2.3 The "Written Culture" & Documentation

The Written Culture is the cornerstone of traceability, knowledge management, and operational scalability. In a high-reliability manufacturing environment, reliance on tribal knowledge (information existing only in people's heads) is a critical point of failure. It cannot be audited, it cannot be replicated across sites, and it disappears when personnel leave. Documentation is not an administrative burden; it is the primary engineering artifact that proves the process is under control.

The "Single Source of Truth" Mandate

The organization operates on a binary principle regarding validity: "If it is not in the authorized system, it did not happen." This is mandatory for ISO 9001 compliance, product liability defense, and root cause analysis.

Defining the Locations of Truth

To prevent information fragmentation, the location of authoritative knowledge is fixed into three distinct systems. Information stored outside these systems (e.g., in email, local spreadsheets, or chat logs) is considered non-existent.

Documentation Standards

Documentation must be actionable and retrievable. Writing "notes" is insufficient; creating structured assets is the requirement.

Completeness and Rationale

• Design Rationale: It is not enough to document what was decided; the why must also be recorded. Design reviews must capture the rationale behind critical component selection or process parameters.
• Risk and Failure: All Risk Assessments (FMEA) and Failure Analyses (RCA) are mandatory documentation. A fix implemented without a documented RCA is considered a temporary patch, not a solution.
• Meeting Output: Decisions made in synchronous meetings must be immediately transcribed into the Project Tracking System as actionable tasks.

Accessibility and Searchability

• Centralization: Documentation must be centralized in a cloud-accessible, searchable repository. Storing process-critical data on local hard drives or personal file shares is prohibited.
• Indexing: Documents must be titled and tagged using standard nomenclature to ensure they are retrievable by any engineer in the future.

The "Living Document" Principle

• Revision Control: Documentation is valid only if it reflects the current reality. When a physical process changes (e.g., a new torque setting), the corresponding documentation (WI) must be updated simultaneously.
• Obsolescence: The presence of obsolete procedures on the shop floor is a critical quality failure. Old revisions must be archived and digitally locked.

The "No Verbal Orders" Protocol

Verbal instructions regarding engineering changes, quality waivers, or process deviations are invalid.

• Mandate: Any direction to deviate from the established standard must be issued in writing via the Change Management System (ECN) or the Project Tracking System.
• Protection: This protocol protects the operator and the engineer by creating an unalterable audit trail of who authorized the deviation and why.

Final Checklist