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Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence. Use active verb in the Instructions column.
| Step # | Role | Instructions | ||
|---|---|---|---|---|
| 1.0 |
| Publications Team | Posts draft standard package for public review | Post for Public Review (website, Wiki, Library) | |
| Public Review (PR) |
| - Supposed to be 60 days (QRS Supplement = 30 days) | ||||
| 2.0 | Project Manager | Responds to Public Review comments and update the draft document | PR comment resolution | |
| 3.0 | FDA | Reviews the standard | FDA review | FDA reviews some, not all, stds, sometimes FDA needs more time, especially for IG we have to allow time for review |
| 4.0 | Project Manager | Responds to FDA comments and update the draft document | FDA comment resolution | |
| 5.0 | Project Manager | Publishes material ready for GGG | Pub material ready for GGG | |
| 6.0 |
| Heads of stds | Meets for publication approval | GGG meeting for Pub approval | |
| 7.0 |
| Project Manager | Signs off for publication approval | GGG sign-off for publication (pub) approval |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
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