FDA Medical Device Industry Coalition Managing Facility Expansions, Equipment Modifications, & Continued Growth Failing to Plan is Planning to Fail Presented by:

Foundational Stuff Interactive process…volunteer or be victimized! The need for an inquisitive nature  Why…  What…  How…  Who? CFR 820 Part 21 & standards like ISO are intended to make organizations think in terms of closed loop processes!

The Blended Triumvirate (also known as competence, definition, and control) The Kaleidoscope Effect! Think in terms of a kaleidoscope, considering all and applying each as needed. It may be different for each process or activity, so consider the kaleidoscope each time!

Managing Expansions & Modifications Establish the big picture Audit & analysis to verify the current position Gap analysis to understand differences & improvements in relation to current conditions & circumstances Planning for Optimization, including qualification/validation

The Big Picture What are we trying to accomplish? What do we hope to gain from it? How soon do we need to have it in place? If we had to rely on existing methods and controls, would we be able to meet regulations and other requirements for the products and processes involved? Establish a preliminary plan for the expansion/modification, including a risk analysis Not resources…but resourcefulness!

Audits & Analysis of What’s Already There Think in terms of performance-based auditing  How well do existing processes help us optimize?  How well do existing processes comply with regulations and other requirements? Analyze data related to process performance to understand:  What the evidence says  What the evidence does not say  If what we observed is to be true, this must also be true  If what we observed is to be true, this cannot be true

Gap Analysis Seeking first to understand…then to undestand what needs to be updated or adjusted  Start with an accurate picture (point of reference) of what is already in place  Using the planned expansion/modification, compare it with existing and note the gaps  Identify the risks associated with the transition, including items impacted by the changes being made  Report on the gaps

Planning For Optimization Establish a plan, considering:  Facility layout  Utility needs, including controls for sustainability  Equipment needs, including qualification/validation  Process controls, to reduce or eliminate risks  People, including required competence  Process instructions Think in terms of optimization for organizational benefit or they will struggle to live it over time.

Coping With Continued Growth Plans and closed-loop process are only effective if they help with brain cell management Management’s review of the management systems is to assess decisions already made, with actions taken intended to make the organization more suitable (fits who the organization is), adequate (covers everything the organization has to live up to), and effective (driving behavior) Changes to the organization, including those related to facilities, equipment, and products need to be facilitated by the management systems. Failing to do so affects the organization’s ability to fulfill its purpose and can have dire consequences!

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