Section 89 of 103
88. Manufacturing Process, Route and Work Instruction
Stable section ID: S05-CON-015-SECTION-89 · 17 content blocks
A Manufacturing Process is a controlled transformation or activity that changes, creates, treats, joins, verifies, or preserves a Product or material.
A Manufacturing Route is the authorized sequence of Processes, resources, inspections, transfers, and decision points through which a Product is produced.
A Work Instruction is the detailed human- or machine-readable direction for performing a specific activity within the Route.
A Work Instruction may define:
required inputs and prerequisites;
equipment, tooling, and software;
setup and calibration;
processing parameters;
safety precautions;
execution sequence;
in-process inspection;
acceptance and rejection criteria;
required records;
response to abnormal conditions.
The Process defines what transformation is controlled. The Route defines when and where controlled activities occur. The Work Instruction defines how a particular activity is executed.
Each shall possess an applicable identity, version, authority, and effective status.
An operator or robot shall not improvise beyond permitted process limits. Departures shall be recorded as deviations and evaluated before the affected Product is released.