Work Instruction

‍Work Instructions are detailed, prescriptive documents used in a Quality Management System (QMS) that provide specific guidance on how to perform tasks, operating at a lower level of the documentation hierarchy than overall procedures.

A Work Instruction is a specific document or description of activities that focuses on details of activities that need to be realized, including the sequencing of steps, the specific tools and methods to be used, and the required accuracy. They are practical, detailed guides intended to ensure consistency in the execution of specific tasks, particularly within production and service provision.

Work instructions are a key component of the documentation hierarchy in a Quality Management System, especially for organizations aiming to comply with standards like ISO 9001.

Hierarchy within the QMS Documentation Structure

In the traditional approach to QMS documentation, work instructions sit near the bottom of the hierarchy, detailing the actions necessary to implement higher-level plans and procedures:

• Relationship to Procedures: Work instructions can be part of a procedure, or they can be referenced from a procedure.
• Level of Detail: While procedures describe what steps and activities are to be followed in performing a process, work instructions focus on the minutiae of how those activities must be performed.
• Traditional Hierarchy: The conventional QMS documentation structure flows downwards, typically placing work instructions immediately below procedures: Quality Policy $\rightarrow$ Quality Manual $\rightarrow$ Procedures $\rightarrow$ Work Instructions $\rightarrow$ Records and Forms.

Required Content and Structure

Work instructions generally share a structure similar to procedures, but the focus is sharply on execution detail:

• Focus on Detail: They specifically cover the details of activities, focusing on the sequencing of the steps, the tools and methods to be used, and the required accuracy.
• Common Elements: Work instructions should generally include elements such as a title, purpose, scope, responsibilities, definitions, a description of the activities, and document control information.
• Format Flexibility: Procedures and work instructions can take different formats, such as narrative text, tables, flow charts, or illustrative imagery (like photos).

Application in Production and Process Control

In regulated environments, documented instructions, such as work instructions, are essential for maintaining control over manufacturing processes:

• Controlling Production: In the manufacture of devices, regulatory requirements state that process controls must include documented instructions, standard operating procedures (SOPs), and methods that define and control the manner of production.
• Consistency: The primary purpose of documenting these instructions is to ensure that critical processes are performed consistently, minimizing variation regardless of who performs the task.

Relationship to Personnel and Training

The need for highly detailed work instructions can be inversely proportional to the competence and training of personnel:

Training Impact: Training personnel and relying on competent personnel can reduce the need for highly detailed work instructions.

Personnel Insight: It is critical to involve the people who actually perform the work when developing work instructions (or SOPs) because their insights are invaluable for creating procedures that are both practical and effective.

Analogy for Understanding Work Instructions

If the entire Quality Management System (QMS) is like a company's comprehensive vehicle owner's manual, the Work Instruction is the specific, highly detailed diagram in the engine section that explains exactly how to adjust the spark plug gap using tool X and measuring device Y.

The high-level procedure might say, "Perform routine engine tuning." Still, the work instruction provides the detailed steps, tool requirements, and exact measurements needed to execute that single, specific task accurately and consistently, ensuring that the critical step is never left to interpretation.

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