History and Charters
VALUE PROPOSITION & PURPOSE
Special Interest Groups, or SIG's, are groups totally independent of SMRP, which exist for connecting people with a shared interest, to share general information within a portion of the field of "Reliability and Physical Asset Management".
An SMRP "Pharmaceutical and Biotech" Special Interest Group (SIG) could therefore help members learn to, within their respective companies:
- Champion "Pharmaceutical and Biotech" Reliability Compliance and Innovation
- Communicate (skills & methods) the value of "Pharmaceutical and Biotech" Reliability
- Collaborate with other “Pharmaceutical and Biotech” Organizations, such as ISPE to Focus on Maintenance and Reliability in this Industry while leveraging successful strategies applied in other Industries.
- Differentiate "Pharmaceutical and Biotech" Maintenance and Reliability Compliance from other Industries less regulated
Show practical applicability of "Pharmaceutical and Biotech" such as answering the FDA’s challenge regarding Utilization of Assets in our Industry
- FDA is starting to pay attention to "manufacturing capacity utilization." Congress is concerned about drug shortages; many drugs come from one or two suppliers globally. Congress is pressing FDA on the problem, and FDA is turning to industry for information.
- Last year, industry executives published a global strategy document that contained a discussion about low capacity utilization rates of 30 - 40 percent, and FDA wants to know why this is so.
- I bring this up because this “Pharmaceutical and Biotech” SIG can leverage this concern and industry hot button subject.
- This “Pharmaceutical and Biotech” SIG will answer to how to comply with regulations, using smart approaches to quality assurance, in a way that enhances business outcomes.
- Evaluate whether their maintenance plans/strategies are working
- Use "Pharmaceutical and Biotech" Compliance Driven Reliability to drive the right changes in strategy and tactics
- Measure the value of changes in strategy and tactics
Through the items listed above, we will be:
- Learning how to make our Employers more profitable
- Helping to advance the practice of reliability engineering in our Industry
- Elevating the understanding of certain concepts and tools within the larger SMRP community, and
- Developing and growing the compliance driven reliability portion of the SMRP Body of Knowledge.