1.2 Documentation Control & Data Integrity

TheDocumentation validityis ofnot aadministrative manufacturingoverhead; processit relies entirely onis the integrityfrozen ofengineering its documentation.intent. If a workproduction instructionline operates on Rev A instructions while Rev B is obsolete,released, the product produced under itresult is technically100% non-conforming, regardlessyield of itsnon-conforming physicalproduct. quality.Data Thisintegrity sectionensures establishesthat thewhat hierarchywe ofthink datawe governancebuilt is what we actually built. Without it, traceability is a myth and theliability strictis protocols for document lifecycle management (ALCOA+ principles).absolute.

The Documentation Hierarchy (Architecture of Truth)

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

• Level 1 (QualityThe Manual)Constitution): TheQuality "Constitutional"Manual. documentDefines defining the scope, exclusions (e.g., "Design" if the shop is build-to-print),Scope and policy commitments.Policy.
• Level 2 (Procedures/SOPs)The Logic): Cross-functionalSOPs. logic definingDefine whoWho doeshands off to whatWhom and when. (e.g., "Purchasing Procedure" defines the handoff between Supply Chain and-> IQC).
• Level 3 (WorkThe Instructions)Action): Task-specific,Work visualInstructions (WI). Visual, step-by-step guides definingfor howHow a task is performedphysically at the workstation. (e.g., "Operating SMT Pick & Place Machine #4").performed.
• Level 4 (Records)The Evidence): Records. Immutable evidencesnapshots of results.reality (e.g., ReflowTorque Profile Logs, Torquevalues, Test Reports, Calibration Certificates)logs).

Control ProtocolsLogic & ALCOA+

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

Lifecycle Rules:

• Approval & Release:IF Documentsa document guides a physical action -> THEN it must undergobe reviewaccessible byat authorizedthe personnelspecific Point of Use (Engineering,e.g., Quality,monitor Operations)above priorthe to release.station).
• Revision Control:IF Aa "Redline"new processrevision is released -> THEN the previous version becomes Obsolete immediately. Automated systems must tracklock changes between versions. The system must ensure that obsolete documents are technically impossibleaccess to accessold onversions theto productionprevent floor."Ghost Builds."
• Record Retention Policy:
  • Commercial (Class 2):IF Typicallya 3-7record years.is created ->
  • Medical (Class 3):THEN Lifetimeit must be Contemporaneous (recorded at the exact moment of the deviceevent).
    • 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, or as specified by regulationYears (often >15 years). Records must remain legible, readily identifiable, and retrievable throughout this period.
• IF Record is digital -> THEN Verify backup integrity Quarterly. A backup that cannot be restored is zero data.

Final Checklist

DocumentControl TypePoint	ControlCritical MethodRequirement	RetentionNon-Negotiable StandardRule
WorkPoint Instructionsof Use	VersionInstructions Controlledvisible /to Digital Displayoperator.	CurrentNo Revision"drawer" Onlydocuments.
QualityRevision RecordsSync	ImmutableFloor (Read-Only)matches /Engineering Backed UpMaster.	DeviceOld LifeRev += 2Immediate YearsLine (Medical)Stop.
ObsoleteData DocsEntry	WatermarkedAttributable /(Who) Removed+ Time Stamped.	SegregatedNo Archiveshared logins/passwords.
External StandardsCorrections	MonitoringSingle forcross-out Updates+ (e.g.,Initials.	NO IPCWhite-out revs)/ Erasures.
Backup	Off-site redundancy.	Subscription"Corrupted /file" Libraryis Accessnot a defense.