1.2 Documentation Control & Data Integrity

Documentation is not administrative overhead; it is the frozen engineering intent. If a production line operates on Rev A instructions while Rev B is released, the result is 100% yield of non-conforming product. Data integrity ensures that what we think we built is what we actually built. Without it, traceability is a myth and liability is absolute.

The Documentation Hierarchy (Architecture of Truth)

The QMS structure dictates the resolution of instructions. Do not mix policy with work steps.

• Level 1 (The Constitution): Quality Manual. Defines Scope and Policy.
• Level 2 (The Logic): SOPs. Define Who hands off to Whom (e.g., Purchasing -> IQC).
• Level 3 (The Action): Work Instructions (WI). Visual, step-by-step guides for How a task is physically performed.
• Level 4 (The Evidence): Records. Immutable snapshots of reality (e.g., Torque values, Test logs).

Control Logic & ALCOA+

We apply the FDA's ALCOA+ framework not just for compliance, but to ensure data relies on physics, not memory.

Lifecycle Rules:

• IF a document guides a physical action -> THEN it must be accessible at the specific Point of Use (e.g., monitor above the station).
• IF a new revision is released -> THEN the previous version becomes Obsolete immediately. Automated systems must lock access to old versions to prevent "Ghost Builds."
• IF a record is created -> THEN it must be Contemporaneous (recorded at the exact moment of the event).

Pro-Tip: Never allow "Batch Signing" at the end of a shift. It destroys the legal standing of the data and invites recall risk.

Correction Protocol:

• IF a manual record requires correction -> THEN use a single strikethrough (~~Error~~), write the correct value, and initial/date it.
• IF white-out or erasure is detected -> THEN the record is Void and treated as missing data.

Retention & Archiving

Storage cost is negligible; the cost of missing evidence during a liability suit is infinite.

Retention Decision Matrix:

• IF Product is Consumer/Commercial -> THEN Retain records for 3 – 5 Years (or Product Life + 1).
• IF Product is Medical/Automotive/Aerospace -> THEN Retain records for Lifetime of Device + 2 Years (often >15 years).
• IF Record is digital -> THEN Verify backup integrity Quarterly. A backup that cannot be restored is zero data.

Final Checklist