Add SOP creation SOP.

rdm/init_files/documents/quality_manual/SOPs/new_sop.md

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+---
+id: SOP Creation SOP
+revision: 1
+title: SOP Creation SOP
+---
+
+# Purpose
+
+This SOP shall be invoked when a new SOP needs to be created. New SOPs may be created for a variety of reasons such as:
+
+- Coming into conformance to existing or new regulations
+- A result of a corrective action / preventative action
+
+# Approvals
+
+| Name | Role | Date |
+|---|---|---|
+| | | |
+
+# Required Roles to Execute
+
+At least a Quality systems SME is required to execute this SOP. Other SMEs shall be involved as necessary.
+
+# Required Roles to Review
+
+The following user roles are required for initial approval, periodic review, and change approval of this SOP:
+
+- Quality systems SME
+
+# Required Inputs and Dependencies
+
+This SOP does not have any required inputs.
+
+# Outputs
+
+The output of this SOP is a new file in the SOPs directory of the quality manual. Additionally, new a new record template
+shall be created in the record_templates directory of the quality manual. 
+
+# Risk Level
+
+Low: Error in SOP or SOP execution is unlikely to result in nonconforming product or patient harm.
+
+# Periodic Review
+
+Low: Only review when SOP is used.
+
+# Record Template
+
+A record of execution for this SOP is a new SOP. The template is found in the `templates/new_sop.md` file.
+
+# Work Instruction
+
+1. Ensure your local quality manual Git repository is up to date. Ensure you are on the `master` branch and perform a `git pull`
+1. Create a new branch in the quality manual Git repository. 
+   Give the branch a descriptive name and use snake case such as: `new_sop/new_complaint_sop`
+1. Make a copy of the `templates/new_sop.md` file. Give the filename the name of the SOP. Use `snake_case` for the filename.
+1. Open the new SOP file in a text editor of choice.
+1. Fill in each section with relevant content for the new SOP.
+1. Commit the newly added files. Push the files up to GitHub.
+1. In GitHub, create Pull Request for the newly created branch. Add reviewers until all roles listed under the section "Required Roles to Review" have been fulfilled. 
+1. Once all reviewers have been satisfied with the SOP, each reviewer shall add their name to the approvals table.

rdm/init_files/documents/quality_manual/templates/new_sop.md

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+---
+id: New SOP Template
+revision: 1
+title: New SOP Template
+---
+
+# Purpose
+
+Author shall clearly identify the purpose of this SOP. What does this SOP do? When should this SOP be invoked?
+
+# Approvals
+
+All approvers shall add a signed commit with their name and roles appended to the table in this section.
+
+| Name | Role | Date |
+|---|---|---|
+| George Costanza | Self Deprecation SME |
+| Jerry Seinfeld | Comedy SME |
+| Kramer (Cosmo) | Weird Jokes SME |
+
+# Change History
+
+The change history section shall contain a brief summary of changes made in this revision.
+
+| Change Description | Date
+| --- | ---
+| Initial version | January 12, 2021
+
+# Required Roles to Execute
+
+The following user roles are required to execute this SOP:
+
+- Example user role
+
+# Required Roles to Review
+
+The following user roles are required for initial approval, periodic review, and change approval of this SOP:
+
+- Example user role
+
+# Required Inputs and Dependencies
+
+The following inputs are required for the execution of this SOP:
+
+- Example input: All code review records from the code review SOP for the last year.
+
+# Outputs
+
+The SOP shall produce the following outputs:
+
+- Example output: A record to capture a review was performed on an SOP.
+
+# Risk Level
+
+Author shall conduct a risk analysis to identify the risk level of this SOP. What is the risk of patient harm if there is an error in the execution of this SOP or an error/omission in the SOP itself?
+
+There are three levels of SOP risk:
+
+Low: Error in SOP or SOP execution is unlikely to result in patient harm.
+Medium: Error in SOP or SOP execution is moderately likely in patient harm.
+High: Error in SOP or SOP execution is likely to result in patient harm.
+
+# Periodic Review
+
+Author shall insert the review periodicity depending on the risk level. For reference:
+
+Low: Review once a year.
+Medium: Review once a year.
+High: Review every six months.
+
+# Record Template
+
+Author shall reference or include the template used to create a record capturing the SOP execution.
+
+# Work Instruction
+
+A step by step recipe for executing the SOP.
+
+1. Example Step 1
+2. Example Step 2