines converted to purified water lines. I asked “You’re supplying the purified water for these mass balance tests via the old natural gas lines?” “Yes.” “Those black steel lines right there?” “Yes.” “You’re supplying highly purified water to a test stand via black steel pipes and your test results have extra rust in them?” The ensuing silence was deafening.
Solution: install non-rust-generating piping to supply the purified water to the test area.
Conclusion: quick, cheap and easy solutions can cost you millions of dollars if you don’t think it through, so make sure that you have experts – real experts - answer the question “What’s the worst that could happen?” before you choose the quick, cheap and easy solution to your problem.
Bottom line: If your life sciences manufacturing operation has problems, please call me or anyone at DLW Partners because we can and will fix those problems whether they are quality, technical, operational, compliance, cultural or all of the above. Best of all, there's no harm in simply contacting us to learn more about how we can help you, so please don't hesitate, just call us. Your ops and your stakeholders will thank you.
Learn more at:
https://lnkd.in/ghWpKtQg
Senior Manager Customer Service Serta, Simmons Bedding, LLC
3moGreat visit as always thanks for the support!