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claude-skills-reference/ra-qm-team/quality-documentation-manager/references/document-control-procedures.md
Alireza Rezvani 15266e99f2 fix(skill): rewrite quality-documentation-manager with document control content (#80) (#155) 
- Remove placeholder files (example.py, api_reference.md, example_asset.txt)
- Add 12 trigger phrases for skill discoverability
- Add Table of Contents for navigation
- Remove marketing language ("comprehensive", "robust", "seamless", "expert-level")
- Create 5 numbered workflows with validation checkpoints:
  - Document Control Workflow with lifecycle stages
  - Document Numbering System with format and category codes
  - Approval and Review Process with comment disposition
  - Change Control Process with classification criteria
  - 21 CFR Part 11 Compliance with electronic controls
- Create document-control-procedures.md (~400 lines):
  - Document numbering format and workflow
  - Lifecycle stages and transitions
  - Review and approval matrix
  - Change control classification and impact assessment
  - Distribution methods and access control
  - Record retention periods and disposal
- Create 21cfr11-compliance-guide.md (~450 lines):
  - Part 11 scope and applicability
  - Electronic record requirements (§11.10)
  - Electronic signature requirements with manifestation
  - System controls (administrative, operational, technical)
  - Validation approach and documentation
  - Compliance checklist and gap assessment template
- Create document_validator.py (~450 lines):
  - Document numbering convention validation
  - Status and lifecycle validation
  - Date validation (effective, review due)
  - Approval requirements checking
  - Change history completeness
  - 21 CFR Part 11 controls validation
  - Interactive mode and JSON output

SKILL.md reduced from 266 to 438 lines with actionable workflows.

Co-authored-by: Claude Opus 4.5 <noreply@anthropic.com>
2026-01-30 17:54:40 +01:00

12 KiB
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Document Control Procedures

Implementation guide for ISO 13485-compliant document control systems.

Table of Contents

Document Numbering System

Numbering Format

Standard format: [PREFIX]-[CATEGORY]-[SEQUENCE]-[REVISION]

Component Format Example Description
PREFIX 2-3 letters SOP, WI, TF Document type identifier
CATEGORY 2-3 digits 01, 02, 10 Functional area code
SEQUENCE 3-4 digits 001, 0001 Sequential number within category
REVISION Letter or number A, 01 Revision indicator

Document Type Prefixes

Prefix Document Type Description
QM Quality Manual Top-level QMS description
SOP Standard Operating Procedure Process procedures
WI Work Instruction Task-level instructions
TF Template/Form Controlled forms and templates
POL Policy Policy statements
SPEC Specification Product/process specifications
PLN Plan Project and quality plans
RPT Report Technical and quality reports

Category Codes

Code Functional Area Examples
01 Quality Management QMS procedures, audits
02 Document Control This area
03 Human Resources Training, competency
04 Design & Development Design control
05 Purchasing Supplier management
06 Production Manufacturing
07 Quality Control Inspection, testing
08 CAPA Corrective/preventive actions
09 Risk Management ISO 14971 processes
10 Regulatory Affairs Submissions, compliance

Numbering Workflow

  1. Author requests document number from Document Control
  2. Document Control verifies category and assigns next sequence number
  3. Document number recorded in Document Master List
  4. Author creates document using assigned number
  5. Validation: Number format matches standard; no duplicates exist

Document Lifecycle

Lifecycle Stages

DRAFT → REVIEW → APPROVED → EFFECTIVE → SUPERSEDED → OBSOLETE
  │        │         │          │            │           │
  │        │         │          │            │           └── Archived/Destroyed
  │        │         │          │            └── New revision effective
  │        │         │          └── Training complete, distribution done
  │        │         └── All approvals obtained
  │        └── Under review/revision
  └── Initial creation

Stage Definitions

Stage Definition Actions Required
Draft Document under creation or revision Author editing, not for use
Review Circulated for review and comment Reviewers provide feedback
Approved All required signatures obtained Ready for training/distribution
Effective Training complete, document released Available for use
Superseded Replaced by newer revision Remove from active use
Obsolete No longer applicable Archive per retention schedule

Document Status Indicators

Status Indicator Location
Draft "DRAFT" watermark Header or footer
Approved Approval signatures with dates Signature page
Effective Effective date Header
Obsolete "OBSOLETE" stamp Across all pages

Review and Approval Workflow

Document Review Workflow

  1. Author completes document draft
  2. Author submits for review via DMS or routing form
  3. Reviewers assigned based on document type and content
  4. Reviewers provide comments within review period (typically 5-10 business days)
  5. Author addresses comments and documents responses
  6. Author resubmits for approval
  7. Approvers sign and date
  8. Validation: All required reviewers completed; all comments addressed

Required Reviewers by Document Type

Document Type Required Reviewers Required Approvers
SOP Process Owner, QA QA Manager, Process Owner
WI Area Supervisor, QA Area Manager
SPEC Engineering, QA Engineering Manager, QA
TF Process Owner QA
POL Department Heads Management Representative
Design Documents Design Team, QA Design Control Authority

Approval Matrix

APPROVAL AUTHORITY MATRIX

Document Level 1 (Policy): CEO or delegate + QA Manager
Document Level 2 (SOP): Department Manager + QA Manager
Document Level 3 (WI/TF): Area Supervisor + QA Representative

Regulatory Submissions: RA Manager + QA Manager + Technical Expert
Design Documents: Design Authority + QA Manager

