8.2 Documentation Control & Data Integrity

The validity of a manufacturing process relies entirely on the integrity of its documentation. If a work instruction is obsolete, the product produced under it is technically non-conforming, regardless of its physical quality. This section establishes the hierarchy of data governance and the strict protocols for document lifecycle management (ALCOA+ principles).

8.2.1 The Documentation Hierarchy

• Level 1 (Quality Manual): The "Constitutional" document defining the scope, exclusions (e.g., "Design" if the shop is build-to-print), and policy commitments.
• Level 2 (Procedures/SOPs): Cross-functional logic defining who does what and when. (e.g., "Purchasing Procedure" defines the handoff between Supply Chain and IQC).
• Level 3 (Work Instructions): Task-specific, visual guides defining how a task is performed at the workstation. (e.g., "Operating SMT Pick & Place Machine #4").
• Level 4 (Records): Immutable evidence of results. (e.g., Reflow Profile Logs, Torque Test Reports, Calibration Certificates).

8.2.2 Control Protocols

• Approval & Release: Documents must undergo review by authorized personnel (Engineering, Quality, Operations) prior to release.
• Revision Control: A "Redline" process must track changes between versions. The system must ensure that obsolete documents are technically impossible to access on the production floor.
• Record Retention Policy:
  • Commercial (Class 2): Typically 3-7 years.
  • Medical (Class 3): Lifetime of the device + 2 years, or as specified by regulation (often >15 years). Records must remain legible, readily identifiable, and retrievable throughout this period.

Final Checklist