Add templates.

rdm/init_files/organization_qms/SOPs/complaint.md

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+---
+revision: 1
+title: New SOP Template
+---
+
+# Approvals
+
+All approvers shall add a signed commit with their name and roles appended to the table in this section.
+
+| Name | Role | Date |
+|---|---|---|
+|      |      |      |
+|      |      |      |
+|      |      ||
+
+# Training Record
+
+By signing below you have acknowledged you have read and understood this document.
+
+| Name | Role | Date |
+| ---- | ---- | ---- |
+|      |      |      |
+
+# Purpose
+
+This SOP details the complaint handling procedure. [[21.CFR.820.198]]
+
+# Customer Complaint Channels
+
+Identify all channels that customer complaints.
+
+
+
+
+
+TODO: Add more process in compliance with 21.CFR.820.198
+
+(a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that:
+
+(1) All complaints are processed in a uniform and timely manner;
+
+(2) Oral complaints are documented upon receipt; and
+
+(3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting.
+
+(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.
+
+(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.
+
+(d) Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by § 820.198(e), records of investigation under this paragraph shall include a determination of:
+
+(1) Whether the device failed to meet specifications;
+
+(2) Whether the device was being used for treatment or diagnosis; and
+
+(3) The relationship, if any, of the device to the reported incident or adverse event.
+
+(e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:
+
+(1) The name of the device;
+
+(2) The date the complaint was received;
+
+(3) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used;
+
+(4) The name, address, and phone number of the complainant;
+
+(5) The nature and details of the complaint;
+
+(6) The dates and results of the investigation;
+
+(7) Any corrective action taken; and
+
+(8) Any reply to the complainant.
+
+(f) When the manufacturer's formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.
+
+(g) If a manufacturer's formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the United States at either:
+
+(1) A location in the United States where the manufacturer's records are regularly kept; or
+
+(2) The location of the initial distributor. 
+
+
+
+# Triggers
+
+This SOP is triggered when a customer complaint is received. 
+
+# 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
+
+Medium: Error in SOP or SOP execution is moderately likely in patient harm.
+
+
+# Periodic Review
+
+Medium: Review once a year.
+
+
+# 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. TODO: Add complaint handling steps.

rdm/init_files/organization_qms/SOPs/generate_quality_metrics.md

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+---
+revision: 1
+title: Generate Quality Metrics SOP
+---
+
+# Approvals
+
+All approvers shall add a signed commit with their name and roles appended to the table in this section.
+
+| Name | Role | Date |
+|---|---|---|
+|      |      |      |
+|      |      |      |
+|      |      ||
+
+# Training Record
+
+By signing below you have acknowledged you have read and understood this document.
+
+| Name | Role | Date |
+| ---- | ---- | ---- |
+|      |      |      |
+
+# Purpose
+
+Author shall clearly identify the purpose of this SOP. What does this SOP do? When should this SOP be invoked?
+
+# Triggers
+
+This SOP is usually created as a result of a CAPA. 
+
+# Change History
+
+The change history section shall contain a brief summary of changes made in this revision.
+
+| Change Description | Date             |
+| ------------------ | ---------------- |
+| Initial version    | January 20, 2021 |
+
+# Required Roles to Execute
+
+The following user roles are required to execute this SOP:
+
+- Quality Systems SME
+- Engineering SME
+
+# 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
+
+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
+
+Low: Error in SOP or SOP execution is unlikely to result in patient harm.
+
+# Periodic Review
+
+Low: Review once a year.
+
+# Record Template
+
+Refer to `templates/quality_metrics_record.md`
+
+# Work Instruction
+
+A step by step recipe for executing the SOP.
+
+1. Extract and / or compute all quality metrics as stated in the quality manual.
+2. Create a new branch called `generate_quality_metrics/YYYY_MM_DD`. Replace the YYYY_MM_DD with todays date.
+3. Create a copy of `templates/quality_metrics_record.md` under `records/generate_quality_metrics/YYYY_MM_DD.md`
+4. Record the values of quality metrics in this record.
+5. Commit the changes, push the branch, and submit a pull request for review.
+

