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The Change & Certification Resource Guide breaks the assessment of a change into three parts, or steps, that are used together to provide a complete evaluation of a change. Each step is done on a single web page as you will see.  The first step asks the user to identify the position in the medical device supply chain that is of interest.  The possible supply chain positions are:  Basic Chemicals, Resin Producer, Formulator, Processor.  Making a selection activates the NEXT button, and when hit it opens the second web page that lists the possible areas of change we have identified for that supply chain position.  Each change has been assigned an impact level, low to high.  When you select a specific change a dialog box opens which shows the specific options that can be selected for that change area.  After selecting the change options of interest you hit the SHOW TASK SUMMARY button that is now visible.  You are then presented with the third page which shows the tasks required to implement the changes selected.  It also has a tab which shows tasks that were deemed not to be required for that change.  If more than one change is selected, then the tasks page lists all of the tasks required for all changes selected, with an indicator under each task which identifies the particular changes that task applies to.  This is especially useful when comparing the requirements of the different changes selected. 

Regarding the overall assessment of a change, we note that one can look at proposed changes for any of the positions in the supply chain.  Looking at various changes over the entire supply chain can provide an in-depth understanding of how changes must be managed by the industry.    

GUIDE NAVIGATION TIPS: 

  1. Hovering over certain spots on the web pages will open up informational dialog boxes.  In particular (I) info icons as well as the change number icons on the task page. 
  2. Do not use the BACK ARROW at the top of the web pages to move back a step.  Hitting that arrow will take you out to the supply chain position page. 
  3. You will see a band toward the top of each page which identifies each step of the process.  As you make selections, those selection will appear under the process step. 

Moving through the steps:

  1. You must select a supply chain position in order to activate the NEXT button to bring up the web page with the list of proposed changes for that supply position.

The Change page will have changes that can be selected (black), and changes that do not apply to that position and can not be selected (gray).  Each specific change shown has associated with it an indication of potential impact, and the impact levels are color coded.  Selecting a change will open a box that lists the various options related to that change, and each of those change options will have a specific impact noted.  Highlight the box for your change of interest to evaluate that change.  More than one box may be selected so that you can compare the requirements of different changes.  Then hit the SHOW TASK SUMMARY button. 

The Task Summary page has a tab for TASKS REQUIRED and one for TASKS NOT REQUIRED

The boxes on the required tasks tab describe the tasks that are required to implement the change.  At the bottom of each task is a button noting the number of the change selected on the previous page that the task applies to.  Hovering over that change number button will open a dialog box that identifies that specific change in more detail.  Also, the color of the change number gives the level of impact of that change. 

You can also use the upper status bar to move around the system.  The selections you made are shown under the bar and are hot links which will take you to the page where that choice operates.