Work instructions specify the actions required to carry out an operation. These documents shall be created for all employees having responsibilities for the operation of processes that impact conformity to product requirements e.g. manufacturing operations including rework and repair, inspection, calibration, maintenance, logistics etc.
These instructions shall be accessible for use at the work station and shall be in a format and language that is easily understandable by the operators.
These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process, and shall be continuously improved through feedback from the operators.
Suppliers shall describe the best operation method with which they can keep the quality, delivery, cost, and also safety.
Minimum Content Requirements
Each work instruction shall include:
Operation number
Operation description
Main steps required to complete the operation
Key points/ Care points and reasons for them
Inspection requirements, inspection criteria and reaction instructions
Identification of Special Characteristics and Key Features.
Reference number, authorization signature & date
The use of photographs/ sketches to support explanations is recommended.
The supplier must ensure consistency throughout all documentation for:
Operation step numbering
Product characteristic identification.
For rules related to document submission, refer to the Submission Rules page.