rdm/init_files/organization_qms/SOPs/release.md

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+---
+revision: 1
+title: Release SOP
+---
+
+# Approvals
+
+All approvers shall add a signed commit with their name and roles appended to the table in this section.
+
+| Name | Role | Date |
+|---|---|---|
+|      |      |      |
+|      |      |      |
+|      |      ||
+
+# Training Record
+
+By signing below you have acknowledged you have read and understood this document.
+
+| Name | Role | Date |
+| ---- | ---- | ---- |
+|      |      |      |
+
+# Purpose
+
+This SOP details activities that must be performed for a product release. [[21.CFR.820.80, 21.CFR.820.30.j]]
+
+# Triggers
+
+This SOP is triggered when a release candidate has successfully undergone all acceptance checkpoints.
+
+# 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:
+
+- Engineering SME
+- Produt Management SME
+- Quality Systems SME
+
+# Required Roles to Review
+
+The following user roles are required for initial approval, periodic review, and change approval of this SOP:
+
+- Engineering SME
+- Produt Management SME
+- Quality Systems SME
+
+# Required Inputs and Dependencies
+
+The following inputs are required for the execution of this SOP:
+
+- TODO: Add release activity inputs
+
+# Outputs
+
+The SOP shall produce the following outputs:
+
+- A new directory inside Dropbox with the following structure:
+  - Design Outputs
+  - Device Master Record [[21.CFR.820.181]]
+    - Shall contain design inputs, installation manual, maintenance, and servicing procedures, verification plan
+- A new directory in the product's DHF named "Design Outputs"
+- Design Outputs directory shall contain:
+  - Snapshot of the code Git repository 
+  - Docker image used for installation
+  - Updated user manual
+- A regulatory submission if necessary
+  - TODO: Add note to file vs new 510k determination process
+- A new row in the products registry.
+- A new entry in the service manual for this release. 
+
+# Risk Level
+
+Medium: Error in SOP or SOP execution is moderately likely in patient harm.
+
+
+# Periodic Review
+
+Medium: Review once a year.
+
+# Record Template
+
+TODO: Create record template to capture a release was approved and executed.
+
+# Work Instruction
+
+A step by step recipe for executing the SOP.
+
+1. TODO: Fill out work instruction

rdm/init_files/organization_qms/registry/device_history_record.md

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+---
+revision: 1
+title: Device History Record
+---
+
+# Purpose
+
+This living document shall contain a listing of all products applicable under this QMS. [[21.CFR.820.184]]
+
+# Change History
+
+The change history section shall contain a brief summary of changes made in this revision.
+
+| Change Description | Date             |
+| ------------------ | ---------------- |
+| Initial version    | January 20, 2021 |
+
+# Product Registry
+
+| Product Name    | Phase     | Release Date | Quantity Installed | UDI  |
+| --------------- | --------- | ------------ | ------------------ | ---- |
+| Windows XP v1.0 | Retired   |              |                    |      |
+| Windows 7 v1.0  | Deployed  |              |                    |      |
+| Windows 11 v1.1 | Inception |              |                    |      |
+

rdm/init_files/organization_qms/registry/personnel.md

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+---
+revision: 1
+title: Personnel Registry
+---
+
+# Purpose
+
+This living document shall contain a listing of all personnel associated with implementationa and execution of the QMS.
+
+# Change History
+
+The change history section shall contain a brief summary of changes made in this revision.
+
+| Change Description | Date             |
+| ------------------ | ---------------- |
+| Initial version    | January 20, 2021 |
+
+# Personnel Registry
+
+| Name | Email | Roles                  |
+| ---- | ----- | ---------------------- |
+|      |       | Quality Systems SME    |
+|      |       | Medical SME            |
+|      |       | Product Management SME |
+