Review Comment Template

REVIEW COMMENT LOG

Document: [Document Number and Title]
Reviewer: [Name, Role]
Review Date: [Date]

| Section | Line/Para | Comment | Disposition | Response |
|---------|-----------|---------|-------------|----------|
| [Ref] | [Location] | [Issue/suggestion] | Accept/Reject/Modify | [Explanation] |

Change Control Process

Change Request Workflow

  1. Identify need for document change
  2. Complete Change Request Form (CRF)
  3. Submit CRF to Document Control
  4. Document Control assigns change number
  5. Route to reviewers for impact assessment
  6. Obtain approvals based on change classification
  7. Author implements approved changes
  8. Validation: Changes match approved scope; version number incremented

Change Classification

Class Definition Approval Level Examples
Administrative No impact on content meaning Document Control Typos, formatting, references
Minor Limited content change, no process impact Process Owner + QA Clarifications, minor additions
Major Significant content change, process impact Full review cycle New requirements, process changes
Emergency Urgent change required for safety/compliance Expedited approval + retrospective review Safety issues, regulatory mandates

Change Impact Assessment

Impact Area Assessment Questions
Training Does change require retraining? Who?
Equipment Does change affect equipment or systems?
Validation Does change require revalidation?
Regulatory Does change affect regulatory filings?
Other Documents Which related documents need updating?
Records What records are affected?

Version Control Rules

Change Type Version Increment Example
Major revision Increment revision number Rev 01 → Rev 02
Minor revision Increment sub-revision Rev 01 → Rev 01.1
Administrative No version change (or sub-increment) Rev 01 → Rev 01a
Draft iterations Use draft version Draft 1, Draft 2

Change History Template

DOCUMENT CHANGE HISTORY

| Revision | Date | Description of Change | Author | Approver |
|----------|------|----------------------|--------|----------|
| 01 | YYYY-MM-DD | Initial release | [Name] | [Name] |
| 02 | YYYY-MM-DD | [Change description] | [Name] | [Name] |

Distribution and Access Control

Distribution Methods

Method Use Case Control Mechanism
Electronic (DMS) Primary method Access permissions
Controlled Print Manufacturing floor Signature log
Uncontrolled Copy External distribution Watermark "UNCONTROLLED"
Reference Copy Training/archive Watermark "REFERENCE ONLY"

Access Permission Levels

Level Permissions Typical Roles
Read View documents only General users
Print View and print controlled copies Area supervisors
Review View, print, add comments Reviewers
Author Create, edit drafts Document authors
Approve Approve documents Approvers
Admin Full system access Document Control

Controlled Print Log

CONTROLLED PRINT LOG

Document: [Document Number]
Revision: [Revision Number]

| Copy # | Location | Issued To | Date Issued | Date Returned | Signature |
|--------|----------|-----------|-------------|---------------|-----------|
| 001 | Production Area 1 | [Name] | [Date] | [Date] | [Sig] |
| 002 | QC Lab | [Name] | [Date] | [Date] | [Sig] |

Obsolete Document Control

  1. Mark document as "OBSOLETE" in DMS
  2. Notify copy holders of obsolescence
  3. Collect and destroy controlled prints
  4. Update Document Master List
  5. Archive master copy per retention schedule
  6. Validation: No obsolete copies remain in active use areas

Record Retention

Retention Periods

Record Type Retention Period Basis
Device Master Record (DMR) Life of device + 2 years 21 CFR 820.181
Device History Record (DHR) Life of device + 2 years 21 CFR 820.184
Design History File (DHF) Life of device + 2 years 21 CFR 820.30
Quality Records 2 years beyond device discontinuation ISO 13485
Training Records Duration of employment + 3 years Best practice
Audit Records 7 years Best practice
Complaint Records Life of device + 2 years 21 CFR 820.198
CAPA Records 7 years Best practice
Calibration Records 2 years beyond equipment disposal Best practice
Supplier Records Life of relationship + 3 years Best practice

Archive Requirements

Requirement Specification
Storage Conditions Temperature 15-25°C, RH 30-60%
Access Control Restricted to authorized personnel
Indexing Searchable by document number, date, type
Media Original format or validated conversion
Backup Offsite backup for electronic records
Integrity Checks Periodic verification of record legibility

Disposal Procedure

  1. Verify retention period has expired
  2. Check for legal holds or ongoing litigation
  3. Obtain disposal authorization
  4. Execute secure destruction (shred paper, wipe electronic)
  5. Document disposal in Disposal Log
  6. Validation: No premature disposal; disposal documented

Disposal Log Template

RECORD DISPOSAL LOG

| Document/Record ID | Description | Retention Expired | Disposal Date | Method | Witness |
|--------------------|-------------|-------------------|---------------|--------|---------|
| [ID] | [Description] | [Date] | [Date] | Shred/Wipe | [Name] |

Document Master List

Master List Content

Field Description Required
Document Number Unique identifier Yes
Title Document title Yes
Current Revision Active revision number Yes
Effective Date Date document became effective Yes
Status Draft/Effective/Obsolete Yes
Process Owner Responsible party Yes
Review Date Next scheduled review Yes
Category Functional area Yes
Storage Location Physical or electronic location Yes

Master List Maintenance

  • Update within 24 hours of document status change
  • Review quarterly for accuracy
  • Audit annually for completeness
  • Archive historical versions

Sample Master List Entry

| Doc # | Title | Rev | Eff Date | Status | Owner | Review Date |
|-------|-------|-----|----------|--------|-------|-------------|
| SOP-02-001 | Document Control | 03 | 2024-01-15 | Effective | QA Mgr | 2025-01-15 |
| WI-06-012 | Assembly Line Setup | 02 | 2024-03-01 | Effective | Prod Mgr | 2025-03-01 |
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