History and Charters


VALUE PROPOSITION & PURPOSE

Shared 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" Shared 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.


 

 

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