Work Instructions vs. SOPs
It is important for organizations to invest in good Standard Operating Procedures (SOPs) and Work Instructions (sometimes referred to a Standard Work) in addition to Company Policies. These two types of documentation requirements (along with Policies, Procedures and Protocol) make up the basis for well-established and consistent operations. Both SOPs and Work Instructions play a significant role in supporting manufacturing and process engineering systems. However, while being closely related, they serve very different purposes.
How Do Processes, Procedures and Work Instructions Relate to One Another?
The SOP basically defines "what" is to be done and the Work Instruction describes "How" it is to be done.
SOP: Standard Operating Procedures are the detail for the company Policies. A good SOP will describe the overall purpose, scope and general requirements for a given process, procedure, or task. It should include the established environmental, health and safety requirements, and list all the procedures and regulations to be executed. It usually includes supporting references, terms and definitions, and the contact person along with the document revision history.
Work Instruction (WIs): The standard work instruction details the specific procedures with all steps clearly defined. It usually includes graphic details, step actions tables, and any sub-procedures to be followed. The main purpose of the Work Instruction is to walk the user through each step in each procedure with enough detail (graphics, tables, screens, etc.) to allow user to complete the task.
Since both SOPs and WIs are critical to operational execution, ExpressTrain (with SOP Express) support both types of content documents, along with the checklists, quick reference cards and user guides to facilitate easy and effective implementation.
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When Are Work Instructions Needed?
Standard Work Instructions can be a significant aid for proper implementation of critical procedures in almost any operation to meet operational requirements. Work Instructions are an integral part of any manufacturing, process engineering or product development system.
Work Instructions can be used in manufacturing equipment operation, including start-up, calibration, normal operations, shut down and downtime maintenance.
The step-actions in the Standard Work should be made available to employees as both document job aids and digital job aids giving step level detail for each type of work task. This will allow for more rapid implantation and onboarding of new employees and cross training of limited available staff.
When Are SOPs Needed?
The use of Standard Operation Procedures (SOPs) is the first level of operational support. The formal SOPs should interact with, and be tied to, the overall business requirements to make sure the business process flow is consistent with the operational process.
For any establishment (or start-up) business, the SOPs need to have the detailed instruction authored by the engineers, managers, and technical staff most familiar with best practices in manufacturing, process engineering, and project management. These typically include Finance, Oppressions, Quality Assurance, Engineering, Maintenance, and Project/Product Management.
More Aspects of SOPs vs. Work Instructions
A well-constructed Standard Operating Procedure and Work Instruction identifies:
- What we do by WHOM
- Where it takes place
- When it happens
- How the work has to been performed and why
The SOP:
- Shows how to accomplish a specific task within a process with very detailed directions.
- Orchestrates the work, method, with guidance.
- Can respond to 1 or more procedures.
- Focuses on the instructions of 1 task or only 1 business unit.
- Identifies one or more roles.
- Explains how to do the task.
A well-constructed Work Instruction gets to the details of how it is done.
- Includes all the detail of all the steps to follow in an activity.
- Provides the workflow model at a high level.
- Documents with both narrative and images, usually in the form of use cases and workflow diagrams
- Explains step by step the instructions that must be carried out in an activity.
Quality Management Systems require well-structured SOPs and supporting Standard Work Instructions
All companies involved in industries with government or industry regulations need well defined Policies, Standard Operating Procedures and Standard Work Instructions to meet regulatory compliance. The Quality Manager needs to define the Quality Management System for the regulated entity. The QMS is usually the defining standard for all Quality related issues. The Quality Standard, Review and Approval Cycle, Document History and Versioning are all critical components of the QMS.
SOP Express has helped startup companies in the Life Science, Pharmaceutical and Healthcare industries create, document, control and implement QMS Guides.
If the quality procedures and services are organized properly and made available on-demand to employees, companies can drastically reduce the risk of citations in quality audits, thus reducing risk and improving quality and maintaining regulatory compliance at the same time.
Training, often last to develop, may be the most important asset.
Training is often the last consideration for implementing Standard Opiating Procedures and Standard Work Instructions across the board in an attempt to support consistent operations. It is, however, the most important component and requires extra attention and necessary investment if the organization intends to implement the SOPs to be consistent, concurrent, and compliant.
Process and Procedure training cut across the organization. These usually involve safety training, and the development of work instruction training aids.
The goal is to make sure all employees are fully trained, and task qualified in all critical, dangerous, costly or time-consuming procedure tasks. A mature company will invest in the development of a full set of training and performance support materials to make sure that the employee has access to the proper information in the proper format at the proper time (and is trained on how to utilize this information effectively).