Imagine a pharmaceutical company that is going to hire an employee for the drug production line. This new employee must undergo a series of training to be able to carry out his activities and help in the production of batches of homogeneous medicines. As much as he has experience in the role, a new company means new rules, new equipment, new formulas, etc.
So what is the correct way to train him?
Relying solely on the transfer of knowledge from an older employee to a new one is a flawed way to pass it on. In addition to being transmitted defects, there is also the possibility of forgetting some essential parts of the process. For the training activity, as well as many others that occur in companies, standard documents are used.
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What is Standard Operating Procedure (SOP)?
The standard operating procedure (SOP) is a document that formalizes the tasks within an organization, relating them to those responsible and the resources used at each stage. Therefore, it brings the identification of the data of “who”, “what” and “when” all phases of the operations are carried out.
The SOP broadly presents this information and generally with a more technical language, according to the words and terms of legislation and standard standards.
The types of SOPs
Standard Operating Procedures (SOPs) are widely used to ensure quality and compliance in various industries. Precisely for this reason, there are many types of SOPs. They can be classified into a few main categories, which you know below:
Production SOPs
Operating Procedures are usually focused on creating a step-by-step guide on how to operate machines, operate equipment or use systems and other tools in the right way, ensuring the efficiency of the operation.
Assembly procedures
They bring instructions to assemble products or systems correctly, avoiding errors or failures that hinder the efficiency of the operation.
Inspection procedures
These are SOPs linked to the guidelines for inspection and quality control during the activities that involve the production of a company. This includes scanning that organization’s machines.
Security SOPs
This type of Standard Operating Procedure is linked to Occupational Safety. In this way, it brings instructions on how to operate safely, minimizing risks and protecting everyone. They are usually linked to Production SOPs.
Emergency procedures
They include the plans and actions to be followed in case of emergencies, such as fires, accidents or exposure to hazardous/radioactive elements.
Maintenance SOPs
These are the Preventive Maintenance Procedures, which provide guidelines to carry out regular maintenance of all devices and thus avoid failures.
Corrective maintenance procedures
When maintenance does not occur correctly or the devices are used incorrectly, it is necessary to adopt Corrective Maintenance SOPs, which show how to repair all this.
Quality SOPs
These are the Quality Control Procedures that include the guidelines to ensure that products/services meet the established quality standards. It applies both to internal and to those created by regulatory entities.
Administrative SOPs: document management procedures
They are usually linked to document management procedures and organization of demands of a company’s internal management.
Customer Service Procedures
They bring guidelines to ensure quality in customer service, as well as measures to deal with problems and resolve doubts brought by them.
Information Technology and Information Security SOPs
Increasingly important, these SOPs aggregate the measures created to store, manage, and restore (when necessary) information and data. In addition, it also includes procedures to protect data and systems from threats.
It is worth remembering that these are just some of the Standard Operating Procedures that a company can use in its operation. In addition to considering what is on this list, also use those specific according to your needs, internal processes, and legislation in the sector in which you operate.
The important thing is that all SOPs meet the objective of ensuring that all those involved follow a uniform standard of action that drives efficiency, safety and quality.
What is Work Instruction (WI)?
Together with the SOP, the Work Instructions (WI) are prepared and attached. These are documents that, in addition to mentioning the activities and those responsible, bring greater detail to the tasks, including issues such as mode and time of execution. In other words, ITs show “how” the activities are carried out.
Based on a user manual, the work instructions must have a simple language and be written through an uncomplicated step-by-step with information really necessary for the execution of the task. Images, photos and tables can be used to make it even easier for employees to understand.
Types of WI
Work Instructions ensure that tasks are performed correctly and consistently. Therefore, they are essential to ensure quality and efficiency in various areas and sectors. This variety is presented in the various types of WI.
Below you can learn more about the main types of Work Instructions. Check!
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Operational work instruction
- Details how to perform specific operations for an area or function. For example: operating machines, assembling products or performing daily activities.
- It often relies on step-by-step instructions to perform these operational tasks accurately.
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Safety work instruction
- It has guidelines designed to ensure that all people carry out their activities safely, minimizing risks.
- Its main element is usually Personal Protective Equipment (PPE), along with guidance on how to use it and other safety practices in the workplace.
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Maintenance work instruction
- Addresses preventive maintenance of problems/accidents. The steps include ways to perform regular maintenance of equipment and systems to avoid failures and extend their useful life.
- It can also include instructions for corrective maintenance, with repair procedures after a failure/breakdown.
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Quality work instruction
- It is linked to quality control. This WI lists the standards for inspection and verification of products/services to ensure compliance.
- In the step-by-step process, it usually includes sampling procedures to collect and test samples that will be analyzed taking into account the quality of the product.
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Administrative work instruction
- It brings the procedures for the management and organization of documents and other records.
- It is advisable to include guidelines for dealing with administrative tasks in a variety of areas, from customer service to recording employee information.
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IT (Information Technology) Work Instruction
- It is WI focused on the maintenance of information systems. It usually includes procedures for managing and maintaining systems, such as backups and updates.
- A point of attention that has been gaining strength is information security. Therefore, this IT can also include instructions to strengthen cybersecurity against threats.
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Formation and training instruction
- This WI is related to the training and qualification programs that a company may have. It includes guidelines for training new employees or updating skills for those who are already in the company.
- In addition, it also encompasses the methods of evaluating the performance of these people, as well as the effectiveness of training.
Learn more: How to implement continuous improvement in your organization
What is the difference between POP and WI?
Although they generally have similar structures, WIs and SOPs have different functions. First, within the documentation of the quality management system, the hierarchy between these documents is different. Below is an example of a level structure:
- Level 1 = Quality Assurance Manual: Starting point for goals, objectives, and responsibility.
- Level 2 = Procedures (SOPs): Interaction between departments/business units in terms of inputs/outputs.
- Level 3 = Work Instructions (WIs): Documents that define how work objectives are achieved.
- Level 4 = Records: Evidence of compliance.
Therefore, WIs are at a level below Procedures and the distinction between these documents is made by their use and their detailing. While the first is applied to operational activities and brings a wealth of details, SOPs are responsible for standardizing management processes, having the characteristic of being a system standard.
Both can be applied at all stages of the process and aim to make different people perform the same task uniformly. Regarding legislation, there is no difference between the two terms.
How to create a SOP and WI
Regardless of the business segment, companies need to have their documents and standards well defined. This allows routine tasks to be performed safely, in compliance with regulations, and consistently, regardless of who is responsible for them.
Although there is no official document that guides on how to prepare these records, there are good practices that can be followed to plan an effective standardization model. Get to know them below:
- List all the activities and processes that will be documented;
- Ask for help from the employees who participate in that process/activity to prepare a document that has a wealth of details and that reflects reality;
- Go to meet the exercise of the activity to have the most real foundation possible;
- Make sure which audience will use the documents to choose the best form of writing;
- Whenever possible, use tables, flowcharts, images and photos to illustrate and facilitate understanding;
- Always keep documents updated and employees trained on each new revision;
- Use references, especially in SOPs, when applicable;
- Check if there is any procedure or instruction that requires the citation of any specific information from standards or legislation;
- When necessary, associate procedures, processes, work instructions and records throughout the document;
- Make documents easily accessible to the public that needs access to them.
Conclusion
Now you know what standard operating procedures and work Instructions are, their benefits, and how to prepare both documents to improve the efficiency of your operation.
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